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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_____________________________________________________
FORM 10-Q
_____________________________________________________
xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2024
or
oTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number 001-39321
_____________________________________________________
Avidity Biosciences, Inc.
(Exact name of registrant as specified in its charter)
_____________________________________________________
Delaware46-1336960
(State or other jurisdiction of
incorporation or organization)
(IRS Employer
Identification No.)
10578 Science Center Drive, Suite 125
San Diego, California
92121
(Address of principal executive offices)(Zip Code)
(858) 401-7900
(Registrant’s telephone number, including area code)
_____________________________________________________
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.0001 par valueRNAThe Nasdaq Global Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filerxAccelerated filero
Non-accelerated fileroSmaller reporting companyo
Emerging growth companyo
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x
As of July 22, 2024, the registrant had 109,801,397 shares of common stock outstanding.


Avidity Biosciences, Inc.
FORM 10-Q
TABLE OF CONTENTS
2

PART I - FINANCIAL INFORMATION
Item 1. Condensed Financial Statements (unaudited)
Avidity Biosciences, Inc.
Condensed Balance Sheets
(in thousands, except par value)
June 30,
2024
December 31,
2023
(unaudited)
Assets
Current assets:
Cash and cash equivalents$575,751 $185,082 
Marketable securities723,295 410,269 
Prepaid and other assets29,755 15,956 
Total current assets1,328,801 611,307 
Property and equipment, net8,498 8,381 
Restricted cash2,795 295 
Right-of-use assets6,967 8,271 
Other assets364 301 
Total assets$1,347,425 $628,555 
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable and accrued liabilities$40,924 $34,341 
Accrued compensation12,826 14,335 
Lease liabilities, current portion3,765 3,639 
Deferred revenue, current portion26,697 28,365 
Total current liabilities84,212 80,680 
Lease liabilities, net of current portion4,617 6,213 
Deferred revenue, net of current portion37,560 40,898 
Total liabilities126,389 127,791 
Commitments and contingencies (Note 7)
Stockholders’ equity:
Common stock, $0.0001 par value; authorized shares – 400,000; issued and outstanding shares 109,266 and 79,275 at June 30, 2024 and December 31, 2023, respectively
11 8 
Additional paid-in capital1,931,890 1,071,395 
Accumulated other comprehensive income (loss)(453)125 
Accumulated deficit(710,412)(570,764)
Total stockholders’ equity1,221,036 500,764 
Total liabilities and stockholders’ equity$1,347,425 $628,555 
See accompanying notes.
3

Avidity Biosciences, Inc.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
(unaudited)
Three Months Ended June 30,Six Months Ended June 30,
2024202320242023
Collaboration revenue$2,045 $2,316 $5,588 $4,549 
Operating expenses:
Research and development63,940 42,672 130,772 90,437 
General and administrative20,731 12,278 34,629 24,342 
Total operating expenses84,671 54,950 165,401 114,779 
Loss from operations(82,626)(52,634)(159,813)(110,230)
Other income (expense):
Interest income11,949 5,771 20,382 11,287 
Other expense(116)(162)(217)(476)
Total other income11,833 5,609 20,165 10,811 
Net loss$(70,793)$(47,025)$(139,648)$(99,419)
Net loss per share, basic and diluted$(0.65)$(0.66)$(1.44)$(1.40)
Weighted-average shares outstanding, basic and diluted106,92871,39097,07070,914
Other comprehensive income (loss):
Net unrealized gains (losses) on marketable securities11 (1,137)(578)32 
Comprehensive loss$(70,782)$(48,162)$(140,226)$(99,387)
See accompanying notes.
4

Avidity Biosciences, Inc.
Condensed Statements of Stockholders' Equity
(in thousands)
(unaudited)
Common StockAdditional
Paid-in
Capital
Accumulated
Other
Comprehensive
Income (Loss)
Accumulated
Deficit
Total
Stockholders’
Equity
SharesAmount
Balance at December 31, 202379,275$8 $1,071,395 $125 $(570,764)$500,764 
Issuance of common stock upon exercise of stock options541— 3,896 — — 3,896 
Issuance of common stock in public offering, net of issuance costs of $143
418— 5,594 — — 5,594 
Issuance of common stock in a private placement, net of issuance costs of $12,821
15,2252 238,386 — — 238,388 
Issuance of pre-funded warrants in a private placement, net of issuance costs of $7,605
— 141,395 — — 141,395 
Issuance of common stock in connection with vesting of restricted stock units135— — — — — 
Stock-based compensation— 10,306 — — 10,306 
Net loss— — — (68,855)(68,855)
Other comprehensive loss— — (589)— (589)
Balance at March 31, 202495,594$10 $1,470,972 $(464)$(639,619)$830,899 
Issuance of common stock upon exercise of stock options1,201— 14,308 — — 14,308 
Issuance of common stock in public offering, net of issuance costs of $28,263
12,1331 432,771 — — 432,772 
Issuance of common stock under Employee Stock Purchase Plan138— 1,027 — — 1,027 
Issuance of common stock in connection with vesting of restricted stock units200— — — — — 
Stock-based compensation— 12,812 — — 12,812 
Net loss— — — (70,793)(70,793)
Other comprehensive income— — 11 — 11 
Balance at June 30, 2024
109,266$11 $1,931,890 $(453)$(710,412)$1,221,036 
See accompanying notes.
5

Avidity Biosciences, Inc.
Condensed Statements of Stockholders' Equity
(in thousands)
(unaudited)
Common StockAdditional
Paid-in
Capital
Accumulated
Other
Comprehensive
Income (Loss)
Accumulated
Deficit
Total
Stockholders’
Equity
SharesAmount
Balance at December 31, 202269,768$7 $939,310 $(2,698)$(358,544)$578,075 
Issuance of common stock upon exercise of stock options102— 520 — — 520 
Issuance of common stock in public offering, net of issuance costs of $408
943— 22,441 — — 22,441 
Stock-based compensation— 9,104 — — 9,104 
Net loss— — — (52,394)(52,394)
Other comprehensive income— — 1,169 — 1,169 
Balance at March 31, 202370,813$7 $971,375 $(1,529)$(410,938)$558,915 
Issuance of common stock upon exercise of stock options12— 7 — — 7 
Issuance of common stock in public offering, net of issuance costs of $977
3,164— 38,106 — — 38,106 
Issuance of common stock under employee stock purchase plan81— 859 — — 859 
Stock-based compensation— 9,453 — — 9,453 
Net loss— — — (47,025)(47,025)
Other comprehensive loss— — — (1,137)— (1,137)
Balance at June 30, 202374,070$7 $1,019,800 $(2,666)$(457,963)$559,178 
See accompanying notes.

6

Avidity Biosciences, Inc.
Condensed Statements of Cash Flows
(in thousands)
(unaudited)
Six Months Ended June 30,
20242023
Cash flows from operating activities
Net loss$(139,648)$(99,419)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation1,328 920 
Stock-based compensation expense23,118 18,557 
Amortization of premiums and discounts on marketable securities, net(7,435)(5,071)
Non-cash operating lease costs1,652 1,420 
Changes in operating assets and liabilities:
Prepaid and other assets(12,112)(5,642)
Accounts payable and accrued liabilities6,047 (816)
Accrued compensation(1,509)(4,663)
Operating lease liabilities(1,819)(1,594)
Deferred revenue(5,006)(2,466)
Net cash used in operating activities(135,384)(98,774)
Cash flows from investing activities
Maturities of marketable securities207,930 128,215 
Purchases of marketable securities(514,100)(275,404)
Purchases of property and equipment(1,446)(2,442)
Net cash used in investing activities(307,616)(149,631)
Cash flows from financing activities
Proceeds from issuance of common stock in public offerings, net of issuance costs438,902 60,547 
Proceeds from issuance of common stock under employee incentive equity plans17,484 1,386 
Proceeds from the issuance of common stock in a private placement, net of issuance costs238,388  
Proceeds from issuance of pre-funded warrants in a private placement, net of issuance costs141,395  
Net cash provided by financing activities836,169 61,933 
Net increase (decrease) in cash, cash equivalents and restricted cash393,169 (186,472)
Cash, cash equivalents and restricted cash at beginning of period185,377 340,647 
Cash, cash equivalents and restricted cash at end of period$578,546 $154,175 
Supplemental schedule of noncash investing and financing activities:
Costs incurred, but not paid, in connection with deferred financing costs included in accounts payable and accrued liabilities$536 $ 
Receivables from stock option exercises included in prepaid and other assets$1,747 $ 
See accompanying notes.
7

Avidity Biosciences, Inc.
Notes to Unaudited Condensed Financial Statements
1.    Description of Business and Basis of Presentation
Description of Business
Avidity Biosciences, Inc. (the Company or Avidity) is a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs). The Company’s proprietary AOC platform is designed to combine the specificity of monoclonal antibodies with the precision of RNA therapeutics to target the root cause of diseases previously untreatable with such therapeutics.
Liquidity
To date, the Company has devoted substantially all of its resources to organizing and staffing the Company, business planning, raising capital, developing its proprietary AOC platform, identifying potential product candidates, establishing its intellectual property portfolio, conducting research, preclinical and clinical studies, and providing other general and administrative support for these operations. In addition, the Company has a limited operating history, has incurred operating losses since inception and expects that it will continue to incur net losses into the foreseeable future as it continues the development of its product candidates and development programs. As of June 30, 2024, the Company had an accumulated deficit of $710.4 million and cash, cash equivalents and marketable securities of $1.3 billion.
The Company believes that existing cash, cash equivalents and marketable securities will be sufficient to fund the Company’s operations for at least 12 months from the date of the filing of this Form 10-Q. The Company plans to finance its future cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other arrangements. If the Company is not able to secure adequate additional funding, it may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or delay or reduce the scope of its planned development programs. Any of these actions could materially harm the Company’s business, results of operations and future prospects.
Basis of Presentation
The accompanying unaudited interim condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and the rules and regulations of the Securities and Exchange Commission (SEC) related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The unaudited interim condensed financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The operating results presented in these unaudited interim condensed financial statements are not necessarily indicative of the results that may be expected for any future periods. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2023 included in the Company’s annual report on Form 10-K filed with the SEC on February 28, 2024.
In December 2023, the Company formed Avidity Biosciences Ireland Limited, a wholly-owned subsidiary (the Subsidiary). There were no operations in, nor assets and liabilities held by, the Subsidiary in any of the periods presented.
8

2.    Summary of Significant Accounting Policies
Use of Estimates
The Company’s condensed financial statements are prepared in accordance with GAAP, which requires the Company to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the condensed financial statements and accompanying notes. The most significant estimates in the Company’s condensed financial statements relate to revenue recognition, stock-based compensation, and accrued research and development costs. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions.
Summary of Significant Accounting Policies
The Company’s significant accounting policies are discussed in “Note 2 – Summary of Significant Accounting Policies” of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the SEC on February 28, 2024. There have been no significant changes to these policies during the six months ended June 30, 2024.
Net Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period, adjusted for the weighted-average number of common shares outstanding that are subject to repurchase or forfeiture. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the common stock equivalent securities would be anti-dilutive. The pre-funded common stock warrants are included in the calculation of basic and diluted net loss per share as the exercise price of $0.001 per share is not substantive and the shares are issuable for little or no consideration.
Common stock equivalent securities not included in the calculation of diluted net loss per share for the three and six month periods ended June 30, because to do so would be anti-dilutive, are as follows (in thousands):
June 30,
20242023
Common stock options12,72810,978
Restricted stock units1,526635
Performance stock units562
Employee Stock Purchase Plan shares pending issuance49
Total14,82011,622
Recently Issued Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (FASB) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which modifies the disclosure and presentation requirements of reportable segments. The amendments in the update require the disclosure of significant segment expenses that are regularly provided to the Chief Operating Decision Maker (CODM) and included within each reported measure of segment profit and loss. The amendments also require disclosure of all other segment items by reportable segment and a description of its composition. Additionally, the amendments require disclosure of the title and position of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. Lastly, the amendment requires that a public entity that has a single reportable segment provide all the disclosures required by ASU 2023-07 and all existing segment disclosures in Topic 280. This update is effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. ASU 2023-07 will be applied retrospectively and early adoption is permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its financial statements and accompanying notes.
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In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which enhances income tax disclosures, primarily through standardization and disaggregation of the income tax rate reconciliation and disaggregation of income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. ASU 2023-09 can be applied either prospectively or retrospectively and early adoption is permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its financial statements and accompanying notes.
3.    Fair Value Measurements
The following tables summarize the Company’s cash equivalents and marketable securities measured at fair value (in thousands):
Fair Value Measurements Using
As of June 30, 2024TotalQuoted Prices in
Active Markets
for Identical
Assets (Level 1)
Significant
Other
Observable
Inputs (Level 2)
Significant
Unobservable
Inputs
(Level 3)
Cash equivalents:
U.S. Treasury securities$10,962 $10,962 $ $ 
Marketable securities:
U.S. Treasury securities721,340 721,340   
Negotiable certificates of deposit1,955  1,955  
Total$734,257 $732,302 $1,955 $ 
Fair Value Measurements Using
As of December 31, 2023TotalQuoted Prices in
Active Markets
for Identical
Assets (Level 1)
Significant
Other
Observable
Inputs (Level 2)
Significant
Unobservable
Inputs
(Level 3)
Marketable securities:
U.S. Treasury securities$399,890 $399,890 $ $ 
U.S. Government agency securities4,998  4,998  
Negotiable certificates of deposit5,381  5,381  
Total$410,269 $399,890 $10,379 $ 
4.    Marketable Securities
The Company’s marketable securities, which consist of highly liquid marketable debt securities, are classified as available-for-sale and are stated at fair value. The following tables summarize the Company’s marketable securities (in thousands):
As of June 30, 2024Maturity
(in years)
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated
Fair Value
U.S. Treasury securities
1 or less
$613,201 $6 $(517)$612,690 
Negotiable certificates of deposit
1 or less
1,959  (4)1,955 
U.S. Treasury securities
1 - 2
108,588 62  108,650 
Total$723,748 $68 $(521)$723,295 
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As of December 31, 2023Maturity
(in years)
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated
Fair Value
U.S. Treasury securities
1 or less
$301,053 $102 $(530)$300,625 
U.S. Government agency securities
1 or less
5,000  (2)4,998 
Negotiable certificates of deposit
1 or less
4,410 1 (4)4,407 
U.S. Treasury securities
1 - 2
98,701 600 (36)99,265 
Negotiable certificates of deposit
1 - 2
980  (6)974 
Total$410,144 $703 $(578)$410,269 
The unrealized losses on the Company’s marketable securities were caused by interest rate increases and resulted in the decrease in market value of these securities. There were no allowances for credit losses at June 30, 2024 and December 31, 2023 because (i) the decline in fair value is attributable to changes in interest rates and not credit quality, (ii) the Company does not intend to sell the investments before maturity, and (iii) it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases.
The following table summarizes marketable securities in a continuous unrealized loss position for which an allowance for credit losses was not recorded (in thousands):
Less Than 12 Months
12 Months or Greater
Total
As of June 30, 2024
Fair Value
Unrealized Losses
Fair Value
Unrealized Losses
Fair Value
Unrealized Losses
U.S. Treasury securities$469,288 $(312)$74,471 $(205)$543,759 $(517)
Negotiable certificates of deposit734  1,221 (4)1,955 (4)
Total$470,022 $(312)$75,692 $(209)$545,714 $(521)
Less Than 12 Months
12 Months or Greater
Total
As of December 31, 2023
Fair Value
Unrealized Losses
Fair Value
Unrealized Losses
Fair Value
Unrealized Losses
U.S. Treasury securities$214,291 $(566)$ $ $214,291 $(566)
U.S. Government agency securities4,998 (2)  4,998 (2)
Negotiable certificates of deposit3,665 (10)  3,665 (10)
Total$222,954 $(578)$ $ $222,954 $(578)
Accrued interest receivable on available-for-sale securities was $4.1 million and $2.6 million at June 30, 2024 and December 31, 2023, respectively. The Company has not written off any accrued interest receivable for the six months ended June 30, 2024 and 2023.
5.    Collaboration, License and Research Agreements
Research Collaboration and License Agreement with Bristol Myers Squibb Company
In November 2023, the Company entered into a Research Collaboration and License Agreement (the BMS Collaboration Agreement) with Bristol Myers Squibb Company (BMS) to expand on its research with MyoKardia Inc. In connection with the BMS Collaboration Agreement, the Company recognized revenue of $2.0 million and $4.5 million for the three and six months ended June 30, 2024, respectively. There were no collaboration receivables related to the BMS Collaboration Agreement in any of the periods presented.
Research Collaboration and License Agreement with Eli Lilly and Company
In April 2019, the Company entered into a Research Collaboration and License Agreement (the Lilly Agreement) with Eli Lilly and Company (Lilly) for the discovery, development and commercialization of AOC
11

products directed against certain targets in immunology and other select indications on a worldwide basis. In connection with the Lilly Agreement, the Company recognized no revenue for the three months ended June 30, 2024 and $2.3 million for the three months ended June 30, 2023. The Company recognized revenue of $1.1 million and $4.5 million for the six months ended June 30, 2024 and 2023, respectively. There were no collaboration receivables related to the Lilly Agreement as of June 30, 2024 and $0.8 million collaboration receivables related to the Lilly Agreement as of December 31, 2023, which are included in prepaid and other assets on the condensed balance sheets. There was no deferred revenue related to the Lilly Agreement at June 30, 2024.
A reconciliation of the closing balance of deferred revenue related to the Company's research collaboration and license agreements for the six months ended June 30, 2024 and 2023 is as follows (in thousands):
Balance at December 31, 2023$69,263 
Revenue recognized that was included in the balance at the beginning of the period(2,961)
Balance at March 31, 2024$66,302 
Revenue recognized that was included in the balance at the beginning of the period(2,045)
Balance at June 30, 2024$64,257 
Balance at December 31, 2022$6,276 
Revenue recognized that was included in the balance at the beginning of the period(1,219)
Balance at March 31, 2023$5,057 
Revenue recognized that was included in the balance at the beginning of the period(1,247)
Balance at June 30, 2023$3,810 
6.    Composition of Certain Financial Statement Items
Prepaid and other assets (in thousands)
June 30,
2024
December 31, 2023
Accounts receivable$ $1,105 
Prepaid assets14,041 7,333
Interest receivable and other assets
15,714 7,518
Total prepaid and other assets$29,755 $15,956 
Property and equipment consist of the following (in thousands):
June 30,
2024
December 31,
2023
Laboratory equipment$12,502 $11,208 
Computers and software262 127 
Office furniture and equipment1,979 1,979 
Leasehold improvements288 288 
Construction in process16  
Property and equipment, gross15,047 13,602 
Less accumulated depreciation(6,549)(5,221)
Total property and equipment, net$8,498 $8,381 
Depreciation expense related to property and equipment was $0.7 million and $0.5 million for the three months ended June 30, 2024 and 2023, respectively, and $1.3 million and $0.9 million for the six months ended June 30, 2024 and 2023, respectively.
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Accounts payable and accrued liabilities (in thousands):
June 30,
2024
December 31,
2023
Accounts payable$8,889 $8,809 
Accrued non-clinical liabilities24,037 19,535
Accrued clinical liabilities7,998 5,997
Total accounts payable and accrued liabilities$40,924 $34,341 
7.    Commitments and Contingencies
Litigation
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. There are no such matters currently outstanding for which liabilities have been accrued.
Operating Lease
In April 2024, the Company entered into a sublease agreement with Turning Point Therapeutics, Inc. to rent 105,000 square feet for office and laboratory space for the Company’s future corporate headquarters. The term of the sublease is approximately 9 years and 9 months with payments expected to begin in August 2025. Pursuant to the terms of the sublease agreement, the sublandlord will provide the Company with a tenant improvement allowance of up to $33.6 million. An additional tenant improvement allowance of up to $5.0 million is also available to be repaid in equal installments through monthly rent payments, subject to 8% interest per annum and annual increases of 3% per annum. The Company also has an option and a right of first refusal for an additional 80,000 square feet in an adjacent available building, which has not been exercised. Total aggregate future lease commitments under the sublease agreement are approximately $72.6 million, inclusive of 3% annual rent increases and various agreed upon rent abatement amounts. The sublease will be measured and recognized upon commencement of the sublease. As of June 30, 2024, the sublease had not commenced because construction of improvements to bring the facility to its intended use was not substantially complete.
In connection with the sublease agreement, the Company is required to maintain a letter of credit for the benefit of the sublandlord in the amount of $2.5 million, which was delivered in April 2024 and is included in restricted cash in the Company’s condensed balance sheet.
8.    Stockholders’ Equity
Common Stock
On November 8, 2022, the Company entered into a sales agreement (the 2022 Sales Agreement) with Cowen and Company, LLC (the 2022 Sales Agent). Under the 2022 Sales Agreement, the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to $200.0 million through the 2022 Sales Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the 2022 Sales Agent. The Company is not obligated to sell, and the 2022 Sales Agent is not obligated to buy or sell, any shares of common stock under the 2022 Sales Agreement. During the six months ended June 30, 2024 and 2023, the Company sold 418,408 and 4,107,810 shares of its common stock, respectively, pursuant to the 2022 Sales Agreement and received net proceeds of $5.6 million and $60.5 million, respectively, after deducting offering-related transaction costs and commissions.
On March 4, 2024, the Company sold 15,224,773 unregistered shares of its common stock and pre-funded warrants in lieu of common stock to purchase up to an aggregate of 9,030,851 shares of its common stock to investors in a private placement at an offering price of $16.50 per share and $16.499 per pre-funded warrant, which represents the offering price per share of common stock less an exercise price of $0.001 per share. The Company valued the common stock at the offering price, concluding that the offering price approximated fair value. The net proceeds from the private placement were $379.8 million after deducting placement fees and offering costs of $20.4 million. The resale of the shares, including the shares issuable upon exercise of the pre-
13

funded warrants, were subsequently registered on an automatically effective Registration Statement on Form S-3 filed with the SEC on April 2, 2024.
The pre-funded warrants are a freestanding instrument that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815. The Company valued the pre-funded warrants at the offering price, concluding that the offering price approximated fair value. The pre-funded warrants meet the equity classification criteria and were accounted for as a component of additional paid-in capital. The pre-funded warrants are immediately exercisable and do not expire.
One of the investors who participated in the private placement met the criteria of a related party as such investor was a principal owner of more than 10% of the voting interest in the Company (the Principal Owner). The Principal Owner purchased 2,121,213 shares of the Company's common stock for $35.0 million. The purchase of common stock under the private placement by the Principal Owner was carried out at arm's length as substantiated by the fact that the per share purchase price equaled the price paid by other participants. No amounts were due from the Principal Owner as of June 30, 2024.
On June 17, 2024, the Company completed a public offering of 12,132,500 shares of its common stock at a public offering price of $38.00 per share. Net proceeds from the offering were approximately $432.8 million, after deducting underwriting discounts and offering expenses of $28.3 million. The shares sold in the offering were registered pursuant to the Company's shelf registration statement on Form S-3, which became automatically effective upon filing on May 9, 2024.
Stock Options
Stock option activity for employee and non-employee awards and related information is as follows (in thousands, except per share data):
Number of
Options
Weighted-
Average
Exercise
Price Per
Share
Outstanding at December 31, 202312,495$14.91 
Granted2,27515.53 
Exercised(1,742)10.45 
Forfeited/expired(300)16.40 
Outstanding at June 30, 202412,728$15.60 
Restricted Stock Units and Performance Stock Units
The Company has granted restricted stock units (RSUs) and performance stock units (PSUs) to employees of the Company under the 2020 Incentive Award and the 2022 Employment Inducement Incentive Award Plans. RSUs and PSUs are valued at the market price of a share of the Company’s stock on the date of grant. RSUs vest ratably on an annual basis over a four-year service period and are payable in shares of common stock on the vesting date. Compensation expense for RSUs is recognized on a straight-line basis over the four-year service period. Compensation expense for PSUs is recognized over the service period when the performance conditions are met or considered probable of achievement, using management's best estimates. Forfeitures are recorded in the period in which they occur.
14

The following table summarizes the RSU activity for the six months ended June 30, 2024 (in thousands, except per share data):
Number of SharesWeighted-Average Grant Date Fair Value
Unvested at December 31, 2023758 $18.73 
Granted984 13.78 
Vested(147)21.70 
Forfeited(69)15.34 
Unvested at June 30, 2024
1,526 $15.41 
The total fair value of RSU shares vested during the six months ended June 30, 2024 was $1.8 million. No RSUs vested during the six months ended June 30, 2023.
The following table summarizes the PSU activity for the six months ended June 30, 2024 (in thousands, except per share data):
Number of SharesWeighted-Average Grant Date Fair Value
Unvested at December 31, 2023750 $6.57 
Granted  
Vested(188)6.57 
Forfeited  
Unvested at June 30, 2024
562 $6.57 
During the six months ended June 30, 2024, the performance conditions related to 375,000 units of outstanding PSUs were met or deemed probable resulting in (1) the immediate vesting of 187,500 shares and (2) the expected vesting of 187,500 shares in December 2024. As a result, the Company recognized $2.0 million of stock-based compensation expense during the six months ended June 30, 2024. No stock-based compensation expense has been recognized for the remaining 375,000 outstanding PSUs as the performance conditions were not deemed probable. The total fair value of PSU shares vested during the six months ended June 30, 2024 was $7.4 million. No PSUs vested during the six months ended June 30, 2023.
Employee Stock Purchase Plan
The Company issued 137,913 and 81,005 shares of common stock under the Employee Stock Purchase Plan (ESPP) during the six months ended June 30, 2024 and 2023, respectively. The Company had an outstanding liability of $0.1 million at June 30, 2024, which is included in accounts payable and accrued liabilities on the condensed balance sheet, for employee contributions to the ESPP for shares pending issuance at the end of the current offering period. As of June 30, 2024, 234,604 shares of common stock were available for issuance under the ESPP.
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Stock-Based Compensation Expense
The assumptions used in the Black-Scholes-Merton model to determine the fair value of stock option grants were as follows:
Options
Six Months Ended June 30,
20242023
Risk-free interest rate
3.9% - 4.7%
3.5% - 4.0%
Expected volatility
79% - 82%
81% - 82%
Expected term (in years)
5.3 - 6.1
5.5 - 6.1
Expected dividend yield
%
%
Risk-Free Interest Rate. The Company bases the risk-free interest rate assumption for equity awards on the rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued.
Expected Volatility. The expected volatility of stock options is estimated based on the average historical volatilities of common stock of comparable publicly traded companies and the Company's own volatility. The comparable companies are chosen based on their size and stage in the life cycle. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Prior to 2023, the Company exclusively used peer group companies to determine expected volatility.
Expected Term. The Company's limited option exercise history does not provide a reasonable basis for estimating expected term, therefore the Company has estimated the expected life of its stock options using the simplified method, whereby the expected life equals the average of the vesting term and the original contractual term of the option. The expected life assumption for employee stock purchases under the ESPP is six months to conform with the six-month ESPP offering period.
Expected Dividend Yield. The Company’s expected dividend yield assumption is zero as it has never paid dividends and has no present intention to do so in the future.
The allocation of stock-based compensation expense for stock option, RSU awards, PSU awards, and shares purchasable under the ESPP was as follows (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2024202320242023
Research and development expense$6,529 $5,442 $12,266 $10,714 
General and administrative expense6,283 4,011 10,852 7,843 
Total stock-based compensation expense$12,812 $9,453 $23,118 $18,557 
As of June 30, 2024, the unrecognized compensation cost related to outstanding time-based options and RSUs was $70.3 million and $21.0 million, respectively, which is expected to be recognized over a weighted-average period of 2.61 years and 3.30 years, respectively. Unrecognized compensation cost related to PSUs was $2.9 million. As of June 30, 2024, the unrecognized compensation cost related to stock purchase rights under the ESPP was $0.6 million, which is expected to be recognized over a weighted-average period of 0.46 years.
9.    Subsequent Events
On August 9, 2024, the Company entered into a sales agreement (the 2024 Sales Agreement) with TD Securities (USA), LLC (the 2024 Sales Agent) with substantially similar terms as the 2022 Sales Agreement described in Note 8 "Stockholders' Equity". Under the 2024 Sales Agreement, the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to $400 million through the 2024 Sales Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the 2024 Sales Agent. The Company is not obligated to sell, and the 2024
16

Sales Agent is not obligated to buy or sell, any shares of common stock under the 2024 Sales Agreement. The 2024 Sales Agent will be entitled to a commission of up to 3.0% of the gross sales price of the ATM Shares sold through it pursuant to the 2024 Sales Agreement.
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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and related notes thereto included elsewhere in this quarterly report on Form 10-Q and with our audited financial statements and notes thereto and management’s discussion and analysis of financial condition and results of operations, both of which are contained in our annual report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission, or SEC, on February 28, 2024.
Cautionary Note Regarding Forward-Looking Statements
This quarterly report contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical fact contained in this quarterly report, including statements regarding our future results of operations and financial position, business strategies and plans, research and development plans, the timing and likelihood of resolution of the partial clinical hold on del-desiran, the anticipated timing, costs, design and conduct of our ongoing and planned preclinical studies and clinical trials for our product candidates, the timing and likelihood of regulatory filings and approvals for our product candidates, the timing and likelihood of success, plans and objectives of management for future operations and future results of anticipated product development efforts, inflationary pressures, and the ongoing hostilities outside the United States on our business, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” or the negative of these terms or other comparable terminology. These forward-looking statements are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak only as of the date of this quarterly report and are subject to a number of risks, uncertainties and assumptions, including those described in Part II, Item 1A, “Risk Factors.” The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Overview
We are a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates, or AOCs. Our proprietary AOC platform is designed to combine the specificity of monoclonal antibodies, or mAbs, with the precision of RNA therapeutics to target the root cause of diseases previously untreatable with such therapeutics. Our advancing and expanding pipeline currently has three programs in clinical development. Delpacibart etedesiran, abbreviated as del-desiran (formerly AOC 1001), is designed to treat people with myotonic dystrophy type 1, or DM1, and is currently in Phase 3 development with the global HARBOR™ trial, which we initiated in June 2024. Delpacibart braxlosiran or del-brax (formerly AOC 1020) is designed to treat people living with facioscapulohumeral muscular dystrophy, or FSHD, and is currently in Phase 1/2 development with the FORTITUDE™ trial. Delpacibart zotadirsen, or del-zota (formerly AOC 1044), is designed for people with Duchenne muscular dystrophy, or DMD, and is currently in Phase 1/2 development with the EXPLORE44™ trial. Del-zota is specifically designed for people with mutations amenable to exon 44 skipping, or DMD44, and is the first of multiple AOCs we are developing for DMD. Del-desiran, del-brax and del-zota have all been granted Orphan Designation by the FDA and the European Medicines Agency, or EMA, and Fast Track Designation by the FDA. In addition, in May 2024, the FDA granted del-desiran Breakthrough Therapy designation for the treatment of DM1, and in February 2024, the FDA granted del-zota Rare Pediatric Disease designation.
We have reported data from each of our three clinical trials of AOC product candidates in 2024. In August 2024, we reported initial data from the 5 mg/kg cohort of our EXPLORE44 trial in people living with DMD44. These data demonstrated consistent delivery of PMO in skeletal muscle, an increase of dystrophin production of 25% of normal and an increase of 37% in exon 44 skipping. In addition, del-zota showed greater than 80% reduction of creatine kinase compared to baseline in people living with DMD44. The initial assessment from the randomized, double-blind, placebo-controlled EXPLORE44 trial assessed the safety and tolerability for 25 participants across two dose levels (5 mg/kg and 10 mg/kg). Del-zota demonstrated favorable safety and
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tolerability, with most treatment emergent adverse events (AEs) mild or moderate in participants with DMD44. Two participants discontinued from the study: one due to a serious adverse event of anaphylaxis which fully resolved and one due to moderate infusion related reaction. For the 5 mg/kg cohort, participants received three doses of 5 mg/kg of del-zota, or placebo, every six weeks. Avidity plans to enroll additional patients in the EXPLORE44 Open-Label Extension (OLE) for del-zota.
In June 2024, we shared initial del-brax data from our FORTITUDE™ trial in people living with FSHD which demonstrated consistent reductions of greater than 50% in double homeobox 4, or DUX4 regulated genes, trends of functional improvement, and favorable safety and tolerability in people living with FSHD as of the May 2024 data cutoff. The initial assessment from the randomized, double-blind, placebo-controlled FORTITUDE™ trial of del-brax provided a four-month look at the safety and tolerability for all 39 participants across two dose levels (2 mg/kg and 4 mg/kg). We plan to accelerate initiation of registrational cohorts in the FORTITUDE™ study, with the biomarker cohort planned in the second half of 2024 and the functional cohort planned in the first half of 2025.
We also initiated and began administration of del-desiran in people living with DM1 in our global Phase 3 HARBOR™ trial in June 2024. In March 2024, we shared new long-term del-desiran data from our ongoing MARINA-OLE™ trial in people living with DM1 showing reversal of disease progression across multiple endpoints including myotonia, muscle strength and patient reported activities of daily living over one year compared to a matched population from the END-DM1 natural history study. With over 265 infusions totaling 61.1 patient-years of exposure as of the January 2024 data cutoff, del-desiran has demonstrated favorable long-term safety and tolerability.
In the fourth quarter of 2024, we plan to announce our lead precision cardiology program target.
We continue to advance and expand our internal discovery pipeline with the addition of new research and development candidates to treat conditions in skeletal muscle and precision cardiology. We are well positioned as we build an integrated global biopharmaceutical company and continue to deliver on the RNA revolution. In addition to our own internal research programs, we continue to explore the full potential of our AOC platform through collaborations and partnerships, including programs in immunology, cardiology and other select indications outside of muscle.
Since our inception in 2012, we have devoted substantially all of our resources to organizing and staffing our company, business planning, raising capital, developing our proprietary AOC platform, identifying potential product candidates, establishing our intellectual property portfolio, conducting research, preclinical and clinical studies, and providing other general and administrative support for these operations. We have not generated any revenue from product sales. In June 2020, we completed our initial public offering, or IPO, and have since raised capital through additional public offerings, private placements, sales agreements, and under collaboration and research service agreements. Refer to “Liquidity and Capital Resources” for further information on the capital raised since inception and our future capital requirements.
We have incurred operating losses in each year since inception. Our net losses were $212.2 million and $174.0 million for the years ended December 31, 2023 and 2022, respectively, and $139.6 million for the six months ended June 30, 2024. As of June 30, 2024, we had an accumulated deficit of $710.4 million. We expect our expenses and operating losses will increase substantially as we conduct our ongoing and planned preclinical studies and clinical trials, continue our research and development activities, utilize third parties to manufacture our product candidates and related raw materials, hire additional personnel and protect our intellectual property. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our preclinical studies and clinical trials and our expenditures on other research and development activities, as well as the generation of any collaboration and services revenue.
Based upon our current operating plans, we believe that our existing cash, cash equivalents and marketable securities of $1.3 billion (as of June 30, 2024) will be sufficient to fund our operations for at least 12 months from the date of the filing of this Form 10-Q. While we may generate revenue under our current and/or future collaboration agreements, we do not expect to generate any revenues from product sales until we successfully complete development and obtain regulatory approval for one or more of our product candidates, which we expect will take a number of years and may never occur. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed, on
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favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Research Collaboration with Bristol Myers Squibb
In November 2023, we entered into (i) a Research Collaboration and License Agreement, or the BMS Collaboration Agreement, with Bristol Myers Squibb Company, or BMS, to expand on our research with MyoKardia for up to five targets utilizing our proprietary AOC platform technology and (ii) a Securities Purchase Agreement with BMS, or the BMS Purchase Agreement, for the purchase by BMS in a private placement of 5,075,304 shares of our common stock at a purchase price of $7.8813 per share, for an aggregate purchase price of approximately $40 million. We refer to the BMS Collaboration Agreement and the BMS Purchase Agreement together as the "BMS Agreements." Under the terms of the BMS Agreements, we received approximately $100 million upfront, which includes a $60 million cash payment under the terms of the BMS Collaboration Agreement, and approximately $40 million for the purchase of our common stock under the terms of the BMS Purchase Agreement. We are also eligible to receive up to approximately $1.35 billion in research and development milestone payments, up to approximately $825 million in commercial milestone payments, and tiered royalties from high single digits to low double-digits on net sales. We are responsible for our own research collaboration costs incurred under the agreement, subject to a cumulative spending limit of $40 million. BMS will fund all future clinical development, regulatory and commercialization activities coming from this collaboration.
Research Collaboration and License Agreement with Eli Lilly and Company
In April 2019, we entered into a Research Collaboration and License Agreement, or the Lilly Agreement, with Eli Lilly and Company, or Lilly, for the discovery, development and commercialization of AOC products in immunology and other select indications on a worldwide basis. Under the Lilly Agreement, we and Lilly will collaborate on preclinical research and discovery activities for such products, with Lilly being responsible for funding the cost of such activities by both parties. Lilly will also lead the clinical development, regulatory approval and commercialization of all such products, at its sole cost. We granted Lilly an exclusive, worldwide, royalty-bearing license, with the right to sublicense, under our technology to research, develop, manufacture, and sell products containing AOCs that are directed to up to six mRNA targets. We retain the right to use our technology to perform our obligations under the agreement and for all purposes not granted to Lilly. Lilly paid us an upfront license fee of $20.0 million in 2019, and we are eligible to receive up to $60.0 million in development milestone payments per target, up to $140.0 million in regulatory milestone payments per target and up to $205.0 million in commercialization milestone payments per target. We are eligible to receive a tiered royalty ranging from the mid-single to low-double digits from Lilly on worldwide annual net sales of licensed products, subject to specified and capped reductions for the market entry of biosimilar products, loss of patent coverage of licensed products and for payments owed to third parties for additional rights necessary to commercialize licensed products in the territory.
Components of Results of Operations
Revenue
Our revenue to date has been derived from payments received under research collaboration and license agreements. For the foreseeable future, we may generate revenue from a combination of upfront payments, milestone payments and reimbursement of services under our current and/or future collaboration agreements. We do not expect to generate any revenue from the sale of products unless and until such time that our product candidates have advanced through clinical development and regulatory approval, if ever. We expect that any revenue we generate, if at all, will fluctuate from quarter-to-quarter as a result of the timing and amount of payments relating to such services and milestones and the extent to which any of our products are approved and successfully commercialized. If we fail to complete preclinical and clinical development of product candidates or obtain regulatory approval for them, our ability to generate future revenues and our results of operations and financial position would be adversely affected.
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Operating Expenses
Research and Development
Research and development expenses consist of external and internal costs associated with our research and development activities, including our discovery and research efforts, and the preclinical and clinical development of our product candidates. Our research and development expenses include:
external costs, including expenses incurred under arrangements with third parties, such as contract research organizations, contract manufacturers, consultants and our scientific advisors; and
internal costs, including;
employee-related expenses, including salaries, benefits and stock-based compensation;
the costs of laboratory supplies and acquiring, developing and manufacturing preclinical study materials; and
facilities, information technology and depreciation, which include direct and allocated expenses for rent and maintenance of facilities and depreciation of leasehold improvements and equipment.
Research and development costs, including costs reimbursed under the Lilly Agreement, are expensed as incurred, with reimbursements of such amounts being recognized as revenue. We account for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received.
At any one time, we are working on multiple programs. Our internal resources, employees and infrastructure are not directly tied to any one research or drug discovery program and are typically deployed across multiple programs.
We expect our research and development expenses to increase for the foreseeable future as we continue to conduct our ongoing research and development activities, advance our preclinical research programs toward clinical development, including conducting IND-enabling studies, and conduct clinical trials. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming. We may never succeed in achieving marketing approval for any of our product candidates.
The timelines and costs associated with research and development activities are uncertain, can vary significantly for each product candidate and development program, and are difficult to predict. We anticipate we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to preclinical and clinical results, regulatory developments, ongoing assessments as to each program’s commercial potential, and our ability to maintain or enter into new collaborations, to the extent we determine the resources or expertise of a collaborator would be beneficial for a given program. We will need to raise substantial additional capital in the future. In addition, we cannot forecast which development programs may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
Our development costs may vary significantly based on factors such as:
the number and scope of clinical, preclinical and IND-enabling studies;
the timing and likelihood of resolution of the partial clinical hold on del-desiran;
per patient trial costs;
the number of trials required for approval;
the number of sites included in the trials;
the countries in which the trials are conducted;
the length of time required to enroll eligible patients;
the number of patients that participate in the trials;
the number of doses that patients receive;
the drop-out or discontinuation rates of patients;
potential additional safety monitoring requested by regulatory agencies;
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the duration of patient participation in the trials and follow-up;
the cost and timing of manufacturing our product candidates;
the phase of development of our product candidates; and
the efficacy and safety profile of our product candidates.
General and Administrative
General and administrative expenses consist primarily of employee-related expenses, including salaries, benefits and stock-based compensation, for employees in our executive, finance, accounting, legal, business development and support functions. Other general and administrative expenses include allocated facility, information technology and depreciation related costs not otherwise included in research and development expenses, and professional fees for auditing, tax, intellectual property, and legal services. Costs related to filing and pursuing patent applications are recognized as general and administrative expenses as incurred since recoverability of such expenditures is uncertain.
We expect our general and administrative expenses will increase for the foreseeable future to support our increased research and development activities and other corporate activities.
Other Income (Expense)
Other income (expense) consists primarily of interest earned on our cash, cash equivalents, and marketable securities.
Results of Operations
Comparison of the Three and Six Months Ended June 30, 2024 and 2023
The following table summarizes our results of operations for the periods presented (in thousands):
Three Months Ended June 30,ChangeSix Months Ended June 30,Change
2024202320242023
Revenue$2,045 $2,316 $(271)$5,588 $4,549 $1,039 
Research and development expenses63,940 42,672 21,268 130,772 90,437 40,335 
General and administrative expenses20,731 12,278 8,453 34,629 24,342 10,287 
Other income11,833 5,609 6,224 20,165 10,811 9,354 
Revenue
Revenue decreased by $0.3 million for the three months ended June 30, 2024 and 2023, primarily due to the recognition of revenues under the Lilly agreement in the prior year for which there were no revenues recognized in the current year comparative period, offset by an increase in revenues recognized under the BMS Agreement in the current year for which there were no revenues recognized in the prior year comparative period. Revenue increased by $1.0 million for the six months ended June 30, 2024 and 2023, primarily due to the recognition of revenues under the BMS agreement in the current year for which there were no revenues recognized in the prior year comparative period.
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Research and Development Expenses
The following tables illustrate the components of our research and development expenses for the periods presented (in thousands):
Three Months Ended June 30,ChangeSix Months Ended June 30,Change
2024202320242023
External costs:
Del-desiran$9,045 $4,216 $4,829 $18,141 $11,176 $6,965 
Del-brax7,768 1,501 6,267 13,931 9,117 4,814 
Del-zota5,081 5,156 (75)10,921 7,692 3,229 
Other programs986 1,511 (525)2,423 4,988 (2,565)
Unallocated13,860 8,360 5,500 33,565 14,991 18,574 
Total external costs36,740 20,744 15,996 78,981 47,964 31,017 
Internal costs:
Employee-related expenses21,554 16,996 4,558 40,890 32,974 7,916 
Facilities, lab supplies and other5,646 4,932 714 10,901 9,499 1,402 
Total internal costs
27,200 21,928 5,272 51,791 42,473 9,318 
Total research and development expenses$63,940 $42,672 $21,268 $130,772 $90,437 $40,335 
Research and development expenses increased by $21.3 million for the three months ended June 30, 2024 as compared to the same period in 2023, primarily due to increased external costs associated with the progression of clinical trials and preclinical studies, including $5.3 million in higher manufacturing costs related to drug product and a $6.8 million out of period adjustment which decreased external research and development expenses in the prior year period, as well as higher internal costs including $4.6 million in higher personnel costs. Similarly, research and development costs increased by $40.3 million for the six months ended June 30, 2024 as compared to the same period in 2023, due to increased external costs associated with the progression of clinical trials and preclinical studies, including $20.8 million in higher manufacturing cost related to drug product and a $3.6 million out of period adjustment which decreased external research and development expenses in the prior year period for costs incurred prior to 2023, as well as higher internal costs including an increase of $7.9 million in personnel costs.
General and Administrative Expenses
General and administrative expenses increased by $8.5 million for the three months ended June 30, 2024 as compared to the same period in 2023, primarily due to $5.1 million in higher personnel costs and $1.5 million in higher professional fees to support our expanded operations. Similarly, general and administrative expenses increased by $10.3 million for the six months ended June 30, 2024 as compared to the same period in 2023, primarily due to $7.6 million in higher personnel costs and $0.7 million in higher professional fees to support our expanded operations.
Other Income
Other income increased by $6.2 million and $9.4 million for the three and six months ended June 30, 2024 and 2023 respectively, due to higher interest income earned on marketable securities investments and cash and cash equivalent balances.
Liquidity and Capital Resources
Sources of Liquidity
On November 8, 2022, we entered into a sales agreement, or the 2022 Sales Agreement, with Cowen and Company, LLC, or the 2022 Sales Agent, which has since been terminated, as discussed below. Under the
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2022 Sales Agreement, we could, from time to time, sell shares of our common stock having an aggregate offering price of up to $200.0 million through the 2022 Sales Agent. Sales of the shares of common stock, if any, would be made at prevailing market prices at the time of sale, or as otherwise agreed with the 2022 Sales Agent. We were not obligated to sell, and the 2022 Sales Agent was not obligated to buy or sell, any shares of common stock under the 2022 Sales Agreement. During the six months ended June 30, 2024 and 2023, we sold 418,408 and 4,107,810 shares of our common stock, respectively, pursuant to the 2022 Sales Agreement and received net proceeds of $5.6 million and $60.5 million, respectively, after deducting offering-related transaction costs and commissions.
On March 4, 2024, we completed a private placement of 15,224,773 shares of our common stock at a price of $16.50 per share and pre-funded warrants to purchase an aggregate 9,030,851 shares of our common stock at a price of $16.499 per pre-funded warrant. The net proceeds from the private placement were $379.8 million after deducting placement fees and offering costs of $20.4 million. Each pre-funded warrant has an exercise price of $0.001 per share of common stock, is immediately exercisable, and does not expire.
On June 17, 2024, the Company completed a public offering of 12,132,500 shares of its common stock at a public offering price of $38.00 per share. Net proceeds from the offering were approximately $432.8 million, after deducting underwriting discounts and offering expenses of $28.3 million. The shares sold in the offering were registered pursuant to the Company's shelf registration statement on Form S-3, which became automatically effective upon filing on May 9, 2024.
On August 9, 2024, we entered into a new sales agreement, or the 2024 Sales Agreement, with TD Securities (USA) LLC, (the 2024 Sales Agent), with substantially similar terms as the 2022 Sales Agreement described above. Under the 2024 Sales Agreement, we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $400 million through the 2024 Sales Agent. We are not obligated to sell, and the 2024 Sales Agent is not obligated to buy or sell, any shares of common stock under the 2024 Sales Agreement. Upon entry into the 2024 Sales Agreement, the 2022 Sales Agreement was terminated.
Since our inception through June 30, 2024, other significant sources of capital raised to fund our operations were comprised of $274.1 million from our IPO, $378.9 million from follow-on public offerings, $140.6 million of net proceeds under a previous sales agreement, aggregate gross proceeds of $131.6 million from the sale and issuance of convertible preferred stock and convertible notes, and $144.6 million from funding under collaboration and research services agreements, including approximately $40.0 million related to the sale of shares of common stock in November 2023 to BMS in a private placement.
Future Capital Requirements
As of June 30, 2024, we had cash, cash equivalents and marketable securities of $1.3 billion. Based upon our current operating plans, we believe that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operations for at least 12 months from the date of the filing of this Form 10-Q. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of conducting preclinical studies and testing product candidates in clinical trials is costly, and the timing of progress and expenses in these studies and trials is uncertain.
Our future capital requirements are difficult to forecast and will depend on many factors, including but not limited to:
the type, number, scope, progress, expansions, results, costs, and timing of discovery, preclinical studies, and clinical trials of our product candidates that we are pursuing or may choose to pursue in the future;
the costs and timing of manufacturing for our product candidates and preparation for possible commercial operations if any product candidate is approved;
the costs, timing, and outcome of regulatory review of our product candidates;
the terms and timing of establishing and maintaining collaborations, licenses and other arrangements;
the costs of obtaining, maintaining, and enforcing our patents and other intellectual property rights;
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the costs associated with hiring additional personnel and consultants as our preclinical and clinical activities, and preparation for future commercial activities, if any, increase;
the timing and amount of the milestone or other payments made to us under our existing and any future collaboration agreements;
the costs and timing of establishing or securing sales and marketing capabilities if any product candidate is approved;
our ability to achieve sufficient market acceptance, coverage and adequate reimbursement from third-party payors and adequate market share and revenue for any approved products; and
costs associated with any products or technologies that we may in-license or acquire.
While we may generate revenue under our current and/or future collaboration agreements, we do not expect to generate any revenues from product sales until we successfully complete development and obtain regulatory approval for one or more of our product candidates, which we expect will take a number of years and may never occur. If we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing, and distribution. Accordingly, until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through equity offerings, debt financings, or other capital sources, including current and potential future collaborations, licenses and other arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed, on favorable terms or at all. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Cash Flows
The following table summarizes our cash flows for the periods presented (in thousands):
Six Months Ended June 30,Change
20242023
Net cash provided by (used in):
Operating activities$(135,384)$(98,774)$(36,610)
Investing activities(307,616)(149,631)(157,985)
Financing activities836,16961,933774,236 
Net increase (decrease) in cash, cash equivalents and restricted cash
$393,169 $(186,472)$579,641 
Operating Activities
Net cash used in operating activities of $135.4 million and $98.8 million for the six months ended June 30, 2024 and 2023, respectively, consisted primarily of cash used to fund our operations related to the development of clinical trials, preclinical studies, and other programs. The increase is due to increased research and development costs as well as general and administrative expenses as described under “Results of Operations” above.
Investing Activities
Net cash used in investing activities of $307.6 million for the six months ended June 30, 2024 consisted primarily of $514.1 million for purchases of marketable securities and reinvestment of proceeds from matured marketable securities as well as $1.4 million in purchases of property and equipment, offset by $207.9 million of proceeds from maturities of marketable securities. Net cash used in investing activities of $149.6 million for the six months ended June 30, 2023 consisted of $275.4 million for purchases of marketable securities due to investing the proceeds from the sale of common stock of $223.8 million in December 2022 and reinvestment of
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proceeds from matured marketable securities, and $2.4 million in purchases of property and equipment, partially offset by $128.2 million of proceeds from maturities of marketable securities.
Financing Activities
Net cash provided by financing activities of $836.2 million for the six months ended June 30, 2024 consisted primarily of $677.3 million in net proceeds from sales of our common stock, $141.4 million in net proceeds from the sale of pre-funded warrants in a private placement, and $17.5 million in proceeds from the issuance of common stock under employee incentive equity plans. Net cash provided by financing activities of $61.9 million for the six months ended June 30, 2023 consisted primarily of net proceeds from sales of our common stock made pursuant to the 2022 Sales Agreement.
Critical Accounting Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these condensed financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses. On an ongoing basis, we evaluate these estimates and judgments. We base our estimates on historical experience and on various assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenue and expenses that are not readily apparent from other sources. Actual results may differ materially from these estimates. As of June 30, 2024, there have been no material changes to our critical accounting estimates from those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates,” included in our annual report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 28, 2024.
Contractual Obligations and Commitments
In April 2024, the Company entered into a sublease agreement to rent office and laboratory space for the Company's future corporate headquarters. Total aggregate future lease commitments under the sublease agreement are approximately $72.6 million. Refer to Note 7, "Commitments and Contingencies" to our condensed financial statements included elsewhere in this quarterly report on Form 10-Q for further details. Except for the sublease agreement, as of June 30, 2024, there have been no material changes outside the ordinary course of our business to the contractual obligations we reported in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Contractual Obligations and Commitments,” included in our annual report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 28, 2024.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As of June 30, 2024, there have been no material changes in our market risk from that described in “Quantitative and Qualitative Disclosures About Market Risk,” included in our annual report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 28, 2024.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our periodic and current reports that we file with the SEC is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable and not absolute assurance of achieving the desired control objectives. In reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
Our management, with the participation of our principal executive officer and principal financial officer, has evaluated, as of the end of the period covered by this quarterly report on Form 10-Q, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on such evaluation, our principal executive officer and principal financial officer have concluded that, as of June 30, 2024, our disclosure controls and procedures were not effective at the reasonable assurance level due to a material weakness in internal control over financial reporting described below.
As disclosed in Item 9A, “Controls and Procedures” of our annual report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 28, 2024, we previously identified a material weakness in our internal control over financial reporting with respect to segregation of duties over certain information technology general controls (ITGCs) related to a module within our enterprise resource planning (ERP) system. These ITGCs were not operating effectively to (i) restrict access to certain data and the ability to make changes thereto, and (ii) to monitor changes to such data. While the control deficiency identified did not result in any misstatements, a reasonable possibility exists that a material misstatement to the annual or interim financial statements and disclosures would not have been prevented or detected on a timely basis. Notwithstanding the identified material weakness, our management believes the unaudited Condensed Financial Statements included in this Quarterly Report on Form 10-Q fairly present, in all material respects, our financial condition, results of operations and cash flows as of and for the periods presented in accordance with GAAP.
Remediation
Our management is committed to maintaining a strong internal control environment. As discussed above and disclosed in Item 9A, “Controls and Procedures” of our annual report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 28, 2024, we have changed the relevant access to address the known segregation of duties issues and will update our access review controls to include additional procedures. While we believe the actions taken thus far are substantive in addressing this control issue, we will consider this remediated once applicable controls operate for a sufficient period of time and management has
27

concluded, through testing, that these controls are operating effectively. We will continue to monitor through testing the effectiveness of these actions to ensure these controls continue to operate effectively.
Changes in Internal Control Over Financial Reporting
Except as described above, there have been no changes in our internal control over financial reporting during the quarter ended June 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II — OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are not currently subject to any material legal proceedings. From time to time, we may be involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of the outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources and other factors, and there can be no assurances that favorable outcomes will be obtained.
ITEM 1A. RISK FACTORS
We do not believe that there have been any material changes to the risk factors set forth in Part I, Item 1A of our annual report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 28, 2024. The risk factors described in such reports are not the only risks we face. Factors that are not currently known to us, factors that we currently consider immaterial or factors that are not specific to us, such as general economic conditions, may also materially adversely affect our business or financial condition.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Unregistered Sales of Equity Securities
None.
Issuer Repurchases of Equity Securities
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
Rule 10b5-1 Trading Arrangements
From time to time, our officers (as defined in Rule 16a–1(f)) and directors may enter into Rule 10b5-1 or non-Rule 10b5-1 trading arrangements (as each such term is defined in Item 408 of Regulation S-K). During the
29

three months ended June 30, 2024, our officers and directors took the following actions with respect to such trading arrangements:
ActionDateTrading ArrangementTotal Shares to be SoldExpiration Date
Rule 10b5-1*Non-Rule 10b5-1**
Michael MacLean (Chief Financial and Chief Business Officer)
Adopt4/2/2024X124,4236/30/2025
W. Michael Flanagan (Chief Scientific and Technical Officer)
Adopt6/12/2024X
271,958(1)
6/12/2026
Teresa McCarthy (Chief Human Resources Officer)
Adopt6/12/2024X200,00012/31/2025
____________________
* Intended to satisfy the affirmative defense of Rule 10b5-1(c)
** Not intended to satisfy the affirmative defense of Rule 10b5-1(c)
(1)Subject to increase based on a future award of our common stock covered by this 10b5-1 plan, the number of such securities is not able to be determined as of the date hereof.
2022 ATM Offering
On November 8, 2022, we entered into a sales agreement, or the 2022 Sales Agreement, with Cowen and Company, LLC, or the 2022 Sales Agent, pursuant to which we could, from time to time, sell shares of our common stock having an aggregate offering price of up to $200.0 million through the 2022 Sales Agent, as our agent, or the 2022 ATM Offering. In connection with the 2022 ATM Offering, we filed a prospectus supplement, dated November 8, 2022, or the 2022 ATM Prospectus, to the prospectus, dated July 2, 2021, filed with a registration statement on Form S-3 (File No. 333-257691), which became automatically effective upon filing with the SEC on July 2, 2021. In connection with the 2024 Sales Agreement, effective August 9, 2024, we terminated the 2022 Sales Agreement, and we have discontinued all offers and sales of shares of our common stock under the 2022 Sales Agreement and the 2022 ATM Prospectus. Between November 8, 2022 and August 9, 2024, we sold an aggregate of 4,526,218 shares of common stock pursuant to the 2022 Sales Agreement for aggregate gross proceeds of approximately $67.7 million.
2024 ATM Offering
On August 9, 2024, we entered into a sales agreement, or the 2024 Sales Agreement, with TD Securities (USA) LLC, or the 2024 Sales Agent, pursuant to which we may, from time to time, sell shares of our common stock, or the ATM Shares, having an aggregate offering price of up to $400 million through the 2024 Sales Agent, as our agent.
Subject to the terms and conditions of the 2024 Sales Agreement, the 2024 Sales Agent will use its commercially reasonable efforts to sell the ATM Shares from time to time, based upon our instructions. We have provided the 2024 Sales Agent with customary indemnification rights, and the 2024 Sales Agent will be entitled to a commission of up to 3.0% of the gross sales price of the ATM Shares sold through it pursuant to the 2024 Sales Agreement.
We will offer and sell the ATM Shares pursuant to an automatic shelf registration statement on Form S-3 (File No. 333-279264), which became automatically effective upon filing with the Securities and Exchange Commission, or SEC, on May 9, 2024. We will file a prospectus supplement with the SEC in connection with the offer and sale of up to $400 million of ATM Shares pursuant to the 2024 Sales Agreement on August 9, 2024.
The ATM Shares may be offered only by means of a prospectus forming a part of the effective registration statement. Sales of the ATM Shares, if any, under the 2024 Sales Agreement may be made in transactions that are deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including sales made by means of ordinary brokers' transactions, including on The Nasdaq Global Market, at market prices, or as otherwise agreed with the 2024 Sales Agent. We have no obligation to sell any of the ATM Shares, and may at any time suspend offers under the 2024 Sales Agreement or terminate the 2024 Sales Agreement.
The foregoing description of the 2024 Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full 2024 Sales Agreement, a copy of which is filed herewith as Exhibit 10.2 and is incorporated by reference herein.
30

A copy of the opinion of Latham & Watkins LLP relating to the validity of the securities to be issued pursuant to the 2024 Sales Agreement is filed hereto as Exhibit 5.1.
This Quarterly Report on Form 10-Q does not constitute an offer to sell the ATM Shares or a solicitation of an offer to buy the ATM Shares, nor shall there be any sale of the ATM Shares in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Amended and Restated Employment Agreements
Effective August 6, 2024, the Human Capital Management Committee of our Board of Directors approved, and we entered into, amended and restated employment agreements with each of our executive officers, including Sarah Boyce, W. Michael Flanagan, Ph.D., Michael MacLean, John Moriarty, and Teresa McCarthy. The amended and restated employment agreements set forth, for each executive officer, his or her annual base salary and eligibility to receive an annual performance bonus.
Regardless of the manner in which the executive officers employment terminates, he or she is entitled to receive amounts previously earned during the executive officer’s employment. Additionally, in the event that the executive officer’s termination occurs after the occurrence of a change of control and after the conclusion of a calendar year in respect of which no annual bonus has yet been paid, the executive officer will be entitled to his or her annual bonus for such completed calendar year based on actual performance, paid when annual bonuses are paid to our employees generally.
In addition, the executive officers are each entitled to certain severance benefits under their respective amended and restated employment agreements, subject to their execution of a release of claims and compliance with post-termination obligations.
Under the amended and restated employment agreements, upon a termination without cause or resignation for good reason (as such terms are defined in the amended and restated employment agreements) outside of the Change of Control Period (as defined below), the executive officer is entitled to: (i) his or her base salary for a period of 12 months (or 18 months in the case of Ms. Boyce), and (ii) payment of the COBRA premiums for the applicable severance period. The cash severance benefits will be paid in a lump sum (other than in the case of Ms. Boyce, whose severance will be paid in the form of salary continuation during the severance period).
Upon a termination without cause or resignation for good reason within 59 days prior to or 24 months after a change of control (as defined in our 2020 Incentive Award Plan), or the Change of Control Period, an executive officer is entitled to: (i) his or her base salary for 18 months (or 24 months in the case of Ms. Boyce), (ii) an amount equal to 150% (or 200% in the case of Ms. Boyce) of his or her target annual bonus for the year in which such termination occurs, (iii) an amount equal to his or her target annual bonus for the calendar year in which such termination occurs, prorated for the portion of the year that elapsed through the date of termination, (iv) payment of the COBRA premiums for the applicable severance period, and (v) accelerated vesting of any unvested time-based vesting equity awards (with the vesting of any performance-based equity awards to be governed by the applicable award agreement). The cash severance benefits will be paid in a lump sum (other than in the case of Ms. Boyce, who will receive 18 months of her base salary severance in the form of salary continuation during such 18 month period).
The foregoing description of the amended and restated employment agreements does not purport to be complete and is qualified in its entirety by reference to the full text of the amended and restated employment agreements, copies of which will be filed as exhibits to our Quarterly Report on 10-Q for the quarter ending September 30, 2024.
31

Item 6. Exhibits
Exhibit
Number
Exhibit DescriptionIncorporated by ReferenceFiled
Herewith
FormDateNumber
3.18-K6/16/20203.1
3.28-K12/13/20233.1
4.1S-15/22/20204.1
4.2
8-K
2/29/20244.1
5.1
X
10.1
8-K
6/12/202410.1
10.2
X
23.1
X
31.1X
31.2X
32.1*X
32.2*X
101.INSInline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document.X
101.SCHInline XBRL Taxonomy Extension Schema DocumentX
101.CALInline XBRL Taxonomy Extension Calculation Linkbase DocumentX
101.DEFInline XBRL Taxonomy Extension Definition Linkbase DocumentX
101.LABInline XBRL Taxonomy Extension Label Linkbase DocumentX
101.PREInline XBRL Taxonomy Extension Presentation Linkbase DocumentX
104Cover Page Interactive Data File (embedded within the Inline XBRL document)X
*This certification is deemed not filed for purpose of section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
32

SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Avidity Biosciences, Inc.
Date: August 9, 2024
By:/s/ Sarah Boyce
Sarah Boyce
President, Chief Executive Officer and Director
(Principal Executive Officer)

Date: August 9, 2024
By:/s/ Michael F. MacLean
Michael F. MacLean
Chief Financial and Chief Business Officer
(Principal Financial and Accounting Officer)
33
Exhibit 5.1 US-DOCS152955846.2 12670 High Bluff Drive San Diego, California 92130 Tel: +1.858.523.5400 Fax: +1.858.523.5450 www.lw.com FIRM / AFFILIATE OFFICES Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul Hamburg Silicon Valley Hong Kong Singapore Houston Tel Aviv London Tokyo Los Angeles Washington, D.C. Madrid August 9, 2024 Avidity Biosciences, Inc. 10578 Science Center Drive, Suite 125 San Diego, California 92121 Re: Registration Statement on Form S-3; Shares of Common Stock, par value $0.0001 per share, having an aggregate offering price of up to $400,000,000 To the addressees set forth above: We have acted as special counsel to Avidity Biosciences, Inc., a Delaware corporation (the “Company”), in connection with the sale through TD Securities (USA) LLC (“TD Cowen”) as the sales agent from time to time by the Company of shares (the “Shares”) of common stock of the Company, par value $0.0001 per share (the “Common Stock”), having an aggregate offering price of up to $400,000,000, to be issued pursuant to a registration statement on Form S- 3 filed by the Company with the Securities and Exchange Commission (the “Commission”) on May 9, 2024 (Registration No. 333–279264) (the “Registration Statement”), the base prospectus included in the Registration Statement (the “Base Prospectus”) and the related prospectus supplement filed by the Company with the Commission on August 9, 2024 (together with the Base Prospectus, the “Prospectus”), and that certain Sales Agreement, dated as of August 9, 2024, by and between the Company and TD Cowen (the “Sales Agreement”). The term “Shares” shall include any additional shares of common stock registered by the Company pursuant to Rule 462(b) under the Securities Act of 1933, as amended (the “Act”), in connection with the offering contemplated by the Registration Statement. This opinion is being furnished in connection with the requirements of Item 601(b)(5) of Regulation S-K under the Act, and no opinion is expressed herein as to any matter pertaining to the contents of the Registration Statement or related Prospectus, other than as expressly stated herein with respect to the issue of the Shares.


 
August 9, 2024 Page 2 US-DOCS152955846.2 As such counsel, we have examined such matters of fact and questions of law as we have considered appropriate for purposes of this letter. With your consent, we have relied upon certificates and other assurances of officers of the Company and others as to factual matters without having independently verified such factual matters. We are opining herein as to the General Corporation Law of the State of Delaware (the “DGCL”), and we express no opinion with respect to any other laws. Subject to the foregoing and the other matters set forth herein, it is our opinion that, as of the date hereof, when the Shares shall have been duly registered on the books of the transfer agent and registrar therefor in the name or on behalf of the purchasers, and have been issued by the Company against payment therefor (not less than par value) in the circumstances contemplated by the Sales Agreement, the issue and sale of the Shares will have been duly authorized by all necessary corporate action of the Company, and the Shares will be validly issued, fully paid and nonassessable. In rendering the foregoing opinion, we have assumed that (i) the Company will comply with all applicable notice requirements regarding uncertificated shares provided in the DGCL and (ii) upon the issue of any of the Shares, the total number of shares of Common Stock issued and outstanding will not exceed the total number of shares of Common Stock that the Company is then authorized to issue under its Amended and Restated Certificate of Incorporation. This opinion is for your benefit in connection with the Registration Statement and may be relied upon by you and by persons entitled to rely upon it pursuant to the applicable provisions of the Act. We consent to your filing this opinion as an exhibit to the Registration Statement and to the reference to our firm in the Prospectus under the heading “Legal Matters.” In giving such consent, we do not thereby admit that we are in the category of persons whose consent is required under Section 7 of the Act or the rules and regulations of the Commission thereunder. Sincerely, /s/ Latham & Watkins LLP


 
Exhibit 10.2 AVIDITY BIOSCIENCES, INC. $400,000,000 COMMON STOCK SALES AGREEMENT August 9, 2024 TD Securities (USA) LLC 1 Vanderbilt Avenue New York, New York 10017 Ladies and Gentlemen: Avidity Biosciences, Inc., a Delaware corporation (the “Company”), confirms its agreement (this “Agreement”) with TD Securities (USA) LLC (“TD Cowen”), as follows: 1. Issuance and Sale of Placement Shares. The Company agrees that, from time to time during the term of this Agreement, on the terms and subject to the conditions set forth herein, it may issue and sell through TD Cowen, acting as agent and/or principal, shares (the “Placement Shares”) of the Company’s common stock, par value $0.0001 per share (the “Common Stock”), having an aggregate offering price of up to $400,000,000 (the “Maximum Amount”). Notwithstanding anything to the contrary contained herein, the parties hereto agree that compliance with the limitation set forth in this Section 1 on the number of shares of Common Stock issued and sold under this Agreement shall be the sole responsibility of the Company, and TD Cowen shall have no obligation in connection with such compliance. The issuance and sale of the Placement Shares through TD Cowen will be effected pursuant to the Registration Statement (as defined below) filed by the Company which became automatically effective under Rule 462(e) of the Securities Act (as defined below) upon filing with the Securities and Exchange Commission (the “Commission”), although nothing in this Agreement shall be construed as requiring the Company to use the Registration Statement (as defined below) to issue the Placement Shares. The Registration Statement is an “automatic shelf registration statement” (as defined in Rule 405) and the Placement Shares (as defined below) have been and remain eligible for registration by the Company on such automatic shelf registration statement. The Company acknowledges and agrees that sales of Common Stock under this Agreement may be made through affiliates of TD Cowen and that TD Cowen may otherwise fulfill its obligations pursuant to this Agreement to or through an affiliated broker-dealer. For the avoidance of doubt, TD Cowen has a duty to fulfill all obligations under this Agreement. The Company has filed, in accordance with the provisions of the Securities Act of 1933, as amended, and the rules and regulations thereunder (collectively, the “Securities Act”), with the Commission an automatic registration statement on Form S-3 (File No. 333-279264), including a base prospectus, relating to certain securities, including the Common Stock, to be issued from time to time by the Company, and which incorporates by reference documents that the Company has filed or will file in accordance with the provisions of the Securities Exchange


 
- 2 - Act of 1934, as amended, and the rules and regulations thereunder (collectively, the “Exchange Act”). The Company has prepared a prospectus supplement specifically relating to the Placement Shares (the “Prospectus Supplement”) to the base prospectus included as part of such registration statement. The Company shall furnish to TD Cowen, for use by TD Cowen, copies of the prospectus included as part of such registration statement, as supplemented by the Prospectus Supplement. Except where the context otherwise requires, such registration statement, and any post-effective amendment thereto, as amended when it becomes effective, including all documents filed as part thereof or incorporated by reference therein, and including any information contained in a Prospectus (as defined below) subsequently filed with the Commission pursuant to Rule 424(b) under the Securities Act or deemed to be a part of such registration statement pursuant to Rule 430B or 462(b) of the Securities Act, or any subsequent registration statement on Form S-3 filed pursuant to Rule 415(a)(6) under the Securities Act by the Company to cover any Placement Shares, is herein called the “Registration Statement.” The base prospectus, including all documents incorporated therein by reference, included in the Registration Statement, as it may be supplemented by any prospectus supplement, including the Prospectus Supplement, as applicable, in the form in which such prospectus, Prospectus Supplement or other prospectus supplement have most recently been filed by the Company with the Commission pursuant to Rule 424(b) under the Securities Act, together with any “issuer free writing prospectus,” as defined in Rule 433 of the Securities Act regulations (“Rule 433), relating to the Placement Shares that (i) is consented to by TD Cowen, hereinafter referred to as a “Permitted Free Writing Prospectus,” (ii) is required to be filed with the Commission by the Company or (iii) is exempt from filing pursuant to Rule 433(d)(5)(i), in each case in the form filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company’s records pursuant to Rule 433(g), is herein called the “Prospectus.” Any reference herein to the Registration Statement, the Prospectus or any amendment or supplement thereto shall be deemed to refer to and include the documents incorporated by reference therein, and any reference herein to the terms “amend,” “amendment” or “supplement” with respect to the Registration Statement or the Prospectus shall be deemed to refer to and include the filing after the execution hereof of any document with the Commission deemed to be incorporated by reference therein. For purposes of this Agreement, all references to the Registration Statement, the Prospectus or to any amendment or supplement thereto shall be deemed to include any copy filed with the Commission pursuant to the Electronic Data Gathering Analysis and Retrieval System (“EDGAR”). 2. Placements. Each time that the Company wishes to issue and sell the Placement Shares hereunder (each, a “Placement”), it will notify TD Cowen by email notice (or other method mutually agreed to in writing by the parties) (a “Placement Notice”) containing the parameters in accordance with which it desires the Placement Shares to be sold, which shall at a minimum include the number of Placement Shares to be issued, the time period during which sales are requested to be made, any limitation on the number of Placement Shares that may be sold in any one Trading Day (as defined in Section 3) and any minimum price below which sales may not be made, a form of which containing such minimum sales parameters necessary is attached hereto as Schedule 1. The Placement Notice shall originate from any of the individuals from the Company set forth on Schedule 2 (with a copy to each of the other individuals from the Company listed on such schedule), and shall be addressed to each of the individuals from TD Cowen set forth on Schedule 2, as such Schedule 2 may be amended from time to time. The Placement Notice shall be effective upon receipt by TD Cowen unless and until (i) in accordance


 
- 3 - with the notice requirements set forth in Section 4, TD Cowen declines to accept the terms contained therein for any reason, in its sole discretion, (ii) the entire amount of the Placement Shares have been sold, (iii) in accordance with the notice requirements set forth in Section 4, the Company suspends or terminates the Placement Notice for any reason in its sole discretion, (iv) the Company issues a subsequent Placement Notice with parameters superseding those on the earlier dated Placement Notice, or (v) this Agreement has been terminated under the provisions of Section 11. The amount of any discount, commission or other compensation to be paid by the Company to TD Cowen in connection with the sale of the Placement Shares shall be calculated in accordance with the terms set forth in Schedule 3. It is expressly acknowledged and agreed that neither the Company nor TD Cowen will have any obligation whatsoever with respect to a Placement or any Placement Shares unless and until the Company delivers a Placement Notice to TD Cowen and TD Cowen does not decline such Placement Notice pursuant to the terms set forth above, and then only upon the terms specified therein and herein. In the event of a conflict between the terms of this Agreement and the terms of a Placement Notice, the terms of the Placement Notice will control. 3. Sale of Placement Shares by TD Cowen. Subject to the terms and conditions herein set forth, upon the Company’s delivery of a Placement Notice, and unless the sale of the Placement Shares described therein has been declined, suspended, or otherwise terminated in accordance with the terms of this Agreement, TD Cowen or its affiliate, for the period specified in the Placement Notice, will use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of the Nasdaq Stock Market, Inc. (“Nasdaq”) to sell such Placement Shares up to the amount specified in such Placement Notice, and otherwise in accordance with the terms of such Placement Notice. TD Cowen will provide written confirmation to the Company (including by email correspondence to each of the individuals of the Company set forth on Schedule 2, if receipt of such correspondence is actually acknowledged by any of the individuals to whom the notice is sent, other than via auto-reply) no later than the opening of the Trading Day (as defined below) immediately following the Trading Day on which it has made sales of Placement Shares hereunder setting forth the number of Placement Shares sold on such day, the volume-weighted average price of the Placement Shares sold, and the Net Proceeds (as defined below) payable to the Company. In the event the Company engages TD Cowen for a sale of Placement Shares that would constitute a “block” within the meaning of Rule 10b-18(a)(5) under the Exchange Act (a “Block Sale”), the Company will provide TD Cowen, at TD Cowen’s request and upon reasonable advance notice to the Company, on or prior to the Settlement Date (as defined below), the opinions of counsel, accountant’s letter and officers’ certificates set forth in Section 8 hereof, each dated the Settlement Date, and such other documents and information as TD Cowen shall reasonably request. TD Cowen may sell Placement Shares by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) under the Securities Act, including without limitation sales made through Nasdaq or on any other existing trading market for the Common Stock. TD Cowen shall not purchase Placement Shares for its own account as principal unless expressly authorized to do so by the Company in a Placement Notice. The Company acknowledges and agrees that (i) there can be no assurance that TD Cowen will be successful in selling Placement Shares, and (ii) TD Cowen will incur no liability or obligation to the Company or any other person or entity if it does not sell Placement Shares for any reason other than a failure by TD Cowen to use its commercially reasonable efforts consistent with its normal trading and sales practices to sell such Placement Shares as required under this Section 3.


 
- 4 - For the purposes hereof, “Trading Day” means any day on which the Company’s Common Stock is purchased and sold on the principal market on which the Common Stock is listed or quoted. Notwithstanding any other provision of this Agreement, the Company shall not offer, sell or deliver, or request the offer or sale, of any Placement Shares pursuant to this Agreement and, by notice to TD Cowen given by telephone (confirmed promptly by email), shall cancel any instructions for the offer or sale of any Placement Shares, and TD Cowen shall not be obligated to offer or sell any Placement Shares, (i) during any period in which the Company is, or could be deemed to be, in possession of material non-public information, or (ii) at any time from and including the date on which the Company shall issue a press release containing, or shall otherwise publicly announce, its earnings, revenues or other results of operations (an “Earnings Announcement”) through and including the time that the Company files a Quarterly Report on Form 10-Q or an Annual Report on Form 10-K that includes consolidated financial statements as of and for the same period or periods, as the case may be, covered by such Earnings Announcement. 4. Suspension of Sales. (a) The Company or TD Cowen may, upon notice to the other party in writing (including by email correspondence to each of the individuals of the other party set forth on Schedule 2, if receipt of such correspondence is actually acknowledged by any of the individuals to whom the notice is sent, other than via auto-reply) or by telephone (confirmed immediately by verifiable facsimile transmission or email correspondence to each of the individuals of the other party set forth on Schedule 2), suspend any sale of Placement Shares; provided, however, that such suspension shall not affect or impair either party’s obligations with respect to any Placement Shares sold hereunder prior to the receipt of such notice. While a suspension is in effect, any obligation under Sections 7(m), 7(n) and 7(o) with respect to delivery of certificates, opinion, or comfort letters to TD Cowen shall be waived. Each of the parties agrees that no such notice under this Section 4 shall be effective against the other unless it is made to one of the individuals named on Schedule 2 hereto, as such schedule may be amended from time to time. (b) If either TD Cowen or the Company has reason to believe that the exemptive provisions set forth in Rule 101(c)(1) of Regulation M under the Exchange Act are not satisfied with respect to the Common Stock, it shall promptly notify the other party, and TD Cowen may, at its sole discretion, suspend sales of the Placement Shares under this Agreement. (c) Notwithstanding any other provision of this Agreement, during any period in which the Registration Statement is not effective under the Securities Act, the Company shall promptly notify TD Cowen, the Company shall not request the sale of any Placement Shares, and TD Cowen shall not be obligated to sell or offer to sell any Placement Shares. 5. Settlement. (a) Settlement of Placement Shares. Unless otherwise specified in the applicable Placement Notice, settlement for sales of Placement Shares will occur on the first (1st) Trading


 
- 5 - Day following the date on which such sales are made (each, a “Settlement Date” and the first such settlement date, the “First Delivery Date”). The amount of proceeds to be delivered to the Company on a Settlement Date against receipt of the Placement Shares sold (the “Net Proceeds”) will be equal to the aggregate sales price received by TD Cowen at which such Placement Shares were sold, after deduction for (i) TD Cowen’s commission, discount or other compensation for such sales payable by the Company pursuant to Section 2 hereof, (ii) any other amounts due and payable by the Company to TD Cowen hereunder pursuant to Section 7(g) (Expenses) hereof, and (iii) any transaction fees imposed by any governmental or self-regulatory organization in respect of such sales. (b) Delivery of Placement Shares. On or before each Settlement Date, the Company will, or will cause its transfer agent to, electronically transfer the Placement Shares being sold by crediting TD Cowen’s or its designee’s account (provided TD Cowen shall have given the Company written notice of such designee prior to the Settlement Date) at The Depository Trust Company through its Deposit and Withdrawal at Custodian System or by such other means of delivery as may be mutually agreed upon by the parties hereto which in all cases shall be freely tradeable, transferable, registered shares in good deliverable form. On each Settlement Date, TD Cowen will deliver the related Net Proceeds in same day funds to an account designated by the Company on, or prior to, the Settlement Date. The Company agrees that if the Company, or its transfer agent (if applicable), defaults in its obligation to deliver duly authorized Placement Shares on a Settlement Date through no fault of TD Cowen, the Company agrees that in addition to and in no way limiting the rights and obligations set forth in Section 9(a) (Indemnification and Contribution) hereto, it will (i) hold TD Cowen harmless against any loss, claim, damage, or reasonable and documented expense (including reasonable and documented legal fees and expenses), as incurred, arising out of or in connection with such default by the Company and (ii) pay to TD Cowen (without duplication) any commission, discount, or other compensation to which it would otherwise have been entitled absent such default. 6. Representations and Warranties of the Company. The Company represents and warrants to, and agrees with, TD Cowen that as of (i) the date of this Agreement, (ii) each Time of Sale (as defined below), (iii) each Settlement Date, and (iv) each Bring-Down Date (as defined below) (each date included in (i) through (iv), a “Representation Date”): (a) Compliance with Registration Requirements. The Registration Statement became effective automatically upon filing with the Commission under the Securities Act. The Registration Statement is an “automatic shelf registration statement” on Form S-3 as defined in Rule 405 of the Securities Act and was filed not earlier than three (3) years prior to the date hereof. No stop order suspending the effectiveness of the Registration Statement or any post- effective amendment thereto is in effect and no proceedings for such purpose have been instituted or are pending or, to the knowledge of the Company, contemplated or threatened by the Commission. The Company meets the requirements for use of Form S-3 under the Securities Act. The sale of the Placement Shares hereunder meets the requirements of General Instruction I.B.1 of Form S-3. (b) No Misstatement or Omission. The Prospectus when filed complied and, as amended or supplemented, if applicable, will comply in all material respects with the Securities Act. Each of the Registration Statement, any Rule 462(b) Registration Statement, the Prospectus


 
- 6 - and any post-effective amendments or supplements thereto, at the time it became effective or its date, as applicable, complied and as of each Representation Date, complied and will comply in all material respects with the Securities Act and did not and, as of each Representation Date, did not and will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading. The Prospectus, as amended or supplemented, as of its date, did not and, as of each Representation Date, will not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The representations and warranties set forth in the two immediately preceding sentences do not apply to statements in or omissions from the Registration Statement, any Rule 462(b) Registration Statement, or any post-effective amendment thereto, or the Prospectus, or any amendments or supplements thereto, made in reliance upon and in conformity with information relating to Agent’s Information (as defined below). There are no contracts or other documents required to be described in the Prospectus or to be filed as exhibits to the Registration Statement which have not been described or filed as required. As used herein, “Time of Sale” means with respect to each offering of Placement Shares pursuant to this Agreement, the time of TD Cowen’s initial entry into contracts with purchasers for the sale of such Placement Shares. (c) Offering Materials Furnished to TD Cowen. The Company has delivered to TD Cowen one complete copy of the Registration Statement and a copy of each consent and certificate of experts filed as a part thereof, and conformed copies of the Registration Statement (without exhibits) and the Prospectus, as amended or supplemented, in such quantities and at such places as TD Cowen has reasonably requested. The Registration Statement, the Prospectus and any Permitted Free Writing Prospectus (to the extent any such Permitted Free Writing Prospectus was required to be filed with the Commission) delivered to TD Cowen for use in connection with the public offering of the Placement Shares contemplated herein have been and will be identical to the versions of such documents transmitted to the Commission for filing via EDGAR, except to the extent permitted by Regulation S-T. (d) [Reserved]. (e) Not an Ineligible Issuer. The Company currently is not an “ineligible issuer,” as defined in Rule 405 under the Securities Act. The Company agrees to notify TD Cowen promptly upon the Company becoming an “ineligible issuer.” (f) Distribution of Offering Material By the Company. The Company has not distributed and will not distribute, prior to the completion of TD Cowen’s distribution of the Placement Shares, any offering material in connection with the offering and sale of the Placement Shares other than the Prospectus or the Registration Statement. (g) WKSI. (i) At the time of filing the Registration Statement, (ii) at the time of the most recent amendment thereto for the purposes of complying with Section 10(a)(3) of the Securities Act (whether such amendment was by post-effective amendment, incorporated report filed pursuant to Section 13 or 15(d) of the Exchange Act or form of prospectus), (iii) at the time the Company or any person acting on its behalf (within the meaning, for this clause only, of Rule 163(c) under the Securities Act) made any offer relating to the Placement Shares in reliance on


 
- 7 - the exemption of Rule 163 under the Securities Act, and (iv) as of the time of any Placement, the Company was and is a “well known seasoned issuer” as defined in Rule 405; the Registration Statement is an “automatic shelf registration statement,” as defined in Rule 405, that has become or became effective automatically not more not more than three (3) years prior to the date of any Placement and the Company has not received from the Commission any notice pursuant to Rule 401(g)(2) under the Securities Act objecting to use of the automatic shelf registration statement form; and the Company has not otherwise ceased to be eligible to use the automatic shelf registration form. (h) The Sales Agreement. This Agreement has been duly authorized, executed and delivered by, and is a valid and binding agreement of, the Company, enforceable in accordance with its terms, except as rights to indemnification hereunder may be limited by applicable law and except as the enforcement hereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws relating to or affecting the rights and remedies of creditors or by general equitable principles. (i) Authorization of the Common Stock. The Placement Shares, when issued and delivered, will be duly authorized for issuance and sale pursuant to this Agreement and, when issued and delivered by the Company against payment therefor pursuant to this Agreement, will be duly authorized, validly issued, fully paid and nonassessable, free and clear of any pledge, lien, encumbrance, security interest or other claim, and the issuance and sale of the Placement Shares by the Company is not subject to preemptive or other similar rights arising by operation of law, under the organizational documents of the Company or under any agreement to which the Company or any of its subsidiaries (as defined in Rule 405 under the Securities Act, each a “Subsidiary”) is a party or otherwise. (j) No Applicable Registration or Other Similar Rights. There are no persons with registration or other similar rights to have any equity or debt securities registered for sale under the Registration Statement or included in the offering contemplated by this Agreement, except for such rights as have been duly waived. (k) XBRL. The interactive data in eXtensible Business Reporting Language included or incorporated by reference in each Registration Statement fairly presents the information called for in all material respects and has been prepared in accordance with the Commission’s rules and guidelines applicable thereto. (l) Incorporation and Good Standing of the Company and its Subsidiaries. The Company has been duly incorporated and is validly existing as a corporation in good standing under the laws of the jurisdiction of its incorporation. Each Subsidiary of the Company has been duly organized and is validly existing as a corporation or other legal entity in good standing (or the foreign equivalent thereof) under the laws of the jurisdiction of its organization. Each of the Company and its Subsidiaries is duly qualified as a foreign corporation or other legal entity to transact business and is in good standing under the laws of each jurisdiction in which such qualification is required, whether by reason of the ownership or leasing of property or the conduct of business, except for such jurisdictions where the failure to so qualify or to be in good standing would not reasonably be expected to (i) have, singly or in the aggregate, a material adverse effect on the business, properties, management, financial position, stockholders’ equity,


 
- 8 - results of operations or prospects of the Company and its Subsidiaries taken as a whole, or (ii) impair in any material respect the ability of the Company to perform its obligations under this Agreement or to consummate any transactions contemplated by this Agreement or the Prospectus (any such effect as described in clauses (i) or (ii), a “Material Adverse Effect”). The Company does not own or control, directly or indirectly, any corporation, association or other entity other than the Subsidiaries listed in Exhibit 21.1 to the Company’s Annual Report on Form 10-K for the most recently ended fiscal year and other than (i) those Subsidiaries not required to be listed on Exhibit 21.1 by Item 601 of Regulation S-K under the Exchange Act and (ii) those Subsidiaries formed since the last day of the most recently ended fiscal year. (m) Capital Stock Matters. The Common Stock conforms in all material respects to the description thereof contained in the Prospectus. All of the issued and outstanding shares of Common Stock have been duly authorized and validly issued, are fully paid and nonassessable and have been issued in compliance with federal and state securities laws. None of the outstanding shares of Common Stock were issued in violation of any preemptive rights, rights of first refusal or other similar rights to subscribe for or purchase securities of the Company. As of the date set forth in the Prospectus, there were no authorized or outstanding options, warrants, preemptive rights, rights of first refusal or other rights to purchase, or equity or debt securities convertible into or exchangeable or exercisable for, any capital stock of the Company or any of its Subsidiaries other than those described above or accurately described in all material respects in the Prospectus. The description of the Company’s stock option, stock bonus and other stock plans or arrangements, and the options or other rights granted thereunder, set forth in the Prospectus accurately and fairly presents in all material respects the information required to be shown with respect to such plans, arrangements, options and rights. (n) Non-Contravention of Existing Instruments; No Further Authorizations or Approvals Required. Neither the Company nor any of its Subsidiaries is in violation of its charter or by-laws (or analogous governing instrument, as applicable) or is in default (or, with the giving of notice or lapse of time, would be in default) (“Default”) under any indenture, mortgage, loan or credit agreement, note, contract, franchise, lease or other instrument to which the Company or any of its Subsidiaries is a party or by which it or any of them is bound, or to which any of the property or assets of the Company or any of its Subsidiaries is subject (each, an “Existing Instrument”), except for such Defaults as would not, singly or in the aggregate, have a Material Adverse Effect. The Company’s execution, delivery and performance of this Agreement and consummation of the transactions contemplated hereby(i) 1will not result in any violation of the provisions of the charter or by-laws (or analogous governing instruments, as applicable) of the Company or any Subsidiary, (ii) will not conflict with or constitute a breach of, or Default under, or result in the creation or imposition of any lien, charge or encumbrance upon any property or assets of the Company or any of its Subsidiaries pursuant to, any Existing Instrument, and (iii) will not result in any violation of any law, administrative regulation or administrative or court decree applicable to the Company or any Subsidiary, except, in the case of clauses (ii) and (iii) above, for such conflicts, breaches, Defaults, liens, charges or encumbrances as would not, singly or in the aggregate, reasonably be expected to have a 1 Already covered by (h) above.


 
- 9 - Material Adverse Effect . No consent, approval, authorization or other order of, or registration or filing with, any court or other governmental or regulatory authority or agency, is required for the Company’s execution, delivery and performance of this Agreement and consummation of the transactions contemplated hereby, except such as have been obtained or may be required under the Securities Act, applicable state securities or blue sky laws and from the Financial Industry Regulatory Authority (“FINRA”) and the Nasdaq Global Market. (o) Independent Auditors. BDO USA, P.C., who have certified certain financial statements and related schedules of the Company and its Subsidiaries included or incorporated by reference in the Registration Statement and the Prospectus, is an independent registered public accounting firm with respect to the Company and its Subsidiaries within the meaning of Article 2-01 of Regulation S-X and the Public Company Accounting Oversight Board (United States) (the “PCAOB”) and as required by the Securities Act and the Exchange Act. (p) Financial Statements. The financial statements, together with the related notes, included or incorporated by reference in the Prospectus and the Registration Statement fairly present, in all material respects, the financial position and the results of operations and changes in financial position of the Company and its consolidated Subsidiaries at the respective dates or for the respective periods therein specified. Such statements and related notes have been prepared in accordance with the generally accepted accounting principles in the United States (“GAAP”) applied on a consistent basis throughout the periods involved except as may be set forth in the related notes included or incorporated by reference in the Registration Statement and the Prospectus and provided that unaudited interim financial statements, which are subject to normal year-end adjustments, may not contain certain footnotes, as permitted by the rules of the Commission. The financial statements, together with the related notes, included or incorporated by reference in the Registration Statement and the Prospectus comply in all material respects with Regulation S-X. No other financial statements or supporting schedules or exhibits are required by Regulation S-X to be described or included in the Registration Statement or the Prospectus. The summary and selected financial data included in the Prospectus and the Registration Statement fairly present in all material respects the information shown therein at the respective dates and for the respective periods specified and are derived from the consolidated financial statements set forth in the Registration Statement and the Prospectus and other financial information. (q) No Material Adverse Change. Except as otherwise disclosed in the Prospectus, subsequent to the respective dates as of which information is given in the Prospectus, neither the Company nor any of its Subsidiaries has sustained, (i) any material loss or interference with its business from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor dispute or action, order or decree of any court or governmental or regulatory authority; (ii) any change in the capital stock (other than the issuance of shares of Common Stock upon exercise of stock options and warrants described as outstanding in, and the grant of options and awards under existing equity incentive plans described in, the Registration Statement and the Prospectus) or long-term debt of the Company or any of its Subsidiaries, or any dividend or distribution of any kind declared, set aside for payment, paid or made by the Company on any class of capital stock, or any material adverse changes, or any development involving a prospective material adverse change, in or affecting the business, properties, assets, general


 
- 10 - affairs, management, financial position, prospects, stockholders’ equity or results of operations of the Company and its Subsidiaries taken as a whole. (r) No Material Actions or Proceedings. Except as disclosed in the Prospectus, there are no legal or governmental actions, suits or proceedings pending or, to the Company’s knowledge, threatened (i) against the Company or any of its Subsidiaries or (ii) which has as the subject thereof any property owned by the Company or any of its Subsidiaries, which if determined adversely to the Company or any of its Subsidiaries, would reasonably be expected to have a Material Adverse Effect. Further, neither the Company nor any of its Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. No labor dispute with the employees of the Company or any of its Subsidiaries exists or, to the Company’s knowledge, is threatened or imminent that could reasonably be expected, singly or in the aggregate, to have a Material Adverse Effect. (s) All Necessary Permits, etc. The Company and each Subsidiary possesses such valid and current certificates, authorizations, registrations, licenses, or permits issued by, and have made all filings with, the appropriate state, federal or foreign regulatory agencies or bodies necessary to conduct their respective businesses, other than those the failure to possess or own, or where the invalidity or failure to be current or make such filings, would not reasonably be expected to have a Material Adverse Effect, and neither the Company nor any Subsidiary has received any written notice of proceedings relating to the revocation or modification of, or non- compliance with, any such certificate, authorization, registration, license, or permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably be expected to have a Material Adverse Effect. (t) Preclinical Studies and Clinical Trials. The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the “FDCA”) and the rules and regulations promulgated thereunder and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies, tests and trials contained in the Registration Statement and Prospectus are accurate in all material respects; the Company is not aware of any studies, tests or trials not described in the Registration Statement and the Prospectus, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement and Prospectus; and, except as disclosed in the Registration Statement and Prospectus, the Company has not received any written notice from the FDA or any comparable governmental entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials currently being conducted or proposed to be conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials.


 
- 11 - (u) Regulatory Compliance. The Company and each of its Subsidiaries have not, for the past three years, received any written notice of adverse filing, warning letter, untitled letter or other written correspondence or written notice from the FDA, or any other court or arbitrator or federal, state, local, or foreign governmental or regulatory authority, alleging or asserting material noncompliance with the FDCA. Except as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company and, to the Company’s knowledge, its directors, officers, employees and agents is and have been, for the past three years, in material compliance with applicable health care laws, including without limitation, (i) the FDCA, (ii) all applicable health care related fraud and abuse laws, including, without limitation the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. § 17921 et seq.) the exclusion laws (42 U.S.C. § 1320a-7), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), and the regulations promulgated pursuant to such laws, and comparable state and foreign laws (collectively, “Health Care Laws”). Additionally, neither the Company, any of its Subsidiaries nor any of their respective employees, officers, directors, or agents has been excluded, suspended or debarred from participation in any U.S. federal healthcare program or human clinical research or, to the Company’s knowledge, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion. (v) Company Not an “Investment Company”. The Company has been advised of the rules and requirements under the Investment Company Act of 1940, as amended (the “Investment Company Act”). The Company is not, and after receipt of payment for the Common Stock will not be, an “investment company” within the meaning of Investment Company Act. (w) No Price Stabilization or Manipulation. The Company has not taken and will not take, directly or indirectly, any action designed to or that might be reasonably expected to cause or result in stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Placement Shares. (x) Intellectual Property. The Company and its Subsidiaries own or possess the valid right to use all (i) patents, patent applications, trademarks, trademark registrations, service marks, service mark registrations, Internet domain name registrations, copyrights, copyright registrations, licenses, trade secret rights (“Intellectual Property Rights”) and (ii) inventions, software, works of authorships, trademarks, service marks, trade names, databases, formulae, know how, Internet domain names and other intellectual property (including trade secrets and other unpatented and/or unpatentable proprietary confidential information, systems, or procedures) (collectively, “Intellectual Property Assets”) necessary to conduct their respective businesses as currently conducted, and as proposed to be conducted and described in the Registration Statement and the Prospectus. The Company and its Subsidiaries have not received any opinion from their legal counsel concluding that any activities of their respective businesses infringe, misappropriate, or otherwise violate, valid and enforceable Intellectual Property Rights


 
- 12 - of any other person, and have not received written notice of any challenge, which is to their knowledge still pending, by any other person to the rights of the Company and its Subsidiaries with respect to any Intellectual Property Rights or Intellectual Property Assets owned or used by the Company or its Subsidiaries. To the Company’s knowledge, the Company and its Subsidiaries’ respective businesses as now conducted do not give rise to any infringement of, any misappropriation of, or other violation of, any valid and enforceable Intellectual Property Rights of any other person. All licenses for the use of the Intellectual Property Rights described in the Registration Statement and the Prospectus are valid, binding upon, and enforceable by or against the parties thereto in accordance to its terms. The Company has complied in all material respects with, and is not in breach nor has received any asserted or threatened claim of breach of any Intellectual Property license, and the Company has no knowledge of any breach or anticipated breach by any other person to any Intellectual Property license. Except as described in the Registration Statement or the Prospectus, no claim has been made against the Company alleging the infringement by the Company of any patent, trademark, service mark, trade name, copyright, trade secret, license in or other intellectual property right or franchise right of any person. The Company has taken all reasonable steps to protect, maintain and safeguard its Intellectual Property Rights, including the execution of appropriate nondisclosure and confidentiality agreements. The consummation of the transactions contemplated by this Agreement will not result in the loss or impairment of or payment of any additional amounts with respect to, nor require the consent of any other person in respect of, the Company’s right to own, use, or hold for use any of the Intellectual Property Rights as owned, used or held for use in the conduct of the business as currently conducted. With respect to the use of the software in the Company’s business as it is currently conducted, the Company has not experienced any material defects in such software including any material error or omission in the processing of any transactions other than defects which have been corrected, and to the Company’s knowledge, no such software contains any device or feature designed to disrupt, disable, or otherwise impair the functioning of any software or is subject to the terms of any “open source” or other similar license that provides for the source code of the software to be publicly distributed or dedicated to the public. To the Company’s knowledge, except as disclosed in the Registration Statement or the Prospectus, (i) all patents and patent applications have been properly filed and each issued patent is being diligently maintained; (ii) the Company has taken reasonable steps to obtain executed nondisclosure, confidentiality agreements and invention assignment agreements and invention assignments with its employees, (iii) no employee of the Company is in or has been in violation of any term of any employment contract, patent disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation agreement, nondisclosure agreement, or any restrictive covenant to or with a former employer where the basis of such violation relates to such employee’s employment with the Company; (iv) the duty of candor and good faith as required by the United States Patent and Trademark Office during the prosecution of the United States patents and patent applications included in the Intellectual Property Rights have been complied with, and in all foreign offices having similar requirements, all such requirements have been complied with; (v) there are no third parties who have rights to any Intellectual Property Rights owned by the Company, except for non-exclusive out-licenses to such Intellectual Property granted in the ordinary course of business; and (vi) there is no infringement by third parties of any Intellectual Property Rights owned or licensed to the Company; in each case that would reasonably be expected, singly or in the aggregate, to have a Material Adverse Effect.


 
- 13 - (y) IT Systems. (i)(x) To the Company’s knowledge, there has been no material security breach or attack or other compromise of or relating to any of the Company’s and its Subsidiaries’ information technology and computer systems, networks, hardware, software, data (including the data of their respective customers, employees, suppliers, vendors and any third party data maintained by or on behalf of them), equipment or technology (“IT Systems and Data”), and (y) the Company and its Subsidiaries have not been notified of, and have no knowledge of any event or condition that would reasonably be expected to result in any material security breach, attack or compromise to their IT Systems and Data, (ii) the Company and each of its Subsidiaries have complied, in all material respects, and are presently in compliance with, all applicable laws, statutes or any judgment, order, rule or regulation of any court or arbitrator or governmental or regulatory authority and all industry guidelines, standards, internal policies and contractual obligations relating to the privacy and security of IT Systems and Data and to the protection of such IT Systems and Data from unauthorized use, access, misappropriation or modification, (iii) the Company and each of its Subsidiaries have implemented commercially reasonable backup and disaster recovery technology consistent with industry standards and practice, and (iv) neither the Company nor any of its Subsidiaries (x) has received notice of any actual or potential liability under or relating to any applicable law, industry guidelines, standards, internal policies and contractual obligations governing the IT Systems and Data, and (y) is party to any order, decree or agreement that imposed any obligations or liability under or relating to any applicable law, industry guidelines, standards, internal policies and contractual obligations governing the IT Systems and Data. (z) [Reserved]. (aa) Title to Real and Personal Property. The Company does not own any real property and the Company and each of its Subsidiaries have valid and marketable rights to lease or otherwise use, all items of real or personal property which are material to the business of the Company and its Subsidiaries taken as a whole, in each case free and clear of all liens, encumbrances, security interests, claims and defects that (i) do not, singly or in the aggregate, materially affect the value of such property and do not materially interfere with the use made and proposed to be made of such property by the Company or any of its Subsidiaries or (ii) could not reasonably be expected, singly or in the aggregate, to have a Material Adverse Effect. (bb) Compliance with ERISA. No “prohibited transaction” (as defined in Section 406 of the Employee Retirement Income Security Act of 1974, as amended, including the regulations and published interpretations thereunder (“ERISA”), or Section 4975 of the Internal Revenue Code of 1986, as amended from time to time (the “Code”)) or “accumulated funding deficiency” (as defined in Section 302 of ERISA) or any of the events set forth in Section 4043(b) of ERISA (other than events with respect to which the thirty (30)-day notice requirement under Section 4043 of ERISA has been waived) has occurred or could reasonably be expected to occur with respect to any employee benefit plan of the Company or any of its Subsidiaries which could, singly or in the aggregate, have a Material Adverse Effect. Each employee benefit plan of the Company or any of its Subsidiaries is in compliance in all material respects with applicable law, including ERISA and the Code. The Company and its Subsidiaries have not incurred and could not reasonably be expected to incur liability under Title IV of ERISA with respect to the termination of, or withdrawal from, any pension plan (as defined in ERISA). Each pension plan for which the Company or any of its Subsidiaries would have any liability that is intended to be


 
- 14 - qualified under Section 401(a) of the Code is so qualified, and to the Company’s knowledge, nothing has occurred, whether by action or by failure to act, which could, singly or in the aggregate, reasonably be expected to cause the loss of such qualification. (cc) Compliance with Environmental Laws. The Company and its Subsidiaries are in compliance in all material respects with all foreign, federal, state and local rules, laws and regulations relating to the use, treatment, storage and disposal of hazardous or toxic substances or waste and protection of health and safety or the environment which are applicable to their businesses (“Environmental Laws”). There has been no storage, generation, transportation, handling, treatment, disposal, discharge, emission, or other release of any kind of toxic or other wastes or other hazardous substances by, due to, or caused by the Company or any of its Subsidiaries (or, to the Company’s knowledge, any other entity for whose acts or omissions the Company or any of its Subsidiaries is or may otherwise be liable) upon any of the property now or previously owned or leased by the Company or any of its Subsidiaries, or upon any other property, in violation of any law, statute, ordinance, rule, regulation, order, judgment, decree or permit or which would, under any law, statute, ordinance, rule (including rule of common law), regulation, order, judgment, decree or permit, give rise to any liability that could, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect; and there has been no disposal, discharge, emission or other release of any kind onto such property or into the environment surrounding such property of any toxic or other wastes or other hazardous substances with respect to which the Company or any of its Subsidiaries has knowledge.2 (dd) Tax Law Compliance. The Company and its Subsidiaries each (i) have timely filed all necessary federal, state, local and foreign tax returns, and all such returns were true, complete and correct in all material respects, (ii) have paid all federal, state, local and foreign taxes, for which it is liable, including, without limitation, all sales and use taxes and all taxes which the Company or any of its subsidiaries is obligated to withhold from amounts owing to employees, creditors and third parties, and (iii) do not have any tax deficiency or claims outstanding or assessed or, to its knowledge, proposed against any of them, except those, in each of the cases described in clauses (i), (ii) and (iii) above, that would not, singly or in the aggregate, have a Material Adverse Effect. (ee) Insurance. The Company and each of its Subsidiaries carry, or are covered by, insurance in such amounts and covering such risks as the Company reasonably believes is adequate for the conduct of their respective businesses and the value of their respective properties. Neither the Company nor any of its Subsidiaries has any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business at a cost that would not have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries has received written notice from any insurer, agent of such insurer or the broker of the Company or any of its Subsidiaries that any material capital improvements or any other material expenditures (other than premium payments) are required or necessary to be made in order to continue such insurance. 2 This and others below track the June follow-on UA.


 
- 15 - (ff) Accounting Controls. The Company maintains a system of “internal control over financial reporting” (as such term is defined in Rule 13a-15(f) of the General Rules and Regulations under the Exchange Act (the “Exchange Act Rules”)) that complies with the requirements of the Exchange Act and has been designed by their respective principal executive and principal financial officers, or under their supervision, to provide reasonable assurances that (i) transactions are executed in accordance with management’s general or specific authorizations; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with U.S. GAAP and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences and (v) interactive data in eXtensible Business Reporting Language included or incorporated by reference in the Registration Statement fairly presents the Commission’s rules and guidelines applicable thereto. Except as described in the Registration Statement or Prospectus, the Company’s internal control over financial reporting is effective. Except as described in the Registration Statement or Prospectus, since the end of the Company’s most recent audited fiscal year, there has been (A) no material weakness in the Company’s internal control over financial reporting (whether or not remediated) and (B) no change in the Company’s internal control over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting. (gg) Disclosure Controls. The Company and its Subsidiaries maintain disclosure controls and procedures (as such term is defined in Rule 13a-15(e) of the Exchange Act Rules) that comply with the requirements of the Exchange Act; such disclosure controls and procedures have been designed to ensure that information required to be disclosed by the Company and its Subsidiaries in reports that they file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Commission’s rules and forms, including controls and procedures designed to ensure that such information is accumulated and communicated to the Company’s management to allow timely decisions regarding disclosures. The Company and its Subsidiaries have conducted evaluations of the effectiveness of their disclosure controls as required by Rule 13a-15 of the Exchange Act. (hh) Brokers. Except for TD Cowen, there is no broker, finder or other party that is entitled to receive from the Company any brokerage commission, finder’s fee or like payment as a result of any transactions contemplated by this Agreement. (ii) Listing. The Company is subject to and in compliance in all material respects with the reporting requirements of Section 13 or Section 15(d) of the Exchange Act. The Common Stock is registered pursuant to Section 12(b) or Section 12(g) of the Exchange Act and is listed on the Nasdaq, and the Company has taken no action designed to, or reasonably likely to have the effect of, terminating the registration of the Common Stock under the Exchange Act or delisting the Common Stock from Nasdaq, nor has the Company received any notification that the Commission or Nasdaq is contemplating terminating such registration or listing. All of the Placement Shares that have been or may be sold under this Agreement have been approved for listing on the Nasdaq, subject to official notice of issuance; the Company has taken all necessary actions to ensure that, upon and at all times after the Nasdaq shall have approved the Placement


 
- 16 - Shares for listing, it will be in compliance with all applicable corporate governance requirements set forth in the Nasdaq’s listing rules that are then in effect. (jj) Sarbanes-Oxley Act. There is and has been no failure on the part of the Company or, to the Company’s knowledge, any of the Company’s officers or directors, in their capacities as such, to comply with any provision of the Sarbanes-Oxley Act of 2002 and the rules and regulations promulgated in connection therewith applicable to the Company or such officers or directors as of the date hereof, including Section 402 related to loans and Sections 302 and 906 related to certifications. (kk) No Unlawful Contributions or Other Payments. Neither the Company nor any of its Subsidiaries nor, to the Company’s knowledge, any director, officer, employee, agent, affiliate or other person acting on behalf of the Company or any Subsidiary has (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government officials or employees, political parties or campaigns, political party officials, or candidates for political office from corporate funds; (iii) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended, or any applicable anti-corruption laws, rules, or regulations of any other jurisdiction in which the Company or any Subsidiary conducts business; or (iv) made any other unlawful bribe, rebate, payoff, influence payment, kickback or other unlawful payment to any person. (ll) No Outstanding Loans or Other Indebtedness. Except as described in the Registration Statement or Prospectus, there are no outstanding loans, advances (except normal advances for business expenses in the ordinary course of business) or guarantees of indebtedness by the Company to or for the benefit of any of the officers or directors of the Company or any of their family members. (mm) Statistical and Market Data. The statistical and market related data included in the Registration Statement and the Prospectus are based on or derived from sources that the Company believes to be reliable and accurate, and such data agree with the sources from which they are derived. (nn) Compliance with Anti-Money Laundering Laws. The operations of the Company and its Subsidiaries are and have been conducted at all times in compliance with all applicable financial recordkeeping and reporting requirements, including those of the U.S. Bank Secrecy Act, as amended by Title III of the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act of 2001 (USA PATRIOT Act), and the applicable anti-money laundering statutes of jurisdictions where the Company and its Subsidiaries conduct business, the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the “Anti-Money Laundering Laws”), and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any of its Subsidiaries with respect to Anti-Money Laundering Laws is pending, or to the knowledge of the Company, threatened. (oo) Compliance with OFAC.


 
- 17 - (A) Neither the Company nor any of its Subsidiaries, nor any director, officer or employee thereof, nor to the Company’s knowledge, any agent, affiliate, representative, or other person acting on behalf of the Company or any of its Subsidiaries, is an individual or entity (“Person”) that is, or is owned or controlled by a Person that is: (i) the subject of any sanctions administered or enforced by the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”), the United Nations Security Council, the European Union (“EU”), His Majesty’s Treasury, or other relevant sanctions authority (collectively, “Sanctions”), nor (ii) located, organized, or resident in a country or territory that is the subject of a U.S. government embargo (including, without limitation, the so-called Donetsk People’s Republic, the so-called Luhansk People’s Republic, the Crimea Region of Ukraine, Cuba, Iran, North Korea and Syria). (B) The Company will not, directly or indirectly, use the Net Proceeds, or lend, contribute or otherwise make available such Net Proceeds to any Subsidiary, joint venture partner or other Person: (i) to fund or facilitate any activities or business of or with any Person that, at the time of such funding or facilitation, is the subject of Sanctions, or in any country or territory that, at the time of such funding or facilitation, is the subject of a U.S. government embargo; or (ii) in any other manner that will result in a violation of Sanctions by any Person (including TD Cowen). (C) Since April 24, 2019, the Company and its Subsidiaries have not knowingly engaged in, are not now knowingly engaged in, and will not engage in, any direct or indirect dealings or transactions with any Person that at the time of the dealing or transaction is or was the subject of Sanctions or any country or territory that, at the time of the dealing or transaction is or was the subject of a U.S. government embargo. (pp) No Associated Persons; FINRA Matters. Neither the Company nor any of its affiliates (within the meaning of FINRA Rule 5121(f)(1)) directly or indirectly controls, is controlled by, or is under common control with, or is an associated person (within the meaning of Article I, Section 1(ee) of the By-laws of FINRA) of, any member firm of FINRA. The Company is an “experienced issuer” as defined in FINRA Rule 5110(j)(6). (qq) No Acquisitions or Dispositions. Except as are described in the Registration Statement and the Prospectus, there are no contracts, letters of intent, term sheets, agreement, arrangements or understandings with respect to the direct or indirect acquisition or disposition by the Company of material interests in real or personal property. (rr) Exchange Act Compliance. The documents incorporated or deemed to be incorporated by reference in the Prospectus, at the time they were or hereafter are filed with the Commission, complied and will comply in all material respects with the requirements of the Exchange Act, and, when read together with the other information in the Prospectus, at the Settlement Dates, will not contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading.


 
- 18 - (ss) No Reliance. The Company has not relied upon TD Cowen or legal counsel for TD Cowen for any legal, tax or accounting advice in connection with the offering and sale of the Placement Shares. Any certificate signed by an officer of the Company and delivered to TD Cowen or to counsel for TD Cowen pursuant to or in connection with this Agreement shall be deemed to be a representation and warranty by the Company to TD Cowen as to the matters set forth therein. The Company acknowledges that TD Cowen and, for purposes of the opinions to be delivered pursuant to Section 7 hereof, counsel to the Company and counsel to TD Cowen, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance. 7. Covenants of the Company. The Company covenants and agrees with TD Cowen that: (a) Registration Statement Amendments. After the date of this Agreement and during any period in which a Prospectus relating to any Placement Shares is required to be delivered by TD Cowen under the Securities Act (including in circumstances where such requirement may be satisfied pursuant to Rule 172 under the Securities Act), (i) the Company will notify TD Cowen promptly of the time when any subsequent amendment to the Registration Statement, other than documents incorporated by reference, has been filed with the Commission and/or has become effective or any subsequent supplement to the Prospectus has been filed and of any request by the Commission for any amendment or supplement to the Registration Statement or Prospectus or for additional information, (ii) the Company will prepare and file with the Commission, promptly upon TD Cowen’s reasonable request, any amendments or supplements to the Registration Statement or Prospectus that, in TD Cowen’s reasonable opinion, may be necessary or advisable in connection with the distribution of the Placement Shares by TD Cowen (provided, however, that (x) the failure of TD Cowen to make such request shall not relieve the Company of any obligation or liability hereunder, or affect TD Cowen’s right to rely on the representations and warranties made by the Company in this Agreement and (y) the only remedy TD Cowen shall have with respect to the failure by the Company to make such filing (other than TD Cowen’s rights under Section 9 hereof) shall be to cease making sales under this Agreement until such amendment or supplement is filed); (iii) the Company will not file any amendment or supplement to the Registration Statement or Prospectus, other than documents incorporated by reference, relating to the Placement Shares or a security convertible into the Placement Shares unless a copy thereof has been submitted to TD Cowen within a reasonable period of time before the filing and TD Cowen has not reasonably objected thereto (provided, however, that (A) the failure of TD Cowen to make such objection shall not relieve the Company of any obligation or liability hereunder, or affect TD Cowen’s right to rely on the representations and warranties made by the Company in this Agreement, (B) the Company has no obligation to provide TD Cowen any advance copy of such filing or to provide TD Cowen an opportunity to object to such filing if the filing does not name TD Cowen and does not relate to the transaction herein and (C) the only remedy TD Cowen shall have with respect to the failure by the Company to provide TD Cowen with such copy, to make such filings, or to obtain such consent (other than TD Cowen’s rights under Section 9 hereof) shall be to cease making sales under this Agreement) and the Company will furnish to TD Cowen at the time of filing thereof a copy of any document that


 
- 19 - upon filing is deemed to be incorporated by reference into the Registration Statement or Prospectus, except for those documents available via EDGAR; (iv) the Company will cause each amendment or supplement to the Prospectus, other than documents incorporated by reference, to be filed with the Commission as required pursuant to the applicable paragraph of Rule 424(b) of the Securities Act, and (v) prior to the termination of this Agreement, the Company will notify TD Cowen if at any time the Registration Statement shall no longer be effective as a result of the passage of time pursuant to Rule 415 under the Securities Act or otherwise. (b) Notice of Commission Stop Orders. The Company will advise TD Cowen, promptly after it receives notice or obtains knowledge thereof, of the issuance or threatened issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement, of the suspension of the qualification of the Placement Shares for offering or sale in any jurisdiction, or of the initiation or threatening of any proceeding for any such purpose; and it will promptly use its commercially reasonable efforts to prevent the issuance of any stop order or to obtain its withdrawal if such a stop order should be issued. (c) Delivery of Prospectus; Subsequent Changes. During any period in which a Prospectus relating to the Placement Shares is required to be delivered by TD Cowen under the Securities Act with respect to a pending sale of the Placement Shares, (including in circumstances where such requirement may be satisfied pursuant to Rule 172 under the Securities Act), the Company will comply with all requirements imposed upon it by the Securities Act, as from time to time in force, and to file on or before their respective due dates all reports and any definitive proxy or information statements required to be filed by the Company with the Commission pursuant to Sections 13(a), 13(c), 14, 15(d) or any other provision of or under the Exchange Act. If during such period any event occurs as a result of which the Prospectus as then amended or supplemented would include an untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances then existing, not misleading, or if during such period it is necessary to amend or supplement the Registration Statement or Prospectus to comply with the Securities Act, the Company will promptly notify TD Cowen to suspend the offering of Placement Shares during such period and the Company will promptly amend or supplement the Registration Statement or Prospectus (at the expense of the Company) so as to correct such statement or omission or effect such compliance; provided, that, the Company may delay the filing of any amendment or supplement, if in the judgment of the Company, it is in the best interest of the Company, during which time of delay of Cowen shall be under no obligation to make any sales of the Placement Shares hereunder. (d) Listing of Placement Shares. During any period in which the Prospectus relating to the Placement Shares is required to be delivered by TD Cowen under the Securities Act with respect to a pending sale of the Placement Shares (including in circumstances where such requirement may be satisfied pursuant to Rule 172 under the Securities Act), the Company will use its commercially reasonable efforts to cause the Placement Shares to be listed on Nasdaq and to qualify the Placement Shares for sale under the securities laws of such jurisdictions as TD Cowen reasonably designates and to continue such qualifications in effect so long as required for the distribution of the Placement Shares; provided, however, that the Company shall not be required in connection therewith to qualify as a foreign corporation or dealer in securities or file a general consent to service of process in any jurisdiction.


 
- 20 - (e) Delivery of Registration Statement and Prospectus. The Company will furnish to TD Cowen and its counsel (at the expense of the Company) copies of the Registration Statement, the Prospectus (including all documents incorporated by reference therein) and all amendments and supplements to the Registration Statement or Prospectus that are filed with the Commission during any period in which a Prospectus relating to the Placement Shares is required to be delivered under the Securities Act (including all documents filed with the Commission during such period that are deemed to be incorporated by reference therein), in each case as soon as reasonably practicable and in such quantities as TD Cowen may from time to time reasonably request and, at TD Cowen’s request, will also furnish copies of the Prospectus to each exchange or market on which sales of the Placement Shares may be made; provided, however, that the Company shall not be required to furnish any document (other than the Prospectus) to TD Cowen to the extent such document is available on EDGAR. (f) Earnings Statement. The Company will make generally available to its security holders as soon as practicable, but in any event not later than 15 months after the end of the Company’s current fiscal quarter, an earnings statement covering a 12-month period that satisfies the provisions of Section 11(a) and Rule 158 of the Securities Act. (g) Expenses. The Company, whether or not the transactions contemplated hereunder are consummated or this Agreement is terminated, in accordance with the provisions of Section 11 hereunder, will pay the following expenses all incident to the performance of its obligations hereunder, including, but not limited to, expenses relating to (i) the preparation, printing and filing of the Registration Statement and each amendment and supplement thereto, of each Prospectus and of each amendment and supplement thereto, (ii) the preparation, issuance and delivery of the Placement Shares, (iii) the qualification of the Placement Shares under securities laws in accordance with the provisions of Section 7(d) of this Agreement, including filing fees (provided, however, that any fees or disbursements of counsel for TD Cowen in connection therewith shall be paid by TD Cowen except as set forth in (vii) below), (iv) the printing and delivery to TD Cowen of copies of the Prospectus and any amendments or supplements thereto, and of this Agreement, (v) the fees and expenses incurred in connection with the listing or qualification of the Placement Shares for trading on Nasdaq, (vi) the filing fees and expenses, if any, of the Commission, (vii) the filing fees and associated legal expenses of TD Cowen’s outside counsel for filings with the FINRA Corporate Financing Department, such legal expense reimbursement not to exceed $15,000 and, (viii) the reasonable fees and disbursements of TD Cowen’s counsel, such legal expense reimbursement set forth in clauses (vii) and (viii) in an amount not to exceed $75,000 in connection with the execution of this Agreement. (h) Use of Proceeds. The Company will use the Net Proceeds as described in the Prospectus in the section entitled “Use of Proceeds.” (i) Notice of Other Sales. During the pendency of any Placement Notice given hereunder, and for 5 trading days following the termination of any Placement Notice given hereunder, the Company shall provide TD Cowen notice as promptly as reasonably practicable before it offers to sell, contracts to sell, sells, grants any option to sell or otherwise disposes of any shares of Common Stock (other than Placement Shares offered pursuant to the provisions of this Agreement) or securities convertible into or exchangeable for Common Stock, warrants or any rights to purchase or acquire Common Stock; provided, that such notice shall not be required


 
- 21 - in connection with the (i) issuance, grant or sale of Common Stock, options to purchase shares of Common Stock or Common Stock issuable upon the exercise of options or other equity awards pursuant to any stock option, stock bonus or other stock plan or arrangement described in the Prospectus, (ii) adopt a new equity incentive plan, and file a registration statement on Form S-8 under the Securities Act to register the offer and sale of securities to be issued pursuant to such new equity incentive plan, and issue securities pursuant to such new equity incentive plan (including, without limitation, the issuance of shares of Common Stock upon the exercise of options or other securities issued pursuant to such new equity incentive plan), provided that such new equity incentive plan satisfies the transaction requirements of General Instruction A.1 of Form S-8 under the Securities Act, (iii) issue shares of Common Stock in connection with a licensing agreement, joint venture, acquisition or business combination or other collaboration or strategic transaction (including the filing of a registration statement on Form S-4 or other appropriate form with respect thereto), provided that the sum of the aggregate number of shares of Common Stock so issued shall not exceed 5% of the total outstanding shares of Common Stock outstanding immediately following the completion of such issuance, (iv) the issuance or sale of Common Stock pursuant to any dividend reinvestment plan that the Company may adopt from time to time provided the implementation of such is disclosed to TD Cowen in advance or (v) the issuance of any shares of Common Stock issuable upon the exchange, conversion or redemption of securities or the exercise of warrants, options or other rights in effect or outstanding. (j) Change of Circumstances. The Company will, at any time during a fiscal quarter in which the Company intends to tender a Placement Notice or sell Placement Shares, advise TD Cowen promptly after it shall have received notice or obtained knowledge thereof, of any information or fact that would alter or affect in any material respect any opinion, certificate, letter or other document provided to TD Cowen pursuant to this Agreement. (k) Due Diligence Cooperation. The Company will cooperate with any reasonable due diligence review conducted by TD Cowen or its agents in connection with the transactions contemplated hereby, including, without limitation, providing information and making available documents and senior corporate officers, during regular business hours and at the Company’s principal offices, as TD Cowen may reasonably request. (l) Required Filings Relating to Placement of Placement Shares. The Company agrees that on such dates as the Securities Act shall require, the Company will (i) file a prospectus supplement with the Commission under the applicable paragraph of Rule 424(b) under the Securities Act and (ii) deliver such number of copies of each such prospectus supplement to each exchange or market on which such sales were effected as may be required by the rules or regulations of such exchange or market. The Company shall disclose in its quarterly reports on Form 10-Q and in its annual report on Form 10-K, the number of the Placement Shares sold through TD Cowen under this Agreement, the gross proceeds to the Company from the sale of the Placement Shares and the average price of the Placement Shares sold pursuant to this Agreement during the relevant quarter or, in the case of an Annual Report on Form 10-K, during the fiscal year covered by such Annual Report and the fourth quarter of such fiscal year. (m) Bring-Down Dates; Certificate. On or prior to the First Delivery Date and each time (i) the Company files the Prospectus relating to the Placement Shares or amends or


 
- 22 - supplements the Registration Statement or the Prospectus relating to the Placement Shares (other than a prospectus supplement filed in accordance with Section 7(l) of this Agreement) by means of a post-effective amendment, sticker, or supplement but not by means of incorporation of document(s) by reference to the Registration Statement or the Prospectus relating to the Placement Shares; (ii) the Company files an annual report on Form 10-K under the Exchange Act; (iii) the Company files its quarterly reports on Form 10-Q under the Exchange Act; or (iv) the Company files a report on Form 8-K containing amended financial information (other than an earnings release) under the Exchange Act (each date of filing of one or more of the documents referred to in clauses (i) through (iv) shall be a “Bring-Down Date”); the Company shall furnish TD Cowen with a certificate, in the form attached hereto as Exhibit 7(m) within one (1) Trading Day of any Bring-Down Date if requested by TD Cowen. The requirement to provide a certificate under this Section 7(m) shall be waived for any Bring-Down Date occurring at a time at which no Placement Notice is pending, which waiver shall continue until the earlier to occur of the date the Company delivers a Placement Notice hereunder (which for such calendar quarter shall be considered a Bring-Down Date) and the next occurring Bring-Down Date. Notwithstanding the foregoing, if the Company subsequently decides to sell Placement Shares following a Bring-Down Date when the Company relied on such waiver and did not provide TD Cowen with a certificate under this Section 7(m), then before the Company delivers the Placement Notice or TD Cowen sells any Placement Shares, the Company shall provide TD Cowen with a certificate, in the form attached hereto as Exhibit 7(m), dated the date of the Placement Notice. (n) Legal Opinion. On or prior to the First Delivery Date and within one (1) Trading Day of each Bring-Down Date with respect to which the Company is obligated to deliver a certificate in the form attached hereto as Exhibit 7(m) for which no waiver is applicable, the Company shall cause to be furnished to TD Cowen a written opinion of Latham & Watkins, LLP (“Company Counsel”), or other counsel satisfactory to TD Cowen, in form and substance satisfactory to TD Cowen and its counsel, dated the date that the opinion is required to be delivered, modified, as necessary, to relate to the Registration Statement and the Prospectus as then amended or supplemented; provided, however, that in lieu of such opinions for subsequent Bring-Down Dates, counsel may furnish TD Cowen with a letter (a “Reliance Letter”) to the effect that TD Cowen may rely on a prior opinion delivered under this Section 7(n) to the same extent as if it were dated the date of such letter (except that statements in such prior opinion shall be deemed to relate to the Registration Statement and the Prospectus as amended or supplemented at such Bring-Down Date). (o) Comfort Letter. On or prior to the First Delivery Date and within one (1) Trading Day of each Bring-Down Date with respect to which the Company is obligated to deliver a certificate in the form attached hereto as Exhibit 7(m) for which no waiver is applicable, the Company shall cause its independent accountants to furnish TD Cowen letters (the “Comfort Letters”), dated the date the Comfort Letter is delivered, in form and substance satisfactory to TD Cowen, (i) confirming that they are an independent registered public accounting firm within the meaning of the Securities Act and the PCAOB, (ii) stating, as of such date, the conclusions and findings of such firm with respect to the financial information and other matters ordinarily covered by accountants’ “comfort letters” to TD Cowen in connection with registered public offerings (the first such letter, the “Initial Comfort Letter”) and (iii) updating the Initial Comfort Letter with any information that would have been included in the Initial Comfort Letter


 
- 23 - had it been given on such date and modified as necessary to relate to the Registration Statement and the Prospectus, as amended and supplemented to the date of such letter; provided that the Company shall be required to furnish to Cowen no more than one Comfort Letter hereunder in connection with each filing of an annual report on Form 10-K or a quarterly report on Form 10- Q. (p) Market Activities. The Company will not, directly or indirectly, (i) take any action designed to cause or result in, or that constitutes or might reasonably be expected to constitute, the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Placement Shares or (ii) sell, bid for, or purchase the Placement Shares to be issued and sold pursuant to this Agreement, or pay anyone any compensation for soliciting purchases of the Placement Shares other than TD Cowen; provided, however, that the Company may bid for and purchase shares of its Common Stock in accordance with Rule 10b-18 under the Exchange Act. (q) Insurance. The Company and its Subsidiaries shall maintain, or cause to be maintained, insurance in such amounts and covering such risks as is reasonable and customary for the business for which it is engaged. (r) Compliance with Laws. The Company and each of its Subsidiaries shall maintain, or cause to be maintained, all material environmental permits, licenses and other authorizations required by federal, state and local law in order to conduct their businesses as described in the Prospectus, and the Company and each of its Subsidiaries shall conduct their businesses, or cause their businesses to be conducted, in substantial compliance with such permits, licenses and authorizations and with applicable Environmental Laws, except where the failure to maintain or be in compliance with such permits, licenses and authorizations could not reasonably be expected to have a Material Adverse Effect. (s) Investment Company Act. The Company will conduct its affairs in such a manner so as to reasonably ensure that neither it nor its Subsidiaries will be or become, at any time prior to the termination of this Agreement, an “investment company,” as such term is defined in the Investment Company Act, assuming no change in the Commission’s current interpretation as to entities that are not considered an investment company. (t) Securities Act and Exchange Act. The Company will use its best efforts to comply with all requirements imposed upon it by the Securities Act and the Exchange Act as from time to time in force, so far as necessary to permit the continuance of sales of, or dealings in, the Placement Shares as contemplated by the provisions hereof and the Prospectus. (u) No Offer to Sell. Other than a Permitted Free Writing Prospectus, neither TD Cowen nor the Company (including its agents and representatives, other than TD Cowen in its capacity as such) will make, use, prepare, authorize, approve or refer to any written communication (as defined in Rule 405 under the Securities Act), required to be filed with the Commission, that constitutes an offer to sell or solicitation of an offer to buy Common Stock hereunder. (v) Sarbanes-Oxley Act. The Company and its Subsidiaries will use their best efforts to comply with all effective applicable provisions of the Sarbanes-Oxley Act.


 
- 24 - (w) Affirmation. Each Placement Notice delivered by the Company to TD Cowen shall be deemed to be (i) an affirmation that the representations, warranties and agreements of the Company herein contained and contained in any certificate delivered to TD Cowen pursuant hereto are true and correct at the time of delivery of such Placement Notice, and (ii) an undertaking that such representations, warranties and agreements will be true and correct on any applicable Time of Sale and Settlement Date, as though made at and as of each such time (it being understood that such representations, warranties and agreements shall relate to the Registration Statement and the Prospectus as amended and supplemented to the time of such Placement Notice acceptance). (x) Renewal. If immediately prior to the third anniversary (the “Renewal Deadline”) of the initial effective date of the Registration Statement, the aggregate gross sales price of Placement Shares sold by the Company is less than the Maximum Amount and this Agreement has not expired or been terminated, the Company will, prior to the Renewal Deadline, file, if it has not already done so and is eligible to do so, a new shelf registration statement relating to the Placement Shares, in a form satisfactory to TD Cowen, and, if not automatically effective, will use its best efforts to cause such registration statement to be declared effective within 60 days after the Renewal Deadline. The Company will take all other action necessary or appropriate to permit the issuance and sale of the Placement Shares to continue as contemplated in the expired registration statement relating to the Placement Shares. References herein to the Registration Statement shall include such new shelf registration statement. 8. Conditions to TD Cowen’s Obligations. The obligations of TD Cowen hereunder with respect to a Placement Notice will be subject to the continuing accuracy and completeness of the representations and warranties made by the Company herein, to the due performance by the Company of its obligations hereunder and thereunder, to the completion by TD Cowen of a due diligence review satisfactory to TD Cowen in its reasonable judgment, and to the continuing satisfaction (or waiver by TD Cowen in its sole discretion) of the following additional conditions: (a) Registration Statement Effective. The Registration Statement shall be effective and shall be available for (i) all sales of Placement Shares issued pursuant to all prior Placement Notices and (ii) the sale of all Placement Shares contemplated to be issued pursuant to any Placement Notice. (b) No Material Notices. None of the following events shall have occurred and be continuing: (i) receipt by the Company or any of its Subsidiaries of any request for additional information from the Commission or any other federal or state governmental authority during the period of effectiveness of the Registration Statement, the response to which would require any post-effective amendments or supplements to the Registration Statement or the Prospectus; (ii) the issuance by the Commission or any other federal or state governmental authority of any stop order suspending the effectiveness of the Registration Statement or the initiation of any proceedings for that purpose; (iii) receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Placement Shares for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose; or (iv) the occurrence of any event that makes any material statement made in the Registration


 
- 25 - Statement or the Prospectus or any material document incorporated or deemed to be incorporated therein by reference untrue in any material respect or that requires the making of any changes in the Registration Statement, related Prospectus or such documents so that, in the case of the Registration Statement, it will not contain any materially untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein not misleading and, that in the case of the Prospectus, it will not contain any materially untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading. (c) No Misstatement or Material Omission. TD Cowen shall not have advised the Company that the Registration Statement or Prospectus, or any amendment or supplement thereto, contains an untrue statement of fact that in TD Cowen’s reasonable opinion is material, or omits to state a fact that in TD Cowen’s reasonable opinion is material and is required to be stated therein or is necessary to make the statements therein not misleading. (d) Material Changes. Except as contemplated in the Prospectus, or disclosed in the Company’s reports filed with the Commission, there shall not have been any material adverse change, on a consolidated basis, in the authorized capital stock of the Company or any Material Adverse Effect or any development that could reasonably be expected to have a Material Adverse Effect, or any downgrading in or withdrawal of the rating assigned to any of the Company’s securities (other than asset backed securities) by any rating organization or a public announcement by any rating organization that it has under surveillance or review its rating of any of the Company’s securities (other than asset backed securities), the effect of which, in the case of any such action by a rating organization described above, in the reasonable judgment of TD Cowen (without relieving the Company of any obligation or liability it may otherwise have), is so material as to make it impracticable or inadvisable to proceed with the offering of the Placement Shares on the terms and in the manner contemplated in the Prospectus. (e) Company Counsel Legal Opinion. TD Cowen shall have received the opinion of Company Counsel required to be delivered pursuant to Section 7(n) on or before the date on which such delivery of such opinion is required pursuant to Section 7(n). (f) TD Cowen Counsel Legal Opinion. TD Cowen shall have received from Cooley LLP, counsel for TD Cowen, such opinion or opinions, on or before the date on which the delivery of the Company Counsel legal opinion is required pursuant to Section 7(n), with respect to such matters as TD Cowen may reasonably require, and the Company shall have furnished to such counsel such documents as they request for enabling them to pass upon such matters. (g) Comfort Letter. TD Cowen shall have received the Comfort Letter required to be delivered pursuant to Section 7(o) on or before the date on which such delivery of such Comfort Letter is required pursuant to Section 7(o). (h) Representation Certificate. TD Cowen shall have received the certificate required to be delivered pursuant to Section 7(m) on or before the date on which delivery of such certificate is required pursuant to Section 7(m).


 
- 26 - (i) Secretary’s Certificate. On or prior to the First Delivery Date, TD Cowen shall have received a certificate, signed on behalf of the Company by its corporate secretary, in form and substance satisfactory to TD Cowen and its counsel. (j) [Reserved]. (k) No Suspension. Trading in the Common Stock shall not have been suspended on Nasdaq. (l) Other Materials. On each date on which the Company is required to deliver a certificate pursuant to Section 7(m), the Company shall have furnished to TD Cowen such appropriate further information, certificates and documents as TD Cowen may have reasonably requested. All such opinions, certificates, letters and other documents shall have been in compliance with the provisions hereof. The Company will furnish TD Cowen with such conformed copies of such opinions, certificates, letters and other documents as TD Cowen shall have reasonably requested. (m) Securities Act Filings Made. All filings with the Commission required by Rule 424 under the Securities Act to have been filed prior to the issuance of any Placement Notice hereunder shall have been made within the applicable time period prescribed for such filing by Rule 424. (n) Approval for Listing. The Placement Shares shall either have been (i) approved for listing on Nasdaq, subject only to notice of issuance, or (ii) the Company shall have filed an application for listing of the Placement Shares on Nasdaq at, or prior to, the issuance of any Placement Notice. (o) No Termination Event. There shall not have occurred any event that would permit TD Cowen to terminate this Agreement pursuant to Section 11(a). 9. Indemnification and Contribution. (a) Company Indemnification. The Company agrees to indemnify and hold harmless TD Cowen, its affiliates, and its and their respective directors, officers, partners, employees and agents and each person, who (i) controls TD Cowen within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act, or (ii) is controlled by or is under common control with TD Cowen from and against any and all losses, claims, liabilities, expenses and damages (including, but not limited to, any and all reasonable and documented investigative, legal and other expenses incurred in connection with, and any and all amounts paid in settlement (in accordance with Section 9(c)) of, any action, suit or proceeding between any of the indemnified parties and any indemnifying parties or between any indemnified party and any third party, or otherwise, or any claim asserted), as and when incurred, to which TD Cowen, or any such person, may become subject under the Securities Act, the Exchange Act or other federal or state statutory law or regulation, at common law or otherwise, insofar as such losses, claims, liabilities, expenses or damages arise out of or are based, directly or indirectly, on (x) any untrue statement or alleged untrue statement of a material fact contained in the Registration Statement or the Prospectus or any amendment or supplement to the Registration Statement or the Prospectus or in any free writing prospectus or in any application or other document executed by


 
- 27 - or on behalf of the Company or based on written information furnished by or on behalf of the Company filed in any jurisdiction in order to qualify the Common Stock under the securities laws thereof or filed with the Commission, (y) the omission or alleged omission to state in any such document a material fact required to be stated in it or necessary to make the statements in it not misleading or (z) any breach by any of the indemnifying parties of any of their respective representations, warranties and agreements contained in this Agreement; provided, however, that this indemnity agreement shall not apply to the extent that such loss, claim, liability, expense or damage arises from the sale of the Placement Shares pursuant to this Agreement and is caused directly or indirectly by an untrue statement or omission made in reliance upon and in conformity with solely Agent’s Information. “Agent’s Information” means, solely, the following information in the Prospectus: the tenth paragraph under the caption “Plan of Distribution”3 in the Prospectus. This indemnity agreement will be in addition to any liability that the Company might otherwise have. (b) TD Cowen Indemnification. TD Cowen agrees to indemnify and hold harmless the Company and its directors and each officer of the Company that signed the Registration Statement, and each person, if any, who controls the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act against any and all loss, liability, claim, damage and expense described in the indemnity contained in Section 9(a), as incurred, but only with respect to untrue statements or omissions, or alleged untrue statements or omissions, made in the Registration Statement (or any amendments thereto) or the Prospectus (or any amendment or supplement thereto) in reliance upon and in conformity with the Agent’s Information. (c) Procedure. Any party that proposes to assert the right to be indemnified under this Section 9 will, promptly after receipt of notice of commencement of any action against such party in respect of which a claim is to be made against an indemnifying party or parties under this Section 9, notify each such indemnifying party of the commencement of such action, enclosing a copy of all papers served, but the omission so to notify such indemnifying party will not relieve the indemnifying party from (i) any liability that it might have to any indemnified party otherwise than under this Section 9 and (ii) any liability that it may have to any indemnified party under the foregoing provision of this Section 9 unless, and only to the extent that, such omission results in the forfeiture of substantive rights or defenses by the indemnifying party. If any such action is brought against any indemnified party and it notifies the indemnifying party of its commencement, the indemnifying party will be entitled to participate in and, to the extent that it elects by delivering written notice to the indemnified party promptly after receiving notice of the commencement of the action from the indemnified party, jointly with any other indemnifying party similarly notified, to assume the defense of the action, with counsel reasonably satisfactory to the indemnified party, and after notice from the indemnifying party to the indemnified party of its election to assume the defense, the indemnifying party will not be liable to the indemnified party for any legal or other expenses except as provided below and except for the reasonable and documented costs of investigation subsequently incurred by the indemnified party in connection with the defense. The indemnified party will have the right to employ its own counsel in any such action, but the fees, expenses and other charges of such


 
- 28 - counsel will be at the expense of such indemnified party unless (1) the employment of counsel by the indemnified party has been authorized in writing by the indemnifying party, (2) the indemnified party has reasonably concluded (based on advice of counsel) that there may be legal defenses available to it or other indemnified parties that are different from or in addition to those available to the indemnifying party, (3) a conflict or potential conflict exists (based on advice of counsel to the indemnified party) between the indemnified party and the indemnifying party (in which case the indemnifying party will not have the right to direct the defense of such action on behalf of the indemnified party) or (4) the indemnifying party has not in fact employed counsel to assume the defense of such action within a reasonable time after receiving notice of the commencement of the action, in each of which cases the reasonable fees, disbursements and other charges of counsel will be at the expense of the indemnifying party or parties. It is understood that the indemnifying party or parties shall not, in connection with any proceeding or related proceedings in the same jurisdiction, be liable for the reasonable fees, disbursements and other charges of more than one separate firm admitted to practice in such jurisdiction at any one time for all such indemnified party or parties. All such fees, disbursements and other charges will be reimbursed by the indemnifying party promptly as they are incurred. An indemnifying party will not, in any event, be liable for any settlement of any action or claim effected without its written consent. No indemnifying party shall, without the prior written consent of each indemnified party, settle or compromise or consent to the entry of any judgment in any pending or threatened claim, action or proceeding relating to the matters contemplated by this Section 9 (whether or not any indemnified party is a party thereto), unless such settlement, compromise or consent includes an unconditional release of each indemnified party from all liability arising or that may arise out of such claim, action or proceeding. (d) Contribution. In order to provide for just and equitable contribution in circumstances in which the indemnification provided for in the foregoing paragraphs of this Section 9 is applicable in accordance with its terms but for any reason is held to be unavailable from the Company or TD Cowen, the Company and TD Cowen will contribute to the total losses, claims, liabilities, expenses and damages (including any investigative, legal and other expenses reasonably incurred in connection with, and any amount paid in settlement of, any action, suit or proceeding or any claim asserted, but after deducting any contribution received by the Company from persons other than TD Cowen, such as persons who control the Company within the meaning of the Securities Act, officers of the Company who signed the Registration Statement and directors of the Company, who also may be liable for contribution) to which the Company and TD Cowen may be subject in such proportion as shall be appropriate to reflect the relative benefits received by the Company on the one hand and TD Cowen on the other. The relative benefits received by the Company on the one hand and TD Cowen on the other hand shall be deemed to be in the same proportion as the total Net Proceeds from the sale of the Placement Shares (before deducting expenses) received by the Company bear to the total compensation received by TD Cowen from the sale of Placement Shares on behalf of the Company. If, but only if, the allocation provided by the foregoing sentence is not permitted by applicable law, the allocation of contribution shall be made in such proportion as is appropriate to reflect not only the relative benefits referred to in the foregoing sentence but also the relative fault of the Company, on the one hand, and TD Cowen, on the other, with respect to the statements or omission that resulted in such loss, claim, liability, expense or damage, or action in respect thereof, as well as any other relevant equitable considerations with respect to such offering. Such relative fault shall be determined by reference to, among other things, whether the


 
- 29 - untrue or alleged untrue statement of a material fact or omission or alleged omission to state a material fact relates to information supplied by the Company or TD Cowen, the intent of the parties and their relative knowledge, access to information and opportunity to correct or prevent such statement or omission. The Company and TD Cowen agree that it would not be just and equitable if contributions pursuant to this Section 9(d) were to be determined by pro rata allocation or by any other method of allocation that does not take into account the equitable considerations referred to herein. The amount paid or payable by an indemnified party as a result of the loss, claim, liability, expense, or damage, or action in respect thereof, referred to above in this Section 9(d) shall be deemed to include, for the purpose of this Section 9(d), any legal or other expenses reasonably incurred by such indemnified party in connection with investigating or defending any such action or claim to the extent consistent with Section 9(c) hereof. Notwithstanding the foregoing provisions of this Section 9(d), TD Cowen shall not be required to contribute any amount in excess of the commissions received by it under this Agreement and no person found guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) will be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. For purposes of this Section 9(d), any person who controls a party to this Agreement within the meaning of the Securities Act, and any officers, directors, partners, employees or agents of TD Cowen, will have the same rights to contribution as that party, and each officer of the Company who signed the Registration Statement and each director of the Company will have the same rights to contribution as the Company, subject in each case to the provisions hereof. Any party entitled to contribution, promptly after receipt of notice of commencement of any action against such party in respect of which a claim for contribution may be made under this Section 9(d), will notify any such party or parties from whom contribution may be sought, but the omission to so notify will not relieve that party or parties from whom contribution may be sought from any other obligation it or they may have under this Section 9(d) except to the extent that the failure to so notify such other party materially prejudiced the substantive rights or defenses of the party from whom contribution is sought. Except for a settlement entered into pursuant to the last sentence of Section 9(c) hereof, no party will be liable for contribution with respect to any action or claim settled without its written consent if such consent is required pursuant to Section 9(c) hereof. 10. Representations and Agreements to Survive Delivery. The indemnity and contribution agreements contained in Section 9 of this Agreement and all representations and warranties of the Company herein or in certificates delivered pursuant hereto shall survive, as of their respective dates, regardless of (i) any investigation made by or on behalf of TD Cowen, any controlling persons, or the Company (or any of their respective officers, directors or controlling persons), (ii) delivery and acceptance of the Placement Shares and payment therefor or (iii) any termination of this Agreement. 11. Termination. (a) TD Cowen shall have the right by giving notice as hereinafter specified at any time to terminate this Agreement if (i) any Material Adverse Effect, or any development that could reasonably be expected to have a Material Adverse Effect has occurred that, in the reasonable judgment of TD Cowen, may materially impair the ability of TD Cowen to sell the Placement Shares hereunder, (ii) the Company shall have failed, refused or been unable to perform any agreement on its part to be performed hereunder, (iii) any other condition of TD


 
- 30 - Cowen’s obligations hereunder is not fulfilled, or (iv) any suspension or limitation of trading in the Placement Shares or in securities generally on Nasdaq shall have occurred. Any such termination shall be without liability of any party to any other party except that the provisions of Section 7(g) (Expenses), Section 9 (Indemnification and Contribution), Section 10 (Representations and Agreements to Survive Delivery), Section 16 (Applicable Law; Consent to Jurisdiction) and Section 17 (Waiver of Jury Trial) hereof shall remain in full force and effect notwithstanding such termination. If TD Cowen elects to terminate this Agreement as provided in this Section 11(a), TD Cowen shall provide the required notice as specified in Section 12 (Notices). (b) The Company shall have the right, by giving ten (10) days’ notice as hereinafter specified to terminate this Agreement in its sole discretion at any time after the date of this Agreement. Any such termination shall be without liability of any party to any other party except that the provisions of Section 7(g), Section 9, Section 10, Section 16 and Section 17 hereof shall remain in full force and effect notwithstanding such termination. (c) TD Cowen shall have the right, by giving ten (10) days’ notice as hereinafter specified to terminate this Agreement in its sole discretion at any time after the date of this Agreement. Any such termination shall be without liability of any party to any other party except that the provisions of Section 7(g), Section 9, Section 10, Section 16 and Section 17 hereof shall remain in full force and effect notwithstanding such termination. (d) Unless earlier terminated pursuant to this Section 11, this Agreement shall automatically terminate upon the issuance and sale of all of the Placement Shares through TD Cowen on the terms and subject to the conditions set forth herein; provided that the provisions of Section 7(g), Section 9, Section 10, Section 16 and Section 17 hereof shall remain in full force and effect notwithstanding such termination. (e) This Agreement shall remain in full force and effect unless terminated pursuant to Sections 11(a), (b), (c), or (d) above or otherwise by mutual agreement of the parties; provided, however, that any such termination by mutual agreement shall in all cases be deemed to provide that Section 7(g), Section 9, Section 10, Section 16 and Section 17 shall remain in full force and effect. (f) Any termination of this Agreement shall be effective on the date specified in such notice of termination; provided, however, that such termination shall not be effective until the close of business on the date of receipt of such notice by TD Cowen or the Company, as the case may be. If such termination shall occur prior to the Settlement Date for any sale of Placement Shares, such Placement Shares shall settle in accordance with the provisions of this Agreement. 12. Notices. All notices or other communications required or permitted to be given by any party to any other party pursuant to the terms of this Agreement shall be in writing, unless otherwise specified in this Agreement, and if sent to TD Cowen, shall be delivered to TD Cowen at TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, fax no. 646-562- 1130, Attention: General Counsel, email: CIBLegal@tdsecurities.com, with a copy to Cooley LLP, e-mail: dgoldberg@cooley.com, attention: Daniel I. Goldberg; or if sent to the Company, shall be delivered to Avidity Biosciences, Inc., 10578 Science Center Drive, Suite 125, San


 
- 31 - Diego, California, 92121 Attention: Chief Legal Officer, email: john.moriarty@aviditybio.com, with a copy to Latham & Watkins LLP, attention: Matthew T. Bush, email: matt.bush@lw.com. Each party to this Agreement may change such address for notices by sending to the parties to this Agreement written notice of a new address for such purpose. Each such notice or other communication shall be deemed given (i) when delivered personally or by verifiable facsimile transmission (with an original to follow) on or before 4:30 p.m., New York City time, on a Business Day (as defined below), or, if such day is not a Business Day on the next succeeding Business Day, (ii) on the next Business Day after timely delivery to a nationally-recognized overnight courier and (iii) on the Business Day actually received if deposited in the U.S. mail (certified or registered mail, return receipt requested, postage prepaid). For purposes of this Agreement, “Business Day” shall mean any day on which the Nasdaq and commercial banks in the City of New York are open for business. 13. Successors and Assigns. This Agreement shall inure to the benefit of and be binding upon the Company and TD Cowen and their respective successors and the affiliates, controlling persons, officers and directors referred to in Section 9 hereof. References to any of the parties contained in this Agreement shall be deemed to include the successors and permitted assigns of such party. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and permitted assigns any rights, remedies, obligations or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement. Neither party may assign its rights or obligations under this Agreement without the prior written consent of the other party; provided, however, that TD Cowen may assign its rights and obligations hereunder to an affiliate of TD Cowen without obtaining the Company’s consent. 14. Adjustments for Share Splits. The parties acknowledge and agree that all share- related numbers contained in this Agreement shall be adjusted to take into account any share split, share dividend or similar event effected with respect to the Common Stock. 15. Entire Agreement; Amendment; Severability. This Agreement (including all schedules and exhibits attached hereto and Placement Notices issued pursuant hereto) constitutes the entire agreement and supersedes all other prior and contemporaneous agreements and undertakings, both written and oral, among the parties hereto with regard to the subject matter hereof. Neither this Agreement nor any term hereof may be amended except pursuant to a written instrument executed by the Company and TD Cowen. In the event that any one or more of the provisions contained herein, or the application thereof in any circumstance, is held invalid, illegal or unenforceable as written by a court of competent jurisdiction, then such provision shall be given full force and effect to the fullest possible extent that it is valid, legal and enforceable, and the remainder of the terms and provisions herein shall be construed as if such invalid, illegal or unenforceable term or provision was not contained herein, but only to the extent that giving effect to such provision and the remainder of the terms and provisions hereof shall be in accordance with the intent of the parties as reflected in this Agreement. 16. Applicable Law; Consent to Jurisdiction. This Agreement shall be governed by, and construed in accordance with, the internal laws of the State of New York without regard to the principles of conflicts of laws. Each party hereby irrevocably submits to the non-exclusive jurisdiction of the state and federal courts sitting in the City of New York, borough of Manhattan,


 
- 32 - for the adjudication of any dispute hereunder or in connection with any transaction contemplated hereby, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is brought in an inconvenient forum or that the venue of such suit, action or proceeding is improper. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof (certified or registered mail, return receipt requested) to such party at the address in effect for notices to it under this Agreement and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law. 17. Waiver of Jury Trial. The Company and TD Cowen each hereby irrevocably waives any right it may have to a trial by jury in respect of any claim based upon or arising out of this Agreement or any transaction contemplated hereby. 18. Absence of Fiduciary Relationship. The Company acknowledges and agrees that: (a) TD Cowen has been retained solely to act as an arm’s length contractual counterparty to the Company in connection with the sale of the Placement Shares contemplated hereby and that no fiduciary, advisory or agency relationship between the Company and TD Cowen has been created in respect of any of the transactions contemplated by this Agreement, irrespective of whether TD Cowen has advised or is advising the Company on other matters; (b) the Company is capable of evaluating and understanding and understands and accepts the terms, risks and conditions of the transactions contemplated by this Agreement; (c) the Company has been advised that TD Cowen and its affiliates are engaged in a broad range of transactions which may involve interests that differ from those of the Company and that TD Cowen has no obligation to disclose such interests and transactions to the Company by virtue of any fiduciary, advisory or agency relationship; and (d) the Company waives, to the fullest extent permitted by law, any claims it may have against TD Cowen, for breach of fiduciary duty or alleged breach of fiduciary duty and agrees that TD Cowen shall have no liability (whether direct or indirect) to the Company in respect of such a fiduciary claim or to any person asserting a fiduciary duty claim on behalf of or in right of the Company, including stockholders, partners, employees or creditors of the Company. 19. Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Delivery of an executed Agreement by one party to the other may be made by facsimile or other electronic transmission (including pdf or any electronic signature complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com or www.echosign.com) or other transmission method and any counterpart so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes. 20. Recognition of the U.S. Special Resolution Regimes.


 
- 33 - (a) In the event that TD Cowen is a Covered Entity and becomes subject to a proceeding under a U.S. Special Resolution Regime, the transfer from TD Cowen of this Agreement, and any interest and obligation in or under this Agreement, will be effective to the same extent as the transfer would be effective under the U.S. Special Resolution Regime if this Agreement, and any such interest and obligation, were governed by the laws of the United States or a state of the United States. (b) In the event that TD Cowen is a Covered Entity and TD Cowen or a BHC Act Affiliate of TD Cowen becomes subject to a proceeding under a U.S. Special Resolution Regime, Default Rights under this Agreement that may be exercised against TD Cowen are permitted to be exercised to no greater extent than such Default Rights could be exercised under the U.S. Special Resolution Regime if this Agreement were governed by the laws of the United States or a state of the United States. (c) For purposes of this Section 20; (a) “BHC Act Affiliate” has the meaning assigned to the term “affiliate” in, and shall be interpreted in accordance with, 12 U.S.C. § 1841(k), (b) “Covered Entity” means any of the following: (i) a “covered entity” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 252.82(b); (ii) a “covered bank” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 47.3(b); or (iii) a “covered FSI” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 382.2(b), (c) “Default Right” has the meaning assigned to that term in, and shall be interpreted in accordance with, 12 C.F.R. §§ 252.81, 47.2 or 382.1, as applicable, and (d) “U.S. Special Resolution Regime” means each of (i) the Federal Deposit Insurance Act and the regulations promulgated thereunder and (ii) Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act and the regulations promulgated thereunder. 21. Termination of Prior Sales Agreement. The Company, TD Cowen and Cowen and Company, LLC (“Cowen”) agree that the Sales Agreement, dated November 8, 2022, by and between the Company and Cowen is hereby terminated. [Remainder of Page Intentionally Blank]


 
34 If the foregoing correctly sets forth the understanding between the Company and TD Cowen, please so indicate in the space provided below for that purpose, whereupon this letter shall constitute a binding agreement between the Company and TD Cowen. Very truly yours, TD SECURITIES (USA) LLC By: /s/ Michael Murphy Name: Michael Murphy Title: Managing Director ACCEPTED as of the date first-above written: AVIDITY BIOSCIENCES, INC. By: /s/ Michael F. MacLean Name: Michael F. MacLean Title: Chief Financial and Chief Business Officer Acknowledged and agreed to with respect to Section 21 hereof, as of the date first-above written: COWEN AND COMPANY, LLC By: /s/ Michael Murphy Name: Michael Murphy Title: Managing Director


 
SCHEDULE 1 FORM OF PLACEMENT NOTICE From: [ ] Cc: [ ] To: [ ] Subject: TD Cowen At the Market Offering—Placement Notice Gentlemen: Pursuant to the terms and subject to the conditions contained in the Sales Agreement between Avidity Biosciences, Inc., a Delaware corporation (the “Company”), and TD Securities (USA) LLC (“TD Cowen”) dated August 9, 2024 (the “Agreement”), I hereby request on behalf of the Company that TD Cowen sell up to [ ] shares of the Company’s common stock, par value $0.0001 per share, at a minimum market price of $_______ per share. Sales should begin on the date of this Notice and shall continue until [DATE] [all shares are sold].


 
SCHEDULE 2 Notice Parties Company Sarah Boyce President and Chief Executive Officer Michael MacLean Chief Financial and Chief Business Officer With a copy to: John Moriarty, Jr. Chief Legal Officer and Corporate Secretary Lisa Brockman Vice President, Finance TD Cowen Michael J. Murphy Managing Director William Follis Managing Director Adriano Pierroz Director Megan Sanford Analyst


 
SCHEDULE 3 Compensation TD Cowen shall be paid compensation up to 3.0% of the gross proceeds from the sales of Placement Shares pursuant to the terms of this Agreement.


 
Exhibit 7(m) OFFICER CERTIFICATE The undersigned, the duly qualified and elected _______________________, of Avidity Biosciences, Inc. (“Company”), a Delaware corporation, does hereby certify in such capacity and on behalf of the Company, pursuant to Section 7(m) of the Sales Agreement dated August 9, 2024 (the “Sales Agreement”) between the Company and TD Securities (USA) LLC, that to the best of the knowledge of the undersigned. (i) The representations and warranties of the Company in Section 6 of the Sales Agreement (A) to the extent such representations and warranties are subject to qualifications and exceptions contained therein relating to materiality or Material Adverse Effect, are true and correct on and as of the date hereof with the same force and effect as if expressly made on and as of the date hereof, except for those representations and warranties that speak solely as of a specific date and which were true and correct as of such date, and (B) to the extent such representations and warranties are not subject to any qualifications or exceptions, are true and correct in all material respects as of the date hereof as if made on and as of the date hereof with the same force and effect as if expressly made on and as of the date hereof except for those representations and warranties that speak solely as of a specific date and which were true and correct as of such date; and (ii) The Company has complied with all agreements and satisfied all conditions on its part to be performed or satisfied pursuant to the Sales Agreement at or prior to the date hereof. Cooley LLP and Latham & Watkins LLP are entitled to rely upon this Certificate in connection with the opinions given by such firms pursuant to the Sales Agreement. Capitalized terms used but not defined herein shall have the meanings ascribed to them in the Sales Agreement. By: Name: Title: Date:


 
Exhibit 5.1 US-DOCS152955846.2 12670 High Bluff Drive San Diego, California 92130 Tel: +1.858.523.5400 Fax: +1.858.523.5450 www.lw.com FIRM / AFFILIATE OFFICES Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul Hamburg Silicon Valley Hong Kong Singapore Houston Tel Aviv London Tokyo Los Angeles Washington, D.C. Madrid August 9, 2024 Avidity Biosciences, Inc. 10578 Science Center Drive, Suite 125 San Diego, California 92121 Re: Registration Statement on Form S-3; Shares of Common Stock, par value $0.0001 per share, having an aggregate offering price of up to $400,000,000 To the addressees set forth above: We have acted as special counsel to Avidity Biosciences, Inc., a Delaware corporation (the “Company”), in connection with the sale through TD Securities (USA) LLC (“TD Cowen”) as the sales agent from time to time by the Company of shares (the “Shares”) of common stock of the Company, par value $0.0001 per share (the “Common Stock”), having an aggregate offering price of up to $400,000,000, to be issued pursuant to a registration statement on Form S- 3 filed by the Company with the Securities and Exchange Commission (the “Commission”) on May 9, 2024 (Registration No. 333–279264) (the “Registration Statement”), the base prospectus included in the Registration Statement (the “Base Prospectus”) and the related prospectus supplement filed by the Company with the Commission on August 9, 2024 (together with the Base Prospectus, the “Prospectus”), and that certain Sales Agreement, dated as of August 9, 2024, by and between the Company and TD Cowen (the “Sales Agreement”). The term “Shares” shall include any additional shares of common stock registered by the Company pursuant to Rule 462(b) under the Securities Act of 1933, as amended (the “Act”), in connection with the offering contemplated by the Registration Statement. This opinion is being furnished in connection with the requirements of Item 601(b)(5) of Regulation S-K under the Act, and no opinion is expressed herein as to any matter pertaining to the contents of the Registration Statement or related Prospectus, other than as expressly stated herein with respect to the issue of the Shares.


 
August 9, 2024 Page 2 US-DOCS152955846.2 As such counsel, we have examined such matters of fact and questions of law as we have considered appropriate for purposes of this letter. With your consent, we have relied upon certificates and other assurances of officers of the Company and others as to factual matters without having independently verified such factual matters. We are opining herein as to the General Corporation Law of the State of Delaware (the “DGCL”), and we express no opinion with respect to any other laws. Subject to the foregoing and the other matters set forth herein, it is our opinion that, as of the date hereof, when the Shares shall have been duly registered on the books of the transfer agent and registrar therefor in the name or on behalf of the purchasers, and have been issued by the Company against payment therefor (not less than par value) in the circumstances contemplated by the Sales Agreement, the issue and sale of the Shares will have been duly authorized by all necessary corporate action of the Company, and the Shares will be validly issued, fully paid and nonassessable. In rendering the foregoing opinion, we have assumed that (i) the Company will comply with all applicable notice requirements regarding uncertificated shares provided in the DGCL and (ii) upon the issue of any of the Shares, the total number of shares of Common Stock issued and outstanding will not exceed the total number of shares of Common Stock that the Company is then authorized to issue under its Amended and Restated Certificate of Incorporation. This opinion is for your benefit in connection with the Registration Statement and may be relied upon by you and by persons entitled to rely upon it pursuant to the applicable provisions of the Act. We consent to your filing this opinion as an exhibit to the Registration Statement and to the reference to our firm in the Prospectus under the heading “Legal Matters.” In giving such consent, we do not thereby admit that we are in the category of persons whose consent is required under Section 7 of the Act or the rules and regulations of the Commission thereunder. Sincerely, /s/ Latham & Watkins LLP


 

Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Sarah Boyce, certify that:
1.I have reviewed this quarterly report on Form 10-Q of Avidity Biosciences, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: August 9, 2024/s/ Sarah Boyce
Sarah Boyce
President, Chief Executive Officer and Director
(Principal Executive Officer)


Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, Michael F. MacLean, certify that:
1.I have reviewed this quarterly report on Form 10-Q of Avidity Biosciences, Inc.;
2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a.designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b.designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c.evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d.disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a.all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b.any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: August 9, 2024/s/ Michael F. MacLean
Michael F. MacLean
Chief Financial and Chief Business Officer
(Principal Financial Officer)


Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the quarterly report of Avidity Biosciences, Inc. (the “Company”) on Form 10-Q for the quarter ended June 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Sarah Boyce, President, Chief Executive Officer and Director of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
(1)The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 9, 2024/s/ Sarah Boyce
Sarah Boyce
President, Chief Executive Officer and Director
(Principal Executive Officer)
The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed as part of the Report or as a separate disclosure document.


Exhibit 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the quarterly report of Avidity Biosciences, Inc. (the “Company”) on Form 10-Q for the quarter ended June 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Michael F. MacLean, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
(1)The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 9, 2024/s/ Michael F. MacLean
Michael F. MacLean
Chief Financial and Chief Business Officer
(Principal Financial Officer)
The foregoing certification is being furnished solely pursuant to 18 U.S.C. Section 1350 and is not being filed as part of the Report or as a separate disclosure document.

v3.24.2.u1
Cover Page - shares
6 Months Ended
Jun. 30, 2024
Jul. 22, 2024
Cover [Abstract]    
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Jun. 30, 2024  
Document Transition Report false  
Entity File Number 001-39321  
Entity Registrant Name Avidity Biosciences, Inc.  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 46-1336960  
Entity Address, Address Line One 10578 Science Center Drive  
Entity Address, Address Line Two Suite 125  
Entity Address, City or Town San Diego  
Entity Address, State or Province CA  
Entity Address, Postal Zip Code 92121  
City Area Code 858  
Local Phone Number 401-7900  
Title of 12(b) Security Common Stock, $0.0001 par value  
Trading Symbol RNA  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Large Accelerated Filer  
Entity Small Business false  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   109,801,397
Entity Central Index Key 0001599901  
Current Fiscal Year End Date --12-31  
Document Fiscal Year Focus 2024  
Document Fiscal Period Focus Q2  
Amendment Flag false  
v3.24.2.u1
Condensed Balance Sheets - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Current assets:    
Cash and cash equivalents $ 575,751 $ 185,082
Marketable securities 723,295 410,269
Prepaid and other assets 29,755 15,956
Total current assets 1,328,801 611,307
Property and equipment, net 8,498 8,381
Restricted cash 2,795 295
Right-of-use assets 6,967 8,271
Other assets 364 301
Total assets 1,347,425 628,555
Current liabilities:    
Accounts payable and accrued liabilities 40,924 34,341
Accrued compensation 12,826 14,335
Lease liabilities, current portion 3,765 3,639
Deferred revenue, current portion 26,697 28,365
Total current liabilities 84,212 80,680
Lease liabilities, net of current portion 4,617 6,213
Deferred revenue, net of current portion 37,560 40,898
Total liabilities 126,389 127,791
Commitments and contingencies (Note 7)
Stockholders’ equity:    
Common stock, $0.0001 par value; authorized shares – 400,000; issued and outstanding shares – 109,266 and 79,275 at June 30, 2024 and December 31, 2023, respectively 11 8
Additional paid-in capital 1,931,890 1,071,395
Accumulated other comprehensive income (loss) (453) 125
Accumulated deficit (710,412) (570,764)
Total stockholders’ equity 1,221,036 500,764
Total liabilities and stockholders’ equity $ 1,347,425 $ 628,555
v3.24.2.u1
Condensed Balance Sheets (Parenthetical) - $ / shares
shares in Thousands
Jun. 30, 2024
Dec. 31, 2023
Statement of Financial Position [Abstract]    
Common stock, par value (in dollars per share) $ 0.0001 $ 0.0001
Common stock, shares authorized (in shares) 400,000 400,000
Common stock, shares issued (in shares) 109,266 79,275
Common stock, shares outstanding (in shares) 109,266 79,275
v3.24.2.u1
Condensed Statements of Operations and Comprehensive Loss - USD ($)
shares in Thousands, $ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Income Statement [Abstract]        
Collaboration revenue $ 2,045 $ 2,316 $ 5,588 $ 4,549
Operating expenses:        
Research and development 63,940 42,672 130,772 90,437
General and administrative 20,731 12,278 34,629 24,342
Total operating expenses 84,671 54,950 165,401 114,779
Loss from operations (82,626) (52,634) (159,813) (110,230)
Other income (expense):        
Interest income 11,949 5,771 20,382 11,287
Other expense (116) (162) (217) (476)
Total other income 11,833 5,609 20,165 10,811
Net loss $ (70,793) $ (47,025) $ (139,648) $ (99,419)
Net loss per share, basic (in dollars per share) $ (0.65) $ (0.66) $ (1.44) $ (1.40)
Net loss per share, diluted (in dollars per share) $ (0.65) $ (0.66) $ (1.44) $ (1.40)
Weighted-average shares outstanding, basic (in shares) 106,928 71,390 97,070 70,914
Weighted-average shares outstanding, diluted (in shares) 106,928 71,390 97,070 70,914
Other comprehensive income (loss):        
Net unrealized gains (losses) on marketable securities $ 11 $ (1,137) $ (578) $ 32
Comprehensive loss $ (70,782) $ (48,162) $ (140,226) $ (99,387)
v3.24.2.u1
Condensed Statements of Stockholders' Equity - USD ($)
shares in Thousands, $ in Thousands
Total
Public Stock Offering
Private Placement
Pre-Funded Warrants Private Placement
Common Stock
Common Stock
Public Stock Offering
Common Stock
Private Placement
Additional Paid-in Capital
Additional Paid-in Capital
Public Stock Offering
Additional Paid-in Capital
Private Placement
Additional Paid-in Capital
Pre-Funded Warrants Private Placement
Accumulated Other Comprehensive Income (Loss)
Accumulated Deficit
Beginning balance (in shares) at Dec. 31, 2022         69,768                
Beginning balance at Dec. 31, 2022 $ 578,075       $ 7     $ 939,310       $ (2,698) $ (358,544)
Increase (Decrease) in Stockholders' Equity [Roll Forward]                          
Issuance of common stock upon exercise of stock options (in shares)         102                
Issuance of common stock upon exercise of stock options 520             520          
Issuance of common stock, net of issuance costs (in shares)           943              
Issuance of common stock, net of issuance costs   $ 22,441             $ 22,441        
Stock-based compensation 9,104             9,104          
Net loss (52,394)                       (52,394)
Other comprehensive income (loss) 1,169                     1,169  
Ending balance (in shares) at Mar. 31, 2023         70,813                
Ending balance at Mar. 31, 2023 558,915       $ 7     971,375       (1,529) (410,938)
Beginning balance (in shares) at Dec. 31, 2022         69,768                
Beginning balance at Dec. 31, 2022 578,075       $ 7     939,310       (2,698) (358,544)
Increase (Decrease) in Stockholders' Equity [Roll Forward]                          
Net loss (99,419)                        
Ending balance (in shares) at Jun. 30, 2023         74,070                
Ending balance at Jun. 30, 2023 559,178       $ 7     1,019,800       (2,666) (457,963)
Beginning balance (in shares) at Mar. 31, 2023         70,813                
Beginning balance at Mar. 31, 2023 558,915       $ 7     971,375       (1,529) (410,938)
Increase (Decrease) in Stockholders' Equity [Roll Forward]                          
Issuance of common stock upon exercise of stock options (in shares)         12                
Issuance of common stock upon exercise of stock options 7             7          
Issuance of common stock, net of issuance costs (in shares)           3,164              
Issuance of common stock, net of issuance costs   38,106             38,106        
Issuance of common stock under Employee Stock Purchase Plan (in shares)         81                
Issuance of common stock under Employee Stock Purchase Plan 859             859          
Stock-based compensation 9,453             9,453          
Net loss (47,025)                       (47,025)
Other comprehensive income (loss) (1,137)                     (1,137)  
Ending balance (in shares) at Jun. 30, 2023         74,070                
Ending balance at Jun. 30, 2023 $ 559,178       $ 7     1,019,800       (2,666) (457,963)
Beginning balance (in shares) at Dec. 31, 2023 79,275       79,275                
Beginning balance at Dec. 31, 2023 $ 500,764       $ 8     1,071,395       125 (570,764)
Increase (Decrease) in Stockholders' Equity [Roll Forward]                          
Issuance of common stock upon exercise of stock options (in shares)         541                
Issuance of common stock upon exercise of stock options 3,896             3,896          
Issuance of common stock, net of issuance costs (in shares)           418 15,225            
Issuance of common stock, net of issuance costs   $ 5,594 $ 238,388 $ 141,395     $ 2   $ 5,594 $ 238,386 $ 141,395    
Issuance of common stock in connection with vesting of restricted stock units (in shares)         135                
Stock-based compensation 10,306             10,306          
Net loss (68,855)                       (68,855)
Other comprehensive income (loss) (589)                     (589)  
Ending balance (in shares) at Mar. 31, 2024         95,594                
Ending balance at Mar. 31, 2024 $ 830,899       $ 10     1,470,972       (464) (639,619)
Beginning balance (in shares) at Dec. 31, 2023 79,275       79,275                
Beginning balance at Dec. 31, 2023 $ 500,764       $ 8     1,071,395       125 (570,764)
Increase (Decrease) in Stockholders' Equity [Roll Forward]                          
Issuance of common stock upon exercise of stock options (in shares) 1,742                        
Net loss $ (139,648)                        
Ending balance (in shares) at Jun. 30, 2024 109,266       109,266                
Ending balance at Jun. 30, 2024 $ 1,221,036       $ 11     1,931,890       (453) (710,412)
Beginning balance (in shares) at Mar. 31, 2024         95,594                
Beginning balance at Mar. 31, 2024 830,899       $ 10     1,470,972       (464) (639,619)
Increase (Decrease) in Stockholders' Equity [Roll Forward]                          
Issuance of common stock upon exercise of stock options (in shares)         1,201                
Issuance of common stock upon exercise of stock options 14,308             14,308          
Issuance of common stock, net of issuance costs (in shares)         12,133                
Issuance of common stock, net of issuance costs 432,772         $ 1   432,771          
Issuance of common stock under Employee Stock Purchase Plan (in shares)         138                
Issuance of common stock under Employee Stock Purchase Plan 1,027             1,027          
Issuance of common stock in connection with vesting of restricted stock units (in shares)         200                
Stock-based compensation 12,812             12,812          
Net loss (70,793)                       (70,793)
Other comprehensive income (loss) $ 11                     11  
Ending balance (in shares) at Jun. 30, 2024 109,266       109,266                
Ending balance at Jun. 30, 2024 $ 1,221,036       $ 11     $ 1,931,890       $ (453) $ (710,412)
v3.24.2.u1
Condensed Statements of Stockholders' Equity (Parenthetical) - USD ($)
$ in Thousands
3 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Jun. 30, 2023
Mar. 31, 2023
Public Stock Offering        
Public offering issuance costs $ 28,263 $ 143 $ 977 $ 408
Private Placement        
Public offering issuance costs   12,821    
Pre-Funded Warrants Private Placement        
Public offering issuance costs   $ 7,605    
v3.24.2.u1
Condensed Statements of Cash Flows - USD ($)
$ in Thousands
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Cash flows from operating activities    
Net loss $ (139,648) $ (99,419)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation 1,328 920
Stock-based compensation expense 23,118 18,557
Amortization of premiums and discounts on marketable securities, net (7,435) (5,071)
Non-cash operating lease costs 1,652 1,420
Changes in operating assets and liabilities:    
Prepaid and other assets (12,112) (5,642)
Accounts payable and accrued liabilities 6,047 (816)
Accrued compensation (1,509) (4,663)
Operating lease liabilities (1,819) (1,594)
Deferred revenue (5,006) (2,466)
Net cash used in operating activities (135,384) (98,774)
Cash flows from investing activities    
Maturities of marketable securities 207,930 128,215
Purchases of marketable securities (514,100) (275,404)
Purchases of property and equipment (1,446) (2,442)
Net cash used in investing activities (307,616) (149,631)
Cash flows from financing activities    
Proceeds from issuance of common stock in public offerings, net of issuance costs 438,902 60,547
Proceeds from issuance of common stock under employee incentive equity plans 17,484 1,386
Proceeds from the issuance of common stock in a private placement, net of issuance costs 238,388 0
Proceeds from issuance of pre-funded warrants in a private placement, net of issuance costs 141,395 0
Net cash provided by financing activities 836,169 61,933
Net increase (decrease) in cash, cash equivalents and restricted cash 393,169 (186,472)
Cash, cash equivalents and restricted cash at beginning of period 185,377 340,647
Cash, cash equivalents and restricted cash at end of period 578,546 154,175
Supplemental schedule of noncash investing and financing activities:    
Costs incurred, but not paid, in connection with deferred financing costs included in accounts payable and accrued liabilities 536 0
Receivables from stock option exercises included in prepaid and other assets $ 1,747 $ 0
v3.24.2.u1
Description of Business and Basis of Presentation
6 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
Description of Business and Basis of Presentation Description of Business and Basis of Presentation
Description of Business
Avidity Biosciences, Inc. (the Company or Avidity) is a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs). The Company’s proprietary AOC platform is designed to combine the specificity of monoclonal antibodies with the precision of RNA therapeutics to target the root cause of diseases previously untreatable with such therapeutics.
Liquidity
To date, the Company has devoted substantially all of its resources to organizing and staffing the Company, business planning, raising capital, developing its proprietary AOC platform, identifying potential product candidates, establishing its intellectual property portfolio, conducting research, preclinical and clinical studies, and providing other general and administrative support for these operations. In addition, the Company has a limited operating history, has incurred operating losses since inception and expects that it will continue to incur net losses into the foreseeable future as it continues the development of its product candidates and development programs. As of June 30, 2024, the Company had an accumulated deficit of $710.4 million and cash, cash equivalents and marketable securities of $1.3 billion.
The Company believes that existing cash, cash equivalents and marketable securities will be sufficient to fund the Company’s operations for at least 12 months from the date of the filing of this Form 10-Q. The Company plans to finance its future cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other arrangements. If the Company is not able to secure adequate additional funding, it may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or delay or reduce the scope of its planned development programs. Any of these actions could materially harm the Company’s business, results of operations and future prospects.
Basis of Presentation
The accompanying unaudited interim condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and the rules and regulations of the Securities and Exchange Commission (SEC) related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The unaudited interim condensed financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The operating results presented in these unaudited interim condensed financial statements are not necessarily indicative of the results that may be expected for any future periods. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2023 included in the Company’s annual report on Form 10-K filed with the SEC on February 28, 2024.
In December 2023, the Company formed Avidity Biosciences Ireland Limited, a wholly-owned subsidiary (the Subsidiary). There were no operations in, nor assets and liabilities held by, the Subsidiary in any of the periods presented.
v3.24.2.u1
Summary of Significant Accounting Policies
6 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
Summary of Significant Accounting Policies Summary of Significant Accounting Policies
Use of Estimates
The Company’s condensed financial statements are prepared in accordance with GAAP, which requires the Company to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the condensed financial statements and accompanying notes. The most significant estimates in the Company’s condensed financial statements relate to revenue recognition, stock-based compensation, and accrued research and development costs. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions.
Summary of Significant Accounting Policies
The Company’s significant accounting policies are discussed in “Note 2 – Summary of Significant Accounting Policies” of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed with the SEC on February 28, 2024. There have been no significant changes to these policies during the six months ended June 30, 2024.
Net Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period, adjusted for the weighted-average number of common shares outstanding that are subject to repurchase or forfeiture. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the common stock equivalent securities would be anti-dilutive. The pre-funded common stock warrants are included in the calculation of basic and diluted net loss per share as the exercise price of $0.001 per share is not substantive and the shares are issuable for little or no consideration.
Common stock equivalent securities not included in the calculation of diluted net loss per share for the three and six month periods ended June 30, because to do so would be anti-dilutive, are as follows (in thousands):
June 30,
20242023
Common stock options12,72810,978
Restricted stock units1,526635
Performance stock units562
Employee Stock Purchase Plan shares pending issuance49
Total14,82011,622
Recently Issued Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (FASB) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which modifies the disclosure and presentation requirements of reportable segments. The amendments in the update require the disclosure of significant segment expenses that are regularly provided to the Chief Operating Decision Maker (CODM) and included within each reported measure of segment profit and loss. The amendments also require disclosure of all other segment items by reportable segment and a description of its composition. Additionally, the amendments require disclosure of the title and position of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. Lastly, the amendment requires that a public entity that has a single reportable segment provide all the disclosures required by ASU 2023-07 and all existing segment disclosures in Topic 280. This update is effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. ASU 2023-07 will be applied retrospectively and early adoption is permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its financial statements and accompanying notes.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which enhances income tax disclosures, primarily through standardization and disaggregation of the income tax rate reconciliation and disaggregation of income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. ASU 2023-09 can be applied either prospectively or retrospectively and early adoption is permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its financial statements and accompanying notes.
v3.24.2.u1
Fair Value Measurements
6 Months Ended
Jun. 30, 2024
Fair Value Disclosures [Abstract]  
Fair Value Measurements Fair Value Measurements
The following tables summarize the Company’s cash equivalents and marketable securities measured at fair value (in thousands):
Fair Value Measurements Using
As of June 30, 2024TotalQuoted Prices in
Active Markets
for Identical
Assets (Level 1)
Significant
Other
Observable
Inputs (Level 2)
Significant
Unobservable
Inputs
(Level 3)
Cash equivalents:
U.S. Treasury securities$10,962 $10,962 $— $— 
Marketable securities:
U.S. Treasury securities721,340 721,340 — — 
Negotiable certificates of deposit1,955 — 1,955 — 
Total$734,257 $732,302 $1,955 $— 
Fair Value Measurements Using
As of December 31, 2023TotalQuoted Prices in
Active Markets
for Identical
Assets (Level 1)
Significant
Other
Observable
Inputs (Level 2)
Significant
Unobservable
Inputs
(Level 3)
Marketable securities:
U.S. Treasury securities$399,890 $399,890 $— $— 
U.S. Government agency securities4,998 — 4,998 — 
Negotiable certificates of deposit5,381 — 5,381 — 
Total$410,269 $399,890 $10,379 $— 
v3.24.2.u1
Marketable Securities
6 Months Ended
Jun. 30, 2024
Investments, Debt and Equity Securities [Abstract]  
Marketable Securities Marketable Securities
The Company’s marketable securities, which consist of highly liquid marketable debt securities, are classified as available-for-sale and are stated at fair value. The following tables summarize the Company’s marketable securities (in thousands):
As of June 30, 2024Maturity
(in years)
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated
Fair Value
U.S. Treasury securities
1 or less
$613,201 $$(517)$612,690 
Negotiable certificates of deposit
1 or less
1,959 — (4)1,955 
U.S. Treasury securities
1 - 2
108,588 62 — 108,650 
Total$723,748 $68 $(521)$723,295 
As of December 31, 2023Maturity
(in years)
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated
Fair Value
U.S. Treasury securities
1 or less
$301,053 $102 $(530)$300,625 
U.S. Government agency securities
1 or less
5,000 — (2)4,998 
Negotiable certificates of deposit
1 or less
4,410 (4)4,407 
U.S. Treasury securities
1 - 2
98,701 600 (36)99,265 
Negotiable certificates of deposit
1 - 2
980 — (6)974 
Total$410,144 $703 $(578)$410,269 
The unrealized losses on the Company’s marketable securities were caused by interest rate increases and resulted in the decrease in market value of these securities. There were no allowances for credit losses at June 30, 2024 and December 31, 2023 because (i) the decline in fair value is attributable to changes in interest rates and not credit quality, (ii) the Company does not intend to sell the investments before maturity, and (iii) it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases.
The following table summarizes marketable securities in a continuous unrealized loss position for which an allowance for credit losses was not recorded (in thousands):
Less Than 12 Months
12 Months or Greater
Total
As of June 30, 2024
Fair Value
Unrealized Losses
Fair Value
Unrealized Losses
Fair Value
Unrealized Losses
U.S. Treasury securities$469,288 $(312)$74,471 $(205)$543,759 $(517)
Negotiable certificates of deposit734 — 1,221 (4)1,955 (4)
Total$470,022 $(312)$75,692 $(209)$545,714 $(521)
Less Than 12 Months
12 Months or Greater
Total
As of December 31, 2023
Fair Value
Unrealized Losses
Fair Value
Unrealized Losses
Fair Value
Unrealized Losses
U.S. Treasury securities$214,291 $(566)$— $— $214,291 $(566)
U.S. Government agency securities4,998 (2)— — 4,998 (2)
Negotiable certificates of deposit3,665 (10)— — 3,665 (10)
Total$222,954 $(578)$— $— $222,954 $(578)
Accrued interest receivable on available-for-sale securities was $4.1 million and $2.6 million at June 30, 2024 and December 31, 2023, respectively. The Company has not written off any accrued interest receivable for the six months ended June 30, 2024 and 2023.
v3.24.2.u1
Collaboration, License and Research Agreements
6 Months Ended
Jun. 30, 2024
Collaboration License And Research Agreements [Abstract]  
Collaboration, License and Research Agreements Collaboration, License and Research Agreements
Research Collaboration and License Agreement with Bristol Myers Squibb Company
In November 2023, the Company entered into a Research Collaboration and License Agreement (the BMS Collaboration Agreement) with Bristol Myers Squibb Company (BMS) to expand on its research with MyoKardia Inc. In connection with the BMS Collaboration Agreement, the Company recognized revenue of $2.0 million and $4.5 million for the three and six months ended June 30, 2024, respectively. There were no collaboration receivables related to the BMS Collaboration Agreement in any of the periods presented.
Research Collaboration and License Agreement with Eli Lilly and Company
In April 2019, the Company entered into a Research Collaboration and License Agreement (the Lilly Agreement) with Eli Lilly and Company (Lilly) for the discovery, development and commercialization of AOC
products directed against certain targets in immunology and other select indications on a worldwide basis. In connection with the Lilly Agreement, the Company recognized no revenue for the three months ended June 30, 2024 and $2.3 million for the three months ended June 30, 2023. The Company recognized revenue of $1.1 million and $4.5 million for the six months ended June 30, 2024 and 2023, respectively. There were no collaboration receivables related to the Lilly Agreement as of June 30, 2024 and $0.8 million collaboration receivables related to the Lilly Agreement as of December 31, 2023, which are included in prepaid and other assets on the condensed balance sheets. There was no deferred revenue related to the Lilly Agreement at June 30, 2024.
A reconciliation of the closing balance of deferred revenue related to the Company's research collaboration and license agreements for the six months ended June 30, 2024 and 2023 is as follows (in thousands):
Balance at December 31, 2023$69,263 
Revenue recognized that was included in the balance at the beginning of the period(2,961)
Balance at March 31, 2024$66,302 
Revenue recognized that was included in the balance at the beginning of the period(2,045)
Balance at June 30, 2024$64,257 
Balance at December 31, 2022$6,276 
Revenue recognized that was included in the balance at the beginning of the period(1,219)
Balance at March 31, 2023$5,057 
Revenue recognized that was included in the balance at the beginning of the period(1,247)
Balance at June 30, 2023$3,810 
v3.24.2.u1
Composition of Certain Financial Statement Items
6 Months Ended
Jun. 30, 2024
Property, Plant and Equipment [Abstract]  
Composition of Certain Financial Statement Items Composition of Certain Financial Statement Items
Prepaid and other assets (in thousands)
June 30,
2024
December 31, 2023
Accounts receivable$— $1,105 
Prepaid assets14,041 7,333
Interest receivable and other assets
15,714 7,518
Total prepaid and other assets$29,755 $15,956 
Property and equipment consist of the following (in thousands):
June 30,
2024
December 31,
2023
Laboratory equipment$12,502 $11,208 
Computers and software262 127 
Office furniture and equipment1,979 1,979 
Leasehold improvements288 288 
Construction in process16 — 
Property and equipment, gross15,047 13,602 
Less accumulated depreciation(6,549)(5,221)
Total property and equipment, net$8,498 $8,381 
Depreciation expense related to property and equipment was $0.7 million and $0.5 million for the three months ended June 30, 2024 and 2023, respectively, and $1.3 million and $0.9 million for the six months ended June 30, 2024 and 2023, respectively.
Accounts payable and accrued liabilities (in thousands):
June 30,
2024
December 31,
2023
Accounts payable$8,889 $8,809 
Accrued non-clinical liabilities24,037 19,535
Accrued clinical liabilities7,998 5,997
Total accounts payable and accrued liabilities$40,924 $34,341 
v3.24.2.u1
Commitments and Contingencies
6 Months Ended
Jun. 30, 2024
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies Commitments and Contingencies
Litigation
Liabilities for loss contingencies arising from claims, assessments, litigation, fines, penalties and other sources are recorded when it is probable that a liability has been incurred and the amount can be reasonably estimated. There are no such matters currently outstanding for which liabilities have been accrued.
Operating Lease
In April 2024, the Company entered into a sublease agreement with Turning Point Therapeutics, Inc. to rent 105,000 square feet for office and laboratory space for the Company’s future corporate headquarters. The term of the sublease is approximately 9 years and 9 months with payments expected to begin in August 2025. Pursuant to the terms of the sublease agreement, the sublandlord will provide the Company with a tenant improvement allowance of up to $33.6 million. An additional tenant improvement allowance of up to $5.0 million is also available to be repaid in equal installments through monthly rent payments, subject to 8% interest per annum and annual increases of 3% per annum. The Company also has an option and a right of first refusal for an additional 80,000 square feet in an adjacent available building, which has not been exercised. Total aggregate future lease commitments under the sublease agreement are approximately $72.6 million, inclusive of 3% annual rent increases and various agreed upon rent abatement amounts. The sublease will be measured and recognized upon commencement of the sublease. As of June 30, 2024, the sublease had not commenced because construction of improvements to bring the facility to its intended use was not substantially complete.
In connection with the sublease agreement, the Company is required to maintain a letter of credit for the benefit of the sublandlord in the amount of $2.5 million, which was delivered in April 2024 and is included in restricted cash in the Company’s condensed balance sheet.
v3.24.2.u1
Stockholders' Equity
6 Months Ended
Jun. 30, 2024
Share-Based Payment Arrangement [Abstract]  
Stockholders' Equity Stockholders’ Equity
Common Stock
On November 8, 2022, the Company entered into a sales agreement (the 2022 Sales Agreement) with Cowen and Company, LLC (the 2022 Sales Agent). Under the 2022 Sales Agreement, the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to $200.0 million through the 2022 Sales Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the 2022 Sales Agent. The Company is not obligated to sell, and the 2022 Sales Agent is not obligated to buy or sell, any shares of common stock under the 2022 Sales Agreement. During the six months ended June 30, 2024 and 2023, the Company sold 418,408 and 4,107,810 shares of its common stock, respectively, pursuant to the 2022 Sales Agreement and received net proceeds of $5.6 million and $60.5 million, respectively, after deducting offering-related transaction costs and commissions.
On March 4, 2024, the Company sold 15,224,773 unregistered shares of its common stock and pre-funded warrants in lieu of common stock to purchase up to an aggregate of 9,030,851 shares of its common stock to investors in a private placement at an offering price of $16.50 per share and $16.499 per pre-funded warrant, which represents the offering price per share of common stock less an exercise price of $0.001 per share. The Company valued the common stock at the offering price, concluding that the offering price approximated fair value. The net proceeds from the private placement were $379.8 million after deducting placement fees and offering costs of $20.4 million. The resale of the shares, including the shares issuable upon exercise of the pre-
funded warrants, were subsequently registered on an automatically effective Registration Statement on Form S-3 filed with the SEC on April 2, 2024.
The pre-funded warrants are a freestanding instrument that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815. The Company valued the pre-funded warrants at the offering price, concluding that the offering price approximated fair value. The pre-funded warrants meet the equity classification criteria and were accounted for as a component of additional paid-in capital. The pre-funded warrants are immediately exercisable and do not expire.
One of the investors who participated in the private placement met the criteria of a related party as such investor was a principal owner of more than 10% of the voting interest in the Company (the Principal Owner). The Principal Owner purchased 2,121,213 shares of the Company's common stock for $35.0 million. The purchase of common stock under the private placement by the Principal Owner was carried out at arm's length as substantiated by the fact that the per share purchase price equaled the price paid by other participants. No amounts were due from the Principal Owner as of June 30, 2024.
On June 17, 2024, the Company completed a public offering of 12,132,500 shares of its common stock at a public offering price of $38.00 per share. Net proceeds from the offering were approximately $432.8 million, after deducting underwriting discounts and offering expenses of $28.3 million. The shares sold in the offering were registered pursuant to the Company's shelf registration statement on Form S-3, which became automatically effective upon filing on May 9, 2024.
Stock Options
Stock option activity for employee and non-employee awards and related information is as follows (in thousands, except per share data):
Number of
Options
Weighted-
Average
Exercise
Price Per
Share
Outstanding at December 31, 202312,495$14.91 
Granted2,27515.53 
Exercised(1,742)10.45 
Forfeited/expired(300)16.40 
Outstanding at June 30, 202412,728$15.60 
Restricted Stock Units and Performance Stock Units
The Company has granted restricted stock units (RSUs) and performance stock units (PSUs) to employees of the Company under the 2020 Incentive Award and the 2022 Employment Inducement Incentive Award Plans. RSUs and PSUs are valued at the market price of a share of the Company’s stock on the date of grant. RSUs vest ratably on an annual basis over a four-year service period and are payable in shares of common stock on the vesting date. Compensation expense for RSUs is recognized on a straight-line basis over the four-year service period. Compensation expense for PSUs is recognized over the service period when the performance conditions are met or considered probable of achievement, using management's best estimates. Forfeitures are recorded in the period in which they occur.
The following table summarizes the RSU activity for the six months ended June 30, 2024 (in thousands, except per share data):
Number of SharesWeighted-Average Grant Date Fair Value
Unvested at December 31, 2023758 $18.73 
Granted984 13.78 
Vested(147)21.70 
Forfeited(69)15.34 
Unvested at June 30, 2024
1,526 $15.41 
The total fair value of RSU shares vested during the six months ended June 30, 2024 was $1.8 million. No RSUs vested during the six months ended June 30, 2023.
The following table summarizes the PSU activity for the six months ended June 30, 2024 (in thousands, except per share data):
Number of SharesWeighted-Average Grant Date Fair Value
Unvested at December 31, 2023750 $6.57 
Granted— — 
Vested(188)6.57 
Forfeited— — 
Unvested at June 30, 2024
562 $6.57 
During the six months ended June 30, 2024, the performance conditions related to 375,000 units of outstanding PSUs were met or deemed probable resulting in (1) the immediate vesting of 187,500 shares and (2) the expected vesting of 187,500 shares in December 2024. As a result, the Company recognized $2.0 million of stock-based compensation expense during the six months ended June 30, 2024. No stock-based compensation expense has been recognized for the remaining 375,000 outstanding PSUs as the performance conditions were not deemed probable. The total fair value of PSU shares vested during the six months ended June 30, 2024 was $7.4 million. No PSUs vested during the six months ended June 30, 2023.
Employee Stock Purchase Plan
The Company issued 137,913 and 81,005 shares of common stock under the Employee Stock Purchase Plan (ESPP) during the six months ended June 30, 2024 and 2023, respectively. The Company had an outstanding liability of $0.1 million at June 30, 2024, which is included in accounts payable and accrued liabilities on the condensed balance sheet, for employee contributions to the ESPP for shares pending issuance at the end of the current offering period. As of June 30, 2024, 234,604 shares of common stock were available for issuance under the ESPP.
Stock-Based Compensation Expense
The assumptions used in the Black-Scholes-Merton model to determine the fair value of stock option grants were as follows:
Options
Six Months Ended June 30,
20242023
Risk-free interest rate
3.9% - 4.7%
3.5% - 4.0%
Expected volatility
79% - 82%
81% - 82%
Expected term (in years)
5.3 - 6.1
5.5 - 6.1
Expected dividend yield
—%
—%
Risk-Free Interest Rate. The Company bases the risk-free interest rate assumption for equity awards on the rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued.
Expected Volatility. The expected volatility of stock options is estimated based on the average historical volatilities of common stock of comparable publicly traded companies and the Company's own volatility. The comparable companies are chosen based on their size and stage in the life cycle. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Prior to 2023, the Company exclusively used peer group companies to determine expected volatility.
Expected Term. The Company's limited option exercise history does not provide a reasonable basis for estimating expected term, therefore the Company has estimated the expected life of its stock options using the simplified method, whereby the expected life equals the average of the vesting term and the original contractual term of the option. The expected life assumption for employee stock purchases under the ESPP is six months to conform with the six-month ESPP offering period.
Expected Dividend Yield. The Company’s expected dividend yield assumption is zero as it has never paid dividends and has no present intention to do so in the future.
The allocation of stock-based compensation expense for stock option, RSU awards, PSU awards, and shares purchasable under the ESPP was as follows (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2024202320242023
Research and development expense$6,529 $5,442 $12,266 $10,714 
General and administrative expense6,283 4,011 10,852 7,843 
Total stock-based compensation expense$12,812 $9,453 $23,118 $18,557 
As of June 30, 2024, the unrecognized compensation cost related to outstanding time-based options and RSUs was $70.3 million and $21.0 million, respectively, which is expected to be recognized over a weighted-average period of 2.61 years and 3.30 years, respectively. Unrecognized compensation cost related to PSUs was $2.9 million. As of June 30, 2024, the unrecognized compensation cost related to stock purchase rights under the ESPP was $0.6 million, which is expected to be recognized over a weighted-average period of 0.46 years.
v3.24.2.u1
Subsequent Events
6 Months Ended
Jun. 30, 2024
Subsequent Events [Abstract]  
Subsequent Events Subsequent Events
On August 9, 2024, the Company entered into a sales agreement (the 2024 Sales Agreement) with TD Securities (USA), LLC (the 2024 Sales Agent) with substantially similar terms as the 2022 Sales Agreement described in Note 8 "Stockholders' Equity". Under the 2024 Sales Agreement, the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to $400 million through the 2024 Sales Agent. Sales of the shares of common stock, if any, will be made at prevailing market prices at the time of sale, or as otherwise agreed with the 2024 Sales Agent. The Company is not obligated to sell, and the 2024
Sales Agent is not obligated to buy or sell, any shares of common stock under the 2024 Sales Agreement. The 2024 Sales Agent will be entitled to a commission of up to 3.0% of the gross sales price of the ATM Shares sold through it pursuant to the 2024 Sales Agreement.
v3.24.2.u1
Pay vs Performance Disclosure - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Jun. 30, 2023
Mar. 31, 2023
Jun. 30, 2024
Jun. 30, 2023
Pay vs Performance Disclosure            
Net loss $ (70,793) $ (68,855) $ (47,025) $ (52,394) $ (139,648) $ (99,419)
v3.24.2.u1
Insider Trading Arrangements
3 Months Ended 6 Months Ended
Jun. 30, 2024
shares
Jun. 30, 2024
shares
Trading Arrangements, by Individual    
Material Terms of Trading Arrangement  
From time to time, our officers (as defined in Rule 16a–1(f)) and directors may enter into Rule 10b5-1 or non-Rule 10b5-1 trading arrangements (as each such term is defined in Item 408 of Regulation S-K). During the
three months ended June 30, 2024, our officers and directors took the following actions with respect to such trading arrangements:
ActionDateTrading ArrangementTotal Shares to be SoldExpiration Date
Rule 10b5-1*Non-Rule 10b5-1**
Michael MacLean (Chief Financial and Chief Business Officer)
Adopt4/2/2024X124,4236/30/2025
W. Michael Flanagan (Chief Scientific and Technical Officer)
Adopt6/12/2024X
271,958(1)
6/12/2026
Teresa McCarthy (Chief Human Resources Officer)
Adopt6/12/2024X200,00012/31/2025
____________________
* Intended to satisfy the affirmative defense of Rule 10b5-1(c)
** Not intended to satisfy the affirmative defense of Rule 10b5-1(c)
(1)Subject to increase based on a future award of our common stock covered by this 10b5-1 plan, the number of such securities is not able to be determined as of the date hereof.
Non-Rule 10b5-1 Arrangement Adopted false  
Rule 10b5-1 Arrangement Terminated false  
Non-Rule 10b5-1 Arrangement Terminated false  
Michael MacLean [Member]    
Trading Arrangements, by Individual    
Name Michael MacLean  
Title (Chief Financial and Chief Business Officer)  
Rule 10b5-1 Arrangement Adopted true  
Adoption Date 4/2/2024  
Expiration Date 6/30/2025  
Arrangement Duration 454 days  
Aggregate Available 124,423 124,423
W. Michael Flanagan [Member]    
Trading Arrangements, by Individual    
Name W. Michael Flanagan  
Title (Chief Scientific and Technical Officer)  
Rule 10b5-1 Arrangement Adopted true  
Adoption Date 6/12/2024  
Expiration Date 6/12/2026  
Arrangement Duration 730 days  
Aggregate Available 271,958 271,958
Teresa McCarthy [Member]    
Trading Arrangements, by Individual    
Name Teresa McCarthy  
Title (Chief Human Resources Officer)  
Rule 10b5-1 Arrangement Adopted true  
Adoption Date 6/12/2024  
Expiration Date 12/31/2025  
Arrangement Duration 567 days  
Aggregate Available 200,000 200,000
v3.24.2.u1
Summary of Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
Basis of Presentation
Basis of Presentation
The accompanying unaudited interim condensed financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) and the rules and regulations of the Securities and Exchange Commission (SEC) related to a quarterly report on Form 10-Q. Certain information and note disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to those rules and regulations. The unaudited interim condensed financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The operating results presented in these unaudited interim condensed financial statements are not necessarily indicative of the results that may be expected for any future periods. These unaudited interim condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto for the year ended December 31, 2023 included in the Company’s annual report on Form 10-K filed with the SEC on February 28, 2024.
Use of Estimates
Use of Estimates
The Company’s condensed financial statements are prepared in accordance with GAAP, which requires the Company to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the condensed financial statements and accompanying notes. The most significant estimates in the Company’s condensed financial statements relate to revenue recognition, stock-based compensation, and accrued research and development costs. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions.
Net Loss Per Share
Net Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period, adjusted for the weighted-average number of common shares outstanding that are subject to repurchase or forfeiture. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period determined using the treasury-stock and if-converted methods. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding as inclusion of the common stock equivalent securities would be anti-dilutive. The pre-funded common stock warrants are included in the calculation of basic and diluted net loss per share as the exercise price of $0.001 per share is not substantive and the shares are issuable for little or no consideration.
Recently Issued Accounting Pronouncements
Recently Issued Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (FASB) issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which modifies the disclosure and presentation requirements of reportable segments. The amendments in the update require the disclosure of significant segment expenses that are regularly provided to the Chief Operating Decision Maker (CODM) and included within each reported measure of segment profit and loss. The amendments also require disclosure of all other segment items by reportable segment and a description of its composition. Additionally, the amendments require disclosure of the title and position of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. Lastly, the amendment requires that a public entity that has a single reportable segment provide all the disclosures required by ASU 2023-07 and all existing segment disclosures in Topic 280. This update is effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. ASU 2023-07 will be applied retrospectively and early adoption is permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its financial statements and accompanying notes.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which enhances income tax disclosures, primarily through standardization and disaggregation of the income tax rate reconciliation and disaggregation of income taxes paid. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. ASU 2023-09 can be applied either prospectively or retrospectively and early adoption is permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its financial statements and accompanying notes.
v3.24.2.u1
Summary of Significant Accounting Policies (Tables)
6 Months Ended
Jun. 30, 2024
Accounting Policies [Abstract]  
Schedule of Potentially Dilutive Securities not Included in Calculation of Diluted Net Loss Per Share
Common stock equivalent securities not included in the calculation of diluted net loss per share for the three and six month periods ended June 30, because to do so would be anti-dilutive, are as follows (in thousands):
June 30,
20242023
Common stock options12,72810,978
Restricted stock units1,526635
Performance stock units562
Employee Stock Purchase Plan shares pending issuance49
Total14,82011,622
v3.24.2.u1
Fair Value Measurements (Tables)
6 Months Ended
Jun. 30, 2024
Fair Value Disclosures [Abstract]  
Schedule of Cash Equivalents and Marketable Securities Measured at Fair Value
The following tables summarize the Company’s cash equivalents and marketable securities measured at fair value (in thousands):
Fair Value Measurements Using
As of June 30, 2024TotalQuoted Prices in
Active Markets
for Identical
Assets (Level 1)
Significant
Other
Observable
Inputs (Level 2)
Significant
Unobservable
Inputs
(Level 3)
Cash equivalents:
U.S. Treasury securities$10,962 $10,962 $— $— 
Marketable securities:
U.S. Treasury securities721,340 721,340 — — 
Negotiable certificates of deposit1,955 — 1,955 — 
Total$734,257 $732,302 $1,955 $— 
Fair Value Measurements Using
As of December 31, 2023TotalQuoted Prices in
Active Markets
for Identical
Assets (Level 1)
Significant
Other
Observable
Inputs (Level 2)
Significant
Unobservable
Inputs
(Level 3)
Marketable securities:
U.S. Treasury securities$399,890 $399,890 $— $— 
U.S. Government agency securities4,998 — 4,998 — 
Negotiable certificates of deposit5,381 — 5,381 — 
Total$410,269 $399,890 $10,379 $— 
v3.24.2.u1
Marketable Securities (Tables)
6 Months Ended
Jun. 30, 2024
Investments, Debt and Equity Securities [Abstract]  
Schedule of Marketable Securities
The Company’s marketable securities, which consist of highly liquid marketable debt securities, are classified as available-for-sale and are stated at fair value. The following tables summarize the Company’s marketable securities (in thousands):
As of June 30, 2024Maturity
(in years)
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated
Fair Value
U.S. Treasury securities
1 or less
$613,201 $$(517)$612,690 
Negotiable certificates of deposit
1 or less
1,959 — (4)1,955 
U.S. Treasury securities
1 - 2
108,588 62 — 108,650 
Total$723,748 $68 $(521)$723,295 
As of December 31, 2023Maturity
(in years)
Amortized
Cost
Unrealized
Gains
Unrealized
Losses
Estimated
Fair Value
U.S. Treasury securities
1 or less
$301,053 $102 $(530)$300,625 
U.S. Government agency securities
1 or less
5,000 — (2)4,998 
Negotiable certificates of deposit
1 or less
4,410 (4)4,407 
U.S. Treasury securities
1 - 2
98,701 600 (36)99,265 
Negotiable certificates of deposit
1 - 2
980 — (6)974 
Total$410,144 $703 $(578)$410,269 
Schedule of Debt Securities, Available-for-Sale, Unrealized Loss Position, Fair Value
The following table summarizes marketable securities in a continuous unrealized loss position for which an allowance for credit losses was not recorded (in thousands):
Less Than 12 Months
12 Months or Greater
Total
As of June 30, 2024
Fair Value
Unrealized Losses
Fair Value
Unrealized Losses
Fair Value
Unrealized Losses
U.S. Treasury securities$469,288 $(312)$74,471 $(205)$543,759 $(517)
Negotiable certificates of deposit734 — 1,221 (4)1,955 (4)
Total$470,022 $(312)$75,692 $(209)$545,714 $(521)
Less Than 12 Months
12 Months or Greater
Total
As of December 31, 2023
Fair Value
Unrealized Losses
Fair Value
Unrealized Losses
Fair Value
Unrealized Losses
U.S. Treasury securities$214,291 $(566)$— $— $214,291 $(566)
U.S. Government agency securities4,998 (2)— — 4,998 (2)
Negotiable certificates of deposit3,665 (10)— — 3,665 (10)
Total$222,954 $(578)$— $— $222,954 $(578)
v3.24.2.u1
Collaboration, License and Research Agreements (Tables)
6 Months Ended
Jun. 30, 2024
Collaboration License And Research Agreements [Abstract]  
Schedule of Reconciliation of Deferred
A reconciliation of the closing balance of deferred revenue related to the Company's research collaboration and license agreements for the six months ended June 30, 2024 and 2023 is as follows (in thousands):
Balance at December 31, 2023$69,263 
Revenue recognized that was included in the balance at the beginning of the period(2,961)
Balance at March 31, 2024$66,302 
Revenue recognized that was included in the balance at the beginning of the period(2,045)
Balance at June 30, 2024$64,257 
Balance at December 31, 2022$6,276 
Revenue recognized that was included in the balance at the beginning of the period(1,219)
Balance at March 31, 2023$5,057 
Revenue recognized that was included in the balance at the beginning of the period(1,247)
Balance at June 30, 2023$3,810 
v3.24.2.u1
Composition of Certain Financial Statement Items (Tables)
6 Months Ended
Jun. 30, 2024
Property, Plant and Equipment [Abstract]  
Schedule of Prepaid and Other Current Assets
Prepaid and other assets (in thousands)
June 30,
2024
December 31, 2023
Accounts receivable$— $1,105 
Prepaid assets14,041 7,333
Interest receivable and other assets
15,714 7,518
Total prepaid and other assets$29,755 $15,956 
Schedule of Property and Equipment
Property and equipment consist of the following (in thousands):
June 30,
2024
December 31,
2023
Laboratory equipment$12,502 $11,208 
Computers and software262 127 
Office furniture and equipment1,979 1,979 
Leasehold improvements288 288 
Construction in process16 — 
Property and equipment, gross15,047 13,602 
Less accumulated depreciation(6,549)(5,221)
Total property and equipment, net$8,498 $8,381 
Schedule of Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities (in thousands):
June 30,
2024
December 31,
2023
Accounts payable$8,889 $8,809 
Accrued non-clinical liabilities24,037 19,535
Accrued clinical liabilities7,998 5,997
Total accounts payable and accrued liabilities$40,924 $34,341 
v3.24.2.u1
Stockholders' Equity (Tables)
6 Months Ended
Jun. 30, 2024
Share-Based Payment Arrangement [Abstract]  
Schedule of Stock Option Activity
Stock option activity for employee and non-employee awards and related information is as follows (in thousands, except per share data):
Number of
Options
Weighted-
Average
Exercise
Price Per
Share
Outstanding at December 31, 202312,495$14.91 
Granted2,27515.53 
Exercised(1,742)10.45 
Forfeited/expired(300)16.40 
Outstanding at June 30, 202412,728$15.60 
Schedule of Unvested Restricted Stock Units Roll Forward
The following table summarizes the RSU activity for the six months ended June 30, 2024 (in thousands, except per share data):
Number of SharesWeighted-Average Grant Date Fair Value
Unvested at December 31, 2023758 $18.73 
Granted984 13.78 
Vested(147)21.70 
Forfeited(69)15.34 
Unvested at June 30, 2024
1,526 $15.41 
Schedule of Nonvested Performance-Based Units Activity
The following table summarizes the PSU activity for the six months ended June 30, 2024 (in thousands, except per share data):
Number of SharesWeighted-Average Grant Date Fair Value
Unvested at December 31, 2023750 $6.57 
Granted— — 
Vested(188)6.57 
Forfeited— — 
Unvested at June 30, 2024
562 $6.57 
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions
The assumptions used in the Black-Scholes-Merton model to determine the fair value of stock option grants were as follows:
Options
Six Months Ended June 30,
20242023
Risk-free interest rate
3.9% - 4.7%
3.5% - 4.0%
Expected volatility
79% - 82%
81% - 82%
Expected term (in years)
5.3 - 6.1
5.5 - 6.1
Expected dividend yield
—%
—%
Schedule of Allocated Stock-based Compensation Expense
The allocation of stock-based compensation expense for stock option, RSU awards, PSU awards, and shares purchasable under the ESPP was as follows (in thousands):
Three Months Ended June 30,Six Months Ended June 30,
2024202320242023
Research and development expense$6,529 $5,442 $12,266 $10,714 
General and administrative expense6,283 4,011 10,852 7,843 
Total stock-based compensation expense$12,812 $9,453 $23,118 $18,557 
v3.24.2.u1
Description of Business and Basis of Presentation - Additional Information (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Accounting Policies [Abstract]    
Accumulated deficit $ (710,412) $ (570,764)
Cash, cash equivalents and marketable securities $ 1,300,000  
v3.24.2.u1
Summary of Significant Accounting Policies - Additional Information (Details)
Jun. 30, 2024
$ / shares
Pre-Funded Common Stock Warrant  
Class of Warrant or Right [Line Items]  
Class of warrant or right, exercise price (in dollar per share) $ 0.001
v3.24.2.u1
Summary of Significant Accounting Policies - Schedule of Potentially Dilutive Securities not Included in Calculation of Diluted Net Loss Per Share (Details) - shares
shares in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]        
Total 14,820 11,622 14,820 11,622
Common stock options        
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]        
Total 12,728 10,978 12,728 10,978
Restricted stock units        
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]        
Total 1,526 635 1,526 635
Performance stock units        
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]        
Total 562 0 562 0
Employee Stock Purchase Plan shares pending issuance        
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]        
Total 4 9 4 9
v3.24.2.u1
Fair Value Measurements (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Marketable securities: $ 723,295 $ 410,269
Recurring    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Total 734,257 410,269
Recurring | U.S. Treasury securities    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Cash equivalents: 10,962  
Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1)    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Total 732,302 399,890
Recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | U.S. Treasury securities    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Cash equivalents: 10,962  
Recurring | Significant Other Observable Inputs (Level 2)    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Total 1,955 10,379
Recurring | Significant Other Observable Inputs (Level 2) | U.S. Treasury securities    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Cash equivalents: 0  
Recurring | Significant Unobservable Inputs (Level 3)    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Total 0 0
Recurring | Significant Unobservable Inputs (Level 3) | U.S. Treasury securities    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Cash equivalents: 0  
Recurring | U.S. Treasury securities    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Marketable securities: 721,340 399,890
Recurring | U.S. Treasury securities | Quoted Prices in Active Markets for Identical Assets (Level 1)    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Marketable securities: 721,340 399,890
Recurring | U.S. Treasury securities | Significant Other Observable Inputs (Level 2)    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Marketable securities: 0 0
Recurring | U.S. Treasury securities | Significant Unobservable Inputs (Level 3)    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Marketable securities: 0 0
Recurring | U.S. Government agency securities    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Marketable securities:   4,998
Recurring | U.S. Government agency securities | Quoted Prices in Active Markets for Identical Assets (Level 1)    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Marketable securities:   0
Recurring | U.S. Government agency securities | Significant Other Observable Inputs (Level 2)    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Marketable securities:   4,998
Recurring | U.S. Government agency securities | Significant Unobservable Inputs (Level 3)    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Marketable securities:   0
Recurring | Negotiable certificates of deposit    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Marketable securities: 1,955 5,381
Recurring | Negotiable certificates of deposit | Quoted Prices in Active Markets for Identical Assets (Level 1)    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Marketable securities: 0 0
Recurring | Negotiable certificates of deposit | Significant Other Observable Inputs (Level 2)    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Marketable securities: 1,955 5,381
Recurring | Negotiable certificates of deposit | Significant Unobservable Inputs (Level 3)    
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items]    
Marketable securities: $ 0 $ 0
v3.24.2.u1
Marketable Securities - Summary of Marketable Securities (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Schedule Of Available For Sale Securities [Line Items]    
Amortized Cost $ 723,748 $ 410,144
Unrealized Gains 68 703
Unrealized Losses (521) (578)
Estimated Fair Value, current 723,295 410,269
Estimated Fair Value 723,295 410,269
U.S. Treasury securities    
Schedule Of Available For Sale Securities [Line Items]    
Amortized Cost, current 613,201 301,053
Amortized Cost, noncurrent 108,588 98,701
Estimated Fair Value, current 612,690 300,625
Estimated Fair Value, noncurrent 108,650 99,265
U.S. Treasury securities | 1 or less    
Schedule Of Available For Sale Securities [Line Items]    
Unrealized Gains 6 102
Unrealized Losses (517) (530)
U.S. Treasury securities | 1 - 2    
Schedule Of Available For Sale Securities [Line Items]    
Unrealized Gains 62 600
Unrealized Losses 0 (36)
U.S. Government agency securities    
Schedule Of Available For Sale Securities [Line Items]    
Amortized Cost, current   5,000
Estimated Fair Value, current   4,998
U.S. Government agency securities | 1 or less    
Schedule Of Available For Sale Securities [Line Items]    
Unrealized Gains   0
Unrealized Losses   (2)
Negotiable certificates of deposit    
Schedule Of Available For Sale Securities [Line Items]    
Amortized Cost, current 1,959 4,410
Amortized Cost, noncurrent   980
Estimated Fair Value, current 1,955 4,407
Estimated Fair Value, noncurrent   974
Negotiable certificates of deposit | 1 or less    
Schedule Of Available For Sale Securities [Line Items]    
Unrealized Gains 0 1
Unrealized Losses $ (4) (4)
Negotiable certificates of deposit | 1 - 2    
Schedule Of Available For Sale Securities [Line Items]    
Unrealized Gains   0
Unrealized Losses   $ (6)
v3.24.2.u1
Marketable Securities - Additional Information (Details) - USD ($)
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Investments, Debt and Equity Securities [Abstract]      
Allowance for credit loss $ 0   $ 0
Accrued interest receivable on available-for-sale securities 4,100,000   $ 2,600,000
Debt securities, available-for-sale, accrued interest writeoff $ 0 $ 0  
v3.24.2.u1
Marketable Securities - Schedule of Available-for-sale Securities in an Unrealized Loss Position (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Fair Value    
Less Than 12 months, Fair Value $ 470,022 $ 222,954
12 months or Greater, Fair Value 75,692 0
Total Fair Value 545,714 222,954
Unrealized Losses    
Less Than 12 months, Gross Unrealized Losses (312) (578)
12 months or Greater, Gross Unrealized Losses (209) 0
Total Gross Unrealized Losses (521) (578)
U.S. Treasury securities    
Fair Value    
Less Than 12 months, Fair Value 469,288 214,291
12 months or Greater, Fair Value 74,471 0
Total Fair Value 543,759 214,291
Unrealized Losses    
Less Than 12 months, Gross Unrealized Losses (312) (566)
12 months or Greater, Gross Unrealized Losses (205) 0
Total Gross Unrealized Losses (517) (566)
U.S. Government agency securities    
Fair Value    
Less Than 12 months, Fair Value   4,998
12 months or Greater, Fair Value   0
Total Fair Value   4,998
Unrealized Losses    
Less Than 12 months, Gross Unrealized Losses   (2)
12 months or Greater, Gross Unrealized Losses   0
Total Gross Unrealized Losses   (2)
Negotiable certificates of deposit    
Fair Value    
Less Than 12 months, Fair Value 734 3,665
12 months or Greater, Fair Value 1,221 0
Total Fair Value 1,955 3,665
Unrealized Losses    
Less Than 12 months, Gross Unrealized Losses 0 (10)
12 months or Greater, Gross Unrealized Losses (4) 0
Total Gross Unrealized Losses $ (4) $ (10)
v3.24.2.u1
Collaboration, License and Research Agreements - Additional Information (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Mar. 31, 2024
Dec. 31, 2023
Mar. 31, 2023
Dec. 31, 2022
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]                
Revenue recognized $ 2,045,000 $ 2,316,000 $ 5,588,000 $ 4,549,000        
Deferred revenue 64,257,000 3,810,000 64,257,000 3,810,000 $ 66,302,000 $ 69,263,000 $ 5,057,000 $ 6,276,000
Research Collaboration, License Agreement and Securities Purchase Agreement with BMS                
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]                
Revenue recognized 2,000,000   4,500,000          
Collaboration receivables 0   0     0    
Research Collaboration and License Agreement with Eli Lilly                
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items]                
Revenue recognized 0 $ 2,300,000 1,100,000 $ 4,500,000        
Collaboration receivables 0   0     $ 800,000    
Deferred revenue $ 0   $ 0          
v3.24.2.u1
Collaboration, License and Research Agreements - Reconciliation of Deferred Revenue (Details) - USD ($)
$ in Thousands
3 Months Ended
Jun. 30, 2024
Mar. 31, 2024
Jun. 30, 2023
Mar. 31, 2023
Contract With Customer, Liability [Roll Forward]        
Beginning balance $ 66,302 $ 69,263 $ 5,057 $ 6,276
Revenue recognized that was included in the balance at the beginning of the period (2,045) (2,961) (1,247) (1,219)
Ending balance $ 64,257 $ 66,302 $ 3,810 $ 5,057
v3.24.2.u1
Composition of Certain Financial Statement Items - Schedule of Prepaid and Other Assets (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Property, Plant and Equipment [Abstract]    
Accounts receivable $ 0 $ 1,105
Prepaid assets 14,041 7,333
Interest receivable and other assets 15,714 7,518
Total prepaid and other assets $ 29,755 $ 15,956
v3.24.2.u1
Composition of Certain Financial Statement Items - Schedule of Property and Equipment (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Property Plant And Equipment [Line Items]    
Property and equipment, gross $ 15,047 $ 13,602
Less accumulated depreciation (6,549) (5,221)
Total property and equipment, net 8,498 8,381
Laboratory equipment    
Property Plant And Equipment [Line Items]    
Property and equipment, gross 12,502 11,208
Computers and software    
Property Plant And Equipment [Line Items]    
Property and equipment, gross 262 127
Office furniture and equipment    
Property Plant And Equipment [Line Items]    
Property and equipment, gross 1,979 1,979
Leasehold improvements    
Property Plant And Equipment [Line Items]    
Property and equipment, gross 288 288
Construction in process    
Property Plant And Equipment [Line Items]    
Property and equipment, gross $ 16 $ 0
v3.24.2.u1
Composition of Certain Financial Statement Items - Additional Information (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Property, Plant and Equipment [Abstract]        
Depreciation expenses related to property and equipment $ 700 $ 500 $ 1,328 $ 920
v3.24.2.u1
Composition of Certain Financial Statement Items - Schedule of Accounts Payable and Accrued Liabilities (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
Property, Plant and Equipment [Abstract]    
Accounts payable $ 8,889 $ 8,809
Accrued non-clinical liabilities 24,037 19,535
Accrued clinical liabilities 7,998 5,997
Total accounts payable and accrued liabilities $ 40,924 $ 34,341
v3.24.2.u1
Commitments and Contingencies (Details)
1 Months Ended
Apr. 30, 2024
USD ($)
ft²
Jun. 30, 2024
USD ($)
Loss Contingencies [Line Items]    
Loss contingencies accrued   $ 0
Turning Point Therapeutics, Inc.    
Loss Contingencies [Line Items]    
Area of land | ft² 105,000  
Term of contract 9 years 9 months  
Tenant improvement allowance $ 33,600,000  
Additional tenant improvement allowance $ 5,000,000  
Additional tenant improvement allowance interest rate 0.08  
Additional tenant improvement allowance interest rate, annual increase 0.03  
Operating lease not yet commenced, area of additional rentable space | ft² 80,000  
Aggregate future lease payments $ 72,600,000  
Restricted cash $ 2,500,000  
v3.24.2.u1
Stockholders' Equity - Additional Information (Details) - USD ($)
$ / shares in Units, $ in Thousands
1 Months Ended 3 Months Ended 6 Months Ended
Jun. 17, 2024
Mar. 04, 2024
Nov. 08, 2022
Dec. 31, 2024
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Stock-based compensation expense         $ 12,812 $ 9,453 $ 23,118 $ 18,557
Expected dividend yield             0.00%  
Unrecognized compensation cost, options         70,300   $ 70,300  
Forecast                
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Vested (in shares)       187,500        
Restricted Stock Units (RSUs)                
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Award vesting period             4 years  
Compensation cost, period for recognition             4 years  
Fair value of shares vested during the period             $ 1,800  
Vested (in shares)             147,000 0
Unrecognized compensation cost, excluding options         $ 21,000   $ 21,000  
Restricted Stock Units (RSUs) | Weighted Average                
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Compensation cost, period for recognition             3 years 3 months 18 days  
Performance Stock Units (PSUs)                
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Fair value of shares vested during the period             $ 7,400  
Vested (in shares)             187,500 0
Outstanding PSUs (in shares)         375,000   375,000  
Stock-based compensation expense             $ 2,000  
Unrecognized compensation cost, excluding options         $ 2,900   $ 2,900  
Employee Stock                
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Compensation cost, period for recognition             5 months 15 days  
Issuance of common stock under Employee Stock Purchase Plan (in shares)             137,913 81,005
Outstanding liability         $ 100   $ 100  
Shares reserved for future issuance (in shares)         234,604   234,604  
Expected term (in years)             6 months  
Award offering period             6 months  
Unrecognized compensation cost, excluding options         $ 600   $ 600  
Common stock options                
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Compensation cost, period for recognition             2 years 7 months 9 days  
Expected dividend yield             0.00% 0.00%
Outstanding Performance Stock Units (PSUs)                
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Stock-based compensation expense             $ 0  
Pre-Funded Common Stock Warrant                
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Class of warrant or right, exercise price (in dollar per share)         $ 0.001   $ 0.001  
Private Placement Offering 2024                
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Sale of stock number of shares issued in transaction (in shares)   15,224,773            
Sale of stock, consideration received on transaction   $ 379,800            
Sale of stock, price per share (in dollars per share)   $ 16.50            
Payments of stock issuance costs   $ 20,400            
Private Placement Offering 2024 | Principal Owner                
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Sale of stock number of shares issued in transaction (in shares)   2,121,213            
Sale of stock, consideration received on transaction   $ 35,000            
Private Placement Offering 2024 | Pre-Funded Common Stock Warrant                
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Class of warrant or right, number of securities called by warrants or rights (in shares)   9,030,851            
Sale of stock, price per share (in dollars per share)   $ 16.499            
Class of warrant or right, exercise price (in dollar per share)   $ 0.001            
Public Stock Offering                
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Sale of stock number of shares issued in transaction (in shares) 12,132,500              
Sale of stock, consideration received on transaction $ 432,800              
Sale of stock, price per share (in dollars per share) $ 38.00              
Payments of stock issuance costs $ 28,300              
Cowen And Company, LLC | Private Placement, 2022 Sales Agreement                
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]                
Sale of common stock maximum aggregate offering price     $ 200,000          
Sale of stock number of shares issued in transaction (in shares)             418,408 4,107,810
Sale of stock, consideration received on transaction             $ 5,600 $ 60,500
v3.24.2.u1
Stockholders' Equity - Schedule of Stock Option Activity (Details)
shares in Thousands
6 Months Ended
Jun. 30, 2024
$ / shares
shares
Number of Options  
Beginning balance (in shares) | shares 12,495
Granted (in shares) | shares 2,275
Exercised (in shares) | shares (1,742)
Forfeited/expired (in shares) | shares (300)
Ending balance (in shares) | shares 12,728
Weighted- Average Exercise Price Per Share  
Beginning balance (in dollars per share) | $ / shares $ 14.91
Granted (in dollars per share) | $ / shares 15.53
Exercised (in dollars per share) | $ / shares 10.45
Forfeited/expired (in dollars per share) | $ / shares 16.40
Ending balance (in dollars per share) | $ / shares $ 15.60
v3.24.2.u1
Stockholders' Equity - Schedule of Unvested Restricted Stock Units Roll Forward (Details) - $ / shares
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Restricted Stock Units (RSUs)    
Number of Shares    
Beginning balance (in shares) 758,000  
Granted (in shares) 984,000  
Vested (in shares) (147,000) 0
Forfeited (in shares) (69,000)  
Ending balance (in shares) 1,526,000  
Weighted-Average Grant Date Fair Value    
Beginning balance (in dollars per share) $ 18.73  
Granted (in dollars per share) 13.78  
Vested (in dollars per share) 21.70  
Forfeited (in dollars per share) 15.34  
Ending balance (in dollars per share) $ 15.41  
Performance Stock Units (PSUs)    
Number of Shares    
Beginning balance (in shares) 750,000  
Granted (in shares) 0  
Vested (in shares) (187,500) 0
Forfeited (in shares) 0  
Ending balance (in shares) 562,000  
Weighted-Average Grant Date Fair Value    
Beginning balance (in dollars per share) $ 6.57  
Granted (in dollars per share) 0  
Vested (in dollars per share) 6.57  
Forfeited (in dollars per share) 0  
Ending balance (in dollars per share) $ 6.57  
v3.24.2.u1
Stockholders' Equity - Schedule of Assumptions to Determine Fair Value (Details)
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Expected dividend yield 0.00%  
Stock Options    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Risk-free interest rate, Minimum 3.90% 3.50%
Risk-free interest rate, Maximum 4.70% 4.00%
Expected volatility, Minimum 79.00% 81.00%
Expected volatility, Maximum 82.00% 82.00%
Expected dividend yield 0.00% 0.00%
Stock Options | Minimum    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Expected term (in years) 5 years 3 months 18 days 5 years 6 months
Stock Options | Maximum    
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]    
Expected term (in years) 6 years 1 month 6 days 6 years 1 month 6 days
v3.24.2.u1
Stockholders' Equity - Schedule of Allocated Stock-based Compensation Expense (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]        
Total stock-based compensation expense $ 12,812 $ 9,453 $ 23,118 $ 18,557
Research and development expense        
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]        
Total stock-based compensation expense 6,529 5,442 12,266 10,714
General and administrative expense        
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items]        
Total stock-based compensation expense $ 6,283 $ 4,011 $ 10,852 $ 7,843
v3.24.2.u1
Subsequent Events (Details) - Subsequent Event - Private Placement 2024 Sales Agreement Member
$ in Millions
Aug. 09, 2024
USD ($)
Subsequent Event [Line Items]  
Agent commission fee as a percentage of gross sales price of shares sold 3.00%
TD Securities (USA), LLC  
Subsequent Event [Line Items]  
Sale of common stock maximum aggregate offering price $ 400

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