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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
_____________________________________________________
FORM 10-Q
_____________________________________________________
| | | | | |
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024
or
| | | | | |
o | TRANSITION 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)
_____________________________________________________
| | | | | | | | |
Delaware | | 46-1336960 |
(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 class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock, $0.0001 par value | RNA | The 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 filer | x | Accelerated filer | o |
Non-accelerated filer | o | Smaller reporting company | o |
| | Emerging growth company | o |
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 April 22, 2024, the registrant had 95,636,748 shares of common stock outstanding.
Avidity Biosciences, Inc.
FORM 10-Q
TABLE OF CONTENTS
PART I - FINANCIAL INFORMATION
Item 1. Condensed Financial Statements (unaudited)
Avidity Biosciences, Inc.
Condensed Balance Sheets
(in thousands, except par value)
| | | | | | | | | | | |
| March 31, 2024 | | December 31, 2023 |
| (unaudited) | | |
Assets | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 471,400 | | | $ | 185,082 | |
Marketable securities | 444,473 | | | 410,269 | |
Prepaid and other assets | 18,601 | | | 15,956 | |
Total current assets | 934,474 | | | 611,307 | |
Property and equipment, net | 8,655 | | | 8,381 | |
Restricted cash | 295 | | | 295 | |
Right-of-use assets | 7,625 | | | 8,271 | |
Other assets | 425 | | | 301 | |
Total assets | $ | 951,474 | | | $ | 628,555 | |
Liabilities and Stockholders’ Equity | | | |
Current liabilities: | | | |
Accounts payable and accrued liabilities | $ | 37,330 | | | $ | 34,341 | |
Accrued compensation | 7,796 | | | 14,335 | |
Lease liabilities, current portion | 3,726 | | | 3,639 | |
Deferred revenue, current portion | 26,103 | | | 28,365 | |
Total current liabilities | 74,955 | | | 80,680 | |
Lease liabilities, net of current portion | 5,421 | | | 6,213 | |
Deferred revenue, net of current portion | 40,199 | | | 40,898 | |
Total liabilities | 120,575 | | | 127,791 | |
Commitments and contingencies (Note 7) | | | |
Stockholders’ equity: | | | |
Common stock, $0.0001 par value; authorized shares – 400,000; issued and outstanding shares – 95,594 and 79,275 at March 31, 2024 and December 31, 2023, respectively | 10 | | | 8 | |
Additional paid-in capital | 1,470,972 | | | 1,071,395 | |
Accumulated other comprehensive income (loss) | (464) | | | 125 | |
Accumulated deficit | (639,619) | | | (570,764) | |
Total stockholders’ equity | 830,899 | | | 500,764 | |
Total liabilities and stockholders’ equity | $ | 951,474 | | | $ | 628,555 | |
See accompanying notes.
Avidity Biosciences, Inc.
Condensed Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
(unaudited)
| | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | |
| 2024 | | 2023 | | | | |
Collaboration revenue | $ | 3,543 | | | $ | 2,233 | | | | | |
Operating expenses: | | | | | | | |
Research and development | 66,832 | | | 47,765 | | | | | |
General and administrative | 13,898 | | | 12,064 | | | | | |
Total operating expenses | 80,730 | | | 59,829 | | | | | |
Loss from operations | (77,187) | | | (57,596) | | | | | |
Other income (expense): | | | | | | | |
Interest income | 8,433 | | | 5,516 | | | | | |
Other expense | (101) | | | (314) | | | | | |
Total other income | 8,332 | | | 5,202 | | | | | |
Net loss | $ | (68,855) | | | $ | (52,394) | | | | | |
Net loss per share, basic and diluted | $ | (0.79) | | | $ | (0.74) | | | | | |
Weighted-average shares outstanding, basic and diluted | 87,212 | | 70,433 | | | | |
Other comprehensive income (loss): | | | | | | | |
Net unrealized gains (losses) on marketable securities | (589) | | | 1,169 | | | | | |
Comprehensive loss | $ | (69,444) | | | $ | (51,225) | | | | | |
See accompanying notes.
Avidity Biosciences, Inc.
Condensed Statements of Stockholders' Equity
(in thousands)
(unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-in Capital | | Accumulated Other Comprehensive Income (Loss) | | Accumulated Deficit | | Total Stockholders’ Equity |
| Shares | | Amount | | | | |
Balance at December 31, 2023 | 79,275 | | $ | 8 | | | $ | 1,071,395 | | | $ | 125 | | | $ | (570,764) | | | $ | 500,764 | |
Issuance of common stock upon exercise of stock options | 541 | | — | | | 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 | 15,225 | | 2 | | | 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 units | 135 | | — | | | — | | | — | | | — | | | — | |
Stock-based compensation | — | | — | | | 10,306 | | | — | | | — | | | 10,306 | |
Net loss | — | | — | | | — | | | — | | | (68,855) | | | (68,855) | |
Other comprehensive loss | — | | — | | | — | | | (589) | | | — | | | (589) | |
Balance at March 31, 2024 | 95,594 | | $ | 10 | | | $ | 1,470,972 | | | $ | (464) | | | $ | (639,619) | | | $ | 830,899 | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
Balance at December 31, 2022 | 69,768 | | $ | 7 | | | $ | 939,310 | | | $ | (2,698) | | | $ | (358,544) | | | $ | 578,075 | |
Issuance of common stock upon exercise of stock options | 102 | | — | | | 520 | | | — | | | — | | | 520 | |
Issuance of common stock in public offerings, 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, 2023 | 70,813 | | $ | 7 | | | $ | 971,375 | | | $ | (1,529) | | | $ | (410,938) | | | $ | 558,915 | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
See accompanying notes.
Avidity Biosciences, Inc.
Condensed Statements of Cash Flows
(in thousands)
(unaudited)
| | | | | | | | | | | |
| Three Months Ended March 31, |
| 2024 | | 2023 |
Cash flows from operating activities | | | |
Net loss | $ | (68,855) | | | $ | (52,394) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Depreciation | 641 | | | 391 | |
Stock-based compensation expense | 10,306 | | | 9,104 | |
Amortization of premiums and discounts on marketable securities, net | (2,960) | | | (2,231) | |
| | | |
Non-cash operating lease costs | 828 | | | 688 | |
Changes in operating assets and liabilities: | | | |
Prepaid and other assets | (2,528) | | | 1,491 | |
Accounts payable and accrued liabilities | 2,575 | | | 1,158 | |
Accrued compensation | (6,539) | | | (5,181) | |
Operating lease liabilities | (887) | | | (774) | |
Deferred revenue | (2,961) | | | (1,219) | |
Net cash used in operating activities | (70,380) | | | (48,967) | |
Cash flows from investing activities | | | |
Maturities of marketable securities | 109,725 | | | 57,490 | |
Purchases of marketable securities | (141,557) | | | (251,350) | |
Purchases of property and equipment | (915) | | | (1,820) | |
Net cash used in investing activities | (32,747) | | | (195,680) | |
Cash flows from financing activities | | | |
Proceeds from issuance of common stock in public offerings, net of issuance costs | 5,594 | | | 22,441 | |
Proceeds from issuance of common stock under employee incentive equity plans | 3,655 | | | 520 | |
Proceeds from the issuance of common stock in a private placement, net of issuance costs | 238,647 | | | — | |
Proceeds from issuance of pre-funded warrants in a private placement, net of issuance costs | 141,549 | | | — | |
Net cash provided by financing activities | 389,445 | | | 22,961 | |
Net increase (decrease) in cash, cash equivalents and restricted cash | 286,318 | | | (221,686) | |
Cash, cash equivalents and restricted cash at beginning of period | 185,377 | | | 340,647 | |
Cash, cash equivalents and restricted cash at end of period | $ | 471,695 | | | $ | 118,961 | |
| | | |
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 | $ | 413 | | | $ | — | |
| | | |
See accompanying notes.
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 March 31, 2024, the Company had an accumulated deficit of $639.6 million and cash, cash equivalents and marketable securities of $915.9 million.
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.
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 three months ended March 31, 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, because to do so would be anti-dilutive, are as follows (in thousands):
| | | | | | | | | | | |
| March 31, |
| 2024 | | 2023 |
Common stock options | 13,485 | | 10,973 |
Restricted stock units | 1,415 | | 607 |
Performance stock units | 750 | | — |
Employee Stock Purchase Plan shares pending issuance | 85 | | 44 |
Total | 15,735 | | 11,624 |
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 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.
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 March 31, 2024 | Total | | Quoted 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 | $ | 440,315 | | | $ | 440,315 | | | $ | — | | | $ | — | |
| | | | | | | |
Negotiable certificates of deposit | 4,158 | | | — | | | 4,158 | | | — | |
| | | | | | | |
Total | $ | 444,473 | | | $ | 440,315 | | | $ | 4,158 | | | $ | — | |
| | | | | | | | | | | | | | | | | | | | | | | |
| | | Fair Value Measurements Using |
As of December 31, 2023 | Total | | Quoted 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 securities | 4,998 | | | — | | | 4,998 | | | — | |
Negotiable certificates of deposit | 5,381 | | | — | | | 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 March 31, 2024 | Maturity (in years) | | Amortized Cost | | Unrealized Gains | | Unrealized Losses | | Estimated Fair Value |
U.S. Treasury securities | 1 or less | | $ | 389,180 | | | $ | 26 | | | $ | (518) | | | $ | 388,688 | |
| | | | | | | | | |
Negotiable certificates of deposit | 1 or less | | 4,165 | | | — | | | (7) | | | 4,158 | |
| | | | | | | | | |
U.S. Treasury securities | 1 - 2 | | 51,592 | | | 69 | | | (34) | | | 51,627 | |
| | | | | | | | | |
| | | | | | | | | |
Total | | | $ | 444,937 | | | $ | 95 | | | $ | (559) | | | $ | 444,473 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
As of December 31, 2023 | Maturity (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 March 31, 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 March 31, 2024 | Fair Value | | Unrealized Losses | | Fair Value | | Unrealized Losses | | Fair Value | | Unrealized Losses |
U.S. Treasury securities | $ | 332,907 | | | $ | 552 | | | $ | — | | | $ | — | | | $ | 332,907 | | | $ | 552 | |
| | | | | | | | | | | |
Negotiable certificates of deposit | 2,204 | | | 1 | | | 1,955 | | | 6 | | | 4,159 | | | 7 | |
Total | $ | 335,111 | | | $ | 553 | | | $ | 1,955 | | | $ | 6 | | | $ | 337,066 | | | $ | 559 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| 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 securities | 4,998 | | | 2 | | | — | | | — | | | 4,998 | | | 2 | |
Negotiable certificates of deposit | 3,665 | | | 10 | | | — | | | — | | | 3,665 | | | 10 | |
Total | $ | 222,954 | | | $ | 578 | | | $ | — | | | $ | — | | | $ | 222,954 | | | $ | 578 | |
Accrued interest receivable on available-for-sale securities was $2.4 million and $2.6 million at March 31, 2024 and December 31, 2023, respectively. The Company has not written off any accrued interest receivable for the three months ended March 31, 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. The BMS Collaboration Agreement and the BMS Purchase Agreement are referred to herein as the "BMS Agreements". In connection with the BMS Collaboration Agreement, the Company recognized
revenue of $2.4 million for the three months ended March 31, 2024. 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 revenue of $1.1 million and $2.2 million for the three months ended March 31, 2024 and 2023, respectively. Collaboration receivables related to the Lilly Agreement were $1.3 million and $0.8 million as of March 31, 2024 and December 31, 2023, respectively, which are included in prepaid and other assets on the condensed balance sheets.
A reconciliation of the closing balance of deferred revenue related to the Company's research collaboration and license agreements three months ended March 31, 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 | |
| | | | | |
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 | |
6. Composition of Certain Financial Statement Items
Prepaid and other assets (in thousands)
| | | | | | | | | | | |
| March 31, 2024 | | December 31, 2023 |
Accounts receivable | $ | 1,575 | | | $ | 1,105 | |
Prepaid assets | 9,561 | | | 7,333 |
Interest receivable and other assets | 7,465 | | | 7,518 |
Total prepaid and other assets | $ | 18,601 | | | $ | 15,956 | |
Property and equipment consist of the following (in thousands):
| | | | | | | | | | | |
| March 31, 2024 | | December 31, 2023 |
Laboratory equipment | $ | 12,008 | | | $ | 11,208 | |
Computers and software | 242 | | | 127 | |
Office furniture and equipment | 1,979 | | | 1,979 | |
Leasehold improvements | 288 | | | 288 | |
Property and equipment, gross | 14,517 | | | 13,602 | |
Less accumulated depreciation | (5,862) | | | (5,221) | |
Total property and equipment, net | $ | 8,655 | | | $ | 8,381 | |
Depreciation expense related to property and equipment was $0.6 million and $0.4 million for the three months ended March 31, 2024 and 2023, respectively.
Accounts payable and accrued liabilities (in thousands):
| | | | | | | | | | | |
| March 31, 2024 | | December 31, 2023 |
Accounts payable | $ | 2,349 | | | $ | 8,809 | |
Accrued non-clinical liabilities | 28,921 | | | 19,535 |
Accrued clinical liabilities | 6,060 | | | 5,997 |
Total accounts payable and accrued liabilities | $ | 37,330 | | | $ | 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.
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 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 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 Sales Agent. The Company is not obligated to sell, and the Sales Agent is not obligated to buy or sell, any shares of common stock under the 2022 Sales Agreement. During the three months ended March 31, 2024 and 2023, the Company sold 418,408 and 943,461 shares of its common stock, respectively, pursuant to the 2022 Sales Agreement and received net proceeds of $5.6 million and $22.4 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 March 31, 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, 2023 | 12,495 | | $ | 14.91 | |
Granted | 1,767 | | 10.37 | |
Exercised | (541) | | 7.21 | |
Forfeited/expired | (236) | | 16.83 | |
Outstanding at March 31, 2024 | 13,485 | | $ | 14.59 | |
Restricted Stock Units and Performance Stock Units
During the three months ended March 31, 2024, the Company granted restricted stock units (RSUs) to employees of the Company under the 2020 Incentive Award and the 2022 Employment Inducement Incentive Award Plans. RSUs 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. Forfeitures are recorded in the period in which they occur.
The following table summarizes the RSU activity for the three months ended March 31, 2024 (in thousands, except per share data):
| | | | | | | | | | | |
| Number of Shares | | Weighted-Average Grant Date Fair Value |
Unvested at December 31, 2023 | 758 | | | $ | 18.73 | |
Granted | 845 | | | 10.53 | |
Vested | (135) | | | 22.42 | |
Forfeited | (53) | | | 15.69 | |
Unvested at March 31, 2024 | 1,415 | | | $ | 13.60 | |
The total fair value of shares vested during the three months ended March 31, 2024 was $1.5 million. No RSUs vested during the three months ended March 31, 2023.
As of December 31, 2023, the Company had 750,000 Performance Stock Options (PSUs) at a weighted-average grant date fair value of $6.57 per share. As of March 31, 2024, no PSUs were vested and no stock-based compensation expense has been recognized as the performance conditions were not deemed probable.
Employee Stock Purchase Plan
The Company did not issue shares of common stock under the Employee Stock Purchase Plan (ESPP) during the three months ended March 31, 2024 and 2023, respectively. The Company had an outstanding liability of $0.6 million at March 31, 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 March 31, 2024, 372,517 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 | | |
| Three Months Ended March 31, | | |
| 2024 | | 2023 | | | | |
Risk-free interest rate | 3.9% - 4.3% | | 3.5% - 4.0% | | | | |
Expected volatility | 79% - 80% | | 81% - 82% | | | | |
Expected term (in years) | 6.0 - 6.1 | | 6.0 - 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 March 31, | | |
| 2024 | | 2023 | | | | |
Research and development expense | $ | 5,737 | | | $ | 5,272 | | | | | |
General and administrative expense | 4,569 | | | 3,832 | | | | | |
Total stock-based compensation expense | $ | 10,306 | | | $ | 9,104 | | | | | |
As of March 31, 2024, the unrecognized compensation cost related to outstanding time-based options and RSUs was $67.9 million and $18.0 million, respectively, which is expected to be recognized over a weighted-average period of 2.69 years and 3.48 years, respectively. Unrecognized compensation cost related to PSUs was $4.9 million. As of March 31, 2024, the unrecognized compensation cost related to stock purchase rights under the ESPP was $0.2 million, which is expected to be recognized over a weighted-average period of 0.21 years.
9. Subsequent Events
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 beginning in August 2025. Pursuant to the terms of the sublease agreement, the landlord will provide the Company with a tenant improvement allowance of up to $33.6 million. Additional tenant improvement allowance of up to $5.0 million is also available to be repaid in equal installments through monthly rent, subject to 8% interest per annum and annual increases
of 3% per annum. The Company also has an option and right of first refusal for an additional 80,000 of rentable square feet in an adjacent available building, which has not been exercised. Total aggregate future lease commitments under the lease were approximately $72.6 million, inclusive of 3% annual rent increase and various agreed upon rent abatement amounts.
In connection with the sublease, the Company is required to maintain a letter of credit for the benefit of the landlord in the amount of $2.5 million, which was delivered in April 2024 and will be included in restricted cash in the Company’s condensed balance sheet.
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 1/2 development with the ongoing MARINA open label extension study, or MARINA-OLE™. We are currently on track to initiate the global Phase 3 HARBOR™ trial of del-desiran this quarter. 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. AOC 1044 is designed for people with Duchenne muscular dystrophy and is currently in Phase 1/2 development with the EXPLORE44™ trial. AOC 1044 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, AOC 1020 and AOC 1044 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 AOC 1044 Rare Pediatric Disease Designation.
With three AOC product candidates in clinical development, we plan to report data from multiple ongoing trials in 2024 and initiate our global Phase 3 HARBOR™ trial of del-desiran for DM1 in the second quarter of 2024. In March 2024, we shared new long-term del-desiran data from our 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
second quarter of 2024, we are planning to share preliminary data in approximately half of the study participants in the Phase 1/2 FORTITUDE™ trial of AOC 1020 in FSHD. In the second half of 2024, we plan to share 5 mg/kg cohort data from the Phase 1/2 EXPLORE44 trial of AOC 1044 in people living with DMD44.
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 as we 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, 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 $68.9 million for the three months ended March 31, 2024. As of March 31, 2024, we had an accumulated deficit of $639.6 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 $915.9 million (as of March 31, 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 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 with BMS, or the BMS Collaboration Agreement, 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.
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;
•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 Months Ended March 31, 2024 and 2023
The following table summarizes our results of operations for the periods presented (in thousands):
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | Change | | | | |
| 2024 | | 2023 | | | | | | |
Revenue | $ | 3,543 | | | $ | 2,233 | | | $ | 1,310 | | | | | | | |
Research and development expenses | 66,832 | | | 47,765 | | | 19,067 | | | | | | | |
General and administrative expenses | 13,898 | | | 12,064 | | | 1,834 | | | | | | | |
Other income | 8,332 | | | 5,202 | | | 3,130 | | | | | | | |
Revenue
Revenue increased by $1.3 million for three months ended March 31, 2024 and 2023, primarily due to revenues recognized under the BMS Agreement for which there were no revenues recognized in the prior year comparative period, partially offset by a decrease in direct billable charges to Lilly under the Lilly Agreement.
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 March 31, | | Change | | | | |
| 2024 | | 2023 | | | | | | |
External costs: | | | | | | | | | | | |
Del-desiran | $ | 9,095 | | | $ | 6,960 | | | $ | 2,135 | | | | | | | |
AOC 1020 | 6,163 | | | 7,616 | | | (1,453) | | | | | | | |
AOC 1044 | 5,839 | | | 2,536 | | | 3,303 | | | | | | | |
Other programs | 1,438 | | | 3,477 | | | (2,039) | | | | | | | |
Unallocated | 19,707 | | | 6,631 | | | 13,076 | | | | | | | |
Total external costs | 42,242 | | | 27,220 | | | 15,022 | | | | | | | |
Internal costs: | | | | | | | | | | | |
Employee-related expenses | 19,336 | | | 15,978 | | | 3,358 | | | | | | | |
Facilities, lab supplies and other | 5,254 | | | 4,567 | | | 687 | | | | | | | |
Total internal costs | 24,590 | | | 20,545 | | | 4,045 | | | | | | | |
Total research and development expenses | $ | 66,832 | | | $ | 47,765 | | | $ | 19,067 | | | | | | | |
Research and development expenses increased by $19.1 million for the three months ended March 31, 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 $15.4 million in higher manufacturing costs related to drug product, and increased internal costs including $3.4 million in higher personnel costs.
General and Administrative Expenses
General and administrative expenses increased by $1.8 million for the three months ended March 31, 2024 as compared to the same period in 2023, primarily due to $2.4 million in higher personnel costs, partially offset by $0.8 million in lower professional fees.
Other Income
Other income increased by $3.1 million for the three months ended March 31, 2024 and 2023, due to higher interest income earned on marketable securities investments.
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 Sales Agent. Under the 2022 Sales Agreement, we may, from time to time, sell shares of our common stock having an aggregate offering price of up to $200.0 million through the 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 Sales Agent. We are not obligated to sell, and the Sales Agent is not obligated to buy or sell, any shares of common stock under the 2022 Sales Agreement. During the three months ended March 31, 2024 and 2023, we sold 418,408 and 943,461 shares of our common stock, respectively, pursuant to the 2022 Sales Agreement and received net proceeds of $5.6 million and $22.4 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.
Since our inception through March 31, 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 $143.3 million from funding under collaboration and research services agreements.
Future Capital Requirements
As of March 31, 2024, we had cash, cash equivalents and marketable securities of $915.9 million. 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, including the impact of any resolution of the partial clinical hold on our completed Phase 1/2 MARINA clinical trial;
•the costs and timing of manufacturing for our product candidates and commercial manufacturing 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;
•the costs associated with hiring additional personnel and consultants as our preclinical and clinical activities increase;
•the timing and amount of the milestone or other payments made to us under the Lilly Agreement or 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):
| | | | | | | | | | | | | | | | | |
| Three Months Ended March 31, | | Change |
| 2024 | | 2023 | |
Net cash provided by (used in): | | | | | |
Operating activities | $ | (70,380) | | | $ | (48,967) | | | $ | (21,413) | |
Investing activities | (32,747) | | (195,680) | | | 162,933 | |
Financing activities | 389,445 | | 22,961 | | 366,484 | |
Net decrease in cash, cash equivalents and restricted cash | $ | 286,318 | | | $ | (221,686) | | | $ | 508,004 | |
Operating Activities
Net cash used in operating activities of $70.4 million and $49.0 million for the three months ended March 31, 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 $32.7 million for the three months ended March 31, 2024 consisted primarily of $141.6 million for purchases of marketable securities and reinvestment of proceeds from matured marketable securities as well as $0.9 million in purchases of property and equipment, offset by $109.7 million of proceeds from maturities of marketable securities. Net cash used in investing activities of $195.7 million for the three months ended March 31, 2023 consisted of $251.4 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 proceeds from matured marketable securities, and $1.8 million in purchases of property and equipment, partially offset by $57.5 million of proceeds from maturities of marketable securities.
Financing Activities
Net cash provided by financing activities of $389.4 million for the three months ended March 31, 2024 consisted primarily of net proceeds from sales of our common stock and pre-funded warrants in a private placement. Net cash provided by financing activities of $23.0 million for the three months ended March 31, 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 March 31, 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
As of March 31, 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.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As of March 31, 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 March 31, 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
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 March 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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 three months ended March 31, 2024, none of our officers or directors adopted or terminated any such trading arrangements.
Item 6. Exhibits
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Exhibit Number | | Exhibit Description | | Incorporated by Reference | | Filed Herewith |
| | | | Form | | Date | | Number | | |
3.1 | | | | 8-K | | 6/16/2020 | | 3.1 | | |
3.2 | | | | 8-K | | 12/13/2023 | | 3.1 | | |
4.1 | | | | S-1 | | 5/22/2020 | | 4.1 | | |
4.2 | | | | 8-K | | 2/29/2024 | | 4.1 | | |
10.1 | | | | | | | | | | X |
10.2 | | | | 8-K | | 2/29/2024 | | 10.1 | | |
31.1 | | | | | | | | | | X |
31.2 | | | | | | | | | | X |
32.1* | | | | | | | | | | X |
32.2* | | | | | | | | | | X |
101.INS | | Inline 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.SCH | | Inline XBRL Taxonomy Extension Schema Document | | | | | | | | X |
101.CAL | | Inline XBRL Taxonomy Extension Calculation Linkbase Document | | | | | | | | X |
101.DEF | | Inline XBRL Taxonomy Extension Definition Linkbase Document | | | | | | | | X |
101.LAB | | Inline XBRL Taxonomy Extension Label Linkbase Document | | | | | | | | X |
101.PRE | | Inline XBRL Taxonomy Extension Presentation Linkbase Document | | | | | | | | X |
104 | | Cover 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.
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: May 9, 2024 | By: | /s/ Sarah Boyce |
| | Sarah Boyce President, Chief Executive Officer and Director (Principal Executive Officer) |
| |
|
Date: May 9, 2024 | By: | /s/ Michael F. MacLean |
| | Michael F. MacLean Chief Financial and Chief Business Officer (Principal Financial and Accounting Officer) |
AVIDITY BIOSCIENCES, INC.
NON-EMPLOYEE DIRECTOR COMPENSATION PROGRAM
(As Amended and Restated Effective April 19, 2024)
Non-employee members of the board of directors (the “Board”) of Avidity Biosciences, Inc. (the “Company”) shall receive cash and equity compensation as set forth in this Non-Employee Director Compensation Program (as amended to date, this “Program”). This Program has been adopted under the Company’s 2020 Incentive Award Plan (the “Equity Plan”). The cash and equity compensation described in this Program shall be paid or be made, as applicable, automatically and without further action of the Board, to each member of the Board who is not an employee of the Company or any parent or subsidiary of the Company (each, a “Non-Employee Director”) who is entitled to receive such cash or equity compensation, unless such Non-Employee Director declines the receipt of such cash or equity compensation by written notice to the Company. This Program shall remain in effect until it is revised or rescinded by further action of the Board. This Program may be amended, modified or terminated by the Board at any time in its sole discretion. The terms and conditions of this Program shall supersede any prior cash and/or equity compensation arrangements for service as a member of the Board between the Company and any of its Non-Employee Directors. No Non-Employee Director shall have any rights hereunder, except with respect to stock options granted pursuant to the Program. Capitalized terms not otherwise defined herein shall have the meanings ascribed in the Equity Plan.
1.Cash Compensation.
(a)Annual Retainers.
(i)Non-Employee Director. Each Non-Employee Director (other than the Executive Chairman) shall receive an annual retainer of $40,000 for service on the Board.
(ii)Chairman of the Board. A Non-Employee Director serving as Chairman of the Board shall receive, in lieu of the annual retainer in clause (i) above, an annual retainer of $70,000 for such service.
(b)Additional Annual Retainers. In addition, each Non-Employee Director shall receive the following additional annual retainers, as applicable:
(i)Audit Committee. A Non-Employee Director serving as Chairperson of the Audit Committee shall receive an additional annual retainer of $15,000 for such service. A Non- Employee Director serving as a member of the Audit Committee (other than the Chairperson) shall receive an additional annual retainer of $7,500 for such service.
(ii)Compensation Committee. A Non-Employee Director serving as Chairperson of the Compensation Committee shall receive an additional annual retainer of $10,000 for such service. A Non-Employee Director serving as a member of the Compensation Committee (other than the Chairperson) shall receive an additional annual retainer of $5,000 for such service.
(iii)Nominating and Corporate Governance Committee. A Non-Employee Director serving as Chairperson of the Nominating and Corporate Governance Committee shall receive an additional annual retainer of $8,000 for such service. A Non-Employee Director serving as a member of the Nominating and Corporate Governance Committee (other than the Chairperson) shall receive an additional annual retainer of $4,000 for such service.
(c)Payment of Retainers. The annual retainers described in Sections 1(a) and 1(b) shall be earned on a quarterly basis based on a calendar quarter and shall be paid by the Company in arrears not later than the fifteenth day following the end of each calendar quarter. In the event a Non-Employee Director does not serve as a Non-Employee Director, or in the applicable positions described in Sections 1(a) or 1(b), for an entire calendar quarter, the retainer paid to such Non-Employee Director shall be prorated for the portion of such calendar quarter actually served as a Non-Employee Director, or in such position, as applicable.
2.Equity Compensation. Non-Employee Directors shall be granted the equity awards described below. The awards described below shall be granted under and shall be subject to the terms and provisions of the Equity Plan, or any other applicable Company equity incentive plan then-maintained by the Company, and shall be granted subject to the execution and delivery of award agreements, including attached exhibits, in substantially the forms previously approved by the Board. All applicable terms of the Equity Plan apply to this Program as if fully set forth herein, and all grants of stock options hereby are subject in all respects to the terms of the Equity Plan and the applicable award agreement. For the avoidance of doubt, the share numbers in this Section 2 shall be subject to adjustment as provided in the Equity Plan.
(a)Initial Awards. Each Non-Employee Director who is initially elected or appointed to the Board shall receive an option under the Equity Plan, or any other applicable Company equity incentive plan then-maintained by the Company, to purchase 55,000 shares of the Company’s common stock on the date of such initial election or appointment (each such award, an “Initial Award”); provided, however, that in the event that the value of an Initial Award on the grant date would exceed $750,000 (the “Initial Award Limit”), calculated on the grant date in accordance with the Black-Scholes option pricing model (utilizing the same assumptions that the Company utilizes in preparation of its financial statements and the average closing price per share of the Company’s common stock on the Nasdaq Stock Market (or such other established stock exchange or national quotation system on which the common stock is quoted) for the 30-calendar day period prior to the date of grant), then the number of options subject to such Initial Award shall be reduced by the number of options necessary to result in the Initial Award having a value on the grant date equal to the Initial Award Limit. No Non-Employee Director shall be granted more than one Initial Award.
(b)Subsequent Awards. A Non-Employee Director who (i) is serving on the Board as of the date of any annual meeting of the Company’s stockholders and has been serving as a Non- Employee Director for at least six months as of the date of such meeting, and (ii) will continue to serve as a Non-Employee Director immediately following such meeting, shall be automatically granted an option under the Equity Plan, or any other applicable Company equity incentive plan then-maintained by the Company, to purchase 27,500 shares of the Company’s common stock on the date of such annual meeting (each such award, a “Subsequent Award”); provided, however, that in the event that the value of a Subsequent Award on the grant date exceeds $375,000 (the “Subsequent Award Limit”), calculated on the grant date in accordance with the Black-Scholes option pricing model (utilizing the same assumptions that the Company utilizes in preparation of its financial statements and the average closing price per share of the Company’s common stock on the Nasdaq Stock Market (or such other established stock exchange or national quotation system on which the common stock is quoted) for the 30-calendar day period prior to the date of grant), then the number of options subject to such Subsequent Award shall be reduced by the number of options necessary to result in the Subsequent Award having a value on the grant date equal to the Subsequent Award Limit. For the avoidance of doubt, a Non-Employee Director elected for the first time to the Board at an annual meeting of the Company’s stockholders shall only receive an Initial Award in connection with such election, and shall not receive any Subsequent Award on the date of such meeting as well.
(c)Termination of Employment of Employee Directors. Members of the Board who are employees of the Company or any parent or subsidiary of the Company who subsequently terminate their employment with the Company and any parent or subsidiary of the Company and remain on the Board will not receive an Initial Award pursuant to Section 2(a) above, but to the extent that they are otherwise entitled, will receive, after termination from employment with the Company and any parent or subsidiary of the Company, Subsequent Awards as described in Section 2(b) above.
(d)Terms of Awards Granted to Non-Employee Directors
(i)Purchase Price. The per share exercise price of each option granted to a Non-Employee Director shall equal the Fair Market Value of a share of common stock on the date the option is granted.
(ii)Vesting. Each Initial Award shall vest and become exercisable in substantially equal monthly installments over the three years following the date of the Non-Employee Director’s election or appointment to the Board, subject to the Non-Employee Director continuing in service on the Board through each such vesting date. Each Subsequent Award shall vest and/or become exercisable on the first to occur of (A) the first anniversary of the date of grant or (B) the next occurring annual meeting of the Company’s stockholders, subject to the Non-Employee Director continuing in service on the Board through such vesting date. Unless the Board otherwise determines, no portion of an Initial Award or Subsequent Award which is unvested and/or exercisable at the time of a Non-Employee Director’s termination of service on the Board shall become vested and/or exercisable thereafter. Upon a Change of Control, all outstanding equity awards granted under the Equity Plan, and any other equity incentive plan maintained by the Company, that are held by a Non-Employee Director shall become fully vested and/or exercisable, irrespective of any other provisions of the Equity Plan or any award agreement.
(iii)Term. The term of each stock option granted to a Non-Employee Director shall be ten years from the date the option is granted.
3.Compensation Limits. Notwithstanding anything to the contrary in this Program, all compensation payable under this Program will be subject to any limits on the maximum amount of Non- Employee Director compensation set forth in the Equity Plan, as in effect from time to time.
4.Reimbursements. The Company shall reimburse each Non-Employee Director for all reasonable, documented, out-of-pocket travel and other business expenses incurred by such Non-Employee Director in the performance of his or her duties to the Company in accordance with the Company’s applicable expense reimbursement policies and procedures as in effect from time to time.
* * * * *
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: May 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: May 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 March 31, 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: May 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 March 31, 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: May 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.
v3.24.1.u1
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Mar. 31, 2024 |
Apr. 22, 2024 |
Cover [Abstract] |
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Avidity Biosciences, Inc.
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v3.24.1.u1
Condensed Balance Sheets - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 471,400
|
$ 185,082
|
Marketable securities |
444,473
|
410,269
|
Prepaid and other assets |
18,601
|
15,956
|
Total current assets |
934,474
|
611,307
|
Property and equipment, net |
8,655
|
8,381
|
Restricted cash |
295
|
295
|
Right-of-use assets |
7,625
|
8,271
|
Other assets |
425
|
301
|
Total assets |
951,474
|
628,555
|
Current liabilities: |
|
|
Accounts payable and accrued liabilities |
37,330
|
34,341
|
Accrued compensation |
7,796
|
14,335
|
Lease liabilities, current portion |
3,726
|
3,639
|
Deferred revenue, current portion |
26,103
|
28,365
|
Total current liabilities |
74,955
|
80,680
|
Lease liabilities, net of current portion |
5,421
|
6,213
|
Deferred revenue, net of current portion |
40,199
|
40,898
|
Total liabilities |
120,575
|
127,791
|
Commitments and contingencies (Note 7) |
|
|
Stockholders’ equity: |
|
|
Common stock, $0.0001 par value; authorized shares – 400,000; issued and outstanding shares – 95,594 and 79,275 at March 31, 2024 and December 31, 2023, respectively |
10
|
8
|
Additional paid-in capital |
1,470,972
|
1,071,395
|
Accumulated other comprehensive income (loss) |
(464)
|
125
|
Accumulated deficit |
(639,619)
|
(570,764)
|
Total stockholders’ equity |
830,899
|
500,764
|
Total liabilities and stockholders’ equity |
$ 951,474
|
$ 628,555
|
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v3.24.1.u1
Condensed Balance Sheets (Parenthetical) - $ / shares shares in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
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$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized (in shares) |
400,000
|
400,000
|
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95,594
|
79,275
|
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95,594
|
79,275
|
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v3.24.1.u1
Condensed Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Income Statement [Abstract] |
|
|
Collaboration revenue |
$ 3,543
|
$ 2,233
|
Operating expenses: |
|
|
Research and development |
66,832
|
47,765
|
General and administrative |
13,898
|
12,064
|
Total operating expenses |
80,730
|
59,829
|
Loss from operations |
(77,187)
|
(57,596)
|
Other income (expense): |
|
|
Interest income |
8,433
|
5,516
|
Other expense |
(101)
|
(314)
|
Total other income |
8,332
|
5,202
|
Net loss |
$ (68,855)
|
$ (52,394)
|
Net loss per share, basic (in dollars per share) |
$ (0.79)
|
$ (0.74)
|
Net loss per share, diluted (in dollars per share) |
$ (0.79)
|
$ (0.74)
|
Weighted-average shares outstanding, basic (in shares) |
87,212
|
70,433
|
Weighted-average shares outstanding, diluted (in shares) |
87,212
|
70,433
|
Other comprehensive income (loss): |
|
|
Net unrealized gains (losses) on marketable securities |
$ (589)
|
$ 1,169
|
Comprehensive loss |
$ (69,444)
|
$ (51,225)
|
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v3.24.1.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, 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
|
|
|
|
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
|
|
|
|
95,594
|
|
|
|
|
|
|
|
|
Ending balance at Mar. 31, 2024 |
$ 830,899
|
|
|
|
$ 10
|
|
|
$ 1,470,972
|
|
|
|
$ (464)
|
$ (639,619)
|
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Condensed Statements of Cash Flows - USD ($) $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Cash flows from operating activities |
|
|
Net loss |
$ (68,855)
|
$ (52,394)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation |
641
|
391
|
Stock-based compensation expense |
10,306
|
9,104
|
Amortization of premiums and discounts on marketable securities, net |
(2,960)
|
(2,231)
|
Non-cash operating lease costs |
828
|
688
|
Changes in operating assets and liabilities: |
|
|
Prepaid and other assets |
(2,528)
|
1,491
|
Accounts payable and accrued liabilities |
2,575
|
1,158
|
Accrued compensation |
(6,539)
|
(5,181)
|
Operating lease liabilities |
(887)
|
(774)
|
Deferred revenue |
(2,961)
|
(1,219)
|
Net cash used in operating activities |
(70,380)
|
(48,967)
|
Cash flows from investing activities |
|
|
Maturities of marketable securities |
109,725
|
57,490
|
Purchases of marketable securities |
(141,557)
|
(251,350)
|
Purchases of property and equipment |
(915)
|
(1,820)
|
Net cash used in investing activities |
(32,747)
|
(195,680)
|
Cash flows from financing activities |
|
|
Proceeds from issuance of common stock in public offerings, net of issuance costs |
5,594
|
22,441
|
Proceeds from issuance of common stock under employee incentive equity plans |
3,655
|
520
|
Proceeds from the issuance of common stock in a private placement, net of issuance costs |
238,647
|
0
|
Proceeds from issuance of pre-funded warrants in a private placement, net of issuance costs |
141,549
|
0
|
Net cash provided by financing activities |
389,445
|
22,961
|
Net increase (decrease) in cash, cash equivalents and restricted cash |
286,318
|
(221,686)
|
Cash, cash equivalents and restricted cash at beginning of period |
185,377
|
340,647
|
Cash, cash equivalents and restricted cash at end of period |
471,695
|
118,961
|
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 |
$ 413
|
$ 0
|
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v3.24.1.u1
Description of Business and Basis of Presentation
|
3 Months Ended |
Mar. 31, 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 March 31, 2024, the Company had an accumulated deficit of $639.6 million and cash, cash equivalents and marketable securities of $915.9 million. 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.
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v3.24.1.u1
Summary of Significant Accounting Policies
|
3 Months Ended |
Mar. 31, 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 three months ended March 31, 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, because to do so would be anti-dilutive, are as follows (in thousands): | | | | | | | | | | | | | March 31, | | 2024 | | 2023 | Common stock options | 13,485 | | 10,973 | Restricted stock units | 1,415 | | 607 | Performance stock units | 750 | | — | Employee Stock Purchase Plan shares pending issuance | 85 | | 44 | Total | 15,735 | | 11,624 |
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 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.
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v3.24.1.u1
Fair Value Measurements
|
3 Months Ended |
Mar. 31, 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 March 31, 2024 | Total | | Quoted 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 | $ | 440,315 | | | $ | 440,315 | | | $ | — | | | $ | — | | | | | | | | | | Negotiable certificates of deposit | 4,158 | | | — | | | 4,158 | | | — | | | | | | | | | | Total | $ | 444,473 | | | $ | 440,315 | | | $ | 4,158 | | | $ | — | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | Fair Value Measurements Using | As of December 31, 2023 | Total | | Quoted 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 securities | 4,998 | | | — | | | 4,998 | | | — | | Negotiable certificates of deposit | 5,381 | | | — | | | 5,381 | | | — | | | | | | | | | | Total | $ | 410,269 | | | $ | 399,890 | | | $ | 10,379 | | | $ | — | |
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- DefinitionThe entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.
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v3.24.1.u1
Marketable Securities
|
3 Months Ended |
Mar. 31, 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 March 31, 2024 | Maturity (in years) | | Amortized Cost | | Unrealized Gains | | Unrealized Losses | | Estimated Fair Value | U.S. Treasury securities | 1 or less | | $ | 389,180 | | | $ | 26 | | | $ | (518) | | | $ | 388,688 | | | | | | | | | | | | Negotiable certificates of deposit | 1 or less | | 4,165 | | | — | | | (7) | | | 4,158 | | | | | | | | | | | | U.S. Treasury securities | 1 - 2 | | 51,592 | | | 69 | | | (34) | | | 51,627 | | | | | | | | | | | | | | | | | | | | | | Total | | | $ | 444,937 | | | $ | 95 | | | $ | (559) | | | $ | 444,473 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | As of December 31, 2023 | Maturity (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 March 31, 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 March 31, 2024 | Fair Value | | Unrealized Losses | | Fair Value | | Unrealized Losses | | Fair Value | | Unrealized Losses | U.S. Treasury securities | $ | 332,907 | | | $ | 552 | | | $ | — | | | $ | — | | | $ | 332,907 | | | $ | 552 | | | | | | | | | | | | | | Negotiable certificates of deposit | 2,204 | | | 1 | | | 1,955 | | | 6 | | | 4,159 | | | 7 | | Total | $ | 335,111 | | | $ | 553 | | | $ | 1,955 | | | $ | 6 | | | $ | 337,066 | | | $ | 559 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 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 securities | 4,998 | | | 2 | | | — | | | — | | | 4,998 | | | 2 | | Negotiable certificates of deposit | 3,665 | | | 10 | | | — | | | — | | | 3,665 | | | 10 | | Total | $ | 222,954 | | | $ | 578 | | | $ | — | | | $ | — | | | $ | 222,954 | | | $ | 578 | |
Accrued interest receivable on available-for-sale securities was $2.4 million and $2.6 million at March 31, 2024 and December 31, 2023, respectively. The Company has not written off any accrued interest receivable for the three months ended March 31, 2024 and 2023.
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v3.24.1.u1
Collaboration, License and Research Agreements
|
3 Months Ended |
Mar. 31, 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. The BMS Collaboration Agreement and the BMS Purchase Agreement are referred to herein as the "BMS Agreements". In connection with the BMS Collaboration Agreement, the Company recognized revenue of $2.4 million for the three months ended March 31, 2024. 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 revenue of $1.1 million and $2.2 million for the three months ended March 31, 2024 and 2023, respectively. Collaboration receivables related to the Lilly Agreement were $1.3 million and $0.8 million as of March 31, 2024 and December 31, 2023, respectively, which are included in prepaid and other assets on the condensed balance sheets. A reconciliation of the closing balance of deferred revenue related to the Company's research collaboration and license agreements three months ended March 31, 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 | |
| | | | | | 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 | |
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v3.24.1.u1
Composition of Certain Financial Statement Items
|
3 Months Ended |
Mar. 31, 2024 |
Property, Plant and Equipment [Abstract] |
|
Composition of Certain Financial Statement Items |
Composition of Certain Financial Statement Items Prepaid and other assets (in thousands) | | | | | | | | | | | | | March 31, 2024 | | December 31, 2023 | Accounts receivable | $ | 1,575 | | | $ | 1,105 | | Prepaid assets | 9,561 | | | 7,333 | Interest receivable and other assets | 7,465 | | | 7,518 | Total prepaid and other assets | $ | 18,601 | | | $ | 15,956 | |
Property and equipment consist of the following (in thousands): | | | | | | | | | | | | | March 31, 2024 | | December 31, 2023 | Laboratory equipment | $ | 12,008 | | | $ | 11,208 | | Computers and software | 242 | | | 127 | | Office furniture and equipment | 1,979 | | | 1,979 | | Leasehold improvements | 288 | | | 288 | | Property and equipment, gross | 14,517 | | | 13,602 | | Less accumulated depreciation | (5,862) | | | (5,221) | | Total property and equipment, net | $ | 8,655 | | | $ | 8,381 | |
Depreciation expense related to property and equipment was $0.6 million and $0.4 million for the three months ended March 31, 2024 and 2023, respectively. Accounts payable and accrued liabilities (in thousands): | | | | | | | | | | | | | March 31, 2024 | | December 31, 2023 | Accounts payable | $ | 2,349 | | | $ | 8,809 | | Accrued non-clinical liabilities | 28,921 | | | 19,535 | Accrued clinical liabilities | 6,060 | | | 5,997 | Total accounts payable and accrued liabilities | $ | 37,330 | | | $ | 34,341 | |
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v3.24.1.u1
Commitments and Contingencies
|
3 Months Ended |
Mar. 31, 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.
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v3.24.1.u1
Stockholders' Equity
|
3 Months Ended |
Mar. 31, 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 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 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 Sales Agent. The Company is not obligated to sell, and the Sales Agent is not obligated to buy or sell, any shares of common stock under the 2022 Sales Agreement. During the three months ended March 31, 2024 and 2023, the Company sold 418,408 and 943,461 shares of its common stock, respectively, pursuant to the 2022 Sales Agreement and received net proceeds of $5.6 million and $22.4 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 March 31, 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, 2023 | 12,495 | | $ | 14.91 | | Granted | 1,767 | | 10.37 | | Exercised | (541) | | 7.21 | | Forfeited/expired | (236) | | 16.83 | | Outstanding at March 31, 2024 | 13,485 | | $ | 14.59 | |
Restricted Stock Units and Performance Stock Units During the three months ended March 31, 2024, the Company granted restricted stock units (RSUs) to employees of the Company under the 2020 Incentive Award and the 2022 Employment Inducement Incentive Award Plans. RSUs 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. Forfeitures are recorded in the period in which they occur. The following table summarizes the RSU activity for the three months ended March 31, 2024 (in thousands, except per share data): | | | | | | | | | | | | | Number of Shares | | Weighted-Average Grant Date Fair Value | Unvested at December 31, 2023 | 758 | | | $ | 18.73 | | Granted | 845 | | | 10.53 | | Vested | (135) | | | 22.42 | | Forfeited | (53) | | | 15.69 | | Unvested at March 31, 2024 | 1,415 | | | $ | 13.60 | |
The total fair value of shares vested during the three months ended March 31, 2024 was $1.5 million. No RSUs vested during the three months ended March 31, 2023. As of December 31, 2023, the Company had 750,000 Performance Stock Options (PSUs) at a weighted-average grant date fair value of $6.57 per share. As of March 31, 2024, no PSUs were vested and no stock-based compensation expense has been recognized as the performance conditions were not deemed probable. Employee Stock Purchase Plan The Company did not issue shares of common stock under the Employee Stock Purchase Plan (ESPP) during the three months ended March 31, 2024 and 2023, respectively. The Company had an outstanding liability of $0.6 million at March 31, 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 March 31, 2024, 372,517 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 | | | | Three Months Ended March 31, | | | | 2024 | | 2023 | | | | | Risk-free interest rate | 3.9% - 4.3% | | 3.5% - 4.0% | | | | | Expected volatility | 79% - 80% | | 81% - 82% | | | | | Expected term (in years) | 6.0 - 6.1 | | 6.0 - 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 March 31, | | | | 2024 | | 2023 | | | | | Research and development expense | $ | 5,737 | | | $ | 5,272 | | | | | | General and administrative expense | 4,569 | | | 3,832 | | | | | | Total stock-based compensation expense | $ | 10,306 | | | $ | 9,104 | | | | | |
As of March 31, 2024, the unrecognized compensation cost related to outstanding time-based options and RSUs was $67.9 million and $18.0 million, respectively, which is expected to be recognized over a weighted-average period of 2.69 years and 3.48 years, respectively. Unrecognized compensation cost related to PSUs was $4.9 million. As of March 31, 2024, the unrecognized compensation cost related to stock purchase rights under the ESPP was $0.2 million, which is expected to be recognized over a weighted-average period of 0.21 years.
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- DefinitionThe entire disclosure for shareholders' equity and share-based payment arrangement. Includes, but is not limited to, disclosure of policy and terms of share-based payment arrangement, deferred compensation arrangement, and employee stock purchase plan (ESPP).
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v3.24.1.u1
Subsequent Events
|
3 Months Ended |
Mar. 31, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Events |
Subsequent Events 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 beginning in August 2025. Pursuant to the terms of the sublease agreement, the landlord will provide the Company with a tenant improvement allowance of up to $33.6 million. Additional tenant improvement allowance of up to $5.0 million is also available to be repaid in equal installments through monthly rent, subject to 8% interest per annum and annual increases of 3% per annum. The Company also has an option and right of first refusal for an additional 80,000 of rentable square feet in an adjacent available building, which has not been exercised. Total aggregate future lease commitments under the lease were approximately $72.6 million, inclusive of 3% annual rent increase and various agreed upon rent abatement amounts. In connection with the sublease, the Company is required to maintain a letter of credit for the benefit of the landlord in the amount of $2.5 million, which was delivered in April 2024 and will be included in restricted cash in the Company’s condensed balance sheet.
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- DefinitionThe portion of profit or loss for the period, net of income taxes, which is attributable to the parent.
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v3.24.1.u1
Summary of Significant Accounting Policies (Policies)
|
3 Months Ended |
Mar. 31, 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.
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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.
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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 and Adopted 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 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.
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v3.24.1.u1
Fair Value Measurements (Tables)
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3 Months Ended |
Mar. 31, 2024 |
Fair Value Disclosures [Abstract] |
|
Summary 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 March 31, 2024 | Total | | Quoted 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 | $ | 440,315 | | | $ | 440,315 | | | $ | — | | | $ | — | | | | | | | | | | Negotiable certificates of deposit | 4,158 | | | — | | | 4,158 | | | — | | | | | | | | | | Total | $ | 444,473 | | | $ | 440,315 | | | $ | 4,158 | | | $ | — | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | Fair Value Measurements Using | As of December 31, 2023 | Total | | Quoted 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 securities | 4,998 | | | — | | | 4,998 | | | — | | Negotiable certificates of deposit | 5,381 | | | — | | | 5,381 | | | — | | | | | | | | | | Total | $ | 410,269 | | | $ | 399,890 | | | $ | 10,379 | | | $ | — | |
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v3.24.1.u1
Marketable Securities (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Investments, Debt and Equity Securities [Abstract] |
|
Summary 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 March 31, 2024 | Maturity (in years) | | Amortized Cost | | Unrealized Gains | | Unrealized Losses | | Estimated Fair Value | U.S. Treasury securities | 1 or less | | $ | 389,180 | | | $ | 26 | | | $ | (518) | | | $ | 388,688 | | | | | | | | | | | | Negotiable certificates of deposit | 1 or less | | 4,165 | | | — | | | (7) | | | 4,158 | | | | | | | | | | | | U.S. Treasury securities | 1 - 2 | | 51,592 | | | 69 | | | (34) | | | 51,627 | | | | | | | | | | | | | | | | | | | | | | Total | | | $ | 444,937 | | | $ | 95 | | | $ | (559) | | | $ | 444,473 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | As of December 31, 2023 | Maturity (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 | |
|
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 March 31, 2024 | Fair Value | | Unrealized Losses | | Fair Value | | Unrealized Losses | | Fair Value | | Unrealized Losses | U.S. Treasury securities | $ | 332,907 | | | $ | 552 | | | $ | — | | | $ | — | | | $ | 332,907 | | | $ | 552 | | | | | | | | | | | | | | Negotiable certificates of deposit | 2,204 | | | 1 | | | 1,955 | | | 6 | | | 4,159 | | | 7 | | Total | $ | 335,111 | | | $ | 553 | | | $ | 1,955 | | | $ | 6 | | | $ | 337,066 | | | $ | 559 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 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 securities | 4,998 | | | 2 | | | — | | | — | | | 4,998 | | | 2 | | Negotiable certificates of deposit | 3,665 | | | 10 | | | — | | | — | | | 3,665 | | | 10 | | Total | $ | 222,954 | | | $ | 578 | | | $ | — | | | $ | — | | | $ | 222,954 | | | $ | 578 | |
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v3.24.1.u1
Collaboration, License and Research Agreements (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Collaboration License And Research Agreements [Abstract] |
|
Summary of Reconciliation of Deferred |
A reconciliation of the closing balance of deferred revenue related to the Company's research collaboration and license agreements three months ended March 31, 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 | |
| | | | | | 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 | |
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v3.24.1.u1
Composition of Certain Financial Statement Items (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Prepaid and Other Current Assets |
Prepaid and other assets (in thousands) | | | | | | | | | | | | | March 31, 2024 | | December 31, 2023 | Accounts receivable | $ | 1,575 | | | $ | 1,105 | | Prepaid assets | 9,561 | | | 7,333 | Interest receivable and other assets | 7,465 | | | 7,518 | Total prepaid and other assets | $ | 18,601 | | | $ | 15,956 | |
|
Schedule of Property and Equipment |
Property and equipment consist of the following (in thousands): | | | | | | | | | | | | | March 31, 2024 | | December 31, 2023 | Laboratory equipment | $ | 12,008 | | | $ | 11,208 | | Computers and software | 242 | | | 127 | | Office furniture and equipment | 1,979 | | | 1,979 | | Leasehold improvements | 288 | | | 288 | | Property and equipment, gross | 14,517 | | | 13,602 | | Less accumulated depreciation | (5,862) | | | (5,221) | | Total property and equipment, net | $ | 8,655 | | | $ | 8,381 | |
|
Schedule of Accounts Payable and Accrued Liabilities |
Accounts payable and accrued liabilities (in thousands): | | | | | | | | | | | | | March 31, 2024 | | December 31, 2023 | Accounts payable | $ | 2,349 | | | $ | 8,809 | | Accrued non-clinical liabilities | 28,921 | | | 19,535 | Accrued clinical liabilities | 6,060 | | | 5,997 | Total accounts payable and accrued liabilities | $ | 37,330 | | | $ | 34,341 | |
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v3.24.1.u1
Stockholders' Equity (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Summary 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, 2023 | 12,495 | | $ | 14.91 | | Granted | 1,767 | | 10.37 | | Exercised | (541) | | 7.21 | | Forfeited/expired | (236) | | 16.83 | | Outstanding at March 31, 2024 | 13,485 | | $ | 14.59 | |
|
Schedule of Unvested Restricted Stock Units Roll Forward |
The following table summarizes the RSU activity for the three months ended March 31, 2024 (in thousands, except per share data): | | | | | | | | | | | | | Number of Shares | | Weighted-Average Grant Date Fair Value | Unvested at December 31, 2023 | 758 | | | $ | 18.73 | | Granted | 845 | | | 10.53 | | Vested | (135) | | | 22.42 | | Forfeited | (53) | | | 15.69 | | Unvested at March 31, 2024 | 1,415 | | | $ | 13.60 | |
|
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 | | | | Three Months Ended March 31, | | | | 2024 | | 2023 | | | | | Risk-free interest rate | 3.9% - 4.3% | | 3.5% - 4.0% | | | | | Expected volatility | 79% - 80% | | 81% - 82% | | | | | Expected term (in years) | 6.0 - 6.1 | | 6.0 - 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 March 31, | | | | 2024 | | 2023 | | | | | Research and development expense | $ | 5,737 | | | $ | 5,272 | | | | | | General and administrative expense | 4,569 | | | 3,832 | | | | | | Total stock-based compensation expense | $ | 10,306 | | | $ | 9,104 | | | | | |
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Fair Value Measurements (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Marketable securities: |
$ 444,473
|
$ 410,269
|
Recurring |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Total |
444,473
|
410,269
|
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 |
440,315
|
399,890
|
Recurring | Significant Other Observable Inputs (Level 2) |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Total |
4,158
|
10,379
|
Recurring | Significant Unobservable Inputs (Level 3) |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Total |
0
|
0
|
Recurring | U.S. Treasury securities |
|
|
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] |
|
|
Marketable securities: |
440,315
|
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: |
440,315
|
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: |
4,158
|
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: |
4,158
|
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
|
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v3.24.1.u1
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Schedule Of Available For Sale Securities [Line Items] |
|
|
Amortized Cost |
$ 444,937
|
$ 410,144
|
Unrealized Gains |
95
|
703
|
Unrealized Losses |
(559)
|
(578)
|
Estimated Fair Value, current |
444,473
|
410,269
|
Estimated Fair Value |
444,473
|
410,269
|
U.S. Treasury securities |
|
|
Schedule Of Available For Sale Securities [Line Items] |
|
|
Amortized Cost, current |
389,180
|
301,053
|
Amortized Cost, noncurrent |
51,592
|
98,701
|
Estimated Fair Value, current |
388,688
|
300,625
|
Estimated Fair Value, noncurrent |
51,627
|
99,265
|
U.S. Treasury securities | 1 or less |
|
|
Schedule Of Available For Sale Securities [Line Items] |
|
|
Unrealized Gains |
26
|
102
|
Unrealized Losses |
(518)
|
(530)
|
U.S. Treasury securities | 1 - 2 |
|
|
Schedule Of Available For Sale Securities [Line Items] |
|
|
Unrealized Gains |
69
|
600
|
Unrealized Losses |
(34)
|
(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 |
4,165
|
4,410
|
Amortized Cost, noncurrent |
|
980
|
Estimated Fair Value, current |
4,158
|
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 |
$ (7)
|
(4)
|
Negotiable certificates of deposit | 1 - 2 |
|
|
Schedule Of Available For Sale Securities [Line Items] |
|
|
Unrealized Gains |
|
0
|
Unrealized Losses |
|
$ (6)
|
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Marketable Securities - Additional Information (Details) - USD ($)
|
3 Months Ended |
|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Investments, Debt and Equity Securities [Abstract] |
|
|
|
Allowance for credit loss |
$ 0
|
|
$ 0
|
Accrued interest receivable on available-for-sale securities |
2,400,000
|
|
$ 2,600,000
|
Debt securities, available-for-sale, accrued interest writeoff |
$ 0
|
$ 0
|
|
X |
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Marketable Securities - Schedule of Available-for-sale Securities in an Unrealized Loss Position (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Fair Value |
|
|
Less Than 12 months, Fair Value |
$ 335,111
|
$ 222,954
|
12 months or Greater, Fair Value |
1,955
|
0
|
Total Fair Value |
337,066
|
222,954
|
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|
|
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553
|
578
|
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6
|
0
|
Total Gross Unrealized Losses |
559
|
578
|
U.S. Treasury securities |
|
|
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|
|
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332,907
|
214,291
|
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0
|
0
|
Total Fair Value |
332,907
|
214,291
|
Unrealized Losses |
|
|
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552
|
566
|
12 months or Greater, Gross Unrealized Losses |
0
|
0
|
Total Gross Unrealized Losses |
552
|
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 |
2,204
|
3,665
|
12 months or Greater, Fair Value |
1,955
|
0
|
Total Fair Value |
4,159
|
3,665
|
Unrealized Losses |
|
|
Less Than 12 months, Gross Unrealized Losses |
1
|
10
|
12 months or Greater, Gross Unrealized Losses |
6
|
0
|
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$ 7
|
$ 10
|
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v3.24.1.u1
Collaboration, License and Research Agreements - Additional Information (Details) - USD ($)
|
3 Months Ended |
|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] |
|
|
|
Revenue recognized |
$ 3,543,000
|
$ 2,233,000
|
|
Research Collaboration, License Agreement and Securities Purchase Agreement with BMS |
|
|
|
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] |
|
|
|
Revenue recognized |
2,400,000
|
|
|
Collaboration receivables |
0
|
|
$ 0
|
Research Collaboration and License Agreement with Eli Lilly |
|
|
|
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] |
|
|
|
Revenue recognized |
1,100,000
|
$ 2,200,000
|
|
Collaboration receivables |
$ 1,300,000
|
|
$ 800,000
|
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v3.24.1.u1
Collaboration, License and Research Agreements - Reconciliation of Deferred Revenue (Details) - USD ($) $ in Thousands |
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Contract With Customer, Liability [Roll Forward] |
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$ 69,263
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$ 6,276
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Composition of Certain Financial Statement Items - Schedule of Prepaid and Other Assets (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Abstract] |
|
|
Accounts receivable |
$ 1,575
|
$ 1,105
|
Prepaid assets |
9,561
|
7,333
|
Interest receivable and other assets |
7,465
|
7,518
|
Total prepaid and other assets |
$ 18,601
|
$ 15,956
|
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v3.24.1.u1
Composition of Certain Financial Statement Items - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Property Plant And Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 14,517
|
$ 13,602
|
Less accumulated depreciation |
(5,862)
|
(5,221)
|
Total property and equipment, net |
8,655
|
8,381
|
Laboratory equipment |
|
|
Property Plant And Equipment [Line Items] |
|
|
Property and equipment, gross |
12,008
|
11,208
|
Computers and software |
|
|
Property Plant And Equipment [Line Items] |
|
|
Property and equipment, gross |
242
|
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
|
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v3.24.1.u1
Composition of Certain Financial Statement Items - Schedule of Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Abstract] |
|
|
Accounts payable |
$ 2,349
|
$ 8,809
|
Accrued non-clinical liabilities |
28,921
|
19,535
|
Accrued clinical liabilities |
6,060
|
5,997
|
Total accounts payable and accrued liabilities |
$ 37,330
|
$ 34,341
|
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v3.24.1.u1
Stockholders' Equity - Additional Information (Details) - USD ($)
|
|
|
3 Months Ended |
|
Mar. 04, 2024 |
Nov. 08, 2022 |
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] |
|
|
|
|
|
Stock-based compensation expense |
|
|
$ 10,306,000
|
$ 9,104,000
|
|
Expected dividend yield |
|
|
0.00%
|
|
|
Unrecognized compensation cost, options |
|
|
$ 67,900,000
|
|
|
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 |
|
|
$ 1,500,000
|
|
|
Vested (in shares) |
|
|
135,000
|
0
|
|
PSUs outstanding (in shares) |
|
|
1,415,000
|
|
758,000
|
Weighted average grant date fair value, unvested (in dollars per share) |
|
|
$ 13.60
|
|
$ 18.73
|
Unrecognized compensation cost, excluding options |
|
|
$ 18,000,000
|
|
|
Restricted Stock Units (RSUs) | Weighted Average |
|
|
|
|
|
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] |
|
|
|
|
|
Compensation cost, period for recognition |
|
|
3 years 5 months 23 days
|
|
|
Performance stock units |
|
|
|
|
|
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] |
|
|
|
|
|
Vested (in shares) |
|
|
0
|
|
|
PSUs outstanding (in shares) |
|
|
|
|
750,000
|
Weighted average grant date fair value, unvested (in dollars per share) |
|
|
|
|
$ 6.57
|
Stock-based compensation expense |
|
|
$ 0
|
|
|
Unrecognized compensation cost, excluding options |
|
|
$ 4,900,000
|
|
|
Employee Stock |
|
|
|
|
|
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] |
|
|
|
|
|
Compensation cost, period for recognition |
|
|
2 months 15 days
|
|
|
Stock issued during period, shares, employee stock purchase plans |
|
|
0
|
0
|
|
Outstanding liability |
|
|
$ 600,000
|
|
|
Shares reserved for future issuance (in shares) |
|
|
372,517
|
|
|
Expected term (in years) |
|
|
6 months
|
|
|
Award offering period |
|
|
6 months
|
|
|
Unrecognized compensation cost, excluding options |
|
|
$ 200,000
|
|
|
Common stock options |
|
|
|
|
|
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] |
|
|
|
|
|
Compensation cost, period for recognition |
|
|
2 years 8 months 8 days
|
|
|
Expected dividend yield |
|
|
0.00%
|
0.00%
|
|
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
|
|
|
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 |
$ 379,800,000
|
|
|
|
|
Sale of stock, price per share (in dollars per share) |
$ 16.50
|
|
|
|
|
Payments of stock issuance costs |
$ 20,400,000
|
|
|
|
|
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 |
$ 35,000,000
|
|
|
|
|
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
|
|
|
|
|
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 |
|
$ 200,000,000
|
|
|
|
Sale of stock number of shares issued in transaction (in shares) |
|
|
418,408
|
943,461
|
|
Sale of stock, consideration received on transaction |
|
|
$ 5,600,000
|
$ 22,400,000
|
|
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Avidity Biosciences (NASDAQ:RNA)
過去 株価チャート
から 8 2024 まで 9 2024
Avidity Biosciences (NASDAQ:RNA)
過去 株価チャート
から 9 2023 まで 9 2024