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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2024
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________to _________
Commission File Number: 001-38470
Unity Biotechnology, Inc.
(Exact Name of Registrant as Specified in its Charter)
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Delaware |
26-4726035 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
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285 East Grand Ave. South San Francisco, CA |
94080 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including area code: (650) 416-1192
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, par value $0.0001 |
UBX |
The Nasdaq Global Select 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 ☒ No ☐
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 ☒ No ☐
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.
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Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of October 31, 2024, the registrant had 16,850,350 shares of common stock outstanding.
Special Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q 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 facts contained in this Quarterly Report on Form 10-Q are statements that could be deemed forward-looking statements reflecting the current beliefs and expectations of management with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. These statements are often identified by the use of words such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “if,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” “until,” and similar expressions or variations. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:
•our plans to develop and commercialize UBX1325 (foselutoclax) or any future product candidates;
•our expectations regarding the potential benefits, activity, effectiveness, and safety of our drug candidates;
•our ongoing and planned clinical trials, including expectations with regard to the results of our clinical studies, preclinical studies and research and development programs, including the timing and availability of data from such studies;
•our predictions about the results of future or ongoing clinical trials, including predictions based on results from a clinical trial;
•our preclinical, clinical and regulatory development plans for our drug candidates, including the timing or likelihood of regulatory filings and approvals for our drug candidates;
•our expectations with regard to our ability to acquire, discover and develop additional drug candidates and advance such drug candidates into, and successfully complete, clinical studies;
•our expectations regarding the potential market size and size of the potential patient populations for our drug candidates, if approved for commercial use;
•our intentions and our ability to establish collaborations and/or partnerships;
•the timing and amount of any milestone payments we are obligated to make pursuant to our existing license agreements and any future license or collaboration agreements that we may enter into;
•our commercialization, marketing and manufacturing capabilities and expectations;
•our intentions with respect to the commercialization of our drug candidates;
•the pricing and reimbursement of our drug candidates, if approved;
•the implementation of our business model and strategic plans for our business and drug candidates, including additional indications that we may pursue;
•the scope of protection we are able to establish and maintain for intellectual property rights covering our drug candidates, including the projected terms of patent protection;
•estimates of our expenses, future revenue, capital requirements, our needs for additional financing, and our ability to obtain additional capital;
•our ability to maintain compliance with the minimum required closing bid price and the other standards for continued listing on the Nasdaq Global Select Market;
•our ability to remediate a material weakness in our internal control over financial reporting;
•developments and projections relating to our competitors and our industry, including competing therapies;
•our financial performance;
•macroeconomic trends and uncertainty, including high interest rates, rising inflation and the potential for local and/or global economic recession; and
•other risks and uncertainties, including those listed under the caption “Risk Factors”.
We caution you that the foregoing list may not contain all of the forward-looking statements made in this Quarterly Report on Form 10-Q.
Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. We discuss these risks in greater detail in “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this Quarterly Report on Form 10-Q. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
This Quarterly Report on Form 10-Q also contains estimates, projections, and other information concerning our industry, our business and the markets for certain drugs, including data regarding the estimated size of those markets, their projected growth rates, and the incidence of certain medical conditions. Information that is based on estimates, forecasts, projections or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from reports, research surveys, studies, and similar data prepared by third parties, industry, medical and general publications, government data, and similar sources. In some cases, we do not expressly refer to the sources from which this data is derived. In that regard, when we refer to one or more sources of this type of data in any paragraph, you should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwise expressly stated or the context otherwise requires.
Risk Factor Summary
Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the Securities and Exchange Commission, or SEC, before making investment decisions regarding our common stock.
•We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale. We have incurred significant losses since our inception, and we anticipate that we will continue to incur losses for the foreseeable future, which, together with our limited operating history, make it difficult to assess our future viability.
•We will require substantial additional financing to achieve our goals, and a failure to obtain this capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, other operations or commercialization efforts.
•Our financial condition raises substantial doubt as to our ability to continue as a going concern.
•We may not be able to maintain compliance with the continued listing requirements of Nasdaq and, if so, we would be subject to delisting.
•Our core therapeutic approach to slow, halt, or reverse diseases of aging is based on our understanding of cellular senescence. Utilizing senolytic molecules to treat diseases of aging is a novel therapeutic approach, which exposes us to unforeseen risks and makes it difficult to predict the time and cost of drug development and potential for regulatory approval.
•Our business is currently dependent on the successful development and regulatory approval of UBX1325.
•Other than UBX1325, all of our other programs are preclinical and face significant development risk.
•We rely on third-party suppliers to manufacture preclinical and clinical supplies of our drug candidates and we intend to continue to rely on third parties to produce such preclinical and clinical supplies as well as commercial supplies of any approved product. The loss of these suppliers, costs and availability of inputs or supplies, supply issues, or the failure of those manufacturers or suppliers to comply with applicable regulatory requirements or to provide us with sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.
•We face significant competition in an environment of rapid technological and scientific change, and our drug candidates, if approved, will face significant competition and our failure to effectively compete may prevent us from achieving significant market penetration. Most of our competitors have significantly greater resources than we do, and we may not be able to successfully compete.
•Our senolytic medicine platform and any future products that we commercialize could be alleged to infringe patent rights and other proprietary rights of third parties, which may require costly litigation and, if we are not successful, could cause us to pay substantial damages and/or limit our ability to commercialize our products. Even if we obtain regulatory approval for a drug candidate, our products will remain subject to regulatory scrutiny.
•We have identified a material weakness in our internal control over financial reporting. This material weakness could continue to adversely affect our ability to accurately report the results of our operations and financial condition. In the future, we may identify additional material weaknesses or otherwise fail to maintain an effective system of internal control over financial reporting or adequate disclosure controls and procedures, which may result in material errors in our financial statements or cause us to fail to meet our period reporting obligations.
UNITY BIOTECHNOLOGY, INC.
QUARTERLY REPORT ON FORM 10-Q
Table of Contents
PART I. FINANCIAL INFORMATION
Item 1. Condensed Financial Statements
Unity Biotechnology, Inc.
Condensed Balance Sheets
(In thousands, except for share amounts and par value)
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
December 31, 2023(1) |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
8,898 |
|
|
$ |
19,803 |
|
Short-term marketable securities |
|
|
20,139 |
|
|
|
23,398 |
|
Prepaid expenses and other current assets |
|
|
1,226 |
|
|
|
3,404 |
|
Total current assets |
|
|
30,263 |
|
|
|
46,605 |
|
Property and equipment, net |
|
|
4,414 |
|
|
|
5,082 |
|
Operating lease right-of-use assets |
|
|
11,359 |
|
|
|
12,981 |
|
Long-term restricted cash |
|
|
896 |
|
|
|
896 |
|
Other long-term assets |
|
|
200 |
|
|
|
126 |
|
Total assets |
|
$ |
47,132 |
|
|
$ |
65,690 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,804 |
|
|
$ |
1,380 |
|
Accrued compensation |
|
|
1,704 |
|
|
|
1,841 |
|
Accrued and other current liabilities |
|
|
5,276 |
|
|
|
4,619 |
|
Total current liabilities |
|
|
8,784 |
|
|
|
7,840 |
|
Operating lease liability, net of current portion |
|
|
20,698 |
|
|
|
23,539 |
|
Warrant liability |
|
|
3,506 |
|
|
|
5,913 |
|
Total liabilities |
|
|
32,988 |
|
|
|
37,292 |
|
Commitments and contingencies (Note 5) |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Convertible preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 300,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 16,850,350 and 16,784,969 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively |
|
|
2 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
516,006 |
|
|
|
512,773 |
|
Accumulated other comprehensive income (loss) |
|
|
39 |
|
|
|
(24 |
) |
Accumulated deficit |
|
|
(501,903 |
) |
|
|
(484,353 |
) |
Total stockholders’ equity |
|
|
14,144 |
|
|
|
28,398 |
|
Total liabilities and stockholders’ equity |
|
$ |
47,132 |
|
|
$ |
65,690 |
|
(1) The balance sheet as of December 31, 2023 is derived from the audited financial statements as of that date.
See accompanying notes to the condensed financial statements.
Unity Biotechnology, Inc.
Condensed Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
2,787 |
|
|
$ |
4,632 |
|
|
$ |
9,971 |
|
|
$ |
16,828 |
|
General and administrative |
|
|
3,815 |
|
|
|
4,347 |
|
|
|
11,209 |
|
|
|
14,560 |
|
Impairment of long-lived assets |
|
|
— |
|
|
|
5,602 |
|
|
|
— |
|
|
|
5,602 |
|
Total operating expenses |
|
|
6,602 |
|
|
|
14,581 |
|
|
|
21,180 |
|
|
|
36,990 |
|
Loss from operations |
|
|
(6,602 |
) |
|
|
(14,581 |
) |
|
|
(21,180 |
) |
|
|
(36,990 |
) |
Interest income |
|
|
396 |
|
|
|
689 |
|
|
|
1,424 |
|
|
|
2,349 |
|
Interest expense |
|
|
— |
|
|
|
(566 |
) |
|
|
— |
|
|
|
(2,451 |
) |
Gain (loss) on warrant liability |
|
|
(215 |
) |
|
|
253 |
|
|
|
2,407 |
|
|
|
2,283 |
|
Other expense, net |
|
|
(60 |
) |
|
|
(577 |
) |
|
|
(201 |
) |
|
|
(711 |
) |
Net loss |
|
|
(6,481 |
) |
|
|
(14,782 |
) |
|
|
(17,550 |
) |
|
|
(35,520 |
) |
Other comprehensive (loss) gain |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on marketable debt securities |
|
|
74 |
|
|
|
81 |
|
|
|
63 |
|
|
|
196 |
|
Comprehensive loss |
|
$ |
(6,407 |
) |
|
$ |
(14,701 |
) |
|
$ |
(17,487 |
) |
|
$ |
(35,324 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.38 |
) |
|
$ |
(1.01 |
) |
|
$ |
(1.04 |
) |
|
$ |
(2.46 |
) |
Weighted-average number of shares used in computing net loss per share, basic and diluted |
|
|
16,849,283 |
|
|
|
14,598,218 |
|
|
|
16,816,706 |
|
|
|
14,446,672 |
|
See accompanying notes to the condensed financial statements.
Unity Biotechnology, Inc.
Condensed Statements of Stockholders’ Equity
(In thousands, except share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Additional Paid-In |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Total Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Income (Loss) |
|
|
Deficit |
|
|
Equity |
|
Balances at December 31, 2023 |
|
|
16,784,969 |
|
|
$ |
2 |
|
|
$ |
512,773 |
|
|
$ |
(24 |
) |
|
$ |
(484,353 |
) |
|
$ |
28,398 |
|
Repurchase of early exercised shares |
|
|
(3,336 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Vesting of restricted stock units |
|
|
5,014 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
1,394 |
|
|
|
— |
|
|
|
— |
|
|
|
1,394 |
|
Unrealized loss on available-for-sale marketable securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(14 |
) |
|
|
— |
|
|
|
(14 |
) |
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(5,790 |
) |
|
|
(5,790 |
) |
Balances at March 31, 2024 |
|
|
16,786,647 |
|
|
$ |
2 |
|
|
$ |
514,167 |
|
|
$ |
(38 |
) |
|
$ |
(490,143 |
) |
|
$ |
23,988 |
|
Issuance of common stock under 2018 ESPP |
|
|
52,494 |
|
|
|
— |
|
|
|
68 |
|
|
|
— |
|
|
|
— |
|
|
|
68 |
|
Vesting of restricted stock units |
|
|
8,481 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
974 |
|
|
|
— |
|
|
|
— |
|
|
|
974 |
|
Unrealized gain on available-for-sale marketable securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
3 |
|
|
|
— |
|
|
|
3 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(5,279 |
) |
|
|
(5,279 |
) |
Balances at June 30, 2024 |
|
|
16,847,622 |
|
|
$ |
2 |
|
|
$ |
515,209 |
|
|
$ |
(35 |
) |
|
$ |
(495,422 |
) |
|
$ |
19,754 |
|
Vesting of restricted stock units |
|
|
2,728 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
797 |
|
|
|
— |
|
|
|
— |
|
|
|
797 |
|
Unrealized gain on available-for-sale marketable securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
74 |
|
|
|
— |
|
|
|
74 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(6,481 |
) |
|
|
(6,481 |
) |
Balances at September 30, 2024 |
|
|
16,850,350 |
|
|
$ |
2 |
|
|
$ |
516,006 |
|
|
$ |
39 |
|
|
$ |
(501,903 |
) |
|
$ |
14,144 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Additional Paid-In |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Total Stockholders’ |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Gain (Loss) |
|
|
Deficit |
|
|
Equity |
|
Balances at December 31, 2022 |
|
|
14,215,302 |
|
|
$ |
1 |
|
|
$ |
500,827 |
|
|
$ |
(251 |
) |
|
$ |
(444,493 |
) |
|
$ |
56,084 |
|
Issuance of common stock, net of issuance costs, under at-the-market (“ATM”) offering program |
|
|
106,781 |
|
|
|
— |
|
|
|
274 |
|
|
|
— |
|
|
|
— |
|
|
|
274 |
|
Vesting of restricted stock units |
|
|
37,131 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
2,175 |
|
|
|
— |
|
|
|
— |
|
|
|
2,175 |
|
Unrealized gain on available-for-sale marketable securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
101 |
|
|
|
— |
|
|
|
101 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(5,279 |
) |
|
|
(5,279 |
) |
Balances at March 31, 2023 |
|
|
14,359,214 |
|
|
$ |
1 |
|
|
$ |
503,276 |
|
|
$ |
(150 |
) |
|
$ |
(449,772 |
) |
|
$ |
53,355 |
|
Issuance of common stock, net of issuance costs, under ATM offering program |
|
|
168,000 |
|
|
|
— |
|
|
|
518 |
|
|
|
— |
|
|
|
— |
|
|
|
518 |
|
Issuance of common stock under 2018 ESPP |
|
|
41,497 |
|
|
|
— |
|
|
|
91 |
|
|
|
— |
|
|
|
— |
|
|
|
91 |
|
Vesting of restricted stock units |
|
|
26,766 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
2,247 |
|
|
|
— |
|
|
|
— |
|
|
|
2,247 |
|
Unrealized gain on available-for-sale marketable securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
14 |
|
|
|
— |
|
|
|
14 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(15,456 |
) |
|
|
(15,456 |
) |
Balances at June 30, 2023 |
|
|
14,595,477 |
|
|
$ |
1 |
|
|
$ |
506,132 |
|
|
$ |
(136 |
) |
|
$ |
(465,228 |
) |
|
$ |
40,769 |
|
Fees related to the ATM offering program |
|
|
— |
|
|
|
— |
|
|
|
(48 |
) |
|
|
— |
|
|
|
— |
|
|
|
(48 |
) |
Vesting of restricted stock units |
|
|
19,413 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
1,705 |
|
|
|
— |
|
|
|
— |
|
|
|
1,705 |
|
Unrealized gain on available-for-sale marketable securities |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
81 |
|
|
|
— |
|
|
|
81 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(14,782 |
) |
|
|
(14,782 |
) |
Balances at September 30, 2023 |
|
|
14,614,890 |
|
|
$ |
1 |
|
|
$ |
507,789 |
|
|
$ |
(55 |
) |
|
$ |
(480,010 |
) |
|
$ |
27,725 |
|
See accompanying notes to the condensed financial statements.
Unity Biotechnology, Inc.
Condensed Statements of Cash Flows
(In thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
2023 |
|
Operating activities |
|
|
|
|
|
|
Net loss |
|
$ |
(17,550 |
) |
|
$ |
(35,520 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
Depreciation and amortization |
|
|
664 |
|
|
|
951 |
|
Amortization of debt issuance costs |
|
|
— |
|
|
|
705 |
|
Debt extinguishment loss upon paydown of principal |
|
|
— |
|
|
|
491 |
|
Net accretion and amortization of premium and discounts on marketable securities |
|
|
(638 |
) |
|
|
(1,199 |
) |
Gain on disposal of property and equipment |
|
|
(23 |
) |
|
|
— |
|
Stock-based compensation |
|
|
3,165 |
|
|
|
6,127 |
|
Non-cash rent expense |
|
|
(937 |
) |
|
|
(811 |
) |
Impairment of long-lived assets |
|
|
— |
|
|
|
5,602 |
|
(Gain) loss on warrant liability |
|
|
(2,407 |
) |
|
|
(2,283 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
2,178 |
|
|
|
(1,858 |
) |
Other long-term assets |
|
|
(74 |
) |
|
|
52 |
|
Accounts payable |
|
|
424 |
|
|
|
(642 |
) |
Accrued compensation |
|
|
(137 |
) |
|
|
(793 |
) |
Accrued liabilities and other current liabilities |
|
|
375 |
|
|
|
(335 |
) |
Net cash used in operating activities |
|
|
(14,960 |
) |
|
|
(29,513 |
) |
Investing activities |
|
|
|
|
|
|
Purchase of marketable securities |
|
|
(21,289 |
) |
|
|
(28,609 |
) |
Maturities of marketable securities |
|
|
25,250 |
|
|
|
74,000 |
|
Purchase of property and equipment |
|
|
— |
|
|
|
(11 |
) |
Sale of property and equipment |
|
|
26 |
|
|
|
1 |
|
Net cash provided by investing activities |
|
|
3,987 |
|
|
|
45,381 |
|
Financing activities |
|
|
|
|
|
|
Payment of debt principal |
|
|
— |
|
|
|
(20,000 |
) |
Payment of debt issuance costs |
|
|
— |
|
|
|
(1,563 |
) |
Proceeds from issuance of common stock under ATM offering program, net of issuance costs |
|
|
— |
|
|
|
744 |
|
Proceeds from issuance of common stock under 2018 ESPP |
|
|
68 |
|
|
|
91 |
|
Net cash provided by (used in) financing activities |
|
|
68 |
|
|
|
(20,728 |
) |
Net decrease in cash, cash equivalents and restricted cash |
|
|
(10,905 |
) |
|
|
(4,860 |
) |
Cash, cash equivalents and restricted cash at beginning of the period |
|
|
20,699 |
|
|
|
13,632 |
|
Cash, cash equivalents and restricted cash at end of the period |
|
$ |
9,794 |
|
|
$ |
8,772 |
|
Supplemental Disclosures of Cash Flow Information: |
|
|
|
|
|
|
Cash paid for interest |
|
$ |
— |
|
|
$ |
1,969 |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
8,898 |
|
|
$ |
7,876 |
|
Long-term restricted cash |
|
|
896 |
|
|
|
896 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
9,794 |
|
|
$ |
8,772 |
|
See accompanying notes to the condensed financial statements.
Unity Biotechnology, Inc.
Notes to Condensed Financial Statements
(Unaudited)
1. Organization
Description of Business
Unity Biotechnology, Inc. (the “Company”) is a biotechnology company engaged in the research and development of therapeutics to slow, halt, or reverse diseases of aging. The Company devotes substantially all of its time and efforts to performing research and development and raising capital. The Company’s headquarters are located in South San Francisco, California. The Company was incorporated in the State of Delaware in 2009.
Liquidity
The accompanying condensed financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The Company has incurred operating losses and has an accumulated deficit as a result of ongoing efforts to develop drug product candidates, including conducting preclinical and clinical trials and providing general and administrative support for these operations. The Company had an accumulated deficit of $501.9 million and $484.4 million as of September 30, 2024 and December 31, 2023, respectively. The Company had net losses of $6.5 million and $14.8 million for the three months ended September 30, 2024 and 2023, respectively, net losses of $17.6 million and $35.5 million for the nine months ended September 30, 2024 and 2023, respectively, and net cash used in operating activities of $15.0 million and $29.5 million for the nine months ended September 30, 2024 and 2023, respectively. To date, none of the Company’s drug product candidates have been approved for sale; therefore, the Company has not generated any product revenue. The Company anticipates operating losses and negative operating cash flows to continue for the foreseeable future. The Company has financed its operations primarily through private placements of preferred stock and promissory notes, public equity issuances and more recently, from its ATM Offering Programs, the sale of common stock and warrants under a Follow-On Offering and the Inducement Offer and will continue to be dependent upon equity and/or debt financing until the Company is able to generate positive cash flows from its operations.
The Company had cash, cash equivalents, and marketable securities of $29.0 million as of September 30, 2024. The Company expects that its cash, cash equivalents, and marketable securities as of September 30, 2024 will not be sufficient to fund its current business plan including related operating expenditure requirements through at least 12 months from the date of issuance of these condensed financial statements are filed with the Securities and Exchange Commission (“SEC”). These conditions raise substantial doubt about the Company’s ability to continue as going concern. The Company plans to seek to address this condition by raising additional capital to finance its operations. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing. If sufficient funds on acceptable terms are not available when needed, the Company could be further required to significantly reduce its operating expenses and delay, reduce the scope of, or eliminate one or more of its development programs. Failure to manage discretionary spending or raise additional financing, as needed, may adversely impact the Company’s ability to achieve its intended business objectives, or the Company may be forced to liquidate assets where possible, or to cease operations or file for bankruptcy protection. Therefore, it is not considered probable that the Company’s plans to raise additional capital nor reduce discretionary spending will alleviate the substantial doubt regarding its ability to continue as a going concern.
2. Summary of Significant Accounting Policies
Basis of Presentation
These condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the United States SEC for interim reporting.
Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted. Accordingly, the condensed financial statements should be read in
conjunction with the audited financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC.
Condensed Financial Statements
The accompanying financial information for the three and nine months ended September 30, 2024 and 2023 are unaudited. The condensed financial statements have been prepared on the same basis as the annual audited financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s financial position as of September 30, 2024 and its results of operations for the three and nine months ended September 30, 2024 and 2023 and cash flows for the nine months ended September 30, 2024 and 2023. The results for interim periods are not necessarily indicative of the results expected for the full fiscal year or any other periods.
Use of Estimates
The condensed financial statements have been prepared in accordance with GAAP, which requires management to make estimates and assumptions that affect the amounts and disclosures reported in the condensed financial statements and accompanying notes. The Company bases its estimates on historical experience and market-specific or other relevant assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s condensed balance sheets and the amount of expenses and income reported for each of the periods presented are affected by estimates and assumptions, which are used for, but are not limited to, determining the fair value of assets and liabilities, the fair value of right-of-use assets and lease liabilities, and stock-based compensation. Actual results could differ from such estimates or assumptions.
Estimating fair values of liability-classified financial instruments requires the development of estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. As liability-classified financial instruments are initially and subsequently carried at fair value, the Company’s financial results will reflect the volatility in these estimate and assumption changes. Changes in estimated fair value are recognized as a component of "Gain (loss) on warrant liability" in the Statements of Operations and Comprehensive Loss.
Segments
The Company has one operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purposes of allocating resources.
Recently Issued Accounting Pronouncements Not Yet Adopted
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which requires all public entities, including public entities with a single reportable segment, to provide in interim and annual periods one or more measures of segment profit or loss used by the chief operating decision maker to allocate resources and assess performance. Additionally, the standard requires disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures. The guidance in this update is effective for fiscal years beginning after December 15, 2023, and interim periods after December 15, 2024. The Company is currently in the process of evaluating the effects of this pronouncement on its related disclosures.
In December 2023, the Financial Accounting Standards Board (FASB) issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which enhances the disclosures required for income taxes in the Company’s annual financial statements. ASU 2023-09 is effective for the Company in its annual reporting for fiscal 2025 on a prospective basis. Early adoption and retrospective reporting are permitted. The Company does not plan to adopt this standard early. The adoption of this standard is not expected to have a material impact on the Company’s financial statements.
3. Fair Value Measurements
The carrying amounts of financial instruments such as cash and cash equivalents, restricted cash, prepaid expenses and other current assets, accounts payable, accrued compensation, accrued and other current liabilities approximate the related fair values due to the short maturities of these instruments.
The Company’s financial assets and liabilities subject to fair value measurements and the level of inputs used in such measurements were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, 2024 |
|
|
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
7,144 |
|
|
$ |
7,144 |
|
|
$ |
— |
|
|
$ |
— |
|
Total cash equivalents |
|
|
7,144 |
|
|
|
7,144 |
|
|
|
— |
|
|
|
— |
|
Short-term marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasuries |
|
|
14,633 |
|
|
|
— |
|
|
|
14,633 |
|
|
|
— |
|
U.S. government debt securities |
|
|
5,506 |
|
|
|
— |
|
|
|
5,506 |
|
|
|
— |
|
Total short-term marketable securities |
|
|
20,139 |
|
|
|
— |
|
|
|
20,139 |
|
|
|
— |
|
Restricted cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
|
896 |
|
|
|
896 |
|
|
|
— |
|
|
|
— |
|
Total restricted cash equivalents |
|
|
896 |
|
|
|
896 |
|
|
|
— |
|
|
|
— |
|
Total assets subject to fair value measurements |
|
$ |
28,179 |
|
|
$ |
8,040 |
|
|
$ |
20,139 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Liability |
|
$ |
3,506 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
3,506 |
|
Total liabilities subject to fair value measurements on a recurring basis |
|
$ |
3,506 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
3,506 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2023 |
|
|
|
Total |
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
Assets: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
$ |
12,864 |
|
|
$ |
12,864 |
|
|
$ |
— |
|
|
$ |
— |
|
U.S. treasuries |
|
|
2,989 |
|
|
|
— |
|
|
|
2,989 |
|
|
|
— |
|
Total cash equivalents |
|
|
15,853 |
|
|
|
12,864 |
|
|
|
2,989 |
|
|
|
— |
|
Short-term marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasuries |
|
|
7,849 |
|
|
|
— |
|
|
|
7,849 |
|
|
|
— |
|
U.S. government debt securities |
|
|
15,549 |
|
|
|
— |
|
|
|
15,549 |
|
|
|
— |
|
Total short-term marketable securities |
|
|
23,398 |
|
|
|
— |
|
|
|
23,398 |
|
|
|
— |
|
Restricted cash equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
|
896 |
|
|
|
896 |
|
|
|
— |
|
|
|
— |
|
Total restricted cash equivalents |
|
|
896 |
|
|
|
896 |
|
|
|
— |
|
|
|
— |
|
Total assets subject to fair value measurements |
|
$ |
40,147 |
|
|
$ |
13,760 |
|
|
$ |
26,387 |
|
|
$ |
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Liability |
|
$ |
5,913 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
5,913 |
|
Total liabilities subject to fair value measurements on a recurring basis |
|
$ |
5,913 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
5,913 |
|
The Company estimates the fair value of its money market funds, U.S. treasuries, and U.S. government debt securities by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads; benchmark securities; prepayment/default projections based on historical data; and other observable inputs.
August 2022 Warrants ("Existing Warrants")
The common stock warrants are classified as a liability on the Balance Sheets and are measured at fair value with the change in fair value recorded within “Gain (loss) on warrant liability” on the Statement of Operations and Comprehensive Loss. The estimated fair value of the outstanding common stock warrants was $1.4 million and $2.8 million as of September 30, 2024 and December 31, 2023, respectively.
The Company estimates the fair value of its warrant liability using a Monte Carlo simulation model based on significant inputs not observable in the market, which represents a Level 3 measurement. The Company used the following key assumptions within its valuation. In all scenarios, the Company also applied the likelihood of a fundamental transaction and the related impact on the Company’s common stock price and volatility.