PMV Pharmaceuticals, Inc.
For the period ended Sep 30, 2026. Filed Nov 10, 2026.
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Sep 30, 2026 · Filed Nov 10, 2026
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Notes to Unaudited Condensed Consolidated Financial Statements
- Formation and Business of the Company
Organization and Liquidity
PMV Pharmaceuticals, Inc. (the “Company”) was incorporated in the state of Delaware in March 2013. Since inception, the Company has devoted substantially all of its time and efforts to performing research and development activities and raising capital. The Company is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. The Company’s headquarters are located at 400 Alexander Park Drive, Suite 301, Princeton, New Jersey.
The Company is subject to risks and uncertainties common to clinical stage companies in the biotechnology industry including, but not limited to, technical risks associated with the successful research, development and manufacturing of product candidates, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Current and future programs will require significant research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel, and infrastructure. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales.
The Company has incurred net losses and negative cash flows from operations since its inception. During the three and nine months ended September 30, 2026, the Company incurred a net loss of $34,372 and $70,496, respectively. For the nine months ended September 30, 2026, the Company used $52,440 of cash for operations. At September 30, 2026, the Company had an accumulated deficit of $516,950. Cash, cash equivalents, and marketable securities were $108,515 as of September 30, 2026. Management expects to incur substantial additional operating losses for the next several years and may need to obtain additional debt or equity financings in order to complete development of its products, obtain regulatory approvals, launch and commercialize its products and continue research and development programs. The Company believes it has adequate cash, cash equivalents, and marketable securities to operate for the next 12 months from the date of issuance of these unaudited condensed consolidated financial statements.
Liquidity and Going Concern
In connection with the issuance of its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 (the “Q2 2026 10-Q”), management determined that the Company’s then-available cash, cash equivalents, and marketable securities may not have been sufficient to fund its planned operations for at least one year from the issuance date of the Q2 2026 10-Q and that there was substantial doubt as to the Company’s ability to continue as a going concern. On September 2, 2026, the Company completed an underwritten public offering of 22,055,000 shares of its common stock and, in lieu of common stock to certain investors, Pre-Funded Warrants (the “Pre-Funded Warrants”) to purchase 19,900,000 shares of common stock, together with accompanying common stock warrants (the “Common Stock Warrants”) to purchase an aggregate of 41,955,000 shares of common stock (the “August 2026 Public Offering”). The Company received gross proceeds of approximately $50.8 million and net proceeds of approximately $46.9 million, after deducting underwriting discounts and commissions and offering expenses. In assessing its ability to continue as a going concern the company carefully evaluated the conditions and events that may raise substantial doubt about its ability to continue operations for one year from the filing of this Quarterly Report. This evaluation considered several factors, including the Company’s current financial condition and available liquidity resources, which now include the proceeds from the August 2026 Public Offering. Management believes that the Company’s cash, cash equivalents, and marketable securities of $108.5 million as of September 30, 2026, which include the net proceeds from the August 2026 Public Offering, will be sufficient to fund its planned operations for at least one year from the date of this Quarterly Report. This assessment does not assume the receipt of any proceeds from the exercise of the Common Stock Warrants. As a result, management has concluded that there is no longer substantial doubt about the Company’s ability to continue as a going concern as of the date of this Quarterly Report.
The Company will need to obtain additional funding in the future to complete the development and potential commercialization of its product candidates. The Company expects to obtain such funding through public or private equity, convertible or debt financing or capital obtained in connection with strategic collaborations or licensing or other sources. There are inherent uncertainties as the outcome of these potential transactions are outside management’s control, and therefore there are no assurances that any of these potential transactions will occur. In addition, there can be no assurances that these transactions will sufficiently improve the Company’s liquidity or that the Company will otherwise realize the anticipated benefits. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, suspend or curtail planned programs, or pursue strategic alternatives. Any of these actions could materially harm the Company’s business, results of operations and future prospects.
The accompanying unaudited condensed consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
- Summary of Significant Accounting Policies
The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2025, included in the Company’s Annual Report on Form 10-K filed with the United States Securities and Exchange Commission (the “SEC”) on March 6, 2026. Since the date of those consolidated financial statements, there have been no changes to its significant accounting policies, except as described below.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the interim period reporting requirements of Form 10-Q and Article 10 of Regulation S-X. The condensed consolidated balance sheet as of September 30, 2026, the condensed consolidated statements of operations and comprehensive loss, condensed consolidated statements of stockholders’ equity and condensed consolidated statements of cash flows for the three and nine months ended September 30, 2026 and 2025 are unaudited, but, in the opinion of management, include all adjustments, consisting only of normal recurring adjustments, which we consider necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for any interim period are not necessarily indicative of results for the year ending December 31, 2026, or for any other subsequent interim period. The condensed consolidated balance sheet as of December 31, 2025, has been derived from the Company’s audited consolidated financial statements.
The accompanying condensed consolidated financial statements include the Company’s accounts and the accounts of its wholly owned subsidiary, PMV Pharma Australia Pvt Ltd. All significant intercompany transactions and balances have been eliminated upon consolidation. These condensed consolidated financial statements are presented in United States (“U.S.”)Dollars, which is also the functional currency of the Company.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and reported amounts of revenues and expenses during the reporting period. The Company bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, research and development costs, accrued research and development costs and related prepaid expenses, stock-based compensation, and the fair value of the warrant liability. Actual results could differ materially from those estimates.
Fair Value of Financial Instruments
The Company discloses and recognizes the fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). The guidance establishes three levels of the fair value hierarchy as follows:
Level 1 - Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2 - Inputs other than quoted prices that are observable for the asset or liability either directly or indirectly, including inputs in markets that are not considered to be active.
Level 3 - Inputs are unobservable in which there is little or no market data available, which require the reporting entity to develop its own assumptions that are unobservable.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
Warrant Liability
In connection with the August 2026 Public Offering (see Note 7), the Company issued Common Stock Warrants that are classified as a liability in accordance with ASC 815-40, Derivatives and Hedging—Contracts in Entity’s Own Equity. The Common Stock Warrants are not considered indexed to the Company’s own stock because their exercise price and the number of shares issuable are subject to adjustment upon a specified regulatory milestone, and they therefore do not meet the conditions for equity classification. The Common Stock Warrants are accounted for as derivative liabilities and are not designated as hedging instruments. The Company does not hold or issue derivative instruments for trading or risk management purposes. The warrant liability is recorded at fair value upon issuance and is remeasured to fair value at each reporting date, with changes in fair value recognized in the condensed consolidated statements of operations within change in fair value of warrant liability. Upon exercise, the warrant liability is remeasured to fair value and reclassified to additional paid-in capital; upon expiration, it is derecognized through earnings.
Pre-Funded Warrants
The Pre-Funded Warrants issued in the August 2026 Public Offering are classified within stockholders’ equity because they are indexed to the Company’s own stock, are settled in shares, and meet the equity classification conditions of ASC 815-40. The Pre-Funded Warrants are recorded in additional paid-in capital and are not subsequently remeasured.
Allocation of Proceeds and Issuance Costs
The Company allocated the gross proceeds of the August 2026 Public Offering first to the warrant liability at its fair value, with the residual proceeds allocated to the common stock and the Pre-Funded Warrants on a relative fair value basis. Offering costs were allocated between the liability-classified and equity-classified instruments in proportion to the allocated proceeds; the portion allocated to the warrant liability was expensed as incurred, and the portion allocated to the equity-classified instruments was recorded as a reduction of additional paid-in capital.
Cash, Cash Equivalents, and Marketable Securities
Management considers all highly liquid investments with original maturities of three months or less to be cash equivalents.
The Company’s marketable debt securities have been classified and accounted for as available-for-sale. The Company classifies its marketable debt securities as either short-term or long-term based on each instrument’s underlying contractual maturity date. Marketable debt securities with maturities of 12 months or less are classified as short-term and marketable debt securities with maturities greater than 12 months are classified as long-term. The Company’s marketable debt securities are carried at fair value, with unrealized gains and losses, net of taxes, reported as a component of accumulated other comprehensive loss in stockholders’ equity. Premiums and discounts on marketable debt securities are amortized into earnings over the life of the security and recorded on the interest income, net line of the income statement. For the nine months ended September 30, 2026 and 2025, the Company recorded $1,200 and $2,258 of accretion, respectively.
Property and Equipment
Property and equipment are recorded at cost net of accumulated depreciation. Property and equipment are depreciated using the straight‑line method over the estimated useful lives of the assets, generally five years, except for leasehold improvements, which are amortized over the shorter of the useful life of the asset or the remaining term of the lease. Upon retirementor sale of assets, the cost and related accumulated depreciation are removed from the balance sheet and the resulting gain or loss is reflected in operations. Repairs and maintenance costs are charged to operations as incurred.
Comprehensive Loss and Accumulated Other Comprehensive Income (Loss)
Other comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources, including unrealized gains and losses on investments and foreign currency translation gains and losses.
Leases
At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the circumstances present. The Company accounts for a contract as a lease when it has the right to control the asset for a period of time while obtaining substantially all of the asset’s economic benefits. The Company determines the initial classification and measurement of its operating right-of-use (“ROU”) assets and operating lease liabilities at the lease commencement date, and thereafter if modified. The lease term includes any renewal options that the Company is reasonably certain to exercise. The Company’s policy is to not record leases with a lease term of 12 months or less on its balance sheets. The Company’s only existing lease recorded on the balance sheet is for office space.
The ROU asset represents the right to use the leased asset for the lease term. The lease liability represents the present value of the lease payments under the lease. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its estimated secured incremental borrowing rate for that lease term.
Lease expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in operating expense in the statements of operations.
Payments due under the lease agreement include fixed and variable payments. Variable payments relate to the Company’s share of the lessor’s operating costs associated with the underlying asset and are recognized when the event on which those payments are assessed occurs. Variable payments have been excluded from the lease liability and associated right-of-use asset. The Company’s lease does not contain residual value guarantees.
The interest rate implicit in lease agreements is typically not readily determinable, and as such, the Company utilizes the incremental borrowing rate to calculate lease liabilities, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment.
Net Loss per Share
Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, including shares issuable under the Company’s Pre-Funded Warrants (which are exercisable for nominal consideration). Diluted net loss per share reflects the potential dilution from outstanding stock options, unvested restricted stock, and common stock warrants, using the treasury stock and two-class methods. In periods of net loss, basic and diluted net loss per share are the same, as potentially dilutive securities are anti-dilutive.
Concentration of Credit Risk and Other Risks and Uncertainties
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist of cash, cash equivalents, and marketable securities. Cash and cash equivalents were held at primarily two financial institutions. At times, such deposits may be in excess of insured limits. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company’s marketable securities are carried at fair value and include any unrealized gains and losses. The Company invests in high-credit-quality, investment-grade securities and limits the amount of credit exposure to any one issuer.
The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, cost of development, uncertainty of market acceptance of the product, competition from substitute products and larger companies, protection of proprietary technology, any future strategic relationships and dependence on key individuals.
Products developed by the Company require clearances from the U.S. Food and Drug Administration or other international regulatory agencies prior to commercial sales. There can be no assurance the Company’s product candidates will receive the necessary clearances. If the Company is denied clearance, clearance is delayed or it is unable to maintain clearance, it could have a materially adverse impact on the Company.
Recently Adopted Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amended guidance enhances income tax disclosures primarily related to the effective tax rate reconciliation and income taxes paid information. This guidance requires disclosure of specific categories in the effective tax rate reconciliation and additional information on reconciling items meeting a quantitative threshold. In addition, the amended guidance requires disaggregating income taxes paid (net of refunds received) by federal, state, and foreign taxes. It also requires disaggregating individual jurisdictions in which income taxes paid (net of refunds received) are equal to or greater than 5 percent of total income taxes paid (net of refunds received). The amended guidance is effective for annual periods beginning after December 15, 2024. The Company adopted this guidance prospectively for the annual period ending December 31, 2025. For additional information, see “Note 9 — Income Taxes.”
Recent Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03, “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses”. This amended guidance requires disaggregation of specific expense categories in the notes to the financial statements and a qualitative description of the remaining expense amounts not separately disaggregated. This standard becomes effective for reporting companies with annual reporting periods beginning after December 15, 2026, and requires prospective application with an option to apply it retrospectively. The Company anticipates adopting this standard in its Annual Report on Form 10-K for the year ending December 31, 2027. The Company is currently evaluating the impact that the adoption of this standard will have on its condensed consolidated financial statements.
In September 2025, the FASB issued ASU No. 2025-07 (“ASU 2025-07”), Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606). The guidance refines the scope of Topic 815 to clarify which contracts are subject to derivative accounting. The guidance also provides clarification under Topic 606 for share-based payments from a customer in a revenue contract. The amendments in ASU 2025-07 are effective for fiscal years beginning after December 15, 2026, and interim reporting periods, with early adoption permitted. The Company is currently evaluating the impact that the adoption of this standard will have on its condensed consolidated financial statements.
- Fair Value Measurements
The Company’s financial instruments consist of money market funds, U.S. government debt securities, corporate debt securities, and Common Stock Warrants. Cash and cash equivalents include money market funds and corporate securities. Money market funds are measured at fair value on a recurring basis using quoted prices and are classified as Level 1. Corporate debt securities are measured at fair value based on inputs other than quoted prices that are derived from observable market data and are classified as Level 2 inputs. Marketable securities include corporate securities and government debt securities.
Government debt securities (excluding off-the-run treasury bills, which are classified as Level 2) are measured at fair value on a recurring basis using quoted prices and are classified as Level 1.
The Common Stock Warrants are classified within Level 3 of the fair value hierarchy because their fair values are based on significant inputs that are unobservable in the market. The fair value of the Common Stock Warrants as of September 30, 2026 was estimated using a Monte Carlo simulation model.
The following tables present the carrying amounts and fair values of the Company’s cash equivalents, available-for-sale securities, and warrant liabilityas of September 30, 2026, and December 31, 2025:
| CarryingAmount | Gross Unrealized Gains | Gross Unrealized Losses | FairValue | QuotedPrices inActiveMarkets(Level 1) | Significantotherobservableinputs(Level 2) | Significantunobservableinputs(Level 3) | |
|---|---|---|---|---|---|---|---|
| Financial assets | |||||||
| Money market funds | $13,748 | $— | $— | $13,748 | $13,748 | $— | $— |
| Corporate securities | 77,451 | 1 | (128) | 77,324 | — | 77,324 | — |
| Government securities | 17,446 | — | (40) | 17,406 | 14,441 | 2,965 | — |
| Total financial assets | $108,645 | $1 | $(168) | $108,478 | $28,189 | $80,289 | $— |
| CarryingAmount | Gross Unrealized Gains | Gross Unrealized Losses | FairValue | QuotedPrices inActiveMarkets(Level 1) | SignificantOtherObservableInputs(Level 2) | SignificantUnobservableInputs(Level 3) | |
|---|---|---|---|---|---|---|---|
| Financial assets | |||||||
| Money market funds | $29,909 | $— | $— | $29,909 | $29,909 | $— | $— |
| Corporate securities | 30,636 | 12 | (4) | 30,644 | — | 30,644 | — |
| Government securities | 52,229 | 68 | — | 52,297 | 52,297 | — | — |
| Total financial assets | $112,774 | $80 | $(4) | $112,850 | $82,206 | $30,644 | $— |
| Liabilities measured at fair value on a recurring basis as of September 30, 2026 | ||||
|---|---|---|---|---|
| (in thousands) | ||||
| Total | Level 1 | Level 2 | Level 3 | |
| Warrant liability | $43,607 | $— | $— | $43,607 |
| Total liabilities | $43,607 | $— | $— | $43,607 |
Cash Equivalents — As of September 30, 2026, the Company had aggregate cash and cash equivalents of $19,994, including cash equivalents of $19,957, consisting of money market funds and corporate securities. As of December 31, 2025, the Company had aggregate cash and cash equivalents of $37,983, including cash equivalents of $29,909, consisting of money market funds and government securities and $7,981 in corporate securities.
Marketable Securities — Marketable securities of $88,521 as of September 30, 2026, consisted of corporate debt securities of $71,115 and government debt securities of $17,406. There were $82,566 current marketable securities and $5,955 noncurrent marketable securities as of September 30, 2026. Marketable securities of $74,960 as of December 31, 2025, consisted of corporate debt securities of $22,663 and government debt securities of $52,298. There were $74,960 of current marketable securities andno noncurrent marketable securities as of December 31, 2025.
As of September 30, 2026, and December 31, 2025, the unrealized losses on available-for-sale securities were primarily attributable to changes in interest rates rather than credit quality, and the Company did not intend to sell, nor was it more likely than not that it would be required to sell, these securities before recovery of their amortized cost basis. Accordingly, no allowance for credit losses was recorded.
Warrant Liabilities - On September 2, 2026, the Company completed the August 2026 Public Offering, at which time the Company issued Common Stock Warrants to purchase an aggregate of 41,955,000 shares of common stock of the Company.
The initial exercise price of the Common Stock Warrants is $1.21 per share of common stock. Beginning on the date of the Company’s initial public announcement of the decision by the FDA regarding the acceptance for review of the Company’s New Drug Application (“NDA”) for rezatapopt for the treatment of patients with platinum-resistant/refractory ovarian cancer harboring a TP53 Y220C mutation (the “NDA Acceptance Announcement”), the exercise price of the Common Stock Warrants will be reduced to the greater of (i)33% of the initial exercise price of the Common Stock Warrants and (ii) the lesser of (x) the then exercise price and (y) the volume weighted average price of the common stock for the five trading day period beginning the trading day following the NDA Acceptance Announcement (the “Reset Exercise Price”). If the exercise price is reduced to the Reset Exercise Price, the number of shares issuable pursuant to the Common Stock Warrant will be increased such that the aggregate exercise price payable thereunder, after taking into account the decrease in the exercise price to the Reset Exercise Price, shall be equal to the aggregate exercise price immediately prior to the date of the NDA Acceptance Announcement.
The Company evaluated the Common Stock Warrants under ASC 815-40 and determined that the Reset Exercise Price provision precludes the Common Stock Warrants from being considered indexed to the Company’s own stock because the adjustment is triggered by a regulatory milestone and the settlement amount varies based on factors that are not inputs to the fair value of a fixed-for-fixed option on the Company’s common stock. Accordingly, the Common Stock Warrants are classified as a Level 3 liability and are measured at fair value at each reporting date, with changes in fair value recognized in earnings.
The following table presents changes in Level 3 liabilities measured at fair value from the measurement date through September 30, 2026:
| Change in fair value of warrant liability (Level 3) | |
|---|---|
| (in thousands) | Warrant Liability |
| Balance at initial recognition (September 2, 2026) | $30,826 |
| Change in fair value recognized in earnings | 12,781 |
| Exercises | — |
| Balance at September 30, 2026 | $43,607 |
The change in fair value of $12,781 relates to the warrant liability held at September 30, 2026 and is included in change in fair value of warrant liability in the condensed consolidated statements of operations.
The Company estimates the fair value of the warrant liability using a Monte Carlo simulation model. Management determines the significant unobservable inputs used in the model and reviews the model and the resulting fair value measurement each reporting period. The significant unobservable input used in the fair value measurement of the warrant liability is expected volatility. There were no transfers into or out of Level 3 during the period. The following table provides quantitative information regarding Level 3 fair value measurements inputs at their measurement date and as of September 30, 2026:
| Key inputs — warrant liability | ||
|---|---|---|
| Input | At issuance (September 2, 2026) | At September 30, 2026 |
| Expected volatility | 80.0% | 80.0% |
| Common stock price | $1.21 | $1.67 |
| Exercise price | $1.21 | $1.21 |
| Expected term (in years) | 0.9 - 5.0 | 0.8 - 4.9 |
| Risk-free interest rate | 4.49% | 5.09% |
| Expected dividend yield | 0% | 0% |
Expected volatility is based on the historical volatility of the Company’s common stock over a five-year lookback period. The common stock price is the closing price on the measurement date and the risk-free rate is the U.S. Treasury constant maturity yield for a commensurate term. The expected term ranges from the earliest assumed exercise date, which reflects Management’s estimated timing of the NDA Acceptance Announcement, to the Common Stock Warrants’ contractual expiration. The Common Stock Warrants permit the Company, following the NDA Acceptance Announcement, to require holders to exercise up to 50% of the warrants for cash. The Monte Carlo simulation assumes the Company exercises this right shortly after the NDA Acceptance Announcement, unless the Company’s common stock price at that time is below the minimum Reset Exercise Price (33% of the initial exercise price). Refer to Note 7 for the contractual terms to exercise the Common Stock Warrants.
The fair value of the warrant liability is most sensitive to the Company’s common stock price and expected volatility. Holding other inputs constant, as of September 30, 2026, a 10% increase (decrease) in the Company’s common stock price would have increased (decreased) the fair value of the warrant liability by approximately $5.7 million ($5.1 million), respectively, and a 10-percentage-point increase (decrease) in expected volatility would have increased (decreased) the fair value by approximately $3.4 million ($3.1 million), respectively.
- Property and Equipment, Net
| September 30,2026 | December 31,2025 | |
|---|---|---|
| Machinery & equipment | $1,410 | $1,447 |
| Computers | 13 | 13 |
| Furniture & fixtures | 23 | 23 |
| Leasehold improvements | 36 | 81 |
| Total property and equipment | 1,482 | 1,564 |
| Less: Accumulated depreciation | (1,351) | (1,327) |
| Property and equipment, net | $131 | $237 |
Depreciation expense for the three months ended September 30, 2026 and 2025 was $23 and $32, respectively. Depreciation expense for the nine months ended September 30, 2026 and 2025 was $81 and $100, respectively.
- Accrued Expenses
Accrued expenses consist of the following:
| September 30,2026 | December 31,2025 | |
|---|---|---|
| Accrued compensation | $4,126 | $4,532 |
| Accrued research and development costs | 3,877 | 3,130 |
| Accrued legal and professional services | 910 | 195 |
| Total | $8,913 | $7,857 |
- Commitments and Contingencies
Operating Leases
In January 2021, the Company signed a lease for 50,581 square feet of office and laboratory space (the “One Research Way Lease”) at One Research Way in Princeton, New Jersey (the “Premises”). The lease term initially extended through 2032, had a five-year extension option, and replaced the Company’s two prior facilities as the Company’s headquarters in March 2023. The Company estimated that payments under the One Research Way Lease would be $19,889 through May 2032. The Company received a lease incentive of $4,046 from the lessor for a buildout of laboratory, vivarium, and office space. Management estimated the timing and amounts of reimbursements and included them as a reduction of lease payments when initially measuring the lease liability and right-of-use asset upon commencement. Since the inception date of the lease, $4,046 reimbursements were received from the lessor.
In August 2024, the Company entered into a Lease Termination Agreement with BMR-One Research Way LLC (the “Landlord”), in connection with the termination of the One Research Way Lease (the “Termination Agreement”). The
Termination Agreement was contingent on the sale of the Premises by the Landlord to a prospective new buyer, which was met on October 1, 2024, and, as a result, there was no modification in August 2024.
Pursuant to the Termination Agreement, the Company surrendered the Premises in October 2024 and paid a total termination fee of approximately $1,420, consisting of (i) a cash payment in the amount of approximately $798 and (ii) a release of a security deposit from the Company’s existing letter of credit in the amount of approximately $622. The transaction was accounted for as an immediate termination of an operating lease before the expiration of the lease term in accordance with ASC 842. The Company derecognized the lease-related asset and liability resulting in a gain of $4,850 in the quarter ended December 31, 2024. Since the termination fee of $1,420 was not already included in the lease payments, the termination fee was recognized as a loss on termination of the lease. Further, the Company abandoned and wrote off all the related leasehold improvements totaling $9,454 held at the Premises. This net activity totaling $6,024 was recorded as a loss within General and Administrative expense in the Statement of Operations for the year ended December 31, 2024.
In August 2024, the Company signed a sublease for 14,201 square feet of office space at 400 Alexander Park Drive, Suite 301, in Princeton, New Jersey, to be used as its new headquarters (“400 Alexander Sublease”). The 400 Alexander Sublease commenced on October 1, 2024 and extends until February 28, 2027. Payments under the 400 Alexander Sublease will total $789 through February 2027.
In September 2024, the Company signed a sublease agreement for 3,205 square feet of office and laboratory space at 311 Pennington Rocky Hill Road in Hopewell, New Jersey (the “311 Pennington Sublease”). The Company utilized the premises as laboratory space for research and development activities. The term of the 311 Pennington Sublease extended through 2029 and provided the Company with the option to extend the term for an additional three year period. Payment under the 311 Pennington Sublease totaled $192 through February 2026.
In March 2026, the 311 Pennington Sublease was terminated effective March 4, 2026, upon the termination of the primary lease between the master landlord and the tenant, in accordance with the terms of the sublease agreement. As a result, the Company accounted for the 311 Pennington Sublease termination as an immediate termination of an operating lease before the expiration of the lease term in accordance with ASC 842. Upon termination, the Company derecognized the related operating lease right‑of‑use asset and lease liabilities and recorded a net gain of approximately $24, which was recognized in General and Administrative expense in the accompanying Statement of Operations for the three months ended March 31, 2026.
In September 2026, the Company entered into a 12-month office space agreement at 100 Walnut Avenue, Suite 210, in Clark, New Jersey, commencing on October 1, 2026. Total contractual payments under the agreement are approximately $11 over the contractual term. Given the termination provisions in the agreement, the Company concluded that the arrangement qualifies for the short-term lease exemption under ASC 842 and, accordingly, will not recognize a right-of-use asset or lease liability upon commencement. Costs incurred under the agreement will be expensed as incurred on a monthly basis.
The components of lease cost for thethree and nine months ended September 30, 2026 and 2025, are as follows:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| (in thousands) | 2026 | 2025 | 2026 | 2025 |
| Operating lease cost | $82 | $118 | 269 | $353 |
| Variable lease cost | — | 20 | 18 | 54 |
| Short-term lease cost | — | — | 100 | — |
| Total lease cost | $82 | $138 | $387 | $407 |
Amounts reported in the balance sheet for leases where the Company is the lessee as of September 30, 2026, and December 31, 2025, are as follows:
| Operating Leases | September 30,2026 | December 31,2025 |
|---|---|---|
| Right-of-use assets, operating leases | $133 | $801 |
| Operating lease liabilities, current | $138 | $403 |
| Operating lease liabilities, non-current | — | 435 |
| Total operating lease liabilities | $138 | $838 |
| Weighted-average remaining lease term (years) | 0.42 | 2.76 |
| Weighted-average discount rate | 13.70% | 13.70% |
Other information related to leases for thenine months ended September 30, 2026 and 2025, respectively, are as follows:
| Nine Months Ended September 30, | ||
|---|---|---|
| (in thousands) | 2026 | 2025 |
| Net cash paid for amounts included in the measurement of lease liabilities | $277 | $360 |
| Leased assets (derecognized) obtained in exchange for new or modified operating lease liabilities | (432) | — |
Future minimum lease payments, net of reimbursements, remaining as of September 30, 2026, under operating leases by fiscal year were as follows:
| Fiscal year | |
|---|---|
| 2026 | 84 |
| 2027 | 56 |
| 2028 | — |
| 2029 | — |
| Thereafter | — |
| Total minimum lease payments | $140 |
| Less: Amounts representing imputed interest | (2) |
| Present value of lease liabilities | $138 |
Rent expense recorded during the three months ended September 30, 2026 and 2025 was $82 and $118, respectively. Rent expense recorded during the nine months ended September 30, 2026 and 2025 was $269 and $353 respectively.
Contingencies
From time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when future expenditures are probable and such expenditures can be reasonably estimated.
- Stockholders’ Equity
The Company is authorized to issue up to 1,000,000,000 shares of common stock with a par value of $0.00001 per share and 5,000,000 shares of preferred stock with a par value of $0.00001 per share. At September 30, 2026 and December 31, 2025, there were 75,534,742 and 53,331,766 shares of common stock issued and outstanding, respectively.
Common stockholders are entitled to receive dividends if and when declared by the board of directors subject to the rights of any preferred stockholders. As of September 30, 2026, no dividends on common stock had been declared by the Company.
ATM Program
On October 4, 2021, the Company entered into an at-the-market offering program (the “ATM Program”) pursuant to which, the Company may offer and sell shares of its common stock having aggregate gross sales proceeds of up to $150.0 million from time to time. During the three and nine months ended September 30, 2026, the Company didnot sell any shares of its common stock under the ATM Program. The continuous offering under the prospectus supplement dated November 27, 2024 related to the ATM Program was terminated on August 31, 2026.
August 2026 Public Offering
On September 2, 2026, the Company completed the August 2026 Public Offering, at which time the Company issued 22,055,000 shares of common stock, Pre-Funded Warrants to purchase an aggregate of 19,900,000 shares of common stock, and accompanying Common Stock Warrants to purchase an aggregate of 41,955,000 shares of common stock. Each share of common stock, together with one Common Stock Warrant, was offered and sold at a combined price of $1.21, and each Pre-Funded Warrant, together with one Common Stock Warrant, was offered and sold at a combined price of $1.20999. Each Pre-Funded Warrant has an initial exercise price of $0.00001 per share, subject to certain adjustments. The pre-funded warrants and common stock warrants entitle their holders to participate in any dividend or other distribution of the Company’s assets to holders of common stock on an as-exercised basis, without regard to limitations on exercise. Participation is subject to the holder’s beneficial ownership limitation of 4.99% (or 9.99%), with any excess held in abeyance until it may be received without exceeding that limitation. Warrant holders have no voting or other rights of a common stockholder until exercise.
The Pre-Funded Warrants are immediately exercisable and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. The Common Stock Warrants are immediately exercisable and expire on September 2, 2031. The initial exercise price of the Common Stock Warrants is $1.21 per share of common stock, subject to certain adjustments. In addition, beginning on the date of the NDA Acceptance Announcement, the exercise price of the Common Stock Warrants will be reduced to the Reset Exercise Price. If the exercise price of the Common Stock Warrants is reduced to the Reset Exercise Price, the number of shares of common stock issuable pursuant to the Common Stock Warrant shall be increased such that the aggregate exercise price payable thereunder, after taking into account the decrease in the exercise price to the Reset Exercise Price, shall be equal to the aggregate exercise price immediately prior to the date of the NDA Acceptance Announcement.
To the extent that the NDA Acceptance Announcement relates to a positive decision of the FDA to accept the NDA, then during the period beginning on the 30th calendar day following the date of the NDA Acceptance Announcement and ending on the 60th calendar day following the date of the NDA Acceptance Announcement, the holders of Common Stock Warrants may be required, at the Company’s option, to exercise up to 50% of their Common Stock Warrants for cash (the “Mandatory Exercise”). Any common stock warrant which has not been exercised pursuant to the Mandatory Exercise shall become null and void and the rights of the holder of the Common Stock Warrant to exercise such Common Stock Warrant shall lapse. Upon the occurrence of certain fundamental transactions, holders of the Common Stock Warrants may have the right to require cash settlement based on the Black-Scholes value of the warrants. The Company may not effect the exercise of any warrant to the extent that, after giving effect to the exercise, the holder would beneficially own more than 4.99% or 9.99%, as applicable, of the Company’s outstanding common stock. After underwriting discounts, commissions and offering expenses, the Company received net proceeds from the public offering of $46.9 million. No Pre-Funded Warrants or Common Stock Warrants have been exercised as of September 30, 2026.
The Company determined that the common stock and Pre-Funded Warrants met the criteria for equity classification, while the Common Stock Warrants were classified as a liability under ASC 815-40 and are measured at fair value at each reporting date, with changes in fair value recognized in earnings. The warrant liability was initially recognized at its fair value of $30.8 million on the closing date of the offering, and the remaining proceeds were allocated between the common stock and Pre-Funded Warrants based on their relative fair values. Issuance costs were allocated to the liability- and equity-classified instruments in proportion to the proceeds allocated to each instrument. Of the $3.9 million of issuance costs, approximately $2.3 million was allocated to the warrant liability and expensed immediately within other income (expense) on the condensed consolidated statements of operations, while approximately $1.5 million was allocated to the equity-classified instruments and recorded as a reduction of additional paid-in capital. See Note 3, Fair Value Measurements, for additional information regarding the accounting for and fair value measurement of the warrant liability.
- Stock Plan
2020 Equity Incentive Plan
The 2020 Equity Incentive Plan (the “2020 Plan”) was approved by the Company’s board of directors on September 24, 2020. The 2020 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock units, restricted stock awards, unrestricted stock awards, cash-based awards and dividend equivalent rights to the Company’s officers, employees, directors and consultants. The number of shares of common stock initially reserved for issuance under the 2020 Plan was 4,406,374, which shall be increased, upon approval by the Company’s board of directors, on January 1, 2021 and each January 1 thereafter, in an amount equal to the least of (i)4,406,374 shares of common stock, (ii) five percent (5%) of the outstanding common stock on the immediately preceding December 31, or (iii) such number of common stock determined by the board of directors no later than the immediately preceding December 31. For 2026, the compensation committee of the Company’s board of directors, as the 2020 Plan administrator, exercised its discretion under clause (ii) to increase the number of shares of common stock reserved for issuance under the 2020 Plan by 2,666,470 shares, effective as of January 1, 2026. As of September 30, 2026, there were 2,591,410 shares available for issuance under the 2020 Plan.
On January 18, 2024, the Company granted 952,665 RSUs to employees VP-level or higher, pursuant to an employee retention program approved by the compensation committee of the Company’s board of directors. As of September 30, 2026 such RSUs were fully vested and common stock was issued upon settlement of the RSUs.
2020 Employee Stock Purchase Plan
The 2020 Employee Stock Purchase Plan (the “2020 ESPP”) was approved by the Company’s board of directors on September 24, 2020. A total of 400,752 shares of common stock were initially reserved for issuance under this plan, which shall be increased, upon approval by the Company’s board of directors, on January 1, 2021 and each January 1 thereafter, to the lesser of (i)801,504 shares of common stock, (ii)1% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (iii) an amount determined by the board of directors or any of its committees no later than the last day of the immediately preceding fiscal year. For 2026, the Company’s board of directors waived the annual increase to the shares reserved under the 2020 ESPP. As of September 30, 2026,740,081 shares are issued or outstanding, and there were 1,033,530 shares available for issuance, under the 2020 ESPP.
Stock Options
On July 16, 2024, the Company filed with the Securities and Exchange Commission a Tender Offer Statement on Schedule TO defining the terms and conditions of a one-time voluntary stock option exchange to its employees of certain options to purchase up to an aggregate of 2,820,491 shares of the Company’s common stock (the “Option Exchange”). On August 13, 2024, the completion date of the Option Exchange, stock options covering an aggregate of 2,786,691 shares of common stock were tendered by eligible employees, and the Company granted new options at an exercise price of $1.48, the Company’s closing stock price on August 13, 2024, covering an aggregate of 2,786,691 shares of common stock under the 2020 Plan in exchange for the tendered options. The new options are subject to a new three or four-year vesting schedule, vesting in equal annual installments over the vesting term. Each new option has a maximum term of ten years. The Option Exchange was treated as a modification for accounting purposes. As a result of the Option Exchange, the Company will recognize incremental stock-based compensation expense of $1,370 over the requisite service period of the new stock options, which isthree orfour years. The Company will recognize the sum of the incremental stock-based compensation expense and the remaining unrecognized compensation expense for the original awards on the modification date, over the requisite service period of the new stock options.
The following table summarizes option activity for the nine-month period ended September 30, 2026:
| Options Outstanding | ||||
|---|---|---|---|---|
| Weighted- | ||||
| Weighted · Average · Aggregate | ||||
| Average · Remaining · Intrinsic | ||||
| Number of | Exercise | Contractual Life | Value | |
| Options | Price | (in years) | (in 000s) | |
| Balances at December 31, 2025 | 11,990,688 | $2.43 | 7.74 | $86 |
| Options granted | 4,530,865 | $1.48 | ||
| Options forfeited / cancelled | (117,680) | $1.98 | ||
| Options exercised | (19,310) | $1.37 | ||
| Balances at September 30, 2026 (unaudited) | 16,384,563 | $2.17 | 7.70 | $2,855 |
| Vested and expected to vest | 16,384,563 | $2.17 | 7.70 | $2,855 |
| Exercisable | 7,994,229 | $2.90 | 6.59 | $1,043 |
At September 30, 2026, the total compensation cost related to nonvested awards not yet recognized was $11,269. The weighted-average period over which the nonvested awards is expected to be recognized was 2.6 years.
The Company estimated the fair value of the options using the Black-Scholes options valuation model. The fair value of the options is being amortized on a straight-line basis over the requisite service period of the awards. The fair value was estimated using the following assumptions:
| For the Nine Months Ended September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Risk-free interest rate | 3.82% - 5.12% | 3.89% - 4.48% |
| Expected life (in years) | 5.00 - 6.26 | 5.50 - 6.25 |
| Dividend yield | 0% | 0% |
| Expected volatility | 76.94% - 77.77% | 78.67% - 80.22% |
The weighted average assumptions used to estimate the fair value of stock purchase rights under the 2020 ESPP are as follows:
| For the Nine Months Ended September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Risk-free interest rate | 3.75% | 4.33% |
| Expected life (in years) | 0.5 | 0.5 |
| Dividend yield | 0% | 0% |
| Expected volatility | 77.77% | 78.67% |
Risk Free Interest Rate: The risk-free rate is based on the U.S. Treasury yields in effect at the time of grant for periods corresponding with the expected term of the option.
Expected Term: The Company uses the simplified method to calculate expected term described in the SEC’s Staff Accounting Bulletin No. 107, which takes into account vesting term and expiration date of the options.
Dividend Yield: The Company has never declared or paid any cash dividends and does not plan to pay cash dividends in the foreseeable future, and therefore, used an expected dividend yield ofzero in the valuation model.
Volatility: Volatility is based on the historical volatility of the Company’s publicly traded shares for the expected term.
Restricted Stock Units
For the quarter ending September 30, 2026, no RSU awards were granted, vested, or unvested. As of September 30, 2026 there wasno unrecognized compensation cost related to RSUs that are expected to vest.
Stock-based compensation expense recorded under ASC 718 related to stock options granted and common stock issued under the 2020 ESPP were allocated to research and development and general and administrative expense as follows:
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Research and development | $735 | $615 | $2,069 | $1,992 |
| General and administrative | 870 | 768 | 2,470 | 2,567 |
| Total stock-based compensation | $1,605 | $1,383 | $4,539 | $4,559 |
Stock-based compensation expense by award type included within the condensed consolidated statements of operations is as follows:
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2026 | 2025 | 2026 | 2025 | |
| Stock options | $1,572 | $1,350 | $4,441 | $3,840 |
| Restricted stock units | — | — | — | 559 |
| Employee stock purchase plan | 33 | 33 | 98 | 160 |
| Total stock-based compensation | $1,605 | $1,383 | $4,539 | $4,559 |
- Income Taxes
The Company’s effective tax rates were 0% and 0% for thethree months ended September 30, 2026 and 2025, respectively.
During the three and nine months ended September 30, 2026 and 2025, the Company recorded a full valuation allowance on federal and state net deferred tax assets since management does not forecast the Company to be in a taxable position in the near future.
The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell unused net operating loss (“NOL”) carryforwards and R&D tax credits to other New Jersey-based corporate taxpayers. For the nine months ended September 30, 2026, the Company didnot receive any benefit for income taxes. For thenine months ended September 30, 2025, the Company received a benefit for income taxes of $2,196. As of September 30, 2026, the Company received a total of $18,372 of cash for the NOL and R&D tax credit sales related to the tax years ended December 31,2015 to 2023.
- Net Loss per Share
The Company excluded all outstanding stock options and RSUs at each period end from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect. The following common stock equivalents were excluded from the calculation of diluted net loss per share:
| As of September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Options to purchase common stock | 16,384,563 | 12,211,331 |
| Expected shares to be purchased under 2020 ESPP | 12,659 | 33,006 |
| Common Stock Warrants | 41,955,000 | - |
| Total | 58,352,222 | 12,244,337 |
Shares of the Company’s common stock underlying the Pre-Funded Warrants are included in the calculation of basic and diluted net loss per share.
- Related Parties
The Company has consulting agreements withtwo members of its board of directors. Total consulting fees paid during the three months ended September 30, 2026 and 2025 were $30 and $50, respectively. Total consulting fees paid during thenine months ended September 30, 2026 and 2025 were $90 and $150, respectively. There wereno amounts owed under the consulting agreements as of September 30, 2026.
- Segment Information
The Company has viewed its operations and manages its business asone operating and reporting segment. Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the Company’s chief operating decision maker (“CODM”)to make decisions with respect to resource allocation and assessment of performance. The Company’s CODM is its Chief Executive Officer (the“CEO”), who reviews and evaluates consolidated net loss from operations for purposes of assessing performance, making operating decisions, allocating resources, and planning and forecasting for future periods. The determination of a single segment is consistent with the financial information regularly reviewed by the CEO.
The CEO regularly reviews the condensed consolidated statement of operations and a disaggregation of operating expenses, of which the significant expenses are related to research and development. The following table represents the significant segment expenses regularly provided to the CEO:
| For the Nine Months Ended September 30, | ||
|---|---|---|
| 2026 | 2025 | |
| Research and Development | ||
| Research | $1,899 | $4,016 |
| Development | 31,009 | 37,611 |
| Personnel related | 11,092 | 10,431 |
| Stock-based compensation | 2,069 | 1,992 |
| Total research and development | 46,069 | $54,050 |
| General and administrative | ||
| Personnel related | $4,564 | $4,239 |
| Stock-based compensation | 2,470 | 2,566 |
| External | 4,860 | 6,109 |
| Total general and administrative | 11,894 | 12,914 |
| Loss from Operations | $57,963 | $66,964 |
- Subsequent Event
The Company has evaluated subsequent events through November 10, 2026, the date these financial statements were issued. The Company determined that there were no subsequent events that required adjustment to or disclosure in the financial statements.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.