Neumora Therapeutics Inc
For the period ended Dec 31, 2024. Filed Mar 3, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 3, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to the Consolidated Financial Statements
- Organization and Liquidity
Description of Business
Neumora Therapeutics, Inc. (the Company), was originally incorporated in the State of Delaware in November 2019, and is headquartered in Watertown, Massachusetts.
The Company is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. The Company has rapidly scaled its therapeutic pipeline, which currently consists of seven neuroscience programs, including two clinical programs, that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. The Company's most advanced product candidate, navacaprant (NMRA-140), is a novel once-daily oral kappa opioid receptor (KOR) antagonist that is being developed for the treatment of major depressive disorder (MDD), which the Company believes has the potential to provide significant advantages relative to the standard of care, if approved. Navacaprant is being investigated in the KOASTAL program, a pivotal Phase 3 program, evaluating navacaprant monotherapy in patients with moderate to severe MDD. Neumora expects to report topline data from KOASTAL-3 in the first quarter of 2026 and KOASTAL-2 in the second quarter of 2026. The Company's next most advanced product candidate is NMRA-511, a highly selective, novel antagonist of the vasopressin 1a receptor (V1aR) being developed for the treatment of agitation associated with dementia due to Alzheimer's disease (AD). The Company is advancing a Phase 1b signal-seeking study investigating NMRA-511 initially in healthy elderly adult participants and then people with agitation associated with dementia due to AD, and the Company expects to report data from this study in by the end of 2025. The Company's M4 positive allosteric modular (PAM) franchise comprises multiple novel compounds that each have different chemical composition but optimal pharmacological properties, which have demonstrated robust activity in preclinical efficacy models and high selectivity for the M4 receptor subtype. The Company expects to progress our next M4 PAM into the clinic by mid-2025.
Liquidity
The Company has incurred net losses and negative cash flows from operations since inception and as of December 31, 2024, had an accumulated deficit of $947.2 million. In September, 2023, the Company completed its initial public offering (IPO), pursuant to which it issued and sold an aggregate of 14,710,000 shares of its common stock at a price to the public of $17.00 per share, resulting in net proceeds of $226.5 million, after deducting underwriting discounts and commissions of $17.5 million and other offering expenses of $6.0 million. In October 2024, the Company entered into a sales agreement with Leerink Partners LLC (Leerink) to sell shares of the Company’s common stock, from time to time, with aggregate gross sales proceeds of up to $300.0 million, through an at-the-market equity offering program (ATM) with Leerink as the sales agent. During the year ended December 31, 2024, the Company received aggregate net proceeds of $13.7 million after deducting commissions and offering expenses of $0.8 million.
As of December 31, 2024, the Company had cash, cash equivalents and marketable securities of $307.6 million, which are available to fund future operations. The Company believes that its existing cash, cash equivalents and marketable securities as of December 31, 2024 will be sufficient to support operations for at least the next 12 months from the date these consolidated financial statements were available to be issued.
The Company expects to incur additional losses in the future as it continues its research and development efforts, advances its product candidates through preclinical and clinical development, enhances its precision neuroscience approach and programs, expands its product pipeline, seeks regulatory approval, prepares for commercialization, as well as hires additional personnel, protects its intellectual property and grows its business. The Company will need to raise additional capital to support its continuing operations and pursue its long-term business plan, including to complete the development and commercialization of its product candidates, if approved. Such activities are subject to significant risks and uncertainties, including clinical failure which can impact the Company’s ability to secure additional funding. The Company expects to finance its cash needs through a combination of public or private equity offerings or debt financings or other capital sources, which may include strategic collaborations or other arrangements with third parties, or other sources of financing. However, there is no guarantee that any of these financing or opportunities will be executed or realized on favorable terms, if at all, and some could be dilutive to existing stockholders.
- Summary of Significant Accounting Policies and Basis of Presentation
Basis of Presentation and Consolidation
The accompanying consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) and applicable rules and regulations of the Securities and Exchange Commission (SEC) regarding annual financial reporting. The consolidated financial statements include all accounts of the Company and its wholly owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.
In September, 2023, the Company’s board of directors approved an amended and restated certificate of incorporation to effect a reverse split of shares of the Company’s common stock and convertible preferred stock on a 7.8463-for-1 basis (the “Reverse Stock Split”). The par value and authorized shares of the common stock and convertible preferred stock were not adjusted as a result of the Reverse Stock Split. All share data and per share data amounts for all periods presented in the consolidated financial statements and notes thereto have been retrospectively adjusted to reflect the effect of the Reverse Stock Split.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts in the consolidated financial statements and accompanying notes. These estimates form the basis for judgments the Company makes about the carrying values of assets and liabilities that are not readily apparent from other sources. The Company bases its estimates and judgments on historical experience and on various other assumptions that the Company believes are reasonable under the circumstances. These estimates are based on management’s knowledge about current events and expectations about actions the Company may undertake in the future. These judgments, estimates and assumptions are used for, but not limited to, accrued research and development expenses, accounting for acquisitions of assets, fair value of certain assets and liabilities, the fair value of the Company’s convertible preferred stock, the fair value of the Company’s common stock, stock-based compensation, the measurement of right-of-use assets and lease liabilities and related incremental borrowing rate, and uncertain tax positions and the valuation allowance for net deferred tax assets. Actual results may differ from the Company’s estimates.
Risks and Uncertainties
The Company is subject to certain risks and uncertainties, including, but not limited to, changes in any of the following areas that the Company believes could have a material adverse effect on future financial position or results of operations: successfully develop, manufacture, and market any approved products; obtain regulatory approval from the U.S. Food and Drug Administration or foreign regulatory agencies prior to commercial sales; new technological innovations; dependence on key personnel, protection of intellectual property; compliance with governmental regulations; uncertainty of market acceptance of any approved products; product liability; and the need to obtain additional financing.
Cash and Cash Equivalents
All highly liquid investments, including money market funds, with original maturities of three months or less at the time of purchase are considered to be cash equivalents. All of the Company’s cash equivalents have liquid markets and high credit ratings. The Company maintains its cash in bank deposits and other accounts.
Restricted Cash
Restricted cash consists of a facility lease agreement collateralized by a letter of credit pursuant to certain banking and lease agreements. Restricted cash, which is unavailable for a period of less than one year from the consolidated balance sheet date, is classified as a current asset.
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents deposited in accounts at several financial institutions that may exceed the Federal Deposit Insurance Corporation’s insurance limit. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash and cash equivalents to the extent recorded in the consolidated balance sheets. The Company believes it is not exposed to significant credit risk due to the financial position of the financial institutions in which those deposits are held.
Marketable Securities
The Company invests its excess cash in marketable debt securities with high credit ratings including but not limited to money market funds, securities issued by the U.S. government and its agencies, commercial paper and corporate debt securities that are accounted for as available-for-sale and carried at fair value. Marketable securities are classified as short-term or long-term based on the maturity date and their availability to meet current operating requirements. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income in the consolidated statements of operations and comprehensive loss. Realized gains and losses on marketable securities, if any, are included in other income (expense), net. The cost of securities sold is determined based on the trade date using the specific identification method.
The Company periodically assesses its available-for-sale debt securities for impairment. For debt securities in an unrealized loss position, this assessment first considers the Company’s intent to sell, or whether it is more likely than not that it will be required to sell the security before recovery of its amortized cost basis. If either of these criteria are met, the debt security’s amortized cost basis is written down to fair value within other income (expense), net. For debt securities in an unrealized loss position that do not meet the aforementioned criteria, the Company assesses whether the decline in fair value has resulted from credit losses or other factors. In making this assessment, the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency, and any adverse conditions specifically related to the security is considered, among other factors. If this assessment indicates that a credit loss may exist, the present value of cash flows expected to be collected from the security are compared to the amortized cost basis of the security. If the present value of cash flows expected to be collected is less than the amortized cost basis, a credit loss exists and an allowance for credit losses will be recorded in other income (expense), net, limited by the amount that the fair value is less than the amortized cost basis. Any additional impairment not recorded through an allowance for credit losses is recognized in other comprehensive income (loss). Changes in the allowance for credit losses are recorded as provision for (or reversal of) credit loss expense. Losses are charged against the allowance when management believes the un-collectability of an available-for-sale security is confirmed or when either of the criteria regarding intent or requirement to sell is met. These changes are recorded in other income (expense), net.
Fair Value of Financial Instruments
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 the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. The Company measures fair value by maximizing the use of observable inputs, where available, and minimizing the use of unobservable inputs when measuring fair value. Financial assets and liabilities recorded at fair value in the consolidated balance sheets are categorized in the fair value hierarchy based upon the lowest level of input that is significant to the fair value as follows:
Level 1—Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2—Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable inputs for similar assets or liabilities. These include quoted prices for identical or similar assets or liabilities in active markets and quoted prices for identical or similar assets or liabilities in markets that are not active.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value of the instrument.
Property and Equipment, Net
Property and equipment, net is stated at cost less accumulated depreciation. Depreciation of property and equipment is computed using the straight-line method over the estimated useful lives of the assets, which isthree toseven years. Leasehold improvements are amortized using the straight-line method over the lesser of the estimated useful lives of the assets or the remaining term of the lease. Construction in progress is stated at cost and not depreciated until the asset is placed into service. Upon sale or retirement of the assets, the cost and related accumulated depreciation are removed from the consolidated balance sheets and the resulting gain or loss is recognized in the consolidated statements of operations and comprehensive loss. Expenditures for maintenance and repairs are expensed as incurred.
Impairment of Long-Lived Assets
The Company reviews the carrying amount of its long-lived assets, including property and equipment and right-of-use assets, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. If indicators of impairment exist, an impairment loss is recognized when the estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. The impairment charge is determined based upon the excess of the carrying value of the asset over its estimated fair value, with estimated fair value determined based upon an estimate of discounted future cash flows or other appropriate measures of estimated fair value. Estimating discounted cash flows requires the Company to make significant judgments and assumptions. Actual results may vary from the Company’s estimates as of the date of impairment testing and adjustments may occur in future periods. The Company believes thatno impairment of long-lived assets is required as of and for the years ended December 31, 2024, 2023, and 2022.
Leases
The Company determines if an arrangement is or contains a lease at inception by assessing whether it conveys the right to control the use of an identified asset in exchange for consideration. If a lease is identified, classification is determined at lease commencement. To date, all of the Company’s leases have been determined to be operating leases. Operating lease liabilities are recognized at the present value of the future lease payments at the lease commencement date. The Company’s leases do not provide an implicit interest rate and therefore the Company estimates its incremental borrowing rate to discount lease payments. The incremental borrowing rate reflects the estimated interest rate that the Company would have to pay to borrow on a collateralized basis, an amount equal to the lease payments in a similar economic environment over a similar term. Operating lease right-of-use (ROU) assets are determined based on the corresponding lease liability adjusted for any lease payments made at or before commencement, initial direct costs, and lease incentives. The operating lease ROU asset also includes impairment charges if the Company determines the ROU asset is impaired. The Company considers a lease term to be the noncancelable period that it has the right to use the underlying asset, including any periods where it is reasonably assured the Company will exercise the option to extend the contract. Periods covered by an option to extend are included in the lease term if the lessor controls the exercise of that option. Operating lease expenses are recognized, and the ROU assets are amortized on a straight-line basis over the lease term. The Company has elected to not separate lease and non-lease components for its leased assets and accounts for all lease and non-lease components of its agreements as a single lease component. The Company has elected not to recognize on the consolidated balance sheets leases with terms of one year or less.
Acquisitions
The Company evaluates mergers, acquisitions, and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or an acquisition of assets. The Company first identifies who is the acquiring entity by determining if the target is a legal entity or a group of assets or liabilities. If control over a legal entity is being evaluated, the Company also evaluates if the target is a variable interest or voting interest entity. For acquisitions of voting interest entities, the Company applies a screen test to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen test is met, the transaction is accounted for as an acquisition of assets. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs which would meet the definition of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets.
For an acquisition of assets, a cost accumulation model is used to determine the cost of the acquisition. Common stock and convertible preferred stock issued as consideration in an acquisition of assets are generally measured based on the acquisition date fair value of the equity interests issued. Direct transaction costs are recognized as part of the cost of an acquisition of assets. The Company also evaluates which elements of a transaction should be accounted for as a part of an acquisition of assets and which should be accounted for separately.
The cost of an acquisition of assets, including transaction costs, are allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not recognized in an acquisition of assets. Any difference between the cost of an acquisition of assets and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values. Assets acquired as part of an acquisition of assets that are considered to be in-process research and development intangible assets (IPR&D) are immediately expensed and recorded as a component of acquired in-process research and development expense in the consolidated statements of operations and comprehensive loss unless there is an alternative future use in other research and development projects.
In addition to upfront consideration, the Company’s acquisitions of assets may also include contingent consideration payments to be made for future milestone events or royalties on net sales of future products. The Company assesses whether such contingent consideration is subject to liability classification and fair value measurement or meets the definition of a derivative. Contingent consideration payments in an acquisition of assets not required to be classified as a liability at fair value, or are accounted for as derivatives that qualify for a scope exception from derivative accounting, are recognized when the contingency is resolved, and the consideration is paid or becomes payable. Contingent consideration payments required to be classified as a liability, or are accounted for as derivatives and do not qualify for a scope exception from derivative accounting, are recorded at fair value on the date of the acquisition and are subsequently remeasured to fair value at each reporting date. Contingent consideration payments made prior to regulatory approval are expensed as incurred. Any future payments that are contingent upon continued services to the Company are treated as compensation and recognized when it is probable such amounts will become payable.
If the target legal entity is determined to be a variable interest entity (VIE) and not a business, all tangible and intangible assets acquired, including any IPR&D assets but excluding goodwill, and liabilities assumed, including contingent consideration, are recorded at their fair values. If the acquisition is determined to be a business combination, all tangible and intangible assets acquired, including any IPR&D assets, and liabilities assumed, including contingent consideration, are recorded at their fair values. Goodwill is recognized for any difference between the consideration transferred and fair value determination. In addition, direct transaction costs in connection with business combinations are expensed as incurred, rather than capitalized.
The tax basis of assets acquired in either a business combination or acquisition of assets are compared to the book basis of such assets resulting in the recognition of deferred tax assets and liabilities.
Research and Development Expenses and Related Prepaid Assets and Accrued Liabilities
Research and development costs are expensed as incurred. Research and development expenses primarily consist of internal research and development expense, including personnel-related expenses (such as salaries, benefits and noncash stock-based compensation) and other expenses, including laboratory supplies and other non-capital equipment utilized for in-house research, research and consulting expenses, software development costs, license fees and allocated expenses, including facilities costs and depreciation and amortization; external research and development expenses incurred under arrangements with service providers conducting research and development services on its behalf, such as contract research organizations (CROs), preclinical testing organizations and contract manufacturing organizations (CMOs). Payments made prior to the receipt of goods or services to be used in research and development are capitalized, evaluated for current or long-term classification, and included in prepaid expenses and other current assets or other assets in the consolidated balance sheets based on when the goods are received or the services are expected to be received or consumed, and recognized in research and development expenses when they are realized.
The Company is required to estimate expenses resulting from its obligations under contracts with service providers in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations which vary from contract to contract and may result in cash flows that do not match the periods over which materials or services are provided. The Company estimates and records accrued expenses for the related research and development activities based on the level of services performed but not yet invoiced pursuant to agreements established with its service providers, according to the progress of preclinical studies, clinical trials or related activities, and discussions with applicable personnel and service providers as to the progress or state of consummation of goods and services.
During the course of a clinical trial, the rate of expense recognition is adjusted if actual results differ from the Company’s estimates. The Company estimates accrued expenses as of each balance sheet date in its consolidated financial statements based on the facts and circumstances known at that time. The clinical trial accrual is dependent in part upon the timely and accurate reporting of CROs, CMOs and other service providers. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its estimate may vary from the actual results. To date, the Company has not experienced material differences between its accrued expenses and actual expenses.
Stock-Based Compensation
The Company maintains equity incentive plans (the Plans) as a long-term incentive for employees, directors, and service providers. The Company accounts for all stock-based awards based on their fair value on the date of the grant. For stock-based awards with service only vesting conditions, the Company recognizes expense on a straight-line basis over the requisite service period, which is generally the vesting period of the respective award. For awards with performance vesting conditions, the Company evaluates the probability of achieving the performance vesting condition at each reporting date. The Company begins to recognize expense for awards with performance-based vesting conditions using an accelerated attribution method when it is deemed probable that the performance condition will be met. For awards with both market and service vesting conditions, the Company recognizes expense using the accelerated attribution method over the derived requisite service period. Stock-based compensation is classified in the consolidated statements of operations and comprehensive loss based on the function to which the related services are provided. Forfeitures are accounted for as they occur.
The fair value of stock option awards with only service conditions and/or performance-based vesting conditions are estimated on the date of grant using the Black-Scholes option pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the option, the risk-free interest rate for a period that approximates the expected term of the option, and the expected dividend yield. The fair value of stock options awards with market-based vesting conditions is estimated on the grant date using the Monte Carlo simulation model, which utilizes subjective assumptions, including volatility and the derived service periods, that determine the probability of satisfying the market condition stipulated in the award to estimate the fair value of the award. The fair value of restricted stock is based on the estimated fair value of the Company’s common stock on the grant date.
Income Taxes
The Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for the expected future tax consequences of events that have been included in the Company’s consolidated financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences between the financial statement carrying amounts and the tax bases of existing assets and liabilities and for loss and credit carryforwards, using enacted tax rates expected to be in effect in the year in which the differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if it is more likely-than-not that these assets may not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which the temporary differences representing net future deductible amounts become deductible.
The Company recognizes and measures uncertain tax positions using a two-step approach. The Company determines whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely-than-not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more-likely-than-not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. Judgment is required to evaluate uncertain tax positions. The Company evaluates uncertain tax positions on a regular basis. The evaluations are based on a number of factors, including changes in facts and circumstances, changes in tax law, correspondence with tax authorities during the course of the audit, and effective settlement of audit issues.
The Company’s policy is to include penalties and interest expense related to income taxes as a component of its provision for income taxes. The Company has not reported any interest or penalties associated with income tax for any period presented.
Net Loss Per Share
Basic net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given the net loss for each period presented.
Comprehensive Loss
Comprehensive loss includes net loss and certain changes in stockholders’ equity (deficit) that are excluded from net loss, such as unrealized losses on the Company’s available-for-sale marketable securities.
Emerging Growth Company Status
The Company was an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the JOBS Act) until December 31, 2024. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act, until such time as those standards apply to private companies. The Company has evaluated if any accounting standards which it previously delayed adopting would have a material impact to the consolidated financial statements or disclosures and concluded that there is no such material impact.
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (ASU 2023-07), which requires issuers to make additional disclosures with respect to segment expenses, including required disclosure on an annual and interim basis for significant segment expenses and other segment items. The improved disclosure requirements apply to all public entities that are required to report segment information, including those with only one reportable segment. The Company adopted the guidance in the annual period ended December 31, 2024. There was no impact on the Company’s reportable segments identified and additional required disclosures have been included in Note 14.
Recent Accounting Pronouncements Not Yet Adopted
In December 2023, the Financial Standards Accounting Board (FASB) issued Accounting Standards Update (ASU) 2023-09, Income Taxes(ASU 2023-09), which requires issuers to make additional discloses on an annual basis related to specific categories in the rate reconciliation and provide additional information for reconciling items that meet a quantitative threshold on an annual basis, disclose additional information about income taxes paid as well as other disaggregated disclosures. ASU 2023-09 is effective for the Company as of January 1, 2025 for annual periods. The Company is evaluating the impact of this ASU on its consolidated financial statements.
- Cash Equivalents and Marketable Securities
The following tables summarize the amortized cost and fair value of the Company’s cash equivalents and marketable securities by major investment category for the periods indicated:
| AmortizedCost | GrossUnrealizedGain | GrossUnrealizedLoss | EstimatedFair Value | |
|---|---|---|---|---|
| (in thousands) | ||||
| Cash equivalents: | ||||
| Money market funds | $94,411 | $— | $— | $94,411 |
| Commercial paper | 30,875 | 6 | — | 30,881 |
| Total cash equivalents | $125,286 | $6 | $— | $125,292 |
| Marketable securities: | ||||
| Commercial paper | 61,374 | 11 | (2) | 61,383 |
| Certificates of deposit | 1,918 | — | — | 1,918 |
| U.S. government securities | 74,411 | 36 | (3) | 74,444 |
| Corporate debt securities | 27,671 | 17 | (3) | 27,685 |
| Total marketable securities | 165,374 | 64 | (8) | 165,430 |
| Total cash equivalents and marketable securities | $290,660 | $70 | $(8) | $290,722 |
| AmortizedCost | GrossUnrealizedGain | GrossUnrealizedLoss | EstimatedFair Value | |
|---|---|---|---|---|
| (in thousands) | ||||
| Cash equivalents: | ||||
| Money market funds | $306,801 | $— | $— | $306,801 |
| Commercial paper | 42,455 | 6 | — | 42,461 |
| U.S. government and agency debt securities | 12,998 | — | (6) | 12,992 |
| Total cash equivalents | $362,254 | $6 | $(6) | $362,254 |
| Marketable securities: | ||||
| Commercial paper | $47,534 | $17 | $(4) | $47,547 |
| U.S. government and agency debt securities | 37,515 | — | (91) | 37,424 |
| Corporate debt securities | 4,816 | 3 | (1) | 4,818 |
| Total marketable securities | 89,865 | 20 | (96) | 89,789 |
| Total cash equivalents and marketable securities | $452,119 | $26 | $(102) | $452,043 |
As of December 31, 2024, the contractual maturities of all marketable securities is less than one year and the Company has not realized any material gains or losses on its marketable securities, including any impairment charges on its securities related to expected credit losses. As of December 31, 2024, the aggregate difference between the amortized cost and fair value of each security in an unrealized loss position was de minimis. Since any provision for expected credit losses for a security held is limited to the amount the fair value is less than its amortized cost, no allowance for expected credit loss was deemed necessary at December 31, 2024 (see Note 4).
- Fair Value Measurements
The carrying amounts of the Company’s financial instruments, including prepaid expenses and other current assets, accounts payable, accrued liabilities and the current portion of operating lease liabilities approximate fair value due to the short-term nature of those instruments.
The following tables summarize the Company’s assets and liabilities measured at fair value on a recurring basis by level within the valuation hierarchy:
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| (in thousands) | ||||
| Assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $94,411 | $— | $— | $94,411 |
| Commercial paper | — | 30,881 | — | 30,881 |
| Marketable securities: | ||||
| Commercial paper | — | 61,383 | — | 61,383 |
| Certificates of deposit | — | 1,918 | — | 1,918 |
| U.S. government securities | 74,444 | — | — | 74,444 |
| Corporate debt securities | — | 27,685 | — | 27,685 |
| Total assets measured at fair value | $168,855 | $121,867 | $— | $290,722 |
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| (in thousands) | ||||
| Assets: | ||||
| Cash equivalents: | ||||
| Money market funds | $306,801 | $— | $— | $306,801 |
| Marketable securities: | ||||
| Commercial paper | — | 90,008 | — | 90,008 |
| U.S. government and agency debt securities | 19,473 | 30,943 | — | 50,416 |
| Corporate debt securities | — | 4,818 | — | 4,818 |
| Total assets measured at fair value | $326,274 | $125,769 | $— | $452,043 |
Money market funds are highly liquid and actively traded marketable securities that generally transact at a stable $1.00 net asset value representing its estimated fair value. The Company estimates the fair value of its U.S. government and agency debt securities, commercial paper and corporate 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.
- Balance Sheet Components
Property and equipment, net
Property and equipment, net, consisted of the following:
| December 31, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Laboratory equipment | $2,844 | $2,800 |
| Computer and software | 287 | 287 |
| Furniture and fixtures | 58 | 97 |
| Construction in progress | — | 41 |
| Total property and equipment | 3,189 | 3,225 |
| Less: accumulated depreciation and amortization | (2,049) | (1,435) |
| Total property and equipment | $1,140 | $1,790 |
Depreciation and amortization expense for the years ended December 31, 2024, 2023 and 2022 was $0.6 million, $0.7 million and $0.6 million, respectively. As of December 31, 2024, all of the Company’s property and equipment was located in the United States.
Accrued Liabilities
Accrued liabilities consisted of the following:
| December 31, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Accrued clinical trial and preclinical costs | $11,606 | $4,705 |
| Compensation and benefits | 9,975 | 10,011 |
| Professional services | 2,686 | 787 |
| Other | 326 | 750 |
| Accrued research and development services (nil and $3.1 million due to related party in 2024 and 2023, respectively) | — | 5,004 |
| Total accrued liabilities | $24,593 | $21,257 |
- Acquisitions of Assets
BlackThorn Therapeutics, Inc.
In June 2020, the Company entered into an agreement and plan of merger (BlackThorn Merger Agreement) to acquire all of the equity interests of BlackThorn Therapeutics, Inc. (BlackThorn), which became effective in September 2020. The Company acquired BlackThorn for its in-process research and development programs, including an antagonist of the kappa opioid receptor (navacaprant (NMRA-140)) for the treatment of major depressive disorders and an antagonist of the vasopressin 1a receptor (NMRA-511) for the treatment of agitation in Alzheimer's disease. The Company also gained access to a cloud-based computational psychiatry and data platform that was being developed to support drug target identification, patient stratification and objective clinical trial endpoints. Both navacaprant and NMRA-511 were exclusively licensed to BlackThorn by The Scripps Research Institute (TSRI). The acquisition was accounted for as an acquisition of assets.
The BlackThorn Merger Agreement requires the Company to pay the former stockholders of BlackThorn contingent consideration (i) with respect to navacaprant, in the form of development and regulatory approval milestones of up to an aggregate amount of $365.0 million, which includes amilestone payment that became due in October 2023 upon dosing the first patient in the Phase 3 clinical trial for navacaprant, and sales-based milestones of up to an aggregate amount of $450.0 million and (ii) with respect to NMRA-511, in the form of development and regulatory approval milestones of up to an aggregate amount of $100.0 million, and sales-based milestones of up to an aggregate amount of $100.0 million (BlackThorn Milestones). At the Company’s sole discretion, the BlackThorn Milestone payments may be settled in cash or shares of the Company, or a combination of both, subject to the provisions of the BlackThorn Merger Agreement, other than one development milestone in the amount of $10.0 million, which must be settled in cash. None of the BlackThorn Milestones were subject to liability classification and/or derivative accounting and any such contingent consideration will be recognized when the contingency is resolved, and the consideration becomes payable. The Company settled the Phase 3 navacaprant dosing milestone in December 2023 by issuing 6,072,445 shares of its common stock based on the volume weighted average price per share prior to the date the milestone was met and paying cash of $2.3 million to the former stockholders of BlackThorn and participants in the carveout plan (discussed below). As a result, the Company recognized $60.8 million in acquired in-process research and developed expenses in the fourth quarter of 2023 related to the BlackThorn Milestones. None of the other Blackthorn Milestones have been achieved andno such amounts were deemed due or payable as of December 31, 2024.
BlackThorn Carveout Plan
The BlackThorn Merger Agreement required that the Company establish a carveout plan (the BlackThorn Carveout Plan), pursuant to which each BlackThorn stock option holder as of immediately prior to the closing date was allocated a certain number of units (the BlackThorn Carveout Units) based on the number of shares underlying the outstanding options held by each participant at that time. Each BlackThorn Carveout Unit represents a right to receive a portion of the BlackThorn Milestone payment (the BlackThorn Carveout Payments) upon the later of (i) the achievement of a BlackThorn Milestone and (ii) the vesting of the BlackThorn Carveout Unit.
The BlackThorn Carveout Units vest based on time-based schedules that mirror the vesting schedules for the original option awards held by each participant. As of the closing date in September 2020, a portion of the BlackThorn Carveout Units corresponding to the pre-acquisition service periods were fully vested (Vested Carveout Units). The remainder of the BlackThorn Carveout Units vest subject to the continued service of the participants.
The Vested Carveout Units represent contingent consideration for the acquisition as they are attributable to pre-acquisition services rendered by the participants and continuing service is not required for the participants to receive future payments upon a BlackThorn Milestone being achieved. The Company recognizes the contingent consideration obligation for the Vested Carveout Units when the contingency is resolved, and the consideration becomes payable. The BlackThorn Carveout Units that were unvested as of the closing date are dependent on the continued service of participants and were deemed to be a compensation arrangement. The Company recognizes compensation starting from the time payment becomes probable over each participant’s service period.
The Company settled the Phase 3 navacaprant dosing milestone in December 2023. The Company recognized contingent consideration related to Vested Carveout Units, which was included in acquired in-process research and developed expenses in the fourth quarter of 2023 related to the BlackThorn Milestones as described above. In addition, the Company recognized and paid $1.8 million in compensation related to the BlackThorn Carveout Units that were a compensatory arrangement in 2023. None of the other BlackThorn Milestones had been achieved andno such amounts were deemed due or payable as of December 31, 2024.
Amgen Inc. Licenses
In September 2021, the Company entered intotwo license agreements with Amgen Inc. (Amgen) pursuant to which it obtained exclusive, worldwide licenses to develop, manufacture, use, commercialize and distribute products containing compounds that are directed to, in one case, CK1δ, and in the other case, glucocerebrosidase (GCase), both for the treatment of neurodegenerative diseases (the Amgen License Agreements) and related know-how and clinical material (collectively, the Amgen IPR&D Assets). The Company accounted for these transactions as acquisitions of assets. Concurrently, the Company also executed a research collaboration agreement as well as a stock purchase agreement with Amgen. Both agreements were deemed to be separate transactions and not accounted for as part of the acquisition of assets.
The total upfront consideration transferred to Amgen of 20.0 million shares of the Company's Series A-2 convertible preferred stock, with an acquisition date fair value of $157.0 million was allocated to the Amgen IPR&D Assets and expensed in 2021.
Under these two license agreements, Amgen is eligible to receive contingent consideration up to an aggregate of $360.0 million in commercial milestone payments per product payable in cash with a compound directed to CK1δ and up to an aggregate of $360.0 million in commercial milestone payments per product payable in cash with a compound directed to GCase, in each case, upon the achievement of certain sales thresholds and single digit royalties on potential future net sales, related to CK1δ or GCase (the Amgen Milestones). Such contingent consideration was not subject to liability classification and/or derivative accounting and will be recognized when the contingency is resolved, and the consideration becomes payable. As of December 31, 2024, none of the Amgen Milestones had been achieved andno such amounts were deemed due or payable.
In addition, until a specified period of time following the achievement of the first successful Phase 2 clinical trial for any licensed product, if the Company chooses to sell, transfer, sublicense or divest rights to a licensed product in certain major markets, Amgen has a period of time to enter into an agreement with the Company for such rights. The Company determined that these rights of first negotiation were not freestanding instruments from the Amgen License Agreements and did not meet the definition of a derivative.
Vanderbilt License
In February 2022, as amended in July 2023 and May 2024, the Company and Vanderbilt University (Vanderbilt) entered into a license agreement (Vanderbilt License Agreement). Pursuant to the Vanderbilt License Agreement, as amended, the Company obtained an exclusive, worldwide royalty-bearing, sublicensable (subject to certain restrictions) license under certain patent rights and a non-exclusive, worldwide, royalty-bearing, sublicensable (subject to certain restrictions) license under certain know-how covering small molecule positive allosteric modulators (PAMs) predominantly of the muscarinic acetylcholine receptor subtype 4 (M4) to develop, manufacture, and commercialize products, processes and services covered by such patent rights or that incorporate or use such know-how, for any and uses (the Vanderbilt IPR&D Assets). Concurrently, the Company also executed a sponsored research agreement (see Note 8) with Vanderbilt. The sponsored research agreement was deemed to be separate transactions and not accounted for as part of the acquisition of assets. The acquisition of Vanderbilt IPR&D Assets became effective in February 2022.
The licensed patent rights are subject to Vanderbilt’s right to use the patent rights for research, internal non-commercial use, and educational purposes. The Company intends to develop the PAMs for the treatment of schizophrenia and other neuropsychiatric disorders. The Company has agreed to use commercially reasonable efforts to develop and commercialize licensed products, and to achieve certain development milestones.
The Company paid Vanderbilt a non-refundable, non-creditable upfront cash payment of $13.0 million for the Vanderbilt IPR&D Assets, which was immediately recognized as acquired in-process research and development expense in the condensed consolidated statement of operations and comprehensive loss as it was determined to have no alternative future use as of the acquisition date. Under the Vanderbilt License Agreement, Vanderbilt is eligible to receive contingent consideration payable in cash up to an aggregate of $42.4 million upon the achievement of specified development milestones and up to an aggregate of $380.0 million upon the achievement of commercial milestone events as well as tiered royalties at mid-single digit percentages on potential future net sales, subject to specified reductions for the lack of patent coverage, generic entry and payment obligations for third-party licenses (the Vanderbilt Milestones). Such contingent consideration was not subject to liability classification and/or derivative accounting and will be recognized when the contingency is resolved, and the consideration becomes payable. In October 2023, a $2.0 million Vanderbilt Milestone was achievedand settled in cash in November 2023 and was recognized in acquired in-process research and developed expenses in the fourth quarter of 2023. None of the other Vanderbilt Milestones had been achieved andno such amounts were deemed due or payable as of December 31, 2024.
In addition, the Company also had an exclusive option, exercisable for a specified period of time, to negotiate an exclusive license to certain patent rights conceived or developed by Vanderbilt in the course of carrying out the sponsored research pursuant to the sponsored research agreements between the Company and Vanderbilt, the first of which was entered into at the same time as the Vanderbilt License Agreement and the second of which was executed in May 2024. The Company determined that the right to negotiate was not a freestanding instrument from the Vanderbilt License Agreement and did not meet the definition of a derivative. The Company exercised the above disclosed exclusive option under the first sponsored research agreement and the parties executed an agreement in December 2023 pursuant to which the Company licensed certain patent rights in return for a payment of $0.8 million that was recognized in acquired in-process research and developed expenses in the fourth quarter of 2023.
- Commitments and Contingencies
Operating Leases
Lease Agreement
In May 2022, the Company executed a sublease agreement for a 30,067 square feet office and laboratory facility in Watertown, Massachusetts. The term of the sublease commenced in June 2022 with respect to the office space and commenced in August 2022 with respect to the laboratory space. The term of the sublease expires in June 2025. A letter of credit was executed in connection with this sublease agreement that is included in restricted cash on the consolidated balance sheets. In August 2023, the sublease was amended to include 972 square feet of additional space, which also expires in June 2025.
Under the lease agreements, the Company is generally required to pay certain operating costs, in addition to rent, such as common area maintenance, taxes, utilities and insurance. Such additional charges are considered variable lease costs and are recognized in the period in which they are incurred. Rent expense for the year ended December 31, 2024 was $3.7 million. Short term lease expense and variable costs were immaterial. Rent expense for the year ended December 31, 2023 was $4.3 million, including $0.3 million related to short term lease expense, and variable costs were immaterial. Rent expense for the year ended December 31, 2022 was $3.5 million, including $1.1 million related to short term lease expense, and variable costs were $0.1 million.
The Company’s operating leases include various covenants, indemnities, defaults, termination rights, security deposits and other provisions customary for lease transactions of this nature.
The maturity of the Company’s operating lease liabilities as of December 31, 2024 were as follows (in thousands):
| Undiscounted lease payments | |
|---|---|
| 2025 | 1,892 |
| Total undiscounted lease payments | 1,892 |
| Less: Imputed interest | (39) |
| Operating lease liabilities, current portion | $1,853 |
Supplemental information on the Company's operating leases was as follows:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Cash paid for operating lease agreements (in thousands) | $3,723 | $4,071 | $2,486 |
| Weighted average remaining lease term (in years) | 0.5 | 1.5 | 2.4 |
| Weighted-average discount rate | 10.0% | 10.0% | 10.0% |
Indemnification
In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend an indemnified party for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. The Company has not incurred material costs to defend lawsuits or settle claims related to these indemnification provisions. The Company has also entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers to the fullest extent permitted by Delaware corporate law. The Company currently has directors’ and officers’ insurance.
Other Commitments
The Company has various manufacturing, clinical, research and other contracts with vendors in the conduct of the normal course of its business. Such contracts are generally terminable with advanced written notice and payment for any products or services received by the Company through the effective time of termination and any non-cancelable and non-refundable obligations incurred by the vendor at the effective time of the termination. In the case of terminating a clinical trial agreement at a particular site, the Company would also be obligated to provide continued support for appropriate medical procedures at that site until completion or termination.
- Strategic License and Research and Collaboration Agreements
2015 TSRI License Agreement
In connection with the acquisition of BlackThorn (see Note 6), the Company gained certain exclusive rights to intellectual property related to Kappa Opioid Receptor and V1aR Receptor Antagonist programs as well as an oxytocin receptors positive allosteric modulator program (collectively, the TSRI Programs) under a license agreement between BlackThorn and TSRI originally entered into in November 2015 (as amended, the 2015 TSRI License Agreement). The technology licensed under the 2015 TSRI License Agreement is used in the Company’s navacaprant and NMRA-511 research and development programs.
Pursuant to the 2015 TSRI License Agreement, the Company is obligated, among other things, to pay TSRI (i) a nominal annual license fee due and payable on the first day of each calendar year and after the fourth anniversary creditable against any royalties due for such calendar year, (ii) development and regulatory milestone payments of up to $1.5 million in aggregate for the first product from each TSRI Program, which are contingent upon achieving specific development and regulatory milestone events, (iii) commercial milestone payments of up to $3.5 million in aggregate for each occurrence, which are contingent upon achieving specified commercialization milestone events, (iv) tiered low-single digit royalties on future net sales of each royalty-bearing product and (v) a percentage in the mid-single digits of any sublicensing revenues the Company receives. In October 2023, the Phase 3 navacaprant dosing milestone was met and the Company paid $0.3 million to TSRI, which was recognized in acquired in-process research and developed expenses for the year ended December 31, 2023. None of the other milestones have been achieved andno royalties were due under the 2015 TSRI License Agreement as of December 31, 2024.
Research and Collaboration Agreement with Amgen
In September 2021, and concurrently with the Amgen License Agreements (see Note 6), the Company entered into a research collaboration agreement with Amgen (Amgen Collaboration Agreement) to collectively discover drug targets, biomarkers, and other insights associated with central nervous system (CNS) diseases utilizing Amgen’s deCODE genetics and human data research capabilities. The Company received exclusive rights under intellectual property generated in the collaboration to exploit therapeutic compounds and diagnostics for use with therapeutics in the CNS field and Amgen received exclusive rights to exploit therapeutic compounds and diagnostics for use with therapeutics outside of the CNS field.
In return for Amgen performing research and development activities under the agreement, the Company committed to making non-refundable, non-creditable quarterly payments over the first two years totaling $50.0 million and for the third year $12.5 million. As of December 31, 2024, 2023, and 2022, the related prepaid research and development costs included in the consolidated balance sheets were nil, $6.3 million and $11.9 million, respectively, within prepaid expenses and other current assets. The Company recorded $12.5 million, $24.4 million and $25.1 million of research and development expenses during the years ended December 31, 2024, 2023, and 2022, respectively.
The Amgen Collaboration Agreement automatically terminated upon its third anniversary in September 2024.
Sponsored Research Agreement with Vanderbilt
In February 2022, concurrently with the Vanderbilt License Agreement (see Note 6), the Company entered into a sponsored research agreement with Vanderbilt (Vanderbilt Research Agreement), pursuant to which Vanderbilt agreed to provide the Company research services to develop a M4 PAM back-up program.
In return for Vanderbilt performing research and development activities under the agreement, the Company agreed to make quarterly payments for research up to a total of $1.7 million on an annual basis. The term of the agreement ended in September 2023. In addition, the Company also had an exclusive option to negotiate an exclusive license to certain patent rights conceived or developed by Vanderbilt in the course of carrying out the sponsored research (see Note 6).
In May 2024, concurrently with the Second Amendment to the Vanderbilt License Agreement (see Note 6), the Company entered into a second sponsored research agreement with Vanderbilt (Second Vanderbilt Research Agreement), pursuant to which Vanderbilt agreed to provide the Company additional research and development activities on the M4 PAM back-up program.
In return for Vanderbilt performing research and development activities under the agreement, the Company agreed to make payments for research up to a total of $0.5 million. The term of the agreement ended in November 2024. In addition, the Company also has an exclusive option to negotiate an exclusive license to certain patent rights conceived or developed by Vanderbilt in the course of carrying out the sponsored research (see Note 6).
Parkinson's Research Ventures Funding Agreement
In March 2024, the Company entered into a research funding agreement with Parkinson's Research Ventures Limited (PRV), pursuant to which PRV agreed to provide the Company funding up to a total of $2.6 million in two tranches to carry out preclinical research and development activities related to the Company’s NLPR3 program.
The first tranche was due upon execution of the agreement and was received in March 2024, for $1.1 million. The Company notified PVB of a successful drug candidate nomination, the trigger for the second tranche of funding, in December 2024 and received payment of $1.5 million in January 2025.
The Company concluded the funding arrangement was an obligation to perform services and the funding received is recognized as a contra-R&D expense as project costs are incurred. $0.8 million of costs were incurred during the year ended December 31, 2024. Upon achievement of certain development, regulatory or commercial trigger events, the Company agreed to pay PRV in aggregate an amount equal to no more than four times the funding provided by PRV, i.e., a maximum repayment amount of up to £8.4 million. The trigger event payments meet the derivative scope exception under ASC 815 Derivatives and Hedging, and therefore do not need to be bifurcated and separately accounted for.
- Stockholders’ Equity
Preferred Stock
The Company's board of directors has the authority to issue up to 50,000,000 shares of preferred stock in one or more series with rights, preferences and privileges to be determined. There areno shares of preferred stock issued and outstanding as of December 31, 2024.
Common Stock
Common stock outstanding in the consolidated balance sheet and consolidated statement of convertible preferred stock and stockholders’ equity as of December 31, 2024 includes 404,297 shares of restricted stock that vest based on service conditions and are subject to the Company’s right of repurchase upon termination of services. Common stock reserved for future issuance consisted of the following:
| (in thousands) | |
|---|---|
| Shares reserved for options and restricted stock units issued under the equity plans | 15,814 |
| Shares reserved for future issuance under the equity plans | 19,714 |
| Shares reserved for future issuance under the employee stock purchase plan | 3,064 |
| Total | 38,592 |
In addition, the Company may be required to issue additional shares of its capital stock if certain milestone conditions are met pursuant to the contingent consideration associated with the Company’s acquisitions of assets (see Note 6). In December 2023,6,072,445 shares of common stock were issued related to BlackThorn Merger Agreement upon achievement of the Phase 3 navacaprant dosing milestone that was met in October 2023. As of December 31, 2024, no shares have been reserved for potential future issuances as no other BlackThorn Milestones have been achieved.
- Stock-Based Compensation
Equity Plans
2023 Equity Incentive Plan
In September 2023, the Company adopted the 2023 Equity Incentive Plan (the 2023 Plan). The 2023 Plan provides for the grant of stock options, restricted stock awards, restricted stock unit awards, and other stock-based awards to employees, directors, and non-employee service providers of the Company. The 2023 Plan replaced the Company’s 2020 Equity Incentive Plan (the “2020 Plan”). The Company no longer grants stock options or other awards under its 2020 Plan, but any stock options outstanding under the 2020 Plan remain outstanding and effective in accordance with their terms. Awards granted under the 2023 Plan expire no later thanten years from the date of grant. The price of stock options shall not be less than 100% of the estimated fair value on the date of grant and typically vest over afour-year period although may be granted with different vesting terms.
The 2023 Plan provides for an annual increase, to be added on the first day of each fiscal year, by up to 5% of the Company’s outstanding shares of common stock as of the last day of the prior year. On January 1, 2024, the number of shares of common stock available for issuance under the 2023 Plan increased by 7,941,517 shares as a result of the automatic increase provision of the 2023 Plan.
2023 Employee Share Purchase Plan
In September 2023, the Company adopted the 2023 Employee Share Purchase Plan (the ESPP). The Company may hold one or more offering periods each year during which employees will be able to purchase shares under the 2023 ESPP through payroll deductions made over the term of the offering. The per-share purchase price at the end of each offering period is equal to the lesser of 85% of the closing price of the Company's common stock at the beginning or end of the offering period. On January 1, 2024, the number of shares of common stock available for issuance under the 2023 ESPP increased by 1,588,303 shares as a result of the automatic increase provision of the ESPP. The Company issued 51,704 shares during the year ended December 31, 2024.
Stock Option Activity
| OutstandingStock Options | Weighted-AverageExercisePrice PerShare | Weighted-AverageRemainingContractualTerm (years) | AggregateIntrinsic Value | |
|---|---|---|---|---|
| (in thousands, except per share amounts and years) | ||||
| Outstanding as of December 31, 2023 | 13,783 | $6.39 | 8.7 | $146,966 |
| Granted | 3,710 | 16.10 | ||
| Exercised | (1,957) | 3.82 | ||
| Canceled and forfeited | (1,472) | 7.90 | ||
| Expired | (137) | 3.62 | ||
| Outstanding as of December 31, 2024 | 13,927 | $9.20 | 7.8 | 44,953 |
| Exercisable as of December 31, 2024 | 5,252 | $6.05 | 6.8 | 25,871 |
The stock option activity table above excludes options granted to purchase 446,068 shares of common stock that were originally granted with market conditions to one of the Company’s executives.
The weighted-average fair value of stock options granted was$12.48, $7.77 and $3.77 per share for the years ended December 31, 2024, 2023 and 2022, respectively. The intrinsic value of stock options exercised was $16.7 million, $5.1 million and $1.3 million for the years ended December 31, 2024, 2023 and 2022, respectively. The aggregate grant-date fair value of options vested was$24.6 million, $9.1 million and $5.2 million for the years ended December 31, 2024, 2023 and 2022, respectively.
Fair Value of Stock Options
The fair value of stock options granted for employee and non-employee awards was estimated at the grant date using the Black-Scholes option pricing model based on the following assumptions:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2023 | |
| (in thousands) | |||
| Expected volatility | 91.6% - 97.9% | 89.6% - 96.5% | 87.2% - 91.1% |
| Expected term (years) | 5.27 - 6.08 | 4.0 - 6.1 | 4.5 - 6.5 |
| Risk-free interest rate | 3.5% - 4.6% | 3.4% - 4.9% | 1.7% - 4.2% |
| Expected dividend yield | — | — | — |
Expected volatility—As there is limited trading history for the Company’s common stock, the Company has determined expected volatility based on the average historical stock price volatility of comparable publicly-traded companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. The comparable companies are chosen based on their similar size, stage in the life cycle or area of therapeutic focus. The historical volatility is calculated based on a period of time commensurate with the expected term assumption.
Expected term—The expected term of the Company’s stock options has been estimated using the simplified method for awards that qualify as plain-vanilla stock options. The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the stock options.
Risk-free interest rate—The risk-free interest rate assumption was based on the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award.
Expected dividend yield—The expected dividend yield assumption iszero as the Company has never paid and has no plans to pay dividends on its common stock in the foreseeable future.
Early Exercise of Employee Stock Options
The Company’s Plans allow for certain employees to exercise their stock options prior to vesting into shares of restricted common stock. The proceeds from early exercised stock options are recorded as liabilities in the consolidated balance sheets at the time of exercise and reclassified to common stock and additional paid-in capital as the underlying stock options vest and the Company’s repurchase right lapses. As of December 31, 2024, the Company had issued 1,004,607 shares of restricted common stock upon the early exercise of unvested stock options, of which 848,164 shares had vested and 122,987 unvested shares had been repurchased, such that 33,456 shares or restricted stock remained outstanding and unvested.
Restricted Stock Activity
The Company’s Plans allow for the grant of restricted common stock and restricted stock units to certain employees, executives, non-employee scientific advisors, and third-party service providers. The restrictions lapse over time primarily according to service-based vesting conditions of each award. In the event of a voluntary or involuntary termination of the holder’s continuous provision of services to the Company, any unvested portion of the restricted stock award is automatically forfeited.
The following table summarizes the Company’s restricted stock activity:
| Shares ofRestrictedCommonStock | Weighted-AverageGrant DateFair ValuePer Share | Shares ofRestrictedStockUnits | Weighted-Average GrantDate FairValue PerShare | |
|---|---|---|---|---|
| (in thousands, except per share amounts) | ||||
| Outstanding and unvested as of December 31, 2023 | 840 | $6.11 | 353 | $17.00 |
| Granted | 414 | 14.22 | 1,265 | 17.43 |
| Vested | (620) | 8.59 | (88) | 17.00 |
| Forfeited and expired | — | — | — | — |
| Cancelled | (263) | 6.41 | (89) | 18.07 |
| Outstanding and unvested as of December 31, 2024 | 371 | $10.82 | 1,441 | $17.32 |
Awards with Performance Conditions with the Company's Scientific Advisors
In 2020, the Company approved grants of 892,136 shares of restricted common stock to certain of the Company’s scientific advisors, which vest based on the achievement of performance conditions to be determined and continued service to the Company.
In April 2024, the Company amended the terms of two restricted stock purchase agreements of 127,448 shares each, with performance conditions that had never been set, such that they lapsed in their entirety and become fully vested and unrestricted effective April 1, 2024. The modifications were determined to be improbable-to-probable modifications which resulted in $3.6 million in total expense that was fully recognized during the three months ended June 30, 2024.
Also, in April 2024, the Company revised the vesting schedule for two other restricted stock purchase agreements each consisting of 79,656 shares. These agreements originally had performance condition tranches that had been set but were not probable of being met and were amended to instead vest monthly over three years, subject to continued service. The modification of the performance-based tranches were deemed to be improbable-to-probable modifications. Total compensation cost of $2.3 million, equal to the modification date fair value, will be recognized over the remaining service period.
Additionally, in 2020, the Company approved grants of 700,965 stock options to certain of the Company’s scientific advisors, which vest based on the achievement of performance conditions and continued service to the Company. In December 2022 and January 2023, the Company’s board of directors established performance conditions for 337,738 stock options and 63,724 stock options, respectively, such that the criteria for establishing a grant date, and accordingly a measurement date, were met for these performance stock options and the remaining 299,503 stock options with performance conditions to be established were cancelled in July 2023 because certain of the Company’s scientific advisors were terminated.
As of December 31, 2024 the performance conditions for all restricted common stock and stock options were established, amended or cancelled.
Stock-Based Compensation
The following table summarizes total stock-based compensation included in the Company’s consolidated statements of operations and comprehensive loss:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| Research and development | $17,662 | $8,067 | $4,252 |
| General and administrative | 22,328 | 9,173 | 4,046 |
| Total stock-based compensation | $39,990 | $17,240 | $8,298 |
As of December 31, 2024, there was$70.3 million and$23.6 million of unrecognized stock-based compensation related to stock options and restricted stock outstanding, respectively, which were expected to be recognized over a weighted-average remaining service period of 2.1 years and 2.8 years, respectively.
- Income Taxes
A reconciliation of the Company's federal income tax rate and effective income tax rate is summarized as follows:
| Year Ended December 31, | ||||||
|---|---|---|---|---|---|---|
| 2024 · 2023 · 2022 | ||||||
| (in thousands) | ||||||
| Federal income taxes | 21.0 | % | 21.0 | % | 21.0 | % |
| State income taxes, net of federal benefit | 3.7 | 2.8 | 3.7 | |||
| Milestone payments | — | (5.3) | — | |||
| Permanent differences | (0.1) | (0.3) | (0.5) | |||
| Research and development tax credits | 6.4 | 1.9 | 1.8 | |||
| Transaction costs | 0.7 | — | — | |||
| Executive compensation | (1.3) | (0.6) | — | |||
| Tax law change | (2.9) | 3.6 | — | |||
| State rate adjustment | — | 0.5 | 2.2 | |||
| Valuation allowance | (27.6) | (23.7) | (28.2) | |||
| Effective income tax rate | (0.1) | % | (0.1) | % | — | % |
Deferred tax assets and liabilities reflect the net tax effects of net operating loss and tax credit carryforwards and temporary differences between the carrying amount of assets and liabilities for financial reporting and the amounts used for tax purposes. Significant components of the Company’s deferred tax assets and liabilities are summarized as follows:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Deferred tax assets: | ||
| Net operating losses | $112,075 | $79,117 |
| Capitalized license agreements | 34,699 | 41,032 |
| Capitalized research and development expense | 81,544 | 57,872 |
| Research and development credits | 28,716 | 12,981 |
| Compensation related | 6,887 | 5,942 |
| Operating lease liabilities | 465 | 1,429 |
| Other | 531 | 407 |
| Total deferred tax assets | 264,917 | 198,780 |
| Less: valuation allowance | (264,379) | (197,280) |
| Total deferred tax assets less valuation allowance | 538 | 1,500 |
| Deferred tax liabilities: | ||
| Operating lease right-of-use assets | (446) | (1,385) |
| Fixed assets | (92) | (115) |
| Total deferred tax liabilities | (538) | (1,500) |
| Net deferred tax assets | $— | $— |
The Company determines its valuation allowance on deferred tax assets by considering both positive and negative evidence in order to ascertain whether it is more likely than not that deferred tax assets will be realized. Realization of deferred tax assets is dependent upon the generation of future taxable income, if any, the timing, and amount of which are uncertain. Due to the Company’s recent history of operating losses, the Company believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not likely to be realized and, accordingly, has provided a valuation allowance on its deferred tax assets. The valuation allowance increased by $67.1 million and $55.7 million for the years ended December 31, 2024 and 2023, respectively, primarily due to the increase in the Company’s net operating losses (NOL) during the periods and deferred tax assets related to capitalized research and development expenses.
NOLs and tax credit carryforwards as of December 31, 2024, were as follows (in thousands):
| Amount | Expiration Years | |
|---|---|---|
| NOLs, federal (post-December 31, 2017) | $401,749 | Indefinite (1) |
| NOLs, federal (pre-January 1, 2018) | 40,370 | 2034 through 2036 |
| NOLs, state | 345,972 | 2034 thru 2044 |
| Research and development tax credits, federal | 27,262 | 2034 thru 2044 |
| Research and development tax credits, California | 6,334 | Indefinite |
| Research and development tax credits, Massachusetts | 1,237 | 2034 thru 2039 |
(1) NOL carryforward generated after 2017 which can be carried forward indefinitely and can generally be used to offset up to 80% of future taxable income
Utilization of the NOL carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986, as amended (Section 382) due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not conducted a study to assess whether a change of control has occurred, including changes of control associated with the acquisitions of assets. Any limitation may result in expiration of a portion of the NOL carryforwards or research and development tax credit carryforwards before utilization; however, such limitation, if any, would not have an impact on the Company’s financial statement due to the full valuation.
Uncertain Tax Positions
A reconciliation of the beginning and ending balance of total gross unrecognized tax benefits is as follows:
| December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| Beginning balance of unrecognized tax benefits | $8,664 | $8,176 | $7,821 |
| Gross increase based on tax positions related to current year | 1,805 | 391 | 355 |
| Gross increase (decrease) based on tax positions related to prior years | (788) | 97 | — |
| Ending balance of unrecognized tax benefits | $9,681 | $8,664 | $8,176 |
The unrecognized tax benefits, if recognized, would not have an impact on the Company’s effective tax rate assuming the Company continues to maintain a full valuation allowance position. As of December 31, 2024, no significant increases or decreases are expected to the Company’s uncertain tax positions within the next twelve months.
The Company files income tax returns in the United States, and the states of California and Massachusetts. Due to net operating loss carryforwards, all years effectively remain open for income tax examination by tax authorities in the United States and states in which the Company files tax returns.
- Net Loss Per Share
The following table summarizes the computation of basic and diluted net loss per share:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands, except per share amounts) | |||
| Numerator: | |||
| Net loss | $(243,787) | $(235,925) | $(130,904) |
| Denominator: | |||
| Weighted-average common shares outstanding, basic and diluted | 159,377 | 65,021 | 27,207 |
| Net loss per share, basic and diluted | $(1.53) | $(3.63) | $(4.81) |
The following outstanding potentially dilutive common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive:
| December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| Convertible preferred stock | — | — | 104,417 |
| Common stock options and restricted stock units | 15,814 | 14,582 | 8,570 |
| Performance stock options (with performance conditions to be established) | — | — | 363 |
| Early exercised stock options subject to future vesting | 33 | 64 | 532 |
| Unvested restricted stock awards | 371 | 840 | 2,902 |
| Performance restricted stock (with performance conditions to be established) | — | 255 | 510 |
| Employee stock purchase plan | 10 | — | — |
| Total | 16,228 | 15,741 | 117,294 |
- Segment Reporting
Operating segments are defined as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker (CODM), or decision-making group, in making decisions on how to allocate resources and assess performance. The Company views its operations and manages its business inone operating segment related to the development of clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. The Company’s Chief Executive Officer (CEO) serves as the CODM.
The CEO manages and allocates resources to the operations of the Company on a consolidated basis. Managing and allocating resources on a consolidated basis enables the CEO to assess the overall level of resources available and how to best deploy these resources across functions and research and development projects that are in line with the Company’s strategic goals. Consistent with this decision-making process, the CEO uses consolidated financial information for purposes of evaluating performance, cash forecasting, allocating resources and setting incentive targets. The CEO bases this assessment on the Company’s consolidated net loss. Through this analysis, the CEO assesses performance by comparing budget to actual results, and then decides how to allocate resources to invest in the Company’s research and development programs. The measure of segment assets is reported on the consolidated balance sheets as total assets.
The table below is a summary of the segment loss, including significant segment expenses (in thousands):
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Program expenses | |||
| Navacaprant (NMRA-140) program | $(105,442) | $(37,929) | $(9,685) |
| M4 PAM programs | (11,041) | (11,507) | (4,601) |
| NMRA-511 program | (7,236) | (6,588) | (860) |
| Preclinical programs | (5,776) | (10,622) | (11,597) |
| Research and development personnel-related costs | (47,036) | (36,789) | (27,445) |
| General and administrative expense | (62,537) | (45,475) | (31,121) |
| Acquired in-process research and development | — | (63,904) | (13,000) |
| Interest income | 19,933 | 16,611 | 4,561 |
| Other segment items(1) | (24,652) | (39,722) | (37,156) |
| Net loss | $(243,787) | $(235,925) | $(130,904) |
(1) Includes other research and development costs, provision for income taxes, and other income (expense)
- Related Party Transactions
The Amgen Collaboration Agreement expired in September 2024. As of December 31, 2023, the Company was obligated to pay Amgen $3.1 million which was recorded within current liabilities and $6.3 million related to amounts prepayable to Amgen were recorded as prepaid expenses and other current assets on the condensed consolidated balance sheets. During the twelve months ended December 31, 2024, 2023, and 2022, the Company recorded $12.5 million, $24.4 million, and $25.1 million respectively, of research and development expenses with Amgen.
- Defined Contribution Plan
The Company sponsors a 401(k) Plan whereby eligible employees can elect to contribute to the 401(k) Plan, subject to certain limitations, on a pretax basis. Effective from January 1, 2022, the Company commenced matching employee contributions at a rate of 50%, with a maximum matching employer contribution of up to 3% of employee contributions.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.