Acumen Pharmaceuticals, Inc. 10-K

Item 8. Financial Statements and Supplementary Data. ACUMEN PHARMACEUTICALS, INC. INDEX TO FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 ) 90 Balance Sheets as of December 31, 2023 and 2022 91 Statements of Operations and Comprehensive Loss for the years ended December 31, 2023 and 2022 92 Statements of Changes in Stockholders’ Equity for the years ended December 31, 2023 and 2022 93 Statements of Cash Flows for the years ended December 31, 2023 and 2022 94 Notes to Financial Statements 95 89 Table of Contents Report of Independent Registered Public Accounting Firm To the Shareholders and the Board of Directors of Acumen Pharmaceuticals, Inc. Opinion on the Financial Statements We have audited the accompanying balance sheets of Acumen Pharmaceuticals, Inc. (the Company) as of December 31, 2023 and 2022, the related statements of operations and comprehensive loss, changes in stockholders’ equity and cash flows for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with U.S. generally accepted accounting principles. Basis for Opinion These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion. /s/ Ernst & Young LLP We have served as the Company’s auditors since 2021. Tysons, Virginia March 26, 2024 90 Table of Contents ACUMEN PHARMACEUTICALS, INC. BALANCE SHEETS (in thousands, except share and per share data) December 31, 2023 2022 ASSETS Current assets Cash and cash equivalents $ 66,886 $ 130,101 Marketable securities, short-term 176,636 47,504 Prepaid expenses and other current assets 3,093 2,724 Total current assets 246,615 180,329 Marketable securities, long-term 62,553 15,837 Restricted cash 233 — Property and equipment, net 122 165 Right-of-use asset 381 105 Other assets 221 151 Total assets $ 310,125 $ 196,587 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable $ 1,379 $ 1,640 Accrued clinical trial expenses 4,387 2,717 Accrued expenses and other current liabilities 6,339 3,350 Finance lease liability, short-term 756 — Operating lease liability, short-term 110 105 Total current liabilities 12,971 7,812 Operating lease liability, long-term 284 — Debt, long-term 29,897 — Total liabilities 43,152 7,812 Commitments and contingencies (Note 11) Stockholders’ equity Preferred stock, $ 0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding as of December 31, 2023 and 2022 — — Common stock, $ 0.0001 par value; 300,000,000 shares authorized as of December 31, 2023 and 2022; 57,910,461 and 41,025,062 shares issued and outstanding as of December 31, 2023 and 2022, respectively 6 4 Additional paid-in capital 489,453 359,949 Accumulated deficit ( 222,798 ) ( 170,427 ) Accumulated other comprehensive income (loss) 312 ( 751 ) Total stockholders’ equity 266,973 188,775 Total liabilities and stockholders’ equity $ 310,125 $ 196,587 The accompanying notes are an integral part of these financial statements. 91 Table of Contents ACUMEN PHARMACEUTICALS, INC. STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share data) Year Ended December 31, 2023 2022 Operating expenses Research and development $ 42,318 $ 32,361 General and administrative 18,820 12,876 Total operating expenses 61,138 45,237 Loss from operations ( 61,138 ) ( 45,237 ) Other income (expense) Interest income 10,791 2,392 Change in fair value of embedded derivatives ( 1,360 ) — Interest expense ( 581 ) — Other expense, net ( 83 ) ( 11 ) Total other income 8,767 2,381 Net loss ( 52,371 ) ( 42,856 ) Other comprehensive gain (loss) Unrealized gain (loss) on marketable securities 1,063 ( 520 ) Comprehensive loss $ ( 51,308 ) $ ( 43,376 ) Net loss per common share, basic and diluted $ ( 1.08 ) $ ( 1.06 ) Weighted-average shares outstanding, basic and diluted 48,609,383 40,601,936 The accompanying notes are an integral part of these financial statements. 92 Table of Contents ACUMEN PHARMACEUTICALS, INC. STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (in thousands, except share data) Common Stock Additional Paid-in Capital Accumulated Deficit Accumulated Other Comprehensive Income (Loss) Total Stockholders’ Equity Shares Amount Balance as of January 1, 2022 40,473,270 $ 4 $ 352,981 $ ( 127,571 ) $ ( 231 ) $ 225,183 Issuance of common stock for cash, net of issuance costs of $ 412 422,160 — 3,792 — — 3,792 Unrealized loss on marketable securities — — — — ( 520 ) ( 520 ) Stock options exercised for cash 124,886 — 115 — — 115 Cashless exercise of stock options 4,746 — — — — — Stock-based compensation — — 3,061 — — 3,061 Net loss — — — ( 42,856 ) — ( 42,856 ) Balance as of December 31, 2022 41,025,062 4 359,949 ( 170,427 ) ( 751 ) 188,775 Issuance of common stock for cash, net of issuance costs of $ 8,096 16,774,193 2 121,902 — — 121,904 Stock options exercised for cash 111,206 — 325 — — 325 Issuance of warrant with Term Loan — — 1,132 — — 1,132 Unrealized gain on marketable securities — — — — 1,063 1,063 Stock-based compensation — — 6,145 — — 6,145 Net loss — — — ( 52,371 ) — ( 52,371 ) Balance as of December 31, 2023 57,910,461 $ 6 $ 489,453 $ ( 222,798 ) $ 312 $ 266,973 The accompanying notes are an integral part of these financial statements. 93 Table of Contents ACUMEN PHARMACEUTICALS, INC. STATEMENTS OF CASH FLOWS (in thousands) Year Ended December 31, 2023 2022 Cash flows from operating activities Net loss $ ( 52,371 ) $ ( 42,856 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 61 32 Stock-based compensation expense 6,145 3,061 Amortization of premiums and accretion of discounts on marketable securities, net ( 3,121 ) 487 Change in fair value of embedded derivatives 1,360 — Amortization of right-of-use asset 123 137 Non-cash research and development expense 739 — Realized gain on marketable securities ( 11 ) — Non-cash interest expense 145 — Changes in operating assets and liabilities: Prepaid expenses and other current assets ( 369 ) 1,700 Other assets ( 70 ) ( 137 ) Accounts payable ( 261 ) 552 Accrued clinical trial expenses 1,670 2,570 Accrued expenses and other current liabilities 2,989 ( 562 ) Finance lease liability 17 — Operating lease liability ( 110 ) ( 137 ) Net cash used in operating activities ( 43,064 ) ( 35,153 ) Cash flows from investing activities Purchases of marketable securities ( 250,634 ) ( 41,514 ) Proceeds from maturities and sales of marketable securities 78,981 80,860 Proceeds from sale of property and equipment 3 — Purchases of property and equipment ( 21 ) ( 161 ) Net cash provided by (used in) investing activities ( 171,671 ) 39,185 Cash flows from financing activities Proceeds from issuance of common stock, net of issuance costs 121,904 3,792 Proceeds from Term Loan 30,000 — Payments for financing costs ( 476 ) — Proceeds from exercise of stock options 325 115 Net cash provided by financing activities 151,753 3,907 Net change in cash and cash equivalents and restricted cash ( 62,982 ) 7,939 Cash and cash equivalents and restricted cash at the beginning of the period 130,101 122,162 Cash and cash equivalents and restricted cash at the end of the period $ 67,119 $ 130,101 Supplemental disclosure of cash flow information Cash paid for income taxes $ — $ — Cash paid for interest $ 169 $ — Supplemental disclosure of noncash financing activities Right-of-use assets obtained in exchange for finance lease liabilities $ 739 $ — Right-of-use assets obtained in exchange for operating lease liabilities $ 399 $ 242 Issuance of warrant with Term Loan $ 1,132 $ — The accompanying notes are an integral part of these financial statements. 94 Table of Contents ACUMEN PHARMACEUTICALS, INC. NOTES TO FINANCIAL STATEMENTS NOTE 1. DESCRIPTION OF ORGANIZATION AND BUSINESS OPERATIONS Acumen Pharmaceuticals, Inc. (“Acumen” or the “Company”) was incorporated in 1996 in the state of Delaware. Acumen is a clinical-stage biopharmaceutical company developing a novel disease-modifying approach to target what the Company believes to be a key underlying cause of Alzheimer’s disease (“AD”). Alzheimer’s disease is a progressive neurodegenerative disease of the brain that leads to loss of memory and cognitive functions and ultimately results in death. The Company’s scientific founders pioneered research on soluble amyloid-beta oligomers (“AßOs”), which are globular assemblies of the amyloid-beta (“Aß”) peptide that are distinct from Aß monomers and amyloid plaques. Based on decades of research and supporting evidence, AßOs have gained increasing scientific acceptance as a primary toxin involved in the initiation and propagation of AD pathology. The Company is currently focused on advancing a targeted immunotherapy drug candidate, sabirnetug, in clinical development following Phase 1 results in “early AD” patients (patients with mild cognitive impairment or mild dementia due to Alzheimer’s pathology) that were reported in July 2023. Sabirnetug is a recombinant humanized immunoglobulin gamma 2 (“IgG2”) monoclonal antibody (“mAb”) that was designed to selectively target AßOs , has demonstrated functional and protective effects in in vitro assays, and has demonstrated in vivo safety and pharmacologic activity in multiple animal species, including transgenic mouse models for AD. The Company is subject to the uncertainty of whether its intellectual property will develop into successful commercial products. Public Offering On July 21, 2023, the Company issued 16,774,193 shares of its common stock, $ 0.0001 par value per share (“Common Stock”), in a public offering (the “Offering”) at a price of $ 7.75 per share. The aggregate net proceeds from the Offering, after underwriting discounts and commissions and other offering expenses, were $ 121.9 million. See additional discussion in Note 8. Stockholders’ Equity. Liquidity and Capital Resources The Company has incurred operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of December 31, 2023 and 2022, the Company had an accumulated deficit of $ 222.8 million and $ 170.4 million, respectively, and working capital of $ 233.6 million and $ 172.5 million, respectively. During 2023, the Company received cash from the Offering and borrowings with net proceeds of $ 29.5 million under a term loan facility (see Note 6. Debt ). Management believes that the Company has sufficient cash to continue operating activities for beyond 12 months from issuance of these financial statements. Future capital requirements will depend upon many factors, including the timing and extent of spending on research and development and market acceptance of the Company’s products, if approved for commercial sale. The Company expects that it will need to obtain additional financing to complete clinical trials and launch and commercialize any product candidates for which it receives regulatory approval. Until such time, if ever, as the Company can generate revenue sufficient to achieve profitability, the Company expects to finance its operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. There can be no assurance that any such financing will be available on terms acceptable to the Company, or at all. To the extent that the Company raises additional capital through the sale of equity or convertible debt securities, the ownership interest of its stockholders will be diluted, and the terms of these securities may include liquidation of other preferences that adversely affect the rights of common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting the Company’s ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends. If the Company is unable to maintain sufficient financial resources, its business, financial condition and results of operations will be materially and adversely affected. The Company may be required to delay, limit, reduce or terminate its product discovery and development activities or future commercialization efforts. The Company completed a Phase 1 clinical trial of sabirnetug in the second quarter of 2023, which the Company named “INTERCEPT-AD.” This trial enrolled 65 patients with “early AD” and 62 participants received at least one dose of study drug. INTERCEPT-AD was a U.S.-based, multi-center, randomized, double-blind, placebo-controlled clinical trial with overlapping single ascending dose and multiple ascending dose cohorts evaluating patients with early AD. In July 2023, the 95 Table of Contents Company announced topline results from INTERCEPT-AD, which demonstrated that sabirnetug met the primary and secondary objectives of this study in 62 participants with early AD . The Company expects to initiate a Phase 2 clinical trial of sabirnetug called “ALTITUDE-AD” in the first half of 2024. NOTE 2. BASIS OF PRESENTATION, SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND RECENT ACCOUNTING PRONOUNCEMENTS Basis of Presentation The accompanying financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). In the opinion of management, all adjustments (consisting of normal recurring adjustments) have been made that are necessary to present fairly the Company’s financial position, and the results of its operations and its cash flows. Emerging Growth Company From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial statements upon adoption. Under the Jumpstart Our Business Startups Act of 2012, as amended, the Company meets the definition of an emerging growth company and has elected to use the extended transition period for complying with new or revised accounting standards, which delays the adoption of these accounting standards until they would apply to private companies. 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 of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting periods. These estimates and assumptions are based on the Company’s historical experience, and on various other factors that management believes are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. The more significant estimates and assumptions by management include, among others: the valuation allowance of deferred tax assets resulting from net operating losses, the valuation of stock options, the valuation of the warrant to purchase Common Stock and the valuation of embedded derivatives within the Company’s debt, long-term. Cash and Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with an original maturity of three months or less at the date of purchase to be cash equivalents. All of the Company’s cash equivalents have liquid markets and high credit ratings. The Company had $ 66.2 million and $ 129.1 million in cash equivalents as of December 31, 2023 and 2022, respectively. Restricted cash primarily consists of deposited cash collateral for the Company’s credit card program. 96 Table of Contents The following table provides a reconciliation of cash, cash equivalents and restricted cash from the balance sheets to the statements of cash flows (in thousands): December 31, 2023 2022 Cash and cash equivalents $ 66,886 $ 130,101 Restricted cash 233 — Total cash, cash equivalents and restricted cash $ 67,119 $ 130,101 Marketable Securities The Company’s marketable securities portfolio consists primarily of investments in money market funds, asset-backed securities, U.S. treasury and agency securities and short-term highly liquid, high credit quality corporate debt securities. The Company considers its marketable securities to be available-for-sale. Available-for-sale securities are classified as cash equivalents, or as short-term or long-term marketable securities based on the maturity date at the time of purchase and their availability to meet current operating requirements. Available-for-sale securities that mature in three months or less from the date of purchase are classified as cash equivalents. Available-for-sale securities, excluding cash equivalents, that mature in one year or less are classified as short-term marketable securities and those that mature in more than one year are classified as long-term. Securities that are classified as available-for-sale are measured at fair value; see “ Fair Value of Financial Instruments ” below. Any premium arising at purchase is amortized to the earliest call date and any discount arising at purchase is accreted to maturity. Amortization of premiums and accretion of discounts are recorded along with interest income on investments in interest income, net in the statements of operations and comprehensive loss. Unrealized gains and losses are excluded from earnings and are reported as a component of other comprehensive income. The cost of investments sold will be calculated using the specific-identification method. For securities available-for-sale, Accounting Standards Update 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments eliminates the concept of other-than-temporary impairment and instead requires entities to determine if impairment is related to credit loss or non-credit loss. In making the assessment of whether a loss is from credit or other factors, management considers the extent to which fair value is less than amortized cost, any changes to the rating of the security by a rating agency and adverse conditions related to the security, among other factors. If this assessment indicates that a credit loss exists, 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 is less than the amortized cost basis, a credit loss exists and an allowance is created, limited by the amount that the fair value is less than the amortized cost basis. Subsequent activity related to the credit loss component in the form of write-offs or recoveries is recognized as part of the allowance for credit losses on securities available-for-sale. The Company has made the accounting policy election to exclude accrued interest receivable on securities from the estimate of credit losses and will record a credit loss expense for accrued interest receivable in the period when a credit loss is recorded for the related securities. Management determined that t he Company did not require an allowance for credit losses for available-for-sale securities as of December 31, 2023 or 2022, as only a small number of investments had a present value of cash flows expected to be collected in excess of the amortized cost, and the aggregate amount of this credit loss was immaterial. The Company did not have any related write-offs or recoveries for the years ended December 31, 2023 and 2022. Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company maintains deposits in financial institutions in excess of government insured limits. Management believes that the Company is not exposed to significant credit risk as the Company’s cash and cash equivalents are held at financial institutions that management believes to be of high credit quality. The Company has not experienced any losses due to credit risk on such accounts during any of the periods presented. 97 Table of Contents Fair Value of Financial Instruments The Company’s financial assets and liabilities are accounted for in accordance with Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures , which defines fair value as the exchange price that would be received for 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 on the measurement date. The fair value hierarchy requires an entity to maximize the use of observable inputs when measuring fair value and classifies those inputs into three levels: Level 1 — Observable inputs, such as quoted prices in active markets for identical assets or liabilities. Level 2 — Inputs other than Level 1 inputs that are either directly or indirectly observable, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the instrument’s anticipated life. Level 3 — Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. To the extent the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair values requires more judgment. Accordingly, the degree of judgment exercised by management in determining fair value is greatest for instruments categorized as 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 measurement. There were no transfers made among the three levels in the fair value hierarchy for the years ended December 31, 2023 and 2022 . The carrying values reported in the balance sheets for cash (excluding cash equivalents which are recorded at fair value on a recurring basis), restricted cash, accounts payable, accrued clinical trial expenses and accrued expenses are reasonable estimates of their fair values due to the short-term nature of these items. The carrying amount of the Company’s long-term debt approximates fair value due to its variable market interest rate and management’s opinion that current rates and terms that would be available to the Company with the same maturity and security structure would be essentially equivalent to that of the Company’s long-term debt. Certain features of the term loan were determined to be an embedded derivative requiring separate measurement from the loan host instrument. Property and Equipment Property and equipment are stated at cost. Depreciation expense is computed using the straight-line method over the estimated useful lives of the assets, including leasehold improvements and finance lease right-of-use assets that are amortized over the shorter of their estimated useful lives or the terms of the respective leases. The Company generally uses the following useful lives for its property and equipment categories: three years for computer-related assets and five years for furniture. See Note 7. Leases for additional discussion regarding our finance lease for computer equipment . Leases The Company accounts for its leases under ASC 842, Leases . Under this guidance, arrangements meeting the definition of a lease are classified as operating or finance leases and are recorded in the balance sheet at the commencement date as both a right-of-use asset and a lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and right-of-use assets are amortized over the lease term, or, for finance leases, over the shorter of the lease term or the estimated useful life of the assets. For operating leases, interest on the lease liability and the amortization of the right-of-use asset results in straight-line rent expense over the lease term. For finance leases, the right-of-use asset is amortized on a straight-line basis and the amortization is presented as an operating expense separately from interest expense on the lease liability. Variable lease expenses are recorded when incurred and not included in the measurement of right-of-use assets and lease liabilities. ASC 842 provides practical expedients for an entity’s ongoing accounting. In calculating right-of-use assets and lease liabilities, the Company has elected to combine lease and non-lease components for real estate leases, but has not elected to combine lease and non-lease components for computer equipment leases. Additionally, the Company has elected not to 98 Table of Contents recognize a right-of-use asset or lease liability for leases with an initial term of 12 months or less. For short-term leases, the Company recognized lease payments on a straight-line basis over the lease term. Debt Discount and Debt Issuance Costs The debt discount, which reduces the related debt balance in the balance sheets, is comprised of debt issuance costs, contractual fees due upon repayment of the debt, the issuance date fair value of warrants issued with the debt and the issuance date fair value of any derivatives that are bifurcated from the debt. Debt issuance costs include direct costs (e.g., legal costs and bank fees) incurred to issue non-revolving debt instruments. The debt discount is amortized to interest expense over the contractual term of the related debt using the effective interest method. Embedded Derivatives The Company evaluates embedded derivatives within debt to determine whether the embedded derivatives should be bifurcated from the host instrument and accounted for as a derivative at fair value that will be remeasured at each reporting period for the term of the loan, with changes in fair value recorded in the statements of operations and comprehensive loss. Management initially assesses the probability of the occurrence of trigger events for bifurcated embedded derivatives in determining fair value. The probability is reassessed at each reporting period during the term of a loan. Common Stock Warrant The Company assesses whether warrants issued require accounting as derivatives. The Company determined that its warrant to purchase Common Stock is not a liability within the scope of ASC 480, Distinguishing Liabilities from Equity , but met the requirements to be classified within stockholders’ equity, as the warrant is indexed to the Company’s own stock and met all of the conditions for equity classification in accordance with ASC 815, Derivatives and Hedging . Research and Development Expenses Research and development (“R&D”) expenses primarily consist of consultants and materials, biologic storage, salaries and other personnel-related expenses related to R&D activities and are expensed as incurred. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected on the balance sheets as prepaid or accrued expenses. The Company records accruals for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies, including the phase or completion of events, invoices received and contracted costs. Clinical trial costs are a significant component of R&D expenses and include costs associated with third-party contractors. The Company accrues and expenses costs for clinical trial activities performed by third parties based upon the work completed to date for each clinical trial in accordance with established agreements. The Company determines its costs through discussions with internal clinical stakeholders and outside service providers as to the progress or stage of completion of clinical trials or services and the contracted fee to be paid for such services. In the event advance payments are made to an outside service provider, the payments are recorded within prepaid expenses and other current assets in the balance sheets and subsequently recognized as R&D expense in the statements of operations and comprehensive loss when the associated services have been performed. As actual costs become known, the Company adjusts its estimates, liabilities and assets. Inputs used in the determination of estimates discussed above may vary from actual, which will result in adjustments to R&D expense in future periods. Stock-based Compensation The Company expenses stock-based compensation to employees, non-employees and board members over the requisite service period based on the estimated grant date fair value of the awards and actual forfeitures. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model, which requires the use of a number of complex assumptions including the fair value of the Common Stock, expected volatility, risk-free interest rate, expected dividends, and the expected term of the option. The fair value of restricted stock units (“RSUs”) is the closing market price of the Common Stock on the date of the grant. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. Stock-based awards with graded-vesting schedules are recognized on a straight-line basis over the requisite service period. 99 Table of Contents All stock-based compensation costs are recorded in research and development expense or general and administrative expense in the Statements of Operations and Comprehensive Loss based upon the respective employee’s or non-employee’s roles within the Company. Forfeitures are recorded as they occur. See also Note 9. Stock-based Compensation below. Income Taxes Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse, and net operating loss (“NOL”) carryforwards and R&D tax credit carryforwards. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company has recorded a full valuation allowance to reduce its net deferred income tax assets to zero . In the event the Company were to determine that it would be able to realize some or all of its deferred income tax assets in the future, an adjustment to the deferred income tax asset valuation allowance would increase income in the period such determination was made. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit would more likely than not be realized assuming examination by the taxing authority. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. The Company has not recorded any liabilities related to uncertain tax positions as of December 31, 2023 and 2022. The Company’s policy is to record interest and penalties, if any, as part of income tax benefit. No interest or penalties were recorded during the years ended December 31, 2023 and 2022. Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share of common stock includes the effect, if any, from the potential exercise or conversion of securities, such as convertible debt, stock options, restricted stock units and warrants, which would result in the issuance of incremental shares of common stock. However, potential shares of common stock are excluded if their effect is anti-dilutive. For diluted net loss per share, the weighted-average number of shares of common stock is the same for basic net loss per share due to the fact that when a net loss exists, dilutive securities are not included in the calculation as the impact is anti-dilutive. For the year ended December 31, 2023, potential common shares consisted of stock options, restricted stock units, convertible debt and a warrant to purchase Common Stock. For the year ended December 31, 2022, potential shares of common stock consisted of stock options. Potentially dilutive securities not included in the calculation of diluted net loss per share of common stock as of the periods presented, because to do so would be anti-dilutive, were as follows: December 31, 2023 2022 Shares issuable upon exercise of stock options 7,523,947 5,610,893 Shares issuable upon conversion election for Term Loan 988,142 — Shares issuable upon exercise of warrant 730,769 — Unvested RSUs 328,500 — Total 9,571,358 5,610,893 Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one segment. 100 Table of Contents Recently Adopted Accounting Pronouncements In June 2016, the FASB issued Accounting Standards Update 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which was codified with its subsequent amendments as ASC 326. ASC 326 seeks to provide financial statement users with more decision-useful information about the expected credit losses on financial instruments, including trade receivables, and other commitments to extend credit held by a reporting entity at each reporting date. The amendments require an entity to replace the incurred loss impairment methodology in current U.S. GAAP with a methodology that reflects current expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The Company adopted this guidance on January 1, 2023. The Company’s marketable securities portfolio consists entirely of available-for-sale debt securities and, as such, the adoption of this guidance did not have a material impact on its financial statements and disclosures upon adoption, but it did require the Company to provide additional disclosures related to its available-for-sale debt securities in a continuous unrealized loss position. In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470- 20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”), to address the complexity associated with applying U.S. GAAP to certain financial instruments with characteristics of liabilities and equity. ASU 2020-06 includes amendments to the guidance on convertible instruments and the derivative scope exception for contracts in an entity’s own equity and simplifies the accounting for convertible instruments, which include beneficial conversion features or cash conversion features by removing certain separation models in Subtopic 470-20. Additionally, ASU 2020-06 requires entities to use the “if-converted” method when calculating diluted earnings per share for convertible instruments. The Company early adopted this guidance on January 1, 2023, with no impact to the financial statements or results of operations of the Company. NOTE 3. MARKETABLE SECURITIES The Company’s marketable securities consisted of the following (in thousands): December 31, 2023 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Available-for-sale securities, short-term Corporate debt securities $ 144,184 $ 97 $ ( 191 ) $ 144,090 Government and agency - U.S. securities 32,470 82 ( 6 ) 32,546 Total available-for-sale securities, short-term 176,654 179 ( 197 ) 176,636 Available-for-sale securities, long-term Corporate debt securities 57,240 320 ( 15 ) 57,545 Government and agency - U.S. 4,985 23 — 5,008 Total available-for-sale securities, long-term 62,225 343 ( 15 ) 62,553 Total available-for-sale securities $ 238,879 $ 522 $ ( 212 ) $ 239,189 101 Table of Contents December 31, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Available-for-sale securities, short-term Corporate debt securities $ 30,174 $ — $ ( 249 ) $ 29,925 Government and agency - U.S. securities 15,032 — ( 357 ) 14,675 Asset-backed securities 3,006 — ( 102 ) 2,904 Total available-for-sale securities, short-term 48,212 — ( 708 ) 47,504 Available-for-sale securities, long-term Corporate debt securities 15,880 — ( 43 ) 15,837 Total available-for-sale securities, long-term 15,880 — ( 43 ) 15,837 Total available-for-sale securities $ 64,092 $ — $ ( 751 ) $ 63,341 The following tables summarize the amount of unrealized losses, defined as the amount by which the amortized cost exceeds fair value, and the related fair value of available-for-sale marketable securities with unrealized losses, which have been segregated into two categories: those that have been in a continuous unrealized loss position for less than 12 months and those that have been in a continuous unrealized loss position for 12 or more months (in thousands): December 31, 2023 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses Corporate debt securities $ 78,995 $ ( 152 ) $ 12,074 $ ( 54 ) $ 91,069 $ ( 206 ) Government and agency - U.S. securities 5,585 ( 6 ) — — 5,585 ( 6 ) Total $ 84,580 $ ( 158 ) $ 12,074 $ ( 54 ) $ 96,654 $ ( 212 ) December 31, 2022 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Losses Fair Value Unrealized Losses Fair Value Unrealized Losses Corporate debt securities $ 29,515 $ ( 58 ) $ 16,247 $ ( 234 ) $ 45,762 $ ( 292 ) Asset-backed securities — — 2,904 ( 102 ) 2,904 ( 102 ) Government and agency - U.S. securities 3,026 ( 7 ) 11,649 ( 350 ) 14,675 ( 357 ) Total $ 32,541 $ ( 65 ) $ 30,800 $ ( 686 ) $ 63,341 $ ( 751 ) As of December 31, 2023, the Company’s available-for-sale securities classified as short-term mature in one year or less and the Company’s available-for-sale securities classified as long-term mature within two years . As noted in the table above, although some of the Company’s available-for-sale marketable securities as of December 31, 2023 have been in an unrealized loss position for more than 12 months, the Company does not intend to sell these securities and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity. No credit losses were recognized on the Company’s available-for-sale securities during the years ended December 31, 2023 and 2022. The Company recorded an immaterial realized gain during the year ended December 31, 2023 and had no realized gains or losses during the year ended December 31, 2022. 102 Table of Contents NOTE 4. FAIR VALUE MEASUREMENTS The Company’s financial assets and liabilities subject to fair value measurement on a recurring basis and the level of inputs used for such measurements were as follows (in thousands): Fair value measurements at reporting date using Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Fair Value at December 31, 2023 Assets included in: Cash and cash equivalents Money market securities $ 66,207 $ — $ — $ 66,207 Marketable securities Corporate debt securities — 201,635 — 201,635 U.S. treasury securities — 37,554 — 37,554 Total fair value $ 66,207 $ 239,189 $ — $ 305,396 Liabilities included in: Debt, long-term Embedded derivative liabilities $ — $ — $ 2,560 $ 2,560 Total fair value $ — $ — $ 2,560 $ 2,560 Fair value measurements at reporting date using Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Fair Value at December 31, 2022 Assets included in: Cash and cash equivalents Money market securities $ 129,100 $ — $ — $ 129,100 Marketable securities Corporate debt securities — 45,762 — 45,762 Asset-backed securities — 2,904 — 2,904 Government and agency - U.S. — 14,675 — 14,675 Total fair value $ 129,100 $ 63,341 $ — $ 192,441 The fair value of the Company’s money market funds is determined using quoted market prices in active markets for identical assets. The fair value for the available-for-sale marketable securities is determined based on valuation models using inputs that are observable either directly or indirectly (Level 2 inputs), such as quoted prices for similar assets or liabilities, yield curve, volatility factors, credit spreads, default rates, loss severity, current market and contractual prices for the underlying instruments or debt, broker and dealer quotes, as well as other relevant economic measures. 103 Table of Contents The following table presents changes in Level 3 liabilities measured at fair value for the year ended December 31, 2023 (in thousands): Balance, January 1, 2023 $ — Fair value of embedded derivatives at issuance of Term Loan 1,200 Change in fair value of embedded derivatives 1,360 Balance, December 31, 2023 $ 2,560 For the year ended December 31, 2023, the fair value of the embedded derivatives in the Term Loan has been estimated using the Monte Carlo model. A summary of the weighted-average significant unobservable inputs (Level 3 inputs) used in measuring the embedded derivatives in the Term Loan as of December 31, 2023 and November 10, 2023 (inception) is as follows: December 31, November 10, 2023 2023 Conversion price $ 2.53 $ 2.53 Expected term (in years) 4.7 4.9 Expected equity volatility 106.7 % 102.5 % Risk-free interest rate 3.9 % 4.7 % Discount for lack of marketability 11.5 % 9.5 % Expected dividend yield 0 % 0 % NOTE 5. SUPPLEMENTAL FINANCIAL INFORMATION Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2023 2022 Research and development service agreements $ 1,680 $ 1,077 Prepaid insurance 807 1,106 Interest receivable 225 — Dues and subscriptions 175 105 Prepaid raw materials 98 199 Other 108 237 Total prepaid expenses and other current assets $ 3,093 $ 2,724 Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2023 2022 Compensation and other employee liabilities $ 3,692 $ 2,008 Research and development 2,186 1,211 Interest 249 — Other 212 131 Total accrued expenses and other current liabilities $ 6,339 $ 3,350 104 Table of Contents NOTE 6. DEBT Term Loan On November 10, 2023, the Company entered into a Loan and Security Agreement with K2 HealthVentures LLC (the “Loan Agreement”). The Loan Agreement provided the Company with a term loan facility (the “Term Loan”) in the aggregate principal amount of $ 50.0 million, of which the Company borrowed $ 30.0 million in the first tranche upon closing. The remaining $ 20.0 million is available for borrowing upon the Company’s request based on review of certain information and discretionary approval from the lenders. The Loan Agreement bears interest per annum at the greater of 9.65 % or the sum of the prime rate last quoted in The Wall Street Journal plus 1.15 % for such interest period and the principal amount of Term Loan outstanding under the Loan Agreement. The Term Loan matures on November 1, 2027, and can be extended to November 1, 2028, if the Company achieves certain financing milestones. The Loan Agreement provides for a final payment fee of an additional $ 1.6 million (the “Final Payment”) due upon repayment of the Term Loan. The principal and interest of the Term Loan are to be repaid in equal monthly installments beginning on July 1, 2026 through the maturity of the Loan Agreement. The Loan Agreement allows prepayments of the entire Term Loan or a portion of the Term Loan of more than $ 5.0 million, provided that any partial prepayment will leave outstanding borrowings of at least $ 15.0 million. The lenders can elect to convert up to $ 2.5 million of the Term Loan (the “Conversion Amount”) to Common Stock at a conversion price of $ 2.53 (the “Conversion Option”). If the lenders elect to convert the Conversion Amount upon the Next Qualified Financing, as defined in the Loan Agreement whereby the Company receives aggregate gross proceeds of at least $ 20.0 million, the conversion price will equal the lowest effective cash price per share of securities issued in such Qualified Financing (the “Share-Settled Redemption”). The Conversion Option and Share-Settled Redemption within the Loan Agreement are required to be bifurcated as a single compound embedded derivative (the “Embedded Derivatives”) at fair value, with subsequent changes in fair value recognized in the statements of operations and comprehensive loss. In accordance with the Loan Agreement, the Company issued an equity-classified warrant to purchase 730,769 shares of Common Stock (the “Loan Warrant”), with an initial allocated fair value of $ 1.1 million. See additional discussion in Note 8. Stockholders’ Equity. The initial recognition of the direct fees of $ 0.5 million, the Final Payment of $ 1.6 million, the fair value of the Embedded Derivatives of $ 1.2 million and the fair value of the Loan Warrant of $ 1.1 million for the Loan Agreement resulted in a discount of $ 4.4 million, which is being amortized to interest expense over the term of the Loan Agreement using the effective interest method. Outstanding debt consisted of the following (in thousands): December 31, 2023 Principal value of Term Loan, including final payment of $ 1,635 $ 31,635 Fair value of bifurcated embedded derivatives 2,560 Unamortized debt discount ( 4,298 ) Total debt, long-term $ 29,897 The following table provides the components of interest expense (in thousands): Year Ended December 31, 2023 Interest expense based on the coupon interest rate of the outstanding debt $ 418 Accretion of debt discount 145 Total interest expense $ 563 For the year ended December 31, 2023, the effective interest rate for the Term Loan was 14.3 %. 105 Table of Contents As of December 31, 2023, the aggregate principal payments due for the Term Loan by year are as follows (in thousands): Year ended December 31, 2026 $ 10,104 Year ended December 31, 2027 21,531 Total principal payment due for Term Loan $ 31,635 NOTE 7. LEASES Office leases On September 11, 2023, the Company entered into a lease for office space in Newton, Massachusetts, with a lease term of approximately 38 months beginning October 20, 2023, and which expires on December 31, 2026. On September 28, 2022, the Company entered into a lease for office space in Charlottesville, Virginia with a lease term of 15 months beginning October 1, 2022. On December 1, 2022, the Company entered into a lease for additional office space in the same building in Charlottesville, Virginia with a lease term of 12 months beginning on January 1, 2023. There is no automatic renewal for either of the Charlottesville, Virginia leases, but the lease agreements provide that any holdover tenancy shall be on a month-to-month basis thereafter. The Company had been subleasing space in Carmel, Indiana since March 1, 2020. The Company executed a new sublease for this space that was effective on February 1, 2021 and expired on August 30, 2023, at which time the Company ceased to occupy this space. The Company allowed others to sublease a portion of the space from the Company for less than a one-year period. The Company recognizes sublease income in other expense, net in the statements of operations and comprehensive Loss. Computer Equipment Lease In September 2023, the Company entered into an agreement with a vendor that included the lease of certain computer equipment for its planned Phase 2 clinical trial with an October 2023 lease commencement date. In January 2024, the Company paid $ 0.8 million for the computer equipment which will be returned to the vendor at the completion of the vendor’s services under the agreement. Upon the lease inception, the Company recorded non-cash expense of $ 0.7 million in research and development expense in the statement of operations and comprehensive loss for the right-of-use assets related to the computer equipment lease as the equipment is being used for R&D and does not have an alternative future use. The following table summarizes quantitative information about the Company’s leases (in thousands): Year Ended December 31, 2023 2022 Finance lease Interest lease cost $ 17 $ — Finance lease expense 17 — Operating leases Operating lease cost 133 154 Less: sublease income ( 5 ) ( 43 ) Operating lease expense 128 111 Short-term lease rent expense 15 13 Total rent expense $ 160 $ 124 106 Table of Contents Supplemental information related to leases was as follows (dollar amounts in thousands): Year Ended December 31, 2023 2022 Operating cash flows from finance lease $ 17 $ — Operating cash flows from operating leases $ 121 $ 154 Right-of-use assets obtained in exchange for finance lease liabilities $ 739 $ — Right-of-use assets obtained in exchange for operating lease liabilities $ 399 $ 242 Noncash research and development expense for the right-of-use assets (finance lease) $ 739 — Weighted-average remaining lease term – finance leases (in years) 3.8 — Weighted-average remaining lease term – operating leases (in years) 3.0 0.7 Weighted-average discount rate – finance leases 9.7 % — Weighted-average discount rate – operating leases 9.7 % 10.0 % As of December 31, 2023, the present value of maturities of the Company’s finance lease liabilities were as follows (in thousands): Year ended December 31, 2024 $ 763 Total 763 Less: present value discount ( 7 ) Finance lease liability $ 756 As of December 31, 2023, the present value of maturities of the Company’s operating lease liabilities were as follows (in thousands): Year ended December 31, 2024 $ 143 Year ended December 31, 2025 155 Year ended December 31, 2026 158 Total 456 Less: present value discount ( 63 ) Operating lease liability $ 393 NOTE 8. STOCKHOLDERS’ EQUITY Authorized Shares As of December 31, 2023, the total number of shares of capital stock authorized to be issued per the Company’s Amended and Restated Certificate of Incorporation is 310,000,000 , with 10,000,000 shares designated as preferred stock with a par value of $ 0.0001 , and 300,000,000 shares designated as Common Stock. Each share of Common Stock issued and outstanding is entitled to one vote. Public Offering On July 21, 2023, the Company issued 16,774,193 shares of its Common Stock in a public offering (the “Offering”) at a price of $ 7.75 per share. The aggregate net proceeds from the Offering, after underwriting discounts and commissions and other offering expenses, were $ 121.9 million. 107 Table of Contents Shelf Registration and At-The-Market Equity Offering On July 1, 2022, the Company filed a shelf registration statement on Form S-3 (the “Registration Statement”). Pursuant to the Registration Statement, the Company may offer and sell securities having an aggregate public offering price of up to $ 200.0 million. In connection with the filing of the Registration Statement, the Company also entered into a sales agreement (the “Sales Agreement”) with BofA Securities, Inc. (“BofA”) and Stifel, Nicolaus & Company, Incorporated (“Stifel”), as sales agents, pursuant to which the Company may issue and sell shares of its Common Stock for an aggregate offering price of up to $ 50.0 million under an at-the-market offering program (the “ATM”), which is included in the $ 200.0 million of securities that may be offered pursuant to the Registration Statement. On April 23, 2023, the Company entered into an amendment to the Sales Agreement (as amended, the “Amended Sales Agreement”) to add BTIG, LLC (“BTIG”) as a sales agent under the Amended Sales Agreement (BTIG, together with BofA and Stifel, the “Sales Agents”). Pursuant to the Amended Sales Agreement, the Company will pay the Sales Agents a commission rate of up to 3.0 % of the gross proceeds from the sale of any shares of Common Stock. The Company is not obligated to make any sales of shares of its common stock under the ATM. The Company did not sell any shares of its Common Stock under the ATM during the year ended December 31, 2023. In October 2022, the Company issued 422,160 shares of common stock under the ATM for net proceeds of $ 3.8 million, at a weighted average price of $ 10.06 per share. See additional discussion in Note 12. Subsequent Events. Common Stock Warrant On November 10, 2023, in accordance with the Loan Agreement, the Company issued the Loan Warrant to purchase 730,769 shares of Common Stock at an exercise price of $ 1.95 with a ten-year contractual term and an allocated fair value of $ 1.1 million. This warrant is outstanding as of December 31, 2023. In accordance with ASC 815, the Loan Warrant issued in 2023 did not meet the definition of a derivative and was classified in stockholders’ equity in the balance sheet. The Black-Scholes option-pricing model was used to estimate the fair value of the warrant on November 10, 2023 with the following weighted average assumptions: Risk-free interest rate 4.6 % Contractual term (in years) 10 Expected volatility 98.4 % Expected dividend yield 0 % NOTE 9. STOCK-BASED COMPENSATION 2021 Equity Incentive Plan The 2021 Equity Incentive Plan (the “2021 Plan”), which provides for the grant of incentive stock options to employees, and the grant of nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance awards and other forms of stock awards to employees, directors and consultants, became effective on June 30, 2021. The 2021 Plan is a successor to the Company’s Amended and Restated Stock Performance Plan that was adopted by the Company’s board of directors (“Board”) and stockholders on April 8, 2013 (as amended from time to time, most recently on November 20, 2020, the “2013 Plan”). Following the effectiveness of the 2021 Plan, no further grants may be made under the 2013 Plan; however, any outstanding equity awards granted under the 2013 Plan continue to be governed by the 2013 Plan. As of December 31, 2023, there were 3,231,274 options outstanding under the 2013 Plan. The number of shares of Common Stock reserved for issuance under the 2021 Plan automatically increases on January 1 of each calendar year through January 1, 2031, in an amount equal to 5 % of the total number of shares of Common Stock outstanding on December 31 of the fiscal year before the date of each automatic increase, or a lesser number of shares determined by the Board prior to the applicable January 1. On January 1, 2023, the number of shares of Common Stock reserved for issuance under the 2021 Plan automatically increased by 2,051,253 shares. The maximum number of shares of Common Stock that may be issued upon the exercise of incentive stock options under the 2021 Plan is 12,000,000 . As of December 31, 2023, 11,773,198 shares were authorized for issuance under the 2021 Plan and 3,674,730 shares remained available for issuance under the 2021 Plan. 108 Table of Contents The Company recorded stock-based compensation expense related to stock options and RSUs in the following expense categories of the statements of operations and comprehensive loss for the periods shown (in thousands): Year Ended December 31, 2023 2022 General and administrative $ 4,288 $ 2,163 Research and development 1,857 898 Total stock-based compensation $ 6,145 $ 3,061 Stock Options The Black-Scholes option-pricing model was used to estimate the fair value of stock options granted during the years ended December 31, 2023 and 2022 with the following weighted average assumptions: Year Ended December 31, 2023 2022 Risk-free interest rate 3.5 % – 4.7 % 1.7 % – 4.2 % Expected term (in years) 5.5 – 6.1 5.8 – 6.1 Expected volatility 90 % - 98 % 90 % Expected dividend yield 0 % 0 % The weighted average grant date fair value of options granted during the years ended December 31, 2023 and 2022 was $ 4.38 per share and $ 3.79 per share, respectively. Stock options granted after December 31, 2017 generally vest monthly over a range of 12 to 48 months or vest monthly over a total of 48 months following a one-year cliff and all have a ten-year contractual term. During the year ended December 31, 2023, the Company also issued option awards to members of its Board that vest in full on the first anniversary of the grant date. Stock options granted prior to December 31, 2017 were either fully vested upon grant or generally vested monthly over a range of three to 24 months and have a ten-year term. The Company became publicly traded in July 2021 and lacks sufficient company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility using a weighted average blend of historical volatility of a publicly traded set of peer companies, as well as its own historical volatility. Due to the lack of historical exercise history, the expected term of the Company’s stock options has been determined using the “simplified” method for awards. The risk-free interest rate is determined by reference to 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 is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The following table reflects summarized stock option activity: Stock Options Weighted Average Exercise Price Weighted Average Remaining Contractual Life (in years) Aggregate Intrinsic Value (in thousands) Outstanding at January 1, 2023 5,610,893 $ 3.36 Granted 2,045,000 $ 5.76 Exercised ( 111,206 ) $ 2.92 Forfeited ( 14,489 ) $ 2.88 Expired ( 6,251 ) $ 8.33 Outstanding at December 31, 2023 7,523,947 $ 4.01 7.7 $ 9,004 Vested and exercisable at December 31, 2023 4,021,147 $ 3.17 7.1 $ 7,055 109 Table of Contents The intrinsic value of stock options exercised during the years ended December 31, 2023 and 2022 was approximately $ 0.5 million and $ 0.6 million, respectively. As of December 31, 2023, total unrecognized compensation costs related to unvested stock option awards granted was approximately $ 12.3 million, which the Company expects to recognize over a weighted-average period of approximately 2.2 years. Restricted Stock Units In January 2023, the Company granted a RSU award to each of its then-current employees. These RSU awards vest in equal annual installments on the first three anniversaries of the grant date. Number of Shares Weighted Average Grant Date Fair Value Unvested as of January 1, 2023 — $ — Granted 328,500 $ 6.11 Unvested at December 31, 2023 328,500 $ 6.11 As of December 31, 2023, total unrecognized compensation costs related to unvested RSUs was approximately $ 1.4 million, which the Company expects to recognize over a weighted-average period of approximately 2.1 years. Employee Stock Purchase Plan The 2021 Employee Stock Purchase Plan (the “ESPP”), which permits employees to purchase shares of Common Stock, became effective on June 30, 2021. The number of shares of Common Stock reserved for issuance automatically increases on January 1 of each calendar year through January 1, 2031, by the lesser of (1) 1 % of the total number of shares of Common Stock outstanding on the last day of the fiscal year before the date of the automatic increase, and (2) 800,000 shares; provided that before the date of any such increase, the Board may determine that such increase will be less than the amount set forth in clauses (1) and (2). On January 1, 2023, the number of shares of Common Stock reserved for issuance under the ESPP automatically increased by 410,251 shares. As of December 31, 2023, there are a total of 1,189,983 shares authorized for issuance and there have been no purchases of shares under the ESPP. NOTE 10. INCOME TAXES The Company has not recorded any tax provision or benefit for federal income taxes for the years ended December 31, 2023 and 2022. Current income taxes are based upon the year’s income taxable for federal and state tax reporting purposes. Deferred income taxes (benefits) are provided for certain income and expenses, which are recognized in different periods for tax and financial reporting purposes. Deferred tax assets and liabilities are computed for differences between the financial statements and tax bases of assets and liabilities that will result in taxable or deductible amounts in the future based on enacted tax laws and rates applicable to the period in which the differences are expected to affect taxable income, and NOL and R&D tax credit carryforwards. A reconciliation of the expected tax computed at the U.S. statutory federal income tax rate to the total benefit for income taxes for the years ended December 31, 2023 and 2022 is as follows: Year Ended December 31, 2023 2022 Statutory federal income tax rate 21.0 % 21.0 % State tax, net of federal benefit 2.5 2.7 Non-deductible stock compensation ( 0.4 ) ( 0.5 ) Rate change ( 0.1 ) ( 1.1 ) Other ( 0.5 ) — Change in valuation allowance ( 22.5 ) ( 22.1 ) Income tax provision 0.0 % 0.0 % 110 Table of Contents Significant components of the Company’s deferred tax assets as of December 31, 2023 and 2022 were as follows (in thousands): December 31, 2023 2022 Deferred tax assets: Net operating loss $ 16,555 $ 13,125 Capitalized R&D 13,328 6,788 Stock compensation 1,849 675 R&D credit 1,350 1,381 Intangible assets 441 — Accruals and other temporary differences 575 179 Gross deferred tax assets 34,098 22,148 Valuation allowance ( 33,661 ) ( 22,118 ) Total deferred tax assets 437 30 Deferred tax liabilities: Embedded debt derivative liabilities ( 274 ) — Other ( 163 ) — Depreciation — ( 30 ) Total deferred tax liabilities ( 437 ) ( 30 ) Net deferred tax assets $ — $ — In assessing the realizability of deferred tax assets as of December 31, 2023 and 2022, management considered whether it is more likely than not that some portion or all of the deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible or the net operating loss (“NOL”) carryforwards and R&D tax credit carryforwards will be used. The Company has determined that it is not more likely than not that its deferred tax assets will be realized. Accordingly, a valuation allowance for the full amount of the net deferred tax assets has been recorded as of December 31, 2023 and 2022. The change in the valuation allowance as of December 31, 2023 from December 31, 2022 is due to the pretax loss incurred for the year ended December 31, 2023. As of December 31, 2023, the Company had approximately $ 67.2 million of NOL carryforwards available for federal tax purposes. As a result of the Tax Act of 2017, for U.S. income tax purposes, NOLs generated prior to December 31, 2017 can still be carried forward for up to 20 years, but NOLs generated after December 31, 2017 carryforward indefinitely, but are limited to 80% utilization against taxable income. Of the total federal NOLs of $ 67.2 million, $ 6.5 million will begin to expire on December 31, 2028 and $ 60.7 million will not expire. As of December 31, 2023, the Company also had approximately $ 46.9 million of state NOL carryforwards. The state NOLs begin to expire on December 31, 2028. As of December 31, 2023, the Company had approximately $ 1.4 million of R&D credit carryforwards available for federal tax purposes, which begin to expire on December 31, 2024. Utilization of the NOL and R&D credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations that may have occurred or that could occur in the future, as required by Sections 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), as well as similar state provisions. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change” as defined by Section 382 of the Code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50% of the outstanding stock of a company by certain stockholders. The Company has not completed a formal analysis of the potential impact of Section 382 on its deferred tax assets as of December 31, 2023. Until this analysis has been completed, the Company has 111 Table of Contents not adjusted any of its deferred tax assets, including NOLs or R&D credits. The Company will reassess the amount of NOLs and credits subject to limitation under Section 382 when a study is complete. Due to the existence of the valuation allowance, future changes in the deferred tax assets related to these tax attributes will not impact the Company’s effective tax rate. The Company is subject to U.S. federal and various state taxes. Generally, the tax years remain open for examination by the federal statute under a three-year statute of limitation; however, states generally keep their statutes open for four years. However, the Company’s tax years from 2004 and after are subject to examination by the United States and state taxing authorities due to the carry forward of unused NOLs and R&D credits. NOTE 11. COMMITMENTS AND CONTINGENCIES The Company is not a party to any material legal proceedings and is not aware of any pending or threatened claims. From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of its business activities. In November 2023, the Company entered into a Non-exclusive Collaboration and License Agreement (the “Halozyme License Agreement”) with Halozyme, Inc. (“Halozyme”). Under the terms of the Halozyme License Agreement, Halozyme granted the Company a non-exclusive license to Halozyme’s drug delivery technology for the development of a subcutaneous formulation of sabirnetug (such combination, the “Halozyme Product”). For the year ended December 31, 2023, the Company recorded R&D expense with an offsetting accrual in accrued expenses and other current liabilities as of December 31, 2023, for the majority of the seven-figure upfront license payment for the Halozyme Product (the “Upfront Payment”), as the Halozyme Product is in its development stage and does not have an alternative future use. See Note 12. Subsequent Events for more information regarding the Upfront Payment. Additionally, the Company will make milestone payments tied to achievement of certain development and commercialization milestone events with respect to the Halozyme Product, as well as milestone payments based on achievement of certain net sales levels of the Halozyme Product. The Company will also make single-digit royalty payments based on worldwide net sales of the Halozyme Product. In November 2022, the Company entered into a License Agreement (“Lonza License Agreement”) with Lonza Sales AG (“Lonza”). Under the terms of the Lonza License Agreement, Lonza granted the Company a worldwide non-exclusive license to use Lonza’s glutamine synthetase gene expression system to manufacture and commercialize sabirnetug (the “Lonza Product”). Under the terms of the Lonza License Agreement, in consideration of the licenses and consents granted to the Company, the Company paid an upfront fee of 1.0 million Swiss Francs. The Company is also required to pay certain royalties upon commercialization and annual payments on a country-by-country basis in respect of the manufacturing and sale of the Lonza Product, which include (i) a royalty of less than 1 % on net sales where Lonza manufactures the Lonza Product, (ii) an annual royalty payment in Swiss Francs in the low six-digits and a royalty of less than 1 % on net sales where the Company manufactures the Lonza Product and (iii) an annual payment in Swiss Francs in the mid six-digits per sublicense and a royalty on net sales in the low single digits where a third party manufactures the Lonza Product. These payment obligations would expire ten years from the first commercial sales of the Lonza Product in such country of sale. NOTE 12. SUBSEQUENT EVENTS In January 2024, the Company issued 2,068,246 shares of Common Stock under the ATM for net proceeds of $ 7.9 million, or $ 3.84 per share. In January 2024, the Company paid the seven-figure Upfront Payment for the Halozyme Agreement. See Note 11. Commitments and Contingencies for additional information. 112 Table of Contents Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure. None.