ARS Pharmaceuticals, Inc. 10-K

Item 8. Financial Statements and Supplementary Data Page Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 ) 116 Consolidated Balance Sheets 117 Consolidated Statements of Operations and Comprehensive Loss 118 Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) 119 Consolidated Statements of Cash Flows 120 Notes to Financial Statements 121 115 Report of Independent Registered Public Accounting Firm To the Stockholders and the Board of Directors of ARS Pharmaceuticals, Inc. Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of ARS Pharmaceuticals, Inc. (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations and comprehensive loss, convertible preferred stock and stockholders’ equity (deficit) 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 “consolidated financial statements”). In our opinion, the consolidated 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 auditor since 2019. San Diego, California March 21, 2024 116 ARS Pharmaceuticals, Inc. CONSOLIDATED BALANCE SHEETS (In thousands, except par value and share amounts) December 31, 2023 December 31, 2022 Assets Current assets: Cash and cash equivalents $ 70,971 $ 210,518 Short-term investments 157,389 63,863 Prepaid expenses and other current assets 3,366 3,319 Total current assets 231,726 277,700 Right-of-use asset 250 445 Fixed assets, net 574 329 Other assets 638 2,961 Total assets $ 233,188 $ 281,435 Liabilities, convertible preferred stock and stockholders’ equity Current liabilities: Accounts payable and accrued liabilities (including related party amounts of $ 178 and $ 16 , respectively) $ 2,154 $ 4,931 Lease liability, current 237 230 Contract liability, current — 283 Total current liabilities 2,391 5,444 Lease liability, net of current portion 37 251 Contract liability, net of current portion — 2,854 Total liabilities 2,428 8,549 Commitments and contingencies (Note 7) Stockholders’ equity Preferred stock, $ 0.0001 par value per share; 10,000,000 shares authorized at December 31, 2023 and 2022; no shares issued and outstanding at December 31, 2023 and 2022 — — Common stock, $ 0.0001 par value per share; 200,000,000 shares authorized at December 31, 2023 and 2022; 96,414,963 and 93,943,316 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively 10 9 Additional paid-in capital 362,004 349,408 Accumulated other comprehensive gain, net 49 407 Accumulated deficit ( 131,303 ) ( 76,938 ) Total stockholders’ equity 230,760 272,886 Total liabilities, convertible preferred stock and stockholders’ equity $ 233,188 $ 281,435 The accompanying notes are an integral part of these financial statements. 117 ARS Pharmaceuticals, Inc. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share information) Year Ended December 31, 2023 2022 Revenue under collaboration agreements $ 30 $ 1,316 Operating expenses: Research and development (including related party amounts of $ 1,796 and $ 2,144 , respectively) 20,266 18,376 General and administrative (including related party amounts of $ 940 and $ 603 , respectively) 47,284 18,456 Total operating expenses 67,550 36,832 Loss from operations ( 67,520 ) ( 35,516 ) Other income, net 13,155 974 Change in fair value of financial instruments — ( 140 ) Net loss $ ( 54,365 ) $ ( 34,682 ) Change in unrealized gains and losses on available-for-sale securities ( 358 ) 407 Comprehensive loss $ ( 54,723 ) $ ( 34,275 ) Net loss per share, basic and diluted $ ( 0.57 ) $ ( 0.87 ) Weighted-average shares outstanding used in computing net loss per share, basic and diluted 95,215,322 39,956,043 The accompanying notes are an integral part of these financial statements. 118 ARS Pharmaceuticals, Inc. CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) (In thousands, except share amounts) Series A Convertible Preferred Stock Series B Convertible Preferred Stock Series C Convertible Preferred Stock Series D Convertible Preferred Stock Common Stock Shares Amount Shares Amount Shares Amount Shares Amount Shares Amount Additional Paid-in Capital Accumulated Other Comprehensive Gain, Net Accumulated Deficit Total Stockholders’ Equity Balance at December 31, 2021 4,764,000 $ 365 606,060 $ 1,000 7,692,309 $ 19,868 9,337,066 $ 54,806 30,369,413 $ 3 $ 10,984 $ — $ ( 42,256 ) $ ( 31,269 ) Conversion of preferred stock to common stock as a result of the Merger ( 4,764,000 ) ( 365 ) ( 606,060 ) ( 1,000 ) ( 7,692,309 ) ( 19,868 ) ( 9,337,066 ) ( 54,806 ) 26,473,899 3 76,036 — — 76,039 Issuance of common stock to Silverback stockholders as a result of the Merger — — — — — — — — 36,535,541 3 255,758 — — 255,761 Reclassification of warrant liability to equity — — — — — — — — — — 223 — — 223 Exercise of common stock options, shares issued under the employee stock purchase plan, and release of restricted stock units — — — — — — — — 564,463 — 564 — — 564 Stock-based compensation — — — — — — — — — — 5,843 — — 5,843 Net loss and comprehensive loss — — — — — — — — — — — 407 ( 34,682 ) ( 34,275 ) Balance at December 31, 2022 — $ — — $ — — $ — — $ — 93,943,316 $ 9 $ 349,408 $ 407 $ ( 76,938 ) $ 272,886 Exercise of common stock options, shares issued under the employee stock purchase plan, and release of restricted stock units — — — — — — — — 2,471,647 1 6,899 — — 6,900 Stock-based compensation — — — — — — — — — — 9,347 — — 9,347 Removal of retrospective insurance policy acquired in the Merger — — — — — — — — — — ( 3,650 ) — — ( 3,650 ) Net loss and comprehensive loss — — — — — — — — — — — ( 358 ) ( 54,365 ) ( 54,723 ) Balance at December 31, 2023 — $ — — $ — — $ — — $ — 96,414,963 $ 10 $ 362,004 $ 49 $ ( 131,303 ) $ 230,760 The accompanying notes are an integral part of these financial statements 119 ARS Pharmaceuticals, Inc. CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) Year Ended December 31, 2023 2022 Cash flows from operating activities: Net loss $ ( 54,365 ) $ ( 34,682 ) Non-cash adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 9,235 5,843 Acquired in-process research and development — 1,056 Depreciation 73 34 Amortization and accretion, net ( 6,878 ) 285 Change in fair value of warrant liability — 140 Changes in operating assets and liabilities: Prepaid and other assets ( 1,435 ) ( 1,186 ) Donation of equipment 30 — Accounts payable and accrued liabilities (including related party amounts of $ 162 and $( 143 ), respectively) ( 2,777 ) ( 10,285 ) Operating right-of-use assets and lease liabilities, net ( 12 ) 33 Contract liability ( 3,137 ) ( 1,316 ) Net cash used in operating activities ( 59,266 ) ( 40,078 ) Cash flows from investing activities: Purchases of short-term investments, available-for-sale ( 272,005 ) — Maturities of short-term investments, available-for-sale 185,000 — Purchase of property and equipment ( 175 ) ( 199 ) Net cash used in investing activities ( 87,180 ) ( 199 ) Cash flows from financing activities: Cash proceeds from the Merger, net of transaction costs — 198,843 Proceeds from exercise of common stock options and employee stock purchase plan 6,899 570 Repayment of bank note payable — ( 8,681 ) Net cash provided by financing activities 6,899 190,732 Net change in cash and cash equivalents ( 139,547 ) 150,455 Cash and cash equivalents at beginning of period 210,518 60,063 Cash and cash equivalents at end of period $ 70,971 $ 210,518 Supplemental cash flow information: Conversion of Series A, B, C, and D convertible preferred stock to common stock $ — $ 76,039 Short-term investments assumed in the Merger $ — $ 63,473 Prepaid expense and other current assets assumed in the Merger $ — $ 4,404 Accounts payable and accrued liabilities assumed in the Merger $ — $ 12,017 Reclassification of warrant liability to equity $ — $ 223 Interest paid $ — $ 366 Removal of retrospective insurance policy acquired in the Merger, included in prepaid and other current assets and other assets, and related reduction in additional paid in capital $ 3,649 $ — Purchases of property and equipment included in accounts payable $ — $ 91 Purchases of property and equipment reclassed from prepaid expenses and other current assets $ 174 $ — The accompanying notes are an integral part of these financial statements. 120 ARS Pharmaceuticals, Inc. Notes to Financial Statements 1. Nat ure of Business Description of Business ARS Pharmaceuticals, Inc. (“ARS”, “ARS Pharma” or the “Company”) is focused on the development of ARS-1 (brand name neffy ), a proprietary product candidate for the needle-free intranasal delivery of epinephrine for the emergency treatment of Type I allergic reactions including anaphylaxis. The Company incorporated in Delaware in January 2016 and is located in San Diego, California. The Company has a wholly owned subsidiary, ARS Pharmaceuticals Operations, Inc., incorporated in Delaware in August 2015, through which it conducts substantially all its operations. ARS Pharmaceuticals Operations, Inc. has a wholly owned subsidiary in Ireland, ARS Pharmaceuticals IRL, Limited, to facilitate the filing of regulatory approval for neffy in European countries. Merger Transaction On November 8, 2022 (the “Closing Date”), Silverback Therapeutics, Inc., a Delaware corporation (“Silverback”), now known as ARS Pharmaceuticals, Inc., completed its reverse merger (the “Merger”) with privately-held ARS Pharma, in accordance with the terms of the agreement and plan of merger and reorganization, dated July 21, 2022, as amended on August 11, 2022 and October 25, 2022 (the “Merger Agreement”), whereby Sabre Merger Sub, Inc. (“Merger Sub”), a Delaware corporation and wholly-owned subsidiary of Silverback, merged into ARS Pharma, with ARS Pharma surviving as Silverback’s wholly-owned subsidiary. ARS Pharma was renamed ARS Subsidiary, Inc., and then subsequently renamed ARS Pharmaceuticals Operations, Inc. At the effective time of the Merger (the “Effective Time”), each share of ARS Pharma common stock outstanding immediately prior to the Effective Time, after giving effect to the automatic conversion of all shares of preferred stock of ARS Pharma into shares of ARS Pharma common stock immediately prior to the Effective Time (excluding shares held as treasury stock by ARS Pharma or held or owned by Silverback, Merger Sub or any subsidiary of Silverback or ARS Pharma and dissenting shares), was automatically converted into the right to receive shares of Silverback common stock equal to the exchange ratio of 1.1819 . At the completion of the Merger, the prior ARS Pharma equityholders owned 62 % and the prior Silverback equityholders owned 38 % of the combined company, in each case on a fully diluted basis using the treasury stock method and excluding out-of-money options of Silverback. The Merger was accounted for as a reverse recapitalization, with ARS Pharma being treated as the acquirer for accounting purposes. Pursuant to the Merger Agreement, Silverback changed its name to ARS Pharmaceuticals, Inc., and changed its corporate ticker symbol on the Nasdaq Global Market to “SPRY”. See discussions of the transactions in connection with the Merger at Note 3 - Merger and Related Transactions . Liquidity and Capital Resources The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company has incurred net operating losses since its inception and had an accumulated deficit of $ 131.3 million as of December 31, 2023. The Company had cash, cash equivalents, and short-term investments of $ 228.4 million as of December 31, 2023 and has not generated positive cash flows from operations. To date, the Company has funded its operations primarily with proceeds from the Merger, the issuance of convertible preferred stock, payments earned under collaboration agreements and bank debt. The Company’s currently available cash, cash equivalents, and short-term investments as of December 31, 2023 are sufficient to meet its anticipated cash requirements for at least the 12 months following the date these financial statements are issued. From August 5, 2015 (inception) through December 31, 2023, the Company has devoted substantially all of its efforts to developing intellectual property, conducting product development and clinical trials, raising capital, and building infrastructure. The Company has a limited operating history, and the sales and income potential of the Company’s business and market are unproven. If the Company does not successfully commercialize any product candidates for which it receives regulatory approval, it will be unable to generate recurring product revenue or achieve profitability. Management expects operating expenses to increase for the foreseeable future and there can be no assurance that the Company will ever achieve profitability, or if achieved, that it will be sustained on a continuing basis. The Company’s ability to raise additional capital may be adversely impacted should the global economic conditions worsen or as a result of further disruptions to, and volatility in, the credit and financial markets in the United States, including bank failures, future health epidemics or pandemics, geopolitical actions or other macroeconomic factors. If such further disruption occurs, the Company could experience an inability to access additional capital. If the Company is not able to secure adequate additional funding, it may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations, and future prospects. 121 Reduction in Force On September 19, 2023, the FDA issued a CRL regarding our NDA for neffy . On September 29, 2023, we initiated a 20 % reduction in force (“RIF”) in order to conserve our cash resources and manage operating expenses until the anticipated PDUFA target action date in the middle of the second half of 2024. We provided severance payments, continuation of group health insurance coverage, and other benefits for a specified period to the affected employees. We incurred costs of $ 0.6 million for termination benefits resulting from the RIF, of which $ 0.1 million remains accrued for as of December 31, 2023. 2. Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”), and Accounting Standards Update (“ASU”), of the Financial Accounting Standards Board (“FASB”). The Company’s financial statements are presented on a consolidated basis, which include the accounts of ARS Pharmaceuticals, Inc., ARS Pharmaceuticals Operations, Inc. and ARS Pharmaceuticals IRL, Limited. All intercompany accounts and transactions have been eliminated in consolidation. The Company’s functional and reporting currency is the U.S. dollar. Assets and liabilities that are not denominated in the functional currency are remeasured into U.S. dollars at foreign currency exchange rates in effect at the balance sheet date except for nonmonetary assets, which are remeasured at historical foreign currency exchange rates in effect at the date of transaction. Net realized and unrealized gains and losses from foreign currency transactions and remeasurement are reported in other income (expense) in the consolidated statements of operations and comprehensive loss. All adjustments considered necessary for a fair presentation have been included. Since ARS Pharma was determined to be the accounting acquirer in connection with the Merger, for periods prior to the Merger the consolidated financial statements were prepared on a stand-alone basis for ARS Pharma and did not include the combined entities activity or financial position. For periods subsequent to the Merger, the consolidated financial statements include Silverback’s activity and Silverback’s assets and liabilities at their acquisition date fair value. Historical share and per share figures of ARS Pharma have been retroactively restated based on the exchange ratio in the Merger of 1.1819 . Use of Estimates The preparation of the Company’s consolidated financial statements requires it to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. The most significant estimates in the Company’s consolidated financial statements relate to revenue recognized for its collaboration agreements, accruals for research and development expenses and valuation of equity awards. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be 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 revenue and expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. Cash and Cash Equivalents Cash and cash equivalents include cash readily available in checking and money market mutual funds. The Company considers all highly liquid investments with remaining maturities when purchased of 90 days or less to be cash equivalents. Investments The Company invests excess cash in investment grade fixed income securities. These investments are included in short-term investments on the balance sheets, classified as available-for-sale, and reported at fair value with unrealized gains and losses included in accumulated other comprehensive (loss) gain, net. Realized gains and losses on the sale of securities are recognized in net loss. Fair Value of Financial Instruments Cash, cash equivalents, and short-term investments are carried at fair value. The carrying amounts of all prepaid expenses and other current assets, accounts payable, accrued liabilities, and contract liability, are considered to be representative of their respective fair values because of the short-term nature of those instruments. 122 Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, and short-term investments. The Company maintains deposits in federally insured financial institutions in excess of federally insured limits and limits its exposure to cash risk by placing its cash with high credit quality financial institutions. The Company reviews its financial instruments portfolio on a quarterly basis to determine if any unrealized losses have resulted from a credit loss or other factors. As part of the review, management considers factors such as historical experience, market data, issuer-specific factors, and current economic conditions. This review is subjective, as it requires management to evaluate whether an event or change in circumstances has occurred in that period that may be related to credit issues. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets, generally five years. Repair and maintenance costs are charged to expense as incurred. Impairment of Long-Lived Assets Long-lived assets consist primarily of property and equipment. The Company reviews its long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. Recoverability is measured by comparison of the carrying amount to the future undiscounted net cash flows which the asset or asset group are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the assets exceeds its fair value. The Company has not recognized any impairment losses from inception through December 31, 2023 . Leases The Company determines the initial classification and measurement of its right-of-use (“ROU”) asset and lease liabilities at the lease commencement date and thereafter, if modified. The Company recognizes a ROU asset for its operating leases with lease terms greater than 12 months. The lease term includes any renewal options and termination options that the Company is reasonably assured to exercise. The lease liability is calculated by using the present value of all lease payments, with the present value determined by using the incremental borrowing rate for operating leases determined by using the incremental borrowing rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments in a similar economic environment as well as a review of peer companies. Variable charges for common area maintenance and other variable costs are recognized as expense as incurred. Rent expense for operating leases is recognized on a straight-line basis over the reasonably assured lease term based on the total lease payments and is included in research and development and general and administrative expenses in the consolidated statements of operations and comprehensive loss. Revenue Recognition Our revenues generally consist of licenses and research services under license and collaboration agreements. We recognize revenue when we transfer promised goods or services to customers in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligation(s) in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract; and (v) recognize revenue when (or as) we satisfy the performance obligation(s). At contract inception, we assess the goods or services promised within each contract, assess whether each promised good or service is distinct and identify those that are performance obligations. We recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Research and Development Costs Research and development are expensed in the period incurred. Research and development costs primarily consist of salaries and related expenses for personnel, stock-based compensation expense, external research and development costs incurred under agreements with contract research organizations, investigative sites and consultants to conduct our clinical studies, costs related to compliance with regulatory requirements, costs related to manufacturing the Company’s product candidates for clinical trials and other allocated expenses. 123 Payments for research and development activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and payments made in advance of performance are reflected in the accompanying consolidated balance sheets as prepaid expenses. The Company records accruals for estimated costs incurred for ongoing research and development activities. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the services, including the phase or completion of events, invoices received and contracted costs. The Company uses judgments and estimates to determine the prepaid or accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. Patent Costs Costs related to filing and pursuing patent applications are recorded as general and administrative expenses in the statements of operations and expensed as incurred since recoverability of such expenditures is uncertain. License Fees Costs incurred to acquire technology licenses and milestone payments made on existing agreements are charged to research and development expense or capitalized based upon the asset achieving technological feasibility in accordance with management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. Acquired in-process research and development expense Acquired in-process research and development expense (“IPR&D”) is expensed on the acquisition date if there is no alternative future use. Contingent consideration payments in asset acquisitions are recognized when the contingency is resolved and the consideration becomes payable. Milestone payments made to third parties subsequent to regulatory approval will be capitalized as intangible assets and amortized over the estimated remaining useful life of the related product. Stock-Based Compensation Stock-based compensation expense represents the cost of the grant date fair value of stock option grants recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. The Company recognizes expense for awards subject to performance-based milestones over the remaining service period when management determines that achievement of the milestone is probable. Management evaluates when the achievement of a performance-based milestone is probable based on the expected satisfaction of the performance conditions at each reporting date. The Company estimates the fair value of stock option grants using the Black-Scholes option pricing model and recognizes forfeitures as they occur. In the event that stock-based awards are granted in contemplation of or shortly before a planned release of material non-public information, and such information is expected to result in a material increase in the share price of our common stock, the Company may consider whether an adjustment to the observable market price is required when estimating the grant date fair value. Income Taxes The Company accounts for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements. Under this method, deferred tax assets and liabilities are determined on the basis of the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date. The Company recognizes net deferred tax assets to the extent that the Company believes these assets are more likely than not to be realized. In making such a determination, management considers all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. If management determines that the Company would be able to realize its deferred tax assets in the future in excess of their net recorded amount, management would make an adjustment to the deferred tax asset valuation allowance, which would reduce the provision for income taxes. The Company records uncertain tax positions on the basis of a two-step process whereby (1) management determines whether it is more likely than not that the tax positions will be sustained on the basis of the technical merits of the position and (2) for those tax positions that meet the more-likely-than-not recognition threshold, management recognizes the largest amount of tax benefit that is more than 50 percent likely to be realized upon ultimate settlement with the related tax authority. The Company recognizes interest and penalties related to unrecognized tax benefits within income tax expense. Any accrued interest and penalties are included within the related tax liability. 124 Comprehensive Loss Comprehensive loss is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources. The Company’s comprehensive loss typically consists of the change in unrealized gains and losses on available-for-sale securities. Segment Reporting Operating segments are components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker for purposes of making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business as one operating segment. Net Loss Per Common Share Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding for the period, without consideration of potentially dilutive securities. Diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since the effect of potentially dilutive securities is anti-dilutive given the net loss of the Company. For purposes of this calculation, convertible preferred stock, stock options, and warrants are considered to be common stock equivalents but are not included in the calculations of diluted net loss per share for the periods presented as their effect would be antidilutive. The following securities are excluded from the calculation of weighted-average dilutive common shares because their inclusion would have been anti-dilutive. As of December 31, 2023 2022 Warrants to purchase common stock 45,456 45,456 Common stock options granted and outstanding 11,493,481 12,063,560 Restricted stock units 4,144 10,651 Total 11,543,081 12,119,667 Recently Adopted Accounting Pronouncements In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which changes the accounting for recognizing impairments of financial assets. Under the new guidance, credit losses for certain types of financial instruments will be estimated based on expected losses. The new guidance also modifies the impairment models for available-for-sale debt securities and for purchased financial assets with credit deterioration since their origination. This standard was effective for the Company beginning January 1, 2023. The adoption of this new standard did not have a material impact on the Company's consolidated financial statements. Recently Issued Accounting Pronouncements — Not Yet Adopted 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. ASU 2023-07 also permits the disclosure of more than one measure of a segment’s profit or loss. ASU 2023-07 is effective for the Company as of January 1, 2024 for annual periods and as of January 1, 2025 for interim periods. The Company is evaluating the expected impact of ASU 2023-07 on the consolidated financial statements. In December 2023, the FASB issued ASU 2023-09, Income Taxes (ASU 2023-09), which requires issuers to make additional disclosures 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 expected impact of ASU 2023-09 on the consolidated financial statements. 125 3. Merger and Related Transactions As described in Note 1 - Nature of Business , ARS Pharma merged with Silverback on November 8, 2022. The Merger was accounted for as a reverse recapitalization under U.S. GAAP. ARS Pharma was considered the accounting acquirer for financial reporting purposes. This determination was based on the facts that, immediately following the Merger: (i) ARS Pharma stockholders own a substantial majority of the voting rights of the combined organization; (ii) ARS Pharma designated a majority (eight of eleven) of the initial members of the board of directors of the combined organization; and (iii) ARS Pharma’s senior management holds all key positions in senior management of the combined organization. The transaction was accounted for as a reverse recapitalization because on the effective date of the Merger, the pre-combination assets of Silverback were primarily cash and other non-operating assets. Additionally, the Company concluded that the in-process research and development (“IPR&D”) assets that remained as of the combination were not significant when compared to the cash and investments obtained through the transaction. Under reverse recapitalization accounting, the assets and liabilities of Silverback were recorded at their fair value, which approximated book value due to the short-term nature of the instrum ents. No goodwill or intangible assets were recognized. Under the terms of the Merger Agreement, immediately prior to the effective time of the Merger, each share of ARS Pharma’s preferred stock was converted into one share of ARS Pharma’s common stock. As the accounting acquirer, ARS Pharma is deemed to have assumed all of Silverback’s outstanding and unexercised stock options. The assumed options continue to be governed by the terms of the 2016 and 2020 Equity Incentive Plans of Silverback (as discussed more in Note 10 - Stock-Based Compensation ) under which the options were originally granted. As part of the reverse recapitalization, ARS Pharma obtained $ 262.3 million in cash, cash equivalents and short-term investments, net of transaction costs. ARS Pharma also obtained prepaids and other current assets of approximately $ 0.8 million and assumed payables and accruals of approximately $ 12.0 million. ARS Pharma also obtained $ 1.1 million in IPR&D assets that have no alternative future use. The fair value attributable to these IPR&D assets was recorded as research and development expense in the Company’s consolidated statement of operations and comprehensive loss for the year ended December 31, 2022. ARS Pharma also incurred transaction costs of approximately $ 2.1 million and this amount was recorded as a reduction to additional paid-in capital. During the fourth quarter ended December 31, 2023, the Company determined that the retrospective insurance policy that was recorded as an asset at the date of the Merger on November 8, 2022, should have been expensed by Silverback prior to the Merger. As a result, the Company has made a correction of an immaterial error during the quarter ended December 31, 2023, by reversing $ 0.6 million in previously recorded amortization expense incurred from the date of the Merger through September 30, 2023, removing the asset and reducing additional paid in capital in the amount of $ 3.6 million. 4. Fair Value Measurements The Company categorizes its assets and liabilities measured at fair value in accordance with the authoritative accounting guidance that establishes a consistent framework for measuring fair value and expands disclosures for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as the exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1- Quoted prices (unadjusted) in active markets for identical assets or liabilities; Level 2- Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable; and Level 3- Unobservable inputs in which little or no market activity exists, therefore requiring an entity to develop its own assumptions about the assumptions that market participants would use in pricing. 126 The following table identifies the Company’s assets that were measured at fair value on a recurring basis (in thousands): December 31, 2023 Level Amortized Cost Gross unrealized gains Gross unrealized losses Estimated Fair Value Cash and cash equivalents - Money market mutual funds 1 $ 69,938 $ — $ — $ 69,938 Short-term investments - U.S. Treasury securities 2 157,340 61 ( 12 ) 157,389 Total $ 227,278 $ 61 $ ( 12 ) $ 227,327 December 31, 2022 Cash and cash equivalents - Money market mutual funds 1 $ 209,273 $ — $ — $ 209,273 Short-term investments - U.S. Treasury securities 2 63,456 407 — 63,863 Total $ 272,729 $ 407 $ — $ 273,136 There were no transfers between the Level 1 and Level 2 categories or into or out of the Level 3 category during the periods presented. During the year ended December 31, 2023, the Company purchased $ 272.0 million in short-term investments and there was $ 185.0 million in maturities of short-term investments. During the year ended December 31, 2022, the Company purchased no short-term investments and there were no maturities of short-term investments. The Company’s short-term investments portfolio contains investments in U.S. Treasury securities that have an effective maturity date that is less than one year from the respective balance sheet date. The Company's money market mutual fund holdings are highly liquid and invest primarily in cash and U.S. Treasury securities. There was a $ 0.4 mi llion unrealized loss on available-for-sale securities for the year ended December 31, 2023 and a $ 0.4 million unrealized gain on available-for-sale securities for the year ended December 31, 2022. Management determined that the gross unrealized losses on the Company’s available-for-sale securities as of December 31, 2023 were primarily attributable to current economic and market conditions and not credit risk. As of December 31, 2023 and December 31, 2022, no allowance for credit losses was recorded. It is neither management’s intention to sell nor is it more likely than not that the Company will be required to sell any investments prior to recovery of its amortized cost basis, which is expected to be at maturity. Accrued interest on the Company's available-for-sale securities was $ 0.7 million as of December 31, 2023 and is included in prepaid expenses and other current assets in the accompanying consolidated balance sheet. As of December 31, 2023 and December 31, 2022, the Company did no t have any liabilities that were measured at fair value on a recurring basis. 5. Balance Sheet Details Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2023 December 31, 2022 Prepaid expenses $ 1,124 $ 771 Prepaid insurance 904 1,539 Interest receivable 686 796 Prepaid development costs 380 — Capitalized software implementation costs 163 — Other receivables 109 213 Total $ 3,366 $ 3,319 127 Property and equipment consisted of the following (in thousands): December 31, 2023 December 31, 2022 Equipment $ 695 $ 377 Less accumulated depreciation ( 121 ) ( 48 ) Total $ 574 $ 329 Depreciation expense was $ 0.1 million for the years ended December 31, 2023 and 2022. Other long-term assets consisted of the following (in thousands): December 31, 2023 December 31, 2022 Capitalized software implementation costs $ 617 $ — Prepaid insurance — 2,940 Security deposit 21 21 Total $ 638 $ 2,961 Accounts payable and accrued liabilities consisted of the following (in thousands): December 31, 2023 December 31, 2022 Accounts payable $ 759 $ 1,659 Accrued clinical expenses 515 609 Accrued compensation 315 447 Accrued development expenses 190 133 Accrued legal and professional fees 174 908 Accrued pre-commercialization marketing related expenses 42 — Accrued tax expenses 4 174 Other 155 1,001 Total $ 2,154 $ 4,931 6. Collaboration and Out-Licensing The Company has entered into collaboration and licensing agreements to license certain rights to neffy to third parties. The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; clinical, regulatory, and/or commercial milestone payments; payment for clinical and commercial supply and royalties or a transfer price on the net sales of licensed products. Licenses of Intellectual Property . If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, revenue is recognized from non-refundable, up-front payments allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. If the license is not a distinct performance obligation, the Company evaluates the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. 128 Milestone Payments . At the inception of each arrangement that includes clinical, regulatory or commercial milestone payments, the Company evaluates whether achieving the milestones is considered probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. Milestone payments that are not within the Company’s control, such as approvals from regulators or where attainment of the specified event is dependent on the development activities of a third party, are not considered probable of being achieved until those approvals are received or the specified event occurs. Revenue is recognized when the underlying performance obligation has been transferred to the customer. Research and Development Revenues . For arrangements that contain research and development commitments, any arrangement consideration allocated to the research and development work is recognized as the underlying services are performed over the research and development term. Clinical and Commercial Supply . Arrangements that include a promise for the future supply of drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. We assess if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations. The Company has not earned revenues for clinical or commercial supply sales as of December 31, 2023. Royalty/Transfer Price Revenues . For arrangements that include sales-based royalties or transfer price, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). The Company has not received any royalty or transfer price revenues as of December 31, 2023. Alfresa Agreement In March 2020, the Company signed a Letter of Intent (“LOI”) with Alfresa Pharma Corporation (“Alfresa”) for the right to negotiate a definitive agreement for the exclusive license and sublicensable right to develop, register, import, manufacture and commercialize neffy in Japan in exchange for an upfront payment of $ 2.0 million. In April 2020, the Company entered into a Collaboration and License Agreement for the rights pursuant to the LOI. Under the agreement, the Company delivered a license to the neffy technology and is responsible for completion of a certain clinical study and for the manufacturing of development and commercial drug supply. The parties agreed to share the cost of any additional clinical studies required for approval of neffy in Japan. Alfresa is solely responsible for regulatory and commercialization activities and may elect to assume responsibility for manufacturing and supplying drug product for commercial use in Japan. Either party may terminate the agreement for certain breaches of the agreement. Unless terminated earlier by either or both parties, the term of the agreement will continue until the later of (i) expiration of the last-to-expire patent in Japan; or (ii) 10 years after the commercial sale of neffy in Japan. In addition to the $ 2.0 million received under the LOI, the Company is eligible to receive up to $ 13.0 million of milestone payments upon achievement of certain clinical and regulatory milestones. Further, the Company is eligible to receive a negotiable transfer price expected to be in the low double-digit percentage on net sales subject to the regulatory approval to commercialize neffy in Japan. In July 2020, the Company earned a $ 5.0 million milestone payment upon the completion of a clinical milestone in Japan. At the commencement of this collaboration, the Company identified the following performance obligations: the license for neffy and research and development services. The Company determined the initial transaction price to be $ 7.0 million, which includes a clinical milestone as it was deemed not probable of significant reversal at the inception of the agreement. Due to the uncertainty in the achievement of the regulatory and commercial milestones, the variable consideration associated with these future milestone payments has been fully constrained and is excluded from the transaction price until such time that the Company concludes that it is probable that a significant reversal of previously recognized revenue will not occur. These estimates will be re-assessed at each reporting period. T he transaction price was allocated to the performance obligations based on the estimated stand-alone selling price of each performance obligation. The Company recognized revenue of less than $ 0.1 million and $ 0.1 million for the years ended December 31, 2023 and 2022, respectively. There was no contract liability as of December 31, 2023. 129 Recordati Agreement In September 2020, the Company entered into a License and Supply Agreement (the “Recordati Agreement”) with Recordati Ireland, Ltd. (“Recordati”) for the exclusive license and sublicensable right to develop, import, manufacture or have manufactured commercial product, file and hold regulatory approvals and commercialize neffy in Europe and certain European Free Trade Association, Russia/the Commonwealth of Independent States, Middle East and African countries (the “Recordati Territory”). Under the terms of the Recordati Agreement, the Company received an upfront payment of $ 11.8 million and a regulatory milestone payment of $ 6.0 million during 2020. At the commencement of this collaboration, the Company identified the following performance obligations: the license for neffy in the defined territory and the research and development services. The Company determined the initial transaction price to be the $ 11.8 million. Due to the uncertainty in the achievement of all the developmental and commercial milestones, at inception of the contract, the variable consideration associated with future milestone payments was fully constrained and excluded from the transaction price until such time that the Company concludes that it is probable that a significant reversal of previously recognized revenue will not occur. The transaction price was allocated to the performance obligations based on the estimated stand-alone selling price of each performance obligation. In November 2020, the Company earned a regulatory milestone of $ 6.0 million. On February 22, 2023, the Company and Recordati entered into a termination agreement (the “Termination Agreement”), pursuant to which, among other things, the Company and Recordati agreed to terminate the Recordati Agreement. Pursuant to the Termination Agreement, the Company reacquired all of the Recordati rights, paid Recordati a one-time upfront payment of € 3.0 million, and has agreed to pay additional payments upon achievement of certain milestones including: (i) an EMA regulatory milestone payment of € 2.0 million, (ii) a milestone payment of € 5.0 million upon first commercial sale of a Recordati Licensed Product in the Recordati Territory, and (iii) royalty payments of up to € 5.0 million in the aggregate from sales of Recordati Licensed Product(s) in the Recordati Territory. The Company determined that the Recordati rights at the time of entering into the Termination Agreement had no alternative future use and therefore recorded the € 3.0 million upfront payment to Recordati as an IPR&D expense presented within research and development expense. The Termination Agreement ended the Company’s performance obligations pursuant to the Recordati Agreement and consequently the existing contract liability of $ 3.1 million previously received from Recordati was recorded against IPR&D expense presented within research and development expense. Accordingly, no revenue was recognized in the year ended December 31, 2023. The Company recognized revenue of $ 1.2 million for the year ended December 31, 2022. Pediatrix Agreement In March 2021, the Company entered into a Collaboration and Distribution Agreement with Pediatrix Therapeutics, Inc. (“Pediatrix”) for the exclusive license and sublicensable right to develop, import, manufacture or have manufactured commercial product, file and hold regulatory approvals and commercialize neffy in the People’s Republic of China, Taiwan, Macau, and Hong Kong. Under the agreement, Pediatrix is responsible, at its sole cost and expense, for all ongoing development work that is necessary for or otherwise supports regulatory approval in the defined territory, including all clinical trials, and activities related to post approval commitments and commercialization tests. In addition, Pediatrix is responsible for commercialization activities and may elect to assume responsibility for manufacturing and supplying drug product for commercial use. The Company is responsible for the manufacturing of product for clinical studies as well as commercial supply, all at a negotiated transfer price. Either party may terminate the agreement for certain breaches of the agreement. Unless terminated earlier by either or both parties, the term of the agreement will continue as long as Pediatrix has commercial sales of neffy in the region, or 10 years after the first commercial sale. Under the terms of the agreement, the Company received an upfront payment of $ 3.0 million. In addition, the Company is eligible to receive up to $ 84.0 million of milestone payments upon achievement of certain regulatory and commercial sales milestones. Subject to regulatory approval, the Company will earn tiered royalties in the low double-digits on annual net sales in the region and will receive a per unit supply price for the sale of commercial supply to Pediatrix. 130 At the commencement of this collaboration, the Company identified performance obligations related to the delivery of the license for neffy in the defined territory and manufacturing of product for clinical studies and commercial supply. The Company concluded that the license was distinct from potential supply obligation. The supply provisions are effectively options granted to Pediatrix to purchase future goods and would only constitute a performance obligation if they contain a material right. The Company determined the option to purchase the clinical and commercial supply was not at a significantly discounted price and does not represent a material right, therefore does not constitute a performance obligation. The Company determined the initial transaction price to be the $ 3.0 million. Due to the uncertainty in the achievement of all the developmental and commercial milestones, the variable consideration associated with these future milestone payments has been fully constrained and is excluded from the transaction price until such time that the Company concludes that it is probable that a significant reversal of previously recognized revenue will not occur. These estimates will be re-assessed at each reporting period. The Company recognized revenue of the full $ 3.0 million during the year ended December 31, 2021. A reconciliation of contract liability from the Alfresa, Recordati, and Pediatrix collaboration agreements was as follows (in thousands): Balance at December 31, 2022 $ 3,137 IPR&D expense related to the Termination Agreement ( 3,107 ) Revenue recognized ( 30 ) Balance at December 31, 2023 $ — 7. Commitments and Contingencies Note Payable In September 2019, the Company entered into a Loan and Security Agreement with Silicon Valley Bank for working capital in the principal amount, as amended, of $ 10.0 million (the “Note”). The Note required interest only payments through June 30, 2021 and had a maturity date of March 1, 2024. In addition, there was a final payment (“Balloon Payment”) of $ 0.3 million at maturity. In connection with the Note, the lender received warrants to purchase 38,460 shares of Series C convertible preferred stock at $ 2.60 per share. The warrants were immediately exercisable and will expire on September 30, 2029. The estimated fair value of the warrants at issuance was $ 86,000 , which was recorded as a debt discount. In addition, the Company recorded debt issuance costs totaling $ 47,000 . The debt discount, debt issuance costs and Balloon Payment were amortized to interest expense using the effective interest rate method over the loan term. In November 2022, as a result of the Merger, the warrants converted to warrants to purchase 45,456 shares of the Company’s common stock at $ 2.20 per share. On November 7, 2022, the Company paid off the remaining balance of $ 5.4 million on its loans with Silicon Valley Bank, including all principal and interest and the Balloon Payment. The warrants issued to Silicon Valley Bank in connection with the loans continue to be outstanding. 131 Leases In October 2021, the Company entered into a 38-month noncancelable lease for its current headquarters location consisting of 4,047 rentable square feet of office space in San Diego, California. Under the terms of the agreement, there is no option to extend the lease , and the Company is subject to additional charges for common area maintenance and other costs . Monthly rental payments due under the lease commenced on December 6, 2021 and escalate through the lease term. The Company prepaid the first month’s rent upon execution of the lease, and the lease agreement provided full rent abatement for the second and third months of the rental term. As of December 31, 2023 , the remaining lease term of the Company’s operating lease was 14 months , and the discount rate on the Company’s operating lease was 8 %. As there was not an implicit rate within the lease, the discount rate was determined by using a set of peer companies incremental borrowing rates. The Company's operating lease expense was $ 0.2 million for each of the years ended December 31, 2023 and 2022. The Company's variable lease expense was immaterial for each of the years ended December 31, 2023 and 2022. Cash paid for amounts included in the measurement of lease liabilities was $ 0.2 million for each of the years ended December 31, 2023 and 2022. As of December 31, 2023, future minimum noncancelable operating lease payments are as follows (in thousands): Year ended December 31, Amount 2024 $ 245 2025 42 Total lease payments 287 Less imputed interest ( 13 ) Lease liability 274 Less current portion of lease liability ( 237 ) Lease liability, net of current portion $ 37 Contingencies From time to time, the Company may be involved in various legal proceedings and subject to claims that arise in the ordinary course of business. On August 12, 2021, Amphastar Pharmaceuticals, Inc. (“Amphastar”) filed a Petition for Inter Partes Review with the United States Patent and Trademark Office (“USPTO”), seeking to invalidate claims 1-20 of United States Patent No. 10,682,414 (the “‘414 patent”). The ‘414 patent issued on June 16, 2020 and is entitled “Intranasal Epinephrine Formulations and Methods for the Treatment of Disease.” The claims of the ‘414 patent are directed to methods of treating a type-1 hypersensitivity reaction, including anaphylaxis, using an aqueous nasal spray pharmaceutical formulation containing epinephrine or a salt thereof in a single dose. On February 9, 2023, the USPTO issued a Final Written Decision finding claims 3-6 and 18-20, which encompass the Company’s neffy product candidate, patentable, and claims 1-2 and 7-17 unpatentable. On April 12, 2023, Amphastar filed a notice of appeal with the United States Court of Appeals for the Federal Circuit. On May 15, 2023, the Company filed a motion to dismiss for lack of standing, which will be heard along with the merits of the case. Briefing on the merits is expected to be completed in the second quarter of 2024, and a decision from the Federal Circuit is expected by mid-2025. The results of any appeal proceedings are inherently unpredictable and uncertain, and could result in the Federal Circuit finding some or all of claims 1-20 of the ‘414 patent to be invalid or unenforceable. On July 24, 2023, Aera A/S, an IP consultancy firm in Denmark representing an unidentified opponent, filed a notice of opposition with the European Patent Office (the “EPO”) in respect of EP 3678649 (the “EP ‘649 Patent”), which is a patent directed to a nasal spray formulation of epinephrine, and uses thereof. We filed a response to the notice of opposition on December 15, 2023, and we will continue to vigorously defend the EP ‘649 Patent. The results of any notice of opposition are inherently unpredictable and uncertain, and could result in the EPO finding the patent to be invalid or unenforceable. Regardless of the outcome, involvement in legal proceedings may have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors. The Company cannot predict the outcome of these suits, and failure by the Company to obtain favorable resolutions could have a material adverse effect on its business, results of operations, and financial condition. The Company’s chances of success on the merits of these suits are still uncertain and any possible loss or range of loss cannot be reasonably estimated and as such the Company has not recorded a liability as of December 31, 2023. 132 Except as described above, there is no action, suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or other body pending or, to the knowledge of the Company’s executive officers, threatened against or affecting the Company, the Company’s common stock, any of its subsidiaries or its subsidiaries’ officers or directors in their capacities as such, in which an adverse decision could have a material adverse effect. 8. In-Licensing and Supply License Agreement with Aegis In June 2018, the Company entered into a License Agreement (the “Aegis Agreement”) with Aegis Therapeutics, LLC (“Aegis”). Under the Aegis Agreement, the Company licensed the exclusive, worldwide, royalty-bearing, sublicensable, rights to certain proprietary Aegis technology, patent rights and know-how to develop and commercialize epinephrine products. The Company utilizes this technology for the development of its lead product candidate, neffy . As consideration for the license, the Company paid an upfront license fee of $ 50,000 , which was recorded in research and development expenses in the consolidated statement of operations. The Company is required to make aggregate milestone payments of up to $ 20.0 million upon achievement of certain regulatory and commercial milestones. The regulatory milestone payments under the Aegis Agreement will be recognized as research and development expense upon completion of the required events, as the triggering events are not considered to be probable until they are achieved. The Company made a $ 0.5 million milestone payment to Aegis upon the achievement of a regulatory milestone during 2019, and a $ 1.0 million payment to Aegis upon the FDA’s acceptance of the Company’s NDA submission for neffy , which occurred in the third quarter of 2022. The Company may be required to pay royalties based on annual net product sales in the low to mid-single digits on its or its sublicensees’ net sales of the Licensed Products (as defined in the Aegis Agreement) on a country-by-country and product-by-product basis. The Company is responsible for reimbursing Aegis for patent costs incurred in connection with prosecuting and maintaining patent rights that are specific to epinephrine or epinephrine products. There were no expenses recognized in connection with legal patent fees for the years ended December 31, 2023 and 2022. The Company may terminate the Aegis Agreement with 30 days written notice or either party may terminate the Aegis Agreement for certain breaches of the Aegis Agreement. Unless terminated earlier by either or both parties, the term of the Aegis Agreement will continue until the final expiration of all royalty obligations under the Aegis Agreement. In conjunction with the Aegis Agreement, the Company also entered into a Supply Agreement (the “Supply Agreement”) with Aegis that allows the Company to purchase materials for preclinical, development and commercial use at predetermined prices. The Company may elect to have Aegis supply minimum quantities but there are no minimum or maximum purchase obligations under the Supply Agreement unless this election is made. The parties may terminate the Supply Agreement at any time by mutual agreement. In addition, the parties may terminate the Supply Agreement in the event of certain breaches of the Supply Agreement or upon the earlier of the expiration or termination of the Aegis Agreement or June 2028. The Supply Agreement term may be extended by mutual written agreement. Under the Supply Agreement, $ 0.3 million and $ 1.0 million in expense was recognized in the years ended December 31, 2023 and 2022, respectively. Manufacturing Agreement with Renaissance In September 2020, the Company entered into a manufacturing agreement with Renaissance Lakewood, LLC (“Renaissance”), which was subsequently amended in July 2023 (the “Renaissance Agreement”). Pursuant to the Renaissance Agreement, Renaissance agreed to manufacture for, and provide to the Company, neffy nasal unit dose sprays (“Renaissance Products”). The Company is obligated to provide Renaissance with certain supplies to manufacture the Renaissance Products and to purchase from Renaissance a mid double-digit percentage of the Company’s annual aggregate Renaissance Product requirements in the E.U., and a high double-digit percentage of the Company’s annual aggregate Renaissance Product requirements in the U.S. The Renaissance Agreement contains conventional commercial pharmaceutical manufacturing provisions including certain minimum purchase amounts to be determined in the future based on forecast needs and minimum batch size projections. The Company may also request Renaissance to perform certain services related to the Renaissance Product, for which the Company will pay reasonable compensation to Renaissance. 133 The initial term of the Renaissance Agreement commenced on September 9, 2020 and continues (a) for Renaissance Product designated for commercial sale in the U.S. until the earlier of the fifth anniversary of the (i) target U.S. launch date and (ii) the initial U.S. launch date (“U.S. Initial Term”), and (b) for Renaissance Product designated for commercial sale in the E.U. and other countries, the earlier of the fifth anniversary of (i) the target E.U. launch date and (ii) the initial E.U. launch date (“E.U. Initial Term”), in each case unless earlier terminated by one of the parties. The U.S. Initial Term and E.U. Initial Term automatically renew for successive two-year terms (“Renewal Term”). Either party may elect not to renew the U.S. Renewal Term and/or the E.U. Renewal Term by providing the requisite prior notice to the other party. Either party may terminate the Renaissance Agreement (1) for uncured material breach of the other party, (2) upon notice for insolvency-related events of the other party that are not discharged within a defined time period, (3) on a product-by-product basis if the manufacture, distribution or sale would materially contravene any applicable law, (4) by providing the requisite notice if (a) the Company has not submitted a regulatory filing for any Renaissance Product in the U.S. on or before June 30, 2022, (b) the authorization and approval to distribute or sell Renaissance Product in the U.S. is not granted on or before the target U.S. launch date, (c) the authorization and approval representing more than a targeted number of units of Renaissance Product sold in the U.S. during the last calendar year is withdrawn by the FDA, or (d) the Company decided in its sole discretion to cease commercializing the Renaissance Product in the U.S., (5) in the case of a force majeure event that continues for six months or more, or (6) a violation by the other party of trade control or anti-corruption laws. 9. Convertible Preferred Stock and Common Stock and Stockholders’ Equity (Deficit) Authorized Shares The Company’s current Amended and Restated Certificate of Incorporation authorizes 200,000,000 shares of common stock, par value $ 0.0001 per share, and 10,000,000 shares of preferred stock, par value $ 0.0001 per share. Convertible Preferred Stock In November 2022, ARS Pharma completed the Merger with Silverback in accordance with the Merger Agreement. Under the terms of the Merger Agreement, immediately prior to the effective time of the Merger, 22,399,435 shares of ARS Pharma’s convertible preferred stock were converted into 26,473,899 shares of ARS Pharma’s common stock. Common Stock In November 2022, upon completion of the Merger and as the accounting acquirer, ARS Pharma is deemed to have issued 36,535,541 shares of its common stock to Silverback stockholders. Common stock reserved for future issuance consisted of the following: December 31, 2023 December 31, 2022 Common stock options granted and outstanding 11,493,481 12,063,560 Restricted stock units granted and outstanding 4,144 10,651 Common stock reserved for future awards or option grants 6,220,866 3,373,801 Warrants to purchase common stock 45,456 45,456 Total 17,763,947 15,493,468 10. Stock-Based Compensation Stock-based compensation expense recognized for all equity awards has been reported in the consolidated statements of operations and comprehensive loss as follows (in thousands): Year Ended December 31, 2023 2022 Research and development expense $ 2,274 $ 213 General and administrative expense 6,961 5,630 Total stock-based compensation expense $ 9,235 $ 5,843 134 As of December 31, 2023, the total unrecognized stock-based compensation expense related to outstanding employee options was $ 22.7 million, which is expected to be recognized over a remaining weighted-average period of approximately 2.43 years. In November 2022, in connection with the Merger, the Company assumed restricted stock units granted by Silverback, of which 10,651 were outstanding as of December 31, 2022 and 4,144 are outstanding as of December 31, 2023. Equity Incentive Plans In September 2018, ARS Pharma adopted the 2018 Equity Incentive Plan. As a result of the Merger, on November 8, 2022 ARS Pharma assumed Silverback’s 2016 and 2020 Equity Incentive Plans, and Employee Stock Purchase Plan (“ESPP”). There were 44,961 shares and an immaterial number of shares of common stock purchased under the ESPP durin g the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023 , the 2016 and 2020 Equity Incentive Plans authorized a total of 16,018,660 shares, of which 5,923,521 shares are available for future grant, and 5,963,430 shares are outstanding. As of December 31, 2023 , the 2018 Equity Incentive Plan authorized a total of 6,634,333 shares, of which 297,345 shares are available for future grant, and 5,534,195 shares are outstanding. The Company does not intend to grant future stock options or other equity awards under the 2016 or 2018 Equity Incentive Plans. Stock Options Stock options granted under the Company’s equity incentive plans expire no later than 10 years from the date of grant and generally vest over a four-year period, with vesting either occurring at a rate of 25 % at the end of the first year and thereafter in 36 equal monthly installments or on a monthly basis. In the case of awards granted to our non-employee board members, vesting generally occurs on a monthly basis over three years or in full on an annual basis. The Company issues new shares of common stock upon the exercise of stock options. A summary of the Company’s stock option activity for the year ended December 31, 2023 is as follows: Shares Subject to Options Outstanding Weighted- Average Exercise Price Weighted- Average Remaining Contractual Life (Years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2022 12,063,560 $ 6.07 Granted 4,749,600 $ 8.03 Exercised ( 2,422,636 ) $ 2.76 Forfeited ( 2,897,043 ) $ 15.06 Outstanding at December 31, 2023 11,493,481 $ 5.32 7.89 $ 25,078 Exercisable at December 31, 2023 7,502,931 $ 3.86 7.27 $ 25,078 The exercisable shares subject to options outstanding at December 31, 2023 in the table above include vested and early exercisable awards. The aggregate intrinsic value in the table above is calculated as the difference between the exercise price of the underlying options and the estimated fair value of the Company’s common stock for all options that were in-the-money at December 31, 2023 . The aggregate intrinsic value of options exercised during the years ended December 31, 2023 and 2022 was $ 8.5 million and $ 1.2 million, respectively. The weighted-average grant date fair value per share of option grants for the years ended December 31, 2023 and 2022 was $ 6.31 and $ 1.50 , respectively. The total fair value of shares vested during the years ended December 31, 2023 and 2022 was $ 4.5 million and $ 2.7 million, respectively. The fair value of stock options granted was estimated using a Black-Scholes option-pricing model (“Black-Scholes”) with the following weighted-average assumptions: Year Ended December 31, 2023 2022 Expected term (in years) 6.0 6.1 Expected volatility 95.3 % 91.3 % Risk-free interest rate 3.9 % 2.1 % Expected dividend yield — — 135 The fair value of stock options was determined using the Black-Scholes assumptions below. Each of these inputs is subjective and generally requires significant judgment. Fair Value of Common Stock . Prior to the Merger on November 8, 2022, grant date fair market value of the shares of common stock underlying stock options was determined by ARS Pharma’s Board of Directors. Prior to the Merger, there was no public market for the ARS Pharma’s common stock, therefore the ARS Pharma Board of Directors determined the fair value of common stock at the time of grant of the option by considering a number of objective and subjective factors including independent third-party valuations of the ARS Pharma common stock, sales of convertible preferred stock to unrelated third parties, operating and financial performance, the lack of liquidity of capital stock and general and industry specific economic outlook, amongst other factors. Following the Merger, the fair market value of the Company's common stock is based on its closing price as reported on the date of grant on the primary stock exchange on which the Company’s common stock is traded. Expected Term . The expected term represents the period that the options granted are expected to be outstanding. The expected term of stock options issued is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term) as the Company has concluded that its stock option exercise history does not provide a reasonable basis upon which to estimate expected term. Expected Volatility . Given the Company’s limited historical stock price volatility data, the Company derived the expected volatility from the average historical volatilities over a period approximately equal to the expected term of comparable publicly traded companies within its peer group that were deemed to be representative of future stock price trends as the Company has limited trading history for its common stock. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Risk-free Interest Rate . The risk-free interest rate is based on the U.S. Treasury rate, with maturities similar to the expected term of the stock options. Expected Dividend Yield . The Company has never paid dividends on its common stock and does not anticipate paying any dividends in the foreseeable future. Therefore, the Company uses an expected dividend yield of zero. 11. Income Taxes A reconciliation of the federal statutory income tax rate to the Company’s effective tax rate is as follows (in thousands): Years Ended December 31, 2023 2022 Tax computed at federal statutory rate $ ( 11,416 ) $ ( 7,283 ) State income taxes, net of federal benefit ( 22 ) ( 21 ) Officers Compensation (Sec 162(m)) 745 195 Equity compensation 749 290 Research and development credits ( 1,179 ) ( 624 ) Other ( 88 ) 257 Valuation allowance 11,211 7,186 Provision for income taxes $ — $ — 136 Significant components of the Company’s net deferred tax assets were as follows (in thousands): Years Ended December 31, 2023 2022 Deferred tax assets: Net operating losses $ 16,127 $ 8,252 Research and development credits 4,143 2,964 Intangible assets 7,322 3,746 Equity compensation 1,498 2,279 Contract liability — 661 Other 66 104 Total deferred tax assets 29,156 18,006 Deferred tax liabilities: ROU asset ( 53 ) ( 94 ) Other ( 59 ) ( 155 ) Total deferred liabilities ( 112 ) ( 249 ) Gross deferred tax assets 29,044 17,757 Valuation allowance ( 29,044 ) ( 17,757 ) Net deferred tax assets $ — $ — The Company has established a valuation allowance against net deferred tax assets due to the uncertainty that such assets will be realized. The Company periodically evaluates the recoverability of the deferred assets. At such time as it is determined that it is more likely than not that the deferred tax asset will be realized, the valuation allowance will be reduced. The change in the valuation allowance for the year ended December 31, 2023 was an increase of $ 11.3 million. At December 31, 2023, the Company had federal and state net operating loss carryforwards (NOL) of $ 76.2 million and $ 2.5 million, respectively. Federal NOL carryforwards of $ 76.2 million, generated after 2017, may be carried forward indefinitely but can only be utilized to offset 80 % of future taxable income. The state NOL carryforwards begin expiring in 2036. State NOLs totaling $ 2.0 million may be carried forward indefinitely. In addition, the Company also has federal and California research and development credit carryforwards totaling $ 3.8 million and $ 0.4 million, respectively. The federal research and development credit carryforwards will begin to expire in 2035 unless previously utilized. The California research credits do not expire. The NOL and credit carryovers noted above do not include the pre-Merger amounts attributable to Silverback as noted in the IRC Section 382 disclosure in the paragraph below. Pursuant to Internal Revenue Code (IRC) Sections 382 and 383, annual use of the company's NOL and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. The Company has not completed an ownership change analysis pursuant to IRC Section 382. If ownership changes have occurred or occurs in the future, the amount of remaining tax attribute carryforwards available to offset taxable income and income tax expense in future years may be restricted or eliminated. If eliminated, the related asset would be removed from deferred tax assets with a corresponding reduction in the valuation allowance. Due to the existence of the valuation allowance, limitations created by future ownership changes, if any, will not impact the Company’s effective tax rate. Additionally, as part of the transaction with Silverback, certain deferred tax assets generated in the Silverback pre-Merger periods were acquired by the Company consisting of federal and state net operation loss carryovers, research tax credit carryovers, and other tax attributes. These deferred tax assets will be subject to limitations on future use under IRC Section 382 and some of the attributes may expire unused. The Company has not completed an analysis under IRC Section 382 to determine the amount of such tax attributes that will be available annually and how much, if any, of the tax attributes may expire unused. As a result, the Company has not included any of these deferred tax assets in its components of deferred tax asset in the table above. Once the analysis is complete, to the extent that such deferred tax assets are available for future utilization, such assets will be included in the deferred tax assets and will be fully offset by valuation allowance as of December 31, 2023. 137 The evaluation of uncertainty in a tax position is a two-step process. The first step involves recognition. The Company determines whether it is more likely than not that a tax position will be sustained upon tax examination, including resolution of any related appeals or litigation, based on only the technical merits of the position. The technical merits of a tax position are derived from both statutory and judicial authority (legislation and statutes, legislative intent, regulations, rulings, and case law) and their applicability to the facts and circumstances of the tax position. If a tax position does not meet the more-likely-than-not recognition threshold, the benefit of that position is not recognized in the financial statements. The second step is measurement. A tax position that meets the more-likely-than-not recognition threshold is measured to determine the amount of benefit to recognize in the financial statements. The tax position is measured as the largest amount of benefit that is greater than 50% likely of being realized upon ultimate resolution with a taxing authority. The following table summarizes the reconciliation of the unrecognized tax benefits activity during the years ended December 31, 2023 and 2022 (in thousands): Years Ended December 31, 2023 2022 Unrecognized tax benefits - beginning $ 1,520 $ 1,147 Gross increases – tax positions in prior period 951 — Gross increase – current-period tax positions 475 373 Unrecognized tax benefits - ending $ 2,946 $ 1,520 The unrecognized tax benefit amounts are reflected in the determination of the Company’s deferred tax assets. If recognized, none of these amounts would affect the Company’s effective tax rate, since it would be offset by an equal corresponding adjustment in the deferred tax asset valuation allowance. The Company does not foresee material changes to its liability for uncertain tax benefits within the next twelve months. The Company files income tax returns in the United States, various states, and Ireland. Due to the Company’s losses incurred, the Company's income tax returns for all jurisdictions are subject to examination by tax authorities from inception. The Company’s policy is to recognize interest expense and penalties related to income tax matters as tax expense. As of December 31, 2023, there were no significant accruals for interest related to unrecognized tax benefits or tax penalties. The Company has not incurred any material interest or penalties as of the current reporting date with respect to income tax matters. The Company does not expect that there will be unrecognized tax benefits of a significant nature that will increase or decrease within 12 months of the reporting date. 12. Employee Benefit Plans In June 2022, the Company adopted a retirement plan, which is qualified under section 401(k) of the Internal Revenue Code of 1986, as amended, for the Company’s U.S. employees. The plan allows eligible employees to defer, at the employee’s discretion, pretax compensation up to the Internal Rev enue Service (the “IRS”) annual limits. The Company matches up to 5 % of an employee’s pay that they contribute to the plan, subject to IRS limitations. Expenses associated with the Company’s matching contribution totaled $ 0.4 million and $ 0.1 million for the years ended December 31, 2023 and 2022, respectively. 13. Related-Party Transactions In September 2015, the Company entered into a consulting agreement, superseded in July 2022, for regulatory and development services with Pacific-Link Regulatory Consulting, Inc., an entity owned by the President/Chief Executive Officer/director and his spouse, the Chief Medical Officer of the Company. The Company incurred consulting expense related to this agreement totaling $ 1.9 million and $ 2.1 million during the years ended December 31, 2023 and 2022, respectively. In September 2018, the Company entered into a consulting agreement with Marlinspike Group, LLC (“Marlinspike Group”) to provide management, business consulting services and business development support. The managing member of Marlinspike Group is the Chair of the Board of Directors of the Company and one of its stockholders. The Company incurred annual expenses related to this agreement totaling $ 0.2 million for both of the years ended December 31, 2023 and 2022. In November 2018, the Company entered into a consulting agreement for commercial and marketing consulting services with Red Team Associates, LLC (“Red Team”), an entity controlled by the former Executive Vice President of Commercial Strategy of the Company. The Company incurred consulting expense related to this agreement totaling $ 0.4 million and $ 0.2 million during the years ended December 31, 2023 and 2022, respectively. 138 In April 2021, the Company entered into a consulting agreement, as amended in April 2022, with a member of the Board of Directors of the Company for general advice and assistance with the development of its current and future product candidates. As compensation for the consulting services the Company granted the member of the Board of Directors 590,950 stock options that vest over a four-year period. The Company incurred stock-based compensation expense related to this agreement totaling $ 0.1 million for both of the years ended December 31, 2023 and 2022. Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure. None.