ARS Pharmaceuticals, Inc. 10-K

Item 8. Financial Statements and Supplementary Data Page Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 ) 107 Consolidated Balance Sheets 108 Consolidated Statements of Operations and Comprehensive Loss 109 Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) 110 Consolidated Statements of Cash Flows 111 Notes to Financial Statements 112 106 Report of Independent Registered Public Accounting Firm To the Shareholders 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, 2022 and 2021, 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, 2022, 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, 2022 and 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2022, 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 23, 2023 107 ARS Pharmaceuticals, Inc. CONSOLIDATED BALANCE SHEETS (In thousands, except par value and share amounts) December 31, 2022 2021 Assets Current assets: Cash and cash equivalents $ 210,518 $ 60,063 Short-term investments 63,863 — Prepaid expenses and other current assets 3,319 667 Total current assets 277,700 60,730 Right-of-use asset 445 621 Fixed assets, net 329 72 Other assets 2,961 23 Total assets $ 281,435 $ 61,446 Liabilities, convertible preferred stock and stockholders’ equity (deficit) Current liabilities: Accounts payable and accrued liabilities (including related party amounts of $ 16 in 2022 and $ 159 in 2021) $ 4,931 $ 3,107 Lease liability, current 230 144 Contract liability, current 283 1,457 Note payable, current — 3,479 Total current liabilities 5,444 8,187 Lease liability, net of current portion 251 480 Contract liability, net of current portion 2,854 2,996 Note payable, net of current portion — 4,930 Preferred stock warrant liability — 83 Total liabilities 8,549 16,676 Commitments and contingencies (Note 7) Convertible preferred stock and stockholders’ equity (deficit): Preferred stock, $ 0.0001 par value; 10,000,000 shares authorized at December 31, 2022 and 2021; no shares issued and outstanding at December 31, 2022 and 2021 — — Series A convertible preferred stock, $ 0.01 par value; no shares and 4,764,000 shares authorized at December 31, 2022 and 2021, respectively; no shares and 4,764,000 shares issued and outstanding at December 31, 2022 and 2021, respectively — 365 Series B convertible preferred stock, $ 0.01 par value; no shares and 606,060 shares authorized at December 31, 2022 and 2021, respectively; no shares and 606,060 shares issued and outstanding at December 31, 2022 and 2021, respectively — 1,000 Series C convertible preferred stock, $ 0.01 par value; no shares and 7,749,999 shares authorized at December 31, 2022 and 2021, respectively; no shares and 7,692,309 shares issued and outstanding at December 31, 2022 and 2021, respectively — 19,868 Series D convertible preferred stock, $ 0.01 par value; no shares and 9,337,066 shares authorized at December 31, 2022 and 2021, respectively; no shares and 9,337,066 shares issued and outstanding at December 31, 2022 and 2021, respectively — 54,806 Stockholders’ equity (deficit) Common stock, $ 0.0001 par value; 200,000,000 and 56,000,000 shares authorized at December 31, 2022 and 2021, respectively; 93,943,316 and 30,369,413 shares issued and outstanding at December 31, 2022 and 2021, respectively 9 3 Additional paid-in capital 349,408 10,984 Accumulated other comprehensive gain 407 — Accumulated deficit ( 76,938 ) ( 42,256 ) Total stockholders’ equity (deficit) 272,886 ( 31,269 ) Total liabilities, convertible preferred stock and stockholders’ equity (deficit) $ 281,435 $ 61,446 The accompanying notes are an integral part of these financial statements. 108 ARS Pharmaceuticals, Inc. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share information) Years Ended December 31, 2022 2021 Revenue under collaboration agreements $ 1,316 $ 5,506 Operating expenses: Research and development (including related party amounts of $ 2,144 in 2022 and $ 1,072 in 2021) 18,376 20,273 General and administrative (including related party amounts of $ 603 in 2022 and $ 476 in 2021) 18,456 4,687 Total operating expenses 36,832 24,960 Loss from operations ( 35,516 ) ( 19,454 ) Other income (expense): Other income (expense), net 974 ( 789 ) Change in fair value of financial instruments ( 140 ) — Total other income (expense): 834 ( 789 ) Net loss $ ( 34,682 ) $ ( 20,243 ) Unrealized gain on available-for-sale securities 407 — Comprehensive loss attributable to common stockholders $ ( 34,275 ) $ ( 20,243 ) Net loss per share attributable to common stockholders, basic and diluted $ ( 0.87 ) $ ( 0.70 ) Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted 39,956,043 28,872,242 The accompanying notes are an integral part of these financial statements. 109 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 Additional Paid-in Accumulated Other Accumulated Total Stockholders’ Equity Shares Amount Shares Amount Shares Amount Shares Amount Shares Amount Capital Comprehensive Gain Deficit (Deficit) Balance at December 31, 2020 4,764,000 $ 365 606,060 $ 1,000 7,692,309 $ 19,868 — $ — 26,411,772 $ 3 $ 7,958 $ — $ ( 22,013 ) $ ( 14,052 ) Issuance of Series D convertible preferred stock for cash, net of issuance costs of $ 194 — — — — — — 9,337,066 54,806 — — — — — — Vesting of restricted common stock — — — — — — — — 3,756,226 — 28 — — 28 Exercise of stock options — — — — — — — — 201,415 — 169 — — 169 Stock-based compensation — — — — — — — — — — 2,829 — — 2,829 Net loss and comprehensive net loss — — — — — — — — — — — — ( 20,243 ) ( 20,243 ) 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 The accompanying notes are an integral part of these financial statements 110 ARS Pharmaceuticals, Inc. CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands) Years Ended December 31, 2022 2021 Cash flows from operating activities: Net loss $ ( 34,682 ) $ ( 20,243 ) Non-cash adjustments to reconcile net loss to net cash provided by (used) in operating activities: Stock-based compensation expense 5,843 2,829 Acquired in-process research and development 1,056 — Change in fair value of warrant liability 140 ( 4 ) Depreciation, amortization and accretion expense 319 213 Changes in operating assets and liabilities: Prepaid and other assets ( 1,186 ) 1,173 Accounts payable and accrued liabilities (including related party amounts of $( 143 ) in 2022 and $ 13 in 2021) ( 10,285 ) 974 Operating right-of-use assets and lease liabilities, net 33 4 Contract liability ( 1,316 ) ( 2,507 ) Net cash used in operating activities ( 40,078 ) ( 17,561 ) Cash flows from investing activities: Purchase of property and equipment ( 199 ) ( 55 ) Net cash used in investing activities ( 199 ) ( 55 ) Cash flows from financing activities: Cash proceeds from the Merger, net of transaction costs 198,843 — Proceeds from exercise of common stock options 570 169 Repayment of bank note payable ( 8,681 ) ( 1,817 ) Proceeds from issuance of preferred stock, net — 54,806 Net cash provided by financing activities 190,732 53,158 Net change in cash and cash equivalents 150,455 35,542 Cash and cash equivalents at beginning of year 60,063 24,521 Cash and cash equivalents at end of year $ 210,518 $ 60,063 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 $ — Purchases of property and equipment included in accounts payable $ 91 $ — Interest paid $ 366 $ 576 The accompanying notes are an integral part of these financial statements. 111 ARS Pharmaceuticals, Inc. Notes to Financial Statements 1. Nat ure of Business Description of Business ARS Pharmaceuticals, Inc. (“ARS” 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 1 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, which survived the Merger as more fully described below. 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 Pharmaceuticals, Inc. (“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. 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 $ 76.9 million as of December 31, 2022. The Company had cash, cash equivalents, and short-term investments of $ 274.4 million as of December 31, 2022 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 investments as of December 31, 2022 are sufficient to meet its anticipated cash requirements for at least the 12 months following the date the financial statements are issued. From August 5, 2015 (inception) through December 31, 2022, the Company has devoted substantially all of its efforts to developing intellectual property and 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. T he novel coronavirus-2019 (“COVID-19”) epidemic and geopolitical events have resulted in a significant disruption of global financial markets. The Company’s ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and further disruptions to, and volatility in, the credit and financial markets in the United States, including recent bank failures, and worldwide resulting from a resurgence of COVID-19, 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. 112 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 consolidated financial statements include the accounts of the Company and ARS Pharmaceuticals IRL, Limited for the year ended December 31, 2022. 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. Subsequent to the Merger, the consolidated financial statements as of and for the year ended December 31, 2022 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 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, money market and sweep accounts. The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Investments The Company invests excess cash in investment grade intermediate-term 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. Realized gains and losses on the sale of these securities are recognized in net loss. Fair Value of Financial Instruments Cash and cash equivalents and 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. Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. 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. 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. Repairs and maintenance costs are charged to expense as incurred. 113 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, 2022 . Leases Effective January 1, 2021, the Company early adopted ASC No. 2016-02, Leases (Topic 842) (“ASC 842”), which supersedes the current accounting for leases, using the modified retrospective transition method. The Company has elected to apply the practical expedients allowed by the standard for existing leases. The new standard, while retaining two distinct types of leases, finance and operating, (i) requires lessees to record a right-of-use (“ROU”) asset and a related liability for the rights and obligations associated with a lease, regardless of lease classification, and recognize lease expense in a manner similar to current accounting, (ii) eliminates current real estate specific lease provisions, (iii) modifies the lease classification criteria and (iv) aligns many of the underlying lessor model principles with those in the new revenue standard. The Company determines the initial classification and measurement of its 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. Warrant Liability The Company has issued freestanding warrants to purchase shares of its Series C convertible preferred stock. Prior to the Merger, the Company adjusted the carrying value of such Series C convertible preferred stock warrants to the estimated fair value at each reporting date, with any related increases or decreases in the fair value being recorded within other income (expense) in the consolidated statements of operations and comprehensive loss. Pursuant to the Merger Agreement the Series C convertible preferred stock warrants became warrants to purchase shares of the combined company's common stock. As a result of the Merger, the warrants no longer meet the requirements for liability accounting, as such, the Company adjusted the value of the warrants to the estimated fair value as of the Merger date and reclassified them to equity. Revenue Recognitio n 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. 114 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. 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. The Company’s equity incentive plans allow for the issuance of restricted stock awards that may be subject to vesting. The unvested shares of any restricted stock awards are held in escrow as the stock award vests or until the holder’s termination of services, whichever occurs first. In the event the holder’s services terminate, the Company has the right of repurchase, at its option, the portion of unvested stock awards. For all early exercised unvested stock awards, a liability is established related to the cash received for the unvested portion of the stock award, which represents the Company’s repurchase rights if the award holders were to be terminated and their stock repurchased. 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. 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 was the same as its reported net loss for all periods presented. 115 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 preferred stock 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. Historical share figures have been retroactively restated based on the exchange ratio of 1.1819 . December 31, 2022 December 31, 2021 Convertible preferred stock — 26,473,899 Warrants to purchase convertible preferred stock — 45,456 Warrants to purchase common stock 45,456 — Common stock options granted and outstanding 12,063,560 4,769,572 Total 12,109,016 31,288,927 Recently Issued Accounting Pronouncements — Not Yet Adopted 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 update is effective for the Company beginning January 1, 2023. The Company is currently evaluating the impact the standard may have on its financial statements and related disclosures. 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 has 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 instruments. No goodwill or intangible assets were recognized. Consequently, the Company's consolidated financial statements reflect the issuance of 36,535,541 shares to the former stockholders of Silverback. 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 a share of ARS Pharma’s common stock. 116 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 $ 4.4 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 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 is recorded as a reduction to additional paid-in capital in th e accompanying consolidated statement of convertible preferred stock and stockholders’ equity (deficit) for the year ended December 31, 2022. 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. In 2021, based on the borrowing rates currently available to the Company for loans with similar terms, management believe the fair value of the note payable approximates its carrying value. In 2022, the note payable was fully paid off. The following table identifies the Company’s assets that were measured at fair value on a recurring basis (in thousands): December 31, 2022 Level Amortized Cost Gross unrealized gains Gross unrealized losses Estimated Fair Value Money market funds 1 $ 209,273 $ — $ — $ 209,273 Short-term investments - U.S. Treasury securities 1 63,456 407 — 63,863 Total 1 272,729 407 — 273,136 December 31, 2021 Money market funds 1 $ 59,401 $ — $ — $ 59,401 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. 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. As of December 31, 2022, the Company did not have any investments in an unrealized loss position. 117 As of December 31, 2022, the Company did not have any liabilities that were measured at fair value on a recurring basis. As a result of the Merger, the preferred stock warrant liability that was outstanding was remeasured as of the Merger date and reclassified to equity. During 2022, the Company recorded total other expense relating to this warrant of $ 0.1 million. 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. 5. Balance Sheet Details Prepaid expenses and other current assets consisted of the following (in thou sands): December 31, 2022 December 31, 2021 Prepaid insurance $ 1,539 $ 666 Prepaid expenses 771 — Interest receivable 796 1 Other receivables 213 — Total $ 3,319 $ 667 Property and equipment consisted of the following (in thousands): December 31, 2022 December 31, 2021 Equipment $ 377 $ 86 Less accumulated depreciation ( 48 ) ( 14 ) Total $ 329 $ 72 Depreciation expense was immaterial for the years ended December 31, 2022 and 2021. Other assets consisted of the following (in thousands): December 31, 2022 December 31, 2021 Prepaid insurance $ 2,940 $ — Security deposit 21 23 Total $ 2,961 $ 23 Accounts payable and accrued liabilities consisted of the following (in thousands): December 31, 2022 December 31, 2021 Accounts payable $ 1,659 $ 1,786 Accrued legal and professional fees 908 53 Accrued clinical expenses 609 477 Accrued compensation 447 660 Accrued tax expenses 174 — Accrued development expenses 133 109 Other 1,001 22 Total $ 4,931 $ 3,107 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. 118 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, 2022. 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, 2022. 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 the $ 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. The 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 $ 0.1 million and $ 0.2 million for the years ended December 31, 2022 and 2021 , respectively and had a contract liability of an immaterial amount and $ 0.1 million as of December 31, 2022 and 2021, respectively. 119 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 Recordati Agreement, the Company is responsible for completion of any clinical studies for neffy required by the European Medicines Agency (“EMA”) before granting European Union Marketing Authorization, and by the Medicines and Healthcare products Regulatory Agency (“MHRA”) prior to granting United Kingdom Marketing Authorization. The Company filed the initial regulatory submissions with the EMA in the fourth quarter of 2022 and will file the initial regulatory submissions with the MHRA for neffy and is responsible for the manufacturing of commercial supply. Recordati is solely responsible all regulatory activities in the region after the Company’s initial regulatory submissions to the EMA and MHRA, for any post-approval clinical studies and commercialization activities. Either party may terminate the Recordati Agreement for certain breaches. Unless terminated earlier by either or both parties, the term of the Recordati Agreement will continue as long as Recordati has commercial sales of neffy in the region. 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. In addition, the Company is eligible to receive up to 90.0 million euros 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 Recordati. The per unit commercial supply costs are subject to a cap. The combined tiered royalty and supply price have a low double-digit cap. 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. These estimates will be re-assessed at each reporting period. 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. The Company recognized revenue of $ 1.2 million and $ 2.3 million for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022 and 2021 , there was a contract liability of $ 3.1 million and $ 4.4 million, respectively. 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 and the Company will reacquire all of the Recordati’s rights under the Recordati Agreement, as described in Note 14- Subsequent Events . 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. 120 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 collaboration agreements was as follows (in thousands): Balance at December 31, 2021 $ 4,453 Revenue recognized ( 1,316 ) Balance at December 31, 2022 $ 3,137 7. Commitments and Contingencies Note Payable In September 2019, the Company entered into a Loan and Security Agreement (“Loan 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. The Company recognized interest expense of $ 0.6 million and $ 0.8 million for the years ended December 31, 2022 and 2021 , respectively, and debt discount amortization of $ 0.3 million and $ 0.2 million for the years ended December 31, 2022 and 2021, respectively. 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. 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, 2022, the remaining lease term of the Company’s operating lease was 26 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 and immaterial for the years ended December 31, 2022 and 2021 , respectively. The Company's variable lease expense was $ 0.1 million and immaterial for the years ended December 31, 2022 and 2021 , respectively. Cash paid for amounts included in the measurement of lease liabilities was $ 0.2 million and zero for the years ended December 31, 2022 and 2021, respectively. 121 Future minimum noncancelable operating lease payments are as follows (in thousands): Year ended December 31, Amount 2023 $ 238 2024 245 2025 42 Total lease payments 525 Less imputed interest ( 44 ) Lease liability 481 Less current portion of lease liability ( 230 ) Lease liability, net of current portion $ 251 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 (“IPR”) 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, including the Company’s neffy product candidate, 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. Both the Company and Amphastar have the right to file a motion for reconsideration with the USPTO in addition to a notice of appeal with the United States Court of Appeals for the Federal Circuit. Although the results of any motion for reconsideration or notice of appeal are inherently unpredictable and uncertain, and could result in either the USPTO or the Federal Circuit finding some or all of claims 1-20 of the ‘414 patent to be invalid or unenforceable, the Company does not believe that an adverse outcome will have a material adverse effect on its business, operating results, cash flows or financial condition. On November 5, 2021, a securities class action complaint was filed against Silverback and certain of Silverback’s former officers and directors in the U.S. District for the Western District of Washington, captioned Dresner v. Silverback Therapeutics, Inc., et al., Case No. 2:21-cv-01499 (the “Dresner Case”). The court has appointed lead plaintiff and lead plaintiff's counsel, and plaintiff's counsel then filed the amended complaint on April 11, 2022. The amended complaint alleges that between December 3, 2020 and March 31, 2022, Silverback and certain of its officers and directors violated (1) Sections 11 and 15 of the Securities Act of 1933, as amended; and (2) Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Securities and Exchange Commission (“SEC”) Rule 10b-5 promulgated thereunder, by making allegedly false and misleading statements in various SEC filings and press releases regarding the clinical and commercial prospects of its product candidate, SBT6050, which is now discontinued. The complaint seeks unspecified damages and interest, as well as attorneys’ fees and other costs. Silverback and the other defendants filed a motion to dismiss on May 26, 2022 and lead plaintiff filed an opposition brief on July 11, 2022. On August 10, 2022, Silverback and the other defendants filed a reply brief. The court held a hearing on October 28, 2022 and issued an order granting defendants’ motion to dismiss without prejudice on November 4, 2022. Plaintiffs were given leave to amend and filed a Second Amended Complaint (“SAC”) on December 5, 2022, which asserted Section 11 claims only with respect to Silverback’s December 3, 2020 IPO and Section 10(b) claims during a shorter class period of March 29, 2021 through March 31, 2022. Defendants filed a motion to dismiss the SAC on January 2, 2023. Lead plaintiff filed an opposition brief on January 23, 2023, and defendants filed a reply brief January 27, 2023. The court is expected to issue a ruling on the motion to dismiss in the first half of 2023. 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 either 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, 2022. Except as described above, the Company is not currently involved in any legal proceeding that it believes could have a materially adverse effect on its financial condition or results of operations. 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. 122 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 New Drug Application (“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, 2022 and 2021. 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. Expense recognized under the Supply Agreement was $ 1.0 million and $ 0.2 million for the years ended December 31, 2022 and 2021, respectively. Manufacturing Agreement with Renaissance In September 2020, the Company entered into a manufacturing agreement (the “Renaissance Agreement”) with Renaissance Lakewood, LLC (“Renaissance”). 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. 123 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. Expense recognized under the Renaissance Agreement was $ 2.0 million and $ 3.1 million for the years ended December 31, 2022 and 2021 , respectively. 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 April 2016, the ARS Pharma issued 3,600,000 shares of Series A convertible preferred stock at $ 0.0833 per share for net cash proceeds of $ 0.3 million. Subsequently, in July 2017, an additional 1,164,000 shares of Series A convertible preferred stock were issued at $ 0.0833 per share for net cash proceeds of $ 0.1 million. In March, June and July 2018, ARS Pharma issued a total of 606,060 shares of Series B convertible preferred stock at $ 1.65 per share for net cash proceeds of $ 1.0 million. In September and December 2018, ARS Pharma issued 7,692,309 shares of Series C convertible preferred stock at $ 2.60 per share for net cash proceeds of $ 19.8 million. In August 2021, ARS Pharma issued 9,337,066 shares of Series D convertible preferred stock at $ 5.89 per share for net cash proceeds of $ 54.8 million. Collectively, the Series A, B, C and D convertible preferred stock issuances will be referred to as “Series Convertible Preferred Stock.” On November 8, 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 preferred stock were converted into 26,473,899 shares of ARS Pharma’s common stock. Common Stock Upon completion of the Merger on November 8, 2022, 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, 2022 Common stock options granted and outstanding 12,063,560 Common stock reserved for future awards or option grants 3,373,801 Total 15,437,361 124 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): Years Ended December 31, 2022 2021 Research and development expense $ 213 $ 2,114 General and administrative expense 5,630 715 Total stock-based compensation expense $ 5,843 $ 2,829 As of December 31, 2022 , the total unrecognized stock-based compensation expense was $ 4.6 million, which is expected to be recognized over a remaining weighted-average period of approximately 2.48 years. For the year ended December 31, 2022, ARS Pharma recognized $ 1.3 million in stock-based compensation expense for 236,380 performance-based option s that vested upon the closing of the Merger. For the year ended December 31, 2021, no performance-based stock-based compensation was recognized. In connection with the Merger, the Company repl aced (only for accounting purposes) 6,599,068 stock options and 493,456 restricted stock units held by Silverback employees and directors. The replacement awards were revalued at their acquisition-date fair value and then attributed to pre and post-combination service. This resulted in $ 3.1 million in expense attributed to post-combination service to be recognized as compensation cost by the Company, of which $ 3.0 million has been recognized in general and administrative expense in the accompanying consolidated statements of operations for the year ended December 31, 2022. 482,805 replaced restricted stock units vested in connection with the Merger and the remaining 10,651 are outstanding as of December 31, 2022. 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, as the accounting acquirer, is deemed to have assumed Silverback's 2016 and 2020 Equity Incentive Plans, and Employee Stock Purchase Plan (“ESPP”). For the year ended December 31, 2022 , ESPP activity is not material to the consolidated financial statements . As of December 31, 2022 , the 2016 and 2020 Equity Incentive Plans authorized a total of 11,321,495 shares, of which 3,079,688 shares are available for future grant, and 6,439,311 shares are outstanding. As of December 31, 2022 , the 2018 Equity Incentive Plan authorized a total of 6,634,333 shares, of which 294,113 shares are available for future grant, and 5,634,900 shares are outstanding. The Company does not intend to grant future stock options or other equity awards under the 2018 Equity Incentive Plan. 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. 125 A summary of the Company’s stock option activity for the year ended December 31, 2022 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, 2021 4,828,667 $ 1.06 Assumed in the Merger 6,599,068 $ 10.14 Granted 1,472,647 $ 1.50 Exercised ( 548,768 ) $ 1.04 Forfeited ( 288,054 ) $ 1.26 Outstanding at December 31, 2022 12,063,560 $ 6.07 5.56 $ 60,437 Vested and expected to vest at December 31, 2022 12,063,560 $ 6.07 5.56 $ 60,437 Exercisable at December 31, 2022 12,032,474 $ 6.06 5.56 $ 60,336 The exercisable shares subject to options outstanding at December 31, 2022 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, 2022. The aggregate intrinsic value of options exercised during the years ended December 31, 2022 and 2021 was $ 1.2 million and $ 0.1 million, respectively. The weighted-average grant date fair value per share of option grants for the years ended December 31, 2022 and 2021 was $ 1.50 and $ 0.97 , respectively. The total fair value of shares vested during the years ended December 31, 2022 and 2021 was $ 2.7 million and $ 0.4 million, respectively. The fair value of stock options granted or assumed in connection with the Merger was estimated using a Black-Scholes option-pricing model ( “Black-Scholes”) with the following weighted-average assumptions: Assumed on Years Ended December 31, November 8, 2022 2022 2021 Expected term (in years) 0.8 6.1 6.0 Expected volatility 98.9 % 91.3 % 91.6 % Risk-free interest rate 4.5 % 2.1 % 1.2 % Expected dividend yield — — — 126 The fair value of stock options was determined using the Black-Scholes assumptions below. Each of these inputs is subjective and generally requires significant judgement. 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. 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. 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. 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, 2022 2021 Tax computed at federal statutory rate $ ( 7,283 ) $ ( 4,251 ) State income taxes, net of federal benefit ( 21 ) ( 9 ) Equity compensation 290 562 Research and development credits ( 624 ) ( 1,120 ) Other 452 38 Valuation allowance 7,186 4,780 Provision for income taxes $ — $ — 127 Significant components of the Company’s net deferred tax assets were as follows (in thousands): Years Ended December 31, 2022 2021 Deferred tax assets: Net operating losses $ 8,252 $ 5,457 Research and development credits 2,964 2,340 Intangible assets 3,746 219 Equity compensation 2,279 63 Contract liability 661 943 Other 104 257 Total deferred tax assets 18,006 9,279 Deferred tax liabilities: ROU asset ( 94 ) ( 131 ) Other ( 155 ) ( 10 ) Total deferred liabilities ( 249 ) ( 141 ) Gross deferred tax assets 17,757 9,138 Valuation allowance ( 17,757 ) ( 9,138 ) 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, 2022 was an increase of $ 8.6 million. At December 31, 2022, the Company had federal and state net operating loss carryforwards (“NOL”) of $ 38.9 million and $ 7.2 million, respectively. Federal NOL carryforwards of $ 38.9 million, generated after 2017, may be carryforward indefinitely but can only be utilized to offset 80 % of future taxa ble income. The state NOL carryforwards begin expiring in 2036. State NOLs totaling $ 1.6 million may be carried forward indefinitely. In addition, the Company also has federal and California research and development credit carryforwards totaling $ 3.4 million and $ 0.7 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, 2022. 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. 128 The following table summarizes the reconciliation of the unrecognized tax benefits activity during the years ended December 31, 2022 and 2021 (in thousands): Years Ended December 31, 2022 2021 Unrecognized tax benefits - beginning $ 1,147 $ 941 Gross increase – current-period tax positions 373 206 Unrecognized tax benefits - ending $ 1,520 $ 1,147 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 within the United 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, 2022, 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 Revenue Service (the “IRS”) annual limits. The Company matches up to 5 % of an employee’s contributions, subject to IRS limitations. Expense associated with the Company’s matching contribution totaled $ 0.1 million for the year ended December 31, 2022 . 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 Consulting, LLC, an entity owned by the President/Chief Executive Officer/director and the Chief Medical Officer of the Company. The Company incurred consulting expense related to this agreement totaling $ 2.1 million and $ 1.1 million during the years ended December 31, 2022 and 2021, 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. In addition, Marlinspike Group provides the use of its facilities to the Company from time to time. 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, 2022 and 2021. 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 Executive Vice President of Commercial Strategy of the Company. The Company incurred consulting expense related to this agreement totaling $ 0.2 million and $ 0.1 million during the years ended December 31, 2022 and 2021, respectively. 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, 2022 and 2021. 129 14. Subsequent Events Termination Agreement On February 22, 2023, the Company entered into the Termination Agreement with Recordati, pursuant to which, among other things, the Company and Recordati agreed to terminate the Recordati License and Supply Agreement. Pursuant to the Termination Agreement, the Company will reacquire all of the Recordati Rights and has agreed to pay Recordati a one-time upfront payment of € 3.0 million and 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) milestone payments of up to € 5.0 million in the aggregate from sales of Recordati Licensed Product(s) in the Recordati Territory. Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure. None.