Jade Biosciences, Inc. 10-K

Item 9A. Controls and Procedures. Management’s Evaluation of our Disclosure Controls and Procedures We maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our principal executive and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their control objectives. Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2024. Based upon such evaluation, our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of such date. Management’s Report on Internal Control over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as a process designed by, or under the supervision of, our principal executive officer and our principal financial officer, and effected by our board of directors, management, and other personnel, to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP, and includes those policies and procedures that: ● pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of assets; ● provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that receipts and expenditures are being made only in accordance with authorizations of management and directors; and ● provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our financial statements. Under the supervision of and with the participation of our management, including our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework provided in Internal Control—Integrated Framework issued by the Committee of Sponsoring 77 Table of Contents Organizations of the Treadway Commission in (2013 Framework). Based on this evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2024. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Attestation Report of the Registered Public Accounting Firm This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm due to an exemption established by the JOBS Act for “emerging growth companies.” Changes in Internal Control over Financial Reporting There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this Annual Report on Form 10-K that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. Item 9B. Other Information. (a) None. (b) Rule 10b5-1 Plans ​ On November 4, 2024 , Timothy Noyes , our Chief Executive Officer , terminated a trading arrangement that was intended to satisfy the affirmative defense of Rule 10b5-1(c), or the Noyes 10b5-1 Plan. The Noyes 10b5-1 Plan was entered into on November 27, 2023, and commenced on April 1, 2024, with a termination date of the earlier of July 31, 2025, or the date all shares under the plan were sold. The aggregate number of securities sold under the Noyes 10b5-1 Plan was 40,000 . On November 4, 2024 , Ralph Niven , our former Chief Scientific Officer , terminated a trading arrangement that was intended to satisfy the affirmative defense of Rule 10b5-1(c), or the Niven 10b5-1 Plan. The Niven 10b5-1 Plan was entered into on April 9, 2024, and commenced on August 8, 2024, with a termination date of the earlier of April 9, 2025, or the date all shares under the plan were sold. There were no securities sold under the Niven 10b5-1 Plan. ​ Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. Not applicable. PART III Item 10. Directors, Executive Officers and Corporate Governance. The information required by this Item 10 is incorporated herein by reference from our Registration Statement on Form S-4, as amended, which is deemed to be a definitive proxy statement under Section 14a-6 of the Exchange Act, that has been filed with the SEC on March 25, 2025, or the 2025 Proxy Statement, under the captions “Proposal No. 7 – The Director Election Proposal,” “Aerovate Executive Officers and Corporate Governance,” and “Proposal No. 8 – The Auditor Ratification Proposal.”. 78 Table of Contents Item 11. Executive Compensation. The information required by this Item 11 is incorporated herein by reference from the 2025 Proxy Statement, including the information in the 2025 Proxy Statement appearing under the captions “Aerovate Executive Compensation” and “Aerovate Executive Officers and Corporate Governance.” Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. The information required by this Item 12 is incorporated herein by reference from the 2025 Proxy Statement, including the information in the 2025 Proxy Statement appearing under the captions “Equity Compensation Plan Information” and “Principal Stockholders of Aerovate.” Item 13. Certain Relationships and Related Transactions, and Director Independence. The information required by this Item 13 is incorporated herein by reference from the 2025 Proxy Statement, including the information in the 2025 Proxy Statement appearing under the captions “Certain Relationships and Related Party Transactions of the Combined Company” and “Proposal No. 7 – The Director Election Proposal.” Item 14. Principal Accounting Fees and Services. Our independent public accounting firm is KPMG LLP, San Diego, California (PCAOB Auditor ID: 185 ). The information required by this Item 14 is incorporated herein by reference from the 2025 Proxy Statement, including the information in the 2025 Proxy Statement appearing under the caption “Proposal No. 8 – The Auditor Ratification Proposal.”. PART IV Item 15. Exhibits, Financial Statement Schedules 1. All financial statements. Our consolidated financial statements, together with the report thereon of KPMG LLP, our independent registered public accounting firm, are included in this annual report on Form 10-K beginning on page F-1. 2. Financial statement schedules. All schedules have been omitted because the information required to be set forth therein is not applicable or is shown in the consolidated financial statements or notes thereto. 3. Exhibits A list of exhibits is set forth on the Exhibit Index immediately preceding the signature page of this annual report on Form 10-K and is incorporated herein by reference. Item 16. Form 10-K Summary We have elected not to include summary information. ​ ​ 79 Table of Contents AEROVATE THERAPEUTICS, INC. INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm (Auditor Firm ID: 185) F-2 Consolidated Balance Sheets F-3 Consolidated Statements of Operations and Comprehensive Loss F-4 Consolidated Statements of Stockholders’ Equity F-5 Consolidated Statements of Cash Flows F-6 Notes to Consolidated Financial Statements F-7 ​ ​ ​ F-1 Table of Contents REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Stockholders and Board of Directors Aerovate Therapeutics, Inc.: Opinion on the Consolidated Financial Statements We have audited the accompanying consolidated balance sheets of Aerovate Therapeutics, Inc. and subsidiary (the Company) as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for the years then ended, and the related notes (collectively, the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for the years then ended, in conformity with U.S. generally accepted accounting principles. Basis for Opinion These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated 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 consolidated 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 consolidated 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 consolidated 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 consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion. /s/ KPMG LLP ​ We have served as the Company’s auditor since 2019. ​ San Diego, California February 24, 2025 ​ F-2 Table of Contents AEROVATE THERAPEUTICS, INC. CONSOLIDATED BALANCE SHEETS (IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ ​ 2024 2023 Assets ​ ​ ​ Current assets: ​ ​ ​ Cash and cash equivalents ​ $ 33,751 ​ $ 23,491 ​ Short-term investments ​ 44,872 ​ 98,948 ​ Prepaid expenses and other current assets ​ 1,494 ​ 1,793 ​ Total current assets ​ 80,117 ​ 124,232 ​ Property and equipment, net ​ 6 ​ 288 ​ Operating lease right-of-use assets ​ 209 ​ 614 ​ Other long-term assets ​ — ​ 2,284 ​ Total assets ​ $ 80,332 ​ $ 127,418 ​ ​ ​ ​ ​ ​ ​ ​ ​ Liabilities and Stockholders’ Equity ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Current liabilities: ​ ​ ​ Accounts payable ​ $ 224 ​ $ 2,396 ​ Accrued and other current liabilities ​ 3,187 ​ 14,821 ​ Operating lease liabilities ​ 417 ​ 420 ​ Total current liabilities ​ 3,828 ​ 17,637 ​ Operating lease liabilities, net of current portion ​ — ​ 255 ​ Other liabilities ​ 70 ​ 70 ​ Total liabilities ​ 3,898 ​ 17,962 ​ ​ ​ ​ ​ ​ ​ ​ ​ Commitments and contingencies (Note 5) ​ ​ ​ Stockholders’ equity: ​ ​ ​ Preferred stock, $ 0.0001 par value; 10,000,000 shares authorized as of December 31, 2024 and December 31, 2023, respectively; no shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively ​ ​ — ​ ​ — ​ Common stock, $ 0.0001 par value; 150,000,000 shares authorized at December 31, 2024 and December 31, 2023, respectively; 28,985,019 and 27,762,703 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively ​ 3 ​ 3 ​ Additional paid-in capital ​ 309,378 ​ 272,640 ​ Accumulated other comprehensive gain ​ 105 ​ 237 ​ Accumulated deficit ​ ( 233,052 ) ​ ( 163,424 ) ​ Total stockholders’ equity ​ 76,434 ​ 109,456 ​ Total liabilities and stockholders’ equity ​ $ 80,332 ​ $ 127,418 ​ ​ See accompanying notes to consolidated financial statements. ​ F-3 Table of Contents AEROVATE THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (IN THOUSANDS, EXCEPT SHARE AND PER SHARE AMOUNTS) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2024 2023 Operating expenses: ​ ​ ​ Research and development ​ $ 53,187 ​ $ 64,219 ​ General and administrative ​ 21,409 ​ 17,190 ​ Total operating expenses ​ 74,596 ​ 81,409 ​ Loss from operations ​ ( 74,596 ) ​ ( 81,409 ) ​ Other income (expense): ​ ​ ​ Interest income ​ 5,042 ​ 5,945 ​ Other expense: ​ ( 19 ) ​ ( 1 ) ​ Total other income ​ 5,023 ​ 5,944 ​ Net loss before income taxes ​ ( 69,573 ) ​ ( 75,465 ) ​ Provision for income taxes ​ 55 ​ 56 ​ Net loss ​ $ ( 69,628 ) ​ $ ( 75,521 ) ​ Comprehensive loss: ​ ​ ​ Net loss ​ $ ( 69,628 ) ​ $ ( 75,521 ) ​ Other comprehensive loss: ​ ​ ​ Unrealized (loss) gain on securities ​ ( 132 ) ​ 703 ​ Comprehensive loss ​ $ ( 69,760 ) ​ $ ( 74,818 ) ​ Net loss per share, basic and diluted ​ $ ( 2.44 ) ​ $ ( 2.87 ) ​ Weighted-average shares of common stock outstanding, basic and diluted ​ 28,582,194 ​ 26,331,630 ​ ​ See accompanying notes to consolidated financial statements. ​ ​ F-4 Table of Contents AEROVATE THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (IN THOUSANDS, EXCEPT SHARE AMOUNTS) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ Other ​ ​ ​ ​ Total ​ ​ Common Stock ​ Paid-In ​ Comprehensive ​ Accumulated ​ Stockholders’ ​ Shares Amount Capital (Loss) Income Deficit Equity Balance at December 31, 2022 24,722,974 ​ $ 2 ​ $ 215,110 ​ $ ( 466 ) ​ $ ( 87,903 ) ​ $ 126,743 Unrealized gain on investments — ​ — ​ — ​ 703 ​ — ​ 703 Stock based compensation — ​ — ​ 11,906 ​ — ​ — ​ 11,906 Issuance of common stock in connection with ATM, net 2,662,721 ​ 1 ​ 44,282 ​ — ​ — ​ 44,283 Vesting of restricted stock units 9,913 ​ — ​ — ​ — ​ — ​ — Issuance of common stock upon exercise of stock options ​ 338,987 ​ ​ — ​ ​ 986 ​ ​ — ​ ​ — ​ ​ 986 Issuance of common stock under ESPP ​ 28,108 ​ ​ — ​ ​ 356 ​ ​ — ​ ​ — ​ ​ 356 Net loss — ​ — ​ — ​ — ​ ( 75,521 ) ​ ( 75,521 ) Balance at December 31, 2023 27,762,703 ​ $ 3 ​ $ 272,640 ​ $ 237 ​ $ ( 163,424 ) ​ $ 109,456 Unrealized loss on investments — ​ — ​ — ​ ( 132 ) ​ — ​ ( 132 ) Issuance of common stock in connection with ATM, net ​ 800,000 ​ ​ — ​ ​ 23,635 ​ ​ — ​ ​ — ​ ​ 23,635 Issuance of common stock upon exercise of stock options ​ 382,790 ​ ​ — ​ ​ 1,484 ​ ​ — ​ ​ — ​ ​ 1,484 Issuance of common stock under ESPP 34,034 ​ — ​ 308 ​ — ​ — ​ 308 Vesting of restricted stock units 5,492 ​ — ​ — ​ — ​ — ​ — Stock based compensation — ​ — ​ 11,311 ​ — ​ — ​ 11,311 Net loss — ​ — ​ — ​ — ​ ( 69,628 ) ​ ( 69,628 ) Balance at December 31, 2024 28,985,019 ​ $ 3 ​ $ 309,378 ​ $ 105 ​ $ ( 233,052 ) ​ $ 76,434 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ See accompanying notes to consolidated financial statements. ​ ​ F-5 Table of Contents AEROVATE THERAPEUTICS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ ​ ​ 2024 2023 ​ Cash flow from operating activities: ​ ​ ​ Net loss ​ $ ( 69,628 ) ​ $ ( 75,521 ) ​ ​ Adjustments to reconcile net loss to net cash used in operating activities: ​ ​ ​ ​ Stock-based compensation expense ​ 11,311 ​ 11,906 ​ ​ Depreciation and amortization expense ​ 282 ​ 96 ​ ​ Impairment of right-of-use asset ​ ​ 256 ​ ​ — ​ ​ Accretion of discounts and amortization of premiums on investments, net ​ ( 2,248 ) ​ ( 3,057 ) ​ ​ Changes in operating assets and liabilities: ​ ​ ​ ​ Prepaid expenses and other current assets ​ 299 ​ 483 ​ ​ Other long-term assets ​ 563 ​ ( 110 ) ​ ​ Accounts payable ​ ( 2,172 ) ​ ( 164 ) ​ ​ Accrued and other liabilities ​ ( 9,913 ) ​ 9,999 ​ ​ Operating lease assets and liabilities, net ​ ( 109 ) ​ ( 26 ) ​ ​ Other liabilities ​ 163 ​ ( 384 ) ​ ​ Net cash used in operating activities ​ $ ( 71,196 ) ​ $ ( 56,778 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cash flow from investing activities: ​ ​ ​ ​ Purchases of short-term investments ​ ​ ( 19,683 ) ​ ​ ( 123,982 ) ​ ​ Maturities of short-term investments ​ ​ 75,712 ​ ​ 136,000 ​ ​ Purchases of property and equipment ​ — ​ ( 142 ) ​ ​ Net cash provided by investing activities ​ $ 56,029 ​ $ 11,876 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cash flow from financing activities: ​ ​ ​ ​ Proceeds from sale of common stock in connection with ATM, net ​ 23,942 ​ 44,888 ​ ​ Payments for offering costs ​ ​ ( 307 ) ​ ​ ( 234 ) ​ ​ Proceeds from issuance of common stock under ESPP ​ ​ 308 ​ ​ 356 ​ ​ Proceeds from issuance of common stock upon exercise of stock options ​ 1,484 ​ 986 ​ ​ Net cash provided by financing activities ​ $ 25,427 ​ $ 45,996 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Net increase in cash and cash equivalents ​ 10,260 ​ 1,094 ​ ​ Cash and cash equivalents at the beginning of the year ​ 23,491 ​ 22,397 ​ ​ Cash and cash equivalents at the end of the period ​ $ 33,751 ​ $ 23,491 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Supplemental disclosure of noncash investing and financing activities: ​ ​ ​ ​ Right-of-use asset obtained in exchange for operating lease liability ​ $ 206 ​ $ — ​ ​ ​ See accompanying notes to consolidated financial statements. ​ F-6 Table of Contents AEROVATE THERAPEUTICS, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (1) ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (a) Organization and Nature of Operations Aerovate Therapeutics Inc. (“Aerovate” or the “Company”) was incorporated in the state of Delaware in July 2018, and is headquartered in Waltham, Massachusetts. The Company has a wholly owned subsidiary, Aerovate Securities Corporation. The Company is a biopharmaceutical company. The Company’s initial focus was on advancing AV-101, the Company’s dry powder inhaled formulation of imatinib for the treatment of pulmonary arterial hypertension (“PAH”). However, in June 2024, the Company announced negative results from the Phase 2b portion of its global Phase 2b/Phase 3 trial of AV-101 in adults with PAH, and, as a result, the Company decided to halt enrollment and shut down the Phase 3 portion of the Phase 2b/Phase 3 trial as well as the long-term extension study. In June 2024, the Company announced a corporate restructuring and in July 2024, the Company engaged Wedbush Securities Inc. as the Company’s exclusive strategic financial advisor to assist in the process of exploring strategic alternatives, including but not limited to an acquisition, merger, reverse merger, business combination, liquidation or other transaction. On October 30, 2024, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”), by and among the Company, Caribbean Merger Sub I, Inc., a Delaware corporation and a wholly owned subsidiary of the Company (“Merger Sub I”), Caribbean Merger Sub II, LLC, a Delaware limited liability company and a wholly owned subsidiary of the Company (“Merger Sub II” and together with Merger Sub I, the “Merger Subs”), and Jade Biosciences, Inc., a Delaware corporation (“Jade”), pursuant to which, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, among other things, Merger Sub I will merge with and into Jade, with Jade surviving the merger as the surviving corporation (the “First Merger”), and as part of the same overall transaction, Jade will merge with and into Merger Sub II, with Merger Sub II continuing as a wholly owned subsidiary of the Company and the surviving corporation of the merger (the “Second Merger” and together with the First Merger, the “Merger”). In addition, in connection with the closing of the Merger (the “Closing”), the Company expects to declare a cash dividend to its pre-Merger stockholders of approximately $ 65.0 million in the aggregate (the “Cash Dividend”), provided such amount is subject to adjustment as set forth in the Merger Agreement. The Merger was approved by the Company’s board of directors (the “Board”), and the Board resolved to recommend approval of the Merger Agreement to the Company’s stockholders. The Closing is subject to approval by the stockholders of the Company and Jade as well as other customary closing conditions, including the effectiveness of a registration statement filed with the U.S. Securities and Exchange Commission (“SEC”) in connection with the transaction. If the Merger is completed, the business of Jade will continue as the business of the combined company. (b) At-the-Market Offering On April 5, 2023, the Company entered into an ATM Equity Offering SM Sales Agreement (the “Sales Agreement”) with BofA Securities, Inc., or the Agent, pursuant to which the Company can sell, from time to time, at its option, up to an aggregate of $ 75.0 million of shares of its common stock, through the Agent, as its sales agent. As of December 31, 2024, 3,462,721 shares have been sold under the Sales Agreement, generating $ 67.9 million of net proceeds after deducting commissions to the Agent and other offering costs. As of the date of this Annual Report on Form 10-K, up to $ 6.0 million of shares of the Company’s common stock remain available for sale from time to time under the Sales Agreement. (c) Liquidity and Management Plans Since inception, the Company has devoted substantially all of its resources to research and development activities, business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations and has not realized revenues from its planned principal operations. The Company has incurred losses and negative cash flows from operations since F-7 Table of Contents inception. As of December 31, 2024, the Company had cash and cash equivalents and short-term investments of $ 78.6 million. Management believes that the Company’s current cash and cash equivalents and short-term investments will provide sufficient funds to enable the Company to meet its obligations for at least twelve months from the filing date of this report while it explores strategic alternatives. (2) BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES (a) Basis of Presentation The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and include the Company’s wholly owned subsidiary, Aerovate Securities Corporation. All intercompany transactions and balances have been eliminated in consolidation. (b) Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Reported amounts and note disclosures reflect the overall economic conditions that are most likely to occur and anticipated measures management intends to take. Actual results could differ materially from those estimates. Accounting estimates and management judgements reflected in the consolidated financial statements include: normal recurring accruals, including the accrual for research and development expenses, stock-based compensation, fair value of investments, and operating lease right-of-use assets and lease liabilities. Estimates and assumptions are reviewed quarterly. Any revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. (c) Cash and Cash Equivalents Cash and cash equivalents include cash in readily available checking accounts, money market funds and commercial paper. The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. (d) Short-term Investments Short-term investments consist of corporate debt securities, commercial paper and U.S. Treasury bills, classified as available-for-sale securities and have maturities of greater than three months. The Company has classified all of its available-for-sale investment securities as current assets on the consolidated balance sheets because these are considered highly liquid securities and are available for use in current operations. The Company carries these securities at fair value and reports unrealized gains and losses as a separate component of accumulated other comprehensive loss. The cost of debt securities is adjusted for amortization of purchase premiums and accretion of discounts to maturity. Such amortization and accretion is included in interest income in the consolidated statements of operations and comprehensive loss. Realized gains and losses on sales of securities are determined using the specific identification method and recorded in other income (expense), net in the consolidated statement of operations and comprehensive loss. (e) Concentration of Credit Risk Financial instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash, cash equivalents and short-term investments. The Company maintains cash, cash equivalents and short-term investments with various high credit quality banks and other financial institutions in the United States. Such deposits may be in excess of federally insured limits. Management believes that the Company is not exposed to F-8 Table of Contents significant credit risk due to the financial position of the depository institutions in which those deposits are held. The Company has not experienced any losses on deposits since inception. (f) Comprehensive Loss Comprehensive loss consists of net loss and unrealized gains or losses on available-for-sale investments. The Company displays comprehensive loss and its components as part of the consolidated statements of operations and comprehensive loss. (g) Fair Value Measurements The accounting guidance defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or non-recurring basis. Fair value is defined as an 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 accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: Level 1: Observable inputs such as quoted prices in active markets. Level 2: Inputs, other than the quoted prices in active markets that are observable either directly or indirectly. Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions. The carrying amounts of prepaid expenses and other current assets, accounts payable, accrued liabilities and other current liabilities are reasonable estimates of their fair value due to the short-term nature of these accounts. (h) Prepaid Expenses and Other Current Assets Any expenses paid prior to the related services rendered are recorded as prepaid expenses. Such prepaid expenses are expensed in the period the expense is incurred. If the expense is for a service covering multiple periods, it is expensed from the date the services begin and over the period of the service rendered (or contract service period if services rendered dates are not defined). (i) Property and Equipment, Net Property and equipment, which consist of leasehold improvements, furniture and fixtures, research equipment, computers and construction-in-progress are stated at cost less accumulated depreciation or accumulated amortization. Depreciation and amortization is calculated using the straight-line method over the estimated useful lives of the assets, which ranges from three to five years . Leasehold improvements are amortized over the remaining life of the lease for leasehold improvements at the time the asset is placed into service. (j) Impairment of Long-lived Assets The carrying value of long-lived assets, including property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the asset may not be recoverable. An impairment loss is recognized when the total of estimated future undiscounted cash flows, expected to result from the use of the asset and its eventual disposition, are less than its carrying amount. Impairment, if any, would be assessed using discounted cash flows or other appropriate measures of fair value. Following the Company’s Workforce Reduction Plan, the Company terminated all employees in the Foster City office and vacated the premises in September 2024. As a result, the Company impaired the related right-of-use asset of approximately $ 0.3 million, and recognized a loss on impairment in its general and administrative operating expenses during the year ended December 31, 2024. F-9 Table of Contents (k) Leases At the commencement date of a lease, the Company recognizes lease liabilities which represent its obligation to make lease payments, and right-of-use assets (“ROU assets”) which represent its right to use the underlying asset during the lease term. The lease liability is measured at the present value of lease payments over the lease term. As the Company’s leases typically do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at the lease commencement date. The ROU asset is measured at cost, which includes the initial measurement of the lease liability and initial direct costs incurred by the Company and excludes lease incentives. ROU assets are recorded in operating lease ROU assets and lease liabilities are recorded in operating lease liabilities, current and noncurrent in the consolidated balance sheets. Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Operating lease expense is recognized on a straight-line basis over the lease term. The Company has elected not to separate lease and non-lease components and not recognize lease liabilities and ROU assets for short-term leases with terms of twelve months or less. (l) Research and Development Expenses Research and development costs are expensed as incurred. Research and development costs consist primarily of salaries and other benefits of research and development personnel, including associated share-based compensation, costs related to research activities, preclinical studies, clinical trial, drug manufacturing and allocated overhead and facility-related expenses. The Company accounts for non-refundable advance payments for goods or services that will be used in future research and development activities as expenses when the goods have been received or when the service has been performed rather than when the payment is made. Clinical trial costs are a component of research and development expenses. The Company expenses costs for its clinical trial activities performed by third parties, including clinical research organizations and other service providers, as they are incurred, based upon estimates of the work completed over the life of the individual study in accordance with associated agreements. The Company uses information it receives from internal personnel and outside service providers to estimate the clinical trial costs incurred. (m) Stock-Based Compensation Stock-based compensation expense represents the cost of the grant-date fair value of employee, officer, director, and non-employee stock option grants and restricted stock units, estimated in accordance with the applicable accounting guidance, recognized using the straight-line method over the vesting period for service-based options and using the graded vesting method for performance-based options. The vesting period generally approximates the expected service period of the awards. Forfeitures are recognized and accounted for as they occur. The fair value of stock options is estimated using a Black-Scholes option pricing model on the date of grant. This method requires certain assumptions be used as inputs, such as the fair value of the underlying common stock, expected term of the option before exercise, expected volatility of the Company’s common stock, expected dividend yield, and a risk-free interest rate. Options and awards granted during the year have a maximum contractual term of ten years . The Company has limited historical stock option activity and therefore estimates the expected term of stock options granted using the simplified method, which represents the average of the contractual term of the stock option and its weighted-average vesting period. The expected volatility of stock options is based upon the historical volatility of a number of publicly traded companies in similar stages of clinical development. The Company has historically not declared or paid any dividends and does not currently expect to do so in the foreseeable future. The risk-free interest rates used are based on the U.S. Department of Treasury (“U.S. Treasury”) yield in effect at the time of grant for zero-coupon U.S. Treasury notes with maturities approximately equal to the expected term of the stock options. F-10 Table of Contents (n) Income Taxes Income taxes are accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and net operating loss ("NOL") and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. 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. (o) Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker in making decisions on how to allocate resources and assess performance. The Company views its operations and manages its business as one operating segment. In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses on an interim and annual basis. The standard is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company adopted this standard in the current period and disclosed a summary of significant segment expenses in Note 9 to our consolidated financial statements. (p) Net Loss Per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period, without consideration of potential dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the sum of the weighted average number of common shares plus the potential dilutive effects of potential dilutive securities outstanding during the period. Potential dilutive securities are excluded from diluted earnings or loss per share if the effect of such inclusion is antidilutive. The Company’s potentially dilutive securities, which include outstanding stock options under the Company’s equity incentive plan, have been excluded from the computation of diluted net loss per share as they would be anti-dilutive to the net loss per share. For all periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to the Company’s net loss position. The following table summarizes the Company’s net loss per share: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 Numerator: ​ ​ Net loss ​ $ ( 69,628 ) ​ $ ( 75,521 ) Net loss attributable to common stockholders ​ $ ( 69,628 ) ​ $ ( 75,521 ) ​ ​ ​ ​ ​ ​ ​ Denominator: ​ ​ Weighted-average common stock outstanding, basic and diluted ​ 28,582,194 ​ 26,331,630 Net loss per share, basic and diluted ​ $ ( 2.44 ) ​ $ ( 2.87 ) ​ F-11 Table of Contents Potentially dilutive securities not included in the calculation of diluted net loss per share attributable to common stockholders because to do so would have had an anti-dilutive effect are as follows (in common stock equivalent shares): ​ ​ ​ ​ ​ ​ ​ As of December 31, ​ 2024 2023 Options to purchase common stock 2,434,535 5,230,344 Unvested restricted stock units ​ — ​ 21,968 ​ 2,434,535 5,252,312 ​ ​ ​ ​ ​ (q) Recently Issued Accounting Pronouncements In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740) : Improvements to Income Tax Disclosures, which expands disclosures in an entity’s income tax rate reconciliation table and regarding cash taxes paid both in the U.S. and foreign jurisdictions. The standard is effective for fiscal years beginning after December 15, 2024, and interim periods in fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact the adoption of this standard may have on its consolidated financial statements and related disclosures, and does not anticipate this ASU to materially impact our consolidated financial statements and related disclosures. On November 4, 2024, the FASB issued ASU 2024-03 Income Statement Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) , which requires disaggregated disclosure of income statement expenses for public business entities. ASU 2024-03 requires, in a tabular presentation, each relevant expense caption on the face of the income statement that includes any of the following natural expenses: (1) purchases of inventory, (2) employee compensation, (3) depreciation, (4) intangible asset amortization, and (5) depreciation, depletion, and amortization (DD&A) recognized as part of oil- and gas-producing activities or other types of depletion expenses. The tabular disclosure would also include certain other expenses, when applicable. The standard is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. The Company is currently evaluating the impact the adoption of this standard will have on its consolidated financial statements and related disclosures. ​ ​ (3) FAIR VALUE OF FINANCIAL INSTRUMENTS The following tables summarize the Company’s financial assets measured at fair value on a recurring basis and their respective input levels based on the fair value hierarchy (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Fair Value Measurements Using ​ ​ ​ ​ ​ Quoted Prices in ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Active Markets ​ Significant Other ​ Significant ​ ​ ​ ​ ​ for Identical ​ Observable ​ Unobservable ​ ​ December 31, ​ Assets ​ Inputs ​ Inputs ​ 2024 (Level 1) (Level 2) (level 3) Assets: ​ ​ ​ ​ ​ ​ ​ ​ Cash equivalents ​ ​ ​ ​ Money market funds ​ $ 33,529 ​ $ 33,529 ​ $ — ​ $ — Total cash equivalents ​ 33,529 ​ 33,529 ​ — ​ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Short-term investments ​ ​ ​ ​ Agency bonds ​ 27,429 ​ — ​ 27,429 ​ — Corporate debt securities ​ ​ 9,057 ​ ​ — ​ ​ 9,057 ​ ​ — U.S. Treasury bills ​ 8,386 ​ 8,386 ​ ​ — ​ ​ — Total short-term investments ​ 44,872 ​ 8,386 ​ 36,486 ​ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total fair value of assets ​ $ 78,401 ​ $ 41,915 ​ $ 36,486 ​ $ — F-12 Table of Contents ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Fair Value Measurements Using ​ ​ ​ Quoted Prices in ​ ​ ​ ​ ​ ​ ​ Active Markets Significant Other ​ Significant ​ ​ ​ for Identical Observable ​ Unobservable ​ December 31, Assets Inputs ​ Inputs ​ 2023 (Level 1) (Level 2) (level 3) Assets: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cash equivalents ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Money market funds ​ $ 19,787 ​ $ 19,787 ​ $ — ​ $ — Total cash equivalents ​ 19,787 ​ 19,787 ​ — ​ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Short-term investments ​ ​ ​ ​ Agency bonds ​ ​ 42,255 ​ ​ — ​ ​ 42,255 ​ ​ — Commercial paper ​ 38,386 ​ — ​ 38,386 ​ — U.S. Treasury bills ​ 10,362 ​ 10,362 ​ — ​ — Corporate debt securities ​ 7,945 ​ — ​ 7,945 ​ — Total short-term investments ​ 98,948 ​ 10,362 ​ 88,586 ​ — ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Total fair value of assets ​ $ 118,735 ​ $ 30,149 ​ $ 88,586 ​ $ — ​ Cash Equivalents and Short-Term Investments Financial assets measured at fair value on a recurring basis consist of the Company’s cash equivalents and short-term investments. Cash equivalents consisted of money market funds and commercial paper, and short-term investments consisted of U.S. Treasury bills, agency bonds, corporate debt securities, and commercial paper. The Company obtains pricing information from its investment manager and generally determines the fair value of investment securities using standard observable inputs, including reported trades, broker/dealer quotes, and bids and/or offers. The following tables summarize the Company’s short-term investments (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of December 31, 2024 ​ ​ ​ ​ ​ ​ ​ Gross ​ Gross ​ ​ ​ ​ ​ ​ ​ Amortized ​ unrealized ​ unrealized ​ Estimated fair ​ Maturity cost gains losses value Agency bonds 1 year or less ​ 27,358 ​ ​ 71 ​ ​ — ​ 27,429 ​ Corporate debt securities ​ 1 year or less ​ ​ 9,031 ​ ​ 27 ​ ​ ( 1 ) ​ ​ 9,057 ​ U.S. Treasury bills 1 year or less ​ 8,378 ​ 8 ​ — ​ 8,386 ​ ​ ​ ​ ​ $ 44,767 ​ $ 106 ​ $ ( 1 ) ​ $ 44,872 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of December 31, 2023 ​ ​ ​ ​ ​ ​ Gross ​ Gross ​ ​ ​ ​ ​ ​ Amortized unrealized ​ unrealized ​ Estimated fair ​ ​ Maturity cost gains losses value ​ Agency bonds 2 years or less ​ $ 42,090 ​ ​ 179 ​ ​ ( 14 ) ​ $ 42,255 ​ Commercial paper ​ 2 years or less ​ ​ 38,362 ​ ​ 29 ​ ​ ( 5 ) ​ ​ 38,386 ​ U.S. Treasury bills 2 years or less ​ 10,334 ​ 31 ​ ( 3 ) ​ 10,362 ​ Corporate debt securities 2 years or less ​ 7,925 ​ ​ 21 ​ ​ ( 1 ) ​ 7,945 ​ ​ ​ ​ ​ $ 98,711 ​ $ 260 ​ $ ( 23 ) ​ $ 98,948 ​ ​ F-13 Table of Contents The following tables summarize the Company’s short-term investments with unrealized losses for less than 12 months and 12 months or greater: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of December 31, 2024 ​ ​ Less than 12 months ​ 12 months or Greater ​ ​ ​ ​ ​ ​ ​ ​ Unrealized ​ ​ ​ Unrealized ​ Total ​ Total Unrealized ​ Fair Value Losses Fair Value Losses Fair Value ​ Losses Corporate debt securities $ 2,016 $ ( 1 ) ​ $ — ​ $ — $ 2,016 ​ $ ( 1 ) ​ $ 2,016 ​ $ ( 1 ) ​ $ — ​ $ — ​ $ 2,016 ​ $ ( 1 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of December 31, 2023 ​ ​ Less than 12 months ​ 12 months or Greater ​ ​ ​ ​ ​ ​ ​ ​ Unrealized ​ ​ ​ Unrealized ​ Total ​ Total Unrealized ​ Fair Value Losses Fair Value Losses Fair Value ​ Losses Commercial paper $ 6,042 $ ( 5 ) ​ $ — ​ $ — $ 6,042 ​ $ ( 5 ) Agency bonds ​ 3,760 ​ ​ ( 6 ) ​ ​ 6,579 ​ ​ ( 8 ) ​ ​ 10,339 ​ ​ ( 14 ) U.S. Treasury bills 488 ​ ( 2 ) ​ 1,007 ​ ( 1 ) ​ 1,495 ​ ​ ( 3 ) Corporate debt securities 3,110 ​ ( 1 ) ​ — ​ — ​ 3,110 ​ ​ ( 1 ) ​ $ 13,400 ​ $ ( 14 ) ​ $ 7,586 ​ $ ( 9 ) ​ $ 20,986 ​ $ ( 23 ) ​ The Company considers whether unrealized losses have resulted from a credit loss or other factors. The unrealized losses on the Company’s short-term investments as of December 31, 2024, were caused by fluctuations in market value and interest rates as a result of the economic environment and not credit risk. The Company concluded that an allowance for credit losses was unnecessary as of December 31, 2024. It is neither management’s intention to sell nor is it more likely than not that the Company will be required to sell these investments prior to recovery of their cost basis or recovery of fair value. Unrealized gains and losses are included in accumulated other comprehensive loss. Accrued interest receivable is written off through net realized investment gains (losses) at the time the issuer of the bond defaults or is expected to default on payment. Accrued interest receivable related to short-term investments was $ 0.5 million and $ 0.6 million as of December 31, 2024 and December 31, 2023, respectively. ​ ​ (4) BALANCE SHEET COMPONENTS Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ ​ 2024 2023 Other current assets ​ $ 845 ​ $ 250 ​ Prepaid expenses ​ ​ 649 ​ ​ 1,168 ​ Prepaid research and development ​ ​ — ​ ​ 375 ​ Total prepaid expenses and other current assets ​ $ 1,494 ​ $ 1,793 ​ ​ Accrued and Other Current Liabilities In June 2024, following the Company’s decision to halt further development of AV-101, the Company announced its plan to terminate nearly all of its workforce in the coming months (the “Workforce Reduction Plan”). As of December 31, 2024, 47 individuals, or approximately 92 % of the Company’s workforce, have been terminated. F-14 Table of Contents The affected individuals have been and will be provided severance benefits, including cash severance payments. Each affected individual’s eligibility for severance benefits is contingent upon entering into a separation agreement, which includes a general release of claims against the Company. In connection with the Workforce Reduction Plan, the Company incurred costs (in consideration of releases) of approximately $ 6.7 million, which are primarily one-time severance benefits, during the year ended December 31, 2024. The Company has paid approximately $ 3.8 million of severance benefits, and liabilities associated with the Workforce Reduction Plan were approximately $ 2.9 million as of December 31, 2024. The Company estimates that the remaining liabilities will be paid in the first quarter of 2025. Accrued and other current liabilities consisted of the following (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ ​ 2024 2023 ​ Accrued payroll and other employee benefits ​ ​ 2,868 ​ ​ 4,368 ​ Other ​ ​ 319 ​ ​ 1,090 ​ Accrued research and development ​ ​ — ​ ​ 9,363 ​ Total accrued and other current liabilities ​ $ 3,187 ​ $ 14,821 ​ ​ ​ (5) COMMITMENTS AND CONTINGENCIES In August 2021, the Company entered into a lease agreement (the “Waltham Lease”) for approximately 5,000 square feet of office space in Waltham, Massachusetts for the Company’s corporate headquarters. The Waltham Lease has a term of thirty-nine months (“Lease Term”), unless extended or earlier terminated. The Company has the option to extend the Waltham Lease for one additional period of three years . The Lease Term had an initial abatement period, and the initial base rent payable is approximately $ 18,000 per month following the abatement period. The initial base rent payable will increase by approximately 2 % per year over the Lease Term. The Waltham Lease commencement date was September 1, 2021. In January 2024, the Company entered into the First Amendment to the Waltham Lease resulting in the lease expiring on December 31, 2025, and an increase of $ 1.00 per rentable square foot during the additional lease term. In obtaining this lease extension, the Company no longer has the option to extend the Waltham Lease for one additional period of three years . In April 2022, the Company entered into a lease agreement (the “Foster City Lease”) for approximately 3,500 square feet of office space in Foster City, California. The Foster City Lease has a term of thirty-nine months , unless extended or earlier terminated. The Company has the option to extend the Foster City Lease for on additional period of one year . The base rent payable under the Lease Term will be $ 22,600 per month and will be subject to annual increase of 3 % on each anniversary. Following the Company’s Workforce Reduction Plan, the Company terminated all employees in the Foster City office and vacated the premises in September 2024. As a result, the Company impaired the related right-of-use asset of approximately $ 0.3 million, and recognized a loss on impairment in its general and administrative operating expenses during the year ended December 31, 2024. As of December 31, 2024, the future minimum annual lease payments under the operating leases were as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ Total Minimum ​ ​ ​ Lease Payments ​ 2025 $ 429 ​ Total operating lease payments ​ 429 ​ Less: Amount representing interest ​ ( 12 ) ​ Present value of net minimum lease payments ​ $ 417 ​ ​ ​ ​ ​ ​ ​ ​ ​ As the Company’s leases do not provide an implicit rate, the Company uses an incremental borrowing rate based on the information available at the lease commencement date. The components of operating leases for the years F-15 Table of Contents ended December 31, 2024 and December 31, 2023 were as follows (in thousands except lease term and discount rate): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ Operating lease liabilities: ​ 2024 2023 ​ Current ​ ​ 417 ​ ​ 420 ​ Non-current ​ ​ — ​ ​ 255 ​ Total lease liabilities ​ $ 417 ​ $ 675 ​ Weighted-average remaining lease term (in years) ​ 0.8 ​ 1.5 ​ Weighted-average incremental borrowing rate ​ 6.4 % 6.0 % ​ Supplemental cash flow information related to cash paid for amounts included in the measurement of operating lease liabilities was as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ 2024 2023 Cash paid included in operating cash flows ​ $ 507 ​ $ 442 ​ ​ Rent expense was as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year ended December 31, ​ 2024 2023 Operating lease ​ $ 458 ​ $ 464 ​ Short-term lease ​ 165 ​ — ​ Total rent expense ​ $ 623 ​ $ 464 ​ ​ ​ ​ (6) STOCKHOLDERS’ EQUITY On July 2, 2021, the Company’s certificate of amendment to its certificate of incorporation became effective, which provided 150,000,000 authorized shares of common stock with a par value of $ 0.0001 per share and 10,000,000 authorized shares of undesignated preferred stock with a par value of $ 0.0001 per share. The holders of the common stock are entitled to one vote for each share of common stock held at all meetings of stockholders. As of December 31, 2024, the Company had reserved the following shares of common stock for future issuance: ​ ​ ​ ​ ​ ​ December 31, 2024 Common stock options granted and outstanding 2,434,535 ​ Shares reserved for issuance under the 2021 Plan 4,144,366 ​ Reserved for future ESPP issuances 401,218 ​ Total 6,980,119 ​ ​ ​ (7) SHARE-BASED COMPENSATION (a) Stock Option Plan The Company’s 2021 Stock Option and Incentive Plan (the “2021 Plan”) was adopted by the Company’s board of directors and approved by the Company’s stockholders in June 2021 and became effective as of June 29, 2021. Upon the effectiveness of the 2021 Plan, the Company’s 2018 Equity Incentive Plan (the “2018 Plan”) was F-16 Table of Contents terminated and no further grants may be made thereunder. The Company’s 2021 Plan allows for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, stock bonuses, restricted stock, stock units and other forms of awards including cash awards to its officers, directors, employees, consultants and advisors. As of December 31, 2024, a total of 5,675,841 shares of the Company’s common stock were authorized for issuance with respect to awards granted under the 2021 Plan. The share limit will automatically increase on the first trading day in January of each year (commencing with 2022) by an amount equal to the lesser of (1) 4 % of the total number of outstanding shares of the Company’s common stock on the last trading day in December in the prior year, or (2) such lesser number as determined by the Company’s board of directors. Since adoption, the annual increases have accumulated to a total of 3,075,841 shares through January 1, 2024. Any shares subject to awards granted under the 2021 Plan or the 2018 Plan that are not paid, delivered or exercised before they expire or are canceled or terminated, or otherwise fail to vest, as well as shares used to pay the purchase or exercise price of such awards or related tax withholding obligations, will become available for new award grants under the 2021 Plan. As of December 31, 2024, 1,676,073 and 758,462 options been granted and outstanding under the 2021 Plan and 2018 Plan, respectively. The options that are granted under the 2021 Plan and the 2018 Plan are exercisable at various dates as determined upon grant and terminate within 10 years of the date of grant. The vesting period generally occurs over three to four years . The following table summarizes the option activity under the 2021 Plan and 2018 Plan for the year ended December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted- ​ ​ ​ ​ ​ ​ ​ ​ ​ Average ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Remaining ​ Aggregate ​ ​ ​ ​ Weighted-Average ​ Contractual Term ​ Intrinsic Value ​ Options Exercise Price (in years) (in thousands) Outstanding at December 31, 2023 5,230,344 ​ $ 13.66 8.16 ​ $ 49,728 ​ Granted 1,489,191 ​ ​ 19.70 ​ ​ ​ ​ Exercised ( 382,790 ) ​ ​ 3.88 ​ ​ Cancelled/Forfeited ( 3,902,210 ) ​ ​ 18.01 ​ ​ Outstanding at December 31, 2024 2,434,535 ​ $ 11.93 ​ 6.91 ​ $ 387 ​ Vested and exercisable at December 31, 2024 1,740,379 ​ ​ 10.22 ​ 6.44 ​ ​ 336 ​ ​ The weighted-average grant date fair value of stock option grants was $ 14.92 and $ 15.69 per share for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024 there was approximately $ 7.1 million of unrecognized stock-based compensation expense related to nonvested stock-based compensation arrangements granted under the 2021 Plan and 2018 Plan, which is expected to be recognized over a weighted-average period of 1.7 years. (b) Employee Stock Purchase Plan The Company’s Employee Stock Purchase Plan (the “ESPP”) was adopted by the Company’s board of directors and stockholders in June 2021 and became effective upon the consummation of the IPO. A total of 230,000 shares of the Company’s common stock is initially available for issuance under the ESPP. The share limit will automatically increase on the first trading day in January of each year (commencing with 2022) by an amount equal to the lesser of (1) 1 % of the total number of outstanding shares of the Company’s common stock on the last trading day in December in the prior year, or (2) such lesser number as determined by the Company’s board of F-17 Table of Contents directors. The number of shares available under the 2021 Plan increased by 247,229 shares effective January 1, 2023 as determined by the Company’s board of directors. The ESPP allows eligible employees to purchase shares of the Company’s common stock at a discount through payroll deductions of up to 15 % of their eligible compensation, subject to any plan limitations. The ESPP provides for six-month offering periods, and at the end of each offering period, employees are able to purchase shares at 85 % of the lower of the fair market value of the Company’s common stock on the first trading day of the offering period or on the last trading day of the offering period. As of December 31, 2024, 76,011 shares had been issued under the ESPP, and 401,218 shares authorized under the ESPP Plan were available for issuance. ​ (c) Restricted Stock Units As of December 31, 2024, 31,881 restricted stock units had been awarded under the 2021 Plan. A summary of the status of and changes in unvested restricted stock unit activity under the Company’s equity award plans for the year ended December 31, 2024, was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted- ​ ​ ​ ​ Average Grant ​ ​ ​ ​ Date Fair Value ​ ​ Units ​ Per Unit Unvested restricted stock units as of December 31, 2023 21,968 $ 22.26 ​ Granted — ​ ​ — ​ Vested ( 5,492 ) ​ 21.30 ​ Forfeited ( 16,476 ) ​ 22.58 ​ Unvested restricted stock units as of December 31, 2024 — ​ $ — ​ ​ Stock-based compensation of restricted stock units is based on the fair value of the Company’s common stock on the date of grant and recognized over the vesting period. The vesting period generally occurs over one to four years . As of December 31, 2024, the Company had had no unrecognized stock-based compensation expense related to its unvested restricted stock units. (d) Stock-Based Compensation Expense The Company estimated the fair value of stock options using the Black-Scholes valuation model. The Company accounts for any forfeitures of options when they occur. Previously recognized compensation expense for an award is reversed in the period that the award is forfeited. The fair value of stock options was estimated using the following assumptions: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2024 ​ 2023 Expected term (in years) 5.3 - 6.0 5.3 - 6.1 ​ Expected volatility 70.0 - 89.8 % 73.9 - 91.5 % ​ Risk-free interest rate 3.6 - 4.5 % 3.5 - 4.8 % ​ Expected dividend — — ​ ​ ​ F-18 Table of Contents Stock-based compensation expense recognized for stock option grants has been reported in the statements of operations and comprehensive loss as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2024 2023 General and administrative ​ $ 6,296 ​ $ 5,285 ​ Research and development ​ ​ 5,015 ​ ​ 6,621 ​ Total ​ $ 11,311 ​ $ 11,906 ​ ​ Stock-based compensation expense by type of award included within the consolidated statements of operations and comprehensive (loss) income was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2024 2023 ​ Stock options ​ $ 11,133 ​ $ 11,494 ​ Restricted stock awards and units ​ ​ 62 ​ ​ 201 ​ Employee stock purchase plan awards ​ ​ 116 ​ ​ 211 ​ Total ​ $ 11,311 ​ $ 11,906 ​ ​ ​ ​ ​ (8) INCOME TAXES Significant components of the Company’s net deferred tax assets are as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ 2024 2023 Deferred income tax assets: ​ ​ NOL carryforwards ​ $ 23,931 ​ $ 16,199 Research credit carryforwards ​ 7,870 ​ 5,153 Capitalized R&D ​ 26,132 ​ 19,404 Stock based compensation ​ ​ 1,044 ​ ​ 1,929 Other ​ 1,265 ​ 1,117 Gross deferred tax assets ​ 60,242 ​ 43,802 Less: valuation allowance ​ ( 60,199 ) ​ ( 43,596 ) Total deferred tax assets ​ 43 ​ 206 Deferred income tax liabilities: ​ ​ Other ​ ( 43 ) ​ ( 206 ) Total deferred tax liabilities ​ ( 43 ) ​ ( 206 ) Net deferred tax assets (liabilities) ​ $ — ​ $ — ​ F-19 Table of Contents A reconciliation between the provision for income taxes and income taxes computed using the U.S. federal statutory corporate tax rate is as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ Years ended December 31, ​ 2024 2023 U.S. Federal statutory income tax rate ​ $ ( 14,604 ) ​ $ ( 15,831 ) State taxes ​ ( 2,809 ) ​ ( 3,389 ) Permanent and other differences ​ 248 ​ 416 Stock-based compensation ​ 2,704 ​ 1,049 Research and development credits ​ ( 2,054 ) ​ ( 2,676 ) Change in valuation allowance ​ 16,570 ​ 20,487 Total tax provision ​ $ 55 ​ $ 56 ​ The Company had federal NOL carryforwards available of $ 95.7 million and $ 64.8 million as of December 31, 2024 and December 31, 2023, respectively, before consideration of limitations under Section 382 of the Internal Revenue Code or Section 382, as further described below. The NOL generated from 2018 onwards of $ 95.7 million will carryforward indefinitely and be available to offset up to 80% of future taxable income each year. Additionally, the Company had state NOL carryforwards available of $ 64.1 million and $ 43.9 million as of December 31, 2024 and December 31, 2023, respectively. The state NOLs may be used to offset future taxable income and will begin to expire in 2038. At December 31, 2024 the Company had federal and state research and development credit carryforwards available of $ 9.0 million and $ 2.2 million, respectively. The federal credit carryforwards will begin to expire in 2038, unless previously utilized. The Massachusetts credit carryforwards will begin expiring in 2036, unless previously utilized. The California credits carry forward indefinitely. The Company has established a full valuation allowance for its deferred tax assets due to uncertainties that preclude it from determining that it is more likely than not that the Company will be able to generate sufficient taxable income to realize such assets. Management assesses the available positive and negative evidence to estimate if sufficient future taxable income will be generated to utilize the existing deferred tax assets. A significant piece of objective negative evidence evaluated was the cumulative loss incurred since inception. Such objective evidence limits the ability to consider other subjective evidence such as the Company’s projections for future growth. Based on this evaluation, as of December 31, 2024 and December 31, 2023, a valuation allowance of $ 60.2 million and $ 43.6 million, respectively, has been recorded against all of the Company’s net deferred tax assets, as the Company has determined that none of the Company’s balance of net deferred tax assets is more likely than not to be realized. The amount of the deferred tax assets considered realizable, however, could be adjusted in the future if objective negative evidence in the form of cumulative losses is no longer present and additional weight may be given to subjective evidence, such as estimates of future taxable income during carryforward periods and the Company’s projections for growth. The future utilization of the Company’s NOL and tax credit carryforwards to offset future taxable income may be subject to a substantial annual limitation as a result of changes in ownership by stockholders that hold 5% or more of the Company’s common stock. An assessment of such ownership changes under Section 382 and 383 was not completed through December 31, 2024. Utilization of our net operating loss and income tax credit carryforwards may be subject to a substantial annual limitation due to ownership changes that may have occurred or that could occur in the future. These ownership changes may limit the amount of the net operating loss and income tax credit carryover that can be utilized annually to offset future taxable income. The Company will examine the impact of any potential ownership changes in the future. F-20 Table of Contents The following table summarizes the activity related to the Company’s gross unrecognized tax benefits at the beginning and end of the years ended December 31, 2024 and 2023 (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ Years ended December 31, ​ 2024 2023 Beginning balance of unrecognized tax benefits ​ $ 2,214 ​ $ 993 Additions based on tax positions related to the current year ​ ​ 950 ​ ​ 1,127 Additions based on tax positions related to the prior year ​ — ​ 94 Ending balance of unrecognized tax benefits ​ $ 3,164 ​ $ 2,214 ​ 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 is subject to taxation in the United States and various states. The Company’s Federal and state returns are subject to examination, due to the carryforward of unutilized net operating losses and research and development credits. (9) Segment Reporting Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision making group, in deciding how to allocate resources in assessing performance. The Company has one reportable segment: life science. The life science segment consists of the development of clinical and preclinical product candidates. The Company’s chief operating decision maker (“CODM”) is the chief executive officer. The accounting policies of the life science segment are the same as those described in the summary of significant accounting policies. The CODM assesses performance for the life science segment based on net loss, which is reported on the income statement as consolidated net loss. The measure of segment assets is reported on the balance sheet as total consolidated assets. To date, the Company has not generated any product revenue and has incurred losses and negative cash flows from operations since inception. The Company’s future life science expenses will be significantly dependent on our ability to successfully consummate the Merger, related audit and legal expenses and whether we decide to pursue any future product development efforts. The table below summarizes the significant expense categories regularly reviewed by the CODM for the years ended December 31, 2024, and 2023. ​ ​ ​ ​ ​ ​ ​ ​ ​ Years ended December 31, ​ 2024 2023 Operating expenses: ​ ​ ​ ​ ​ ​ AV-101 clinical trials ​ $ 19,740 ​ $ 26,548 Employee costs ​ ​ 19,512 ​ ​ 21,244 Professional fees and services ​ ​ 11,482 ​ ​ 6,289 Stock-based compensation ​ ​ 11,311 ​ ​ 11,906 Chemistry, manufacturing, and controls ​ ​ 11,110 ​ ​ 14,339 Other segment items (a) ​ ​ 1,515 ​ ​ 1,140 Interest income ​ ​ ( 5,042 ) ​ ​ ( 5,945 ) Consolidated net loss ​ $ 69,628 ​ $ 75,521 (a) Other segment items include rent and facilities related expenses. ​ ​ ​ ​ ​ ​ ​ ​ F-21 Table of Contents ​ EXHIBIT INDEX Exhibit ​ ​ Number ​ Description 2.1 Agreement and Plan of Merger, dated as of October 30, 2024, by and among the Registrant, Caribbean Merger Sub I, Inc., Caribbean Merger Sub II, LLC and Jade Biosciences, Inc. (incorporated by reference to Exhibit 2.1 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-40544) filed with the SEC on November 12, 2024). 3.1 ​ Second Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-40544) filed with the SEC on July 2, 2021). 3.2 ​ Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-40544) filed with the SEC on July 2, 2021). 4.1 ​ Form of Specimen Common Stock Certificate (incorporated by reference to Exhibit 4.1 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 4.2 ​ Investors’ Rights Agreement among the Registrant and certain of its stockholders, dated August 5, 2020 (incorporated by reference to Exhibit 4.2 to the Registrant’s Registration Statement on Form S-1 (File No. 333-256949) filed with the SEC on June 9, 2021). 4.3 ​ Description of Securities ( incorporated by reference to Exhibit 4.3 to the Registrant’s Annual Report on Form 10-K (File No. 001-40544) filed with the SEC on March 30, 2022) . 10.1# ​ 2018 Equity Incentive Plan, and form of award agreements thereunder (incorporated by reference to Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-256949) filed with the SEC on June 9, 2021). 10.2# ​ 2021 Stock Option and Incentive Plan, and form of award agreements thereunder (incorporated by reference to Exhibit 10.2 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 10.3# ​ 2021 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.3 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 10.4# ​ Non-Employee Director Compensation Policy (incorporated by reference to Exhibit 10.4 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 10.5# ​ Form of Indemnification Agreement between the Registrant and each of its directors and executive officers (incorporated by reference to Exhibit 10.5 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 10.6# ​ Form of Employment Agreement (incorporated by reference to Exhibit 10.6 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 10.7# ​ Senior Executive Cash Incentive Bonus Plan (incorporated by reference to Exhibit 10.10 to the Registrant’s Registration Statement on Form S-1A (File No. 333-256949) filed with the SEC on June 17, 2021). 10.8 ​ Lease, dated August 6, 2021, by and between the Registrant and PDM 930 Unit, LLC (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8 K (File No. 001 40544) filed with the SEC on August 12, 2021). 10.9 ​ Lease Amendment, dated January 2, 2024, by and between the Registrant and PDM 930 Unit, LLC (incorporated by reference to Exhibit 10.9 to the Registrant’s Annual Report on Form 10-K (File No. 001-40544) filed with the SEC on March 25, 2024). 10.10 ​ Lease, dated April 26, 2022, by and between the Registrant and Hudson Metro Center, LLC (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-40544) filed with the SEC on April 29, 2022) . 10.11 ​ ATM Equity Offering SM Sales Agreement, dated as of April 5, 2023, by and between Aerovate Therapeutics, Inc. and BofA Securities, Inc. (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-40544) filed with the SEC on April 5, 2023). 10.12 ​ Separation and Release Agreement, by and between the Registrant and Timothy Pigot, dated August 15, 2024 (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-40544) filed with the SEC on November 12, 2024). 80 Table of Contents 19.1 ​ Aerovate Therapeutics, Inc. Insider Trading Policy (incorporated by reference to Exhibit 19.1 to the Registrant’s Annual Report on Form 10-K (File No. 001-40544) filed with the SEC on March 25, 2024). 21.1 ​ List of Subsidiaries of Registrant (incorporated by reference to Exhibit 21.1 to the Registrant’s Annual Report on Form 10-K (File No. 001-40544) filed with the SEC on March 30, 2022). 23.1* ​ Consent of KPMG LLP, Independent Registered Public Accounting Firm. 24.1* ​ Power of Attorney (included on signature page). 31.1* Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 31.2* ​ Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 32.1** ​ Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 32.2** ​ Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 97.1# ​ Compensation Recovery Policy (incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-40544) filed with the SEC on August 14, 2023). 101.INS* ​ Inline XBRL Instance Document 101.SCH* ​ Inline XBRL Taxonomy Extension Schema Document 101.CAL* ​ Inline XBRL Taxonomy Extension Calculation Linkbase Document 101.DEF* ​ Inline XBRL Taxonomy Extension Definition Linkbase Document 101.LAB* ​ Inline XBRL Taxonomy Extension Label Linkbase Document 101.PRE* ​ Inline XBRL Taxonomy Extension Presentation Linkbase Document 104 ​ Cover Page Interactive Data File * Filed herewith. # Indicates a management contract or compensatory plan, contract or arrangement. ** The certifications furnished in Exhibit 32.1 and 32.2 hereto are deemed to accompany this Annual Report on Form 10-K and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certifications will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference. ​ 81 Table of Contents SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Annual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized . ​ ​ ​ AEROVATE THERAPEUTICS, INC. ​ ​ ​ Date: March 27, 2025 ​ By: /s/ Timothy P. Noyes ​ ​ ​ Timothy P. Noyes ​ ​ ​ Chief Executive Officer ​ Each person whose individual signature appears below hereby authorizes and appoints Timothy P. Noyes and George A. Eldridge, and each of them, with full power of substitution and resubstitution and full power to act without the other, as his or her true and lawful attorney-in-fact and agent to act in his or her name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated below, and to file any and all amendments to this annual report on Form 10-K and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing, ratifying and confirming all that said attorneys-in-fact and agents or any of them or their or his substitute or substitutes may lawfully do or cause to be done by virtue thereof. Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Annual Report on Form 10-K has been signed below by the following persons on behalf of the Registrant in the capacities and on March 27, 2025. ​ Name Title Date ​ ​ ​ ​ ​ ​ /s/ Timothy P. Noyes ​ Chief Executive Officer and Director ​ March 27, 2025 ​ Timothy P. Noyes ​ (Principal Executive Officer) ​ ​ ​ ​ ​ ​ ​ ​ /s/ George A. Eldridge ​ Chief Financial Officer ​ March 27, 2025 ​ George A. Eldridge ​ (Principal Financial Officer and Principal ​ ​ ​ ​ Accounting Officer) ​ ​ ​ ​ ​ ​ ​ ​ ​ /s/ Habib Dable ​ Director ​ March 27, 2025 ​ Habib Dable ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ /s/ Allison Dorval ​ Director ​ March 27, 2025 ​ Allison Dorval ​ ​ ​ ​ ​ ​ ​ ​ ​ /s/ David Grayzel, M.D ​ Director ​ March 27, 2025 ​ David Grayzel, M.D ​ ​ ​ ​ ​ ​ ​ ​ ​ /s/ Mark Iwicki ​ Director ​ March 27, 2025 ​ Mark Iwicki ​ ​ ​ ​ ​ ​ ​ ​ ​ /s/ Joshua Resnick, M.D. ​ Director ​ March 27, 2025 ​ Joshua Resnick, M.D. ​ ​ ​ ​ ​ ​ ​ ​ ​ /s/ Donald J. Santel ​ Director ​ March 27, 2025 ​ Donald J. Santel ​ ​ ​ ​ ​ ​ ​ ​ 82