Aerovate Therapeutics Inc 2025年季度报告

FORM10-Q (Mark One) ☒QUARTERLY REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934 For the quarterly period endedMarch31,2025OR ☐TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934 For the transition period from _____________ to _____________Commission File Number:001-40544 AEROVATE THERAPEUTICS,INC. (Exact Name of Registrant as Specified in its Charter) Registrant’s telephone number, including area code: (617)443-2400 Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or15(d)of the Securities Exchange Act of 1934 during the preceding 12months (or for such shorter period that theregistrant was required to file such reports), and (2)has been subject to such filing requirements for the past90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required tobe submitted pursuant to Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12months(or for such shorter period that the registrant was required to submit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-acceleratedfiler, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,”“accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule12b-2 of theExchange Act. Large accelerated filer☐Accelerated filer☐Non-accelerated filer☒Smaller reporting company☒Emerging growth company☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extendedtransition period for complying with any new or revised financial accounting standards provided pursuant toSection13(a)of the Exchange Act.☒ Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act).Yes☐No☒ As of April 24, 2025, the registrant had28,985,019shares of common stock, $0.0001 par value per share,outstanding. Table of Contents PagePARTI.FINANCIAL INFORMATION6Item1.Financial Statements (Unaudited)6Condensed Consolidated Balance Sheets6Condensed Consolidated Statements of Operations and Comprehensive Loss7Condensed Consolidated Statements of Stockholders’ Equity8Condensed Consolidated Statements of Cash Flows9Notesto Unaudited Condensed Consolidated Financial Statements10Item2.Management’s Discussion and Analysis of Financial Condition and Results ofOperations20Item3.Quantitative and Qualitative Disclosures About Market Risk29Item4.Controls and Procedures30PARTII.OTHER INFORMATION30Item1.Legal Proceedings30Item1A.Risk Factors31Item2.Unregistered Sales of Equity Securities and Use of Proceeds63Item3.Defaults Upon Senior Securities63Item4.Mine Safety Disclosures63Item5.Other Information63Item6.Exhibits64Signatures65 SUMMARY OF THE MATERIAL AND OTHER RISKS ASSOCIATED WITH OURBUSINESS Our business is subject to numerous material and other risks and uncertainties that you should beaware of in evaluating our business. These risks include, but are not limited to, the following: ●We may not be successful inconsummating the Merger.●If we are successful in completing the Merger, we may be exposed to other operational andfinancial risks.●If the Merger is not completed, our board of directors may pursue a dissolution andliquidation. In such event, the amount of cash available for distribution to our stockholderswill depend heavily on the timing of such liquidation and the amount of cash that will needto be reserved for commitments and contingent liabilities.●Failure to complete the Merger may result in either Jade or us paying a termination fee to theother party and could harm our common stock price and the future business and operationsof each company.●Some of Jade’s and our executive officers and directors have interests in the Merger that aredifferent from yours.●We are a biopharmaceutical company with a limited operating history.●We have incurred significant operating losses since our inception and anticipate that we willcontinue to incur losses for the foreseeable future. We may never achieve or maintainprofitability.●We have no products approved for commercial sale and have not generated any revenue fromproduct sales.●The results of earlier studies and trials may not be predictive of future trial results.●We have six issued U.S. patents and many pending patent applications with respect to AV-101, however, we have begun the process of abandoning our patent estate and we are nolonger prosecuting our patent applications. Further, we can provide no assurance that any ofour future patent applications will result in issued patents. If we cannot protect our patentrights or our other proprietary rights, others may develop products similar or identical toours, and we may not be able to compete effectively in our mar