Talphera Inc 2025年季度报告

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.For the transition period from (Exact name of registrant as specified in its charter) (State or other jurisdiction ofincorporation or organization) Trading symbol(s) Common Stock, $0.001 par valueTLPH Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d) of the Securities ExchangeAct of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)has beensubject to such filing requirements for the past 90 days.Yes☒No☐Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant wasrequired to submit such files).Yes☒No☐ forward-looking statements in this Form 10-Q are contained principally under “Part I. Financial Information - Item 2. Management’sDiscussion and Analysis of Financial Condition and Results of Operations” and “Part II. Other Information - Item 1A. Risk Factors”. In somecases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,”“plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or othercomparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties andother factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the informationexpressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-lookingstatement contained in this Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently knownby us and our projections of the future, about which we cannot be certain. Many important factors affect our ability to achieve our objectives, •our ability to maintain listing of our securities trading on the Nasdaq exchange; •the historical performance and high volatility in the market price of our common stock; •macroeconomic uncertainties, including tariffs, inflationary pressures, domestic and global supply chain disruptions, labor •our ability to conduct ourselves, or through a contract research organization, clinical trials in a timely and effective manner toadvance the development of our product candidates, including our lead nafamostat developmental product candidate, Niyad™; •our ability to successfully file for and obtain regulatory approval for, and then successfully launch and commercialize our •the impact of the discontinuation by our corporate partner, Vertical Pharmaceuticals LLC, a wholly owned subsidiary of AloraPharmaceuticals, LLC, or Alora, of its marketing, sales, and distribution of the DSUVIA product; •the extent of future sales of DSUVIA by Alora to the Department of Defense, or DoD, given the discontinuation of its marketing,sales and distribution efforts related to DSUVIA; •the size and growth potential of the potential markets for our developmental product candidates in the United States and in otherjurisdictions, and our ability to serve those markets; •our ability to develop sales and marketing capabilities in a timely fashion, whether alone through recruiting qualified employees, byengaging a contract sales organization, or with potential future collaborators; •successfully establishing and maintaining commercial manufacturing and supply chain relationships with domestic and globalthird-party service providers, including single sources of supply for Niyad active pharmaceutical ingredients and finished goodslocated outside the U.S.; 3 •our ability to identify and secure potential strategic partners to develop, secure regulatory approval for and then commercialize ourdevelopmental product candidates;•our ability to successfully retain our key commercial, scientific, engineering, medical or management personnel and hire newpersonnel as needed;•existing and future legislation and other regulatory developments in the United States and foreign countries;•the performance of our third-party suppliers and manufacturers, including any supply chain impacts or work limitations;•the success of competing therapies that are or become available; and•our ability to obtain and maintain intellectual property protection for our approved products and product candidates.In addition, you should refer to “Part II. Other Information - Item 1A. Risk Factors” in this Form 10-Q for a discussion of these and otherimportant factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Asa result of these fa