Business
Aquestive Therapeutics Reports First Quarter 2023 Financial Results and Provides Business Update
Continues to advance development of AQST-109 (epinephrine sublingual film); received FDA conditional approval of brand name Anaphylm™Raises full year 2023
About this update from Aquestive Therapeutics, Inc.
[{"type":"text","content":"Continues to advance development of AQST-109 (epinephrine sublingual film); received FDA conditional approval of brand name Anaphylm™Raises full year 2023 revenue and non-GAAP adjusted EBITDA guidanceReaffirms commitment to pursue early market access for Libervant™ (diazepam) Buccal FilmObtains dismissal of outstanding shareholder lawsuitsGenerated $47 million non-dilutive cash in the last 12 monthsHosts investment community conference call on May 3, 2023 WARREN, N.J., May 02, 2023 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to solve patients' problems with current standards of care and provide transformative products to improve their lives, today reported financial results for the first quarter ended March 31, 2023 and provided an update on recent developments in its business. “Our first quarter 2023 results continue to drive the Company towards important upcoming inflection points,” said Daniel Barber, Chief Executive Officer of Aquestive. “We achieved strong year-over-year revenue and EBITDA growth in our commercial collaboration and manufacturing business, significantly reduced our debt, and continued to execute on all of our key 2023 initiatives. We will seek to carry this momentum into the rest of the year as we focus on meeting our product development milestones and pursuing opportunities to secure additional collaborations and refinancing our debt.” Anaphylm™ Aquestive is advancing the development of Anaphylm, the first and only non-device based, orally delivered epinephrine product candidate to demonstrate clinical results comparable to autoinjectors (such as EpiPen® and Auvi-Q®) for the emergency treatment of severe allergic reactions, including anaphylaxis. The United States Food and Drug Administration (FDA) has conditionally accepted the proprietary name Anaphylm™ (pronounced “ana-PHYLM”) as the proposed brand name for AQST-109, the Company’s polymer matrix-based epinephrine prodrug administered as a sublingual film in development for the treatment of severe allergic reactions, including anaphylaxis. Final approval of the Anaphylm™ proprietary name is conditioned on FDA approval of the product candidate, AQST-109. Aquestive received final minutes in December 2022 from the End-of-Phase 2 (EOP2) meeting with the FDA and obtained further clarification fro...