Summary of Aquestive Therapeutics FY Conference Call Company Overview - **Company Name**: Aquestive Therapeutics (NasdaqGM:AQST) - **Industry**: Biopharmaceuticals - **Focus**: Development of orally administered products for complex molecules, particularly in the allergy treatment space with their lead product, Anaphylm, a sublingual formulation of epinephrine for severe allergic reactions [1][2][3] Core Points and Arguments - **Drug Delivery Technology**: The company specializes in oral thin film technology, which aims to improve the delivery of existing molecules that are considered sub-optimized [2][3] - **Product Pipeline**: - **Anaphylm**: Focused on severe allergic reactions, with a fast absorption profile (T-max of 12 minutes) compared to auto-injectors (20 minutes) [12][14] - **Libervant**: A diazepam buccal film for acute repetitive seizures, tentatively approved by the FDA, awaiting competitor exclusivity expiration in January [7][8] - **AQST108**: A topical gel for alopecia areata, currently in phase 1 trials [9][23] - **Market Dynamics**: The current market is dominated by auto-injectors (over 90%). The company anticipates a shift towards their film product as it offers ease of use and rapid absorption [15][16][28] Financial Position - **Capital Raise**: The company raised over $80 million in August 2025, positioning itself well for FDA processes and product launches [11][40] - **Cash Balance**: Ended 2025 with over $121 million, providing a comfortable runway for operations and launch preparations [40][41] - **Revenue Potential**: The U.S. market for epinephrine products is expected to grow, with scripts just under $5 million last year and projected growth in 2025 [15] Regulatory and Launch Readiness - **FDA Interaction**: Received a complete response letter from the FDA requiring additional human factors work and a pharmacokinetic study, with plans to resubmit in Q3 2026 [21][22] - **Launch Strategy**: The commercial team is prepared for a launch, with a focus on patient education and awareness to facilitate market acceptance [20][41] Additional Insights - **Consumer Behavior**: Surveys indicate that many individuals forget to carry their auto-injectors, highlighting the importance of a more convenient delivery method like Anaphylm [16][17][18] - **Market Awareness**: The company believes that as awareness and comfort with new delivery systems grow, there will be a significant shift away from traditional auto-injectors [28][29] Conclusion - **Future Outlook**: The company is optimistic about the potential of Anaphylm and its other products, with a strong financial position and a clear strategy for navigating regulatory challenges and market entry [41][42]

WARREN, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced today that the management team will participate in four upcoming investor conferences in March as follows: TD Cowen 46th Annual Health Care Conference: Management will be available for 1x1 meetings on Tuesday, March 3rdLeerink Pa ...

Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Significant Losses In Aquestive Therapeutics To Contact Him Directly To Discuss Their OptionsIf you suffered significant losses in Aquestive Therapeutics stock or options and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information]New York, New York--(Newsfile Corp. - Febru ...

WARREN, N.J., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that it will report results for the fourth quarter ended December 31, 2025 and provide an update on recent developments in its business after market close on Wednesday, March 4, 2026. Management will host a conference call ...

When Jeff Bezos said that one breakthrough technology would shape Amazon’s destiny, even Wall Street’s biggest analysts were caught off guard. Fast forward a year and Amazon’s new CEO Andy Jassy described generative AI as a “once-in-a-lifetime” technology that is already being used across Amazon to reinvent customer experiences. At the 8th Future Investment Initiative conference, Elon Musk predicted that by 2040 there would be at least 10 billion humanoid robots, with each priced between $20,000 and $25,000 ...

WARREN, N.J., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced today that the management team will participate in the upcoming Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25-26, which is a virtual event. The Aquestive team will be presenting on February 26th, at 1 ...

Core Viewpoint - Aquestive Therapeutics announced the investigational use of Anaphylm™ (dibutepinephrine) sublingual film, which achieved clinically relevant epinephrine plasma concentrations without causing a dip in diastolic blood pressure, highlighting its potential to transform anaphylaxis management [1][2]. Group 1: Product Details - Anaphylm™ is a polymer matrix-based epinephrine prodrug that is small, lightweight, and dissolves on contact, requiring no water or swallowing for administration [3]. - The product's packaging is designed to be portable and weather-resistant, making it easy to carry in a wallet or phone [3]. - If approved by the FDA, Anaphylm would be the first oral medication for the rescue treatment of severe allergic reactions, including anaphylaxis [3]. Group 2: Clinical Data and Presentations - Multiple poster presentations at the 2026 AAAAI Annual Meeting will showcase the clinical data for Anaphylm, emphasizing its differentiated profile and potential for meaningful outcomes [2]. - Key findings include the absence of a diastolic blood pressure dip following sublingual administration, which is a significant clinical concern in anaphylaxis treatment [2]. Group 3: Company Overview - Aquestive Therapeutics focuses on advancing medicines through innovative science and delivery technologies, operating as both a product developer and a Contract Development and Manufacturing Organization (CDMO) [5]. - The company has a portfolio that includes four commercialized products and a library of over 20 epinephrine prodrugs for various allergy and dermatological indications [5].

Board-certified allergist and leading food allergy and anaphylaxis researcher joins Aquestive to support Anaphylm™ (dibutepinephrine) sublingual film NDA resubmission and pipeline WARREN, N.J., Feb. 18, 2026 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the appointment of Matthew Greenhawt, MD, ...

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