Aquestive Therapeutics Announces $75M Strategic Funding Agreement with RTW to Support the Potential Launch of Anaphylm™ (epinephrine) Sublingual Film

Anaphylm launch funding of $75 million committed by RTW, subject to FDA approval of Anaphylm and other conditions

Strategic financing will further strengthen the Company's balance sheet in advance of potential commercialization of Anaphylm for the emergency treatment of allergic reactions, including anaphylaxis

WARREN, N.J., Aug. 14, 2025 (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 a $75 million strategic funding agreement with funds managed by RTW Investments, LP ("RTW"), subject to United States Food and Drug Administration (FDA) approval of Anaphylm™ (epinephrine) Sublingual Film and other conditions.

"This financing provides critical capital that will support Aquestive Therapeutics through 2027, enabling us to successfully bring Anaphylm to market, if approved by the FDA, and deliver a new treatment option for patients in need," said Dan Barber, Chief Executive Officer of Aquestive. "We continue to believe Anaphylm, potentially the first and only oral rescue medication for the treatment of severe allergic reactions, including anaphylaxis, can transform how patients carry and access their rescue medication. We are excited to partner with RTW to bring this important medication to patients, if approved by the FDA."

"We are excited to support Aquestive, and today's investment reflects our belief in the commercial prospects of Anaphylm as a rescue treatment for patients experiencing a severe allergic reaction, including anaphylaxis," said Roderick Wong, MD, Managing Partner and Chief Investment Officer of RTW Investments, LP. "We remain committed to helping life science companies bring meaningful innovations, like Anaphylm, to patients, caregivers, and healthcare providers."

The commercial launch financing will become available upon approval of Anaphylm by the FDA, and satisfaction of certain refinancing and other customary conditions related to the Company's existing debt. Under the terms of the agreement, RTW will receive a tiered single digit percentage of annual net sales of Anaphylm in the U.S. for the treatment of type I allergic reactions (including anaphylaxis), subject to a cap.

Cantor Fitzgerald & Co acted as exclusive financial advisor to Aquestive on the royalty financing.

About Anaphylm™ (epinephrine) Sublingual FilmAnaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The Anaphylm trade name for AQST-109 has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate.

About Aquestive TherapeuticsAquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has four commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed ...