Aquestive Therapeutics has secured a $75 million strategic funding agreement with RTW Investments to support the commercial launch of its lead product candidate Anaphylm, a sublingual film treatment for severe allergic reactions including anaphylaxis. The funding is contingent on FDA approval of the epinephrine-based therapy and other customary conditions.
Novel Oral Delivery Platform for Emergency Treatment
Anaphylm represents a potentially transformative approach to emergency allergy treatment, designed as the first and only oral rescue medication for severe allergic reactions. The polymer matrix-based epinephrine prodrug is formulated as a sublingual film similar in size to a postage stamp and weighs less than an ounce.
"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," said Dan Barber, Chief Executive Officer of Aquestive.
The product begins dissolving on contact with the sublingual tissue, requiring no water or swallowing for administration. Its packaging is thinner and smaller than an average credit card, designed for pocket portability and engineered to withstand weather excursions including exposure to rain and sunlight.
Strategic Partnership Structure
Under the funding agreement terms, RTW will receive a tiered single-digit percentage of annual net sales of Anaphylm in the U.S. for type I allergic reactions treatment, subject to a cap. The commercial launch financing becomes available upon FDA approval and satisfaction of certain refinancing conditions related to the company's existing debt.
"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.
Financial Runway and Development Pipeline
The strategic funding provides Aquestive with critical capital through 2027, supporting both the potential commercial launch of Anaphylm and continued development activities. Cantor Fitzgerald & Co served as exclusive financial advisor to Aquestive on the royalty financing structure.
Beyond Anaphylm, Aquestive is advancing AQST-108, an earlier-stage epinephrine prodrug topical gel product candidate for various dermatology conditions, including alopecia areata. The company currently has four commercialized products marketed by licensees globally and serves as the exclusive manufacturer of these licensed products.
Regulatory Status and Market Positioning
The FDA has conditionally approved the Anaphylm trade name for AQST-109, with final approval of the proprietary name conditioned on FDA approval of the product candidate. The company's New Drug Application for Anaphylm is currently under FDA review.
Aquestive's proprietary PharmFilm technology platform enables the development of orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. The company collaborates with pharmaceutical partners to bring new molecules to market using these delivery technologies.
