Aquestive Therapeutics: Positive Phase III Data Unlocks Additional Catalysts For 2024

Core Insights - Aquestive Therapeutics is approaching a significant milestone with the anticipated topline data readout for their Anaphylm (AQST-109) epinephrine sublingual film, expected in Q1 of this year, with a potential New Drug Application (NDA) filing in 2024 [3][11] - The company announced positive Phase III data in March, showing that Anaphylm matches leading auto-injectors in key endpoints, including a quicker time to maximum concentration (Tmax) [3][7] - Following a $75 million public offering, the stock price has decreased from over $6 to approximately $4 per share, despite the positive Phase III results [3][5] Company Background - Aquestive Therapeutics is a pharmaceutical company focused on developing differentiated products using its proprietary PharmFilm platform, which allows for rapid dissolution of oral film drugs [4][5] - The company has a portfolio of five FDA-approved products and over 150 patents worldwide, with a focus on addressing unmet needs in CNS disorders and anaphylaxis [5][6] Financial Performance - In 2023, Aquestive's total revenues increased from $40 million in 2022 to $50.6 million, representing a 26% rise, while the net loss decreased from $54.4 million in 2022 to $7.9 million in 2023 [5][6] - The company ended 2023 with $23.9 million in cash and projects revenues between $48 million to $51 million for 2024 [6][5] Phase III Results - The Phase III study of Anaphylm met primary and secondary endpoints, demonstrating comparability with leading auto-injectors and a faster Tmax, confirming its potential as a needle-free alternative [7][9] - Anaphylm's exposure levels (AUC) were similar to auto-injectors for up to 30 minutes post-dosing, indicating a sustained therapeutic effect [7][9] Upcoming Catalysts - Upcoming catalysts include a self-administration study and an allergen PK study in Q2, a Pediatric PK study in Q3, and pre-NDA discussions in H2 of this year, all leading up to the NDA submission [11][12] - The NDA submission is expected to be a significant catalyst, marking the start of the FDA review timeline [12][11] Market Potential - Anaphylm has the potential to disrupt the epinephrine auto-injector market, which is projected to exceed $1 billion in peak sales, while Aquestive's market cap is around $370 million [12][13] - Revenue estimates suggest strong double-digit growth for Aquestive, with projections nearing half a billion in revenue over the next decade [12][13]