Aquestive Therapeutics’ Q1 2025: Focus on Anaphylm

Aquestive Therapeutics, Inc. ( (AQST) ) has released its Q1 earnings. Here is a breakdown of the information Aquestive Therapeutics, Inc. presented to its investors.

Aquestive Therapeutics, Inc. is a pharmaceutical company focused on developing innovative drug delivery technologies to improve patient outcomes, particularly in the treatment of severe allergic reactions and other medical conditions.

In its first quarter of 2025, Aquestive Therapeutics reported significant progress with the submission of a New Drug Application (NDA) for Anaphylm, an oral sublingual film for severe allergic reactions, marking a pivotal step in its product pipeline. The company is gearing up for a potential U.S. launch in early 2026, contingent on FDA approval.

Key financial highlights for the quarter include a 28% decrease in total revenues to $8.7 million, primarily due to reduced manufacture and supply revenue. Despite this, the company increased its focus on Anaphylm’s pre-commercial efforts, which resulted in higher selling, general, and administrative expenses. Aquestive also reported a net loss of $22.9 million, up from $12.8 million in the previous year, driven by increased regulatory and commercial spending.

Strategically, Aquestive is prioritizing the launch of Anaphylm and has de-emphasized other projects like AQST-108 and Libervant due to recent regulatory and legal challenges. The company plans to initiate a Phase 2a clinical trial for AQST-108 in 2026, post-Anaphylm launch, while Libervant’s market access is expected in 2027.

Looking ahead, Aquestive remains committed to advancing Anaphylm through the FDA approval process and expanding its market presence, with a focus on achieving commercial success in the growing epinephrine market.