Aquestive Therapeutics, Inc. (AQST) reported first-quarter 2026 financial results and provided a business update as the company continues advancing Anaphylm, its sublingual epinephrine film, toward a planned NDA resubmission later this year.
For the first quarter of 2026, total revenue rose to $14.4 million, up from $8.7 million in the same quarter of 2025, driven by higher license, royalty, and manufacturing revenue.
The company reported a net loss of $8.1 million or $0.07 per share, a significant improvement from the $22.9 million, or $0.24 per share reported in the first quarter of 2025.
Aquestive ended the quarter with $110.7 million in cash and cash equivalents.
Business and Regulatory Update
Aquestive said it made "made rapid and meaningful progress in the first quarter," including completing its Type A meeting with the FDA and aligning on the study designs needed to support the resubmission of the Anaphylm NDA. The company continues to target Q3 2026 for the resubmission.
The company also affirmed that its existing clinical data is sufficient to support regulatory filings in Canada, the European Union and United Kingdom, and it recently submitted its initial Pediatric Investigation Plan (PIP) to the European Medicines Agency (EMA).
Commercial readiness efforts for Anaphylm are underway, including expanding the planned field force to approximately 75 representatitves, up from prior guidance of 50.
Pipeline progress
Anaphylm (dibutepinephrine) sublingual film
Anaphylm is being developed as a no-needle, no-device epinephrine alternative for severe Type I allergic reactions.
Data presented at the AAAAI Annual Meeting showed Anaphylm achieved clinically relevant epinephrine levels without the diastolic blood pressure dip associated with auto-injectors, supporting its differentiation.
AQST-108 (epinephrine) topical gel
Aquestive completed its second Phase 1 study evaluating AQST-108 for dermatologic conditions. No drug-related adverse events were observed, and the study identified a biomarker signal involving TSLP suppression, which will be explored in upcoming studies.
The company continues to believe AQST-108 may have potential applications in alopecia areata, atopic dermatitis, rosacea, and psoriasis.
Debt Refinancing & Liquidity Aquestive entered into a $150 million debt facility with Oaktree Capital Management, which is expected to save $45 million in principal payments over the next three years and extend maturity to 2031.
The structure includes additional capital availability tied to FDA approval of Anaphylm and future sales milestones.
Combined with its strategic funding agreement with RTW investments, Aquestive expects to have up to $150 million available to support the potential U.S launch of Anaphylm in 2027, if approved.
Manufacturing & Commercial Collaborations
The Company manufactured approximately 33 million doses in Q1 2026, up from 27 million doses in Q1 2025 supporting its global collaborations including Suboxone, Sympazan, Ondif, Emylif. Aquestive noted that its supply chains remain largely unaffected by current or proposed U.S tariffs.
Libervant buccal film remains tentatively approved until January 2027, when orphan drug exclusivity for a competing product is scheduled to expire.
2026 Outlook
Aquestive reaffirmed its full-year 2026 guidance expecting:
- Total revenue of $46 million to $50 million compared to $44.5 million in FY2025
- Non-GAAP adjusted EBITDA loss of $30 million to $35 million compared to $49.7 million in FY2025
AQST has traded between $2.14 and $7.55 over the past year. The stock closed yesterday's trading at $4.13, up 0.72%. During overnight trading the stock is at $4.55, up 10.17%.
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Business News
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