Aquestive Therapeutics NASDAQ: AQST said it remains on track to resubmit its new drug application for Anaphylm, its epinephrine sublingual film for severe allergic reactions, in the third quarter of 2026, while reporting higher first-quarter revenue and a narrower net loss.
On the company’s first-quarter earnings call, Chief Executive Officer Dan Barber said Aquestive has made “significant” progress since its prior update, including completing a Type A face-to-face meeting with the U.S. Food and Drug Administration, holding a teleconference with the U.K. Medicines and Healthcare products Regulatory Agency, submitting a pediatric investigational plan to the European Medicines Agency and submitting its human factors protocol to the FDA.
Barber said Aquestive currently expects to have human factors data and potentially pharmacokinetic data for Anaphylm available in time for its August earnings call. He said that timeline depends on the FDA providing timely feedback on the company’s human factors protocol and that feedback being within expectations.
“With these assumptions in mind, we continue to guide to a third quarter resubmission to the FDA, recognizing this timing remains subject to FDA feedback and ongoing review processes,” Barber said.
Anaphylm resubmission remains central focus
Aquestive received a complete response letter from the FDA for Anaphylm on Jan. 30, 2026. Chief Financial Officer Ernie Toth said the company has since aligned with the agency on remaining requirements for approval, including a human factors validation study and a pharmacokinetic study, both of which are underway.
Barber said the company expects the Anaphylm resubmission to be classified as a Type 2 submission, which would carry a six-month review period, though he noted the final classification is determined by the FDA. He said Aquestive plans to request expedited review and believes the limited scope of the resubmission could support a faster process, though he cautioned that timing decisions rest solely with the agency.
In response to an analyst question about FDA interactions, Senior Vice President of Regulatory Affairs Melina Cioffi said the review team remains intact. “These are the same individuals that have worked with us early on during the development of the product as well as during the review,” she said.
Aquestive also highlighted ex-U.S. regulatory progress. Barber said the company received confirmation from the MHRA that it does not need to conduct additional studies before submitting an application in the U.K. He said the company now believes it can submit applications in the European Union, U.K. and Canada without conducting further clinical studies. The company continues to target a 2026 filing in Canada and is aiming for a European filing in late 2026 or early 2027.
Company prepares for potential U.S. launch
Aquestive said commercial preparations for Anaphylm are advancing ahead of a potential FDA approval. Barber said the company’s planned launch includes a strong medical affairs presence, a 75-person sales force and focused marketing efforts. He said the company has also been watching the launch of a nasal spray epinephrine product in the market and has drawn lessons from it.
Chief Commercial Officer Sherry Korczynski said rapid payer coverage and reducing friction in physicians’ offices will be key priorities if Anaphylm is approved. She said Aquestive is in “robust discussions” with pharmacy benefit managers and payers and is setting up hub and patient support services to help physicians and patients navigate coverage requirements.
“It’s going to take some time,” Korczynski said, adding that the company is focused on making sure patients and health care providers are aware of Anaphylm and prepared for prescribing.
Chief Medical Officer Dr. Matt Greenhawt said Aquestive has attended 13 conferences so far this year and expects to attend more than 40, while also targeting more than 20 publications. Barber said the company’s awareness work has been “punching above our weight.”
First-quarter revenue rises, losses narrow
Aquestive reported total revenue of $14.4 million for the first quarter of 2026, up 66% from $8.7 million in the first quarter of 2025. Toth said the increase was primarily driven by higher license and royalty revenue and higher manufacturing and supply revenue.
License and royalty revenue rose to $5.4 million from $0.8 million a year earlier, primarily due to royalty revenue from Zevra.
Manufacturing and supply revenue increased to $8.8 million from $7.2 million, primarily reflecting higher Suboxone revenue, partially offset by lower “Undie” revenue as stated on the call.
Research and development expenses declined to $4.2 million from $5.4 million, mainly due to lower Anaphylm clinical trial costs, partially offset by higher R&D personnel costs.
Selling, general and administrative expenses fell to $11.0 million from $19.1 million, reflecting the absence of a prior-year Anaphylm PDUFA fee, lower legal fees, reduced commercial spending and lower regulatory and licensing fees, partially offset by higher severance, personnel and share-based compensation costs.
The company posted a net loss of $8.1 million, or $0.07 per share, compared with a net loss of $22.9 million, or $0.24 per share, in the prior-year quarter. Non-GAAP adjusted EBITDA loss was $1.7 million, compared with a loss of $17.6 million a year earlier.
Toth said the company ended the quarter with approximately $110 million in cash and cash equivalents. Aquestive maintained its 2026 guidance for total revenue of $46 million to $50 million and a non-GAAP adjusted EBITDA loss of $35 million to $30 million as of May 13, 2026.
Oaktree financing strengthens balance sheet
Subsequent to quarter-end, Aquestive announced a new $150 million debt facility with funds and accounts managed by Oaktree Capital Management. Toth said the refinancing reduces the company’s interest rate, extends the interest-only period and saves $45 million in principal payments over the next three years that had been scheduled to begin June 30.
The facility includes four tranches: $55 million to refinance existing debt, $20 million available upon FDA approval of Anaphylm, $25 million available upon achieving certain sales levels and $50 million available by mutual consent of Oaktree and Aquestive.
Barber said the financing also satisfies a pre-approval requirement for the company’s funding agreement with RTW Investments. He said that, together with existing cash and the RTW agreement, Aquestive currently projects it would have more than $150 million in cash at launch, before considering potential ex-U.S. Anaphylm or U.S. Libervant out-licensing deals.
AQST-108 shows early safety and biomarker findings
Aquestive also provided an update on AQST-108, a pipeline program based on its Adrenoverse epinephrine prodrug platform. Barber said the company recently completed a Phase 1 safety study in men with androgenic alopecia, with no drug-related adverse events and no appreciable signs of systemic absorption of the epinephrine prodrug or epinephrine itself.
Barber said early biomarker work suggested the cytokine TSLP “appeared to be impacted” by AQST-108 in subjects with alopecia, while placebo did not show the same effect. He emphasized the data were not statistically powered and should be viewed as directional only.
Chief Development Officer Dr. Matthew Davis said the TSLP finding may suggest optionality across dermatologic conditions, including alopecia areata, androgenic alopecia and atopic dermatitis. However, he said the company will provide more guidance on next steps after the Anaphylm resubmission.
Barber closed the call by saying Aquestive is “ready to go” on the remaining Anaphylm studies, awareness-building efforts and potential launch preparations if the product is approved by the FDA.
About Aquestive Therapeutics NASDAQ: AQST
Aquestive Therapeutics, Inc is a specialty pharmaceutical company focused on the development and commercialization of novel drug delivery systems. Leveraging its proprietary PharmFilm® technology, Aquestive designs thin-film formulations that facilitate sublingual, buccal and oral delivery of small molecules, offering rapid onset of action and improved patient compliance compared with traditional dosage forms.
The company's lead product, Libervant® (diazepam) Buccal Film, is approved by the U.S.
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