Aquestive Therapeutics, Inc.

Aquestive Therapeutics, Inc. announced the election of Richard J. Daly to its Board of Directors, effective October 14, 2026. Mr. Daly, an experienced life sciences executive, will serve as a Class I director, and his appointment increases the Board size to eight members. He will receive an initial award of 57,000 stock options as part of the non-employee director compensation program. The company highlighted Mr. Daly's extensive experience in commercial and operating roles within the biopharmaceutical industry.

Aquestive Therapeutics, Inc. has filed an 8-K report detailing an investor presentation. The company announced the resubmission of its New Drug Application (NDA) for Anaphylm (dibutepinephrine) sublingual film to the FDA on September 17, 2026, following a Complete Response Letter (CRL) received earlier in the year. The presentation also highlights the company's pipeline, including AQST-108 for atopic dermatitis, and its financial position, with $98.5 million in cash and access to additional funding upon Anaphylm's potential FDA approval. Key product attributes and market opportunities for Anaphylm and AQST-108 are discussed.

Aquestive Therapeutics reported a 51% increase in revenue for the first six months of 2026, reaching $28.265 million, with net loss improving to $(30.921) million year-over-year. For the second quarter of 2026, revenue grew 38% to $13.819 million, but the company posted a net loss of $(22.864) million, primarily due to an $11.683 million loss on extinguishment of debt. The company also secured $54.337 million in new long-term debt and repaid $45 million of existing debt.

Aquestive Therapeutics reported Q2 2026 financial results, with total revenue increasing 38% to $13.8 million. The company posted a net loss of $22.9 million, primarily due to an $11.7 million one-time loss on extinguishment of debt, though non-GAAP adjusted EBITDA loss improved to $5.2 million. Aquestive remains on track to resubmit its Anaphylm NDA to the FDA in Q3 2026 after successfully completing required studies, and plans to begin ex-U.S. filings in Q4 2026. The company also provided updates on its AQST-108 program and Libervant's tentative approval status.

Aquestive Therapeutics reported Q2 2026 total revenue of $13.8 million, a 38% increase year-over-year, driven by higher manufacture and supply revenue. The company's net loss widened to $22.9 million, primarily due to an $11.7 million one-time loss on extinguishment of debt. Non-GAAP adjusted EBITDA loss improved to $5.2 million. Strategically, Aquestive successfully completed human factors validation and pharmacokinetic studies for Anaphylm™, reaffirming its plan to resubmit the NDA to the FDA in Q3 2026 and begin ex-U.S. filings in Q4 2026.

Aquestive Therapeutics announced positive topline results from its human factors validation study and pharmacokinetic study for Anaphylm™ (dibutepinephrine) sublingual film. These results support the planned resubmission of its New Drug Application (NDA) to the U.S. FDA in the third quarter of 2026 for the treatment of Type 1 allergic reactions. The revised packaging and instructions significantly improved ease of use, and both self-administered and even purposely misplaced film showed clinically meaningful results.

Aquestive Therapeutics, Inc. held its 2026 Annual Meeting of Stockholders on June 10, 2026. Stockholders elected Gregory B. Brown, M.D., John S. Cochran, and Abigail L. Jenkins as Class II members to the Board of Directors for a three-year term. Additionally, the proposal to approve executive compensation on a non-binding advisory basis was passed, and KPMG LLP was ratified as the independent registered public accounting firm for the fiscal year ending December 31, 2026.

Aquestive Therapeutics reported a significant improvement in its first quarter 2026 financial results, with total revenues increasing by 65.7% to $14.45 million compared to the prior year. The company substantially reduced its net loss to $8.06 million from $22.93 million in Q1 2025, driven by higher license and royalty revenue, including a $4.5 million royalty from Zevra, and lower operating expenses. Aquestive ended the quarter with $110.73 million in cash and cash equivalents, indicating sufficient liquidity for the next twelve months.

Aquestive Therapeutics reported improved Q1 2026 financial results, with total revenues increasing to $14.4 million and net loss significantly decreasing to $8.1 million. The company also secured a new $150 million debt facility with Oaktree Capital Management, which is expected to save $45 million in principal payments over three years and extend its cash runway. Additionally, Aquestive reaffirmed its guidance to resubmit the Anaphylm™ NDA in Q3 2026 and completed a Phase 1 study for AQST-108 with no safety issues.

Aquestive Therapeutics announced the refinancing of its existing debt with a new $150 million debt facility from Oaktree Capital Management, L.P. This transaction provides additional flexibility to fund the potential launch of Anaphylm , if approved by the FDA. The new five-year facility includes an initial $55 million, primarily used to repay the company's existing $45 million loan, with further tranches available upon FDA approval and sales milestones. This agreement eliminates $45 million in principal debt repayments over the next three years and reduces interest rates.