Anaphylm (dibutepinephrine) Sublingual Film - The FDA confirmed that it will not require an Advisory Committee to review the Company's New Drug Application for Anaphylm[8] - The company is preparing for a U S launch in Q1 2026, if approved by the FDA[8] - The company broadened the patent estate for Anaphylm with the issuance of two new patents, extending patent protection into 2037[8] AQST-108 and AdrenaVerse Platform - The company plans to open Investigational New Drug application for AQST-108 with FDA in Q4 2025[11] - The company expects to initiate a clinical study for AQST-108 for Alopecia Areata in 1H 2026[11] Financial Position - The company successfully completed an equity raise of $85 million in August 2025[11] - The company also completed a strategic financing for $75 million with RTW Investments, LP, subject to FDA approval of Anaphylm and refinancing of the Company's existing debt[11] - The company's ending cash balance in Q3 2025 was $129.1 million[17] - The company expects to meet near-term milestones with projected cash runway into 2027[16] - The company's 2025 outlook includes total revenues of approximately $44-$50 million and a non-GAAP adjusted EBITDA loss of approximately $47-$51 million[23]

Core Insights - Aquestive Therapeutics announced pivotal progress with the FDA's acceptance of the NDA for Anaphylm, which could become the first oral, sublingual film epinephrine product if approved [2][3] - The company is preparing for a potential U.S. launch in 2026 and is also engaging in regulatory discussions for global expansion in Canada and the EU [2][4] - Financial results for Q2 2025 showed total revenues of $10.0 million, a decrease from $20.1 million in Q2 2024, primarily due to the prior year's one-time revenue recognition [11][14] Regulatory and Product Development - The FDA has accepted the NDA for Anaphylm, with a PDUFA date set for January 31, 2026, and the company is preparing for an Advisory Committee meeting [3][7] - Anaphylm has completed 10 clinical studies with approximately 935 administrations across 379 subjects, addressing the unmet need for non-invasive epinephrine delivery options [3][5] - The company is also advancing AQST-108, a topical gel for alopecia areata, with an anticipated IND submission in Q4 2025 [6] Commercial Strategy - Aquestive is building a commercial launch team for Anaphylm and leveraging existing infrastructure for execution [4] - The company views international markets as critical for long-term strategy and is actively pursuing regulatory meetings in Canada and the EU [4][5] - Anaphylm is positioned to address barriers to epinephrine adoption, such as fear of needles and device complexity, potentially transforming emergency allergy treatment [5] Financial Performance - Total revenues for Q2 2025 increased by $0.3 million, or 3%, year-over-year, excluding the impact of one-time deferred revenue recognition [11] - Manufacturing and supply revenue rose to $9.6 million in Q2 2025 from $8.1 million in Q2 2024, driven by increased Ondif revenues [12] - The net loss for Q2 2025 was $13.5 million, compared to a net loss of $2.7 million in Q2 2024, primarily due to decreased revenues and increased administrative expenses [14][15] Future Outlook - The company expects total revenue for the full year 2025 to be between $44 million and $50 million, with a non-GAAP adjusted EBITDA loss projected between $47 million and $51 million [17] - Cash and cash equivalents were reported at $60.5 million as of June 30, 2025, indicating a stable financial position for ongoing operations [16]

Core Insights - Aquestive Therapeutics announced significant progress with the submission of the New Drug Application (NDA) for Anaphylm, an oral, non-invasive epinephrine treatment for severe allergic reactions, with expectations for FDA acceptance in Q2 2025 and a potential U.S. launch in Q1 2026 if approved [2][3][4] Financial Performance - Total revenues for Q1 2025 decreased to $8.7 million from $12.1 million in Q1 2024, marking a 28% decline primarily due to reduced manufacture and supply revenue [14] - Manufacture and supply revenue fell to $7.2 million from $10.5 million year-over-year, largely due to decreased Suboxone revenues [15] - Research and development expenses decreased slightly to $5.4 million from $5.9 million, attributed to lower clinical trial costs for Anaphylm [16] - Selling, general and administrative expenses rose significantly to $19.1 million from $10.7 million, driven by regulatory fees and increased commercial spending [17] - The net loss for Q1 2025 was $22.9 million, or $0.24 per share, compared to a net loss of $12.8 million, or $0.17 per share, in Q1 2024 [18] Product Development and Market Strategy - Anaphylm is positioned as a potential best-in-class epinephrine therapy in a growing multi-billion dollar market, with commercialization efforts ramping up ahead of the spring allergy season [2][4] - The company plans to initiate regulatory submissions for Anaphylm in key international markets following FDA approval [4][5] - Preparations for an Advisory Committee meeting during the FDA review process are underway to present Anaphylm's clinical profile [5] - The launch of AQST-108, a topical gel for alopecia areata, is planned for the first half of 2026, post-Anaphylm launch [6][9] Regulatory and Legal Updates - Libervant's approval status was downgraded to tentative due to a court ruling, impacting sales and marketing activities, with plans to provide access in 2027 [10][11] - The company has decided not to appeal the court decision regarding Libervant to focus resources on Anaphylm's launch [11] Market Outlook - The company revised its full-year 2025 financial guidance, expecting total revenue between $44 million and $50 million, down from a prior estimate of $47 million to $56 million [20] - Non-GAAP adjusted EBITDA loss is now projected to be between $47 million and $51 million, slightly adjusted from previous guidance [20]