Company Overview - Aquestive Therapeutics, Inc. is a pharmaceutical company focused on advancing medicines to improve patients' lives through innovative science and delivery technologies [5] - The company is developing orally administered products to deliver complex molecules, providing alternatives to invasive therapies [5] - Currently, Aquestive has four commercialized products marketed by its licensees globally and is the exclusive manufacturer of these products [5] Offering Details - The company announced an underwritten offering of 21,250,000 shares of common stock at a price of $4.00 per share, expecting gross proceeds of $85 million before expenses [1] - The net proceeds will primarily be used to advance the launch and commercialization of Anaphylm™ (epinephrine) Sublingual Film for treating severe allergic reactions, pending FDA approval [1] - The offering is expected to close around August 15, 2025, subject to customary closing conditions [1] Underwriters and Management - The offering was led by RTW Investments, LP, with participation from several investment firms including Samsara BioCapital and EcoR1 Capital [2] - Leerink Partners, Cantor, and Oppenheimer & Co. are acting as joint bookrunning managers, while H.C. Wainwright & Co. is the lead manager [2] Regulatory Information - A shelf registration statement relating to the offering was filed with the SEC and declared effective on April 23, 2024 [3] - A final prospectus supplement and accompanying prospectus will be filed with the SEC and made available on their website [3]

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, Inc. announced two poster presentations on Anaphylm™ (epinephrine) Sublingual Film at the CFAAR Food Allergy Summit, highlighting its potential as the first orally delivered epinephrine option for severe allergic reactions in the U.S. [1] Group 1: Product Details - Anaphylm™ is a polymer matrix-based epinephrine prodrug that is small, lightweight, and dissolves on contact without the need for water or swallowing [3] - The product's packaging is designed to be portable and weather-resistant, making it convenient for users [3] - Anaphylm has received conditional approval for its trade name from the FDA, pending final product approval [3] Group 2: Presentation Information - The first poster presentation focuses on the physicochemical properties of Anaphylm under extreme temperatures and real-world conditions, led by Nils Confer, PhD [2] - The second poster presentation discusses the pharmacokinetic and pharmacodynamic responses of Anaphylm, led by Carl Kraus, MD [2] Group 3: Company Overview - Aquestive Therapeutics is dedicated to advancing medicines through innovative science and delivery technologies, with a focus on orally administered products [4] - The company has four commercialized products and collaborates with other pharmaceutical companies to bring new molecules to market [4] - In addition to Anaphylm, the company is developing an earlier-stage epinephrine prodrug topical gel for dermatological conditions [4]

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]

Core Insights - Aquestive Therapeutics announced positive topline results from its pediatric study for Anaphylm™ (epinephrine) sublingual film, indicating its potential as a treatment for severe allergic reactions in patients aged seven to seventeen [1][2] - The company has submitted the New Drug Application (NDA) for Anaphylm to the FDA, with expectations for acceptance in the second quarter of 2025 [1][6] - If approved, Anaphylm is planned to be launched in the first quarter of 2026 [2] Pediatric Study Results - The pediatric study was a multi-site, single treatment study involving thirty-two patients, demonstrating consistent pharmacokinetic (PK) profiles with previous adult studies [2] - Anaphylm was found to be safe and well-tolerated, with no serious adverse events reported [2] Product Overview - Anaphylm is a polymer matrix-based epinephrine prodrug designed for the treatment of severe allergic reactions, including anaphylaxis [3] - The product is compact, similar in size to a postage stamp, and does not require water or swallowing for administration [3] Company Background - Aquestive Therapeutics focuses on advancing medicines through innovative science and delivery technologies, with five commercialized products and collaborations with other pharmaceutical companies [4] - The company is also developing an earlier stage epinephrine prodrug topical gel for dermatological conditions [4]