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 Viewpoint - Aquestive Therapeutics has announced a $75 million strategic funding agreement with RTW Investments to support the commercialization of Anaphylm, a sublingual film for emergency treatment of allergic reactions, pending FDA approval [1][2]. Company Overview - Aquestive Therapeutics is focused on advancing medicines through innovative science and delivery technologies, with a portfolio that includes four commercialized products and a late-stage product candidate for severe allergic reactions [5]. - The company aims to provide novel alternatives to invasive therapies, utilizing proprietary technologies like PharmFilm® [5]. Product Details - Anaphylm™ (epinephrine) Sublingual Film is designed to be a convenient, oral rescue medication for severe allergic reactions, weighing less than an ounce and dissolving on contact without the need for water [4]. - The product's packaging is compact and weather-resistant, making it easy to carry [4]. Funding Agreement - The $75 million funding will be available upon FDA approval of Anaphylm and satisfaction of certain refinancing conditions related to the company's existing debt [2][7]. - RTW Investments will receive a tiered single-digit percentage of annual net sales of Anaphylm in the U.S., subject to a cap [2]. Strategic Importance - The financing is critical for supporting the company through 2027 and aims to transform how patients access their rescue medication [2]. - RTW Investments expresses confidence in the commercial prospects of Anaphylm as a rescue treatment for severe allergic reactions [2].

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]

Company Overview - Aquestive Therapeutics, Inc. is a pharmaceutical company focused on advancing medicines to improve patients' lives through innovative science and delivery technologies [4] - The company is developing orally administered products to deliver complex molecules, providing alternatives to invasive therapies [4] - Currently, Aquestive has four commercialized products marketed by its licensees and collaborates with other pharmaceutical companies to bring new molecules to market [4] Leadership Change - Sherry Korczynski has been promoted from Senior Vice President of Sales and Marketing to Chief Commercial Officer effective July 22, 2025 [1] - Her promotion is attributed to her exceptional track record in commercial leadership, particularly in the allergy market, and her strategic oversight of the EpiPen brand at Mylan [2] - Korczynski joined Aquestive in February 2024 and has over two decades of experience in commercial and launch roles across various pharmaceutical companies [2] Product Development - Anaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug candidate that is designed to be the first and only device-free, orally delivered epinephrine product [3] - The product is small, weighing less than an ounce, and dissolves on contact without the need for water or swallowing [3] - Anaphylm has been conditionally approved by the U.S. Food and Drug Administration (FDA), with final approval dependent on the product candidate's approval [3] Market Positioning - Anaphylm is positioned to potentially redefine anaphylaxis care, with a focus on successful launch and delivery to patients in the U.S. and abroad [3] - The company aims to leverage Korczynski's deep market knowledge and experience to drive its global commercial strategy for Anaphylm [2]

Core Viewpoint - Aquestive Therapeutics is advancing its regulatory strategy for Anaphylm™ (epinephrine) Sublingual Film, with meetings scheduled with Health Canada and the European Medicines Agency, aiming to provide a needle-free treatment option for anaphylaxis [1][2][4]. Regulatory Strategy - The company has received a meeting with Health Canada to discuss its New Drug Submission for Anaphylm™ and has submitted an initial briefing book to the EMA [1][8]. - A Marketing Authorization Application (MAA) is planned for submission to the EMA as soon as possible [1][2]. Product Overview - Anaphylm™ is an orally administered epinephrine product that addresses issues related to traditional auto-injectors, such as needle phobia and device malfunctions [3][6]. - The product is designed to be portable, weather-resistant, and easy to use, requiring no water or swallowing for administration [6]. Market Focus - The company's ex-U.S. regulatory strategy targets markets with significant unmet medical needs, with Canada and the EMA being prioritized due to their supportive regulatory environments [4][5]. - The company aims to establish Anaphylm as the new standard of care for severe allergic reactions and anaphylaxis globally [5]. Company Background - Aquestive Therapeutics has a portfolio of six FDA-approved drugs and a global presence across six continents, which enhances its ability to navigate international regulatory processes [2][7]. - The company is also developing other product candidates, including a topical gel for dermatological conditions [7].

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]

FDA assigns PDUFA target action date of January 31, 2026 Anaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/o ...

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]