Core Viewpoint - Aquestive Therapeutics, Inc. has reported its financial results for Q4 and the full year 2024, highlighting significant advancements in its product pipeline, particularly the Anaphylm application process with the FDA and the development of AQST-108 for alopecia areata. Financial Performance - Total revenues for Q4 2024 decreased to $11.9 million from $13.2 million in Q4 2023, a 10% decline primarily due to reduced license and royalty revenue [17] - For the full year 2024, total revenues increased to $57.6 million from $50.6 million in 2023, marking a 14% increase driven by higher license and royalty revenue [25] - The net loss for Q4 2024 was $17.1 million, or ($0.19) per share, compared to a net loss of $8.1 million, or ($0.12) per share in Q4 2023 [23] - The full year net loss for 2024 was $44.1 million, or ($0.51) per share, compared to a net loss of $7.9 million, or ($0.13) per share in 2023 [29] Product Development Updates - The company has initiated the Anaphylm application process with the FDA, expecting to complete it in Q1 2025 and achieve FDA acceptance by the end of Q2 2025 [2][4] - Anaphylm, a non-device based epinephrine product, has shown clinical results comparable to autoinjectors and completed all adult clinical trials with positive feedback from the FDA [3][4] - AQST-108 (epinephrine) Topical Gel is set to enter Phase 2a clinical trials in Q2 2025, targeting alopecia areata, which affects approximately 6.7 million people in the U.S. [7][8] Market Strategy and Outlook - The company is preparing for the launch of Anaphylm, focusing on market access and increasing awareness through medical affairs strategies [6] - The estimated market opportunity for JAK inhibitors for alopecia areata exceeds $1 billion, indicating significant potential for AQST-108 if approved [10] - The company expects total revenue for 2025 to be between $47 million and $56 million, with a non-GAAP adjusted EBITDA loss projected between $46 million and $53 million [33][34] Cash Position - As of December 31, 2024, cash and cash equivalents were approximately $71.5 million, with proforma cash and cash equivalents around $93.0 million following a capital raise [31]

Core Insights - Aquestive Therapeutics, Inc. is participating in two investor conferences in March 2025, including the Leerink's Global Biopharma Conference and Barclays 27th Annual Global Healthcare Conference [1][4] Company Overview - Aquestive is a pharmaceutical company focused on advancing medicines through innovative science and delivery technologies, developing orally administered and topical gel products to deliver complex molecules [2] - The company has five commercialized products marketed in the U.S. and globally, and it is the exclusive manufacturer of these licensed products [2] - Aquestive is advancing a late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis, and an early-stage epinephrine prodrug topical gel for various dermatology conditions, including alopecia areata [2] Upcoming Events - The Leerink's Global Biopharma Conference will take place from March 10 to March 12, with a fireside chat scheduled for March 10th at 4:20-4:50 PM EST, and management will be available for one-on-one meetings [4] - The Barclays 27th Annual Global Healthcare Conference will occur from March 11 to March 13, with management also available for one-on-one meetings on March 12 [4]

Core Viewpoint - Aquestive Therapeutics, Inc. is set to report its fourth quarter results for the period ending December 31, 2024, and will provide updates on recent business developments on March 5, 2025, after market close [1] Company Overview - Aquestive Therapeutics is a pharmaceutical company focused on advancing medicines that significantly improve patients' lives through innovative science and delivery technologies [4] - The company is developing orally administered products to deliver complex molecules, offering alternatives to invasive and inconvenient standard therapies [4] - Currently, Aquestive has five commercialized products marketed in the U.S. and globally, and it is the exclusive manufacturer of these licensed products [4] - The company collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies, such as PharmFilm® [4] - Aquestive is advancing a late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis, and an earlier stage epinephrine prodrug topical gel for various dermatological conditions, including alopecia areata [4] Upcoming Events - Management will host a conference call for investors on March 6, 2025, at 8:00 a.m. ET, with registration required for participation [2] - A live webcast of the call will be available on the Investors section of the company's website [2] - A replay of the webcast will be accessible for 30 days following the call [3]

Core Viewpoint - Aquestive Therapeutics is advancing its investigational product Anaphylm, an epinephrine sublingual film, aimed at providing a reliable and portable treatment for severe allergic reactions, including anaphylaxis, with results to be presented at the 2025 AAAAI Annual Meeting [1][2]. Group 1: Product Development and Clinical Data - Anaphylm is designed to offer a more accessible option for emergency epinephrine administration without the need for an injection or device, pending FDA approval [2]. - The Phase 2 OASIS study involved 36 adults with Oral Allergy Syndrome, demonstrating that Anaphylm maintains stability and potency under extreme conditions, which is crucial for real-world application [2][4]. - Anaphylm showed consistent epinephrine absorption and matched or exceeded intramuscular (IM) epinephrine in key pharmacokinetic parameters, with median symptom resolution time of 12 minutes compared to 74 minutes without treatment [5][4]. Group 2: Presentation Details - Multiple posters will be presented at the AAAAI Annual Meeting, including topics on the durability of Anaphylm under real-world use, stability under extreme temperature conditions, and pharmacokinetic and pharmacodynamic responses [3][6]. - The lead authors for the presentations include Steve Wargacki, PhD, and Carl N. Kraus, MD, with specific presentation times scheduled for March 1, 2025 [3][6]. Group 3: Company Overview - Aquestive Therapeutics focuses on advancing medicines through innovative science and delivery technologies, with a portfolio that includes five commercialized products and collaborations with other pharmaceutical companies [8]. - The company is also developing an earlier-stage epinephrine prodrug topical gel for various dermatology conditions, showcasing its commitment to addressing complex medical needs [8].

Core Insights - Aquestive Therapeutics, Inc. will participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference virtually on February 11-12, 2025, with a fireside chat scheduled for February 11 at 3:20 PM ET [1] Company Overview - Aquestive is a pharmaceutical company focused on advancing medicines that improve patients' lives through innovative science and delivery technologies [3] - The company is developing orally administered and topical gel products to deliver complex molecules, providing alternatives to standard therapies [3] - Currently, Aquestive has five commercialized products marketed in the U.S. and globally, and it is the exclusive manufacturer of these licensed products [3] - The company collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies like PharmFilm [3] - Aquestive is advancing a late-stage proprietary product candidate for treating severe allergic reactions, including anaphylaxis, and an early-stage epinephrine prodrug topical gel for dermatology conditions [3]

On track to submit Anaphylm™ (epinephrine) Sublingual Film NDA in Q1 2025Actively recruiting subjects in the Anaphylm pediatric clinical trialSuccessfully completed AQST-108 (epinephrine) Topical Gel pre-IND meeting and on track to begin Phase 2a clinical trial in alopecia areata in Q2 2025 Unaudited cash and cash equivalents of approximately $70 million as of December 31, 2024 WARREN, N.J., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharm ...

Company Overview - Aquestive Therapeutics (NASDAQ: AQST) has transitioned from a pharmaceutical company focused on partnering or licensing its PharmFilm technology to a clinical-stage company [1] - The company has been covered by the analyst since 2019, highlighting its evolution and potential in the healthcare sector [1] Analyst's Perspective - The analyst has a beneficial long position in AQST through stock ownership, options, or other derivatives, indicating a positive outlook on the company's future [2] - The article reflects the analyst's personal opinions and is not influenced by compensation or business relationships with the mentioned companies [2] Industry Focus - The analyst specializes in innovative companies developing breakthrough therapies and pharmaceuticals, with a focus on potential acquisition catalysts [1] - The healthcare investment group led by the analyst offers several model healthcare portfolios, a weekly newsletter, a daily watchlist, and a chat for dialogue and questions [1]

Core Points - The U.S. FDA has granted seven years of orphan drug exclusivity to Libervant® (diazepam) Buccal Film for treating seizure clusters in pediatric patients aged 2 to 5 [1] - Libervant is the first and only FDA-approved orally administered rescue therapy for this specific patient population [2] - The FDA's orphan designation provides financial incentives and market exclusivity benefits for drugs treating rare diseases affecting fewer than 200,000 people in the U.S. [1] Company Overview - Aquestive Therapeutics, Inc. is focused on advancing medicines through innovative science and delivery technologies, with a portfolio that includes five commercialized products [11] - The company aims to provide non-invasive treatment alternatives to existing therapies for patients with refractory epilepsy [3] - Libervant was originally granted Orphan Drug Designation on November 10, 2016, and the exclusivity extends to April 2031 [1] Product Details - Libervant is a buccal film formulation of diazepam intended for acute treatment of frequent seizure activity distinct from a patient's usual seizure pattern [3] - The product was approved for pediatric patients aged 2 to 5 in April 2024, following tentative approval for patients aged 12 and older in August 2022 [3] - The buccal route of administration is considered a significant improvement over the rectal route, enhancing ease of use for caregivers [1]

Aquestive Therapeutics, Inc. (NASDAQ:AQST) Q3 2024 Earnings Call Transcript November 5, 2024 8:00 AM ET Company Participants Bennett Watson - IR, ICR Westwicke IR Dan Barber - CEO Ernie Toth - CFO Sherry Korczynski - SVP of Sales and Marketing Carl Kraus - CMO Steve Wargacki - CSO Conference Call Participants Roanna Ruiz - Leerink Partners David Amsellem - Piper Sandler Francois Brisebois - Oppenheimer Raghuram Selvaraju - HC Wainwright & Co. Jason Butler - JMP Securities Thomas Flaten - Lake Street Capital ...

Aquestive Therapeutics (NASDAQ: AQST ) is a small-cap pharmaceutical company specializing in the composition and delivery of unique film-based medicines for several different indications. The company was founded in 2004 and pioneered its "PharmFilm" platform as an alternative method to invasive andI am a corporate strategy professional with work experience across industrials, energy, and technology. My primary investment interest is in biotech where I have over a decade of investment experience. My secondar ...