Aquestive Therapeutics, Inc. - AQST STOCK NEWS

Aquestive Therapeutics, Inc. (NASDAQ: AQST) has announced its participation in the H.C. Wainwright Global Investment Conference from May 23-26, 2022. The management team will present on May 25 at 2:30 PM ET and will host investor meetings throughout the event. A webcast of the presentation will be accessible on the company's Investors webpage, with a replay available for 30 days post-event. The company focuses on innovative therapies, including five commercialized products and ongoing development of its proprietary pipeline aimed at CNS diseases and severe allergic reactions.

Aquestive Therapeutics, Inc. (NASDAQ: AQST) reported financial results for Q1 2022 with total revenues of $12.3 million, up from $11.1 million in Q1 2021. However, the company posted a net loss of $13.2 million, improved from $14.7 million in the prior year. Key developments include the commencement of Part 3 of the EPIPHAST trial for AQST-109 and the ongoing orphan drug exclusivity review for Libervant by the FDA. The company anticipates full-year revenues between $42 million and $47 million.

Aquestive Therapeutics, Inc. (NASDAQ: AQST) announced it will report its Q1 results for the period ending March 31, 2022, on May 3, 2022, after market close. A conference call for investors is scheduled for May 4, 2022, at 8:00 a.m. ET, accessible via phone or a live webcast on their website. The company specializes in developing innovative orally administered products targeting CNS diseases and severe allergic reactions. Notably, it has five commercialized products and a pipeline that includes proprietary and licensed drug candidates.

Aquestive Therapeutics (NASDAQ: AQST) announced a common stock purchase agreement with Lincoln Park Capital for up to $40 million. This agreement allows Aquestive to sell shares at its discretion over a 36-month term, based on prevailing market prices. The proceeds will support working capital and corporate needs. CEO Keith Kendall expressed that this partnership enhances capital flexibility for the company's growth. Further details will be disclosed in a forthcoming SEC filing. The stock offerings are made under an effective registration statement as of April 5, 2021.

AQST-109, the first orally delivered epinephrine product candidate, shows promising results in the EPIPHAST study. A larger population confirmed rapid absorption with a median time to peak concentration of just 15 minutes, compared to 50 minutes for intramuscular injection. The product is safe and well-tolerated, with no serious adverse events reported. Part 3 of the trial begins this month, and a pivotal PK study is expected in the second half of 2022. The results could significantly enhance the management of severe allergies, including anaphylaxis.

Aquestive Therapeutics (NASDAQ:AQST) announced that the FDA granted Fast Track designation for AQST-109, the first orally delivered epinephrine product for treating allergic reactions, including anaphylaxis. This designation signifies the FDA's acknowledgment of the product's potential to address unmet medical needs. AQST-109 is delivered as a sublingual film, facilitating easier access to emergency medication. The company expects to report topline results from its EPIPHAST study in the first half of 2022 and plans to conduct further meetings with the FDA.

Aquestive Therapeutics (AQST) provided a comprehensive business update, highlighting the ongoing FDA review of its NDA for Libervant™ (diazepam) Buccal Film, designed for epilepsy patients. Following positive results from Part 1 of the EPIPHAST study for AQST-109, an epinephrine oral film, Part 2 has commenced. The company announced a $7 million licensing agreement for riluzole oral film in China and reported Q4 2021 revenues of $11.1 million, a 55% increase year-over-year. Despite a net loss of $28.9 million, Aquestive anticipates strong revenue growth in 2022, projecting total revenues between $42 to $47 million.

Aquestive Therapeutics (NASDAQ: AQST) has signed a License, Development, and Supply Agreement with Haisco Pharmaceutical Group Co., Ltd. for the exclusive commercialization of EXSERVAN™ (riluzole oral film) in China, targeting amyotrophic lateral sclerosis (ALS) treatment. Aquestive will act as the sole manufacturer, receiving a $7 million upfront payment, regulatory milestones, and royalties on sales. EXSERVAN offers ALS patients an alternative delivery method, potentially addressing the swallowing difficulties associated with traditional tablet forms of riluzole.

On February 28, 2022, Aquestive Therapeutics (NASDAQ: AQST) presented positive topline data from a Phase 1 study of AQST-109, an epinephrine oral film, during the AAAAI annual meeting in Phoenix, Arizona. The study demonstrated that dosing resulted in pharmacokinetic and pharmacodynamic responses within the expected therapeutic range, indicating the potential of AQST-109 as a viable alternative to injection for managing anaphylaxis. The FDA opened the Investigational New Drug Application on February 24, 2022, and the company plans to advance AQST-109 through pivotal studies in 2022.