Aquestive Therapeutics, Inc. - AQST STOCK NEWS

Aquestive Therapeutics (NASDAQ: AQST) announced a definitive agreement for a registered direct offering of 8,850,000 shares of common stock and warrants, generating approximately $8.5 million in gross proceeds. Shares will be sold at $0.96 each to a healthcare-focused institutional investor and at $1.09 to certain executives. The offering is expected to close around June 8, 2022, pending customary conditions. The funds will be allocated for general corporate purposes. A.G.P./Alliance Global Partners is the sole placement agent for this offering.

Aquestive Therapeutics (NASDAQ: AQST) announces a leadership change with Daniel Barber appointed as the new President and CEO, succeeding Keith Kendall, who is leaving the company. Barber, previously the COO, will also join the Board of Directors. Kendall, who has been with the company since its inception, will serve as a consultant until the year's end to ensure a smooth transition. The company emphasized that Kendall's departure is unrelated to its financial performance or strategy. Barber aims to focus on key product candidates like Libervant and AQST-109 while managing costs.

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.