WARREN, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the pricing of an underwritten public offering of 16,666,667 shares of its common stock at a public offering price of $4.50 per share. The gross proceeds of the offering to Aquestive, before deducting the underwriting disc ...

Core Viewpoint - Aquestive Therapeutics, Inc. plans to conduct an underwritten public offering of its common stock, with a potential additional 15% of shares available for purchase by underwriters [1][2] Group 1: Offering Details - The public offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1] - Leerink Partners and Piper Sandler are the joint bookrunning managers, while Oppenheimer & Co. serves as the lead manager for the offering [2] Group 2: Use of Proceeds - The net proceeds from the offering will be used to advance the development and commercialization of the product pipeline, including Anaphylm™ Sublingual Film and Libervant™ Buccal Film, as well as for working capital and general corporate purposes [2] Group 3: Company Overview - Aquestive Therapeutics focuses on innovative science and delivery technologies to improve patient lives, with a pipeline that includes treatments for severe allergic reactions and central nervous system diseases [5] - The company has five commercialized products and collaborates with other pharmaceutical companies to bring new molecules to market using proprietary technologies [5]

Core Insights - Aquestive Therapeutics, Inc. (AQST) shares surged 16% on March 15 after achieving primary and secondary endpoints in a pivotal phase III clinical study for Anaphylm, a sublingual film for treating severe allergic reactions [1][4] - Anaphylm is positioned as a non-invasive alternative to traditional autoinjectors like EpiPen, offering potential advantages in convenience and speed of administration [1][2] Clinical Study Results - In the pivotal phase III study, Anaphylm demonstrated non-inferiority to leading autoinjectors immediately after administration and was consistently faster in reaching maximum concentration (Tmax) [1][2] - Tmax is a critical metric for assessing the absorption rate of epinephrine, essential for treating severe allergic reactions [2] - Anaphylm's exposure levels, measured by area under the curve (AUC), were comparable to autoinjectors for 30 minutes post-dosing, indicating similar efficacy [2] Regulatory Developments - The FDA provided positive feedback during a Type C meeting, outlining the necessary steps for a pre-new drug application (NDA) meeting in the latter half of the year [4] - The company plans to file an NDA for Anaphylm by the end of 2024, contingent on a successful pre-NDA meeting [4] - The FDA has recommended that the company initiate a pediatric study for Anaphylm after completing adult studies [4] Stock Performance - Over the past year, AQST shares have increased by 668.9%, contrasting with a 4.6% decline in the industry [4]

Group 1 - Aquestive Therapeutics (AQST) shares increased by 16% to $6.09, with a notable trading volume, following a 93% gain over the past four weeks [1] - The stock price surge is linked to the successful achievement of primary and secondary endpoints in a phase III clinical study for Anaphylm (epinephrine) Sublingual Film, aimed at treating severe allergic reactions [1] - The company plans to file a new drug application for Anaphylm by the end of 2024, which is expected to further influence stock performance [1] Group 2 - The upcoming quarterly report for Aquestive Therapeutics is projected to show a loss of $0.09 per share, a year-over-year decline of 181.8%, with revenues expected to reach $12.47 million, reflecting a 12% increase from the previous year [2] - The consensus EPS estimate for the quarter has been revised 13.3% higher in the last 30 days, indicating a potential for price appreciation [2] - The stock currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook compared to other stocks in the same industry [3] Group 3 - Collegium Pharmaceutical (COLL), a peer in the Zacks Medical - Drugs industry, saw a 2.8% increase in its stock price, with a 12% return over the past month [3] - Collegium's consensus EPS estimate has risen by 11.9% over the past month, indicating positive momentum in earnings expectations [3] - Collegium Pharmaceutical holds a Zacks Rank of 1 (Strong Buy), contrasting with Aquestive's current ranking [3]

Anaphylm meets all predefined primary and secondary pharmacokinetic endpointsAnaphylm time to maximum concentration (Tmax) is consistently faster than autoinjectorsAnaphylm exposure levels (AUC) are comparable to autoinjectors for 30 minutes after dosing Anaphylm is well-tolerated with no serious adverse events Company receives positive Type C meeting feedback from the U.S. Food and Drug Administration (FDA) regarding the clinical development of Anaphylm Company reaffirms goal of filing NDA before the end o ...

Aquestive Therapeutics, Inc. (NASDAQ:AQST) Q4 2023 Earnings Conference Call March 6, 2024 8:00 AM ET Company Participants Bennett Watson - Investor Relations, ICR Westwicke Dan Barber - Chief Executive Officer Ernie Toth - Chief Financial Officer Carl Kraus - Chief Medical Officer Conference Call Participants François Brisebois - Oppenheimer Jason Butler - Citizens JMP Securities Andreas Argyrides - Wedbush Thomas Flaten - Lake Street Capital Markets Ram Selvaraju - H.C. Wainwright James Molloy - Alliance G ...

Q4 2024 Earnings Supplemental Materials March 5, 2024 Advancing medicines. Solving problems. Improving lives. 1 ...

Aquestive Therapeutics (AQST) came out with a quarterly loss of $0.12 per share versus the Zacks Consensus Estimate of a loss of $0.08. This compares to loss of $0.23 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -50%. A quarter ago, it was expected that this specialty pharmaceutical company would post a loss of $0.11 per share when it actually produced a loss of $0.03, delivering a surprise of 72.73%.Over the last four quar ...

Reports full year 2023 revenue of $50.6 million and non-GAAP adjusted EBITDA loss of $11.6 millionReaffirms expected release of topline pivotal clinical data for Anaphylm™ (epinephrine) Sublingual Film in March 2024Reaffirms anticipated FDA decision on Libervant™ (diazepam) Buccal Film application in April 2024Provides full year 2024 financial guidanceHosts investment community conference call on March 6, 2024 WARREN, N.J., March 05, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pha ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share AQST NASDAQ Global Market FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ C ...