WARREN, N.J., June 27, 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, announced today that the Aquestive management team will participate in the Leerink Partners Therapeutics Forum: I&I and Metabolism and host investor meetings on July 9, 2024. The forum will include panels exploring key therapeutic themes a ...

WARREN, N.J., June 18, 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 its expected addition to the broad-market Russell 3000® and Russell 2000® Indexes at the conclusion of the 2024 Russell U.S. indexes annual reconstitution, effective at the open of U.S. equity markets on Monday, July 1, acc ...

WARREN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, announced today that the management team will participate in The Citizens JMP Life Sciences Conference on May 13, 2024. The Aquestive management team will hold a fireside chat on May 13 at 11:30 am ET and will host investor meetings. A webcast of the fireside chat will b ...

Aquestive Therapeutics, Inc. (NASDAQ:AQST) Q1 2024 Earnings Conference Call May 8, 2024 8:00 AM ET Company Participants Bennett Watson – ICR Westwicke Investor Relations Dan Barber – Chief Executive Officer and President Ernie Toth – Chief Financial Officer Stephen Wargacki – Chief Science Officer Conference Call Participants David Amsellem – Piper Sandler Francois Brisebois – Oppenheimer Ram Selvaraju – H.C. Wainwright Gary Nachman – Raymond James Thomas Flaten – Lake Street Capital Markets Operator Good m ...

Advancing medicines. Solving problems. Improving lives. 1 First Quarter 2024 Earnings Supplemental Materials May 7, 2024 Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. 2 ® Disclaimer Certain statements in this presentation include "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "anticipate," "plan," "expect," "estimate," "intend," "may," "will," or the negative o ...

Aquestive Therapeutics (AQST) reported $12.05 million in revenue for the quarter ended March 2024, representing a year-over-year increase of 8.3%. EPS of -$0.17 for the same period compares to $0.11 a year ago. The reported revenue represents a surprise of -1.37% over the Zacks Consensus Estimate of $12.22 million. With the consensus EPS estimate being -$0.09, the EPS surprise was -88.89%. While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectatio ...

Aquestive Therapeutics (AQST) came out with a quarterly loss of $0.17 per share versus the Zacks Consensus Estimate of a loss of $0.09. This compares to earnings of $0.11 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -88.89%. A quarter ago, it was expected that this specialty pharmaceutical company would post a loss of $0.08 per share when it actually produced a loss of $0.12, delivering a surprise of -50%.Over the last four ...

Product Development and Clinical Trials - The company aims to file the NDA for Anaphylm™ (epinephrine) Sublingual Film with the FDA before the end of 2024, following a pre-NDA meeting expected in the second half of 2024[104]. - Anaphylm has shown clinical results comparable to auto-injectors for the emergency treatment of allergic reactions, with positive topline data from multiple studies reported in 2022 and 2023[103]. - The pivotal clinical study for Anaphylm commenced in Q4 2023, with the FDA providing clarity on the study design and endpoints[103]. - The company is conducting additional studies for Anaphylm, including a temperature/pH study expected to complete in Q2 2024 and a pediatric study planned for the second half of 2024[103]. - AQST-108, a sublingual film composed of the prodrug dipivefrin, is in development and is expected to provide an alternative delivery method for epinephrine[104]. - AQST-108, a sublingual film formulation for systemic epinephrine, has shown rapid absorption in preclinical trials and is being developed for various dermatological conditions[105]. - The FDA granted Fast Track designation for Anaphylm in March 2022, indicating the product's potential to address unmet medical needs[103]. - The company reported no serious adverse events in clinical studies for Anaphylm, indicating a favorable safety profile[103]. Financial Performance - The licensed product portfolio generated $50.6 million in revenue for the year ended December 31, 2023, compared to $47.7 million in 2022, with Q1 2024 revenue at $12.1 million, up from $11.1 million in Q1 2023[107]. - Total revenues for the three months ended March 31, 2024, increased by 8% or $919, reaching $12,053 compared to $11,134 in the same period of 2023[126]. - Manufacture and supply revenue rose by approximately 8% or $756, totaling $10,518, driven by a 24% increase in Suboxone revenue and a 27% increase in Sympazan revenue[128]. - License and royalty revenue increased by 23% or $213, reaching $1,132, primarily due to a 158% increase in royalty revenues from Azstarys and a 28% increase from Sympazan[128]. Expenses and Costs - Research and development expenses surged by 67% or $2,385, totaling $5,932, mainly due to clinical trial costs for the Anaphylm program[129]. - Selling, general and administrative expenses rose by 43% or $3,234, amounting to $10,689, reflecting increased operational costs[129]. - Interest expense increased by 94% or $1,349, totaling $2,784, indicating higher borrowing costs[129]. - Total project expenses for Anaphlym increased 85%, or $1,446, for the three months ended March 31, 2024, compared to the same period in 2023[131]. - Clinical trial expenses for Anaphlym rose 113%, or $1,579, to $2,975 for the three months ended March 31, 2024, primarily due to ongoing clinical trial costs[131]. - Selling, general and administrative expenses increased 43%, or $3,234, for the three months ended March 31, 2024, compared to the same period in the prior year[131]. Cash Flow and Financing - The company had $95,200 in cash and cash equivalents as of March 31, 2024, providing liquidity for operating needs for at least the next twelve months[132]. - For the three months ended March 31, 2024, net cash used for operating activities was $(10,384), a decrease of $19,200 compared to the same period in 2023[135][136]. - The company completed an Underwritten Public Offering of 16,666,667 shares at a price of $4.50 per share, resulting in gross proceeds of $75,000 and net proceeds of $70,500 after underwriting discounts[139]. - Net cash provided by financing activities for the three months ended March 31, 2024, was $81,741, an increase of $90,946 compared to the same period in 2023[135][138]. - The company plans to use net proceeds from recent transactions to advance the development of its product pipeline, including Anaphylm and Libervant[139]. Debt and Financial Risks - The company has a significant level of debt with ongoing interest payments and principal repayments starting in June 2026[140]. - The ability to secure additional equity financing is influenced by operating performance, regulatory approval processes, existing debt levels, and market conditions[141]. - If adequate funds are not available, the company may need to reduce staff, delay or discontinue research and development programs, and significantly cut spending[141]. - The company may face dilution of stockholder rights if additional equity securities are issued, which could adversely affect stockholder interests[141]. Regulatory and Market Position - The company remains a smaller reporting company, allowing it to take advantage of certain disclosure exemptions[111]. - As a smaller reporting company, the company is not required to provide detailed market risk disclosures[143].

Exhibit 99.1 Aquestive Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Update • Met all endpoints in Phase 3 pivotal study for Anaphylm™ (epinephrine) Sublingual Film in first quarter 2024 when compared to EpiPen and other injectors used for the treatment of anaphylaxis • On track to complete Anaphylm temperature/pH study in second quarter 2024 • Received positive feedback from FDA on Anaphylm self-administration and allergen exposure protocols; remains on track to complete b ...

Met all endpoints in Phase 3 pivotal study for Anaphylm™ (epinephrine) Sublingual Film in first quarter 2024 when compared to EpiPen® and other injectors used for the treatment of anaphylaxisOn track to complete Anaphylm temperature/pH study in second quarter 2024Received positive feedback from FDA on Anaphylm self-administration and allergen exposure protocols; remains on track to complete both studies in third quarter 2024Continues to target filing an Anaphylm New Drug Application (NDA) with the FDA by th ...