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 ...

Libervant is the first and only FDA approved orally administered rescue product for the treatment of seizure clusters in patients ages 2 to 5Announces immediate availability of Libervant 5mg, 7.5mg, 10mg, 12.5mg, and 15mg for patients between 2 to 5 years of ageCompany track record now includes 4 FDA approvals since 2018Anaphylm program on track; NDA submission expected by the end of 2024Hosts conference call for investors on April 29 at 8:00 a.m. ET WARREN, N.J., April 29, 2024 (GLOBE NEWSWIRE) -- Aquestiv ...

Core Insights - Aquestive Therapeutics, Inc. is presenting a crossover study of its product candidate Libervant™ (diazepam) Buccal Film for treating epilepsy in children aged two to five at the 76th Annual Meeting of the American Academy of Neurology [1][2] - Libervant is designed as an oral alternative to existing device-based treatments for seizure clusters in pediatric patients, aiming to improve patient well-being [2][3] - The FDA has granted tentative approval for Libervant for patients aged 12 and older, with a New Drug Application (NDA) for younger patients currently under review, targeting a PDUFA action date of April 28, 2024 [3][4] Company Overview - Aquestive Therapeutics focuses on advancing medicines through innovative science and delivery technologies, with a pipeline aimed at treating central nervous system diseases and severe allergic reactions [4] - The company has five commercialized products and collaborates with other pharmaceutical companies to develop new molecules using proprietary technologies [4]

WARREN, N.J., April 12, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (the “Company” or “Aquestive”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced a poster presentation highlighting the crossover study for the Company’s product candidate, Libervant™ (diazepam) Buccal Film for treatment of children with epilepsy aged two to five, will be presented at the 76th Annual ...

Core Insights - Aquestive Therapeutics is approaching a significant milestone with the anticipated topline data readout for their Anaphylm (AQST-109) epinephrine sublingual film, expected in Q1 of this year, with a potential New Drug Application (NDA) filing in 2024 [3][11] - The company announced positive Phase III data in March, showing that Anaphylm matches leading auto-injectors in key endpoints, including a quicker time to maximum concentration (Tmax) [3][7] - Following a $75 million public offering, the stock price has decreased from over $6 to approximately $4 per share, despite the positive Phase III results [3][5] Company Background - Aquestive Therapeutics is a pharmaceutical company focused on developing differentiated products using its proprietary PharmFilm platform, which allows for rapid dissolution of oral film drugs [4][5] - The company has a portfolio of five FDA-approved products and over 150 patents worldwide, with a focus on addressing unmet needs in CNS disorders and anaphylaxis [5][6] Financial Performance - In 2023, Aquestive's total revenues increased from $40 million in 2022 to $50.6 million, representing a 26% rise, while the net loss decreased from $54.4 million in 2022 to $7.9 million in 2023 [5][6] - The company ended 2023 with $23.9 million in cash and projects revenues between $48 million to $51 million for 2024 [6][5] Phase III Results - The Phase III study of Anaphylm met primary and secondary endpoints, demonstrating comparability with leading auto-injectors and a faster Tmax, confirming its potential as a needle-free alternative [7][9] - Anaphylm's exposure levels (AUC) were similar to auto-injectors for up to 30 minutes post-dosing, indicating a sustained therapeutic effect [7][9] Upcoming Catalysts - Upcoming catalysts include a self-administration study and an allergen PK study in Q2, a Pediatric PK study in Q3, and pre-NDA discussions in H2 of this year, all leading up to the NDA submission [11][12] - The NDA submission is expected to be a significant catalyst, marking the start of the FDA review timeline [12][11] Market Potential - Anaphylm has the potential to disrupt the epinephrine auto-injector market, which is projected to exceed $1 billion in peak sales, while Aquestive's market cap is around $370 million [12][13] - Revenue estimates suggest strong double-digit growth for Aquestive, with projections nearing half a billion in revenue over the next decade [12][13]

Aquestive Therapeutics (AQST) ended the recent trading session at $4.14, demonstrating a +0.24% swing from the preceding day's closing price. The stock's change was more than the S&P 500's daily loss of 0.72%. Elsewhere, the Dow saw a downswing of 1%, while the tech-heavy Nasdaq depreciated by 0.95%.Prior to today's trading, shares of the specialty pharmaceutical company had lost 1.2% over the past month. This has lagged the Medical sector's loss of 0.03% and the S&P 500's gain of 2.16% in that time.The inv ...

Company Performance - Aquestive Therapeutics (AQST) closed at $4.38, showing no change from the previous session, outperforming the S&P 500 which lost 0.14% [1] - The stock has increased by 66.54% over the past month, leading the Medical sector's gain of 0.88% and the S&P 500's gain of 5.34% [1] - The upcoming earnings disclosure is anticipated, with an expected EPS of -$0.09, reflecting a 181.82% decline year-over-year, while revenue is projected at $12.47 million, a 12% increase from the previous year [1] Earnings Estimates - Full-year Zacks Consensus Estimates predict earnings of -$0.38 per share and revenue of $50.85 million, indicating year-over-year changes of -192.31% for earnings and +0.52% for revenue [2] - Recent changes in analyst estimates are crucial as they reflect short-term business trends, with upward revisions indicating analysts' positive outlook on the company's operations [2] Zacks Rank and Industry Position - The Zacks Rank system, which ranges from 1 (Strong Buy) to 5 (Strong Sell), shows that AQST currently holds a Zacks Rank of 3 (Hold) [3] - The Medical - Drugs industry, to which AQST belongs, has a Zacks Industry Rank of 145, placing it in the bottom 43% of over 250 industries [3] - The Zacks Industry Rank measures the strength of industry groups, with top-rated industries outperforming the bottom half by a factor of 2 to 1 [3]

Aquestive Therapeutics (NASDAQ:AQST) stock is falling on Wednesday after the pharmaceutical company revealed details of a public offering for its shares.Aquestive Therapeutics is selling 16,666,667 shares of AQST stock for $4.50 each in this public offering. There’s also a 30-day option for underwriters to acquire an additional 2.5 million shares at that same price.Aquestive Therapeutics is expecting $75 million in gross proceeds from the stock offering. The company will use these funds to continue the deve ...