Aquestive Therapeutics, Inc. - AQST STOCK NEWS

Aquestive Therapeutics (NASDAQ:AQST) reported Q3 2024 financial results with total revenues of $13.5 million, up 4% from Q3 2023. The company reported a net loss of $11.5 million ($0.13 per share). Key developments include positive topline data from the OASIS study for Anaphylm™, their oral epinephrine treatment, with a pre-NDA meeting scheduled for Q4 2024. The company maintains $77.9 million in cash and expects a cash runway into 2026. Full-year 2024 guidance projects revenue of $57-60 million with a non-GAAP adjusted EBITDA loss of $20-23 million.

Aquestive Therapeutics (NASDAQ: AQST) announced a subsequent analysis of their pivotal study for Anaphylm™ (epinephrine) Sublingual Film to be presented at the ACAAI 2024 Annual Meeting. The analysis demonstrates that the film maintains consistent pharmacokinetics and pharmacodynamics regardless of placement or movement in the mouth.

The study showed that 87.5% of subjects had no change in film location between 1.5 to 3 minutes after administration. In cases where movement occurred (12.5% of subjects), there were no significant differences in drug concentration metrics. The geometric mean maximum concentration was 351.14 and 490.27 pg/mL for subjects with and without film movement, respectively, with a median peak drug concentration of 12 minutes for both groups.

Aquestive Therapeutics (NASDAQ: AQST) announced positive topline results from its Oral Allergy Syndrome (OAS) challenge study for Anaphylm™ sublingual film. The study met both primary and secondary endpoints, demonstrating rapid symptom resolution beginning two minutes after administration. The median time for complete symptom resolution was twelve minutes, significantly faster than the 74-minute baseline. The pharmacokinetic profile remained consistent with previous studies, showing a 12-minute time to maximum plasma concentration. The company plans a pre-NDA meeting with FDA in Q4 2024, aims to submit an NDA in Q1 2025, and targets product launch in Q1 2026.

Aquestive Therapeutics (NASDAQ: AQST) hosted a virtual investor day highlighting its Adrenaverse™ epinephrine prodrug platform, focusing on two key products: Anaphylm™ (epinephrine) Sublingual Film and AQST-108 (epinephrine) Topical Gel. The company announced:

1. Completion of enrollment in the oral allergen challenge study for Anaphylm™
2. Plans to submit a New Drug Application (NDA) for Anaphylm™ in Q1 2025
3. Development strategy for AQST-108 to treat Alopecia areata
4. Completion of the first human clinical study for AQST-108

Aquestive aims to hold a pre-NDA meeting with the FDA in Q4 2024 for Anaphylm™ and plans a full product launch, if approved, by end of 2025 or Q1 2026. For AQST-108, the company expects to hold a pre-IND meeting with the FDA in Q1 2025 and commence a Phase 2 study in H2 2025.

Aquestive Therapeutics (NASDAQ: AQST) has announced a virtual investor day scheduled for September 27, 2024, at 8:00 am ET. The event will focus on pipeline updates, particularly for two key products: Anaphylm™ (epinephrine) Sublingual Film and AQST-108 (epinephrine) Topical Gel. Both are candidate products from the company's Adrenaverse™ epinephrine prodrug platform.

The presentation will feature Aquestive's management team and a guest speaker, Dr. J. David Farrar, Associate Professor of Immunology/Molecular Biology at UT Southwestern Medical Center. Investors can register for the event online, and a webcast will be available for 30 days after the presentation on the company's investor relations website.

Aquestive Therapeutics (NASDAQ: AQST) has announced its participation in two upcoming investor conferences in September 2024. The company will present at the H.C. Wainwright 26th Annual Global Investor Conference on September 9th at 8:30 am ET and host investor meetings. Additionally, Aquestive will be available for investor meetings at the Lake Street BIG8 Conference on September 12th.

A webcast of the H.C. Wainwright presentation will be accessible on the company's website under the "Events and Presentation" page in the Investors section. The webcast replay will remain available for 30 days after the event. Aquestive Therapeutics is a pharmaceutical company focused on developing innovative medicines and delivery technologies to improve patients' lives.

Aquestive Therapeutics (NASDAQ: AQST) has commented on the FDA's recent approval of the first non-injection-based epinephrine device for treating severe allergic reactions, including anaphylaxis. The company views this as a positive development for patients seeking alternatives to needle-based epinephrine delivery. Aquestive is developing its own product, Anaphylm™ (epinephrine) Sublingual Film, which could potentially become the first oral epinephrine treatment for anaphylaxis.

Aquestive reiterates its timeline for Anaphylm™, expecting to file a New Drug Application (NDA) with the FDA in Q1 2025. The company anticipates a full product launch, if approved, by late 2025 or early 2026. Currently, Aquestive is conducting its final supportive study, the oral allergy syndrome (OAS) challenge, expected to conclude in late Q3 or early Q4 2024.

Aquestive Therapeutics (NASDAQ:AQST) reported its Q2 2024 financial results and shared business updates. Key highlights include:

• Anaphylm™ (epinephrine) Sublingual Film remains on track for FDA submission in early 2025, with a potential launch by late 2025 or early 2026.
• Positive topline pharmacokinetic (PK) and pharmacodynamic (PD) data reported, showing no significant differences based on temperature and pH variability.
• Libervant™ (diazepam) Buccal Film expanded for ages two to five, with national retail distribution expected by Q4 2024.
• Q2 2024 revenue surged 52% to $20.1 million, up from $13.2 million in Q2 2023.
• Net loss decreased to $2.7 million from $5.8 million in Q2 2023, with non-GAAP adjusted EBITDA income at $1.8 million.
• Cash reserves stand at approximately $90 million, with a cash runway extending into 2026.

An investor call is scheduled for August 7, 2024, at 8:00 am ET.

Aquestive Therapeutics (NASDAQ: AQST) reported positive topline data from the self-administration study of Anaphylm™ (epinephrine) Sublingual Film. The study met primary endpoints, showing comparable pharmacokinetics whether administered by subjects or healthcare providers. Key findings include:

1. No statistical difference between self-administered and HCP-administered Anaphylm
2. Median time to maximum concentration (Tmax) was 15 minutes for Anaphylm vs. 50 minutes for Adrenalin IM injection
3. Oral Allergy Syndrome challenge study currently enrolling, expected to complete in Q3/Q4 2024
4. Company anticipates requesting pre-NDA meeting before end of Q3
5. Full product launch projected for late 2025 or Q1 2026