Anaphylm (Epinephrine) Sublingual Film - FDA accepted the NDA for Anaphylm in Q2 2025, with a PDUFA date scheduled for January 31, 2026[8] - The company is preparing for a U S launch of Anaphylm in Q1 2026, pending FDA approval[8] - A pediatric study showed that 12 mg Anaphylm administration demonstrated comparable PK curves in adult and pediatric subjects, with no statistical differences between PK parameters[16] - Pharmacodynamic (PD) outcomes in the pediatric study showed a positive inflection for Heart Rate (HR), Systolic Blood Pressure (SBP), and Diastolic Blood Pressure (DBP) after Anaphylm exposure[25] Financial Performance and Outlook - As of June 30, 2025, the company had a cash balance of approximately $60.5 million[8] - The company projects its cash runway into 2026[8] - The company is guiding for total revenues of approximately $44-$50 million for 2025[34] - The company anticipates a Non-GAAP adjusted EBITDA loss of approximately $47-$51 million for 2025[34] Manufacturing Operations - Manufacturing operations continue to generate cash[30] - Doses shipped in Q2 2025 were 37204 (thousands)[31]

Company Overview - Aquestive Therapeutics is a publicly traded pharmaceutical company (NASDAQ: AQST) focused on advancing medicines through innovative science and delivery technologies[7] - The company has shipped over 25 billion PharmFilm doses worldwide[10] - Aquestive Therapeutics reported over $57 million in revenue in 2024[13, 14] - The company anticipates 2 product launches in the U S by 2027[17] - The company estimates over $15 billion in potential peak annual net sales from pipeline assets[18] Anaphylm (epinephrine) Sublingual Film - The U S epinephrine market has the potential to grow to approximately $2 billion in value by 2031[54] - The current market size in 2024 is approximately $800 million[55] - The epinephrine market has experienced a 15% CAGR from 2021 to 2023[55, 56] - 95% of patients are interested in a film-dosing option for epinephrine[66] - The PDUFA action date for Anaphylm is scheduled for January 31, 2026[27, 69] AQST-108 (epinephrine) Topical Gel - The company is pursuing alopecia areata (AA) as a potential initial indication for AQST-108[75] - The market opportunity for JAK inhibitors for alopecia areata is estimated at over $1 billion[80]

Financial Position - The company reported a strong balance sheet with approximately $68.7 million in cash as of March 31, 2025 [10] - The company projects a cash runway into 2026 [10, 19] - The company expects total revenues of approximately $44-$50 million for 2025 [26] - The company anticipates a Non-GAAP adjusted EBITDA loss of approximately $47-$51 million for 2025 [26] Product Development & Regulatory Milestones - The NDA for Anaphylm (epinephrine) Sublingual Film was submitted in Q1 2025 [11] - The FDA acceptance of the NDA for Anaphylm is expected in Q2 2025 [11, 18] - The pediatric clinical trial for Anaphylm has been completed with positive top-line results [11] - The company is preparing for a potential Anaphylm launch in Q1 2026, pending FDA approval [11] Market & Manufacturing - Manufacturing operations continue to generate cash flow [21] - The company shipped 27,392 doses in Q1 2025 [22] - Market research indicates that 80% of patients and HCPs prefer a non-injection dosing method for epinephrine [14] - Market research indicates that 95% of patients and HCPs are interested in a film-dosing option [14] - Market research indicates that 85% of healthcare providers indicated they would prescribe a film-dosing option [16]