Financial Data and Key Metrics Changes - Total revenues for Q2 2025 increased by $300,000 or 3% year over year to $10,000,000, excluding the impact of one-time recognition of deferred revenue in 2024 [21][22] - Net loss for Q2 2025 was $13,500,000 or $0.14 per share, compared to a net loss of $2,700,000 or $0.03 per share in Q2 2024 [24][25] - Non-GAAP adjusted EBITDA loss was $9,300,000 in Q2 2025, compared to a non-GAAP adjusted EBITDA income of $1,800,000 in Q2 2024 [25] Business Line Data and Key Metrics Changes - Manufacturer and supply revenue increased to $9,600,000 in Q2 2025 from $8,100,000 in Q2 2024, primarily due to increases in ONDEEP revenues, partially offset by decreases in Suboxone revenues [22] - Research and development expenses decreased to $9,500,000 for the six months ended June 30, 2025, from $10,100,000 for the same period in 2024 [23] Market Data and Key Metrics Changes - The rescue market for severe allergic reactions is expected to grow from approximately 5,000,000 prescriptions a year to as many as 10,000,000 prescriptions a year, potentially generating over $2,000,000,000 annually in global market [9][10] - A survey indicated that 90% of the market is expected to shift from injectables to non-injectable products over the coming years [10] Company Strategy and Development Direction - The company is focused on the launch of ANNAFILM, an oral product for treating severe allergic reactions, with an FDA action date set for January 31, 2026 [6][19] - The company is exploring multiple financing options to support the launch of ANNAFILM, including non-dilutive alternatives [20][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical data package for ANNAFILM, highlighting a robust set of studies conducted [31] - The company is committed to addressing market access challenges and ensuring patients have access to ANNAFILM, including a cash pay program for patients [12][13] Other Important Information - The company ended Q2 2025 with $60,500,000 in cash, which is deemed sufficient for the initial launch but will require additional funding for ongoing support [15][26] - The company’s full-year 2025 financial guidance remains unchanged, expecting total revenue of $44,000,000 to $50,000,000 [26] Q&A Session Summary Question: Likelihood of FDA Advisory Committee Meeting - Management indicated that the likelihood of an Advisory Committee meeting remains uncertain and will depend on the FDA's mid-cycle review [30] - The clinical data package is robust, consisting of 10 independent studies with over 350 subjects [31] Question: Out-of-Pocket Exposure and Payer Landscape - Discussions with payers are focused on awareness rather than coverage at this stage, with cash pay expected to be a significant part of the market [38][39] Question: Pediatric Study Safety and NDA Submission - The pediatric study showed no significant differences in safety outcomes compared to adults, and the data is expected to support the NDA submission [52] Question: Commercial Preparation and Awareness of ANNAFILM - The company is actively increasing awareness through various channels, receiving positive feedback from the allergy community [56] Question: Business Development Strategy for ANNAFILM - The company is considering partnerships for ANNAFILM but emphasizes the importance of broad patient access [61] Question: Characteristics of Ideal Prescribers - The ideal prescribers for ANNAFILM are allergists, who are expected to be key targets upon launch due to their enthusiasm for the product [68]

As filed with the Securities and Exchange Commission on September 18, 2023. Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Avenue Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 47-4113275 (I.R.S. Employer Identification Number) 1 ...