Avenue Therapeutics(ATXI) - 2024 Q4 - Annual Report

Financial Performance - The net loss for Avenue Therapeutics for the years ended December 31, 2024 and 2023 was approximately $11.7 million and $10.5 million, respectively, with an accumulated deficit of approximately $102.6 million as of December 31, 2024[386]. - The net loss for 2024 was $11.7 million, a 12% increase from the $10.5 million net loss in 2023[419]. - Cash and cash equivalents increased to $2.6 million in 2024 from $1.8 million in 2023[430]. - The company reported a loss on common stock warrant liabilities of $0.8 million in 2024, compared to no such loss in 2023[427]. - The change in fair value of warrant liabilities improved by 96%, from a loss of $4.3 million in 2023 to a loss of $0.2 million in 2024[419]. - Total cash used in operating activities was approximately $9.0 million in 2024, slightly lower than the $9.5 million used in 2023[432][433]. - The company maintained a full valuation allowance on deferred tax assets due to not achieving sustained profitable operations[415]. Research and Development - Avenue Therapeutics expects to continue incurring research and development costs and general administrative costs, leading to operating losses for at least the next several years[387]. - The company paid an initial cash license fee of $3.0 million for the exclusive rights to the AJ201 product candidate, with additional payments of up to $10.8 million expected for the Phase 1b/2a clinical trial[391]. - The Phase 1b/2a trial for AJ201 is expected to enroll approximately 25 patients, with the primary endpoint assessing safety and tolerability[394]. - In January 2024, Avenue Therapeutics announced the completion of enrollment for the Phase 1b/2a trial, with the last patient visit reported in May 2024[395]. - The company reached a final agreement with the FDA on the Phase 3 safety study protocol for IV tramadol, which will involve approximately 300 post bunionectomy patients[401]. - BAER-101 demonstrated full suppression of seizure activity in preclinical data with a minimal effective dose of 0.3 mg/kg, presented at the American Epilepsy Society 2023 Annual Meeting[404]. Stock and Financing Activities - On March 17, 2025, Avenue Therapeutics was notified of its delisting from Nasdaq due to a violation of the stockholders' equity requirement of at least $2,500,000[405]. - Following the delisting, the company's common stock began trading on the OTC Markets under the symbol "ATXI" on March 19, 2025[406]. - Avenue Therapeutics plans to continue filing required periodic reports and other filings with the SEC despite the change in trading platform[406]. - In September 2023, the company issued 10,227 shares in a private placement for approximately $0.6 million at a price of $53.775 per share[441]. - The November 2023 public offering included the sale of 221,779 units, generating net proceeds of approximately $3.8 million after deducting fees and expenses[446]. - The November 2023 Series A and B Warrants are exercisable at $22.545 per share for five years and 18 months, respectively[445]. - The company entered into inducement agreements in January 2024, resulting in gross proceeds of approximately $5.0 million from the exercise of existing warrants[447]. - The May 2024 Warrant Inducement involved the exercise of warrants for cash at a reduced price of $6.20 per share, with net proceeds of approximately $3.7 million[452]. - The company has a maximum obligation of $10.8 million for Phase 1b/2a clinical development payments related to the AJ201 product candidate, with $6.3 million remaining as of December 31, 2023[457]. - Development milestones totaling approximately $81.5 million are due under license agreements with AstraZeneca and Cincinnati Children's Hospital, with additional commercial payments of approximately $151.0 million possible[458]. - The company has entered into an At the Market Offering Agreement allowing for the sale of up to $3.85 million of common stock[453]. - For the twelve months ended December 31, 2024, the company sold 591,205 shares under the ATM Agreement, resulting in net proceeds of approximately $1.6 million[455]. - The company has obligations under various contracts with third parties for services related to biopharmaceutical development, which may include cancellation fees[456]. - The company entered into a license agreement with Revogenex for IV tramadol, receiving a $3.0 million regulatory milestone upon approval and will pay high single-digit to low double-digit royalties on net sales[459]. - A share repurchase agreement with InvaGen requires the company to pay 7.5% of future financing proceeds, capped at $4 million, with $0.7 million and $0.5 million paid in 2024 and 2023, respectively[460]. Company Classification - The company is classified as a "smaller reporting company," with a market value of shares held by non-affiliates below $250 million[417].