Avenue Therapeutics, Inc. reported a net loss of $11.7 million for the year ended December 31, 2024, compared to a net loss of $10.5 million in 2023. Research and development expenses increased by $0.5 million to $6.6 million in 2024, primarily due to higher clinical trial expenses, partially offset by lower Fortress-Avenue Master Services Agreement fees and IV tramadol supply expenses. General and administrative expenses rose by $0.5 million to $4.6 million, mainly due to increased payments to InvaGen and personnel costs. The company's cash and cash equivalents increased from $1.8 million to $2.6 million during the year.
Significant changes compared to the previous fiscal year include a $4.2 million expense in 2023 related to the acquisition of the AJ201 license, which had no comparable expense in 2024. The company also reported a $0.8 million loss on common stock warrant liabilities in 2024, compared to none in 2023. A $4.1 million increase in the change in fair value of warrant liabilities was also noted, moving from a loss of $4.3 million in 2023 to a loss of $0.2 million in 2024. The company completed enrollment for the Phase 1b/2a trial of AJ201 in January 2024 and the last patient last visit in May 2024. Final agreement was reached with the FDA in January 2024 on a Phase 3 safety study protocol for IV tramadol.
Strategic developments included the acquisition of Baergic Bio, Inc. in November 2022, expanding the company's product pipeline to include BAER-101. Preclinical data for BAER-101 were reported in August 2023, showing full suppression of seizure activity in a rat model of absence epilepsy. The company also entered into a license agreement with AnnJi Pharmaceutical Co., Ltd. in February 2023 for AJ201, resulting in an initial cash license fee of $3 million and further milestone payments. A dispute arose with AnnJi in March 2025 regarding the attempted termination of the license agreement. The company also underwent a 1-for-75 reverse stock split in April 2024 and was subsequently delisted from Nasdaq in March 2025, beginning to trade on the OTC Pink Open Market.
As of December 31, 2024, Avenue Therapeutics had two full-time employees. The company raised additional capital through various offerings and agreements throughout 2023 and 2024, including a public offering, private placements, and an at-the-market offering. The company's financial statements include details on these transactions and their impact on the company's financial position. The company's outlook is contingent upon securing additional funding to continue its operations and advance its product candidates through clinical development and regulatory approval. The company acknowledges substantial doubt about its ability to continue as a going concern.
About AVENUE THERAPEUTICS, INC.
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