Avenue Therapeutics, Inc. reported its financial results for the third quarter of 2025, revealing a net loss of $692,000, a significant reduction from the $3.1 million loss recorded in the same period of 2024. For the nine months ending September 30, 2025, the company reported a net loss of $2.2 million, down from $10.1 million in the prior year. The decrease in losses is attributed to a substantial reduction in operating expenses, which fell to $724,000 for the quarter, compared to $3.2 million in the previous year, and $3.7 million for the nine-month period, down from $9.7 million.
The company's revenue for the nine months ended September 30, 2025, amounted to $1.4 million, primarily generated from the termination of a license agreement with AnnJi Pharmaceutical Co. Ltd. In contrast, Avenue Therapeutics had no revenue during the same period in 2024. The reduction in research and development expenses, which dropped to $177,000 for the third quarter from $2.3 million in 2024, reflects the cessation of costs associated with the AJ201 product candidate, which was sold earlier in the year.
Avenue Therapeutics has undergone significant organizational changes, including the termination of its license agreement with AnnJi for the AJ201 product candidate, which was previously in clinical trials. The termination agreement included a transfer of rights back to AnnJi and a repurchase of shares held by them. The company is now focusing on its remaining product candidate, intravenous tramadol, for which it is seeking regulatory approval. Avenue's cash and cash equivalents increased to $3.7 million as of September 30, 2025, up from $2.6 million at the end of 2024, primarily due to financing activities.
The company has faced challenges, including a delisting from the Nasdaq Stock Market in March 2025, which has since affected its ability to raise capital. Avenue's common stock is now traded on the over-the-counter market under the symbol "ATXI." The company has expressed substantial doubt about its ability to continue as a going concern, emphasizing the need for additional funding to support ongoing operations and product development. Avenue plans to explore various financing options, including equity or debt offerings, to secure the necessary capital for its future endeavors.
Looking ahead, Avenue Therapeutics anticipates continued operating losses as it advances its product development plans. The company is actively evaluating the feasibility of a Phase 3 safety study for intravenous tramadol, which is contingent upon securing adequate financing. The management remains focused on navigating the challenges posed by market conditions and regulatory requirements while seeking to enhance its product pipeline through potential acquisitions or partnerships.
About AVENUE THERAPEUTICS, INC.
Avenue Therapeutics, Inc. is a specialty pharmaceutical company developing therapies for neurologic diseases. Its pipeline includes AJ201 for spinal and bulbar muscular atrophy, IV tramadol for postoperative acute pain, and BAER-101 for epilepsy and panic disorders. Avenue focuses on advancing clinical-stage drug candidates with novel mechanisms, targeting unmet medical needs in neurology and pain management, leveraging licensing agreements and clinical development to bring innovative treatments to market.
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