Avenue Therapeutics Q1 2024 Financial Results and Corporate Highlights
Avenue Therapeutics, Inc., a specialty pharmaceutical company listed on Nasdaq under the ticker symbol ATXI, has released its financial results and corporate highlights for the first quarter ending March 31, 2024. Led by CEO Dr. Alexandra MacLean, Avenue Therapeutics is dedicated to developing and commercializing therapies for neurologic diseases.
Dr. MacLean noted the productive nature of the first quarter, emphasizing the company’s progress in its CNS treatment pipeline. The company's leading clinical program, AJ201, for spinal and bulbar muscular atrophy (SBMA), also known as Kennedy's Disease, is advancing, with topline data expected mid-2024. Additionally, Avenue showcased promising preclinical data for BAER-101, a potential treatment for epilepsy, at the American Society for Experimental Neurotherapeutics (ASENT) Annual Meeting and in the journal Drug Development Research. The company also reached an agreement with the FDA on the safety study design for intravenous (IV) tramadol, setting the stage for a Phase 3 study pending necessary funding.
Key corporate highlights include:
- AJ201: Avenue hosted a virtual event in April featuring key opinion leaders in the field of SBMA. The event included insights from Dr. Christopher Grunseich of the National Institute of Neurological Disorders and Stroke and Dr. Tahseen Mozaffar from the University of California, Irvine. The discussion centered on the characteristics of SBMA and the potential of AJ201 as a treatment.
- BAER-101: In the first quarter of 2024, Avenue presented preclinical results for BAER-101 at the ASENT Annual Meeting and in the journal Drug Development Research. The data demonstrated BAER-101's potential to suppress seizures in the GAERS model of epilepsy. Avenue plans to initiate a Phase 2a clinical trial to further explore BAER-101’s effects, subject to securing necessary financing.
- IV Tramadol: In January 2024, Avenue finalized an agreement with the FDA on the safety study protocol for a Phase 3 study of IV tramadol. The study will compare IV tramadol to IV morphine in approximately 300 post-bunionectomy patients, with the trial expected to begin upon receiving necessary funding.
From a financial standpoint, Avenue Therapeutics reported a cash position of $3.2 million as of March 31, 2024, up from $1.8 million at the end of 2023. This increase was bolstered by a warrant inducement transaction completed in May 2024, generating $4.4 million in gross proceeds.
Research and development expenses for Q1 2024 were $2.4 million, doubling from $1.2 million in Q1 2023. The first quarter of 2023 also included an additional $4.2 million in expenses related to acquiring the AJ201 license. General and administrative expenses rose modestly from $1.0 million in Q1 2023 to $1.3 million in Q1 2024.
Despite these increased expenditures, the net loss attributable to common stockholders decreased significantly from $7.5 million in Q1 2023 to $4.3 million in Q1 2024. This reduction in net loss reflects a shift in the company’s financial strategies and operational efficiencies.
In summary, Avenue Therapeutics remains focused on advancing its trio of key therapeutic assets: AJ201 for SBMA, BAER-101 for epilepsy, and IV tramadol for acute post-operative pain. With strategic efforts in securing additional funding and progressing through clinical trials, Avenue aims to provide impactful therapies for patients suffering from neurologic diseases while delivering long-term value to its shareholders.
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