Acasti Reports Q1 2025 Financials and Business Update

Acasti Pharma Inc., a biopharmaceutical company specializing in treatments for rare diseases, has reported significant progress and financial results for the quarter ending June 30, 2024. The company, listed on Nasdaq under the ticker ACST, is advancing its lead product, GTX-104, an innovative injectable formulation of nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH).

CEO Prashant Kohli announced that the pivotal Phase 3 STRIVE-ON safety trial for GTX-104 has surpassed the 50% enrollment milestone. The company's dedicated efforts and collaboration with clinical trial sites have facilitated this achievement. The trial, registered as NCT05995405, aims to assess the safety and efficacy of GTX-104, which offers a vital IV alternative to oral nimodipine. The complexity of administering oral nimodipine to aSAH patients, who often present with numerous complications, underscores the potential benefits of GTX-104. Based on current trends, Acasti expects to complete the enrollment of all 100 patients by late 2024 to early 2025, with a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) anticipated in the first half of 2025.

For the first fiscal quarter of 2025, Acasti highlighted its key developments. Besides surpassing the 50% enrollment in the STRIVE-ON trial, the company also conducted a pivotal meeting with trial investigators in April 2024.

Financially, Acasti reported a net loss of $2.6 million for the quarter ending June 30, 2024, which is a significant improvement from the $4.0 million net loss in the same quarter of the previous year. The reduction in net loss is attributed to restructuring costs incurred in the prior year and a decrease in the fair value of derivative warrant liabilities, although these gains were partially offset by increased research and development expenses. The company's R&D costs rose to $2.7 million from $1.1 million due to intensified research activities for GTX-104. General and administrative expenses also saw a rise, reaching $2.3 million, up from $1.9 million, primarily due to increased professional fees related to the proposed jurisdictional change of incorporation from Québec, Canada, to Delaware, USA.

As of June 30, 2024, Acasti had cash and cash equivalents of $19.4 million, compared to $23.0 million as of March 31, 2024. The company believes its cash reserves are sufficient to support operations until the second calendar quarter of 2026.

Aneurysmal subarachnoid hemorrhage (aSAH) is a severe condition characterized by bleeding in the subarachnoid space of the brain, often resulting from an aneurysm rupture. This condition affects approximately 50,000 people in the United States annually, with higher incidences reported globally. Acasti's GTX-104 aims to meet significant unmet medical needs in this area by offering a more manageable IV infusion of nimodipine, potentially reducing complications associated with oral administration.

GTX-104 has demonstrated promising results in over 150 healthy volunteers, exhibiting lower pharmacokinetic variability compared to oral nimodipine. The unique nanoparticle technology used in GTX-104 facilitates its aqueous formulation, making it suitable for standard peripheral IV infusion. This method also helps mitigate issues related to food effects, drug interactions, and dosing errors, while potentially offering better management of hypotension in aSAH patients. The addressable market for GTX-104 in the U.S. is estimated to be around $300 million.

In addition to GTX-104, Acasti’s portfolio includes GTX-102 and GTX-101, although their development has been deprioritized to focus on GTX-104. GTX-102 is a betamethasone oral spray for Ataxia-Telangiectasia, and GTX-101 is a bupivacaine spray for postherpetic neuralgia. Both candidates may be licensed or sold in the future.

Acasti is dedicated to leveraging its drug delivery technologies to enhance treatment options for rare diseases, ensuring better efficacy, reduced side effects, and more convenient administration. The company’s lead assets have received Orphan Drug Designation from the FDA, granting seven years of market exclusivity post-launch in the U.S.

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