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Acasti Pharma, Inc. (NASDAQ: ACST) is a cutting-edge pharmaceutical company headquartered in Quebec, specializing in developing innovative drug delivery technologies. As a subsidiary of Neptune Technologies & Bioressources, Acasti leverages marine phospholipids to create products used in prescription medications, medical foods, and over-the-counter applications, targeting cardiometabolic disorders.
Acasti Pharma is at the forefront of addressing rare and orphan diseases with its late-stage specialty pharmaceutical development. The company is particularly known for its advanced drug delivery technologies that enhance the performance of existing drugs, offering faster onset of action, improved efficacy, reduced side effects, and more convenient delivery methods. This focus aims to increase treatment compliance and enhance patient outcomes.
The company's flagship development program is GTX-104, a novel formulation of nimodipine designed for intravenous infusion to treat aneurysmal subarachnoid hemorrhage (aSAH), a life-threatening condition. Recently, Acasti Pharma has made significant strides in advancing GTX-104 through pivotal Phase 3 clinical trials known as STRIVE-ON. The U.S. Food and Drug Administration (FDA) has confirmed the 505(b)(2) regulatory pathway for GTX-104, a critical milestone. Furthermore, Acasti has aligned with the FDA on the Phase 3 trial protocol, with patient dosing expected to start in the second half of 2023.
In the financial realm, Acasti reported substantial progress in its fiscal year ending March 31, 2023. The company maintained $27.9 million in cash, cash equivalents, and short-term investments, providing a runway through Q2 2025 to achieve key milestones, including a potential NDA filing for GTX-104. Additionally, the company has streamlined its operations, focusing resources exclusively on GTX-104 while evaluating strategic alternatives for other pipeline assets like GTX-101 and GTX-102.
Acasti’s financial health remains robust, with significant reductions in general and administrative expenses due to strategic realignment efforts. The company has also successfully raised an additional $7.5 million in a private placement, extending its cash runway into the first calendar quarter of 2026.
The company's leadership, led by CEO Prashant Kohli, has demonstrated a commitment to achieving critical milestones and enhancing shareholder value. With over 40 granted and pending patents and Orphan Drug Designation from the FDA, Acasti Pharma is well-positioned to bring new treatment options to markets with high unmet medical needs.
For more information, visit Acasti Pharma's website.
Acasti Pharma will host a conference call on November 10, 2021, at 1:00 PM ET to discuss its Q2 2022 financial results and corporate progress. The call can be accessed via telephone or webcast. Acasti focuses on drug delivery technologies for rare diseases, with three lead assets receiving FDA Orphan Drug Designation that secures seven years of marketing exclusivity in the U.S. These assets target critical conditions such as Subarachnoid Hemorrhage and Ataxia-telangiectasia. For more information, visit their Investor Relations page.
Acasti Pharma has received composition of matter patents for GTX-101 and GTX-102 from various international patent offices. GTX-101 targets Postherpetic Neuralgia with a novel topical spray formulation, while GTX-102 addresses the neurological symptoms of Ataxia-telangiectasia using an oral mucosal spray. Patents for GTX-101 and GTX-102 are valid until 2036 and 2037, respectively. These advancements aim to improve patient outcomes and fulfill unmet medical needs in underserved markets. Both drug candidates have been designated as Orphan Drug status by the FDA.
Acasti Pharma has initiated a pharmacokinetic (PK) bridging study for GTX-104, an intravenous formulation of nimodipine, aimed at treating Subarachnoid Hemorrhage (SAH) patients. The study, involving 50 healthy subjects, will compare GTX-104's bioavailability against oral nimodipine. Completion is expected in the first half of 2022, followed by a Phase 3 safety study if FDA review is favorable. GTX-104 has received Orphan Drug Designation, potentially offering Acasti significant market exclusivity. The annual addressable market for this treatment in the U.S. is estimated at $300 million.
Acasti Pharma (Nasdaq: ACST) announced that it has regained compliance with Nasdaq's minimum bid price requirement. CEO Jan D’Alvise expressed satisfaction with the integration of Grace Therapeutics and emphasized the company's focus on advancing their clinical pipeline targeting rare diseases. Acasti's three lead drug candidates have received Orphan Drug Designation from the FDA, which provides various regulatory advantages and exclusivity. The company aims to improve drug delivery and patient outcomes through innovative formulations backed by over 40 patents.
Acasti Pharma Inc. announced its participation in the Oppenheimer Fall Healthcare Summit, scheduled for September 20-23, 2021. CEO Jan D’Alvise will present on September 21, 2021, at 2:05 PM ET. The event will allow management to engage in one-on-one meetings with investors. Acasti specializes in drug delivery technologies for rare diseases, with three lead assets—GTX-104, GTX-102, and GTX-101—each granted Orphan Drug Designation by the FDA. These drugs target serious conditions, potentially improving patient outcomes.
Acasti Pharma announced that CEO Jan D’Alvise will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The presentation will be available on-demand starting September 13, 2021, at 7:00 AM ET. Acasti focuses on innovative drug delivery technologies for rare diseases, with three lead clinical assets holding Orphan Drug Designation by the FDA. These assets target conditions like Subarachnoid Hemorrhage, Ataxia-telangiectasia, and Postherpetic Neuralgia, providing significant marketing exclusivity and patent protection.
Acasti Pharma Inc. (NASDAQ: ACST) has completed its acquisition of Grace Therapeutics, marking a strategic step towards becoming a leading specialty pharmaceutical company focused on rare diseases. Management forecasts sufficient cash reserves for at least two years of operations post-merger. Acasti has acquired Grace’s clinical and pre-clinical assets, all receiving Orphan Drug Designation from the FDA, potentially providing seven years of marketing exclusivity. A reverse stock split at an 8-1 ratio will also be implemented to comply with NASDAQ’s minimum bid price rule.
Acasti Pharma Inc. (ACST) provided a business update and Q1 fiscal 2022 financial results, reporting a net loss of $3.1 million, down from $4.7 million in Q1 2021. The company is pursuing the acquisition of Grace Therapeutics, aiming to enhance its capabilities in treating rare diseases. Acasti plans to utilize the FDA's 505(b)(2) pathway for expedited drug development, potentially benefiting from seven years of marketing exclusivity. The approval of the acquisition is pending shareholder votes scheduled for August 26, 2021, with over $60 million in cash expected post-merger to fund future operations.
Acasti Pharma Inc. (NASDAQ: ACST) will hold a business update conference call on August 4, 2021, at 1:00 PM ET to discuss its planned acquisition of Grace Therapeutics, Inc., a biopharmaceutical company focused on novel drug delivery technologies for rare diseases. Interested parties can submit questions via email. The call will be accessible by phone and webcast, with a replay available for later listening. Acasti has filed a registration statement with the SEC regarding the acquisition, urging shareholders to read the prospectus for important details.
Acasti Pharma (Nasdaq: ACST) plans to acquire Grace Therapeutics, an emerging biopharmaceutical company focused on innovative drug delivery for rare diseases. The acquisition aims to enhance Acasti's capabilities in developing and commercializing drug candidates. Key assets from Grace include a diversified drug pipeline, significant market opportunities, and three clinical-stage assets with shorter timelines to key milestones. Acasti expects to maintain over $60 million in cash post-merger, providing at least two years of operational runway for development and regulatory filings.
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