ACST Acasti Pharma Inc

Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), today recognizes and celebrates Rare Disease Day (February 28), as established by the European Organisation for Rare Diseases. Acasti is a late-stage specialty pharma company with three clinical stage drug candidates addressing rare and orphan diseases including subarachnoid hemorrhage (SAH), ataxia telangiectasia (A-T) and postherpetic neuralgia (PHN).

During the month of February, which is designated Rare Disease Month, Acasti CEO Jan D’Alvise participated in several interviews designed to help bring further awareness to these rare conditions that Acasti is working to help address. Ms. D’Alvise brought particular focus to SAH, a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain. The Company recently reported positive interim results in a pharmacokinetics (PK) bridging study for GTX-104, the novel aqueous formulation of water insoluble nimodipine it is developing for the treatment of SAH. Acasti plans to commence a Phase 3 safety study for GTX-104 in the second half of 2022.

The Company is also developing GTX-102, an oral mucosal spray targeting A-T, a progressive, neurodegenerative genetic disease that primarily affects children, causing severe disability, and for which no treatment currently exists, as well as GTX-101, a topical spray targeting PHN, a persistent and often debilitating neuropathic pain caused by nerve damage from the varicella zoster virus (shingles), which may persist for months and even years.

“We believe it is important to develop novel solutions and bring awareness to orphan conditions that may not be well known but represent significant unmet medical needs that can have a devastating impact on patients and their families. We are very encouraged by the interim PK data we previously announced for GTX-104, and look forward to providing the final data for this PK study in calendar Q2, 2022. In the meantime, we continue to advance the other products in our pipeline, including GTX-102 and GTX-101. I was especially grateful to have had the opportunity to help expand the public’s understanding of these important conditions and the new therapies we are developing,” commented Ms. D’Alvise.

Interested parties can replay Ms. D’Alvise’s interviews on The Empowered Patient Podcast here http://empoweredpatientpodcast.com/ and Stock Day Media here https://stockdaymedia.com/podcast-interviews/.

About Rare Disease DayRare Disease Day is the globally coordinated movement on rare diseases, working towards equity in social opportunity, healthcare, and access to diagnosis and therapies for people living with a rare disease. Since its creation in 2008, Rare Disease Day has played a critical part in building an international rare disease community that is multi-disease, global and diverse – but united in purpose. Rare Disease Day is observed every year on 28 February (or 29 in leap years) – the rarest day of the year. Rare Disease Day was set up and is coordinated by EURORDIS and 65+ national alliance patient organization partners. Rare Disease Day provides an energy and focal point that enables rare diseases advocacy work to progress on the local, national, and international levels.

About Acasti

Acasti is a late-stage specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases. Acasti’s novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery—all which could help to increase treatment compliance and improve patient outcomes.

Acasti’s three lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provide the assets with seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Acasti’s lead clinical assets target underserved orphan diseases: (i) GTX-104, an intravenous infusion targeting subarachnoid hemorrhage (SAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull; (ii) GTX-102, an oral mucosal spray targeting ataxia-telangiectasia (A-T), a progressive, neurodegenerative genetic disease that primarily affects children, causing severe disability, and for which no treatment currently exists; and (iii) GTX-101, a topical spray, targeting postherpetic neuralgia (PHN), a persistent and often debilitating neuropathic pain caused by nerve damage from the varicella zoster virus (shingles), which may persist for months and even years. For more information, please visit: https://www.acastipharma.com/en.

Forward-Looking Statements

Statements in this press release that are not statements of historical or current fact constitute “forward-looking information” within the meaning of Canadian securities laws and “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (collectively, “forward-looking statements”). Such forward looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” “potential,” “should,” “may,” “will,” “plans,” “continue”, “targeted” or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.

The forward-looking statements in this press release are based upon Acasti’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions of the PK bridging study for GTX-104 and Acasti’s other pre-clinical and clinical trials; (ii) regulatory requirements or developments; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments, and (v) the effects of COVID-19 on clinical programs and business operations. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and may be filed by Acasti from time to time with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Acasti undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws.

Neither NASDAQ, the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.   

Acasti Contact:Jan D’AlviseChief Executive Officer Tel: 450-686-4555Email: info@acastipharma.com www.acastipharma.com

Investor Contact:Crescendo Communications, LLC Tel: 212-671-1020Email: ACST@crescendo-ir.com

Media Contact :Jules AbrahamJQA Partners, Inc.Tel: 917-885-7378Email: jabraham@jqapartners.com