Apraxia, Oculomotor, Cogan Type

This is the longest Niagen NR clinical trial to date spanning two years and showcases that long-term Niagen NR is safe and well tolerated LOS ANGELES--(BUSINESS WIRE)-- ChromaDex, Inc. (NASDAQ:CDXC), one of the global authorities on Nicotinamide Adenine Dinucleotide (NAD+) and healthy aging research, shares results from a phase II clinical study published in the peer-reviewed journal, Movement Disorders, by a team of researchers led by Dr. Hilde Nilsen, University of Oslo, Arkershus University Hospital, Norway. The clinical trial was part of the ChromaDex External Research Program (CERP™), which donated ChromaDex’s patented nicotinamide riboside (NR) ingredient, Niagen®, one of the most efficient and superior NAD+ precursors available, for the advancement of this research. The promising results demonstrate that long-term supplementation with Niagen NR effectively increased whole blood NAD+ levels up to fourfold, improved coordination, and enhanced eye movement while maintaining biomarkers of stable liver and kidney function in Ataxia Telangiectasia (AT) patients. AT is a rare, inherited neurodegenerative disorder characterized by premature aging, cerebellar degeneration, immunodeficiency, and cancer predisposition. This press release features multimedia. View the full release here: Newly published phase II clinical study demonstrates that supplementation with Niagen, patented nicotinamide riboside (NR), elevates NAD+ up to fourfold, improving motor coordination and eye movement in Ataxia Telangiectasia (AT) patients (Graphic: Business Wire) Building on a growing body of research, this is the second published study (Veenhuis et al. in 2021) analyzing the therapeutic effects of Niagen NR supplementation in AT patients and marks a milestone as it is the longest Niagen NR clinical trial to date, spanning two years, with results showcasing that long-term supplementation is safe and well tolerated. "NR supplementation has shown promising potential in supporting brain health and cognition,” said Dr. Andrew Shao the Vice President of Scientific & Regulatory Affairs at ChromaDex. “Independent research through CERP suggests that NR may play a role in maintaining neuronal function and promoting cognitive well-being by supporting NAD+ levels in brain cells." Individuals diagnosed with AT frequently experience profound challenges in motor function, characterized by neurodegenerative conditions like cerebellar ataxia, resulting in impaired movement and coordination and they may exhibit oculomotor apraxia, difficulties controlling eye movements. These factors often result in a loss of independent walking ability, typically necessitating the use of a wheelchair by the age of ten. Dr. Nilsen remarks, “While the exact mechanisms underlying cerebellar degeneration and neurodegeneration in AT are not fully understood, research indicates inability to repair and respond appropriately to DNA damage. AT research has shown that DNA damage depletes NAD+, the crucial cellular coenzyme that plays an essential role in mitochondrial function, DNA repair and cellular energy production. This growing body of research is promising as it demonstrates that NR supplementation may be a potential therapeutic strategy for AT patients.” About the study This two year phase II clinical study was a single-arm open-label intervention trial investigating the safety and efficacy of long-term NR supplementation in 10 patients with AT (6 were female, 4 were male, of which 7 were children, 3 were adults), between the ages of 3 to 27 years. The patients were given oral NR as an intervention starting with an initial dose of 150 mg/day, gradually increasing to 300 mg/day, and reaching a final dose of 500 mg/day. Study highlights NR supplementation was well tolerated, with no serious adverse events. NR supplementation increased whole blood NAD+ levels up to fourfold. Serum levels of AFP, serum alpha-fetoprotein and Nfl, neurofilament light chain, biomarkers of AT progression, remained stable for most participants over two years of NR supplementation, suggesting that NR may slow or delay progression of AT. Long-term NR supplementation reduced ataxia symptoms and improved motor coordination, eye movements, and overall neurological functioning: Positive correlations were observed between NR supplementation and improved AT Neurological Examination Toolkit (NEST) total score, eye movements, SARA coordination scores, ICARS coordination scores, and oculomotor scores. Biomarkers related to liver and kidney function did not show clinically significant changes during the two-year treatment period, indicating the NR supplementation was safe. Long-term blood glucose regulation, measured as HbA1c level, remained stable in all participants. NR supplementation did not cause changes in hematological or immunological parameters. Relevance Reaching a milestone in NR clinical research as the longest published clinical study to date, results of this study demonstrate that NR effectively increased whole blood NAD+ levels up to fourfold, improved coordination, and enhanced eye movement in both adults and children with AT, while maintaining biomarkers of stable liver and kidney function. The outcomes of this study strongly support the inclusion of NR supplementation as a standard clinical approach for AT, however more research needs to be conducted to confirm the impact of NR on motor skills such as standing and walking. For additional information on the science supporting Niagen® visit . About ChromaDex: ChromaDex Corp. is a global bioscience company dedicated to healthy aging. The ChromaDex team, which includes world-renowned scientists, is pioneering research on nicotinamide adenine dinucleotide (NAD+), levels of which decline with age. ChromaDex is the innovator behind NAD+ precursor nicotinamide riboside (NR), commercialized as the flagship ingredient Niagen®. Nicotinamide riboside and other NAD+ precursors are protected by ChromaDex’s patent portfolio. ChromaDex maintains a website at to which ChromaDex regularly posts copies of its press releases as well as additional and financial information about the Company. Forward-Looking Statements: This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, including statements related to whether the results demonstrate that long-term supplementation with Niagen NR effectively increased whole blood NAD+ levels up to fourfold, improved coordination, and enhanced eye movement while maintaining biomarkers of stable liver and kidney function in Ataxia Telangiectasia (AT) patients, whether the results showcase that long-term supplementation is safe and well tolerated, whether NR supplementation has shown promising potential in supporting brain health and cognition, and whether this growing body of research is promising or if it demonstrates that NR supplementation may be a potential therapeutic strategy for AT patients. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as "expects," "anticipates," "intends," "estimates," "plans," "potential," "possible," "probable," "believes," "seeks," "may," "will," "should," "could" or the negative of such terms or other similar expressions. Risks that contribute to the uncertain nature of these forward-looking statements include the impact of the COVID-19 pandemic on our business and the global economy; our history of operating losses and need to obtain additional financing; the growth and profitability of our product sales; our ability to maintain sales, marketing and distribution capabilities; changing consumer perceptions of our products; our reliance on a single or limited number of third-party suppliers; and the risks and uncertainties associated with our business and financial condition. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex's Annual Report on Form 10-K for the fiscal year ended December 31, 2021, ChromaDex's Quarterly Reports on Form 10-Q and other filings submitted by ChromaDex to the SEC, copies of which may be obtained from the SEC's website at . Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.

LAVAL, Québec, Dec. 28, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, announces that the preliminary topline results of the pharmacokinetic (PK) bridging study for GTX-102 met all outcome measures. The objectives of the study were to evaluate the bioavailability, pharmacokinetics, and safety of GTX-102, a novel, concentrated oral-mucosal metered spray of betamethasone in healthy volunteers. This new formulation is intended to improve the neurological symptoms of Ataxia Telangiectasia (A-T) in a pediatric population for which there are currently no FDA-approved therapies. GTX-102 can be sprayed conveniently over the tongue of A-T patients, who often have difficulties swallowing. This PK study was the next step in the proposed 505(b)(2) regulatory pathway for GTX-102. Jan D’Alvise, Chief Executive Officer of Acasti, stated, “The completion of this PK bridging study is an important milestone in the advancement of our GTX-102 program designed to provide a new and convenient therapy for treating the chronic symptoms of A-T in children with this rare genetic disorder. We are very pleased to report the results of this study, which we expect will now support the advancement of the program directly into Phase 3. Currently there are no drugs approved for A-T, and we are pleased to report the topline findings of this pivotal study as we remain committed to bring this exciting and proprietary treatment to children who suffer from A-T.” This PK bridging study is a Phase 1, randomized, open-label, crossover study in healthy adult subjects to evaluate the comparative bioavailability, PK, and safety of GTX-102 administered as an oral spray compared to intramuscular (IM) betamethasone (which is expected to be the reference product for bridging purposes), and to an oral solution (OS) of betamethasone, which is available in Europe but not approved in the US. The betamethasone OS was shown to reduce neurological symptoms in children with A-T in a published multicenter, double-blind, randomized, placebo-controlled crossover trial conducted in Italy (Zannolli et al, 2012). The primary objective of this PK bridging study was to evaluate and characterize the PK profile of GTX-102 as an oral spray. Details of the study design can be found on ClinicalTrials.gov (Identifier: NCT05531890). A total of 48 healthy adult subjects (27 males and 21 females) were enrolled in this single center, 5-treatment, 8-sequence, 2-period cross-over study. The 5 treatments assessed in the study were: GTX-102: low dose at 0.0125 mg/kg, medium dose at 0.05 mg/kg, and high dose at 0.1 mg/kgOS betamethasone at 0.1 mg/kgIM betamethasone at 0.1 mg/kg Each subject received a single dose of 2 treatments in a cross-over fashion, in a randomized sequence over 2 treatment periods separated by 15 days. The dosing started on September 13, 2022 and ended on November 24, 2022. Betamethasone blood levels were compared between all treatment groups. GTX-102 PK study outcome measures definitions and preliminary topline findings are as follows: Primary outcome measures and their definitions include: AUC0-72 is the area under the concentration time curve up to 72 hours post-doseAUC∞ is the area under the concentration time curve extrapolated to infinityCmax is the maximum concentration occurring between 0 hour to 72 hours after study drug administration. GTX-102 given at doses of 0.0125 (low), 0.5 (medium) or 0.1 (high) mg/kg, showed betamethasone blood concentrations that were highly predictable and consistent based on AUC and Cmax, indicating good linearity and dose-proportionality.Following the high dose of GTX-102 (0.1 mg/kg), betamethasone blood concentrations were within the same range of exposure as IM betamethasone (0.1 mg/kg), based on AUC. The IM formulation of betamethasone will serve as a bridge for GTX-102 in the context of the proposed 505(b)(2) regulatory pathway.In addition, Betamethasone blood concentrations following the high dose of GTX-102 (0.1 mg/kg) were within the same range of exposure as OS betamethasone (0.1 mg/kg), based on AUC. This OS formulation was the same one that was used by Zannolli et al and may serve as a clinical comparator for further clinical development of GTX-102.There was statistically no significant difference (p>0.05) between GTX-102 (0.05 mg/kg) when comparing a fast rate of administration (each spray immediately following the preceding one) to a slow rate (1 spray/minute), as indicated by Cmax and AUC. This is important because being able to use the fast or the slow rate of administration may provide greater flexibility for patients and caregivers.The Cmax of GTX-102 was within the same range of exposure as the OS, but the Cmax for the IM formulation was lower than both GTX-102 and the OS, as well as what has been reported previously for the IM in the literature. It is important to note that achieving bioequivalence with the IM was not an objective of this study, nor was it expected.No serious adverse events (AE) were reported during the study. AEs leading to study discontinuation consisted of cough/fever/body pain/stuffy nose (1 case), Covid-19 (1 case) and elevated creatinine kinase (1 case), and all events occurred prior to receiving the second treatment. None were judged as being related to the study drugs by the investigator. The most frequent drug-related AE was mild headache (4 cases).Based on this data, Acasti will work with our clinical experts and FDA to determine the best final dosing regimen for GTX-102 to incorporate into our Phase 3 study design. D’Alvise concluded, “With the completion of this important comparative PK bridging study, we are confident that the expected final development step for GTX-102 will be to conduct a Phase 3 safety and efficacy trial in A-T patients using a treatment regimen similar to the one already proved effective by Zannolli, et al. We plan to request a Type B meeting with the FDA following the receipt of the full PK study dataset sometime in calendar H1 2023 to confirm the proposed Phase 3 study design. If all proceeds as planned, the Phase 3 study is expected to be initiated in the second half of calendar 2023. If the Phase 3 program meets the primary endpoints, an NDA filing for GTX-102 under Section 505(b)(2) is expected to follow.” About A-T A-T is a progressive, genetic, neurodegenerative disorder that primarily effects young children, causing severe disability, impairment of the immune system and an increasing susceptibility to infections and cancer. The hallmark symptoms of A-T are cerebellar ataxia and other motor dysfunction, and dilated blood vessels (telangiectasia) that occur in the sclera of the eyes and on the skin. Children begin to experience balance and coordination problems when they begin to walk (toddler age), and ultimately become wheelchair bound in their second decade of life. In pre-adolescence (age 5-8 years), patients experience oculomotor apraxia, dysarthria, and dysphagia. They often develop compromised immune systems and are at increased risk of developing respiratory tract infections and cancer (typically lymphomas and leukemia). Patients typically die by age 25 years from complications of lung disease or cancer. A-T is diagnosed through a combination of clinical assessments, laboratory analysis, and genetic testing. There is no known treatment to slow disease progression, and treatments that are used are strictly aimed at symptoms (e.g., physical, occupational or speech therapy for neurologic issues), or conditions secondary to the disease (e.g., antibiotics for lung infections, chemotherapy for cancer, etc.). A market research study commissioned by Acasti found that A-T affects approximately 4,300 patients per year in the United States and has a potential total addressable market of $150 million, based on the number of treatable patients (as disclosed in Acasti’s most recently filed quarterly report on Form 10-Q). 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.acasti.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 each of the planned Type B meeting with the FDA and the anticipated Phase 3 safety and efficacy trial for GTX-102, (ii) the success and timing of regulatory submissions of the PK bridging study and Phase 3 safety study protocol for GTX-104, and Acasti’s other pre-clinical and clinical trials; (iii) regulatory requirements or developments; (iv) changes to clinical trial designs and regulatory pathways; (v) legislative, regulatory, political and economic developments, and (vi) 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 OfficerTel: 450-686-4555Email:info@acasti.comwww.acasti.com Investor Relations:Robert BlumLytham Partners, LLC602-889-9700ACST@lythampartners.com

LAVAL, Québec, Sept. 13, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), today announces the initiation of its planned pharmacokinetic (PK) bridging study to evaluate the comparative bioavailability, pharmacokinetics, and safety of its oral betamethasone spray, GTX-102, compared to an intramuscular injection of betamethasone and to an oral solution of betamethasone, in 48 healthy subjects. The First Subject, First Dose was administered on September 13th. This PK study is the next step in the proposed 505(b)(2) regulatory pathway for GTX-102 and is expected to be completed with top line results reported before year end. GTX-102 is a novel, proprietary, concentrated oral-mucosal metered spray of betamethasone intended to improve the neurological symptoms of Ataxia Telangiectasia (A-T) in a pediatric population for which there are currently no FDA-approved therapies. GTX-102 can be sprayed conveniently over the tongue of the A-T patients, who often have difficulties swallowing. Jan D’Alvise, Chief Executive Officer of Acasti, stated, “The initiation of this PK study is yet another important milestone in the advancement of our GTX-102 program designed to provide a novel therapy for treating the chronic symptoms of Ataxia Telangiectasia in children with this rare genetic disorder. GTX-102 is now the third program to advance into the clinic this year as we continue to leverage our novel drug delivery technologies that 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. We look forward to the completion of this PK study later this year, and assuming positive results, we expect to move rapidly into Phase 3 in the second half of 2023. Currently there are no drugs approved for A-T, and we are very motivated to potentially bring this exciting novel treatment to children who suffer from A-T.” This PK study is a Phase 1, randomized, open-label, crossover study in healthy male and female subjects to evaluate the comparative bioavailability, pharmacokinetics, and safety of GTX-102 administered as an oral spray compared to an intramuscular injection of betamethasone, which is the reference product for U.S. filing purposes, and to an oral solution of betamethasone, which is available on the market in Europe and will be the comparator product for bridging purposes under the 505(b)(2) guidelines. The primary objective of the study is to evaluate and characterize the PK pro GTX-102 as an oral spray. A total of 48 healthy adult male and female subjects will be enrolled in this single center, 5-treatment, 2-period cross-over study. 4 groups of subjects will receive 2 treatments each and will be randomized to receive 3 different doses of GTX-102 (Low Dose, Medium Dose and High Dose), and blood levels and safety measures will be compared to the betamethasone oral solution and to the betamethasone IM injectable. Assuming the PK bridging study meets its primary endpoint, the final development step is to conduct a Phase 3 safety and efficacy trial in A-T patients. The Company plans to request a Type B meeting with the FDA following the completion of the PK study to confirm the Phase 3 study design, and the Phase 3 study is expected to be initiated in the second half of 2023. If both studies meet their primary endpoints, an NDA filing for GTX-102 under Section 505(b)(2) would follow. Senior Management Changes The Company also announces that Prashant Kohli has been named Chief Commercial Officer. Mr. Kohli previously served as Acasti’s VP of Commercial Operations and held the same title at Grace Therapeutics, prior to its acquisition by Acasti in August 2021. About Ataxia Telangiectasia (A-T) A-T is a progressive, genetic, neurodegenerative disorder that primarily effects young children, causing severe disability, impairment of the immune system and an increasing susceptibility to infections and cancer. The hallmark symptoms of A-T are cerebellar ataxia and other motor dysfunction, and dilated blood vessels (telangiectasia) that occur in the sclera of the eyes. Children begin to experience balance and coordination problems when they begin to walk (toddler age), and ultimately become wheelchair bound in their second decade of life. In pre-adolescence (age 5-8 years), patients experience oculomotor apraxia, dysarthria, and dysphagia. They often develop compromised immune systems and are at increased risk of developing respiratory tract infections and cancer (typically lymphomas and leukemia). Patients typically die by age 25 years from complications of lung disease or cancer. A-T is diagnosed through a combination of clinical assessment (especially neurologic and oculomotor deficits), laboratory analysis, and genetic testing. There is no known treatment to slow disease progression, and treatments that are used are strictly aimed at symptoms (e.g., physical, occupational or speech therapy for neurologic issues), or conditions secondary to the disease (e.g., antibiotics for lung infections, chemotherapy for cancer, etc.). A market research study commissioned by Acasti found that A-T affects approximately 4,300 patients per year in the United States and has a potential total addressable market of $150 million, based on the number of treatable patients. About Acasti Acasti is a 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 have 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: . 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 “assuming” “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-102 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’Alvise Chief Executive Officer Tel: 450-686-4555 Email:info@acastipharma.com Investor Relations: Robert Blum Lytham Partners, LLC 602-889-9700 ACST@lythampartners.com