Phoenix, Arizona--(Newsfile Corp. - September 21, 2022) - The Stock Day Podcast welcomed Acasti Pharma Inc. (NASDAQ: ACST) ("the Company"), a specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases. CEO of the Company, Jan D'Alvise, joined Stock Day host Everett Jolly.
Jolly began the interview by commenting on a recent press release detailing the Company's clinical study for its GTX-102 asset, an oral mucosal spray targeting Ataxia-telangiectasia (A-T). "What are you expecting from these results?", he asked. "Ataxia-telangiectasia is a neurodegenerative disorder that is hereditary and typically affects young children between the ages of one and three," explained D'Alvise, before elaborating on the significant side effects of the disease. "Unfortunately, there really is no treatment for these kids today."
"We just started a PK bridging study just this week for GTX-102, our oral mucosal spray of betamethasone, and we will be dosing 48 healthy subjects," continued D'Alvise. "The purpose of the study is to determine the dosing, for example, how much of the drug we will deliver per spray," she said. "Based on these results, which we should receive by the end of the year, we will be submitting that data to the FDA along with a protocol for Phase III, which would be the next and final step in the development program before submission to the FDA for market approval."
Jolly then asked about one of the Company's additional assets, GTX-104, an intravenous infusion targeting Subarachnoid Hemorrhage (SAH). "Subarachnoid Hemorrhage is bleeding on the brain caused by a ruptured aneurysm," said D'Alvise. "10-15% of patients suffering from this condition tend to die before arriving at the hospital," she added, noting that patients receiving treatment for this condition are given nimodipine, a blood pressure lowering drug, over the course of an extended hospital stay. "What we are doing is reformulating nimodipine, which is given today as an oral drug," said D'Alvise. She then shared that currently only about 8-10% of the oral drug makes it into the bloodstream, while this increases to 100% for Acasti's GTX-104, a novel IV formulation of nimodipine. "Furthermore, IV administration of nimodipine results in much better control of drug levels in the bloodstream and therefore blood pressure. It is critically important to carefully manage and maintain consistent blood pressure in these SAH patients, and so we believe GTX-104 will provide a significant improvement over the oral form of the drug.
"We reported very positive results in May for our PK study," continued D'Alvise. "We are now packaging that data for the FDA, along with a protocol for our Phase III study design, which will be submitted within the next two weeks," she shared. "We hope to meet with the FDA by the end of the year and get their feedback on the Phase 3 study design," said D'Alvise. "We will incorporate their feedback into our final protocol, and plan to begin our Phase III in the first half of next year."
"When do you expect the results for GTX-101, your drug candidate for Postherpetic Neuralgia (PHN)?", asked Jolly. "The drug we are developing is designed to treat the very severe nerve pain that can persist following a shingles infection," said D'Alvise. "Unfortunately, 40% of the people that get PHN continue to experience severe pain for months, if not years," she explained. "We have taken a drug called bupivacaine and reformulated it into a topical spray," said D'Alvise. "It is a once per day dosing, and we believe this will give patients 24/7 pain relief," she added. "We have a PK study that is wrapping up right now, and we expect results before the end of this year, which will allow us to move forward into our Phase II next year."
Jolly then asked about the Company's current valuation, as well as their funding. "We have more than $38 million in cash on our balance sheet; enough cash to get us well into 2024," said D'Alvise. "That cash will allow us to completely finish the Phase III program for GTX-104, while significantly advancing GTX-101 and GTX-102," she shared. "However, we currently have a $35 million market cap," said D'Alvise. "I think there is a tremendous opportunity for value creation here that we are going to see over the next six to twelve months."
To close the interview, D'Alvise elaborated on the Company's upcoming catalysts and the transformative potential that they represent. "Next year is going to be a very exciting year for us, moving these programs forward," said D'Alvise. "At the end of the day, it's all about getting these drugs approved to treat these rare and orphan diseases."
To hear Jan D'Alvise's entire interview, follow the link to the podcast here: https://audioboom.com/posts/8161249-acasti-pharma-inc-discusses-clinical-progress-of-lead-assets-and-2022-catalysts-with-the-stock-d
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: https://www.acastipharma.com/en.
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.
Lytham Partners, LLC
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