Acasti Pharma, Inc.

Thank you for holding, ladies and gentlemen, and please remain on the line. The Acosti Pharma Conference will begin shortly. Thank you for your patience. Thank you. Good day, ladies and gentlemen, and welcome to the Acosti Pharma second quarter 2022 earnings call. At this time, all participants have been placed on the listen-only mode, and the floor will be open for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, David Waldman of Investor Relations. Sir, the floor is yours.

Thank you, and good afternoon, everyone. I'd like to welcome you to Acosti Pharma's Fiscal 2022 Second Quarter Conference Call. On the call with us this afternoon are Jan D'Alvis, President and CEO, Dr. Pierre Lemieux, Chief Operating Officer, Canada, Chief Scientific Officer and Co-Founder, Dr. George Cotillo, Chief Operating Officer, U.S., Brian Ford, Chief Financial Officer, and Prashant Kohli, VP of Commercial Operations. We are planning for a Q&A session at the end of our prepared remarks, but if you have any remaining questions after the call or would like any additional information about the company, please contact Crescendo Communications at 212-671-1020. I'd also like to remind everyone that statements on this conference call that are not statements of historical or current fact constitute forward-looking information and within the meaning of the Canadian securities laws, and forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, the Securities Act of 1933, and the Securities Exchange Act of 1934. Such forward-looking statements involve known and unknown risks and uncertainties and other unknown factors that could cause the actual results of a cost CD 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 labeled with the terms belief, expects, intends, anticipates, potential, should, may, will, plans, continue, targeted, or other similar expressions to be uncertain and forward-looking. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Forward-looking statements during this conference call may include but are not limited to the success and timing of regulatory submissions of the PK Bridging Study for GTX 104 and ACOSTI's other preclinical and clinical trials, regulatory requirements or developments, changes to clinical trial designs and regulatory pathways, legislative, regulatory, political, and economic developments, ACOSTI's projected cash position and operating runway, and the effects of COVID-19 on clinical programs and business operations. The forward-looking statements contained in this conference call are expressly qualified in their entirety by this cautionary statement. The cautionary note regarding forward-looking information section contained in Acosti's last quarterly report on Form 10-Q and most recent management discussion analysis, which are available on CEDAR at www.cedar.com, on EDGAR at www.sec.gov, and on the investor section of Acosti's website at www.acostiforma.com. All forward-looking statements in this conference call are made as the date of the conference call. ACASI do not undertake to update any such forward-looking statements, whether it is a result of new information, future events, or otherwise, except as required by law. The forward-looking statements contained herein are also subject generally to assumptions and risks and uncertainties that are described from time to time in ACASI's public securities filings with the Securities and Exchange Commission and the Canadian Securities Commissions, including its latest quarterly form on Form 10Q and most recent MD&A. In addition, any forward-looking statements represent ACOSTI's views as of today and should not be relied upon as representing our views of any subsequent date. While ACOSTI might update forward-looking statements at some point in the future, unless legally required under applicable securities law, ACOSTI specifically disclaims any obligation to do so. I'd now like to turn the call over to Jan de Alice. Please go ahead, Jan.

Thank you, David. And I'd like to welcome everyone on the call today. The second quarter was truly transformational for ACOSTI. As you know, we successfully completed the merger with Grace Therapeutics in August, creating a premier clinical stage specialty pharma company focused on rare and orphan diseases. We now have a diverse technology and product portfolio comprised of unique drug delivery capabilities and several clinical and preclinical stage drug assets. Our lead clinical drug candidates have been specifically designed and formulated to enhance efficacy and safety by providing faster onset of action and reduced side effects, all while being more conveniently delivered, which can ultimately increase patient compliance and potentially lead to improved clinical outcomes. This acquisition brings us new and exciting opportunities in sizable orphan disease markets with substantial unmet medical needs. I'm really pleased to report that in the short time since completing the merger, we've achieved meaningful progress, both in terms of clinical development and business operations. We've swiftly and smoothly integrated the Grace employees with Acosti, and we're now laser focused on advancing our clinical pipeline. Towards this end, immediately following the closing of the acquisition, we commenced enrollment for our pivotal pharmacokinetic bridging study for GTX104, our novel aqueous formulation of nemotipine that's being developed as an IV infusion for patients experiencing subarachnoid hemorrhage or SAH that is triggered by an aneurysm. This important study is the next required step in the proposed 505 regulatory pathway and is being conducted in 50 healthy subjects as a single center randomized two-period crossover study. The primary objective of the study is to evaluate and compare the relative bioavailability of GTX104 with the currently marketed oral nematopene capsules, which are the standard of care. The second objective is to assess the safety and tolerability of GTX-104 as compared to oral nematopene capsules. Per the study protocol, subjects will be randomized, assigned in a one-to-one ratio to one of two treatment sequences with a crossover design. So Group A will switch to Group B, where GTX-104 is administered first, or Group B will switch to Group A, where oral nemotipine capsules are administered first. In both groups, GTX104 nemotipine will be administered intravenously over a 72-hour period, and nemotipine will be administered orally via two 30-milligram capsules with water every four hours for 72 hours. Throughout the study, we will be conducting safety evaluations, which will include capturing any treatment emergent adverse events, serious adverse events, electrocardiogram data, clinical laboratory evaluations, physical examinations and resting vital signs which will include very importantly blood pressure. Subjects will be admitted to the clinical research unit or the CRU on the day prior to dosing and they will remain domiciled in the CRU for the duration of each study period. Again, the goal of this pivotal study is to achieve blood levels with our GTX 104 IV nemotipine formulation that are comparable to the oral form of the drug that is in routine use today. As previously announced, we expect to report results during the first half of calendar 2022. Based on the previous encouraging results from a PK study conducted by Grace, we remain optimistic that this pivotal PK study will achieve its primary and secondary endpoints. Following the data readout and its subsequent review with the FDA, we intend to determine the final design of our planned phase three safety study for GTX104. Assuming the PK study and the FDA meetings proceed as planned, we intend to commence the phase three study in the second half of next year, calendar 2022. Both the PK study and the initiation of the phase three safety study are very important near-term and very meaningful catalysts for the company. As a reminder, SAH is a rare and life-threatening medical emergency where bleeding occurs over the surface of the brain in the subarachnoid space between the brain and the skull. It's estimated to affect about 50,000 patients per year, representing an estimated addressable market of more than $300 million in the United States alone. SAH typically occurs quickly, and the key to patient survival is prompt medical intervention. Normally it requires immediate surgery, and on average about two weeks in a neurointensive care unit to try to prevent death and reduce the risk of long-term disability. Patients typically remain on nemotipine throughout their stay in the neuro ICU. Nemotipine is currently only available in an oral dosage form in the United States, and many of these patients come into the hospital unconscious or have a hard time swallowing during their hospital stay. Therefore, we believe GTX104 delivered intravenously could be a much more convenient and efficient way to deliver nemotipine. And importantly, because of its better absorption profile and more consistent blood levels, GTX104 could potentially provide physicians with a more effective tool for hypotension management. This advantage is really important as GTX 104 could help to reduce the incidence of vasospasm, which requires immediate, aggressive, and costly intervention and can lead to worse outcomes for the patient. Also, please note that GTX 104 has been granted orphan drug designation status by the FDA. This provides us with the potential for seven years of market exclusivity in the United States. Provided that we see a similar safety profile to oral nemotipine upon completion of the Phase III study, we could then expect to proceed with the filing of an NDA using the orphan drug designation and the 505b2 pathway. We're very excited about GTX104's potential, and we look forward to updating you as we progress towards achievement of these important near-term catalysts. Now, regarding our other two clinical candidates, GTX 101 and GTX 102, we've recently been awarded four composition and matter patents between the two drugs. The European Patent Office, the Chinese Patent Office, and the Mexican Patent Office all have issued composition and matter patents for GTX 101, which is our novel bioadhesive film-forming topical spray formulation of bupivacaine. for the treatment of postherpetic neuralgia or PHN. And as a reminder, PHN is a persistent and often debilitating neuropathic pain which is caused by nerve damage from the shingles virus. In fact, it's so often cited as the leading cause of suicide in chronic pain patients over the age of 70. It's also been reported that PHN affects approximately 150,000 patients per year in the United States alone, which represents an estimated addressable market of about $400 million. So based on encouraging results from a Phase I PK study conducted previously by Grace, we believe that GTX 101's biphasic delivery mechanism has the potential for rapid onset as well as continuous pain relief for up to eight hours. This could be a significant improvement over the standard of care and it could potentially provide physicians and patients with an opioid sparing alternative as bupivacaine is well understood, it's safe, and it's a non-habit forming non-narcotic analgesic. So we plan to conduct single and multiple ascending dose or SADMAD studies with GTX 101 next year. and we expect to report those results by the end of calendar 2022. Furthermore, we intend to initiate a Phase 2 study shortly after reporting the SADMAD data. Now, turning to GTX 102, the Japanese Patent Office recently granted Acostia Composition of Matter patent for this novel, concentrated, easy-to-use oral mucosal spray formulation of beta-methasone. We're developing this to improve the neurological symptoms of ataxia telangiectasia or AT. Now, AT is a progressive neurodegenerative genetic disease that's typically diagnosed in children at a very young age. It causes severe disability as it affects many parts of the body including areas of the brain which impact their motor function and their speech. AT is also associated with a weakening of the immune system. predisposing these patients to infection and cancers. Sadly, AT patients typically die in their mid-20s. This disease unfortunately affects about 4,300 patients per year in the United States, creating an estimated addressable market of about $150 million. Now, based on an independent study conducted in Italy with an oral liquid form of beta-methazone, We believe GTX102's novel concentrated oral mucosal spray formulation has the potential to simplify drug administration and improve the symptoms of AT, including posture and gait disturbance, as well as kinetic and speech functions. Therefore, we believe that GTX104 could address a very important unmet medical need as no FDA-approved pharmacotherapies currently exist. In the near term, we plan to conduct a pharmacokinetic bridging study comparing blood levels of GTX102 to a reference product containing beta-methazone. We anticipate reporting those results by the end of next year. Assuming this trial is successful, we would then move forward quickly to conduct a confirmatory phase three safety and efficacy trial in patients with AT. These newly granted composition of matter patents are very important additions to our already strong and established intellectual property portfolio as they provide protection beyond 2036 and create potential opportunities for partnering in these major international markets. I hope you're as pleased as we are by the meaningful progress that has already been made in the two short months since we completed the merger. We look forward to reporting on progress next quarter as we continue to advance our lead drug candidates through clinical development and ultimately to commercialization. So with those operating updates, I'll now turn the call over to Brian Ford, our CFO, to discuss our financial results for fiscal Q2. Brian?