Inhibikase Therapeutics, Inc.

and welcome to NHBK's Therapeutics First Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Alexander Lobo, Stern Investor Relations. Thank you, Mr. Lobo. You may begin.

Good morning, and welcome to Inhibit Case Therapeutics' first quarter 2024 financial results conference call and audio webcast. With me today is Dr. Milton Werner, Chief Executive Officer, and Garth Lees-Wolf, Chief Financial Officer. On May 15, Inhibit Case issued a press release announcing financial results for the first quarter ended March 31, 2024. We encourage everyone to read yesterday's press release, as well as Inhibit Case's quarterly report on Form 10-Q, which is being filed with the SEC. The company's press release and Form 10-Q are also available on Inhibit Case's website at inhibitcase.com. In addition, this conference call is being webcast through the investor relations section of the company's website and will be archived there for future reference. Please note that certain information discussed on today's call is covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Participants are cautioned that this conference call contains time sensitive information that is accurate only as of the date of this live broadcast, May 16, 2024. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. Information on potential risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this webcast, except as may be required by applicable security law. With that said, I would now like to turn the call over to Dr. Milton Werner. Milton, you may begin.

Thank you, Alex, and thank you, everyone, for joining us today to review our first quarter 2024 financial results and recent clinical and business updates. 2024 is shaping up to be a year of clinical and regulatory execution as we advance our core programs towards important inflection points, and we are proud of the achievements already accomplished by our team in the first quarter. We are making rapid progress in the enrollment of our Phase II 201 trial for risk-of-death enable, or RISVO, in Parkinson's disease, and we anticipate enrolling the final patient in June with top-line data reported in the second half of the year. On the regulatory front, we had positive interactions with two FDA divisions for our MATNA ProJab program, IKT-001-Pro, as we continue to position this asset for the potential opportunity in pulmonary or total heart retention and pursue the existing opportunity in blood and stomach cancers. So let's take a deeper dive into each of our programs, beginning with Rizvodetinib. Rizvo is a potent selective inhibitor of C-ABL that is administered once daily that we believe may slow or halt the progression of Parkinson's disease. Our 201 trial is a two-phase trial with an ongoing 12-week double-blinded study across three doses we believe should be achieved therapeutic effect plus placebo. The trial is approximately 83% enrolled as of May 10th with 99 participants. 15 prospective participants in medical screening, 22 potential participants being evaluated for suitability to initiate medical screening. Additionally, 44 participants have completed the full 12-week dosing period. To date, there have been 25 mild and three moderate adverse events observed that might be related to Rizzo treatment. Four people withdrew from the trial without completing 12 weeks. As I mentioned earlier, we anticipate that the last patient will be enrolled in June and we expect to report top-line results from the study in the second half of this year. Following completion of the 12-week double-blinded period, we expect to request an end-of-Phase II meeting with the FDA. Overall, we remain impressed by the speed at which our trial has been enrolling patients, as well as the broader interest expressed in the Parkinson community nationwide. We've worked hard to make sure that our dedicated patient portal, accessible at www.the201trial.com, provides accurate and up-to-date information regarding our trial and how to get involved, and believe that the portal has been instrumental in enabling us to effectively enroll participants across all 32 open clinical trial sites. As we continue to work to find the capital necessary to initiate the 201 extension trial, we are encouraged by what is emerging on the biomarker front. Recently, we disclosed the development of a novel antibody against a key marker of alpha-cytical pathology in Parkinson's disease, namely an antibody that can recognize phosphorylated tyrosine-39. We believe this antibody will serve the dual purpose of allowing us to track alpha-cynical pathology and its possible elimination, along with a measure of target engagement by Rizvo. The development of this antibody prompted our recent grant submissions to the National Institute of Neurological Disease and Stroke, or NINDS, which is an institute of the National Institutes of Health, or NIH. This antibody would be incorporated in both the skin biopsy test and the scene amplification test that are already being used in the 201 trial to track the effect of Rizvo on the underlying pathology of disease in both the central and peripheral nervous systems. Moving now to IKT-01 Pro, our pro drug formulation of imatinib mesylate that has been designed to potentially improve on the safety and tolerability profile of imatinib. We continue to make significant strides in the advancement of the pro drug through our ongoing discussions with the FDA. On January 19th, we held a pre-NDA meeting with the FDA to discuss the requirements for potential approval under the 505 statute. We were pleased with the discussion we had with the agency as we began the process of building our first NDA package. Our discussion with the FDA provided a roadmap to NDA submission to include our agreement to conduct a preclinical test to evaluate how O1-pro and imatinib affect certain gut transporters and to consider evaluating the 1,200 milligram dose of O1-pro as a possible equivalent to the approved dose of 800 milligrams of imatinib mesylate. Notably, we are able to pursue approval of all 11 indications for which imatinib mesylate is approved. As we continue to evaluate how to maximize value for O1-pro, we have also explored non-oncology indications for which O1-pro could prove to be effective. To this end, on April 5th, we held a pre-IND meeting with the Office of Cardiology, Hematology, Endocrinology, and Nephrology in the Division of Cardiology and Nephrology at the FDA. We were discussing the potential of O1 Pro as a disease-modifying treatment for pulmonary arterial hypertension, or PAH. Pulmonary arterial hypertension is a rare disease of the pulmonary microvasculature that primarily affects women between the ages of 30 and 60. There are approximately 30,000 cases of PAH in the U.S. alone, and many treatments for PAH are aimed at addressing symptoms of the disease rather than outright curing it. The global PAH market size is valued at approximately $7.66 billion, And we believe that IKT-O1-PRO would have the potential to deliver imatinib with an improved safety and tolerability profile than imatinib mesylate itself, an improved safety and tolerability profile relative to imatinib mesylate itself for this indication. Although we have yet to conduct any clinical studies to evaluate O1-PRO and PAH, our pre-IND meeting has served to review our proposed late-stage trial design to confirm the new molecular entity status for O1-PRO and PAH and to open the door to exclusivity designations were O1 Pro to be approved for this indication. These outcomes provide the opportunity to unlock substantial value for O1 Pro as an indication of high unmet need that was not anticipated when O1 Pro was first conceived. I will now turn the conversation over to our Chief Financial Officer, Garth Lees-Rolph, to review our financial results for the quarter. Garth?