Inhibikase Therapeutics, Inc.

Greetings, and welcome to the Inhibicase Therapeutics Second 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, Alex Lobo, PrecisionAQ Investor Relations. Thank you, sir. You may begin.

Good morning, and welcome to Inhibit Case Therapeutics second quarter 2024 financial results conference call and audio webcast. With me today is Dr. Milton Werner, Chief Executive Officer, and Garth Lees-Ralph, Chief Financial Officer. On August 14th, Inhibit Case issued a press release announcing financial results, but the second quarter ended June 30th, 2024. We encourage everyone to read to yesterday's press release, as well as Inhibit Case's quarterly report on Form 10-Q, which has been 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 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, August 15, 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 securities law. With that said, I would like to turn the call over to Dr. Milton Werner. Milton, you may begin.

Thank you, Alex. Thank you everybody for joining us today to review our second quarter, 2024 financial results and recent clinical and business updates. We've been very pleased with the strength of our clinical progress to the first half of 2024. The speed at which we executed on key clinical and regulatory milestones has underscored what has been a very successful quarter marked by the accomplishment of many exciting achievements. We recently completed enrollment for our Phase 2-2.1 trial for Rizvodetinib, or often referred to as Rizvo in Parkinson's disease, which is a significant milestone that we have been working tirelessly towards in an effort to bring Rizvo to patients suffering from untreated Parkinson's. and we expect to report top-line data from the trial in November. Additionally, we have had a productive engagement with the US FDA over the past few months regarding IKT-001-PRO's opportunity in pulmonary arterial hypertension, or PAH. Imatinib, the active ingredient in O1-PRO, has previously been shown to be disease-modifying for PAH, and we believe that PRO has the potential to further demonstrate safe and efficacious treatment in PAH patients using our novel PRO drug technology. We filed the R&D for PH and plan to open clinical development with a de-risking phase 2b study as soon as practicable. Let me take a deeper dive into each of these programs as we expect the back half of 2024 will be a catalyst-rich period. Let me first start with Rizvedet today. Rizvo is a potent selective inhibitor of C-ABL that is administered once daily that we believe may slow or halt the progressions of Parkinson's disease. Our 201 trial was a two-phased trial with a 12-week double-blinded study across three doses plus placebo, for which enrollment has been completed. As of July 29th, 41 mild and 8 moderate adverse events have been observed that may be related to Rizvo treatment. We've had six people withdraw from the trial without completing 12 weeks of dosing. Looking ahead, we expect to report top-line results, evaluate the safety and tolerability of Rizzo in untreated Parkinson's disease in November of this year. Following completion of the 12-week double-bonded period, we anticipate meeting with the FDA by year's end to discuss our plans for Phase 3 and intend to launch a 12-month open-label extension study as soon as possible. Moving now to IKT-001-PRO, our PRO drug formulation of imatinib mesylate that has been designed to potentially improve 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. We received final meeting minutes for our pre-IND meeting for pulmonary arterial hypertension in May and filed the IND on August 9th to open clinical development later this year, subject to the receipt of the study may receive letter from the agency. PAH is a rare disease of the pulmonary microvasculature. PAH can arise spontaneously or can be caused by genetic mutations, by drugs, or environmental toxins. PAH is also associated with connective tissue disease, congenital heart disease, HIV infection, and other insults that could affect the right side of the heart. Most treatments for PAH attempt to address symptoms of this progressive disorder, but the recent approval of Cetatricep highlights that disease modification is possible. We see tremendous opportunity in PAH, which has a global market value at $7.7 billion annually worldwide. Imatinib, the active ingredient in PRO, has already been shown to be disease-modifying more than 10 years ago, but the side effect profile observed at that time precluded approval. We believe that PRO has the potential to achieve similar potency to imatinib mesylate without the side effect profile that disqualified imatinib from approval studies reported in 2010. Based on our constructive discussions with the FDA, we believe that we have alignment on our proposed Phase IIb trial design and at the pre-NDA meeting, the FDA confirmed that O1Pro would be viewed as a new molecular entity for pH and that the appropriate path of approval appears to be 505B2 statute. Further, following the advice provided in our pre-NDA meeting with the FDA in January, we have scaled our manufacturing and processed our element efforts for Pro to support late-stage clinical development and NDA batch requirements. Activities include development of new dosage forms to differentiate O1 pro tablets from generic imatinib mesylate in alignment with the FDA feedback. Finally, turning to Rizvo Multiple System Atrophy, or MSA, we are currently exploring alternative financing opportunities, including potential grant funding through a new funding mechanism of clinical development in neuroscience from the National Institute of Neurological Diseases and Stroke, or NINDS. We look forward to advancing this program forward and providing further updates on the program as appropriate. Separately, we are also developing new antibody diagnostic and clinical biomarker tools that we believe will further differentiate the company's efforts in Parkinson's disease and enable analysis of both target engagement and potentially disease modification. Both of these efforts are being pursued through two grant applications that are under review by the NINDS. I'd like to now turn the call over to our Chief Financial Officer, Garth Lees-Rolph, to review our financial results for the quarter. Garth?