Inhibikase Therapeutics, Inc.

Good day and welcome to the Inhibit Case Therapeutics third quarter 2022 financial results conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touchtone phone. To withdraw your questions, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Alex Lobo, Stern Investor Relations. Please go ahead.

Good morning and welcome to Inhibit Case Therapeutics third quarter 2022 financial results conference call and audio webcast. With me today is Dr. Milton Werner, Chief Executive Officer, and Joseph Frateroli, Chief Financial Officer. Yesterday, Inhibicase issued a press release announcing financial results for the third quarter ended September 30, 2022. We encourage everyone to read yesterday's press release, as well as Inhibicase's quarterly report on Form 10-Q, which is being filed with the SEC. The company's press release and quarterly report are also available on Inhibicase's website at Inhibicase.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, November 15, 2022. 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 now like to turn the call over to Dr. Milton Werner. Milton, you may begin.

Thank you, Alex, and thank you for joining us today to review Inhibicase's third quarter 2022 financial results and recent business updates. Let me start by providing an update on our IKT 148009 or 14809 programs. On November 7th, we announced that the U.S. Food and Drug Administration had reviewed our investigational new drug, or IMD, application for IKT14809 for the treatment of multiple system atrophy, or MSA. As a result of their review, they issued a clinical hold on the IKT14809-201 program in Parkinson's disease, or PD, and the use of IKT14809 in MSA. In their email correspondence, the FDA indicated that an official clinical hold letter will be issued within 30 days. I would like to highlight the date that we have observed only two mild adverse events in the ongoing Phase 2a-201 trial and have recorded no serious adverse events. We are actively working with the FDA to understand the agency's concerns and to resolve them as soon as possible. In the interim, we plan to conduct a blinded safety assessment based on the first 11 patients that were enrolled in the 201 trial and were randomized one-to-one to one-to-one for the 12-week once-daily dosing. However, since none of the initial 11 patients had fully completed the study, once the clinical hold is lifted and subject to discussions with the FDA, the study will need to be restarted. In addition, I would like to reiterate results from our Phase 1 and 1B study of IKT 14809 that were presented at the Movement Disorder Society Congress in September of this year. These data highlighted that IKT-14809 was safe and well-tolerated over seven days of daily dosing with high systemic exposure and persistent penetration into the central nervous system, or CNS. That was true in both healthy volunteers and in patients with Parkinson's disease. Moreover, assessments of motor, non-motor, and quality of life in patients enrolled in the study showed that treatment with IKT-14809 did not worsen disease over seven-day dosing. Our highest priority is to resolve any questions and concerns from the FDA to resume our clinical development of IKT 14809 as soon as possible. Turning briefly to our preclinical efforts, we are continuing to advance IKT 001 Pro towards the clinic by the end of the year. As a reminder, 001 Pro is our pro-drug formulation of imatinib mesylate developed to improve the safety of the first FDA-approved Abelson tyrosine kinase inhibitor, known as imatinib, as a treatment for stable-phase chronic myelogenous leukemia, or CML. We received FDA clearance for our IMD application for IKT001 Pro in August of this year. As you know, imatinib is commonly taken for hematological and gastrointestinal cancers that arise from able kinase mutations found in the bone marrow or for gastrointestinal cancers that occur from CKIT mutations in the stomach. Our pro-drug formulation has the potential to be a safer alternative for patients and may improve the number of patients that reach and sustain major or complete cytogenic responses in stable-phase CML. In preclinical studies, IKT-001-pro could be dosed up to three to four times higher than imatinib in non-human primates before inducing an adverse event. If observed in people, this has the potential to reduce the burdensome gastrointestinal side effects that occur following oral administration in the CML or gastrointestinal sternal tumor patients. We are now advancing IKT-001-PRO into a single ascending dose 501 bioequivalent study to evaluate the safety and efficacy of the drug. The study will enroll approximately 56 male and female healthy volunteers between the ages of 25 and 55 who will receive IKT-001-PRO at one of three doses. The study will also aim to identify a dose with a similar systemic exposure of pharmacokinetic profile compared to 400 mg imatinibesylate, the standard of care drug, at 96 hours post-administration. We expect the dosing of the first patient to occur during the fourth quarter of 2022. Before we open the call to questions, I want to provide a brief update on our financials. As of September 30, 2022, we had approximately $26.5 million in cash, cash equivalents, and marketable securities. Net loss for the quarter was approximately $4.5 million, or 18 cents per share. We expect our existing cash, cash equivalents, and marketable securities will be sufficient to fund our normal operations and capital expenditure requirements through February 2024, subject to outcomes from our discussions with the FDA on the Fortune 809 program. As we look to the remainder of the year, we will continue to provide updates as appropriate on the clinical hold of our IKT 14809 programs, and additionally, we expect to initiate our 501 bioequivalence study for IKT 001 Pro by the end of the year. I want to thank our shareholders for their continued long-term support of inhibicase as we remain fully committed to our mission to improve the lives of patients suffering from devastating neurodegenerative and oncological diseases. I would like to now open the call for questions. Operator?

We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star, then 2. Once again, that is star, then 1 to ask a question. This concludes our question and answer session and concludes the conference call. Thank you for attending today's presentation. You may now disconnect.