Inhibikase Therapeutics, Inc.

Hello, and welcome to the HEMPA Case Therapeutics Third Quarter 2023 Financial Results. All participants will be in this anomaly mode. Should you need assistance, please send to 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 your touch-tone phone. To withdraw your question, please press star, then two. Please note, today's event is being recorded. I now turn the conference over to Alexander Lobo of Stern Investor Relations. Please go ahead, sir.

Thank you, operator. Good morning, and welcome to Inhibit Case Therapeutics Third Quarter 2023 Financial Results Conference Call and Audio Webcast. With me today is Dr. Milton Werner, Chief Executive Officer, and Joseph Frateroli, Chief Financial Officer. On Tuesday, November 14, 2023, Inhibit Case issued a press release announcing financial results but the third quarter ended September 30th, 2023. 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 quarterly report 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, November 15, 2023. 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 live 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, everyone, for joining us today. We are very pleased with the progress we've made throughout the third quarter as we advance our clinical and preclinical pipeline programs. In the clinic, we are continuing to evaluate the lead candidate, risvodetinib, in our Phase II 201 trial in Parkinson's disease. The trial is actively screening and enrolling patients and activating the remaining clinical sites. In addition, our 501 bioequivalent study for IKT-001-Pro is now complete, and we are in the process of submitting briefing documents in support of a meeting with the FDA to align on the requirements for approval under the 505 regulatory pathway. Our medicinal chemistry efforts are also progressing, and we are excited to announce the evaluation of second-generation C-able inhibitors that emerge from internal programs and external collaborations. These second-generation molecules may potentially be deployed alone or in combination to improve brain delivery and C-able inhibition in the central nervous system. In the orphan disease areas, we are pleased to receive orphan drug designation from the U.S. FDA for Rizvodecinib as a treatment for multiple system atrophy. We are working towards initiation of the planned phase two study and discussing conduct of the trial with private foundations, federal and industry stakeholders in an effort to initiate this trial in the future. Collectively, we believe that these accomplishments continue to demonstrate the potential of our programs to deliver transformative treatments for patients. Let us now take a deep dive into each of our programs, starting with our 201 trial. As a reminder, the 201 trial is a 12-week, double-blinded study across three doses plus a placebo group. We have been working closely with our 28 active clinical sites to accelerate screening and enrollment. into the trial and are pleased to say that we currently have 24 participants enrolled, seven prospective participants undergoing screening evaluations, and 15 potential participants undergoing informed consent. Let me correct that. That's actually nine prospective participants and 15 potential undergoing consent, as we announced at the press release yesterday. Five participants have completed the full 12-week regimen to date. As we continue to enroll participants into the trial, We are working to initiate a 12-month extension study for the 201 trial, subject to additional financing. The extension study, once implemented, will roll participants who have completed the 201 trial into a study for an additional 12 months of treatment. The extension study will also evaluate our novel tablet formulation of risvodetinib, which we announced in August 2023. This novel tablet formulation is designed to improve drug exposure and overcome existing challenges related to patient use and mimics the oral formulation we used to evaluate efficacy and validated the animal models of Parkinson's disease. The tablet nearly doubles drug exposure at steady state for the same dose of risvodetinib, which may allow for lower doses that could lead to an overall improvement in safety and tolerability of risvodetinib. In addition to the ongoing work in the 201 trial, we recently presented public unblinded functional data from 11 previously enrolled patients with untreated Parkinson's disease excuse me, who were removed from the 2-1 trial due to the temporary clinical hold imposed by the FDA in the fourth quarter of 2022. These results were presented at the Movement Disorder Society Congress in Copenhagen in August 2023. Of the 11 patients enrolled, eight participants were an active drug, three at 50 milligrams, two at 100 milligrams, and three at 200 milligrams, and three were given placebo. For these patients, we evaluated changes in the functional assessments of motor and non-motor features using a hierarchical analysis of 15 secondary endpoints. In particular, the study evaluated non-motor functions such as activities of daily living using the MDS-UPDRS Part 2 score and evaluated motor function using the MDS-UPDRS Part 3 score. The sum of these scores was the top functional readout in the hierarchy. At the end of study time point, the three participants who received the 200 milligram dose had a combined part two and part three score that was lower by an average of minus 8.7 points. By contrast, the combined placebo score increased by an average of plus 1.7 points. This represents a minus 10.4 point spread between actively treated versus placebo participants. For comparison, Parkinson's patients typically have a plus three to plus six point increase in the sum of score assessment over the course of 12 months. Thus, a negative or lower score relative to placebo might be an indication of a clinical benefit. However, the small sample size at each dose and group precludes us from drawing this conclusion at the present time. Patients administered 50 or 100 milligrams experienced an average change of plus 1.7 and minus 1.3 points, respectively, for the combined score. An additional measure of non-motor features of disease utilized what is called the Schwann and Englund activities at daily life scales scale. The S&E scale, as we term it, was reduced for the 200 milligram group by an average of minus 3.3 points relative to baseline, while those on placebo had an average score increase of plus 3.3 points. That is a minus 6.6 point spread between actively treated participants and the placebos. The 50 milligram dose showed no effect for this measure, while the 100 milligram dose was on average minus 5 points lower relative to baseline. While the data set has too few participants to conclude a clinical benefit, We view these results with cautious optimism as we continue to enroll patients in the ongoing 201 trial. Turning now to the IKT-01 Pro program, our pro-drug formulation for imatinib mesylate that has been developed to improve safety of imatinib, we recently completed the 501 bioequivalent studies evaluating the IKT-01 Pro compared to 400 mg imatinib mesylate or 600 mg imatinib mesylate. The study met our expectations and demonstrated that the 600 mg dose of IKT-001-PRO was equivalent to standard of care 400-milligram imatinib mesylate, while a 900-milligram dose of IKT-001-PRO should be equivalent to 600-milligram imatinib mesylate. IKT-001-PRO demonstrated a favorable safety and tolerability profile with minimal adverse events across the 66 subjects in the trial. We are currently submitting briefing documents to the FDA to come to agreement on the particulars for approval of IKT-001-PRO under the 505-BT statute. Before I turn the call over to Joe to discuss our financials, I want to briefly touch on our preclinical activities. As scientists, we are always excited by the prospect of leveraging learnings from our work into new developments. In August, we announced the emergence of several new second-generation molecules from internal medicinal chemistry programs and external collaborations that we believe could enhance suppression of neurodegeneration through C-able inhibition. We believe that such molecules, whether acting alone or in combination with active sun inhibitors like resveratantinib, could be an improved approach to suppress neurodegeneration arising from C-able activation inside and outside of the brain. In addition to these early-stage efforts, we are continuing to advance the preclinical development of rizvodetinib for the treatment of multiple-system atrophy. In October, we were pleased to receive orphan drug designation from the U.S. Food and Drug Administration. Orphan drug designation is provided to drugs or biologics that are used in prevention, diagnosis, or treatment of diseases that affect fewer than 200,000 people. This designation will allow us to advance our work in MSA at greater speed and is encouraging to see the FDA acknowledge the devastating nature of MSA and the high unmet need that exists in the market. I'll now turn the call over to our Chief Financial Officer, Joe Federoli, to review our financial results for the quarter. Joe?