Inhibikase Therapeutics, Inc.

Greetings. Welcome to Inhibicus Therapeutics First Quarter 2022 Financial Legal Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If you would like to ask a question, please press star 1 on your telephone keypad. If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Alex Lobo, Stern Investor Relations. Thank you. You may begin.

Thank you, Sherry. Good morning, and welcome to Inhibicates Therapeutics First 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, Inhibit Case issued a press release announcing financial results for the first quarter ended March 31, 2022. We encourage everyone to read yesterday's press release, as well as Inhibit Case's quarterly report on Form 10-Q for the first quarter of 2022, which has been 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, May 17, 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.

Thanks, and thank you, Alex, and thank you for everyone to joining Inhibit Cases Therapeutics' first quarter 2022 earnings call. As we kicked off the year, we have worked diligently to advance our clinical and preclinical development programs, as well as extend our thought leadership in Parkinson's disease. This past month, for example, we brought together leading KOLs in the field of movement disorders to host an educational investor event. We also participated in multiple medical conferences this past quarter, including the annual ADPD conference, where we presented results from our Phase I and Phase IB studies for IKT14809, as well as the Next Generation Kinase Inhibitor Summit, where we highlighted the rationale behind targeting C-able for Parkinson's disease. As we look ahead to the second quarter, we anticipate achieving a number of key milestones. Most importantly, we expect to dose the first patients in our Phase IIA study for IKT14809 in Parkinson's. In addition, we also expect filing our IND application for IKT-001-PRO for stable-phase chronic myelogenous leukemia, or CML, as well as report preclinical data from at least one study of IKT-14809 in multiple system atrophy, or MSA. Before I dive into our clinical and preclinical pipeline programs, I want to encourage everyone to watch the replay of our educational investor event that we hosted last month. Together with our key opinion leaders, We cover the current unmet need, competitive and regulatory landscape in Parkinson's disease, as well as our development strategy for IKT14809 as a potential therapeutic option for patients. The event can be accessed under the events and presentation section of our IR website. So now let me start with our lead program, IKT14809. IKT14809 is a highly selective non-receptor Abelson tyrosine kinase or C-ABL inhibitor. As you may remember, 14809 was designed to have a predictable low toxicity profile and to have the ability to cross the blood-brain barrier and accumulate in the brain. Animal studies, including chronotoxicology studies, confirm these designs. We are currently evaluating IKT 14809 in a Phase 1b extension study. The trial is a three-to-one randomized placebo-controlled dose escalation trial that is evaluating the safety, tolerability, and pharmacokinetics of seven-day dosing of IKT 14809 at three escalating dose levels. in patients with mild to moderately advanced Parkinson's disease. The study is also assessing motor and non-motor function and gut motility and plans to measure alpha-synuclein aggregate clearance as exploratory endpoints. In March, we presented data from the first cohort of the study at the Alzheimer's and Parkinson's Diseases Conference, or ADPD conference. Data from this cohort suggested that the safety and tolerability profile in patients closely matched that of older healthy volunteers from our phase one study. pharmacokinetics of IKT1409 in volunteers and subjects was also similar, further suggesting the pharmacology of 1409 is consistent across patient groups and penetrates the central nervous system. We have dosed six of eight patients in the second cohort and expect to complete the cohort in the second quarter. We expect to present additional data from the study and comments on the measures of the effects on Parkinson's disease at a medical meeting later this year. While the trial is still blinded, we cannot draw any conclusions about the potential benefit of IKT1409 based on the dosing of a small number of patients for seven days at different doses. We have determined that IKT1409 does not worsen the patient's Parkinson's disease when dosed for seven days, and that the pharmacology of IKT1409 in patients is similar to that of healthy subjects of the same age. Based on these outcomes, we continue to believe that the results seen thus far in our Phase I and Phase II studies support the safety and therapeutic potential of 14809 as a disease-modifying treatment for Parkinson's, and we are working diligently to advance 14 to 9 into a phase 2A study. The phase 2A study, dubbed the 201 trial, will be a 3 to 1 randomized double-blind 12-week dosing trial that will evaluate the safety and tolerability of three doses of 14 to 9 in up to 120 patients diagnosed with Parkinson's disease who have not yet progressed to the need for symptomatic treatment. The trial will also measure a hierarchy of motor and non-motor function using patient and clinician reported outcomes inside and outside of the brain at secondary endpoints, and will evaluate whether treatment with 14 and 9 leads to a reduction or clearance of pathogenic alpha-synuclein aggregates as exploratory endpoints. We are currently in the process of activating clinical sites and look forward to announcing dosing of the first patients in the second quarter. Turning now to our preclinical efforts, we are advancing two programs that leverage our work in neurodegeneration. The first is IKT-01-PRO, our pro-drug formulation of imatinib mesylate, which we have designed as a potentially safer, better-tolerated treatment for imatinib-sensitive cancers. such as stable phase chronic myelogenous leukemia. We are conducting the necessary stability studies for the IND submission package and expect to submit the investigational new drug application this quarter. Following receipt of a study may proceed letter and other discussions with the FDA, we intend to commence bioequivalent studies in accordance with the 505B2 regulatory pathway. Finally, we are continuing our preclinical work, evaluating 14 to 9 for the potential treatment of multiple system atrophy. As you may remember, MSA is a rare, rapidly progressive neurodegenerative movement disorder that affects both the central and autonomic nervous systems. Similar to Parkinson's, MSA is characterized by pathological alpha-cynical aggregation, which may lead to cell dysfunction and degeneration of neurons. MSA affects approximately 20,000 people in the U.S., and there are currently no approved treatments to slow or halt progression of this disease. These preclinical studies are evaluating whether inhibition of Cable could have a therapeutic benefit in MSA, and we expect to report data in at least one of two animal models in the second quarter of 2022. Preliminary readouts from one animal model study indicates that therapeutic administration of IKT 14809 has a beneficial effect. Depending on the full results from these model studies and subject to agreement with the FDA and equivalent regulatory bodies in the European Union, we may advance 14-9 into a Phase 2A clinical study in the fourth quarter of 2022. Now let me turn the call over to our CFO, Joe Frateroli, to review the financials. Joe?

Thank you, Milton. Let me review our financials for the three months ended March 31, 2022. For the first quarter of 2022, we reported a net loss of approximately $4.7 million, or 18 cents, net loss per share compared to a net loss of approximately 2.6 million for 26 cent net loss per share for the first quarter of 2021. Research and development expenses were approximately 3 million for the first quarter 2022 compared to approximately 2.4 million for the first quarter 2021. The increase was driven by a $2.1 million increase in non-grant related research. offset by a decrease of $1.2 million in grant-related research expenditures, and also a decrease of $0.4 million in non-cash stock compensation expense. Non-grant-related research was expended primarily in connection with the company's Phase I Parkinson's disease clinical trial. Selling general and administrative expenses were approximately $1.7 million for the first quarter of 2022, compared to approximately $1.6 million for the same period in 2021. The increase was primarily due to increased headcount, resulting in increased compensation expense of $0.2 million, increased legal fees, board fees, investor relation and consulting fees of $0.1 million, and a net increase of $0.2 million for other normal operating expenses, offset by decreased non-cash stock-based compensation expense of $0.4 million. As of March 31, 2022, HIPAA case had approximately $36.6 million in cash and cash equivalents. We expect that our existing cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2023. That concludes our financial statements. I'd like to hand the call back over to Milton for closing remarks.

Thank you, Joe. We remain very excited about our progress and goals for the second quarter and anticipate achieving multiple milestones across our clinical and preclinical programs as we seek to significantly improve the lives of patients suffering from devastating neurodegenerative diseases. We expect to initiate a phase 2A study for 1409, submit an IND application for O1 Pro, and report data from at least one preclinical study on our MSA program in this quarter. And despite the challenges posed by the current market conditions, we believe that taken together, all of these efforts will position us for success in the long term. To our shareholders, we continue to appreciate your unwavering support, and we will continue to work tirelessly to drive shareholder value and improve patient outcomes. I would now like to open the call to questions. Operator?

Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that is star 1 on your telephone keypad. We will just pause for a brief moment to see if any questions come in. Okay, there are no questions at this time. That would conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.