IKT - NASDAQ

Good morning and welcome to the Inhibikase Fourth Quarter and Full Year 2022 Earnings Conference Call. [Operator Instructions] Please note, today's event is being recorded. I would now like to turn the conference over to Alex Lobo with Stern IR. Please go ahead.

Good morning and welcome to Inhibikase Therapeutics fourth quarter and full year 2022 financial results conference call and audio webcast. With me today is Dr. Milton Werner, Chief Executive Officer; and Joseph Frattaroli, Chief Financial Officer. On Friday, March 31, 2023, Inhibikase issued a press release announcing financial results for the full year ended December 31, 2022. We encourage everyone to read Friday's press release as well as Inhibikase's annual report on Form 10-K which has been filed with the SEC. The company's press release and annual report are also available on Inhibikase'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, April 3, 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 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 all for joining us today to review our full year 2022 financial results and recent clinical and business updates. 2022 was an important year for us as we continue to advance our mission to bring disease-modifying therapeutics to patients living with neurodegenerative diseases and cancer. We were excited to continue to advance our lead asset, IkT-148009, in the clinic as well as further validate the underlying mechanism through presentations at several notable scientific and industry conferences. While the FDA clinical hold on our 148009 programs last year was an unexpected challenge, we were pleased to announce that the agency had lifted our hold on Parkinson's program in January. With that hold lifted, we are working diligently to restart the Phase IIa 201 clinical trial with the agreed-upon amendments. In March, the FDA lifted the clinical hold on IkT-148009 for the treatment of Multiple System Atrophy, or MSA and open the IND, enabling the planning of a future Phase II trial in MSA. Simultaneously, our 501 bioequivalent study for IkT-001Pro which is a prodrug formulation of imatinib mesylate intended to treat Stable-Phase Chronic Myologic Leukemia has completed 3 or 4 dose escalation cohorts and it is anticipated that dose finding and dose equivalence program will be completed by the close of the second quarter of this year. As we work to make 2023 another year of clinical execution, we recently completed a concurrent registered direct offering and private placement which bolstered our cash reserves by approximately $10 million in aggregate gross proceeds. With the addition of these funds, we are well capitalized in the fourth quarter of 2024 to advance our clinical programs through key milestones. Now, let me first start with an update to our IkT-148009 programs. IkT-148009 is our selective nonreceptor Abelson Tyrosine Kinases, or c-Abl inhibitor. As we published in January of this year, IkT-148009 has been shown to halt disease progression, protect and restore lost neurons in the brain and GI tract and clear the underlying protein pathology as was shown in animal studies. Today, Parkinson's disease is one of the most devastating neurodegenerative diseases in the U.S. with roughly 60,000 new diagnoses in the U.S. each year and there are currently no available options that slow or halt the progression of this disease. Let me expand further on the potential of IkT-148009 as a disease-modifying therapy for Parkinson's and related disorders. Our animal model studies which were published in the Journal Science Initiation of Medicine on January 18 of this year, highlights data from once daily oral administration of IkT-148009 in animal models that mimic the rate of disease progression relative to lifespan observed in human Parkinson's disease. These studies showed that IkT-148009 was able to halt disease progression, drive functional recovery, protect neurons -- and protect neurons from degradation. These features correlated with substantial reduction in the underlying protein aggregate pathology. We believe these data form the basis for our belief and the potential of IkT-148009 as a disease-modifying therapy for patients and continues to support clinical development of IkT-148009 in Parkinson's disease. Turning now to our 201 program. Despite the unexpected setback last year, we were pleased to announce that the FDA had lifted the full clinical hold on IkT-148009 in Parkinson's in January. The FDA based the decision on our complete response to the issues raised in the hold letter which we submitted in December to the division of neurology. In our response, we agreed to measure the pharmacokinetics of the 200-milligram top dose planned in the study in 6 healthy volunteers before implementing the dose in the 201 trial itself. This pharmacokinetic profile has now been completed and we anticipate submitting the data to the FDA within the coming days. The FDA further requested the measurement of visual acuity and examination of the cornea and lens to complement the analysis of the retina, macula and fundus that was already part of the ocular monitoring program set up in the trial. This monitoring program is consistent with the ocular pathology monitoring programs of other marketed protein kinase inhibitors. We also want to emphasize that to date, no ocular pathology has been observed in any trial participant administered IkT-148009 and no clinically meaningful adverse events have been observed in any healthy subject of Parkinson's patients to date at any dose or dose duration up to 11 weeks of IkT-148009 given once daily. With 20 of approximately 35 planned sites already opened and several having completed the steps to start screening patients, we are pleased that the first patient screenings began last week. We will update the status of the 201 trial enrollment later in the second quarter. We're also excited to be moving forward with our IkT-148009 program in Multiple System Atrophy, or MSA, following the recent lift of the clinical hold by the FDA. MSA is a rare, rapidly progressive neurodegenerative movement disorder that affects both essential and autonomic nervous systems. In 2021, we published the journal, Neurobiology of Disease that c-Abl activation and alpha-synuclein phosphorylation at tyrosine 39 also occurs in MSA in a manner that is similar to what has previously been described in Parkinson's. Our ongoing animal model studies that we discussed during our recent R&D Day continue to encourage our planning efforts for a future Phase II trial. Turning now to an update of our 501 bioequivalent study of IkT-001Pro. As you might recall, 001Pro is our prodrug formulation of imatinib mesylate intended to enhance the safety and tolerability of imatinib in patients with stable Chronic Myelogenous Leukemia or CML. Imatinib is commonly taken for hematological and gastrointestinal cancers which arise from Abl kinase mutations located in the bone marrow or GI tract. We are evaluating whether IkT-001Pro has the potential to be a safer and better tolerated alternative for patients on chronic imatinib therapy to control their disease. The 501 study is a 2-part bioequivalence trial with the first part comprised of 4 escalating doses across 27 healthy subjects between the ages of 25 and 55. And our intent is to identify the bioequivalent dose. 3 of the 4 dosing cohorts have already been completed in that study. The second phase of the study will confirm the measured bioequivalent dose in 32 additional healthy volunteers using a 2-period crossover study. This study will also evaluate the adverse event profile and patient-reported outcomes as metrics of superiority over standard of care. We are contemplating the evaluation of high dose imatinib such as 600 milligrams and to identify the equivalent dose of 001Pro to further amplify the differences in potential safety and tolerability of high-dose imatinib delivered as prodrug. I would like to now turn the call over to Joe Frattaroli, our Chief Financial Officer, to review the financials. Joe?

Thank you, Milton. Let me review our financials for the year ended December 31, 2022. Grant revenue was $0.1 million for the year ended December 31, 2022, compared to $3.1 million for fiscal year 2021. The decrease was due to the company's primary focus during 2022 being shifted toward advancing our Phase I and II human clinical trials which were not branch-related activities. Research and development expenses were $12 million for the year ended December 31, 2022, compared to $11.4 million for the year ended 2021. The increase was primarily due to ongoing non-grant-related research and development activities mostly related to the Phase IIa 201 clinical trial. Selling, general and administrative expenses were $6.2 million for the year ended December 31, 2022, compared to $6.5 million for the prior fiscal year. The decrease was primarily the result of decreased warrant expense of $0.7 million and a decrease of stock-based compensation of $0.5 million, partially offset by increased legal fees of $0.4 million, increased regulatory and compliance fees of $0.2 million and a net increase of $0.3 million for other normal operating expenses. For the year ended December 31, 2022, we reported a net loss of approximately $18.1 million or $0.72 per share compared to a net loss of $14.8 million or $0.81 per share in the year ended December 31, 2021. As of December 31, 2022, we had approximately $23.1 million in cash, cash equivalents and marketable securities. This excludes the approximately $10 million of aggregate gross proceeds from our January 2023 and current registered direct offering and private placement before deducting placement agent fees and other offering expenses payable by Inhibikase. We expect that existing cash, cash equivalents and marketable securities will be sufficient to fund operations into the fourth quarter of 2024. That concludes our financial statements. I'd like to hand the call back over for any closing remarks.

Thank you, Joe. We remain passionate about the work we do with at Inhibikase and we are confident that we have the resources necessary to advance both our neurodegenerative and oncology programs towards key milestones in the clinic. As we look towards 2023 and beyond, we anticipate sharing additional clinical updates for 148009 as the 201 trial begins to enroll patients, to continue advancing our remaining preclinical efforts in MSA and complete the 501 bioequivalent study for IkT-001Pro. We view 2023 as a year of growth and execution as we continue to ideate groundmaking therapeutics and to help patients and families living with these devastating diseases. We would like to thank our shareholders and partners for their continued support. And now I'd like to open the call to questions. Operator?

[Operator Instructions]

I'm sorry, operator, did you just say there was a question or there was no?