Inhibikase Therapeutics, Inc.
Q1 2023 Earnings Call Transcript

Published: 16 May 2023

[Operator:]

Good morning and welcome to the Inhibikase Therapeutics First Quarter 2023 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Alexander Lobo with Stern Investor Relations. Please go ahead.

[Alex Lobo:]

Thank you. Good morning, everyone. With me today is Dr. Milton Werner, Chief Executive Officer; and Joseph Frattaroli, Chief Financial Officer. On Monday, May 15, 2023, Inhibikase issued a press release announcing financial results for the first quarter ended March 31, 2023. We encourage everyone to read yesterday’s press release, as well as Inhibikase's annual – quarterly report on Form 10-Q which has been filed with the SEC. The company's press release and quarterly report are also available on Inhibikase's website at inhibikase.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 16, 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 go ahead.

[Milton Werner:]

Thank you, Alex, and thanks to everyone for joining us today for Inhibikase Therapeutics first quarter 2023 earnings call. Our focus heading into 2023 is to execute against our portfolio of neurodegenerative and oncology programs. Throughout the first quarter, we continued to validate our lead IkT-148009 program in Parkinson's disease, at multiple industry conferences, including the annual AD/PD conference, where we highlighted the data generated to date in our IkT-148009 program to potentially slow or halt the progression of Parkinson's disease. We began screening patients at the end of the first quarter for our Phase 2 ‘201’ trial for Parkinson's disease and anticipate up to 14 sites to be actively screening patients by the end of May. This morning, we announced the first patient had been enrolled into the 201 study. In addition, we are rapidly advancing our 501 bioequivalence study for IkT-001Pro for Stable-Phase CML and we recently completed the in life portion of the dose escalation phase of the study and following completion of the pharmacokinetic data analysis across all four cohorts. We will be able to determine the bioequivalent dose of 001Pro relative to the standard-of-care 400 milligram in imatinib mesylate. We have commence the confirmatory analysis phase of the study in June. Let me start with an update to our lead program for IkT-148009. As you know, 148009 is a selective inhibitor of the non-receptor Abelson Tyrosine Kinases or c-Abl that has the potential to halt disease progression and drive functional recovery of human Parkinson’s disease and related disorders. We designed 148009 to have a low toxicity profile and have the ability to cross the blood-brain barrier and accumulate in the brain, leading the functional recovery of motor and non-motor function in the brain and GI tract. We are actively screening patients across multiple sites, which we anticipate will expand at the 14 sites by the end of May. The trial is a 1

[Joseph Frattaroli:]

Thank you, Milton. Let me review our financial results for the three months ended March 31, 2023. For the first quarter of 2023, we reported a net loss of approximately $4.5 million or $0.16 per share, compared to a net loss of $4.6 million or $0.18 per share in the quarter ended March 31, 2022. Research and development expenses were $2.9 million for the quarter ended March 31, 2023, compared to $3 million for the quarter ended March 31, 2022. The decrease was primarily due to the company restarting its Phase 2 ‘201’ clinical trial in the quarter. Selling, general and administrative expenses were $1.9 million for the quarter ended March 31, 2023 compared to $1.7 million for the quarter ended March 31, 2022. The increase was primarily with the result of legal consulting fees and promotional related costs. As of March 31, 2023, we had approximately $25.7 million in cash, cash equivalents and marketable securities. This includes the net proceeds from the company's $10 million January 2023 concurrent registered direct offering and private placement. We expect that existing cash, cash equivalents and marketable securities will be sufficient to fund operations into the fourth quarter of 2024. And that concludes our financial statements. I'd like to hand the call back over to Milton for closing remarks.

[Milton Werner:]

Thank you, Joe. We continue to make progress on our clinical efforts for 148009 and 001 (ph) program. We believe the enhanced protocol for our 201 trial for Parkinson's disease, including the implementation of state of the art biomarker analyses in the skin and spinal fluid significantly strengthens the study, and we look forward to enrolling multiple patients into the study in the second quarter. In addition, we expect to advance the confirmatory analysis in our 501 bioequivalence study for 001Pro in July and remain on track to complete the trial by the end of the second quarter. We look forward to providing updates on both our clinical and preclinical efforts later this year. I would now like to open the call to questions. Operator?

[Operator:]

We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Ed White with H.C. Wainwright. Please go ahead.

[Edward White:]

Good morning. Thanks for taking my questions. So congratulations on getting the first patient dosed in the 201 trial. I know it's very early, but I'm just wondering, if you can give us your thoughts on how long do you think the enrollment for the whole 120 patients is going to take?

[Milton Werner:]

In our 2023 Research and Development Day, and that presentation is on our website under the Presentations tab, we had guided that we plan to have the trial enrolled in this calendar year. So that's our target. It's premature to know whether the rate of enrollment is leading that target. That will depend on how we get all the sites running and the screening activities, et cetera.

[Edward White:]

Okay. Thanks, Milton. And just a question on 001Pro, when do you expect to schedule a meeting with the FDA to discuss the path forward and have you -- had any partner interest in the product?

[Milton Werner:]

Well, partner interest in the product, so I'll answer that question first, it's going to be dependent on showing a differentiation between imatinib mesylate standard-of-care and it’s a prodrug. This study is planned was there to establish what bioequivalence was. We have two types of mechanisms that we are contemplating to demonstrate the improvement over standard of care, one is, the potential for an added cohort at the end of the 501 study, where we'll look at high dose imatinib at steady-state, because we've begun to see a separation in the safety profile of 001Pro more favorably than for imatinib mesylate 400 milligram, we can amplify that difference by looking at a common dose that's used in the clinic, which is 600 milligram imatinib and do a steady-state cohort in healthy subjects for that. Once the bioequivalence pharmacokinetic analysis completes, which we think will occur this month, we'll submit that data and the request to the FDA for them to sign-off on adding that cohort because high dose imatinib could carry a number of side effects for healthy subjects and the FDA has to weigh in before we execute on that component. The other path, which is really a path for future work with a potential partner is to do a formal safety superiority study in the target population, which we've previously disclosed would be a roughly year-long study at 98 a stable phase CML patients. And that trial is outlined in our corporate presentations that you can find on our website. We have not yet reached out to partners because we need to see the full pharmacokinetic profile and have the equivalent dose and then put the package together and we'll start marketing it. So that will -- that process will begin within this month and we should be able to go out and begin talking to potential partners beginning in June.

[Edward White:]

Okay. Thank you, Milton. And Joe, just a couple of questions for you. R&D was down sequentially. You mentioned the reasons why, now that the study is up and running, you're enrolling patients in the 201 trial. I just wanted to get your thoughts on how we should think about the progression of R&D expenses this year?

[Joseph Frattaroli:]

Thanks, Ed. Great question. Yeah. I mean really R&D was down slightly. But the composition really was that the prior year's quarter, the PD represented about a little over 83% of the total R&D in the current year quarter, down to 61%. I think that through the end of the year, Parkinson's will again be above 80% to 85% of all the R&D expenses.

[Edward White:]

Okay. Thanks, Joe.

[Operator:]

This concludes our question-and-answer session and the Inhibikase Therapeutics first quarter 2023 financial results conference call. Thank you for attending today's presentation. You may now disconnect.