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spk02: Good morning and welcome to the Inhibitase Therapeutics First Quarter 2023 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a comfort specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. 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.
spk04: Thank you. Good morning, everyone.
spk00: With me today is Dr. Milton Werner, Chief Executive Officer, and Joseph Frateroli, Chief Financial Officer. On Monday, May 15, 2023, Inhibit Case 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 Inhibit Case's 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 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-censored 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.
spk05: Thank you, Alex, and thank you, everyone, for joining us today for Hibicase 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 continue to validate our lead IKT 148009 program in Parkinson's disease at multiple industry conferences, including the annual ADPD 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 two 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 bioequivalent study for IKT-001 pro 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 O1-pro relative to the standard of care 400 milligram imatinib mesylate. We will commence the confirmatory analysis phase of the study in June. Let me start with an update to our lead program for IKT-148-009. As you know, Fortunator-9 is a selective inhibitor of the non-receptor ablesome 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 Fortune 809 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 up to 14 sites by the end of May. The trial is a one-to-one to one-to-one randomized double-blind 12-week study evaluating three doses of IKT1409 and placebo with 30 patients per cohort. The trial is assessing the safety and tolerability of 1409 as primary endpoints. As secondary or exploratory endpoints, the trial will measure a hierarchy of 15 Parkinson-related disease assessments in the brain and gut. Currently, we have selected 36 sites, 27 of which have completed all contracting steps needed to participate in the trial. Recently, the Parkinson's Progression Marker Initiative published new research in Lancet Neurology showing how protein seed amplification assays, or SAAs, use spinal fluid to accurately diagnose Parkinson's disease, even in patients who lack disease manifestation. The publication further concludes that SAAs could form the basis of a spinal fluid biomarker for analysis of treatment benefit in Parkinson's disease. Similarly, skin biopsy analysis has been validated as a biomarker resource for discriminating patients with different forms of Parkinson's and for evaluating treatment benefit. We have implemented these newly described biomarker analyses in the skin and spinal fluid into the 201 trial in order to analyze the response to treatment for enrolled patients. In addition to these enhancements, we recently completed an analysis of the 200 milligram dose of 1409 as requested by the FDA. We evaluated the 200 milligram dose once daily for seven days in six healthy volunteers to gather additional data on the safety and steady-state pharmacokinetic profile of 14809. The pharmacokinetics of the 200-milligram dose were consistent with our expectations and earlier 101 study. Steady-state was reached by the fourth day, and IKT 14809 had a 24-hour half-life. In addition, exposure increased linearly from the 100-milligram dose. There were only six mild potentially drug-related adverse events reported, with each event resolving without any adjustment to the dose and not of clinical significance. We believe that these data continue to support the development of 14809, and in April submitted the data to the FDA. Subsequent to this, we have submitted the inclusion of the 200 milligram dose for ethics committee review. Inclusion of the 200 milligram dose will have a staggered start relative to the 1500 milligram doses, which were the initial doses in the trial. We have also continued to advance preclinical development of 14809 and multiple system atrophy. Multiple system atrophy, or MSA, is a rare Parkinson-like, rapidly progressive neurodegenerative movement disorder that affects both the central and autonomic nervous systems. In March, the FDA opened the IND for MSA for us, initiating the planning steps for a six-month Phase II trial. As with other neurodegenerative diseases we have studied, clinical entry is gated by the outcomes of animal model outcome studies. Preliminary results in one of these animal model studies of MSA were presented during our March 2023 Research and Development Day, for a transgenic model of disease. 20 weeks of once-daily dosing of IKT1409 has precluded functional loss in this model relative to untreated Parkinson's disease, untreated controls. As this study and a second model study continue to progress, we look forward to providing further guidance on whether these model studies support execution of the plan phase 2 clinical trial of IKT1409 in MSA. Finally, I'd like to touch on our 501 bioequivalent study of O1-PRO. O1-Pro is our pro-drug formulation of imatinib mesylate intended to enhance the safety and tolerability of imatinib in patients with stable phase chronic myelogenous leukemia. The study is evaluated in the safety profile of O1-Pro as well as comparing its pharmacokinetic exposure to the standard of care dose of 400 milligrams of imatinib mesylate. The study is also evaluating whether O1-Pro has the potential to be a safer and better tolerated alternative for patients on chronic imatinib therapy to control their disease. In May, we completed the dose escalation portion of the study, evaluating 300, 400, 500, and 600 milligram doses of O1-pro single doses. To date, no clinically significant adverse events have been observed. In fact, O1-pro has shown that it has high oral bioavailability and a pharmacokinetic profile of delivered imatinib that closely matches the exposure of imatinib delivered as 400 milligrams of imatinib mesylate. We are completing the analytical analyses of the four cohort pharmacokinetic data to identify the biochlorine dose of O1-pro. which will then be utilized in a confirmatory analysis of 32 additional healthy volunteers. We are on track to complete the trial in the second quarter of 2023 and look forward to engaging with the FDA to discuss the parameters of drug approval for a workflow under the 505 regulatory pathway. I'd like to now turn the call over to our Chief Financial Officer, Joseph Radaroli, to discuss our financials for the quarter. Joe?
spk01: 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 16 cents per share compared to a net loss of 4.6 million or 18 cents 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, 2-in-1 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 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.
spk05: Thank you, Joe. We continue to make progress in our clinical efforts for 1409 and 01 programs. 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 O1 Pro in June and remain on track to complete the trial by the end of the second quarter. We'll 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?
spk02: We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you're 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 two. At this time, we will pause momentarily to assemble our roster. The first question comes from Ed White with HC Wainwright. Please go ahead.
spk04: Good morning.
spk03: 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?
spk05: In our 2023 Research and Development Day, and that presentation is on our website under the Presentations tab, we have 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 meeting that target. That will depend on how we get all the sites running and their screening activities, et cetera.
spk04: Okay, thanks, Milton. And just a question on Zero One Pro.
spk03: 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?
spk05: Well, partner interest in the product, so I'll answer that question first, is going to be dependent on showing a differentiation between imatinib mesylate standard of care and the prodrug. This study as 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 of imatinib at steady state. Because we've begun to see a separation in the safety profile of O1 pro 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 eight 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 hydrosamatinib 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 in 98 stable-faced 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 process will begin within this month, and we should be able to go out and begin talking to potential partners beginning in June.
spk04: Okay, thank you, Milton.
spk03: And Joe, just a couple of questions for you. R&D was down sequentially. You mentioned the reasons why. Now that the study's 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.
spk04: Thanks, Ed. Great question.
spk01: 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, and 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.
spk04: Okay, thanks, Joe.
spk02: This concludes our question and answer session and the Inhibit Case Therapeutics first quarter 2023 financial results conference call. Thank you for attending today's presentation. You may now disconnect.
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