Inhibikase Therapeutics Inc. Q1 2023 Earnings Call

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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 1 on your telephone keypad. To withdraw your question, please press star then 2. 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.

Thank you.

Good morning, everyone. With me today is Dr. Milton Werner, Chief Executive Officer, and Joseph Fradroli, Chief Financial Officer.

On Monday, May 15, 2023, in case issued a press release announcing financial results for the first quarter and March 31, 2023.

We encourage everyone to read yesterday's press release as well as inhibit cases and quarterly report on form 10Q, which has been filed with the SEC.

The company's press release and quarterly report are also available on Inhipicase's website at Inhipicase.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 to over to Dr. Milton Warner. Milton, make your head.

Thank you, Alex, and thanks to everyone for joining us today for InhibiCase Therapeutics First Quarter 2023 earnings call.

Our focus heading into 2023 is to execute, again, our portfolio of neurodegenerative and oncology programs.

Throughout the first quarter, we continued to validate our lead IKT-14809 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-14809 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 II, 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 that the first patient had been enrolled into the 201 study.

In addition, we are rapidly advancing our 501 bioequivalent study for IKT001Pro 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 FromCoCoConnect data analysis across all four cohorts.

We will be able to determine the bioequivalent dose of O1Pro relative to the standard of care, 400 mg, and active methylate.

We will commence the confirmatory analysis phase of the study in June .

Let me start with an update to our lead program for IKT I148009.

As you know, Fortunator 9 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 Fortunator 9 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 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 IKT 1409 and placebo with 30 patients per cohort.

The trial is assessing the safety and tolerability of 14 and 9 as primary endpoints.

As secondary or exploratory endpoints, the crowd will measure a hierarchy of 50 and 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 SAs could form the basis of a spinal fluid biomarker for analysis of treatment benefit in Parkinson's disease.

Similarly, Saken biopsy analysis has been validated as a biomarker resource.

for discriminating patients with different forms of Parkinson's and for evaluating treatment benefits.

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 200mg dose of 14 of 9 as accrued by the FDA. We evaluated the 200mg dose once daily for seven days and six healthy volunteers to gather additional data on the safety and any state from the tonight profile of the 4-nated item.

The fromeco kinetics of the 200 milligram dose

Steady State was reached by the fourth day, and IKT Fortune 9 had a 24-hour half-life.

In addition, exposure increased linearly from the 100 mg 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 continues to support the development of Fortune Inter 9 and 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 14M9 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 two trial. As with other neurodegenerative diseases we have studied, clinical entry is gated by the outcomes of animal model outcome studies. Eliminating 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 IKT 14 and 9 has precluded functional loss in this model relative to untreated parking disease of one treated 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 faced to clinical trials by KT-14 or nine in MSA.

Finally, I'd like to touch on our 501 biocrylonal study of O1 Pro. O1 Pro is our project formulation of a mat that messulates.

and tended to enhance the safety and tolerability of the mat and then patients with stable phase chronic myelogins leukemia.

The study is evaluating the safety profile of O1Pro as well as comparing its pharmacogenetic exposure to the standard of care dose of 400 mg of matinib nesilate.

The study is also evaluating whether O1 Pro has the potential to be safer and better tolerated alternative for patients on chronic immatin 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 prosynaldesis.

To date, no clinically significant adverse events have been observed. In fact, O1 Pro has shown that it has high mobile availability and a pharmacokinetic growth file of delivered a mat nib that closely matches the exposure of a mat nib delivered as 400 milligrams of mat and mesolate. We are completing the analytical analyses of the four cohort form of coconut and data to identify the bio-colon dose of O1 Pro.

which will then be utilized in the confirmatory analysis of 32 additional healthy volunteers.

We are on track to complete the trial in the second quarter of 2023. I look forward to engaging with the FDA to discuss the parameters of Dr. Prumel for OEMRO under the 502 regulatory pathway. I'd like to now turn the call over to our chief financial officer Joseph Rowe to discuss our financials for the quarter. Joe.

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 right at March 31, 2022. The decrease was primarily due to the company restarting its phase two to a one clinical trial in the quarter.

Selling General and Administrative Expatuses are 1.9 million for the quarter rate at March 31, 2023, compared to 1.7 million for the quarter rate at March 31, 2020.

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 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, the closing remarks.

Thank you, Joe. We continue to make progress on our clinical efforts for 14 and 901 programs.

We believe the enhanced protocol for our 201 trial for Parkinson's disease, including the implementation of state-of-the-art bottom-marker analyses in the Schemin's Final Fluid, significantly strengths in the study, and we look forward to remote and multiple patients into the study in a second quarter. In addition, we expect to enhance the confirmatory analysis in our 501 bioquilin study for 01 Pro.

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At this time, we will pause more entirely to assemble our roster. The first question comes from Ed White with HC Wainwright.

time to pause voluntarily to assemble our roster. The first question comes from Ed White with HC Wainwright. Please go ahead.

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?

In our 2023 Research and Development Day, and that presentation is on our website under the pieces.

We had guided that we planned to have the trial and roll 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 their screening activities, et cetera.

Okay, thanks, Milton. And just a question on zero one pro.

When do you expect a schedule of meeting with the FDA to discuss the path forward, and have you had any partner interest in the product?

Well, partner interest in the product, so I'll answer that question first. It's gonna be dependent on showing a differentiation between a mat and a mesolate.

Well, partner interest in the product, so I'll answer that question first. It's gonna be dependent on showing a differentiation between a mat and a mesolate, a standard of care and the product.

This study as planned was there to establish what bio-culture was.

We have two types of mechanisms that we are contemplating to demonstrate the improvement over standard care.

One is the potential for an added cohort at the end of the 51 study, where we'll look at high dose of matineeb at steady state. Because we've begun to see a separation in the safety profile of O1 pro, more favorably than for a matineeb, that's like 400 milligram.

We can amplify that difference by looking at a common dose that's used in the clinic, which is 600ml of gammamatinib, and do a steady state cohort in eight healthy subjects for that. Once the bioquimates,

Pharmacoconytic analysis completes, which we think will occur this month. We'll submit that data and the request of the FDA for them to sign off on adding that cohort because hyposamatinib could carry a number of side effects for healthy subjects and the FDA has to weigh in before we...

Pharmacocryptinetic analysis completes which we think will occur this month. We'll submit that data and the request of the FDA for them to sign off on adding that cohort because Hidosomatinib could carry a number of side effects for healthy subjects and FDA has to weigh in before we execute on that component.

of the other path, which is really a path for future work with a potential partner.

is to do a formal safety of superiority study in the target population, which we've previously disclosed would be a roughly year-long study in 98 stable phase CML patients. And that trial is outlined in our corporate presentations that you can find on our website.

We've not yet reached out to partners because you need to see the full form of Canada 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 martyrs beginning in June .

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'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. Thanks, Ed. Great question. Yeah, I mean, really R&D was down.

lightly, but the composition really was that the prior years quarter.

the PD represented about a little over 83% of the total R&D and in the current year quarter down to 61%. Well, I think that through the end of the year Parkinson's will again be above 80 to 85% of all the R&D expenses.

Okay, thanks, Joe. 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.