IKT - NASDAQ

Greetings and welcome to Inhibikase Therapeutics First Quarter 2024 Financial Results Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. [Operator Instructions]. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Alexander Lobo, Stern Investor Relations. Thank you, Mr. Lobo. You may begin.

Good morning and welcome to Inhibikase Therapeutics first quarter 2024 financial results conference call and audio webcast. With me today is Dr. Milton Werner, Chief Executive Officer and Garth Lees-Rolfe, Chief Financial Officer. On May 15th, Inhibikase issued a press release announcing financial results for the first quarter ended March 31, 2024. We encourage everyone to read yesterday's press release as well as Inhibikase quarterly report on form 10-Q, which is being filed with the SEC. The company's press release and form 10-Q are also available on the Inhibikase 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, 2024. 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, everyone, for joining us today for to review our first quarter 2024 financial results and recent clinical and business updates. 2024 is shipping up to be a year of clinical and regulatory execution as we advance our core programs towards important inflection points and we are proud of the achievements already accomplished by our team in the first quarter. We are making rapid progress in the enrollment of our Phase 2, 201 trial for Risvodetinib or Risvo. In Parkinson's disease, and we anticipate enrolling the final patient in June with top-line data reported in the second half of the year. On the regulatory front, we had positive interactions with two FDA divisions for Imatinib project program, IkT-001Pro, as we continue to position this asset for the potential opportunity in pulmonary arterial hypertension and pursue the existing opportunity in blood and stomach cancers. So, let's take a deeper dive into each of our programs beginning with Risvo. Risvo is a potent selective inhibitor of c-Abl that is administered once daily that we believe may slow or halt the progression of Parkinson's disease. Our 201 trial is a two-phase trial with an ongoing 12-week double-blinded study across three doses we believe should be achieved therapeutic effect plus a placebo. The trial is approximately 83% enrolled as of May 10th with 99 participants, 15 prospective participants in medical screening, 22 potential participants being evaluated for suitability to initiate medical screening. Additionally, 44 participants have completed the full 12-week dose in period. To-date, there have been 25-mile and three moderate adverse events observed that might be related to Risvo treatment. Four people withdrew from the trial without completing 12 weeks. As I mentioned earlier, we anticipate that the last patient will be enrolled in June when we expect to report top-line results from the study in the second half of this year. Following the completion of the 12-week double-blinded period, we expect to request an end-of-phase team meeting with the FDA. Overall, we remain impressed by the speed at which our trial has been enrolled in patients as well as the broader interests expressed in the Parkinson's community nationwide. We've worked hard to make sure that our dedicated patient portal, accessible at www.the201trial.com, provides accurate and updated information regarding our trial and how to get involved and believe that the portal has been instrumental in enabling us to effectively enroll participants across all 32 open clinical trial sites. As we continue to work to find the capital necessary to initiate the 12-week extension trial, we are encouraged by what is emerging on the biomarker front. Recently, we disclosed the development of a novel antibody against the key marker of alpha-synuclein pathology in Parkinson's disease, namely an antibody that can recognize phosphorylated tyrosine 39. We believe this antibody will serve the dual purpose of allowing us to track alpha-synuclein pathology and its possible elimination, along with a measure of target engagement by Risvo. The development of this antibody prompted our recent grant submissions to the National Institute of Neurological Disease and Stroke, or NINDS, which is an institute of the National Institutes of Health, or NIH. This antibody would be incorporated in both the skin biopsy test and the scene amplification test, then already being used in the 201 trial to track the effect of Risvo on the underlying pathology of disease in both the central and peripheral nervous systems. Moving now to IkT-001Pro, our pro-drug formulation of imatinib mesylate that has been designed to potentially improve on the safety and tolerability profile of imatinib, we continue to make significant strides in the advancement of the pro-drug through our ongoing discussions with the FDA. On January 19th, we held the pre-NDA meeting with the FDA to discuss the requirements for potential approval under the 505(b)(2) statute. We were pleased with the discussion we had with the agency as we begin the process of building our first NDA package. Our discussion with the FDA provided a roadmap to NDA submission to include our agreement to conduct a pre-clinical test to evaluate how 001Pro and imatinib affects certain gut transporters and to consider evaluating the 1200 milligram dose of 001Pro as a possible equivalent to the approved dose of 800 milligram of imatinib mesylate. Notably, we are able to pursue approval on all alone indications for which imatinib mesylate is approved. We have continued to evaluate how to maximize value for 001Pro. We have also explored non-ecology indications for which 001Pro could prove to be effective. To this end, on April 5th, we held a pre-IND meeting with the Office of Cardiology, Hematology, Endocrinology and Nephrology in the Division of Cardiology and Nephrology at the FDA. We were discussing the potential of 001Pro as a disease-modifying treatment for pulmonary arterial hypertension or PAH. Pulmonary arterial hypertension is a rare disease of the pulmonary microvasculature that primarily affects women between the ages of 30 to 60. There are approximately 30,000 cases of PAH in the U.S. alone, and many treatments for PAH are aimed at addressing symptoms of disease rather than outright curing it. The global PAH market side is valued at approximately 7.66 billion, and we believe that IKT-001Pro would have the potential to deliver imatinib with an improved safety and tolerability profile that a imatinib mesylate itself, an improved safety and tolerability profile relative to a imatinib mesylate itself for this indication. Although we have yet to conduct any clinical studies to evaluate 001Pro and PAH, our pre-IND meeting has served to review our proposed light-stage trial design to confirm the new molecular entity status for 001Pro and PAH, and to open the door to exclusivity designations for 001Pro to be approved for this indication. These outcomes provide the opportunity to unlock substantial value for 001Pro as an indication of high unmet need that was not anticipated when 001Pro was first conceived. I will now turn the conversation over to our Chief Financial Officer, Garth Lees-Rolfe, to review our financial results for the quarter. Garth?

Thank you, Milton. Now, let me review our financial results for the year and quarter ended March 31, 2024. Net loss for the quarter ended March 31, 2024, was $4.6 million, or $0.73 per share, compared to a net loss of $4.5 million, or $0.98 per share for the quarter ended March 31, 2023. Research and development expenses for the quarter ended March 31, 2024, were $2.8 million, compared to $2.9 million for the same period in 2023. The $0.1 million decrease was to a decrease of $0.7 million in IkT-001Pro expenses offset by a $0.6 million increase in Risvo imatinib expenses. Selling, general, and administrative expenses for the quarter ended March 31, 2024, were $2 million, compared to $1.9 million for the same period in 2023. The $0.1 million increase was primarily due to a $0.18 million increase in legal and consulting fees and a $0.8 million net decrease in all other general and administrative expenses. As of March 31, 2024, we had $9.7 million in cash and cash equivalents and marketable securities. We expect that the existing cash and cash equivalents will be sufficient to fund operations through November 2024. That concludes our review of financial statements. I'd like to hand the call back over to Milton for closing remarks.

Thank you, Garth. I'd like to now open the call to questions. Operator?

Thank you. We will now be conducting a question and answer session. [Operator Instructions] The first question comes from the line of Ed White with H.C. Wainwright. Please go ahead.

Thanks for taking my questions. I just have one on Risvo and one on 001Pro. So on Risvo, how you would be looking at the data. What to you will be a positive result? And then assuming a positive result, what is your next steps on your pathway to approval?

So. for us, it's a two-fold question. We are sitting at the forefront of biomarker developments. And those biomarker measurements are ongoing. And we believe they will illustrate, hopefully, under treatment only, but we don't know what we're going to see yet, that we're able to impact both central nervous system and peripheral nervous system pools of alpha-synuclein aggregate. As we've defined what the pathological aggregate of alpha-synuclein is, namely, that it's phosphorylated at Ser129 and Tyrosine 39, our ability to track that species and watch whether treatment results in any changes in the pools of that species will allow us to have a direct measure of an impact of a drug treatment on underlying pathology of disease. There has been no prior measurement of that kind, and we think that the biomarker results will be quite illustrative. Secondary to that, we're only treating for 12 weeks, but no one expects to see some remarkable reversal of Parkinson's disease in such a short period of time, but we would expect to see some impact on quality of life measures on Parkinson's disease severity and or on formal measurements of parts one, two, or three, or any combination thereof of the UPG that is known as the UPDRS universal Parkinson's disease rating score. And I think we've said this many times in the past, in press releases and discussions of this kind, we might begin to see trends in the right direction without worsening relative to placebo. And if that's what we see, coupled with biomarkers, that will be in our view a pretty remarkable outcome, and that will motivate what we're doing in Phase 3. We hope to be able to have the capital to run the 12-month extension study so we can keep measuring these patients, but we don't have the capital just yet, so we don't know what's going to happen there

Okay, thanks, Milton. And just on 001Pro, congratulations on getting it viewed as a novel chemical entity for PAH. Just wanted to get your thoughts on what the protocol would look like for the Phase 2, 3 potential trial design?

So there's a pretty standard way to do this. So first of all, to us, what's remarkable about this is that we had this idea to try to address tolerability issues in the design of Abl inhibitors for non-ecology purposes. And our first accomplishment was trying to mask some of the potential GI causes in this class of medication. We were able to measure bioequivalence. And then, and all of that work was paid for by the National Cancer Institute through an SBIR grant. Once we recognize that pro-drugs seems to have, well, we believe, some favorable properties, but certainly not fully proven to be superior or better tolerated yet. We haven't done enough patients. We recognize that the old work that was done in the early 2010s that could allow us to think again whether imatinib is a suitable agent for PAH were not alone in this. Two other companies have pursued such ideas. And so, but they have not been able to do it with systemic administration of imatinib, which we think is the only way to properly inhibit the aBL enzymes necessary to cause an effect in disease. And so, that trial design would use a Phase 2 period with a smaller cohort. That trial design would have a primary end point in pulmonary vascular resistance, which is a pretty typical design. I believe the trial size of design now is 140 patients. And we would look to roll those patients if the safety profile emerging early in that trial because you're measuring it over 24 weeks. If that safety profile looks favorable, we'll amend the protocol to incorporate the entire Phase 3 program so people will roll smoothly from Phase 2 into Phase 3. The Phase 3 programs just like the Phase 2 programs and this indication are pretty standard. You have to measure hemodynamics like things like pulmonary vascular resistance, a secondary end point in the Phase 3. Your primary endpoint has to be six minute walking distance. A success in six minute walking distance is typically viewed as better than 30 meter improvement. And so that's what we'd be looking for. The nice thing about 001Pro, it's a very unique opportunity for us is that we already know imatinib is a highly effective agent, almost as effective or perhaps even superior to women there, which was just approved for Merck, which operates by different mechanism using the same approach. And so, and we think that [indiscernible] and imatinib are complementary, they work at either ends of the disease causing mechanism. And so, one could imagine a combination of therapies, which would be quite compatible in our view, where you can really lead to a real corrective therapy for people. And there are no other agents out there that are like this, just imatinib and to-date. And so, we think this is a fantastic opportunity in a hard to treat patient population. And it's so rare to have an asset where you already know how to dose it, you already have a whole portfolio of safety data going over two decades in a variety of different types of patients. You know something is going to work. Now you have to just reevaluate the safety and tolerability profile in the target population as your primary outcome that you need to accomplish. Because everything else is in line for approval for imatinib in this indication, as long as the older safety data that was observed is not observed in the new treatment paradigm for these patients. So, we're quite excited about this.

Okay, that's great. Thanks, Milton. And just you had mentioned partnering before and just wondering if there's any update on potential partnering of this drug?

We're actively seeking that. The players are pretty obvious and we're in discussions with more than one of them. And I think that's all I could say at the present time, it's an early stage. We needed to see these regulatory milestones achieved with relation to how the FDA would view imatinib delivered as pro drug without accomplishment in hand and seeing that we have the kind of product lifecycle at least potentially available to us as a novel chemical entity with patent and pneumolecularity exclusivity available, potentially accelerated approval aspects available because it's a novel mechanism of action for this indication. Now that that's all under our belt, we have a much stronger case to make with potential partners to either license the drug or to collaborate and help fund or predominantly fund the trial work. This is not trivial trial work and once you put patients on drugs in this indication, you can never take them off. Nobody will participate if you're going to withdraw medication at the end of the trial. So, you have to roll everybody into an extension trial or keep them into the next phase of the trial of clinical development program until you get to approval or it fails to be approved. So, the commitment you make is very significant, very fast and that really requires a partner for a company of our size.

Okay, thanks Milton for taking my questions.

You're welcome, Ed.

Thank you. Ladies and gentlemen, we have reached the end of question and answer session. I would now like to turn the floor over to Dr. Milton Werner for closing comments.

Well, thank you very much for your attention today. Our shareholders have seen a lot of volatility around our stock price. They continue to see our progress in all of our programs and the novel ways we're trying to develop value for our assets and for shareholder return and we really want to thank the shareholders along with all of the trial participants whose commitment has been unparalleled for reasons that we cannot explain. Our trial participants really want to be involved in the trial work they're participating in and they're providing invaluable information towards understanding risk-adaptive could be a transformative therapy and neurodegenerative disease. And so, I want to thank you for all of your attention through this process.