Inhibikase Therapeutics, Inc. Q1 FY2024 earnings call

Management Statement and Operational Highlights: - Progress in Risvo trial: Rapid enrollment with ~83% enrolled, anticipating last patient in June and top-line data in H2 2024. Biomarker development for alpha-synuclein pathology, including a novel antibody. - Regulatory: Positive interactions with FDA divisions for IkT-001Pro, positioning for PAH and cancers. - Financials: Review of Q1 2024 financial results, cash position and funding outlook.

Segment Performance: For Risvo, the Phase 2, 201 trial for Parkinson's disease is ~83% enrolled as of May 10th with 99 participants, 15 in screening, and 22 being evaluated for suitability. 44 participants have completed the full 12-week dose period, with 25 mild and 3 moderate adverse events observed, and 4 withdrawals. Anticipates last patient enrolled in June with top-line data in the second half of 2024. For IkT-001Pro, there were positive interactions with FDA divisions. Financially, 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 same period in 2023. Research and development expenses were $2.8 million vs $2.9 million in 2023, and selling, general, and administrative expenses were $2 million vs $1.9 million in 2023. As of March 31, 2024, cash and cash equivalents were $9.7 million, sufficient to fund operations through November 2024.

Guidance: Existing cash and cash equivalents are expected to be sufficient to fund operations through November 2024.

Risks: Uncertainties associated with clinical trial outcomes, regulatory approvals, and potential differences between forward-looking statements and actual results due to various business risks.

Q: 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? 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? And just you had mentioned partnering before and just wondering if there's any update on potential partnering of this drug?

A: 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 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. 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.