Q2 2024 Inhibikase Therapeutics Inc Earnings Call
Speaker Change: Greetings and welcome to the Inhibic Case Therapeutics second 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.
Speaker Change: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Alex Lobo, Precision AQ, Investor Relations. Thank you, sir. You may begin.
Speaker Change: Good morning and welcome to Inhibit Case Therapeutics second quarter 2024 financial results conference call and audio webcast.
Speaker Change: With me today is Dr. Milton Werner, Chief Executive Officer, and Garth Lees-Rolfe, Chief Financial Officer.
Speaker Change: On August 14th, Inhibit Case issued a press release announcing financial results, but the second quarter ended June 30th, 2024. 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.
Speaker Change: The company's press release and Form 10-Q are also available on Inhibicase's website at inhibicase.com.
Speaker Change: 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.
Speaker Change: Please note that certain information on today's call is covered under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Speaker Change: Participants are cautioned that this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 15, 2024.
Speaker Change: 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.
Speaker Change: Information on potential risks and uncertainties are set forth in our most recent public filings with the SEC at sec.gov.
Speaker Change: 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.
Speaker Change: With that said, I would like to turn the call over to Dr. Milton Werner. Milton, you may begin.
Milton Werner: Thank you Alex. Thank you everybody for joining us today to review our second quarter 2024 financial results and recent clinical and business updates.
Milton Werner: We've been very pleased with the strength of our clinical progress for the first half of 2024.
Speaker Change: The speed at which we executed on key clinical and regulatory milestones has underscored what has been a very successful quarter marked by the accomplishment of many exciting achievements.
Speaker Change: We recently completed enrollment for our Phase 2, 201 trial for Rizvodetinib, or often referred to as Rizvo, in Parkinson's disease, which is a significant milestone that we have been working tirelessly towards in an effort to bring Rizvo to patients suffering from untreated Parkinson's disease.
Speaker Change: and we expect to report top-line data from the trial in November.
Speaker Change: Additionally, we have had a productive engagement with the USFDA over the past few months regarding IKT001PRO's opportunity in pulmonary arterial hypertension or PAH.
Speaker Change: Imatinib, the active ingredient in O1 Pro, has previously been shown to be disease-modifying for PAH, and we believe that Pro has the potential to further demonstrate safe and efficacious treatment in PAH patients using our novel ProDrug technology.
Speaker Change: We filed the R&D for PH and plan to open clinical development with a de-risking Phase IIb study as soon as practicable.
Speaker Change: Let me tell you, we'll take a deeper dive into each of these programs as we expect the back half of 2024 will be a catalyst-rich period. Let me first start with Rosa Detson.
Speaker Change: Rizvo is a potent selective inhibitor of C-ABL that is administered once daily that we believe may slow or halt the progressions of Parkinson's disease.
Speaker Change: Our 201 trial was a two-phased trial with a 12-week double-blinded study across three doses plus placebo, for which enrollment has been completed.
Speaker Change: As of July 29th, 41 mild and 8 moderate adverse events have been observed that may be related to rosewood treatment.
Speaker Change: We've had six people withdraw from the trial without completing 12 weeks of dosing.
Speaker Change: Looking ahead, we expect to report top-line results evaluated the safety, tolerability of RISDO and untreated Parkinson's disease in November of this year.
Speaker Change: Following completion of the 12-week double-blinded period, we anticipate meeting with the FDA by year's end to discuss our plans for Phase III and intend to launch a 12-month open-label extension study as soon as possible.
Speaker Change: Moving now to IKT-001-PRO, our PRO drug formulation of imatinib mesylate that has been designed to potentially improve the safety and tolerability profile of imatinib.
Speaker Change: We continue to make significant strides in the advancement of the prodrug through our ongoing discussions with the FDA.
Speaker Change: We received final meeting minutes for our pre-IND meeting for pulmonary arterial hypertension in May and filed the IND on August 9th to open clinical development later this year, subject to the receipt of the study may proceed letter from the agency.
Speaker Change: PAH is a rare disease of the pulmonary microvasculature.
Speaker Change: PAH can arise spontaneously or can be caused by genetic mutations, by drugs, or environmental toxins.
Speaker Change: PAH is also associated with connected tissue disease, congenital heart disease, HIV infection, and other insults that could affect the right side of the heart. Most treatments for PAH attempt to address symptoms of this progressive disorder, but the recent approval of Cetatercep highlights that disease modification is possible.
Speaker Change: We see tremendous opportunity in PAH, which has a global market value at 7.7 billion annually, worldwide. And MATINIB, the active ingredient in PRO, has already been shown to be disease-modifying more than 10 years ago, but the side effect profile observed at that time precluded approval.
Speaker Change: We believe that Pro has the potential to achieve similar potency to a magnet mesylate without the side effect profile that disqualified a magnet from approval studies reported in 2010.
Speaker Change: Based on our constructive discussions with the FDA, we believe that we have alignment on our proposed Phase IIb trial design, and at the pre-R&D meeting, the FDA confirmed that
Speaker Change: O1 Pro would be viewed as a new molecular entity for pH and that the appropriate path for approval appears to be 505B2 statute.
Speaker Change: Further, following the advice provided in our pre-NDA meeting with the FDA in January, we have scaled our manufacturing and process development efforts for PRO to support late-stage clinical development and NDA batch requirements.
Speaker Change: Activities include development of new dosage forms to differentiate O-1 pro tablets from generic command to best flight, and alignment with the FDA feedback.
Speaker Change: Finally, turning to RISDO Multiple System Atrophy, or MSA, we are currently exploring alternative financing opportunities, including potential grant funding through a new funding mechanism of clinical development in neuroscience from the National Institute of Neurological Diseases and Stroke, or NINDS.
Speaker Change: We look forward to advancing this program forward and providing further updates on the program as appropriate.
Speaker Change: Separately, we are also developing new anti-diagnostic and clinical biomarker tools.
Speaker Change: that we believe will further differentiate the company's efforts in Parkinson's disease and enable analysis of both target engagement and potentially disease modification.
Speaker Change: Both of these efforts are being pursued through two grant applications that are under review by the NINDS.
Speaker Change: I'd like to now turn the call over to our Chief Financial Officer, Garth Lees-Roll, to review our financial results for the quarter. Garth?
Garth Lees-Roll: Thank you, Milton. At Inhibicase, we remain committed to being good stewards of capital as we advance multiple high-value programs in both neurodegenerative and cardiopulmonary disease.
Speaker Change: As we approach multiple inflection points this year, we are pleased to bolster our balance sheet in May, raising $4 million in aggregate gross proceeds from our registered direct offering and concurrent private placement.
Speaker Change: These funds extend our cash runway into December 2024 and are sufficient to see us through top-line data for our 201 trial in Parkinson's disease.
Speaker Change: Now I'd like to take a moment to review highlights from our financial results for the quarter ended June 30, 2024.
Speaker Change: Net loss for the quarter ended June 30, 2024 was $5.0 million, or $0.66 per share, compared to a net loss of $5.8 million, or $0.94 per share, for the quarter ended June 30, 2023.
Speaker Change: Research and development expenses for the quarter ended June 30th, 2024 were $3.1 million compared to $4.5 million for the same period in 2023.
Speaker Change: The $1.5 million decrease in research and development expenses was due to a decrease of $1.4 million in RKT-001 Pro expenses due to the completion of a three-part dose-finding dose-equivalence study in 2023, and a net decrease of $0.1 million in other research and development expenses.
Speaker Change: Selling, general and administrative expenses for the quarter ended June 30, 2024 were $2.0 million compared to $1.8 million for the same period in 2023.
Speaker Change: The $0.2 million increase was primarily driven by a $0.4 million increase in legal and consulting fees, partially offset by a $0.1 million decrease in D&O insurance and a $0.1 million net decrease in all other normal selling, general and administrative expenses.
Speaker Change: As of June 30, 2024, we had $7.9 million in cash, cash equivalents, and marketable securities. We expect that the existing cash and cash equivalents will be sufficient to fund operations into December 2024.
Speaker Change: That concludes our review of our financial statement. I'd like to hand a call back over to Milton for closing remarks.
Milton Werner: Thank you, Garth. We expect the back half of the year will accelerate the momentum that we have seen through the first half. We're proud of the hard work we put in by our clinical investigators across multiple trial sites.
Milton Werner: and we appreciate the continued support we receive from our dedicated shareholders.
Milton Werner: We have multiple exciting near-term milestones we expect to achieve, including top-line data from our 201 trial of Rizzo and Parkinson's disease, and anticipate the opening of clinical development of IKT-01-PRO and PAH that will further differentiate a pipeline of neurological and cardiopulmonary assets.
Speaker Change: I'd like to now open the call to questions. Operator?
Speaker Change: Thank you. We will now be conducting a question and answer session.
Speaker Change: If you would like to ask a question, please press star 1 on your telephone keypad.
Speaker Change: A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker Change: One moment, please, while we poll for questions.
Speaker Change: Our first question comes from Jason McCarthy with the Maxim Group. Please proceed with your question.
Jason Mccarthy: Good morning, Milton. Thank you for taking the question. As far as the RISVO Phase 2 study in the last update back in June , around 70 people had completed the 12 weeks.
Speaker Change: You completed the enrollment. Obviously, the date is coming in November , and you had mentioned starting up the 12-month OLE. Is there going to be some lag time?
Speaker Change: between when patients complete this trial and when they have the option to move to the OLE. And is there the potential that they might opt?
Speaker Change: for symptomatic treatment during that time.
Speaker Change: Well, so the answer is that's already been occurring. I believe currently 89 people are completed in the trial. That leaves 31 total who are still on medication and the last person elected to the trial in late September.
Speaker Change: because it's an ongoing trial. We've had people that have
Speaker Change: completed treatment of 12 weeks as long as 12, nine months ago. I believe it's the oldest patients we had in the trial.
Speaker Change: and while we have been trying to get the OLE study running in a full force.
Speaker Change: We've done all of the preparative work. We've completed now all the regulatory steps as well as the ethics review board steps.
Speaker Change: Mostly been worked out now, and I hope the OLE will be formally launched.
Speaker Change: in the coming couple of months, at least that's our current thinking.
Speaker Change: And so, yes, it has a potential impact on patients, some of whom, because of the progression of their disease, following 12 weeks of viscodetoxin treatment, who may go on to symptomatic meds. And we are tracking the number of people who've done that. So far, it's been a small group.
Speaker Change: The patient experience, at least what we hear anecdotally from the sites, has been extremely positive on the drug.
Speaker Change: That doesn't necessarily mean anything. It just means the drug didn't make him feel badly, so that's a good sign.
Speaker Change: but we don't draw any conclusions from that kind of anecdotal commentary and we'll be communicating this month with all of the sites about the timelines we anticipate for launching the 12-month study with full force. And some of the people in the trial may actually be on symptomatic meds.
Speaker Change: As you know, Jason, most of these extension studies are there to develop and begin to collect a safety database.
Speaker Change: And so, in our view, we also wanted to have as much measurement as possible.
Speaker Change: in the absence of symptomatic meds as we can. At least at the last measurement point we had about a week and a half ago, very few people had gone on symptomatic meds given the number of people in the trial. And so if this thing launches in the time frame we're now thinking,
Speaker Change: We should get mostly people who have not started symptomatic meds and some who have, which will help us learn whether people on symptomatic medications tolerate the addition of rizvodetinib well.
Speaker Change: and what additional benefit that it might have can't be gleaned because there's no control group, but nonetheless we'll be able to see if there's any effect one way or another on the benefit of symptomatic therapy itself, so it could be ultimately informative.
Speaker Change: Thank you. And so when you think about the Phase 3 program,
Speaker Change: Would that entail two studies, and would you be looking to go out?
Speaker Change: beyond three months to 12 to 18 months, targeting, avoidance.
Speaker Change: of use of symptomatic treatments? Is that the goal? Right, so, you know, Parkinson's disease, so even though we're evaluating untreated Parkinson's disease, that's not a subgroup of patients.
Speaker Change: We're evaluating untreated Parkinson's disease because we believe rizvodetsinib is monotherapy and disease modifying. Although we have not proven yet that it's disease modifying of the disease. That's what all of our preclinical and animal model data informs us about.
Speaker Change: So, we want to evaluate rizodefinibin P in Parkinson's without any confounding components of other symptomatic therapies.
Speaker Change: We've developed patient recruitment tools that are just in our view spectacular. We don't think we'll have any trouble recruiting the patient population. We'll need 300 or so patients, rough guess.
Speaker Change: for a pair of phase 3 studies, and it would have to be a pair of studies unless some miracle happens, because you must do that for such a large market opportunity. There's just too many patients out there. It's not a rare disease or an often disease.
Speaker Change: So there will be two phase three trials. They will be dosed for up to 12 months.
Speaker Change: Historically people don't you know in every other trial that has been
Speaker Change: run in the space. Medications that were intended to alter the course of disease have failed.
Speaker Change: with virtually no exceptions. The one possible exception was a GLP-1.
Speaker Change: related molecule last year from that was reported earlier this year the early part of this year that seemed to slow motor dysfunction in the absence of anything else but people were on motor on symptomatic therapy even in that trial so
Speaker Change: In our case, we're going to be enrolling a significant number of people. That'll be a 12-month OC trial. There'll be two trials running at the same time, and they'll be global.
Speaker Change: Got it. And you said you had or near alignment with FDA on the phase to be for PAH. Can you provide us any details on the size and scope of that study or is that forthcoming still?
Speaker Change: No, I think it's probably okay to give you just a rough idea. So we initially imagined this to have an initial safety run-in.
Speaker Change: so that we could confirm that with Prodrug at appropriate doses in a properly enrolled trial where we're really looking carefully at the patient enrollment and the degree of disability the individual patients have.
Speaker Change: that we could have people in trial that have a real unmet medical need and could actually do all the tasks that the trial would require and run a phase 3 right on the back end.
Speaker Change: But as we thought through the process, it makes more sense to have a de-risking trial first.
Speaker Change: So that's formally a phase 2b. It's roughly a hundred patients and two doses and a placebo, placebo-controlled. We're going to do a 12-week, at least we plan to do a 12-week.
Speaker Change: safety review when half the patients have been enrolled and completed 12 weeks of dosing and then we'll do a futility analysis when half the people have completed 24 weeks which is the length of measurement duration.
Speaker Change: So the trial itself is designed to look carefully at safety to make sure that
Speaker Change: with a fresh view and a fresh approach.
Speaker Change: and Prodrug that has the potential to really change the tolerability and safety profile of imatinib itself.
Speaker Change: that will be able to overcome the very unfortunate side effect profile that disqualified Amanda from approval 15 years ago.
Speaker Change: and at that point it's a rare disease. If we see the efficacy that was previously proven for imatinib combined with safety that could be adequate in principle to
Speaker Change: to seek approval on a conditional basis.
Speaker Change: to support going into Phase 3 if approval cannot be sought on that basis, depending on the...
Speaker Change: overall benefit and safety profile we observed, et cetera. So.
Speaker Change: The IND has been filed. Of course this trial design has already been reviewed by the FDA and that wasn't part of their concerns.
Speaker Change: in terms of designing a trial and bringing this drug forward again. And so we're pretty confident that the IND is going to clear naturally. Of course, Prodrug has been in people. It was reviewed by a cancer division. We've already had pre-NDA discussions in one of the cancer divisions.
Speaker Change: There's little, it seems unlikely that there would be any issues that arise in the review by the cardiology division about letting the study go forward.
Speaker Change: Our next question comes from Ed White with HC Wainwright. Please proceed with your question.
Ed White: Good morning. Thanks for taking my question. So, just wanted to get a little bit more clarification on RISBO. Milton, what do you want to see...
Ed White: from the top-line data that you're going to get in November to proceed to the phase three. And then just, can you clarify, is 300 patients for both trials, so 150 each, or is it 300 patients per trial that you're thinking of for the phase three?
Milton Werner: Well, let's deal with the second question first. It's somewhere between, I believe, I'm just taking this off the top of my head because we're still refining the trial design.
Milton Werner: It's about 300 to 300, between 300 and 400 patients to cover both trials. That depends on the effect size that we'll ultimately shoot for in the trial. We need to see the unblinded data in November to finalize our view of the effect size.
Milton Werner: but we believe between 300 and 400 should cover the needs for both trials, at least at current thinking.
Milton Werner: in terms of what we might expect to see in November.
Milton Werner: You know, the...
Milton Werner: when the trial was originally established.
Speaker Change: No one would have thought that 12 weeks of treatment would be adequate to see a very substantial impact on the course of a patient's disease.
Speaker Change: We worked very hard with the design of the 201 trial.
Speaker Change: to make sure that we have a fairly uniform population of people enrolled.
Speaker Change: who have not taken symptomatic medications, who have very significant disability measured by a set of Parkinson's disease assessments, the same type we're using in our secondary endpoints.
Speaker Change: and try to have that group to be roughly the same level of disability across most people.
Speaker Change: We've previously presented at Parkinson's disease-related meetings that our baseline scores were very substantial. Part 3s were in the 30s, excuse me, mid-20s. Part 2 scores of the UPDRS were in the mid-10s.
Speaker Change: That's a very substantial disability and that would allow us to see whether 12 weeks of treatment
Speaker Change: could show any effect on motor or non-motor features of disease by a variety of measures, including measures in the gastrointestinal tract, one of the primary organs of disease.
Speaker Change: As the data has evolved, we've remained very encouraged as we see what the measurements in patients have been like. Of course, it's blinded data. We don't know what that means. We've done the same with biomarker measurements, which have further made us feel encouraged by what could be coming.
Speaker Change: Again, that's just hypothetical stuff, you don't know what you're going to see until it's unblinded.
Speaker Change: but that combination of seeing trends across one or more assessments coupled with the potential of seeing an effect on the underlying protein pathology itself through our biomarker studies.
Speaker Change: inside and outside of the central nervous system I think will give us a very robust support even though it's only 12 weeks.
Speaker Change: has the potential of giving us very robust support to go directly into phase three without further studies.
Speaker Change: The Open Label Extension Study, which we hope to be fully launched, perhaps in a couple of months more time because of the aspects of getting the whole thing fully functional across 32 sites in the U.S.
Speaker Change: will remain an important aspect of this as we continue to gain safety and patient safety tolerability experience at different doses now using our tablet dosage form which we made public about a year ago.
Speaker Change: which has a better delivery profile compared to the current profile using the 201 trial.
Speaker Change: and so we'll be very well positioned for phase three hoping that between the FDA meeting and our other efforts
Speaker Change: sometime in the latter half of next year that those trials could launch.
Speaker Change: which would just be, you know, let's, with the assumption that you do something by the fourth quarter of next year, just hypothetically speaking, that's roughly four years from ground zero. It's a pretty fast development program and a very large market opportunity. I think that just reflects
Speaker Change: the smoothness with which Riz Begatineg has.
Speaker Change: They'll continue to show a good patient safety and tolerability profile and in November we'll learn whether we also see the indications that it's having an impact on them.
Speaker Change: disease. Even if that impact is small, as one might expect for a 12-week dosing study, seeing anything at all in 12 weeks would be very surprising.
Speaker Change: but we're encouraged by what we're seeing emerging in the trial overall.
Speaker Change: Okay, thanks, Milton.
Speaker Change: And then just on
Speaker Change: Zero Zero One Pro
Speaker Change: What are your expectations for, you know, IND clearance? Are there any gating factors to start the trial?
Speaker Change: for locating sites, manufacturing of drugs,
Speaker Change: Good. You know, delay the start of that trial. And you know, when do you expect to concede start?
Speaker Change: So, the patient population for pulmonary arterial hypertension is a really delicate
Speaker Change: patient population. They're literally dying as they're being enrolled. It's a rapidly fatal disease.
Speaker Change: and, as a consequence,
Speaker Change: You really have to be mindful of all of those factors.
Speaker Change: In addition, because these patients are dying and we're working with a medication that's already proven to be effective, once you start dosing them, you have to be able to enroll every patient into an extension study for as long as it takes to get to approval. So you're never losing the patient along that path.
Speaker Change: That creates a lot of infrastructure challenges to build up. We think it's going to take...
Speaker Change: approximately nine to twelve months to gear up the whole trial. Rough guess?
Speaker Change: as we start to think through this process and put in the elements of the execution of that trial in place.
Speaker Change: And we know all the sites. Fortunately, there's a recent study of the approved drug cicatocept.
Speaker Change: which was developed by Acceleron and then approved by Merck following their acquisition of Acceleron in 2021.
Speaker Change: gives us a lot of insight into sites worldwide that should be used for the study, that have a good flow of patients, the right patient characteristics.
Speaker Change: And one of the big advantages we have is that just as we've done in Parkinson's disease where rather than have an internal medical team
Speaker Change: that has some experience in the disease area. We build a relationship with the leading clinical and scientific investigators worldwide, and they work intimately in company in Parkinson's disease. We've now done the same thing.
Speaker Change: in pulmonary arterial hypertension with the two leading investigators worldwide very closely associated with the company now.
Speaker Change: for clinical studies that allows us to also pick sites that are well understood, led by proper clinical investigators who both can do trial work and understand the patient population well and there are a whole bunch of other features that in the future we'll
Speaker Change: will have an opportunity to discuss that we think will also make the trial run efficiently.
Speaker Change: Of course, the biggest factor is
Speaker Change: capital. You know, we have reported yesterday we have about nine, eight million in cash at the moment. Not adequate to do trials of this kind obviously and that's another aspect that we'll have to improve on if we're going to execute this trial.
Speaker Change: at all, but we believe that as we work towards building up the trial aspects.
Speaker Change: though we'll see opportunities to have the trial properly funded and support that work because one of the real advantages what's gotten us excited about this opportunity having created the pro drug is that imatinib has already been shown to work
Speaker Change: We have a number of data points both in the preclinical toxicology setting as well as some information from the clinical studies we've done with PRO that supports our belief that PRO drug may be a better tolerated form of imatinib. We understand the dosing from the bioequivalence studies we've previously discussed.
Speaker Change: in settings like this and in our press releases, etc. And that combination gives you a high chance, a high probability you're going to be successful overall and overcome the safety concerns that existed with imatinib therapy 15 years ago.
Speaker Change: And so, when all those pieces come together, the trial will find us.
Joe Almin: and Joe Almin.
Joe Almin: and a natural source of capital to fund it.
Speaker Change: Thank you for taking my questions.
Speaker Change: We've reached the end of the question and answer session. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.
Speaker Change: Wayvey Rock, Burley Brown, Charles Morse, Richard Shahống, Casey Grymes, Adam Jolow, Peter Headen, Fuinte Petit, Shane well, Darryl MacRet, John Carpenter, James Russell, trick Darpel, Jenkins Denpo, hence the nomadic spirits, a truly col44turniction. Simon Wilden, https://tls.media-