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Greetings and welcome to the Inhibikase 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. [Operator Instructions] 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.

Good morning, and welcome to Inhibikase Therapeutics' Second 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 August 14th, Inhibikase issued a press release announcing financial results for the second quarter ended June 30th, 2024. We encourage everyone to read yesterday's press release as well as Inhibikase's quarterly report on Form 10-Q, which has been filed with the SEC. The company's press release and Form 10-Q are also available on Inhibikase's 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 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, August 15th, 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 like to turn the call over to Dr. Milton Werner. Milton, you may begin.

Thank you, Alex. Thank you everybody for joining us today to review our second quarter 2024 financial results and recent clinical and business updates. We've been very pleased with the strength of our clinical progress through the first half of 2024. 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. We recently completed an enrollment for our Phase 2 201 trial for risvodetinib or often referred to as risvo in Parkinson's disease, which is a significant milestone that we have been working tirelessly towards in an effort to bring risvo to patients suffering from untreated Parkinson's disease and we expect to report top line data from the trial in November. Additionally, we have had a productive engagement with US FDA over the past few months regarding IkT-001Pro's opportunity in pulmonary arterial hypertension or PAH. Imatinib, the active ingredient in IkT-001Pro 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 Pro drug technology. We filed the IND for PAH and plan to open clinical development with a de-risking Phase 2b study as soon as practicable. Let me take a deeper dive into each of these programs, as we expect the back half of 2024 will be a catalyst for each period. Let me first start with risvodetinib. Risvo is a potent selective inhibitor of c-Abl that is administered once daily, that we believe may slow or halt the progression to Parkinson's disease. 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. As of July 29th, 41 mild and eight moderate adverse events have been observed that may be related to risvo treatment. We've had six people withdrawn from the trial without completing 12 weeks of dosing. Looking ahead, we expect to report top line results evaluated in the safety and tolerability of risvo in untreated Parkinson's disease in November of this year, 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 3 and intend to launch a 12 month open label extension study as soon as possible. Moving now to IkT-001Pro, our Pro drug formulation of imatinib mesylate that has been designed to potentially improve 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. 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 receive letter from the agency. PAH is a rare disease of the pulmonary microvasculature. PAH can arise spontaneously or can be caused by genetic mutations by drugs or environmental toxins. PAH is also associated with connective 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 sotatercept highlights that disease modification is possible. We see tremendous opportunity in PAH, which has a global market valued at $7.7 billion annually worldwide. Imatinib, the active ingredient 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. We believe that Pro has the potential to achieve similar potency to imatinib mesylate, without the side effect profile that disqualified imatinib from approval studies, reported in 2010. Based on our constructive discussions with the FDA, we believe that we have alignment on our proposed Phase 2b trial design, and at the pre-IND meeting, the FDA confirmed that 001Pro would be viewed as a new molecular entity for PAH and that the appropriate path of approval appears to be 505(b)(2) statute. 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. Activities include development of new dosage forms to differentiate 001Pro tablets from generic imatinib mesylate in alignment with the FDA feedback. Finally, turning to risvo Multiple System Atrophy or MSA, we are currently exploring alternative financing opportunities, including potential grant funding, through a new funding mechanism of clinical development, and neuroscience from the National Institute of Neurological Diseases and Stroke or NINDS. We look forward to advancing this program forward and providing further updates as on the program as appropriate. Separately, we are also developing new antibody diagnostic and clinical biomarker tools 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. Both of these efforts are being pursued through two grant applications that are under review by the NINDS. I'd like to now turn the call over to our Chief Financial Officer, Garth Lees-Rolfe to review our financial results for the quarter. Garth?

Thank you, Milton. At Inhibikase we remain committed to being good stewards of capital, as we've launched multiple high-value programs in both neurodegenerative and cardiopulmonary disease. 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. 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. Now I'd like to take a moment to review highlights from our financial results for the quarter ended June 30th, 2024. Net loss for the quarter ended June 30th, 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 30th, 2023. 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. The $1.5 million decrease in research and development expenses was due to a decrease of $1.4 million in IkT-001Pro expenses, due to the completion of the three-part dose finding dose equivalent study in 2023 and a net decrease of $0.1 million in other research and development expenses. Selling, general and administrative expenses for the quarter ended June 30th, 2024 were $2.0 million, compared to $1.8 million for the same period in 2023. The $0.2 million increase was primarily driven by a $0.4 million increase in legal and consulting fees, partially offset by $0.1 million decrease in D&O insurance and a $0.1 million net decrease in all other normal selling, general and administrative expenses. As of June 30th, 2024, we had $7.9 million in cash, cash equivalents and marketable securities. We expect that existing cash and cash equivalents will be sufficient to fund operations into December 2024. That concludes our review of our financial statements. I'd like to hand the call back over to Milton for closing remarks.

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 and we appreciate the continued support we receive from our dedicated shareholders. We have multiple exciting near-term milestones we expect to achieve, including top line data from our 201 trial of risvo in Parkinson's disease and anticipate the opening of clinical development of IkT-001Pro in PAH that will further differentiate our pipeline of neurological and cardiopulmonary assets. 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] Our first question comes from Jason McCarthy with the Maxim Group. Please proceed with your question.

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, you completed the enrollment obviously the data is coming in November. And you had mentioned starting up the 12-month OLE. Is there going to be some lag time 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 for symptomatic treatment during that time?

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 will exit the trial in late September because it's an ongoing trial. We've had people that have completed treatment of 12 weeks as long as nine months ago. I believe it's the oldest patient who exited the trial. And while we have been trying to get the OLE study running in a full force, we've done all of the preparative work. We've completed now all the regulatory steps as well as the Ethics Review Board steps. We've had some financial constraints, but I think those have mostly been worked out now and I hope the OLE will be formally launched in the coming couple of months when we start our current thinking. And so, yes, it has a potential impact on patients, some of whom because of the progression of their disease following 12 weeks of risvodetinib treatment who may go on to symptomatic meds, and we are tracking the number of people who have done that. So far, it's been a small group. The patient experience at least what we hear anecdotally from the sites has been extremely positive on the drug that doesn't necessarily mean anything. It just means the drug did make them feel badly, so that's a good sign. 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 time lines 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, as you know, Jason, most of these extension studies are there to develop and begin to collect a safety database. And so in our view, we also wanted to have as much measurement in the absence of symptomatic medicines we can, at least at the last measurement point we had about 1.5 weeks ago, very few people have 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, we should get most of the 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 risvodetinib well. 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.

Thank you. And so when you think about the Phase 3 program, would that entail two studies, and would you be looking to go out beyond three months to 12 to 18 months, targeting avoidance of use of symptomatic treatments. Is that the goal?

Right. So Parkinson's disease so even though we're evaluating untreated Parkinson's disease, that is not a subgroup of patients. We're evaluating untreated Parkinson's disease because we believe risvodetinib is monotherapy and disease modifying, although we have not proven yet that it is disease modifying in the disease. That's what all of our preclinical and animal model data informs us about. So we want to evaluate with risvodetinib in Parkinson's without any confounding components of other symptomatic therapy. 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, will need 300 or so patients rough guess 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 often disease. There will be two Phase 3 trials. They will be dosed for up to 12 months. Historically, people don't -- in every other trial that has been run in the space, medications that were intended to alter the course of the disease have failed with virtually no exceptions. The one possible exception was a GLP-1 related molecule last year from that was reported earlier, early part of this year, that seemed to slow motor dysfunction in the absence of anything else, but people were on symptomatic therapy even in that trial. So in our case, we're going to be enrolling significant number of people that will be a 12-month dosing trial. There'll be two trials running at the same time and they'll be global.

Got it. And you said you had near alignment with FDA on the Phase 2b for PAH. Can you provide us any details on the size and scope of that study or is that forthcoming still?

No, I think it's probably okay to give you just a rough idea. So we initially imagine this to have an initial safety run-in, 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 visibility the individual patients have. But we could have people in the 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 in the back end. But as we thought through the process, it makes more sense to have a derisking trial first. So that's formally a Phase 2b. It's roughly 100 patients and two doses in the placebo, placebo-controlled. We're going to do a 12-week or at least we plan to do a 12-week 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. So the trial itself will be -- is designed to look carefully at safety to make sure that with a fresh view and a fresh approach and prodrug that has the potential to really change the tolerability and safety profile of imatinib itself that we'll be able to overcome the very unfortunate side effect profile that disqualified imatinib from approval 15 years ago. 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 seek approval on a conditional basis, to support going into a Phase 3 if approval cannot be sought on that basis depending on the overall benefit and safety profile we observe, et cetera. So the IND has been filed. Of course, this trial design has already been reviewed by the FDA, and that was a part of their concerns 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 Cancer Division. We've already had pre-NDA discussions in the cancer, in one of the Cancer divisions. So 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.

Great. Thank you, Milton.

Our next question comes from Ed White with H.C. Wainwright. Please proceed with your question.

Good morning. Thanks for taking my question. So just wanted to get a little bit more clarification on risvo. Milton, what do you want to see from the top line data that you're going to get in November to proceed to the Phase 3 and then just can you clarify the 300 patients for both trials, so 150 each or is it 300 patients per trial that you're thinking of for the Phase 3?

Well, let's deal with your second question first. It's somewhere between, I believe just taking this off the top of my head because we're still refining the trial design. It's about 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 viewable effect size, but we believe between 300 and 400 should cover the needs for both trials at least at current thinking. In terms of what we might expect to see in November, when the trial was originally established, no one would have thought that 12 weeks of treatment would be adequate to see a very substantial impact on the course of the patient's disease. We worked very hard with the design of the 201 Trial to make sure that we have a fairly uniform population of people enrolled who have not taken symptomatic medications, who have very significant visibility measured by a set of Parkinson's disease assessments, the same type we're using in our secondary endpoints and try to have that group to be roughly the same level of disability across most people. 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, that's a very substantial disability, and that would allow us to see whether 12 weeks of treatment could show any effect on motor or nonmotor features of disease by a variety of measures, including measures in the gastrointestinal tract, one of the primary organs of disease. 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. Again, that's just a hypothetical stuff. You don't know what you're going to see until it's unblinded. 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 inside and outside of the central nervous system, I think, will give us a very robust support even though it's only 12 weeks, it has the potential of giving us very robust support to go directly into Phase 3 without further studies. 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 US. We will remain an important aspect of this as we continue to gain safety and patient tolerability experience at different doses now using our tablet dosage form, which we made public about a year ago, which has a better delivery profile compared to the current profile using 201 Trial. And so we'll be very well positioned for Phase 3, hoping that between the FDA meeting and our other efforts sometime in the latter half of next year that those trials could launch, which would just be 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 the smoothness with which risvodetinib has continued to show a good patient safety and tolerability profile, and in November, we'll learn whether we also see the indication that it's having an impact on 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 still, but we're encouraged by what we're seeing emerging in the trial overall.

Okay. Thanks Milton. And then just on 001Pro. What are your expectations for IND clearance? Are there any gating factors to start the trial or locating sites, manufacturing of drug, any gating factors at all that could delay the start of that trial? And when do you expect to see it start?

So the patient population for pulmonary arterial hypertension is a really delicate patient population. They're literally dying as they're being enrolled. It's a rapidly fatal disease. And as a consequence, you really have to be mindful of all of those factors. 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, every patient, 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. That creates a lot of infrastructure challenges to build up. We think it's going to take approximately 9 to 12 months to gear up the whole trial, rough guess, as we start to think through this process and put in the elements of the execution of that trial in place. And we know all the sites, fortunately, their recent study of the approved drug sotatercept, which was developed by Acceleron and then approved by Merck following their acquisition of Acceleron in 2021, 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. And one of the big advantages we have is that just as we've done in Parkinson's disease, where rather than having internal medical team 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 in pulmonary arterial hypertension with the two leading investigators worldwide very closely associated with the company now 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 have an opportunity to discuss that we think will also make the trial run efficiently. Of course, the biggest factor is capital. We have reported yesterday, we have about $8 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 at all. And but we believe that as we work towards building up the trial aspects, 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 prodrug is that imatinib has already been shown to work. 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 prodrug may be a better tolerated form of imatinib. We understand the dosing from the bioequivalence studies we've previously discussed in settings like this and in our press releases et cetera. 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. And so when all those pieces come together, the trial will find its natural harmony and a natural source of capital to fund it.

Okay, Milton, thank you for taking my questions.

You're welcome.

We have 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.

Thank you.

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.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Ladies and gentlemen, thank you for standing by. Greetings, and welcome to Inhibikase Therapeutics Fourth Quarter and Full Year 2023 Financial Results. At this time, all participants will be in listen-only mode. A question-and-answer session will follow the formal presentation. Please note that today's conference is being recorded. [Operator Instructions] I'll now turn the call over to Alex Lobo, Stern Investor Relations. Alex, you may now begin.

Thank you, operator. Good morning, and welcome to Inhibikase Therapeutics fourth quarter and full year 2023 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 March 27, Inhibikase issued a press release announcing financial results for the fourth quarter and full year ended December 31, 2023. We encourage everybody to read yesterday's press release as well as Inhibikase's annual report on Form 10-K, which is being filed with the SEC. The company's press release and annual report are also available on Inhibikase's 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, March 28, 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 laws. 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, everybody, for joining the call today. Before I begin, I just want to give a round of applause to our outgoing Chief Financial Officer, Joe Frattaroli, who is on the call. Tomorrow will be his last day with the company and we are very grateful for the six years of work that he and I have done together to bring Inhibikase where we are. Also to introduce you to our new Chief Financial Officer, who will begin on Monday, formally in the job, Garth Lees-Rolfe, who will be discussing our financial results. And so with that, I really appreciate everybody joining the call for our discussion of our fourth quarter and full year 2023 financial results and recent clinical and business updates. 2023 was really a year of execution as we made significant advancements across our clinical pipeline, culminating in our recent pre-NDA meeting with the FDA for IkT-001Pro and the rapid enrollment of Parkinson's patients in our 201 Trial for Risvodetinib or Risvo as we'll refer to it throughout this presentation. We are also evaluating new second-generation molecules arising from our internal medicinal chemistry and external collaborations that could further expand our pipeline and enhance suppression of neurodegeneration or address other diseases that can be benefiting from Abel-kinase inhibition. While we have much work to do in 2024, we believe that we are well positioned for success and continue to build value for our shareholders. Let's now take a deeper dive into each of our programs, starting with Risvodetinib or Risvo. As you may remember, Risvo is a potent selective inhibitor of c-Abl that is administered once daily and that we believe may slow or halt progression of Parkinson's disease. Our 201 Trial is a two phase trial with an ongoing 12-week double-blinded study across three doses that we believe should be therapeutic, plus a fourth group that is taking a placebo. The trial is approximately 61% enrolled as of March 22, with 73 participants, 20 prospective participants in medical screening and an additional 48 potential participants being evaluated for suitability to initiate medical screening. Additionally, 34 participants have completed the full 12-week dosing period. To date, 15 mild and two moderate adverse events have been observed that may be related to Risvo treatment. Two people elected to withdraw from the trial despite having only one or two moderate adverse events. We believe the last patient will be enrolled during the summer of 2024. To date, trial recruitment has been successful in our review, generating broad interest within the Parkinson patient community nationwide, allowing for hundreds of unique individuals to be screened by an outside medical staff and referred into our clinical sites prior to entering a medical record review process in advance of an initiation of formal medical screening. We plan to report top line results from this study in the second half of this year. The 201 Trial plans to enroll everyone who continues to meet the eligibility criteria into a 12-month extension study. Although we have completed several of the infrastructure builds to execute this trial, we are still in need of additional financing to begin enrolling participants into the extension study at our clinical sites. As we have previously disclosed, the extension study will transition participants from the blinded phase who will still meet the enrollment criteria to an additional 12-month of treatment which will also serve the purpose of evaluating our novel commercial tablet formulation for Risvo that we announced last year. As we continue to establish the potential of Risvo in Parkinson's disease, we believe it is important to communicate the progress to key stakeholders in the medical and scientific community. In January, we published the Phase I/Ib data evaluating Risvo in healthy volunteers and the patients treated with anti-Parkinson's medications. That report appear in the peer-reviewed Journal, Journal of Parkinson Disease. The publication highlighted the safety, the tolerability and pharmacokinetics of Risvo across 94 healthy volunteers and 14 participants with Parkinson disease in both single, ascending dose and multiple setting dose studies. We found that Risvo demonstrated a favorable safety and tolerability profile for all trial participants with 12 potentially treatment related adverse events observed, none of clinical significance. Single dose pharmacokinetics were approximately anywhere between 12.5 and 200 milligrams for both Cmax and the area under the curve or AUC measurement with no pharmacokinetic difference between healthy voluntaries and participants with Parkinson's disease. Exposures of these dose were high, relative to other drug in the same class, same kinase inhibitor class. And of note, we used voluntary lumbar puncture to measure the concentration of Risvo in cerebral spinal fluid in six participants with or without PD, which indicated that Risvo crossed the blood-brain barrier and was persistently present in the central nervous system. While this is a limited data set, we find these results encouraging. And we're all, we believe that the totality of the data we've generated to date continues to support the development of Risvo and we look forward to providing updates on the progress of the 201 Trial throughout the year. Moving now to IkT-001Pro, which is a prodrug formulation of imatinib mesylate that has been designed to improve on the safety profile of imatinib, we had a pre-NDA meeting on January 19 of this year with the FDA to discuss the requirements for potential approval of IkT-001Pro under the 505(b)(2) statute. We're pleased with the discussion we had with the agency as we begin the process of building our first NDA package, and we plan to seek all 11 blood and stomach cancer indications for which imatinib mesylate has been approved. The FDA review team from the Division of Hematologic Malignancies determined through a review of our clinical data that 600 milligram and 800 milligram IkT-001Pro provided similar exposures to 400 milligram and 600 milligram imatinib mesylate, respectively. The review team advised that if we want to seek all the indications for which imatinib has previously been approved, we should measure the safety tolerability pharmacokinetics of IkT-001Pro that would deliver up to 800 milligrams, the highest approved dose of the imatinib mesylate. We plan to evaluate IkT-001Pro at a 1200-milligram dose, which we believe will lead to exposures to imatinib that are similar to 800 milligrams of imatinib mesylate. Further review team asked that we evaluate whether 001Pro and imatinib are absorbed differently from the gut. So we are initiating a standard preclinical test to further evaluate IkT-001Pro and imatinib gut absorption, which is a test performed in cell culture. As we continue to advance the elements of the NDA package, we will seek milestone meetings with the FDA to ensure we are meeting manufacturing, scientific and quality control requirements for approval. Now before I turn the call over to our incoming Chief Financial Officer, Garth Lees-Rolfe, to review our financial results for the quarter, I'd like to again extend our deepest gratitude from both the Board of Directors and our entire team to Joe Frattaroli for his years of service as Chief Financial Officer, and we all wish him best in his retirement. With that said, I'll turn the call over to Garth to review our financial results.

Thank you, Milton. Now let me review our financial results for the year and quarter ended December 31, 2023. Net loss for year ended December 31, 2023, was $19.0 million or $3.57 per share, compared to a net loss of $18.1 million, or $4.28 per share for the year ended December 31, 2022. Research and development expenses for the full year ended December 31, 2023 was $13.6 million compared to $12.0 million for the full year 2022. The increase was primarily due to a $1.5 million increase for IkT-001Pro and a decrease of $0.6 million in expenses for Risvo and a net increase of $0.7 million for all other R&D activities. Selling, general and administrative expenses for the full year 2023 was $6.7 million compared to $6.2 million for the same period in 2022. The $0.5 million increase was primarily the result of an increase in investor relation costs of $1.0 million, an increase in employee costs of $0.3 million that were partly offset by decrease in D&O insurance of $0.6 million, a decrease in legal and consulting fees of $0.4 million and a net increase of $0.2 million in all other selling, general and administrative expenses. As of December 31, 2023, we had $13.3 million in cash, cash equivalents and marketable securities. We expect that existing cash and cash equivalents will be sufficient to fund operations into the first quarter of 2025. That concludes review of our financial statements. I'd like to hand the call back over to Milton for closing remarks.

Thank you, Garth. As we look ahead to 2024, we will continue to take advantage of the recent momentum we have experienced to continue to create value for our shareholders. We believe that the recent feedback from our pre-NDA meeting was constructive as we plan to conduct additional tests and studies to begin to build our first NDA submission package. In addition, we will continue to enroll patients into our 201 Trial and expect to provide top line data from this study in the second half of the year. Our recent publication of early clinical data for Risvo in the Journal of Parkinson Disease reinforces our belief that Risvo could be a transformative treatment for patients with Parkinson disease and related disorders. We look forward to continuing to establish ourselves as a leader in the development of treatments for neurodegenerative disease. And we want to thank all our shareholders and trial participants for their continued support since we advance the medicines for patients with high unmet medical needs. I would now like to open the call for questions. Operator?

Thank you. We will now be conducting question-and-answer session. [Operator Instructions] Thank you. And our first question is from the line of Ed White with H.C. Wainwright. Please proceed with your questions.

Good morning. This is Steve on for Ed White. So assuming positive data in Parkinson's in the second half, what are the next steps towards approval and timing?

Well, approval is a little bit hard to gauge. We've been fortunate to be able to enroll the 201 Trial at least for this patient population in a faster rate than other studies of its kind in the last three years since COVID emerged. The Phase III trial or trials would be run again in untreated Parkinson patients on a larger scale. We'll need to assess the degree of benefit if observed at all three doses of Risvodetinib and to decide whether we're going to have a one or two trial -- one or two dose trial before registrational purposes. We also think that based on the outcomes of biomarker analysis, and we don't know that comes to date, but if biomarkers support what we've seen in the preclinical animal models, there are opportunities to seek accelerated approval designations that could assist and accelerate those Phase III one or two trials that will be necessary for administration. I would guess it's probably a two to three year process overall. We would plan depending on the outcome of the trial that we see this year to schedule a meeting with the FDA to discuss the parameters of the Phase III program. On the manufacturing side, we're well ahead of the game. We are already producing Risvodetinib on the order of commercial scale. We have a commercial tablet formulation. We'll be testing in the extension trial and assuming that there are no issues that arise from that tablet formulation. We'll be in a very strong position to complete the other requirements of clinical development and enter into an NDA process.

All right. Thank you. And for IkT-001Pro, can you just comment on the big-picture strategy? And then any comments on potential partnering?

So we have -- 001Pro is a bit of unusual molecule for us. It's technically a novel chemical entity. We have composition of matter protection. We evaluated it originally to determine whether technology ideas that we built into that molecule could improve on a well-established, well-tolerated drug substance. And we see hints of that coming through the clinical work that we've done to date. We also seem to have reasonable support of the FDA that could lead to approval through the 505(b)(2) statute. So along that path, the one qualification is that 001Pro would be a kind of quotations brand and generic. It's earning potential would be -- is unknown at the moment, but it's much more modest given that the frontline drug imatinib mesylate is now generic. And there are 15 generic suppliers in the U.S. for that medication. So it depends on how this evolves moving forward. We would be seeking a partner to assist in the cost of a non-inferiority or superiority trial to further augment the safety knowledge. That trial does not have to be part of any approval process, but we would like to initiate it in the near future, because it would be done in the target patient population to have blood or stomach cancers. Separately from that, as we've disclosed previously, we have an interest in evaluating 001Pro as a potential branded product in non-oncology indications, and we'll be providing a further update on that underlying strategy in the coming days, because we have an upcoming meeting with the FDA on that subject at the end of next week. And I don't want to pre-empt that announcement, but we'll be saying a little bit more about that in the coming days.

All right. Thank you. I was going to ask about that meeting. That’s all our questions. Thanks.

Thank you. I see no additional questions at this time. And this will also conclude today's teleconference. You may now disconnect your lines at this time. We thank you for your participation, and have a wonderful day.

Hello, and welcome to the Inhibikase Therapeutics Third Quarter 2023 Financial Results. [Operator Instructions] Please note today's event is being recorded. I'll now turn the conference over to Alexander Lobo of Stern Investor Relations. Please go ahead, sir.

Thank you, operator. Good morning, and welcome to Inhibikase Therapeutics Third Quarter 2023 Financial Results Conference Call and Audio Webcast. With me today is Dr. Milton Werner, Chief Executive Officer; and Joseph Frattaroli, Chief Financial Officer. On Tuesday, November 14, 2023 Inhibikase issued a press release announcing financial results for the third quarter ended September 30, 2023. We encourage everyone to read yesterday's press release as well as Inhibikase'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 Inhibikase's 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, November 15, 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 begin.

Thank you, Alex, and thank you, everyone, for joining us today. We are very pleased with the progress we've made throughout the third quarter as we have advanced our clinical and preclinical pipeline programs. In the clinic, we are continuing to evaluate the lead candidate, risvodetinib in our Phase II 201 trial in Parkinson's disease. The trial is actively screening and enrolling patients and activating the remaining clinical sites. In addition, our 501 bioequivalent study for IkT-001PRo is now complete, and we are in the process of submitting briefing documents in support of a meeting with the FDA to align on the requirements for approval under the 505(b)(2) regulatory pathway. Our medicinal chemistry efforts are also progressing, and we are excited to announce the evaluation of second-generation c-Abl inhibitors that emerge from internal programs and external collaborations. These second-generation molecules may potentially be deployed alone or in combination to improve brain delivery and c-Abl inhibition in the central nervous system. In the orphan disease areas, we are pleased to receive orphan drug designation from the U.S. FDA for risvodetinib as a treatment for multiple system atrophy. We are working towards initiation of the planned Phase II study and discussing conduct of the trial with private foundations of federal and industry stakeholders in an effort to initiate this trial in the future. Collectively, we believe that these accomplishments continue to demonstrate the potential of our programs to deliver transformative treatments for patients. Let us now take a deep dive into each of our programs, starting with our 201 trial. As a reminder, the 21 trial is a 12-week double-blinded study across 3 doses plus the placebo group. We have been working closely with our 28 active clinical sites to accelerate screening and enrollment into the trial and are pleased to say that we currently have 24 participants enrolled, 7 prospective participants are undergoing screening evaluations and 15 potential participants undergoing informed consents. Let me correct that. That's actually 9 prospective participants and 15 potential undergoing consent as we announced at the press release yesterday. 5 participants have completed the full 12-week regimen to date. As we continue to enroll participants into the trial, we are working to initiate a 12-month extension study for the 201 trial, subject to additional financing. The extension study once implemented, will roll participants who have completed the 201 trial into a study for an additional 12 months of treatment. The extension study will also evaluate our novel tablet formulation of risvodetinib, which we announced in August 2023. This novel tablet formulation is designed to improve drug exposure and overcome existing challenges related to patient use and mimics the oral formulation we used to evaluate efficacy and validated animal models of Parkinson's disease. The tablet nearly doubles drug exposure at steady state for the same dose of risvodetinib, which allow -- which may allow for lower doses that could lead to an overall improvement in safety and tolerability of risvodetinib. In addition, our ongoing work -- in addition to the ongoing work in the 201 trial, we recently presented public unblinded functional data from 11 previously ill patients with untreated Parkinson's disease who are removed from the 201 trial due to the temporary clinical hold imposed by the FDA in the fourth quarter of 2022. These results were presented at the Movement Disorder Congress in Copenhagen in August 2023. Of the 11 patients enrolled, 8 participants were on active drug; 3 at 50 milligrams, 2 at 100 milligrams and 3 at 200 milligrams and 3 were given placebo. For these patients, we evaluated changes in the functional assessments of motor and nonmotor features using a hierarchical analysis of 15 secondary endpoints. In particular, the study evaluated nonmotor functions such as activities of daily living using the MDS-UPDRS Part 2 score and evaluated motor function using the MDS-UPDRS Part 3 score. The sum of these scores was the top functional readout in the hierarchy. At the end of study time point, the 3 participants who received the 200-milligram dose had a combined Part 2 and Part 3 score that was lower by an average of minus 8.7 points. By contrast, the combined placebo score increased by an average of plus 1.7 points. This represents a minus 10.4 point spread between actively treated versus placebo participants. For comparison, Parkinson's patients typically have a plus 3 to plus 6 point increase in the sum of score assessment over the course of 12 months. Thus, a negative or lower score relative to placebo might be an indication of a clinical benefit. However, the small sample size at each dosing group precludes us from drawing this conclusion at the present time. Patients administered 50 or 100 milligrams experienced an average change of plus 1.7 and minus 1.3 points, respectively, for the combined score. An additional measure of nonmotor features of disease utilized what is called the Schwab and England Activities of Daily Life scale, the S&E scale, as we term it, was reduced for the 200-milligram group by an average of minus 3.3 points relative to baseline, while those on placebo had an average score increase of plus 3.3 points. That is a minus 6.6 point spread between actively treated participants and the placebos. The 50-milligram dose showed no effect for this measure, while the 100-milligram dose was on average minus 5 points lower relative to baseline. While the data set has to few participants to conclude a clinical benefit, we view these results with cautious optimism as we continue to roll patients in the ongoing 201 trial. Turning now to the IkT-001PrO program, our prodrug formulation for imatinib mesylate that has been developed to improve safety of imatinib. We recently completed the 501 bioequivalent studies evaluating the IkT-001Pro compared to 400-milligram imatinib mesylate or 600-milligram imatinib mesylate. The study met our expectations and demonstrated that the 600-milligram dose of IkT-001PRo was equivalent to standard of care 400-milligram imatinib mesylate, while a 900-milligram dose of IkT-001Pro should be equivalent to 600-milligram imatinib mesylate. IkT-001Pro demonstrated a favorable safety intolerability profile with minimal adverse events across 66 subjects in the trial. We are currently submitting briefing documents to the FDA to come to agreement on the particulars for approval of IkT-001Pro under the 505(b)(2) statute. Before I turn the call over to Joe to discuss our financials, I want to briefly touch on our preclinical activities. As scientists, we are always excited by the prospect of leveraging learnings from our work into new developments. In August, we announced the emergence of several new second-generation molecules from internal medicinal chemistry programs and external collaborations that we believe could enhance suppression of neurodegeneration through c-Abl inhibition. We believe that such molecules, whether acting alone or in combination with active [ c-Abl ] inhibitors like risvodetinib could be an improved approach to suppressed neurodegeneration arising from c-Abl activation inside and outside of the brain. In addition to these early-stage efforts, we are continuing to advance the preclinical development of risvodetinib for the treatment of multiple system atrophy. In October, we were pleased to receive orphan drug designation from the U.S. Food and Drug Administration. Orphan drug designation is provided to drugs or biologics that are used in prevention, diagnosis or treatment of diseases that affect fewer than 200,000 people. This designation will allow us to advance our work in MSA at greater speed and is encouraging to see the FDA acknowledge of devastating nature of MSA and the high unmet need that exists in the market. I'll now turn our call over to our chief financial officer Joseph Frattaroli to review our financial results for the quarter. Joe?

Thank you Milton. Now let me review our financial results for 3 months ended September 30, 2023 for the third quarter 2023, we report a net loss of approximately $4.6 million or $0.86 per share compared to a net loss of $4.49 million or $1.06 per share for the quarter ended September 30, 2023. Research and development expenses were $3.23 million for the quarter ended September 30, 2023 compared to $2.98 million for the quarter ended September 30, 2022. This increase was primarily due to company's ongoing Phase 0II 201 trial in Parkinson's disease. Selling, general and administrative expenses were $1.62 million for the quarter ended September 30, 2023, compared to $1.4 million for the quarter ended September 30, 2022. This increase was driven by a net increase in normal selling, general and administrative expenses. As of September 30, 2023, we had approximately $16.83 million in cash, cash equivalents and marketable securities. We expect that existing cash, cash equivalents and marketable securities will be sufficient to fund operations into the fourth quarter of 2024. That concludes our financial review of our financial statements. I'd like to hand the call back over to Milton for closing remarks.

Thank you, Joe. We believe that our programs have the potential to provide safe and efficacious treatment options for patients with Parkinson's and Parkinson's related disorders. As the value of c-Abl inhibition in neurodegeneration continues to come in to focus on the scientific community, we believe that the potential of risvodetinib too will continue to be recognized as a potentially disease-modifying treatment for Parkinson's. Before we open the call to questions, I would like to thank all our shareholders and partners for their continued support and dedication to Inhibikase. We work diligently to demonstrate the importance of our research with the scientific and investor communities, and we look forward to providing our shareholders and partners with updates as we progress in studies across our pipeline in order to transform the treatment paradigm for neurodegenetive diseases. I would now like to open the call to questions. Operator?

At this time, we will begin the question-and-answer session. [Operator Instructions] And the first question comes from Ed White with H.C. Wainwright.

First, Milton, I just wanted to get a little bit more information on the Phase II 201 trial. What is the typical time for patients to go from informed consent to dosing?

That varies widely because informed consents are followed by screening visits and there's more than one screening visits typically involved. They'll come in for laboratory safety and ECG measures, and in some cases, the safety measures for cardiovascular function or in a separate facility at the same site location requiring a separate appointment. They then go to the enrollment authorization Committee following baseline measures of Parkinson's disease-related assessments. The authorization committee typically takes 2 days to come to a decision on whether the person is suitable for enrollment unless they have questions. If they have questions, there could be back and forth that last for 1 or more days thereafter. If they're accepted by the enrollment authorization committee, then they'll go for their ophthalmology baseline exams to ensure that they meet the criteria for normal vision within the parameters we've defined in protocol. So collectively, it depends on the site and how it's organized, but it can take between 1 and 2 weeks, something in that order. I'm probably exaggerating that number, but that's my best guesstimate.

Okay. Thanks Milton. And just how many more sites do you plan on opening?

There are 4 plans that we'll get to 32. We had 34 that we've been talking about for a long time, 2 sites in the last month, as we disclosed in our Q, have dissolved the clinical research practice from their medical practice and now the clinical research practices that are breaking off don't have staff to continue their site activities, and we will have to wind down those sites. So right now, we plan on 32. We have several sites that are coming up that are large potential patient enrollment sites, coupled with the 201 trial outreach program that I think will satisfy our needs from trial in a timely manner.

Okay. And just a little bit more information on the potential multiple system atrophy trial. You said -- provided you get funding, I'm just curious as to how we should be thinking about the start to that trial. Is that going to be a 2024 event?

We -- it's aspirational at the moment until the money is in the bank. But yes, it's planned to be 2024. And MSA is really important. The preliminary data from the 11 patients that we pulled from the trial in 2022 is encouraging, but it's too small a data set to draw a strong conclusion. The -- because you saw indications, and these are just mild indications that as you increase the dose, you saw increasing benefit across many anti-Parkinsonian assessments was encouraging to us. Because of that, we are pushing the extension study hard and to be able to -- although it's still in a planned mode, hopefully, will be implemented in the near future. And MSA offers the opportunity to amplify those outcomes because patients with MSA decline at 4x faster rate than patients with Parkinson's disease who have a bigger dynamic range or a bigger measurement range over which you're going to see potential benefits. It's an orphan indication, the number of U.S. patients, although it's a little hard to calibrate it is somewhere between 16,000 and 25,000 people in the U.S. today, perhaps 50,000 to 70,000 people worldwide, and there's a large registry of patients. And so we think the trial is very feasible. Unlike Parkinson's, we don't have to worry about preexisting medications since MSA patients don't respond to anti-Parkinson's meds. We have imaging and biomarker analyses that are validated in the MSA in a way that they are not yet validated in Parkinson's and the faster rate of progression means a faster readout of potential benefit. The trial is planned for 6 months with an additional 6-month extension that will be provided in the updated protocol and we plan to run that trial in a registrational manner. We think there's a lot of interest at both the federal level with NINDS as well as in the primary foundation level, and we're working through those discussions. They'll take some time, but I am aspirational that this will get started in 2024.

Okay. And just a question on 001Pro. Can you make any comments on potential partner interest?

Well, there are 2 areas where that drug could be very attractive, certainly, to the CML and also to the gastrointestinal stromal or GIST community, although we're seeking initially just a label for CML in imatinib intolerance and newly diagnosed. But there is an additional application of imatinib, where the indications of improved safety from 001Pro may be very attractive, and that's in pulmonary arterial hypertension. We have not spoken with any of the current players in pulmonary arterial hypertension about this medication and the potential interest in imatinib. As you may recall, a number of years ago, Phase III program from Novartis was rejected by the FDA and it was not pursued further by Novartis because of safety concerns at the doses used for imatinib in PAH, which is the acronym for pulmonary arterial hypertension, but 001Pro offers a move away from those risk factors. And so it's an interesting potential application that can be further explored. Now that we have a complete data package, we're going to be going after partners, both large and small companies that work in specialty areas around 505(b)(2) approvals. And hopefully, in the early part of next year, we'll have something more to say about that.

Great. And perhaps if I could just ask 2 more financial questions. One, you had said that you have cash into the fourth quarter of '24. Does that include the initiation or the preparation for the MSA trial?

Well, MSA currently is not funded in the program. So Joe, go ahead and speak to that.

There's normal expenses budgeted within the MSA trial, but really not an initiation of the study pending additional working capital raise or nondilutive funding sources?

Okay. And then just the last question. You mentioned that R&D spending we saw was down from -- excuse me, up from last year, but down 29% quarter-over-quarter. I was just wondering if there's anything onetime in nature in the quarter? And how should we be thinking about the fourth quarter?

Yes, great question. To get trial started, there were some nonrecurring costs that will be incurred. Most of the cost are -- many of the costs are variable depending upon the rate of enrollment. So the rate of enrollment will have that fluctuate month-to-month and quarter-to-quarter. But through the next year, we expect to burn an average of about $1.2 million to $1.3 million a month, again, subject to a rate of -- actual rate of recruitment.

Thank you. And this concludes the question-and-answer session as well as the call itself. Thank you for attending today's presentation. You may now disconnect your lines.

Good morning. Welcome to the Inhibikase Therapeutics Second Quarter 2023 Financial Results Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Alex Lobo, Stern Investor Relations. Please go ahead.

Good morning, and welcome to the Inhibikase Therapeutics Second Quarter 2023 Financial Results Conference Call and Audio Webcast. With me today is Dr. Milton Werner, Chief Executive Officer; [ Joseph Frattaroli ], Chief Financial Officer. On Monday, August 14, 2023, Inhibikase issued a press release announcing financial results for the second quarter ended June 30, 2023. We encourage everyone to read yesterday's press release as well as Inhibikase's quarterly report on Form 10-Q, which is being filed with the SEC. The company's press releases -- press release and quarterly report are also available on Inhibikase's 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, August 15, 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 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 Inhibikase Therapeutics' Second Quarter 2023 Earnings Call. We are pleased with the progress we have made across our clinical programs in the first half of this year. Our Phase II 201 trial using IkT-148009 to treat Parkinson's disease is screening and enrolling patients across 22 of up to 35 planned sites, with the first patient [indiscernible] 12 week dosing regimen. Additionally this quarter, we launched a public awareness campaign through the 201trial.com that we believe will enable us to continue to drive enrollment in the trial. The trial website is being augmented with outreach to patient advocacy groups, caregiver networks, foundations and social media advertising throughout the United States. In June, we completed the pivotal phase of the 501 trial evaluating bioequivalence between IkT-001Pro and commercial 400-milligram imatinib mesylate. Following agreements with the FDA, we are contemplating to evaluate the bioequivalent dose between IkT-001Pro and high-dose 600-milligram imatinib mesylate to further explore the potential safety benefit of IkT-001Pro delivery of imatinib. High-dose of imatinib mesylate is in common use for the treatment of CML, but poorly tolerated by most patients, a shortcoming that IkT-001Pro may overcome. We plan to release a full data description for the pivotal phase of our 501 trial in the near term. Upon completion of the study, we plan on engaging the FDA to discuss the parameters of drug approval under the 505(b)(2) regulatory pathway. In addition to these clinical accomplishments, we continue to expand our expertise in drug delivery, not only with IkT-001Pro, but also now with IkT-148009. The development of a commercial tablet formulation of IkT-009 -- 148009 has nearly doubled the efficiency of drug delivery for IkT-148009, providing the opportunity to lower the therapeutic dose and improve safety as well as consistently deliver the dose each and every day to ensure a continuous therapeutic benefit from once-daily dosing. Before I turn the call over to Joe to review our financial results, I would like to touch on our preclinical efforts in other neurodegenerative diseases. Multiple system atrophy or MSA is a rare Parkinson's-related disease that is rapidly progressive -- that is a rapidly progressive neurodegenerative movement disorder of the central and autonomic nervous systems. Currently, we are evaluating MSA in 2 models, one that measures the ability of IkT-148009 to block progression early in the course of MSA, and a second model that evaluates the therapeutic potential to correct functional loss and neurodegeneration late in the course of the disease. The first MSA model study is nearing completion and has demonstrated that treatment with IkT-148009 for 20 weeks prevented functional loss and preserved neural anatomy in mice when IkT-148009 is given orally once daily. Functional benefit in this model was accomplished by substantial reduction in the underlying alpha-synuclein pathology. Evaluation of the effect of IkT-148009 when treatment begins late in the course of the disease remains ongoing, and we expect to complete that study by the end of 2023. These studies will form the basis of our planned Phase II clinical study of IkT-148009 in MSA. We look forward to providing further updates on these studies and potential timing of the planned Phase II trial in the coming quarters. I will now turn it over to our Chief Financial Officer, Joe Frattaroli, to review our financial results for the quarter. Joe?

Thank you, Milton. Before I review our financial results, I'd like to highlight that we recently received notice from the Listing Qualifications Staff of The Nasdaq Stock Market, indicating that we had regained full compliance with the minimum bid price requirement of $1 per share under Nasdaq Listing Rule 5550(a)(2). Regaining compliance allows us to move forward and work to generate meaningful clinical data that will ultimately drive value for our shareholders. Now let me review our financial results for the 3 months ended June 30, 2023. For the second quarter 2023, we reported a net loss of $5.8 million or $1.11 per share compared to a net loss of $4.6 million or $1.10 per share in the quarter ended June 30, 2022. Research and development expenses were $4.5 million for the quarter ended June 30, 2023, compared to $3 million for the quarter ended June 30, 2022. The increase was primarily due to the company's ongoing Phase II 201 PD clinical trial costs and IkT-001Pro for our CML program. Selling, general and administrative expenses were $1.8 million for the quarter ended June 30, 2023, compared to $1.7 million for the quarter ended June 30, 2022. The increase was driven by a net increase in normal selling, general and administrative expenses. As of June 30, 2023, we had approximately $20.9 million in cash and cash equivalents. We expect that existing cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2024. That concludes our review of our financial statements. I'd like to hand the call back over to Milton for closing remarks.

Thank you, Joe. We continue to demonstrate the value of c-Abl inhibition [ as ] therapeutic paradigm for treatment of neurodegenerative disease and the safety profile of our lead c-Abl inhibitor IkT-148009 remains promising. We look forward to reporting the outcomes of the 201 trial and to share our plans for future trials in Parkinson's disease and multiple system atrophy. We'd like to thank our site investigators, our partners and our shareholders for their continued support as we seek to transform the treatment paradigm for neurodegenerative diseases. I'd now like to open the call to questions. Operator?

[Operator Instructions] The first question comes from Ed White with H.C. Wainwright.

So on the Phase II 201 trial, you said screening is ongoing at 22 sites. How many sites have enrolled patients so far? And can you just tell us about the screening process, is the number of patients coming in meeting your expectations?

Well, so first of all, this is a challenging patient population. The untreated Parkinson patients since the advent of COVID in the United States has driven many patients who are diagnosed with Parkinson's disease into telehealth appointments, and that has led physicians to start treatment much earlier than they had previously done, often much sooner than patients actually require when other medical interventions such as exercise and physical therapy would better benefit patients during the course of their disease. So we've not yet provided guidance on the enrollment rate for the number of sites that are enrolling patients because we want to see how that -- the implementation of all of our patient outreach activities over the last 6 weeks and into the fall really bears fruit. I think we've guided that we'll be providing that guidance closer to the next quarterly report.

Okay. And on the 501 trial for IkT-001Pro, you had stated that following discussions with the FDA, you are considering a high-dose bioequivalence cohort. Maybe you could just review some of the pros and cons that you're considering when thinking about running that cohort?

Well, so we had to have a discussion with the FDA related to safety. So the norm in the oncology division at FDA these days is often to do Phase I studies in the target population because many agents to treat cancer are quite toxic, unlike IkT-001Pro. And so it takes some work with the FDA to have them agree to do these studies in healthy subjects. We have agreement with the agency to do things as single doses. We did that in both the dose escalation and pivotal trials in the 501 study so far, and the FDA has agreed to allow us to do the same in the next cohort for a limited number of patients. The 600-milligram dose is generally in wide use by many clinicians who are treating patients for CML, but it's also very poorly tolerated. And so the agency has agreed to a design that's similar to what we did in the dose escalation phase. 8 subjects, a single dose, with a full PK description and a full safety description. And so that's what we're contemplating the addition of. We're just going through all of the nuances and details of the safety profile from the 31-subject pivotal trial. That has been completed, as has the pharmacokinetic analysis. We should be releasing those results very shortly in detail.

Okay. And my last question is just on expenses. How should we be thinking of R&D expenses into the second half of the year where you have patients enrolling in the 201 trial and then the potential for this IkT-001Pro high-dose cohort?

Well, all of our current activities are part of our existing budget. So we don't have a concern that the burn rate will increase and exceed our current resources. So if that's the question you're asking -- I don't know, Joe, if you have additional color you want to add?

Yes. I mean that's exactly it. All of the budgeted items are contemplated in our present cash forecast. When it will flow out will be dependent in part on the rate of enrollment, right, which we are still assessing.

This concludes our question-and-answer session. I would like to turn the conference back over to Dr. Milton Werner for any closing remarks.

Well, thank you, everyone, for participating in our earnings call for the second quarter. This is obviously a challenging time in the public markets. Our financial picture remains strong and consistent, and we remain on track with our overall goals of reading out the current trial work in 501 shortly and in the 201 trial in the coming year. And look forward to how those outcomes will further inform our ability to control neurodegenerative diseases and other diseases that can be treated by [ ABL kinase inhibitors ]. Thank you for your attention.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.