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spk03: Hello, and welcome to the HEMPA Case Therapeutics Third Quarter 2023 Financial Results. All participants will be in this anomaly mode. Should you need assistance, please send to a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touch-tone phone. To withdraw your question, please press star, then two. Please note, today's event is being recorded. I now turn the conference over to Alexander Lobo of Stern Investor Relations. Please go ahead, sir.
spk04: Thank you, operator. Good morning, and welcome to Inhibit Case Therapeutics Third Quarter 2023 Financial Results Conference Call and Audio Webcast. With me today is Dr. Milton Werner, Chief Executive Officer, and Joseph Frateroli, Chief Financial Officer. On Tuesday, November 14, 2023, Inhibit Case issued a press release announcing financial results but the third quarter ended September 30th, 2023. We encourage everyone to read yesterday's press release, as well as Inhibit Case's quarterly report on Form 10-Q, which is being filed with the SEC. The company's press release and quarterly report are also available on Inhibit Case's website at inhibitcase.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.
spk00: 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 advance 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-001-Pro 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 regulatory pathway. Our medicinal chemistry efforts are also progressing, and we are excited to announce the evaluation of second-generation C-able 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-able 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 Rizvodecinib as a treatment for multiple system atrophy. We are working towards initiation of the planned phase two study and discussing conduct of the trial with private foundations, 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 201 trial is a 12-week, double-blinded study across three doses plus a 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, seven prospective participants undergoing screening evaluations, and 15 potential participants undergoing informed consent. Let me correct that. That's actually nine prospective participants and 15 potential undergoing consent, as we announced at the press release yesterday. Five 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 the animal models of Parkinson's disease. The tablet nearly doubles drug exposure at steady state for the same dose of risvodetinib, which may allow for lower doses that could lead to an overall improvement in safety and tolerability of risvodetinib. In addition to the ongoing work in the 201 trial, we recently presented public unblinded functional data from 11 previously enrolled patients with untreated Parkinson's disease excuse me, who were removed from the 2-1 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 Society Congress in Copenhagen in August 2023. Of the 11 patients enrolled, eight participants were an active drug, three at 50 milligrams, two at 100 milligrams, and three at 200 milligrams, and three were given placebo. For these patients, we evaluated changes in the functional assessments of motor and non-motor features using a hierarchical analysis of 15 secondary endpoints. In particular, the study evaluated non-motor 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 three participants who received the 200 milligram dose had a combined part two and part three 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 three to plus six 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 dose and 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 non-motor features of disease utilized what is called the Schwann and Englund activities at daily life scales 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 too few participants to conclude a clinical benefit, We view these results with cautious optimism as we continue to enroll patients in the ongoing 201 trial. Turning now to the IKT-01 Pro program, our pro-drug formulation for imatinib mesylate that has been developed to improve safety of imatinib, we recently completed the 501 bioequivalent studies evaluating the IKT-01 Pro compared to 400 mg imatinib mesylate or 600 mg imatinib mesylate. The study met our expectations and demonstrated that the 600 mg dose of IKT-001-PRO was equivalent to standard of care 400-milligram imatinib mesylate, while a 900-milligram dose of IKT-001-PRO should be equivalent to 600-milligram imatinib mesylate. IKT-001-PRO demonstrated a favorable safety and tolerability profile with minimal adverse events across the 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-001-PRO under the 505-BT 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-able inhibition. We believe that such molecules, whether acting alone or in combination with active sun inhibitors like resveratantinib, could be an improved approach to suppress neurodegeneration arising from C-able activation inside and outside of the brain. In addition to these early-stage efforts, we are continuing to advance the preclinical development of rizvodetinib 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 the devastating nature of MSA and the high unmet need that exists in the market. I'll now turn the call over to our Chief Financial Officer, Joe Federoli, to review our financial results for the quarter. Joe?
spk01: Thank you, Milton. Now let me review our financial results for the three months ended September 30, 2023. For the third quarter of 2023, we reported 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, when the quarter ended September 30, 2022. 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 companies' ongoing Phase 2-201 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 dollars 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.
spk00: 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-able inhibition and neurodegeneration continues to come into focus among the scientific community, we believe that the potential of Rizvodetinib 2 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 Inhibicase. 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 neurodegenerative diseases. I would now like to open the call to questions. Operator?
spk03: Yes, thank you. At this time, we will begin the question and answer session. To ask a question, you may press star, then one on your touchtone phone. If you are using a speakerphone, Please pick up your hands up before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble the roster. And the first question comes from Ed White with HC Wainwright.
spk02: Good morning. Thanks for taking my questions. 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?
spk00: That varies widely because informed consents are followed by screening visits, and there's more than one screening visit typically involved. They'll come in for laboratory safety and ECG measures. In some cases, the safety measures for cardiovascular function are 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 two 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 a back and forth that lasts for one 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. It can take between one and two weeks, something in that order. I'm probably exaggerating that number, but that's my best guess.
spk02: Okay. Thanks, Milton. And just how many more sites do you plan on opening?
spk00: There are four. So we'll get to 32. We had 34 that we've been talking about for a long time. Two sites in the last month, as we disclosed in our queue, 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 sites. potential patient enrollment sites coupled with the 2-1 trial outreach program that I think will satisfy our needs for the trial in a timely manner.
spk02: Okay, thank you. 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?
spk00: We, it's aspirational at the moment until the money's in the bank, but yes, it's planned to be 2024. 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. 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 it will be implemented in the near future. And MSA offers the opportunity to amplify those outcomes. Because patients with MSA decline at four times faster rates than patients with Parkinson's disease, you 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, somewhere between 16 and 25,000 people in the U.S. today, perhaps 50 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 pre-existing medications since MSA patients don't respond to anti-Parkinson meds. We have imaging and biomarker analyses that are validated in 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 benefits. The trial is planned for six months with an additional six 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 the private 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.
spk02: Okay, thanks, Milton. And just a question on 001 Pro. Can you make any comments on potential partner interest?
spk00: Well, there are two 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 the matinib intolerance and immunodiagnosed. But there is an additional application of imatinib where the indications of improved safety from O1 Pro 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 professionals. About this medication and the potential interest in imatinib, as you may recall, a number of years ago, a phase three problem from Novartis was rejected by the FDA and was not pursued further by Novartis because of safety concerns at the doses used for imatinib and PAH, which is the acronym for pulmonary arterial hypertension. But O1 Pro 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 out to partners, both large and small companies that work in specialty areas around 505B2 approvals. And hopefully in the early part of next year, we'll have something more to say about that.
spk02: Great, thanks. And perhaps if I could just ask two 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?
spk00: Well, MSA currently is not funded in the program. So, Joe, go ahead. Speak to that.
spk01: There's nominal expenses budgeted within the MSA trial, but really not an initiation of the study pending additional working capital raised or non-dilutive funding sources.
spk02: Okay, thanks, Joe. 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 one time in nature in the quarter, and how should we be thinking about the fourth quarter?
spk01: Yeah, great question. In getting the trial started, there are some non-recurring costs that will be incurred. 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 to $1.3 million a month. Again, subject to actual rate of recruitment.
spk02: Okay, great. Thank you for taking my questions.
spk03: Thank you. And this concludes the question and answer session as well as the call itself. Thank you for attending today's presentation and may now disconnect your lines.
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