Q4 2023 Inhibikase Therapeutics Inc Earnings Call

Participants

Alex Lobo; Investor Relations; Inhibikase Therapeutics Inc

Milton Werner; President & CEO; Inhibikase Therapeutics, Inc.

Garth Lees-Rolfe; CFO; Inhibikase Therapeutics, Inc.

Presentation

Operator

Ladies and gentlemen, thank you for standing by Greetings and welcome to Inhibikase Therapeutics fourth-quarter and full-year 2023 financial results.
(Operator Instructions) 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.

Alex Lobo

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 Warner, Chief Executive Officer, and Barclays Ross, our Chief Financial Officer on March 27th and have a case 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 in the case, the annual report on Form 10-K, which has been filed with the SEC.
The company's press release and annual report are also available on any of the cases website at inhibit case.com. In addition, this conference call is being webcast on the Investor Relations section of the company's website and will be archived there for future.
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 20, 2024, and 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 Warner.
You may begin.

Milton Werner

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 Fred, early 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. And he and I have done together to bring and hear the case where we are also to introduce you to our new Chief Financial Officer, who will begin on Monday Finally, and the job of Barclays Wealth will be discussing our financial results. And so what that's about really, we 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 IKGO. one Pro and the rapid enrollment of part of Parkinson patients in our two trials for which the data-enabled results that 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 could be benefiting from a 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 risk that's enabled with, though, as you may remember, result is a potent selective inhibitor of C. able that is administered once daily and that we believe may slow or halt the progression of Parkinson's disease.
Our tool one trial is a two phase trial with an ongoing 12-week double-blind 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 22nd 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 to moderate adverse events have been observed that may be related to digital treatments to people who elected to withdraw from the trial despite having only one or two moderate adverse events, we believe the last patient will be rolled during the summer of 2024.
To date, trial recruitment has been successful in our review, generating broad interest within the Parkinson's patient community nationwide, allowing for hundreds of unique individuals to be screened by outside medical staff and referred into our clinical sites prior to entering a medical record review process in advance of initiation of formal medical screening. We plan to report top line results from this study in the second half of this year, but you one trial plans to allow 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 previously disclosed, the extension study will transition participants from the blinded phase who will still meet its enrollment criteria to an additional 12 months of treatment, which will also serve the purpose of evaluating our novel commercial tablet formulation for as well, which we announced last year. As we continue to establish the potential of Brazilian 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 one 1b data evaluating Rizwan healthy volunteers and in patients treated Parkinson's medications. That report appeared in the peer-reviewed journal journal of Parkinson's disease for publication highlighted the safety, the tolerability and pharmacokinetics of Lisewo across 94 healthy volunteers and 14 participants with Parkinson's disease in both single ascending dose and multiple ascending dose studies.
If I'm an original 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 C-max and the area under the curve or AUC measurement with no pharmacokinetic difference between healthy volunteers and participants with Parkinson's disease exposures that retails for high relative to other drugs in the same class same kinase inhibitor class.
And of note, we used voluntary lumbar puncture to measure the concentration of Israel and cerebral spinal fluid and six participants with or without PD., which indicated that resonate across the blood-brain barrier and was persistently presence in the central nervous system for this was a limited dataset. We find these results are encouraging. Overall, we believe the totality of the data we've generated to date continues to support the development of results, and we look forward to providing updates on the progress of the trial throughout the year.
Moving now to IKTO. and Pro, which is a pro-drug formulation of a mountain of Nestle has been designed to improve on the safety profile of a mountain. And we had a pre-NDA meeting on January 19th of this year with the FDA to discuss the requirements for potential approval of IKCOM. Pro on the fabless side, due to statute, we were pleased with the discussion we had with the agency as we begin the process of drilling our first NDA package, and we plan to seek all 11 blood and stomach cancer indications for which demand domestically has been approved.
If there were to review team from a Division of Hematologic Malignancies determined through a review of our clinical data that 600 milligram and 800 milligram IKTO. and Pro provided similar exposures to 400 milligram and six milligram amount unless later respectively. The review team advised that if you want to seek all the indications for which amendment has previously been approved, we should measure the safety, tolerability and pharmacokinetics of IKTO. and Pro that will deliver up to 800 milligrams, the highest approved dose of about domestically. We plan to evaluate IKTL. and Pro at a 12 milligram dose, which we believe will lead to exposures to mandate that are similar to eight milligrams of Mountain escalate.
Further review team as we evaluate whether oh one Pro and imatinib arms or differently from the gut. So we are initiating a standard preclinical tests to further evaluate IKTO. and Pro and amended 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 as well 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 Frater only for his years of service as Chief Financial Officer, and we all wish investments and Chairman. With that said, I'll turn the Coast Guard to review our financial results.

Garth Lees-Rolfe

Thank you, Nelson. And let me review our financial results for the year and quarter ended December 31st, 2023. Net loss for year ended December 31st, 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 31st, 2022 research and development expenses for the full year ended December 31st, 2023 were $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. one program and a decrease of $0.6 million in expenses for risk growth and a net increase of $0.7 million for other R&D activities.
Selling, general and administrative expenses for the full year 2023 were $6.7 million compared to $6.2 million for the same period in 20 $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 a 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 administration.
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 in 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 Tier one 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 reservoir in the Journal of Parkinson's disease reinforces our belief that Brazil could be a transformative treatment for patients with Parkinson's disease and related disorders. We look forward to continuing to establish ourselves as a leader in the development of treatments from Agensys. I want to thank all our shareholders and trial participants for their continued support as we advance new medicines for patients with high unmet medical needs.
I would now like to open the call to questions. Operator?

Question and Answer Session

Operator

(Operator Instructions)
Ed White, H.C. Wainwright.

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?

Milton Werner

Well, approval, a little bit hard to gauge. We've been fortunate to be able to enroll the two one trial at least for this patient population and a faster rate than other studies of its kind of the last three years since COVID emerged, the Phase three trial or trials would be run again in untreated Parkinson patients on a larger scale will need to assess assess the degree of benefit is observed at all three doses of birds reduction and to decide whether we're going to have a one or two trial, one or two dose trial for registrational purposes.
And we also think that based on the outcomes of biomarker analysis and we don't know those outcomes 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 3 one or two trials that will be necessary for registration. I would guess it's probably a two to three year process overall, how we would plan, depending on the outcome of the trial that we see this year to try to schedule a meeting with the FDA to discuss the parameters of the Phase three program.
On the manufacturing side, we're well ahead of the game. We are already producing residential. Maybe on the 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 will 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-001 Pro, can you just comment on the big picture strategy and then any comments on potential partnering?

Milton Werner

So we know how we have oh one Pro is a bit of unusual on 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 to 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 at the FDA that could lead to approval through the fiber fiber to stature. So along that path, the one qualification is that oh one pro would be kind of in quotations branded generic.
Its earning potential would be is unknown at the moment, but it's much more modest given that the frontline drug demand domestically is now generic and there are 15 generic suppliers in the US for that medication. So it depends on what 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 of have bladder stomach cancers separately from that, as we've disclosed previously, we have an interest in evaluating oh one PRO 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'll -- I don't want to preempt 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.

Operator

Thank you. Seeing 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.