Q1 2024 Inhibikase Therapeutics Inc Earnings Call
Greetings and welcome to inhibit keys Therapeutics first part of 'twenty 'twenty four 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.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad. As a reminder, this conference is being recorded it is now my pleasure to introduce your host Mr. Alexander Lobo still in Investor Relations. Thank you. Mr. <unk> you may begin.
Good morning, and welcome to inhibit case Therapeutics first quarter 2024 financial results conference call and audio webcast.
With me today is Dr melting winter, Chief Executive Officer, and cards, Leesville Chief Financial Officer.
On May 15.
Speaker Change: <unk> issued a press release announcing financial results for the first quarter ended March 31st 2024, we encourage everyone to read yesterday's press release as well. It's gonna have a cases 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 I didn't have the case website I didn't have the case dotcom.
In addition, this conference call is being webcast through the Investor Relations section of the company's website and will be archived there for future reference.
Speaker Change: Please note that certain information discussed on today's call is covered under the safe Harbor provisions of the private Securities Litigation Reform Act of 1995.
Phase I caution you that this conference call contains time sensitive information that is accurate only as of the date of this like broadcast may 16th 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 maybe required by applicable securities law.
With that said I would now like to turn the call over to Dr. Melton Winter. Okay. You may begin.
Speaker Change: Thank you Alex and thank you everyone for joining us today to review, our first quarter 2024 financial results and recent clinical and business updates 'twenty.
Speaker Change: 'twenty 'twenty four shaping up to be a year of clinical and regulatory execution as we advance our core programs towards important inflection points.
The achievements already accomplished by our team in the first quarter.
We are making rapid progress in the enrollment of our phase II trial for which the deaths neighborhoods, though.
Parkinson's disease and we.
We anticipate enrolling the final patient in June with topline data reported in the second half of the year on.
On the regulatory front, we had positive interactions to FDA divisions four of them at the project program.
Speaker Change: K T O one pro as we continue to position the SaaS it put a potential opportunity in pulmonary arterial hypertension.
Pursue the existing opportunity in blood and stomach cancers. So.
So, let's take a deeper dive into each of our programs beginning with Richard definitely.
So it was a potent selective inhibitor see April that is administered once daily that we believe may slow or halt the progression of Parkinson's disease or 201 trial is a two phase trial with an ongoing 12 week double blind. The study across three doses, we believe should be achieved therapeutic effect plus placebo.
Speaker Change: The trials approximately 83% of role does it makes sense with 99 participants.
15, prospectus participants and medical screening 22 potential participants being evaluated for suitability to initiate medical screening.
Additionally, 44 participants have completed the full 12 week dosing period.
To date, there have been 25 miles and three moderate adverse events observed that maybe that might be related to original treatment.
Or people withdrew from the trial without completing 12 weeks.
As I mentioned earlier, we anticipate the last patient will be enrolled in June and we expect to report topline results from the stock from the study in the second half of this year.
Speaker Change: The completion of the 12 week double blind period, we expect to request an end of phase two meeting with the FDA.
Overall, we remain impressed by the speed at which our trial has been enrolling patients as well as the broader interest expressed the Parkinson committee nationwide.
Speaker Change: <unk> worked hard to make sure that our dedicated patient portal accessible at Www Dot 201 trial Dot com provides accurate and up to date information regarding a trial and how to get involved and I believe that the portal has been instrumental in enabling us to effectively more participants across all 32 open clinical trial sites.
As we continue to work to find the capital necessary to initiate the tier ones. The extension trial. We are encouraged by what is emerging on the biomarker for it.
Recently, we disclosed the development of a novel antibody against a key marker of Episodically pathology in Parkinson disease.
Namely an antibody that can recognize phosphorylated tyrosine 39.
We believe this antibody will serve a dual purpose of allowing us to track Alpha silicon pathology and its possible elimination along with a measure of target engagement by Russo.
The development of this antibody prompted a recent grants submissions to the National Institute of neurological diseases and stroke rate I had yes, which is an institute of the national institutes of health or NIH.
Anybody would be incorporated both the skin biopsy test and see that application tests done already being used the Mitchell one trial to track. The fact, the brits, though on the underlying pathology of disease in both the central and peripheral nervous systems.
Moving now to I K T O what pro our prodrug formulation of about the best slate that has been designed to potentially improve on the safety and Tolerability profile.
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 discuss discuss the requirements for potential approval under the five would probably be two 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 preclinical a preclinical test.
To evaluate how old one pro and a massive effect certain got transporters and to consider evaluating the 1200 milligram goes about one pro as a possible equivalent to the approved dose of 800 milligrams about the best way, notably we were able to pursue approval of all of the indications for which the Besylate is approved.
It was it continued to evaluate how to maximize value for our one pro we also explored non oncology indications for which O a broker proved to be effective.
To this end on April 5th we held a pre IND meeting with the opposite cardiology hematology adequate allergy and nephrology and the division of cardiology in nephrology at the F D. A.
We were discussing the potential about one pro as a disease modifying treatment for pulmonary arterial hypertension or ph.
On arterial hypertension is a rare disease of the pulmonary much micro vasculature that primarily affects women between the ages of 30 and 60.
There are approximately 30000 cases to the ph in the U S alone and many treat that's for ph are aimed at addressing symptoms of disease rather than outright keurig.
The global PIH market side, it's valid approximately 7.66 billion and we believe that I K T. O. One pro would have the potential to deliver them out there with an improved safety and tolerability profile than a bathroom besylate itself.
Well and improved safety and Tolerability profile relative to the missile itself for the syndication.
Although we have yet to conduct any clinical studies to evaluate all one probe KH. Our pre IMD meeting has served to review our proposed late stage trial designed to confirm the new molecular entity status for all one probably P. H O.
Open the door to exclusivity designations, where oh I'm proud to be approved for this indication.
These outcomes provide the opportunity to unlock substantial value for all our pro as an indication of high unmet need that was not anticipated when Ellen pro was first conceived.
I will now turn.
The conversation over to our Chief Financial Officer correctly, It's Ralph to review our financial results for the quarter.
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, 2020, full with full point 6 million or <unk> 73 per share compatriot net loss of $4 5 million once you're up 198 per share for the quarter ended March 31 2023.
Research and development expenses for the quarter ended March 31, 2024, with $2 8 million compared to $2 9 million for the same period in 2023.
<unk> 1 million.
Decrease.
A decrease of 0.7 million and <unk>, one probably expenses offset by a <unk> 6 million increase in depreciation expenses.
Selling general and administrative expenses for the corner ended March 31, 2024, with 2 million compared to $1 9 million for the same period in 2023.
011 million increase was primarily Judy Chu at 0.1 8 million increase in legal and consulting fees and is there a point 8 million net decrease in all I'd add general and administered.
As of March 31st 2024, we had $9 7 million in cash and cash equivalents and marketable securities.
That 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 as I can knowlton for closing remarks.
Thank you Garth I'd like to now open the call to questions operator.
Yeah.
Speaker Change: Thank you.
We will now be conducting a question and answer session. If you would like to ask a question. Please press star one on the telephone keypad a confirmation tone will indicate your line is in the question queue you might that start to if you would like to move your questions from the queue for participants using speaker equipment. It may be necessary to pick up your hand.
Before passing the stock each one moment, please while you poll for questions the.
The first question comes from the line of Ed White with achieving rate. Please go ahead.
Yes.
Thanks for taking my questions I just have.
100 store on one on.
One pro.
Speaker Change: On Riseborough.
Yeah.
How will you be looking at the data.
What you will be a positive results and then assuming a positive results. What is sure next steps on your pathway to approval.
So for US it's a two fold question, we are sitting at the forefront of a biomarker development and those biomarker measurements have are ongoing and we believe they will illustrates.
Hopefully under treatment only but we don't know what we're gonna see yet that we're able to impact both central nervous system, a peripheral nervous system pools at opposite in aggregate.
Since as we've defined what the pathological aggregate about this and it is.
Namely that its phosphorylated at Siri and 129 and pirates in 39, our ability to track that species and watch whether treatment resulted in any changes in the pools of that species will.
It will allow us to have.
They have a direct measure of the impact of a drug treatment on underlying pathology of disease there.
There has been no prior measurement of that card and we think that the biomarker results will be quite illustrative.
Secondary to that you know, we're only treating for 12 weeks, but no one expects to see some remarkable reversal of parkinson disease in such a short period of time, but we would expect to see some impact on quality of life measures on parkinson disease severity.
<unk> on formal measurements of parts, one two or three or any combination thereof of the UPC, whether there's notice the U P D or S Universal Parkinson's disease rating score.
I think we as we and I think we've said this many times in the past press releases and discussions of the Sky and 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 it.
Our was in our view a pretty remarkable outcome.
And that will motivate what we're doing in phase III, we hope to be able to have the capital to run. The 12 month extension study. So we can keep measuring in these patients.
But we don't have the capital just yet so we don't know what's going to happen there.
Yeah.
Okay. Thanks, smelting and just 001 pro.
[noise] congratulations on getting it.
Speaker Change: Viewed as a novel chemical entity for P. A H.
Just wanted to.
Get your thoughts on what the protocol would look like for the phase two three potential trial design.
So that's a pretty standard way to do this the.
So.
Speaker Change: You know first of all it's to US what's remarkable about this is that we had this idea to try to address.
All their ability issues in the design of able inhibitors for non oncology purposes.
And our first accomplishment was.
<unk> tried to mask some of the potential Gi causes in in this class of medication.
We were able to measure bioequivalence.
Speaker Change: And then in all of that work is paid for by the National Cancer Institute through an SPR Grant.
Once we have recognized that pro drug seems to have.
Well, we believe has 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 20th patents that could allow us.
US to think again weather imatinib as a suitable agent for PIH, we're 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 a bad debt, which we think is the only way to properly inhibit the abel enzymes necessary to cause and effect on disease.
Speaker Change: And so that trial design would use a phase two period.
With a smaller cohort of that trial design would have a primary endpoint in pulmonary vascular resistance, which is a pretty typical design are I believe the trial size has decided 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.
Safety profile looks favorable we will amend the protocol to incorporate the entire phase III program. So people roll smoothly from phase II into phase III.
The phase III programs, just like the phase two programs in the syndication are pretty standard you have to measure hemodynamics are like things like pulmonary vascular resistance secondary endpoints of the phase III.
Maryann point has to be six minute walking distance.
Our success in six minute walking distance is typically viewed as better than 30 meter improvement.
And so so that's what we'd be looking for now.
The nice thing about <unk>, it's a very unique opportunity for us is that we already know imatinib as a highly effective agent.
Almost as effective or perhaps even superior to women rare, which was just approved for Merck.
Op rates by different mechanism using the same approach.
And so and we think that sits out except for repair and Imatinib are complementary they work at either ends of the disease, causing mechanism.
So one could imagine a combination of therapies, which would be quite compatible and argue how where you can really lead to real corrective therapy for people and there are no. Other agents out there that are like this just imatinib and status up to date.
And so we think this is a fantastic opportunity and are hard to treat patient population.
Speaker Change: 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 and now you have to just reevaluate the safety and Tolerability profile in the target population as your primary outcome that you need to accomplish.
Does everything else's of line for approval for <unk> in this indication as long as the oldest safety data that was observed is not observed.
A new treatment paradigm for these patients. So we're quite excited about this.
Yes.
Speaker Change: Okay, that's great. Thanks, Milton and just you.
You had mentioned partnering before and just wondering if there's any update on potential partnering of the stroke.
We're actively seeking that the players are pretty obvious and.
Well, 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 a 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 with that 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 patented.
And new molecular entity exclusivity.
Well potentially accelerated approval aspects available because it's a novel mechanism of action for the syndication.
Now that that's all under our belts, we have a much stronger case to make with potential partners.
To either licensed the drug or to to collaborate and help fund predominantly fund the trial work because this is not trivial trial work.
And once you put patients on drugs in this in this indication you can never take them off nobody will participate if you're going to withdraw a 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 clinical development program until you get to approval or fails to be approved so the commitments you make is very.
Significant very fast and that really requires a partner for a company of our size.
Okay. Thanks for taking my questions.
Yes.
Thank you ladies and gentlemen, we have reached the end of question and answer session I would.
Now I'd like to turn the floor over to Dr. Milton bundle for closing comments.
Speaker Change: Well, thank you very much for your.
Speaker Change: Your attention today, our shareholders have seen a lot of volatility around our stock price. They continue to see our progress on all of our programs and the novel ways, We're trying to develop value for our assets and for shareholder return and we will.
We want to thank the shareholders along with all of the trial participants whose commitment has been unparalleled.
Speaker Change: For reasons that we cannot explain our dart trial participants really want to be involved in the trial work, they're participating in and they are providing invaluable information towards understanding originally that there could be a transformative therapy endogenous disease.
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.
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