Q3 2023 Inhibikase Therapeutics Inc Earnings Call
Hello, and welcome to the hemp a case therapeutics third quarter 2023 financial results all participants will be in listen only mode should you need assistance. Please you know a conference specialist by pressing the star key followed by zero.
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Please note today's event is being recorded I would now turn the conference over to Alexandra level of Stern Investor Relations. Please go ahead Sir.
Yes.
Thank you operator.
Good morning, and welcome to navigate Therapeutics third quarter 2023 financial results conference call and audio webcast.
With me today is Dr. Melton Werner Chief Executive Officer, and Joseph federally Chief Financial Officer.
On Tuesday November 14th 2023, and have issued a press release announcing financial results for the third quarter ended September 32023.
We encourage everyone to read yesterday's press release as well as any of the cases 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 our website I didn't hear the case dot 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 15th 2023.
Actual results could differ materially from those stated or implied by these forward looking statements due to risks and uncertainties associated with the Companys 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 reserve to provide or update any forward looking statements to reflect events or circumstances. After the date of this live webcast, except as maybe required by applicable securities law.
With that said I would now like to turn the call over to document broken winter Okay great.
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 and.
In the clinic, we are continuing to evaluate the lead candidate Richard that's a name in our phase two to a one trial in Parkinson disease. The trial is actively screening and enrolling patients and activating our remaining clinical sites.
In addition, our fiber one bioequivalence study before I could see Oh approach is now complete and we were in the process of submitting briefing documents and supportive of meeting with the FDA to align on the requirements for approval under the five under the fiber fiber to regulatory pathway.
Our medicinal chemistry efforts are also progressing and we are excited to announce the evaluation of second generation CDK inhibitors that emerged with internal programs and external collaborations.
The second generation molecules may potentially be deployed alone or in combination to improve brain delivery of <unk> inhibition in the central nervous system.
In the orphan disease areas, we were pleased to receive orphan drug designation from the U S. FDA for was designated as a treatment for multiple system atrophy.
We are working towards initiation of the plan to space planned phase II study and discussing conduct a trout private foundations and 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.
Well listen I'll take a deep dive into each of our programs starting with our 201 trial as a reminder, the two one trial is a 12 week double blinded study across three doses plus placebo group.
We've been working closely with our 28 active clinical sites to accelerate screening and enrollment.
Until the trial and are pleased to say that we currently have 24 participants rolled seven perspective, it's been sort of going screening evaluations.
15 potential participants undergoing informed consent.
Let me correct that that's actually nine prospective participants 10 15 potential undergoing concept as we announced a press release yesterday quite.
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 tier one trial subject to additional financing.
The extension study once implemented will roll participants who have completed the two one trial into a study for an additional 12 months of treatment.
Extension study will also evaluate our novel tablet formulation that we got to that which we announced in August 2023. This.
This novel tablet formulation is designed to improve drug exposure and overcome existing charges related to patient use and mimics the oral formulation, we used to evaluate efficacy in relevant animal models of Parkinson's disease.
Tablet nearly doubles drug exposure at steady state for the same doses definitely.
Which allow which may allow for lower doses that could lead to an overall improvement in safety and tolerability of risk reduction.
In addition, our ongoing working what's in there.
In addition to the ongoing work in the tier one trial, we recently presented public I'm blinded functional data from 11 previously enrolled patients with untreated Parkinson disease.
Excuse me who were removed from the two one trial due to the temporary clinical hold imposed by the FDA in the fourth quarter of 2022.
The results were presented at the movement disorder Society Congress in Copenhagen in August 2023.
Of the 11 patients who enrolled eight participants were in active drug three at 50 milligrams two at 100 milligrams and three or 200 milligrams and three were given placebo.
For these patients we evaluate it changes from a functional assessments motor and non motor features using a hierarchical analysis of 15 secondary endpoints in.
In particular, the study evaluated non motor functions, such as activities of daily living using the M. D. S. U P. D. R. S part to score and evaluated motor function using the M. D. S U P D or S part three score.
Some of these scores with 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 eight seven points.
By contrast, the combined placebo score increased by an average of plus 1.7 points.
This represents a modest 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 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 non motor features of disease utilize what is called the Schwann and England activities of daily life sketch to scale.
The SME scale as we term it was reduced for the 200 milligram group by an average of minus 313 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.
50 milligram dose showed no effect for this measure it while the 100 milligram dose was on average minus five points lower relative to baseline while.
While the dataset has too few participants to conclude a clinical benefit we view these results with cautious optimism as we continue to roll patients in the ongoing tool in trial.
Turning now to the I K T O. One pro program, our pro drug formulation for Imatinib Mesylate that has been developed to improve safety of Imatinib.
We recently completed the fiber one bioequivalence studies evaluating the IQ T O one crore compared to portable and give them the.
Besylate, where 600 milligram amount domestically.
The study met our expectations and demonstrated at the 600 milligram dose of I K T. O. One pro was equivalent to standard of care 400 milligram I've forgotten the besylate.
While at 900 milligram dose of I K T O one pro should be equivalent to 600 milligrams about domestically.
I K T O one pro demonstrated a favorable safety and tolerability profile with minimal adverse events across the system 66 subjects in the trial.
We are currently submitted briefing documents the F T H come to agreement on the particulars for approval if I could to your own pro under the 505 Btu 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're 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 nerve regeneration through stable inhibition.
We believe that such molecules, whether acting alone or in combination with active Saturday emitters like risk reduction it could be an improved approach to suppress nerve regeneration arising from stable activation inside and outside of the brain.
In addition to these early stage efforts, we are continuing to advance the preclinical development 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 has provided two drugs or biologics that are using prevention diagnosis or treatment of diseases that affect fewer than 200000 people. This designation will allow us to advance our work and MSA at greater speed and it's encouraging to see the FDA acknowledged the devastating nature of MSA.
That exists in the market.
I'll now turn our call over to our Chief Financial Officer, Joe for Outerwear Ali to review, our financial results for the quarter Joe.
Thank you Milton.
Let me review now let me review our financial results for the three months ended September 32023.
Third quarter 2023, we recorded a net loss of approximately 4.6 million or <unk> 86 per share compared to a net loss of $4 four 9 million or $1 six pushing them in the quarter ended September 32022.
Research and development expenses were 3.23 million for the quarter ended September 32023, compared to 2.98 million for the quarter ended September 32022.
This increase was primarily due to company's ongoing phase two 201 trial in Parkinson's disease.
General and administrative expenses were 1.62 million for the corner ended September 32023, compared to $1 4 million for the quarter ended September 32022.
This increase was driven by a net increase in normal selling general and administrative expenses.
It's just timber 30, 2023 we had approximately $16 eight $3 million in cash cash equivalents in marketable securities.
We expect that existing cash cash equivalents 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.
Parkinson's related disorders.
As the value of civil inhibition of nerve regeneration continues to come into focus all the scientific community.
We believe that the potential of rates would definitely have to 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 any of the case.
We worked diligently to 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 from studies across our pipeline in order to transform the treatment paradigm for Neurodegenerative diseases.
I would now like to open the calls to call to questions. Operator, yes. Thank you at this time, we will begin the question and answer session.
Question You May Press Star then one on you touched on phone.
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To try a 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 H C. Wainwright.
Good morning, Thanks for taking my questions.
First smelting I just wanted to get a little bit more information on the phase two to a one trial.
What is the typical time.
For patients to go from informed consent to dosing.
That varies widely because of informed consents are followed by screening visits and theres more than one screening visit typically involve they'll come in the laboratory safety and ECG med remember our 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.
Then go to the enrollment authorization committee following baseline measures of Parkinson disease related assessments.
<unk> Committee typically takes two days to.
To come to a decision on whether the person is suitable for enrollment unless they have questions. They have question there could be a back and forth of Alaska, where one or more days thereafter.
They are accepted by the enrollment authorization Committee then they'll go for their ophthalmology baseline exams to ensure that they meet the criteria for <unk>.
Normal vision within the parameters we've defined in the protocol.
So collectively it depends on the site and how it's organized they can take.
Between one and two weeks something of that order, probably exaggerating that number but that's my best guess.
Okay. Thanks Mountain and just how many more sites do you plan on opening.
There are four.
Lance who will get the 32, we had had 34 that we've been talking about for a long time to sites in the last month as we disclosed in our Q.
Dissolve 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 tier one trial outreach program.
Think will satisfy our need for trial in a timely manner.
Okay. Thank you and just a little bit more information on the potential multiple system atrophy.
Uh huh.
Trial.
You say 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.
Oh, we it's aspirational at the moment, but until the money from the bank, but yes, it's planned to be 'twenty 'twenty four MSA is really important.
The preliminary data from the 11 patients that we hold from a trial in 2022.
Is encouraging but it's too small of a data set to draw strong conclusions.
B because you saw indications and these are just.
Milden indications that as you increase the dose you saw increase in benefit costs. Many anti Parkinson 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 its little hard to calibrate that somewhere between <unk>.
16, and 25000 people in the U S. Today.
Perhaps 50 to 70000 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 MSA patients don't respond to anti Parkinson 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 a potential benefit.
The trial is planned for six months with them additional six month extension that will be provided in the updated protocol and we plan to run that trial and a registrational matter. We think there's a lot of interest at both the federal level with N. I M. D S as well as in primary ambition level and we're working through those discussions they'll take some time, but I am aspirational about this.
We'll get started in 2024.
Okay. Thanks Mountain and just a question on.
001 pro.
Can you make any comments on potential partner interest.
Well there are two areas, where that drug could be a very attractive certainly to the CML and also to the gastrointestinal stromal or just community. Although we're seeking initially just the label for CML in Imatinib tolerance in newly diagnosed.
But there is an additional application of Imatinib where the.
The indications of improved safety from Olin 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.
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 then theres not pursued further by Novartis because of safety concerns at the doses used for Imatinib P. H, which is the acronym for pulmonary arterial hypertension, but Olaf 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 gonna be going out to partners, both large and small companies that work in specialty areas around private private to be two approvals and hopefully in the early part of next year, we'll have something more to say about that.
Great, Thanks, and perhaps if I could just ask two more financial questions one.
That 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 have funded in the in the program. So Joe go ahead.
Yep.
Yeah, Theres, some nominal expenses budgeted within the MSA trial, but really not really not initiation of the study.
Pending a.
Pending additional.
<unk> capital raise.
Non dilutive funding sources.
Okay. Thanks, Joe and then just the last question you mentioned that R&D spending we saw was down from Oh.
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.
Yeah, Great question.
The crowd.
Crowd started there are some nonrecurring costs.
Be incurred.
Most of the cost to vary a lot many of the costs are variable depending upon the rate of enrollment.
So the rate of enrollment will.
Hum.
Month to month or 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 a rate of actual rate of recruitment.
Okay, great. Thank you for taking my questions.
Thank you and this concludes our question and answer session as well as the call itself. Thank you for attending today's presentation and you may now disconnect your lines.