Q4 2022 Inhibikase Therapeutics Inc Earnings Call
Yeah.
Good morning, and welcome to the inhibitory as fourth quarter and full year 2022 earnings conference call.
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I'd now like to turn the conference over to Alex Lobo with Stern IR. Please go ahead.
Yeah.
Good morning, and welcome to you and have a case therapeutics fourth quarter and full year of 'twenty, two financial results conference call and audio webcast.
With me today is Dr. Nothing Warner Chief Executive Officer, and Joseph federally Chief Financial Officer.
On Friday March 31, 2023, and have a case issued a press release announcing financial results for the full year ended December 31 2022.
We encourage everyone to read Fridays press release as well as any of the cases 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 our new cases website and inhibit case dotcom.
In addition, this 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 April 3rd 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 revise or update any forward looking statements to reflect events or circumstances. After the date of this webcast.
As may be required by applicable securities law.
With that said I would now like to call turn the call over to Dr. Melton Warner Nothing you may begin.
Thank you Alex and thank you all for joining us today to review our full year 2022 financial results.
And recent clinical and business updates.
22 was an important year for us as we continue to advance our mission to bring disease modifying therapeutics to patients living with Neurodegenerative diseases and cancer.
We were excited to continue are to advance our lead asset I K T fortunate eight or nine in the clinic as well as further validate the underlying mechanism through presentations at several notable scientific and industry conferences.
The FDA clinical hold on our 14 eight programs last year wasn't unexpected challenge. We were pleased to announce that the agency had lifted our hold on Parkinson's on the Parkinson's program in January .
With that hold lifted we are working diligently to restart the phase two a 201 clinical trial with the agreed upon amendments in March you have to be able to the clinical hold on our K T 48, or nine for the treatment of multiple system atrophy, where MSA and open the R&D, enabling the planning of a future phase two trial in MSA simultaneously our fiber.
One bioequivalence study for Ikea T O one CRO, which is a prodrug formulation of <unk>. The best way intended to treat stable phase of chronic myelogenous leukemia has completed three or four dose escalation cohorts and it is anticipated that.
Dose finding and dose equivalents program will be completed by the close of the second quarter of this year.
As we work to make 2023 and W are clinical execution, we recently completed a concurrent registered direct offering and private placement, which bolstered our cash reserves by approximately $10 million in aggregate gross proceeds.
With the addition of these funds we are well capitalized into the fourth quarter of 2024 to advance our clinical programs through key milestones.
Now let me first start with an update to our I get to your point you did run programs.
I can't see 14 or not is our selective non receptor abelson tyrosine kinase or see able inhibitor.
As we published in January of this year I can't see 14, or nine has been shown to halt disease progression protect and restore lost neurons in the brain and Gi tract unclear the underlying protein pathology as was shown in animal studies.
A day Parkinson disease is one of the most devastating neurodegenerative diseases in the U S with roughly 60000, new diagnoses in the U S. Each year and there are currently no available options that slow or halt the progression of this disease.
Let me expand further on the potential about kitchen fortunate online as a disease modifying therapy Parkinson's unrelated disorders.
Our animal model studies, which were published in the Journal Science Translational Medicine on January 18th of this year highlights data from one from once daily oral administration of <unk> fortunate or dine in animal models that mimic the rate of disease progression relative to lifespan observed in human Parkinson disease.
These studies showed that I can't see 14, or Don was able to halt disease progression drive functional recovery protect neurons and protect around some degradation.
These features correlated with substantial reduction in the underlying protein aggregate pathology.
We believe these data form the basis for our belief in the potential I K T fortunate on as a disease modifying therapy for patients and continues to support clinical development about kids, you're fortunate around in Parkinson disease.
Turning now to our 201 program.
The unexpected setback last year, we were pleased to announce that the FDA had lifted the full clinical hold and I can't see a fortunate in a lot of Parkinson's in January .
The FDA basically decision on our complete response to the issues raised in the whole butter, which was submitted in December to the division of neurology.
And our response, we agreed to merge the pharmacokinetics of the 200 milligram top dose planned in this study and six healthy volunteers before implementing the dose in the tier one trial itself.
Its pharmacokinetic profile has now been completed and we.
We anticipate submitting the data to the FDA within the coming days.
The FDA further requested the measurement of visual acuity, an examination of the cornea lens to complement the analysis of the retina macula in front us that was already part of the ocular monitoring program set up in the trial.
This monitoring program is consistent with what the calls you're monitoring programs or other marketed protein kinase inhibitors.
We also wanted to emphasize that to date no ocular oncology has been observed and trough participant administered I K T. It 14 or nine.
And no clinically meaningful adverse events have been observed in any healthy subject to Parkinson's patients to date at any dose or doses to ratio up to 11 weeks of Ikea T fortunate I'd given once daily.
With 20 of approximately 35 plant sites already open and several having completed the steps to start screening patients. We're pleased that the first patient screenings began last week.
We will update the status of the two one trial enrollment later in the second quarter.
We're also excited to be moving forward with our IQ fortunate line program and multiple system atrophy for MSA.
Following the recent quote lift the clinical hold by the FDA MSA is a rare rapidly progressive neurodegenerative movement disorder that affects both the central and autonomic nervous systems.
In 2021, we published in the journal Neurobiology of disease, That's C able activation in opposite nuclear impossible relation at 39 also occurs in MSA in a manner that is similar to what has previously been described in Parkinson's.
Our ongoing animal model studies that we discussed during our recent R&D day or D day continue to encourage our planning efforts for for a future phase II trial.
Turning now to an update of our fiber one bioequivalence study of Ikea T O and pro as you might recall Oh, one pro is our pro drug formulation of about the Besylate intended to enhance the safety and tolerability of Imatinib in patients with stable chronic myeloid leukemia or CML.
And that name is commonly taken for hematological, and gastrointestinal cancers, which arise to be able to guide expectations located in the bone marrow or Gi track.
We are evaluating whether I K T O. One pro has the potential to be a safer and better tolerated alternative for patients on chronic therapy to control their disease.
The 501 study is a two part bioequivalence trial with the first part comprised of four escalating doses across twenty-seventh healthy subjects between the ages of 25 and 55.
And our intent is to identify the bioequivalence dose.
Three of the four dosing cohorts have already been completed in that study.
The second phase of the study will confirm the measure bioequivalence dose.
In 32 additional healthy volunteers using a two period crossover study this.
This study will also evaluate the adverse event profile in patient reported outcomes as metrics of superiority over standard of care.
We are contemplating the evaluation of hydro <unk>, such as 600 milligrams and to identify the equivalent dose of Olin pro to further amplify the differences and potential safety and Tolerability of hydro subotnick deliberate as prodrug.
I would like to now turn the call over to Joe <unk>, Our Chief Financial Officer to review the financials Joe.
Thank you Milton.
Let me review our financials for the year ended December 31 2022.
Grant revenue was 0.1 million for the year ended December 31, 2022, compared to $3 1 million for fiscal year 2021.
Increase was due to the Companys primary focus during 2022 things shifted toward advancing our phase one and two human clinical trials, which we're not grant related activities and.
Our research and development expenses were $12 million for the year ended December 31, 2022 compared to <unk>.
$11 4 million for the year ended 2021.
The increase was primarily due to ongoing non grant related research and development activities, mostly related to the phase two a 201 clinical trial.
Selling general and administrative expenses were $6 2 million for the year ended December 31, 2022 compared to $6 5 million for the prior fiscal year.
The decrease was primarily the result of decreased warrant expense of 0.7 million and a decrease of stock based compensation zero point $5 million.
Partially offset by increased legal fees of 0.4 million increased regulatory and compliance needs of 0.2 million and a net increase of zero point $3 million.
The other normal operating expenses.
For the year ended December 31, 2022 we reported a net loss of approximately $18 1 million or 72 cents per share compared.
Compared to a net loss of $14 8 million or 81 per share in the year ended December 31 2021.
At December 31, 2022, we had approximately $23 1 million in cash cash equivalents in marketable securities.
This excludes the approximately $10 million of aggregate gross proceeds from our January 2023.
Current registered direct offering and private placement before deducting placement agent fees and other offering expenses payable by the case.
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 statements I would like to hand, the call back over for any closing remarks.
Thank you Jill we remain passionate about the work you do it didn't hear the case and we are confident that we have the resources necessary to advance both our neurodegenerative and oncology programs towards key milestones in the clinic.
As we look towards 2023 and beyond we anticipate sharing additional clinical updates for 14 are behind us until one trial begins to more patients.
To continue advancing our remaining preclinical efforts at MSA and complete the fiber one bioequivalence study for our <unk> pro.
We view 2023 is a year of growth and execution as we continue to Ideate groundbreaking therapeutics.
To help patients and families living with these devastating diseases.
We would like to thank our shareholders and partners for their continued support and now I'd like to open the call to questions operator.
Thank you we will now be.
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I'm sorry, operator did you say there was a question that there was no sorry I was I was just very promising for questions and it appears there are no questions. At this time. So that does conclude today's question and answer session and today's conference call.
Great. Thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.