Q3 2022 Inhibikase Therapeutics Inc Earnings Call
Good day and welcome to the inhibit case therapeutics third quarter 2022 financial results conference call.
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I would now like to turn the conference over to Alex Lobo Stern Investor Relations. Please go ahead.
Good morning, and welcome to and have the case Therapeutics third quarter 2022 financial results conference call and audio webcast.
With me today is Dr Melton, Warner Chief Executive Officer and Joseph.
Ali Chief Financial Officer.
Yesterday and have a case issued a press release announcing financial results for the third quarter ended September 30th 2022.
We encourage everyone to read yesterday's press release as well as any other 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 any of the cases web site and in every 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.
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 2022.
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. Melton water nothing you may begin.
Thank you Alex and thank you for joining us today to review <unk> inhibitor cases third quarter 2022 financial results and recent business updates let.
Let me start by providing update on our I T. T 14, 809 fortunate or non programs.
November 7th we announced that the U S food drug administration had reviewed our investigational new drug or IV application.
I K T 14, eight or nine for the treatment of multiple system atrophy or MSA.
As a result of their review they issued a clinical hold on the KC fortunate on tier one program in Parkinson's disease or PD.
And the use of our J T 14, eight or nine and MSA.
And in their email correspondence the FDA indicated that an official clinical hold letter will be issued within 30 days.
I would like to highlight the date that we have observed only two mild adverse events in the ongoing phase Iia 201 trial and have recorded no serious adverse events.
We are actively working with the FDA to understand the agencies' concerns to resolve them as soon as possible.
In the interim we plan to conduct a blinded safety assessment based on the first 11 patients that were enrolled in a 201 trial and were randomized one to one to one to one for the 12 week once daily dosing.
However, none of the initial 11 patients had fully completed the study once the clinical hold is lifted and subject to discussions with the FDA. The study will need to be restarted.
In addition, I would like to reiterate results from our phase one study of <unk> J T. Fortunately, Illinois that were presented at the movement disorder Society Congress in September of this year.
These data highlighted the ITC works, the interline was safe and well tolerated over seven days of daily dosing with high systemic exposure and persistent penetration into the central nervous system or CNS.
That was true in both healthy volunteers and.
And in patients with Parkinson's disease.
Rover.
Motor non motor and quality of life in patients enrolled in the study showed that treatment with ITC, Fortunately, Illinois did not worsen disease over seven day dosing.
Our highest priority to resolve any questions and concerns from the FDA to resume our clinical development of <unk>.
Casey Fortunately turbine as soon as possible.
Turning briefly to our preclinical efforts, we are continuing to advance our KC 001 pro towards the clinic by the end of the year.
As a reminder, Oh, one pro here's our prodrug formulation of <unk>.
<unk> developed to improve the safety of the first FDA approved abelson tyrosine kinase inhibitor known as a matter as a treatment for stable phase chronic myelogenous leukemia or CML.
We received FDA clearance for our R&D application for Iqos users are what broke in August of this year.
As you know imatinib as commonly taken for Hematological and gastrointestinal cancers that arise from able client expectations.
And in the bone marrow or for gastric shuffled cancers that occur from C kit mutations in the stomach.
Our pro drug formulation has the potential to be a safer alternative for patients.
They improve the number of patients that reached sustained major or complete cytogenic responses in stable CML.
In preclinical studies I K T zero, one pro could be dosed up to three four times higher than Imatinib in nonhuman primates before inducing an adverse event.
If observed in people. This has the potential to reduce the burden some gastrointestinal side effects that occur following oral administration, and CML or gastrointestinal stromal tumor patients.
We are now advancing I K T zero, one throw into a single ascending dose fiber one bioequivalence study.
To evaluate the safety and efficacy of the drug.
The study will enroll approximately 56 male and female healthy volunteers between the ages of 25% and 55.
We'll receive Itt's zero to a one pro at one of three doses.
The study will also aim to identify a dose with a similar systemic exposure pharmacokinetic profile compared to 400 milligram or not in the best light the standard of care drugs.
At 96 hours post administration.
We expect the dosing of the first patient to occur during the fourth quarter of 2022.
Before we open the call to questions I want to provide a brief update on our financials.
As of September 32022, we had approximately $26 $5 million in cash cash equivalents and marketable securities.
Net loss for the quarter was approximately $4 $5 million or <unk> 18 per share.
We expect our existing cash cash equivalents and marketable securities will be sufficient to fund our normal operations and capital expenditure requirements through February 2024 subject to outcomes of our discussions with the FDA on Unfortunately, everybody program.
As we look to the remainder of the year, we will continue to provide updates as appropriate on the clinical hold over IGT for tomato nine programs.
And Additionally, we expect to initiate our fiber one bioequivalence study for a car T or one pro by the end of the year.
Thank our shareholders for their continued long term support of them have a case as we remain fully committed to our mission to improve the lives of patients suffering from devastating neurodegenerative and Hum.
Collateral diseases.
Like to now open the call for questions.
Sure.
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