Inhibikase Therapeutics, Inc. (NASDAQ:IKT) Q3 2022 Earnings Conference Call November 15, 2022 8:00 AM ET
Company Participants
Alex Lobo – Stern Investor Relations
Milton Werner – President and Chief Executive Officer
Conference Call Participants
Operator
Good day, and welcome to Inhibikase Therapeutics’ Third Quarter 2022 Financial Results Conference Call. All participants are in listen-only mode. [Operator Instructions] Please note, this event is being recorded.
I would now turn the conference over to Alex Lobo, Stern Investor Relations. Please go ahead.
Alex Lobo
Good morning, and welcome to Inhibikase Therapeutics third quarter 2022 financial results conference call and audio webcast.
With me today is Dr. Milton Werner, Chief Executive Officer; and Joseph Frattaroli, Chief Financial Officer.
Yesterday, Inhibikase issued a press release announcing financial results for the third quarter ended September 30, 2022. We encourage everyone to read yesterday’s press release, as well as Inhibikase’s 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 Inhibikase’s website at inhibikase.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 15, 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. Milton Werner. Milton, you may begin.
Milton Werner
Thank you, Alex. And thank you for joining us today to review Inhibikase’s third quarter 2022 financial results and recent business updates. Let me start by providing update on our IkT-148009 or 148009 programs. On November 7 we announced that the U.S. Food and Drug Administration had reviewed our investigational new drug or IND application for IkT-148009 for the treatment of multiple system atrophy or MSA. As a result of their review, they issued a clinical hold on the IkT-148009-201 program in Parkinson’s disease or PD and the use of IkT-148009 in MSA. In in their email correspondence, the FDA indicated that an official clinical hold letter will be issued within 30 days.
I would like to highlight today that we have observed only two mild adverse events in the ongoing Phase 2a 201 trial, and have recorded no serious adverse events. We are actively working with the FDA to understand the agency’s concerns and 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 the 201 trial and will randomize 1:1:1:1 for the 12-week once-daily dosing. However, since 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 1 and 1b study of IkT-148009 that were presented at the Movement Disorder Society Congress in September of this year. These data highlighted that IkT-148009 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 in patients with Parkinson’s disease.
Moreover, assessments of motor, non-motor and quality of life in patients enrolled in the study showed that treatment with IkT-148009 did not worsen disease over seven-day dosing. Our highest priority is to resolve any questions or concerns from the FDA to resume our clinical development of IkT-148009 as soon as possible.
Turning briefly to our preclinical efforts, we are continuing to advance IkT-001Pro towards the clinic by the end of the year. As a reminder, IkT-001Pro is our prodrug formulation of the imatinib mesylate developed to improve the safety of the first FDA improved Abelson Tyrosine Kinase inhibitor known as imatinib as a treatment for stable-phase Chronic Myelogenous Leukemia or CML.
We received FDA clearance for our IND application for IkT-001Pro in August of this year. As you know, imatinib is commonly taken for hematological and gastrointestinal cancers that arises from Abl kinase mutations in the bone marrow or for gastrointestinal cancers that occurred from CK mutations in the stomach. Our prodrug formulation has the potential to be a safer alternative for patients and may improve the number of patients that reach and sustain major or complete cytogenic responses in stable phase CML. In preclinical studies, IkT-001Pro could be dosed up 3, 4 times higher than imatinib in non-human primates before inducing adverse event. If observed in people, this has the potential to reduce the burdensome gastrointestinal side effects that occur following oral administration in the CML or gastrointestinal stromal tumor patients.
We are now advancing IKT-001Pro into a single ascending dose 501 bio-equivalence 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 who will receive IkT-001Pro at one of three doses. The study will also aim to identify a dose with a similar systemic exposure of pharmacokinetic profile compared to 400-milligram imatinib mesylate, the standard of care drug at 96 hours post administration. We expect the dosing of the first patient occurred 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 30, 2022 we had approximately $26.5 million in cash, cash equivalents and marketable securities. Net loss for the quarter was approximately $4.5 million or $0.18 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 from our discussions with the FDA on the 148009 program. As we look to the remainder of the year, we will continue to provide updates as appropriate on the clinical hold of our IkT-148009 programs. And additionally, we expect to initiate our 501 bioequivalence study for IkT-001Pro by the end of the year.
I want to thank our shareholders for their continued long-term support of Inhibikase as we remain fully committed to our mission to improve the lives of patients suffering from devastating neurodegenerative and oncological diseases.
I would like to now open the call for questions. Operator?
Operator
[Operator Instructions] This concludes our question-and-answer session and concludes the conference call. Thank you for attending today’s presentation. You may now disconnect.
Question-and-Answer Session
Q –
Be the first to comment