Inhibikase Therapeutics, Inc.
Q3 2022 Earnings Call Transcript

Published: 15 Nov 2022

[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

[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.

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