Kura Oncology, Inc. (NASDAQ:KURA) Q2 2022 Earnings Conference Call August 3, 2022 4:30 PM ET

Company Participants

Pete De Spain - Senior Vice President of Investor Relations

Troy Wilson - President and Chief Executive Officer

Tom Doyle - Senior Vice President of Finance and Accounting

Conference Call Participants

Jonathan Chang - SVB Securities

Tiago Fauth - Credit Suisse

Peter Lawson - Barclays

Roger Song - Jefferies

Li Watsek - Cantor Fitzgerald

Reni Benjamin - JMP Securities

Eva Privitera - Cowen, Inc.

Operator

Good day, and welcome to the Kura Oncology Second Quarter 2022 Conference Call. Today's conference is being recorded.

At this time, I would like to turn the conference over to Pete De Spain, Senior Vice President of Investor Relations. Please go ahead, sir.

Pete De Spain

Thank you, Sarah. Good afternoon and welcome to Kura Oncology's second quarter 2022 conference call. Joining me on the call are Dr. Troy Wilson, our President and Chief Executive Officer; and Tom Doyle, our Senior Vice President of Finance and Accounting.

Before I turn the call over to Dr. Wilson, I would like to remind you that today's call will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from expected results. Please refer to Kura's filings with the SEC, which are available from the SEC or on the Kura Oncology website for information concerning risk factors that could affect the Company.

With that, I'll now turn the call over to Troy.

Troy Wilson

Thank you, Pete, and thank you all for joining us this afternoon. Last year, as we continued in dose escalation with our menin inhibitor ziftomenib in an all-comer population of patients with relapsed or refractory acute myeloid leukemia, we sought FDA feedback regarding the design of our registration-directed trial. In the context of those discussions, FDA advised we spend more time in our Phase 1 study to identify an optimal dose. Guidance we now know was part of a broader FDA initiative in oncology drug development aptly named Project Optimus.

In agreement with FDA, we enrolled a Phase 1b study with two-dose expansion cohorts, 200 milligrams and 600 milligrams, each comprised of 12 patients with NPM1 mutant or KMT2A rearranged relapsed refractory AML. I'm pleased to report we've nearly completed our assessment of these patients in the expansion cohorts for efficacy, safety and tolerability, as well as pharmacokinetics and exposure, and we believe we've identified a recommended Phase 2 dose for ziftomenib. We're working diligently to gather the data package for submission to FDA and look forward to sharing the recommended Phase 2 dose for ziftomenib later this year, pending the agency's review along with top line data from the Phase 1b study with a more complete dataset reserved for presentation at a medical meeting in the fourth quarter.