Kura Oncology, Inc. (NASDAQ:KURA) Q1 2024 Earnings Conference Call May 2, 2024 4:30 PM ET

Company Participants

Pete De Spain - EVP, IR
Troy Wilson - President & CEO
Thomas Doyle - SVP of Finance & Accounting

Conference Call Participants

Jonathan Chang - Leerink Partners
Jason Zemansky - Bank of America
Roger Song - Jefferies
Li Watsek - Cantor Fitzgerald
Bradley Canino - Stifel
Peter Lawson - Barclays
Reni Benjamin - Citizens JMP
Justin Zelin - BTIG
George Farmer - Scotiabank

Operator

Good afternoon, ladies and gentlemen, and welcome to the Q1 2024 Kura Oncology Financial Results Conference Call. At this time, all participants are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. [Operator Instructions] This call is being recorded on Thursday, May 2, 2024.

I would now like to turn the conference over to Pete De Spain, Head of Investor Relations. Please go ahead.

Pete De Spain

Thanks, Chris. Good afternoon, and welcome to Kura Oncology's First Quarter 2024 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'd 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. Let's jump right in. Last week, we were proud to announce that ziftomenib is the first investigational treatment to be granted breakthrough therapy designation for the treatment of NPM1-mutant AML. The FDA granted BTD for Ziftomenib based on data from our ongoing KOMET-001 clinical trial in patients with relapsed refractory NPM1-mutant AML. NPM1-mutant AML is a disease of significant unmet need for which there is no approved targeted therapy, and it represents approximately 30% of new AML cases annually.

BTD is awarded for a drug that treats a serious or life-threatening condition and may demonstrate substantial improvement on one or more clinically significant end points over available therapies. The designation is intended to expedite development and review of drugs, including an organizational commitment by FDA senior managers and experienced review staff as well as eligibility for rolling review and priority review.