The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Jonathan Chang, Ph.D., CFA - Leerink Partners LLC - Analyst
: A couple. First, can you give us some color on how the regulatory interactions on ziftomenib have progressed as we look towards the PDUFA date
later this year?
And then second question, how are you thinking about the scope of the farnesyl transferase inhibitor opportunity? Between the possible combinations
and tumor types, what do you see as an area or areas that Kura can move forward with alone? And which do you see as areas better suited for a
potential partner?
Question: Jason Zemansky - Bofa Merrill Lynch Asset Holdings Inc - Analyst
: Congrats on the progress. Maybe a high-level question for you, Troy. Now that the die has been cast regarding time lines, so to speak, can you
speak to some of the puts and takes regarding the commercial dynamics in the relapsed/refractory NPM1 setting? How much is your competitors'
REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us
consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies.
AUGUST 07, 2025 / 8:30PM, KURA.OQ - Q2 2025 Kura Oncology Inc Earnings Call
first-to-market advantage and current inroads as a hurdle? I mean, ultimately, how quickly do you think you can overcome any residual or at least
initial physician inertia here?
And then maybe secondarily, what are your expectations regarding the evolution of NCCN guidelines for the class, whether they include zifto
specifically or sort of just reference the larger menin inhibitor class?
Question: Ellen Horste, Ph.D. - Cowen and Company LLC - Analyst
: Congrats on such an exciting quarter. I'm just wondering what you think are the biggest potential risk to the pivotal program timelines, if there's
anything that could potentially push initial data out past 2028? And then is there any risk to running combined studies with both the KMT2A
population and the NPM1 population?
Question: Peter Lawson - Barclays Services Corp - Analyst
: I joined late, so I apologize if the question has already been asked just around about your FDA dialogue, how that's proceeding, if it's changed in
frequency or any emphasis that's changed around that? And the second question would be around importance of the AML maintenance setting.
And do you think you have the ability to kind of capture that market as well?
Question: Peter Green - LifeSci Capital LLC - Analyst
: This is Peter on for Charles. A couple of questions from my end. First of all, for the 2806 data in RCC at ESMO this fall, just wondering if you could
provide some color on patient baselines, how heavily pretreated rates of prior cabozantinib exposure?
And then second question, as you're looking down the nose of approval in relapsed/refractory NPM1 for ziftomenib, just wondering what your
plans are, if any, for additional data disclosures in that setting, for example, at ASH or in a journal release? Congrats on all the progress.
Question: Eric Musonza - UBS AG - Analyst
: This is Eric Musonza asking for David Dai. About the commercial readiness, could you share some more details about how Kyowa Kirin's existing
commercial sales force could help expedite the commercial execution? How many salespeople do you think will be needed for a successful launch?
And then just a quick follow-up on that. J&J just initiated their Phase 3 trials for bleximenib in frontline AML. How are you planning to catch up or
potentially leapfrog?
|