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Dec 31, 2023
Kura Oncology Q4 2023 Earnings Report
Reported fourth quarter and full year financial results and provided a corporate update.
Key Takeaways
Kura Oncology reported its fourth quarter and full year 2023 financial results, highlighting positive preliminary data from the KOMET-007 trial of ziftomenib in AML and the first patient dosed in the KOMET-008 trial. The company anticipates completing enrollment in the registration-directed trial of ziftomenib in NPM1-m AML by mid-2024 and has $570 million in pro forma cash providing runway into 2027.
Reported positive preliminary combination data from KOMET-007 trial of ziftomenib in NPM1-m and KMT2A-r AML, including effective mitigation of differentiation syndrome.
Dosed first patient in KOMET-008 trial of ziftomenib in combination with additional standards of care in AML.
Anticipate completion of enrollment in registration-directed trial of ziftomenib in NPM1-m AML by mid-2024.
Possess $570 million in pro forma cash, providing runway into 2027.
Forward Guidance
Kura Oncology provided several forecasted milestones.
Positive Outlook
- Initiate the post-transplant maintenance program for ziftomenib in the first quarter of 2024.
- Complete enrollment of 85 patients in the KOMET-001 registration-directed trial of ziftomenib in NPM1-m AML by mid-2024.
- Initiate an expansion cohort evaluating ziftomenib as a monotherapy in patients who have neither NPM1-mutant nor KMT2A-rearranged AML by mid-2024.
- Determine the RP2D for ziftomenib in combination with ven/aza and initiate dose validation/expansion in frontline AML by mid-2024.
- Determine the RP2D for ziftomenib in combination with 7+3 by mid-2024.
Challenges Ahead
- Dose the first patients in the FIT-001 dose-escalation trial of KO-2806 in combination with cabozantinib in ccRCC by mid-2024.
- Dose the first patients in the FIT-001 dose-escalation trial of KO-2806 in combination with adagrasib in KRASG12C-mutated NSCLC by mid-2024.
- Complete enrollment of two expansion cohorts to support determination of the optimal biologically active dose for tipifarnib in combination with alpelisib by the end of 2024.
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