On May 4, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported first quarter 2022 financial results and provided a corporate update (Press release, Kura Oncology, MAY 4, 2022, View Source [SID1234613515]).
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"We continue to operate from a position of strength, armed with three independent drug development programs, near-term clinical milestones and cash runway through 2024," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Our team continues to execute, having completed enrollment of the Phase 1b expansion cohorts for our menin inhibitor, ziftomenib, and we remain very encouraged by the safety profile, tolerability and clinical activity we are observing in the study. We continue to assess patients in the Phase 1b for safety and tolerability, pharmacokinetics and exposure, as well as efficacy, and we look forward to identifying a recommended Phase 2 dose for ziftomenib and reporting topline data from the study next quarter."
Recent Highlights
Enrollment completed in Phase 1b expansion cohorts for ziftomenib – Kura has completed enrollment of the patients in the Phase 1b portion of KOMET-001 required to identify a recommended Phase 2 dose for ziftomenib. The Phase 1b portion was designed to enroll two expansion cohorts – 200 mg and 600 mg – with each cohort comprised of patients with NPM1-mutant or KMT2A-rearranged relapsed and/or refractory acute myeloid leukemia (AML). The goal of the Phase 1b portion is dose optimization, and the two doses were selected based on the encouraging clinical activity, safety profile and tolerability demonstrated in the Phase 1a portion of KOMET-001. Kura remains on track to identify the recommended Phase 2 dose for ziftomenib and report topline data from the Phase 1b portion of KOMET-001 in the third quarter of 2022, with a more complete dataset reserved for presentation at a medical meeting in the fourth quarter of 2022.
Expanded opportunity for tipifarnib in head and neck squamous cell carcinoma – Enrollment continues in the Phase 1/2 clinical trial (KURRENT-HN) of tipifarnib in combination with the PI3Kα inhibitor alpelisib in patients with head and neck squamous cell carcinoma (HNSCC). The initial cohort includes patients who have PIK3CA-dependent HNSCC, and Kura expects to dose the first patient in an HRAS overexpression cohort in the third quarter of 2022. The Company believes the combination with alpelisib has the potential to drive deeper and more durable responses than either agent as monotherapy and to increase the total addressable population for tipifarnib to as much as 50% of patients with HNSCC.
Preclinical data support use of tipifarnib to prevent relapse to osimertinib – In April 2022, preclinical data supporting the potential of tipifarnib to prevent emergence of resistance to osimertinib in EGFR mutant non-small cell lung cancer (NSCLC) were reported at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Kura is now preparing to initiate a Phase 1 trial (KURRENT-LUNG) of tipifarnib in combination with osimertinib in treatment-naïve locally advanced/metastatic EGFR mutated NSCLC and expect to dose the first patient in the third quarter of 2022. The Company intends to perform initial clinical evaluation with tipifarnib while in parallel advancing KO-2806, Kura’s next-generation farnesyl transferase inhibitor (FTI), through investigational new drug (IND)-enabling studies.
Financial Results
Research and development expenses for the first quarter of 2022 were $20.9 million, compared to $20.3 million for the first quarter of 2021. The increase in R&D expenses was primarily due to increases in ziftomenib clinical trial and personnel costs.
General and administrative expenses for the first quarter of 2022 were $11.9 million, compared to $10.6 million for the first quarter of 2021. The increase in G&A expenses was primarily due to increases in professional fees and non-cash share-based compensation.
Net loss for the first quarter of 2022 was $32.5 million, compared to a net loss of $30.7 million for the first quarter of 2021. This included non-cash share-based compensation expense of $6.7 million, compared to $5.1 million for the same period in 2021.
Cash, cash equivalents and short-term investments totaled $480.1 million as of March 31, 2022, compared with $518.0 million as of December 31, 2021. Based on its current plans, management expects that current cash, cash equivalents and short-term investments will fund current operations through 2024.
2022 Milestones
Identify the recommended Phase 2 dose of ziftomenib and report topline data from the Phase 1b study in the third quarter.
Present updated data from KOMET-001 at a medical meeting in the fourth quarter.
Dose the first patient in the HRAS overexpression cohort of the KURRENT-HN trial by the third quarter.
Dose the first patient in the KURRENT-LUNG trial in the third quarter.
Submit an IND application for KO-2806 in the fourth quarter.
Conference Call and Webcast
Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, May 4, 2022, to discuss the financial results for the first quarter 2022 and to provide a corporate update. The live call may be accessed by dialing (844) 826-3035 for domestic callers and (412) 317-5195 for international callers and entering the conference code: 10166202. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.