On August 3, 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 second quarter 2022 financial results and provided a corporate update (Press release, Kura Oncology, AUG 3, 2022, View Source [SID1234617380]).

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"We continue to advance our programs toward a series of important milestones later this year," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "For our menin inhibitor program, we have nearly completed our assessment of patients in the Phase 1b expansion cohorts of our KOMET-001 trial required to identify a recommended Phase 2 dose and remain enthusiastic about the potential for ziftomenib in the treatment of acute leukemias. We look forward to sharing the recommended Phase 2 dose later this year, pending FDA review, along with topline data from the Phase 1b study, followed by a more complete dataset at a medical meeting in the fourth quarter."

"For our farnesyl transferase inhibitor (FTI) program," Dr. Wilson continued, "we are encouraged by the preliminary safety and tolerability of tipifarnib in combination with the PI3Kα inhibitor, alpelisib, as well as early evidence of clinical activity observed in our KURRENT-HN trial. Meanwhile, we remain on track to initiate our KURRENT-LUNG trial of tipifarnib in combination with the EGFR inhibitor, osimertinib, later this quarter and submit an investigational new drug (IND) application for our next-generation FTI, KO-2806, by year end. And we approach these milestones from a position of financial strength, with $450 million in cash and investments that provide runway through 2024."

Recent Highlights

Recommended Phase 2 dose for ziftomenib identified, pending FDA review – In May 2022, Kura announced that it completed enrollment of the 24 patients in the Phase 1b expansion cohorts of the KOMET-001 trial required to identify a recommended Phase 2 dose for ziftomenib. The two Phase 1b expansion cohorts – 200 mg and 600 mg – are each comprised of patients with NPM1-mutant or KMT2A-rearranged relapsed/refractory acute myeloid leukemia (AML). The Company has nearly completed its assessment of the patients for efficacy, safety and tolerability as well as pharmacokinetics and exposure, and believes it has identified a recommended Phase 2 dose for ziftomenib, pending FDA review.

Additional 18 patients enrolled in KOMET-001 trial – Since May 2022, Kura has enrolled an additional 18 patients with NPM1-mutant or KMT2A-rearranged relapsed/refractory AML in the Phase 1b expansion cohorts as the Company prepares to transition into the Phase 2 registration-directed portion of the KOMET-001 trial and initiate a series of combination studies in the relapsed and frontline settings, pending determination of the recommended Phase 2 dose in consultation with the FDA. Kura believes data from all patients treated at the recommended Phase 2 dose will have the potential to contribute to the registrational patient population.

Preliminary activity observed in KURRENT-HN trial of tipifarnib plus alpelisib –Enrollment continues in the Phase 1/2 KURRENT-HN trial 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. In addition, the first patient has been dosed in a second cohort of patients with HRAS overexpression. Kura is encouraged by the preliminary safety and tolerability of the combination thus far, as well as early evidence of clinical activity. The Company believes the combination with alpelisib has the potential to increase the total addressable population for tipifarnib to as much as 50% of patients with HNSCC.

KURRENT-LUNG trial of tipifarnib plus osimertinib to initiate this quarter – Kura is preparing to initiate a Phase 1 KURRENT-LUNG trial of tipifarnib in combination with osimertinib in EGFR-mutated non-small cell lung cancer (NSCLC) later this quarter. Preclinical data, generated through a collaboration with INSERM (the French National Institute of Health and Medical Research), support the potential of tipifarnib to prevent emergence of resistance to osimertinib in EGFR-mutant NSCLC. The Company intends to perform initial clinical evaluation with tipifarnib while advancing its next-generation FTI, KO-2806, through IND-enabling studies.
Financial Results

Research and development expenses for the second quarter of 2022 were $24.3 million, compared to $21.1 million for the second quarter of 2021. The increase in R&D expenses was primarily due to increases in clinical trial costs related to the ziftomenib program and personnel costs.

General and administrative expenses for the second quarter of 2022 were $11.1 million, compared to $12.6 million for the second quarter of 2021. The decrease in G&A expenses was primarily due to decreases in personnel costs and professional
fees.

Net loss for the second quarter of 2022 was $34.8 million, compared to a net loss of $33.7 million for the second quarter of 2021.This included non-cash share-based compensation expense of $6.5 million, compared to $6.0 million for the same period in 2021.

Cash, cash equivalents and short-term investments totaled $450.3 million as of June 30, 2022, compared with $518.0 million as of December 31, 2021. Based on its operating plan, management expects that cash, cash equivalents and short-term investments will fund current operations through 2024.
2022 Milestones

Determine the recommended Phase 2 dose for ziftomenib in consultation with the FDA and report topline data from the Phase 1b study later this year.

Present updated data from KOMET-001 at a medical meeting in the fourth quarter.

Initiate the KURRENT-LUNG trial of tipifarnib and osimertinib 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, August 3, 2022, to discuss the financial results for the second quarter 2022 and to provide a corporate update. The live call may be accessed by dialing (888) 882-4478 for domestic callers and (323) 794-2590 for international callers and entering the conference ID: 8696904. 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.