On February 23, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported fourth quarter and full year 2022 financial results and provided a corporate update (Press release, Kura Oncology, FEB 23, 2023, View Source [SID1234627617]).

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"We continue to have strong conviction in ziftomenib and its potential to be the best-in-class menin inhibitor," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "The speed with which we have begun enrolling patients with NPM1-mutant acute myeloid leukemia (AML) in our registration-directed trial speaks to our impressive Phase 1 data in this population as well as the significant interest in ziftomenib among investigators. In addition, we believe ziftomenib is well positioned for future combination strategies, with no evidence of drug-induced QTc prolongation, no predicted adverse drug-drug interactions and oral daily dosing that should enable convenient administration with standards of care. We continue to prioritize investment in the program and look forward to sharing further updates as the year progresses, including the presentation of a more mature dataset from our Phase 1 trial of ziftomenib in NPM1-mutant AML patients at a medical meeting in mid-2023."

"Meanwhile, clearance of the IND for KO-2806 marks an important next step for our next-generation farnesyl transferase inhibitor (FTI) program," Dr. Wilson continued. "Our preclinical data is supportive of FTIs in combination with a growing number of targeted therapies, including EGFR inhibitors and PI3 kinase alpha inhibitors as well as tyrosine kinase inhibitors in renal cell carcinoma and KRAS G12C inhibitors in lung cancer, and we look forward to starting our first-in-human trial of KO-2806 in the coming months."

Recent Highlights

Updated clinical data from Phase 1 trial of ziftomenib at ASH (Free ASH Whitepaper) – In December, Kura reported updated data from its Phase 1 trial of ziftomenib, the Company’s potent and selective menin inhibitor, in an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The data highlighted the encouraging safety profile and clinical activity of ziftomenib in patients with relapsed/refractory AML, including a 30% complete response (CR) rate with full count recovery among 20 patients with NPM1-mutant AML treated at the 600 mg dose. Notably, two-thirds of NPM1-mutant AML patients who achieved a CR at 600 mg had IDH and/or FLT3 co-mutations, all of whom had failed prior treatment with IDH and/or FLT3 inhibitors. A median duration of response had not been reached as of the ASH (Free ASH Whitepaper) data cutoff on October 24, 2022.

Recommended Phase 2 dose for ziftomenib in NPM1-mutant AML – In December, Kura also announced that 600 mg once-daily dosing has been designated as the recommended Phase 2 dose and schedule for ziftomenib in NPM1-mutant AML following a positive Type C meeting with the U.S. Food and Drug Administration (FDA). Agreement was also reached on key elements of the Company’s Phase 2 registration-directed trial design.

First patients dosed in registration-directed trial of ziftomenib in NPM1-mutant AML – Earlier this month, Kura announced that multiple patients had been dosed in its Phase 2 registration-directed trial (KOMET-001) of ziftomenib in NPM1-mutant relapsed or refractory AML. The Company expects to enroll a total of 85 patients in the U.S. and Europe. The primary endpoint is CR or CR with partial hematologic recovery (CRh), and key secondary endpoints include duration of response, transfusion independence, safety and tolerability. NPM1-mutant AML accounts for approximately 30% of new AML cases annually and represents a disease of significant unmet need for which no approved targeted therapy exists.

Combination trials to support commercial potential for ziftomenib – Kura is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML. The Company intends to establish a foundation where ziftomenib can be combined safely with various commonly used regimens, such as venetoclax plus azacitidine, FLT3 inhibitors and standard induction cytarabine plus daunorubicin (7+3) chemotherapy, then prioritize those combinations that represent the largest populations and greatest potential commercial value. Kura expects to initiate the first of these trials, KOMET-007, in the first half of 2023.

Preliminary proof of mechanism of tipifarnib plus alpelisib in HNSCC – In October, Kura reported the first demonstration that the combination of tipifarnib and alpelisib can induce a durable clinical response in PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC) at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium. A patient with stage III squamous cell carcinoma of the tonsil with a PIK3CA mutation achieved a durable partial response in the Company’s KURRENT-HN trial and continued on-study for more than 27 weeks as of the data cutoff on September 14, 2022. Treatment-related adverse events in KURRENT-HN are consistent with the known safety profiles of each drug and are manageable, with no dose-limiting toxicities reported to date.

IND for KO-2806, a next-generation farnesyl transferase inhibitor – Last month, Kura announced FDA clearance of its Investigational New Drug (IND) application for KO-2806 for the treatment of advanced solid tumors. KO-2806 is a potent inhibitor of farnesyl transferase designed to improve upon potency, pharmacokinetic and physicochemical properties of earlier FTI drug candidates. The Company intends to evaluate safety, tolerability and preliminary antitumor activity of KO-2806 in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors.

$25 million equity investment from Bristol Myers Squibb – In November, Kura sold 1,370,171 shares to Bristol Myers Squibb at a price of $18.25 per share for gross proceeds of $25 million. In connection with the equity investment, Bristol Myers Squibb has appointed a member to Kura’s Global Steering Committee. The equity investment further strengthens the relationship between the two organizations and enables Bristol Myers Squibb, a leader in the discovery and development of transformational cancer treatments, to provide valuable strategic input into Kura’s global development strategy.
Financial Results

Research and development expenses for the fourth quarter of 2022 were $22.7 million, compared to $21.0 million for the fourth quarter of 2021. R&D expenses for the full year 2022 were $92.8 million, compared to $84.7 million for the prior year.

General and administrative expenses for the fourth quarter of 2022 were $12.5 million, compared to $12.1 million for the fourth quarter of 2021. G&A expenses for the full year 2022 were $47.1 million, compared to $46.5 million for the prior year.

Net loss for the fourth quarter of 2022 was $33.1 million, compared to a net loss of $32.7 million for the fourth quarter of 2021. Net loss for the full year 2022 was $135.8 million, compared to a net loss of $130.5 million for the prior year. Net loss for the fourth quarter and full year 2022 included non-cash, share-based compensation expense of $6.8 million and $26.3 million, respectively, compared to $6.4 million and $23.6 million for the same periods in 2021.

Cash, cash equivalents and short-term investments totaled $438.0 million as of December 31, 2022, including the $25 million equity investment from Bristol Myers Squibb and a one-time $10 million draw from a term loan facility with Hercules Capital, 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 into the fourth quarter of 2025.
Forecasted Milestones

Dose the first patients in the KOMET-007 combination trial of ziftomenib in the first half of 2023.

Present updated data from the KOMET-001 trial of ziftomenib in NPM1-mutant AML at a medical meeting in mid-2023.

Dose the first patients in the KOMET-008 combination trial of ziftomenib in the second half of 2023.

Determine the optimal biologically active dose in the KURRENT-HN trial of tipifarnib in combination with alpelisib in mid-2023.

Dose the first patients in the FIT-001 dose-escalation trial of KO-2806 in the third quarter of 2023.
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, February 23, 2023, to discuss the financial results for the fourth quarter and full year 2022 and to provide a corporate update. The live call may be accessed by dialing (877) 407-4018 for domestic callers and (201) 689-8471 for international callers and entering the conference ID: 13735896. 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.