On November 4, 2021 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported third quarter 2021 financial results and provided a corporate update (Press release, Kura Oncology, NOV 4, 2021, View Source [SID1234594418]).

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"I am pleased by the progress our team has made over the past quarter, highlighted by accelerated enrollment in the Phase 1b expansion cohorts for KO-539," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We continue to be encouraged by preliminary results from the Phase 1b study, with evidence of activity at both doses and a favorable safety and tolerability profile. Pending determination of a recommended Phase 2 dose, we are designing a development strategy that builds on the potential to register KO-539 as a monotherapy, while giving us the flexibility to get to larger opportunities in combination more quickly, including in earlier lines of therapy. We look forward to providing a more comprehensive update, including results from the Phase 1a and Phase 1b studies, at a future medical meeting."

Recent Highlights

Continued enrollment in Phase 1b expansion cohorts for KO-539 – Kura is currently enrolling two expansion cohorts in the Phase 1b portion of its KOMET-001 trial – a lower dose of 200 mg and a higher dose of 600 mg. Each cohort is comprised of patients with NPM1-mutant or KMT2A-rearranged relapsed or refractory acute myeloid leukemia (AML). Approximately half of an estimated 40 global sites are now actively screening patients for enrollment in the study. The Company maintains its enrollment guidance of 12 evaluable patients in each cohort by the first quarter of 2022. Once enrolled, patients in each cohort will be assessed for safety and tolerability, pharmacokinetics and efficacy to determine the recommended Phase 2 dose for KO-539.

Comprehensive clinical development strategy for KO-539 – Pending determination of a recommended Phase 2 dose, Kura intends to conduct a comprehensive clinical development plan for KO-539, both as a monotherapy and in combination. This development strategy builds on the potential to register KO-539 as a monotherapy while giving the Company the flexibility to address larger opportunities in combination more efficiently, including earlier lines of therapy.

ASH presentation to highlight potential for synergistic activity of KO-539 with venetoclax – Encouraging pre-clinical data has been generated through a research collaboration with Dr. Kapil Bhalla at the MD Anderson Cancer Center highlighting the molecular mechanisms of anti-leukemic activity for KO-539 and its potential for synergistic activity in combination with venetoclax in KMT2A-rearranged and NPM1-mutant AML models. These data have been accepted for presentation at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2021. The abstract was published earlier today and is now available on the ASH (Free ASH Whitepaper) website.

Final results from Phase 2 study of tipifarnib in T-cell lymphoma at ASH (Free ASH Whitepaper) – Final results from a Phase 2 study of tipifarnib in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) have been accepted for oral presentation by Dr. Thomas Witzig, Hematologist at Mayo Clinic and the study’s lead investigator, at the upcoming ASH (Free ASH Whitepaper) Annual Meeting. The abstract is now available on the ASH (Free ASH Whitepaper) website. The clinical benefit demonstrated in patients with certain subtypes of T-cell lymphoma, including an overall response rate of 56.3% (18/32) and a median overall survival of 32.8 months in patients with angioimmunoblastic T-cell lymphoma (AITL), underscores the potential to target farnesyl transferase to drive clinical benefit in patients with cancer.

First clinical site activated in Phase 1/2 trial of tipifarnib plus alpelisib in HNSCC – In July, Kura announced a clinical collaboration with Novartis to evaluate the combination of tipifarnib and the PI3Kα inhibitor alpelisib in patients with head and neck squamous cell carcinoma (HNSCC). The Company believes this combination has the potential to increase the total addressable population for tipifarnib to as much as 50% of patients with HNSCC and is now beginning a Phase 1/2 clinical trial (KURRENT) of tipifarnib in combination with alpelisib in patients who have HRAS- and/or PIK3CA-dependent HNSCC. Kura has now activated the first clinical site and expects to dose the first patient in the trial by the end of 2021.

Next-generation FTI program focused on delaying onset of drug resistance in large solid tumor indications – Last quarter, Kura nominated KO-2806 as the lead development candidate in its next-generation farnesyl transferase inhibitor (FTI) program. The Company’s next-generation FTI program is designed to target innovative biology and address large solid tumor indications of high unmet need through rational combinations, with a focus on delaying the onset of drug resistance. IND-enabling studies of KO-2806 are ongoing.
Financial Results and Guidance

Research and development expenses for the third quarter of 2021 were $22.4 million, compared to $16.6 million for the third quarter of 2020.

General and administrative expenses for the third quarter of 2021 were $11.3 million, compared to $7.6 million for the third quarter of 2020.

Net loss for the third quarter of 2021 was $33.4 million, compared to a net loss of $23.8 million for the third quarter of 2020. This included non-cash share-based compensation expense for the third quarter of 2021 of $6.1 million, compared to $3.4 million for the same period in 2020.

Cash, cash equivalents and short-term investments totaled $543.4 million as of September 30, 2021, compared with $633.3 million as of December 31, 2020.

Operating expenses for the full year 2021 are expected to be in the range of $130 million to $140 million.

Net cash used in operating activities for the full year 2021 is expected to be $105 million to $115 million.

Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2024.
Upcoming Milestones

Dose first patient in the KURRENT Phase 1/2 study of tipifarnib in combination with alpelisib by the end of 2021.

Complete enrollment of 24 evaluable patients in the KOMET-001 Phase 1b expansion cohorts by the first quarter of 2022.

Determine the recommended Phase 2 dose of KO-539 by the first quarter of 2022.

Submit an IND application for KO-2806 by the end of 2022.
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, November 4, 2021, to discuss the financial results for the third quarter 2021 and provide a corporate update. The live call may be accessed by dialing (866) 269-4260 for domestic callers and (323) 347-3277 for international callers and entering the conference code: 9395801. 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.