On November 5, 2020 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 2020 financial results and provided a corporate update (Press release, Kura Oncology, NOV 5, 2020, View Source [SID1234570120]).
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"Our team is focused on developing novel therapies for patients with cancer," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "With our menin inhibitor, KO-539, we are encouraged by the early evidence of activity in our KOMET-001 Phase 1/2 clinical trial in patients with acute myeloid leukemia (AML), and look forward to presenting updated data from the trial in an oral presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting next month. With tipifarnib, in addition to conducting our ongoing AIM-HN registration-directed trial of tipifarnib in recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma (HNSCC), we recently presented preclinical data that underscore the potential to combine tipifarnib with a PI3Kα inhibitor to treat between 25% and 50% of HNSCC patients, and look forward to initiating a combination trial of these two targeted therapies in mid-2021."
Corporate Update
Preliminary data for KO-539 accepted for oral presentation at ASH (Free ASH Whitepaper) – An abstract reporting preliminary data from KOMET-001, a first-in-human study of the Company’s oral, potent and selective menin inhibitor, KO-539, has been accepted for oral presentation at ASH (Free ASH Whitepaper). The abstract, posted on the ASH (Free ASH Whitepaper) website on November 4, 2020, highlighted encouraging safety and tolerability, as well as evidence of anti-leukemic activity as of the data cutoff of August 10, 2020. Kura plans to present a more mature dataset, including data from approximately 10 patients, in the oral presentation at ASH (Free ASH Whitepaper) on December 5, 2020, followed by a virtual investor event featuring two of the trial’s investigators.
KO-539 approaching recommended Phase 2 dose, expansion cohorts – Kura remains focused on its goal of reaching a recommended Phase 2 dose for KO-539 as KOMET-001 continues in dose escalation. The Company continues to add clinical sites in anticipation of moving into the expansion cohorts, pending additional clinical data. The planned expansion cohorts include NPM1-mutant AML and KMT2A(MLL)-rearranged AML, selected patient populations where KO‑539 has the potential to demonstrate increased clinical benefit. Kura believes KO-539 represents a differentiated approach to target genetic subsets representing potentially 35% or more of the total adult AML population. In addition, Kura continues to explore options to potentially broaden the opportunity in the treatment of acute leukemias.
Preclinical data support expansion opportunity for tipifarnib in HNSCC – Last month, Kura reported new preclinical data showing compelling activity of its late-stage drug candidate, tipifarnib, when combined with a PI3Kα inhibitor in models of HRAS-dependent and/or PI3K dependent HNSCC. The data, presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, support the Company’s upcoming Phase 1/2 trial of tipifarnib in combination with a PI3Kα inhibitor in advanced or unresectable relapsed/refractory HNSCC harboring PIK3CA mutations or amplifications and/or HRAS overexpression. Kura believes that the total addressable population for tipifarnib may be between 25-50% of HNSCC.
Leadership team enhanced with addition of Dr. Stephen Dale – In August, Kura appointed Stephen Dale, M.D., as its new Chief Medical Officer. Dr. Dale joined the Company most recently from Kyowa Kirin, where he served as Senior Vice President and Global Head of Medical Science with a primary focus in oncology. Previously, he was Global Clinical Vice President and Clinical Head of Oncology at AstraZeneca, where he oversaw the development of Tagrisso (osimertinib) for metastatic EGFR-T790M mutation-positive non-small cell lung cancer.
Financial Results
Research and development expenses for the third quarter of 2020 were $16.6 million, compared to $12.5 million for the third quarter of 2019.
General and administrative expenses for the third quarter of 2020 were $7.6 million, compared to $5.1 million for the third quarter of 2019.
Net loss for the third quarter of 2020 was $23.8 million, compared to a net loss of $16.4 million for the third quarter of 2019.
Cash, cash equivalents and short-term investments totaled $325.4 million as of September 30, 2020, compared with $236.9 million as of December 31, 2019.
Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2023.
Conference Call and Webcast
Kura’s management will host a webcast and conference call today at 8:00 a.m. ET / 5:00 a.m. PT today, November 5, 2020, to discuss the financial results for the third quarter 2020 and provide a corporate update. The live call may be accessed by dialing (877) 516-3514 for domestic callers and +1 (281) 973-6129 for international callers and entering the conference code: 7456326. A live webcast of the call will be available from the Investors and Media section of the Company’s website at www.kuraoncology.com, and will be archived there for 30 days.