On November 7, 2017 Kura Oncology, Inc., (Nasdaq:KURA) a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported third quarter 2017 financial results and provided a corporate update (Press release, Kura Oncology, NOV 7, 2017, View Source;p=RssLanding&cat=news&id=2315104 [SID1234521681]).
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"Over the last several months, Kura has continued to deliver important advances against our pipeline priorities," said Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology. "We recently achieved a key milestone with positive Phase 2 results for our lead product candidate, tipifarnib, to treat relapsed or refractory head and neck squamous cell carcinomas (HNSCC) with HRAS mutations. This positive study validates the potential of our precision medicine approach to generate evidence of clinical activity in a well-defined, difficult-to-treat patient population that we believe justifies continued and rapid drug development. Based on these very encouraging clinical results and, subject to further input from regulatory authorities, we plan to initiate a registration-enabling study of tipifarnib in HRAS mutant HNSCC in 2018.
"In addition, we continue to evaluate tipifarnib in our ongoing Phase 2 trials in peripheral T-cell lymphoma (PTCL), myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML), as well as advance our pipeline programs, KO-947 and KO-539, and we look forward to providing additional updates on these programs over the next several quarters. Finally, we expect the proceeds from our capital raise in August, coupled with our existing cash on hand, will provide the resources necessary to support our pipeline of precision medicines through a series of significant milestones anticipated in 2018."
Recent Operational Highlights
Positive Phase 2 study of tipifarnib in HRAS mutant HNSCC – In September, Kura announced positive topline results from a Phase 2 trial of tipifarnib in patients with HRAS mutant HNSCC. The trial achieved its primary endpoint prior to the completion of patient enrollment. Updated results from this study presented at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference in October showed that confirmed partial responses were observed in four out of six patients with HRAS mutant HNSCC, and tipifarnib demonstrated rapid and durable responses, with partial responses observed beyond one year in duration.
KO-539 shows robust anti-tumor activity in preclinical models of AML – In October, Kura presented preclinical data for KO-539, an inhibitor of the menin-MLL interaction, which supports the potential clinical utility of KO-539 in NPM1- and DNMT3A-mutant acute myeloid leukemia (AML). The data, presented at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference, suggest KO-539 drives robust and persistent responses in preclinical models of AML and has the potential to be active in subtypes representing approximately half of patients with AML.
Completed follow-on offering – In August, Kura completed an underwritten public offering resulting in net proceeds to the company of approximately $53.5 million.
Upcoming Potential Milestones and Expectations for Clinical Programs
Presentation of preliminary results from the ongoing Phase 2 trial of tipifarnib in CMML at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2017
Presentation on the CXCL12/CXCR4 Pathway as a potential target of tipifarnib in AML and MDS at ASH (Free ASH Whitepaper) in December 2017
Presentation on the CXCL12/CXCR4 Pathway as a potential target of tipifarnib from the ongoing Phase 2 trial of tipifarnib in PTCL at ASH (Free ASH Whitepaper) in December 2017
Presentation of updated results from the Phase 2 trial of tipifarnib in HRAS mutant HNSCC at the Multidisciplinary Head and Neck Cancers Symposium in February 2018
Additional data from the Phase 2 trials of tipifarnib in PTCL, CMML and MDS in 2018
Data from the KO-947 Phase 1 trial in non-hematological malignancies in 2018
Initiation of a registration-enabling trial of tipifarnib in HRAS mutant HNSCC in 2018
Financial Results for the Third Quarter 2017
Cash, cash equivalents and short-term investments totaled $100.8 million as of September 30, 2017, compared with $53.2 million as of June 30, 2017. Cash, cash equivalents and short-term investments at the end of September includes net proceeds of approximately $53.5 million from the follow-on offering in August. Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into 2019.
Research and development expenses for the third quarter of 2017 were $7.1 million, compared to $5.3 million for the third quarter of 2016.
General and administrative expenses for the third quarter of 2017 were $2.4 million, compared to $1.7 million for the third quarter of 2016.
Net loss for the third quarter of 2017 was $9.3 million, or $0.38 per share, compared to a net loss of $6.9 million, or $0.37 per share, for the third quarter of 2016.
Conference Call and Webcast
Kura’s management will host a webcast and conference call regarding this announcement at 1:30 p.m. PT/4:30 p.m. ET today. The live call may be accessed by dialing (877) 516-3514 for domestic callers and (281) 973-6129 for international callers and using conference ID # 2685708. A live webcast of the call will be available from the investor relations section of the company website at www.kuraoncology.com, and will be archived there for 30 days. A telephone replay of the call will be available by dialing (855) 859-2056 for domestic callers, or (404) 537-3406 for international callers, and entering the conference ID # 2685708.