On May 15, 2017 Kura Oncology, Inc., (NASDAQ:KURA) a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, reported first quarter 2017 financial results and provided a corporate update (Press release, Kura Oncology, MAY 15, 2017, View Source [SID1234519150]). Schedule your 30 min Free 1stOncology Demo! "We remain focused on operational execution, delivering on our portfolio and key milestones," said Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology. "With tipifarnib, we are working to build upon the encouraging clinical activity we observed in our Phase 2 trial in HRAS mutant squamous cell head and neck cancers. We are also seeking to validate the potential novel biomarkers we identified in our Phase 2 trial in patients with PTCL, which we believe are associated with the initial activity we observed. We recently advanced KO-947, our second product candidate, into clinical testing, and we believe its profile and a substantial body of preclinical data make it a compelling therapeutic candidate. I’m pleased with our progress to advance multiple targeted programs aimed at addressing the urgent needs of cancer patients facing a poor prognosis and limited treatment options."
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Recent Operational Highlights
First patient dosed in Phase 1 trial of KO-947 – In April, Kura began clinical testing of KO-947 as a potential treatment for cancers in which the mitogen activated protein kinase (MAPK) pathway is dysregulated. The trial design includes a dose escalation, maximum tolerated dose expansion and one or more tumor-specific extension cohorts.
Composition of matter patent issued for KO-947 – In April, the U.S. Patent and Trademark Office issued a patent that covers KO-947, a drug candidate targeting extracellular-signal-regulated kinases (ERK), and structurally-related compounds, as well as methods of using the compounds for the treatment of diseases including cancer.
Preclinical data presentation for KO-947 at AACR (Free AACR Whitepaper) – In April, Kura presented preclinical data for KO-947 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017. The data showed that KO-947 demonstrated prolonged inhibition of the MAPK pathway and durable tumor regression was observed in preclinical cell line and patient-derived xenograft models, including KRAS- and BRAF-mutant adenocarcinomas and squamous cell carcinomas lacking BRAF/RAS mutations.
Preclinical data presentation for KO-539 at AACR (Free AACR Whitepaper) – In April, Kura presented preclinical data for KO-539, its development candidate targeting the menin-MLL interaction. The data showed that KO-539 demonstrated robust, sustained tumor regressions in multiple aggressive models of MLL-rearranged leukemias that correlated with modulation of target gene expression.
Upcoming Potential Milestones and Expectations for Clinical and Preclinical Programs
A trial-in-progress poster presentation for the Phase 2 trial of tipifarnib in HRAS mutant squamous cell carcinomas of the head and neck (SCCHN), including supporting rationale from patient-derived xenograft models at the ASCO (Free ASCO Whitepaper) Annual Meeting on June 2-6, 2017.
Poster presentation with data from the first and second stages of the Phase 2 trial of tipifarnib in peripheral T-cell lymphomas (PTCL) and associated biomarkers at the European Hematology Association (EHA) (Free EHA Whitepaper) conference on June 22-25, 2017.
Additional data from the Phase 2 trial of tipifarnib in HRAS mutant SCCHN in the second half of 2017.
Additional preclinical and clinical data for tipifarnib in PTCL, in the second half of 2017.
Data from the Phase 2 tipifarnib trials in lower risk myelodysplastic syndromes (MDS) and in chronic myelomonocytic leukemia (CMML) in the first half of 2018.
Data from KO-947 Phase 1 in 2018.
Financial Results for the First Quarter 2017
Cash, cash equivalents and short-term investments totaled $59.2 million as of March 31, 2017, compared with $67.8 million as of December 31, 2016. Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund current operations into the second half of 2018.
Research and development expenses for the first quarter of 2017 were $5.5 million, compared to $4.6 million for the first quarter of 2016.
General and administrative expenses for the first quarter of 2017 were $2.1 million, compared to $2.4 million for the first quarter of 2016.
Net loss for the first quarter of 2017 was $7.5 million, or $0.39 per share, compared to a net loss of $6.6 million, or $0.36 per share, for the first quarter of 2016.