On March 14, 2017 Kura Oncology, Inc., (NASDAQ:KURA) a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, reported fourth quarter and full year 2016 financial results and provided a corporate update (Press release, Kura Oncology, MAR 14, 2017, View Source;p=RssLanding&cat=news&id=2253894 [SID1234518171]).
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"Our precision medicine approach continues to deliver results, and we are pleased to have achieved important milestones in each of our programs," said Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology. "We are encouraged by the durability of responses observed in patients with HRAS mutant squamous cell carcinomas of the head and neck treated with tipifarnib, and believe our data validate HRAS as a driver oncogene in that disease. In our Phase 2 trial in PTCL, we have observed initial signals of clinical activity and identified potential biomarkers, including genes that are expressed and/or altered, which appear to be associated with the activity of tipifarnib. In our Phase 2 trial of tipifarnib in lower-risk MDS, based on anecdotal evidence of hematological improvement observed in several patients, we have amended the study to evaluate further dose regimens in an effort to optimize those initial findings. With KO-947, our ERK inhibitor, we anticipate initiating the Phase 1 study, and through preclinical studies have identified potential development opportunities, including KRAS and BRAF mutant cancers and squamous cell carcinomas. We also selected a development candidate in our menin-MLL inhibitor program, KO-539, which demonstrates potent anti-tumor activity in certain preclinical models of acute leukemia."
Recent Operational Highlights
Selection of KO-539, an orally-available small molecule inhibitor of the menin-MLL interaction, as a development candidate for the treatment of mixed lineage leukemias, a genetically-defined subset of the two most common forms of acute leukemia, acute myeloid leukemia and acute lymphoblastic leukemia
FDA acceptance of an Investigational New Drug (IND) application to begin Phase 1 clinical testing of KO-947, a small molecule inhibitor of extracellular-signal-regulated kinases 1 and 2 (ERK1/2) as a treatment for cancers in which the mitogen activated protein kinase (MAPK) pathway is dysregulated
Appointment of Steven H. Stein, M.D., to Kura’s board of directors. Dr. Stein currently serves as Executive Vice President and Chief Medical Officer of Incyte Corporation and has extensive experience in the discovery, development and commercialization of oncology therapeutics.
First patient dosed in Phase 2 clinical trial of tipifarnib in patients with chronic myelomonocytic leukemia (CMML)
Presentation of preclinical data highlighting the characterization of KO-947, and preclinical data relating to the identification and optimization of potent and selective inhibitors of the menin-MLL interaction. Both presentations took place at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Munich, Germany.
Upcoming Potential Milestones and Expectations for Clinical and Preclinical Programs
Initiation of the Phase 1 clinical trial for KO-947 during the first half of 2017
Data from the first and second stages of the Phase 2 trial of tipifarnib in peripheral T-cell lymphomas (PTCL) and associated biomarkers in the first half of 2017
Preclinical data for KO-947 and KO-539 in the first half of 2017
Additional data from the Phase 2 trial of tipifarnib in HRAS mutant squamous cell carcinomas of the head and neck (SCCHN) during 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 CMML during the first half of 2018
Financial Results for the Fourth Quarter and the Full Year 2016
Cash, cash equivalents and short-term investments totaled $67.8 million as of December 31, 2016, compared with $74.6 million as of September 30, 2016 and $85.7 million as of December 31, 2015. 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 fourth quarter of 2016 were $5.5 million, compared to $5.1 million for the fourth quarter of 2015. Research and development expenses for the full year 2016 were $20.4 million, compared to $17.8 million for the prior year.
General and administrative expenses for the fourth quarter of 2016 were $2.0 million, compared to $1.7 million for the fourth quarter of 2015. General and administrative expenses for the full year 2016 were $8.0 million, compared to $6.1 million for the prior year.
Net loss for the fourth quarter of 2016 was $7.3 million, compared to a net loss of $6.5 million for the fourth quarter of 2015. Net loss for the full year 2016 was $27.6 million, compared to a net loss of $22.6 million for the prior year.