On November 7, 2016 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 2016 financial results and recent business highlights (Press release, Kura Oncology, NOV 7, 2016, View Source;p=RssLanding&cat=news&id=2220292 [SID1234516570]).

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"During the third quarter, we have continued to advance our tipifarnib development program," said Troy Wilson, Ph.D., J.D., President and CEO of Kura Oncology. "Our Phase 2 HRAS solid tumor trial is progressing and the two patients from stage 1 with partial responses have now been on study for 15 months and 8 months, which is encouraging given the relatively limited clinical benefit these patients observed on prior therapy. We have focused the second stage of the trial on patients with HRAS mutant squamous cell head and neck cancer, and we look forward to additional results in this patient population."

"In addition, our trials in PTCL and lower-risk MDS are ongoing, and we recently initiated our planned Phase 2 trial for tipifarnib in patients with CMML," stated Dr. Wilson. "We believe each of these Phase 2 studies has a strong scientific and clinical rationale, and they provide multiple potential opportunities for registration-enabling studies."

Dr. Wilson continued, "We are preparing to advance our ERK inhibitor, KO-947, into clinical testing and are encouraged by the consistent and compelling activity we have observed in preclinical models of cancers with mutations or dysregulation of the MAPK pathway as well as by our identification of potential biomarkers to guide development. I am very pleased we are on track to submit an IND before year-end."

Upcoming Clinical and Preclinical Activities for Kura Oncology Programs

Submission of the investigational new drug (IND) for KO-947 is anticipated in the fourth quarter of 2016.

Nomination of a development candidate for the menin-MLL program is anticipated in the fourth quarter of 2016.

Presentation of preclinical data for KO-947 and menin-MLL program at EORTC in Munich in November 2016.

Initiation of a Phase 1 study for KO-947 is anticipated in the first half of 2017.

Topline data from the Phase 2 study of tipifarnib in PTCL is anticipated in the first half of 2017.

Additional data from the Phase 2 study of tipifarnib in HRAS mutant tumors is anticipated in the first half of 2017.
Financial Results for the Third Quarter 2016

Cash, cash equivalents and short-term investments totaled $74.6 million as of September 30, 2016, compared with $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 2018.

Research and development expenses for the third quarter of 2016 were $5.3 million, compared to $4.6 million for the third quarter of 2015.

General and administrative expenses for the third quarter of 2016 were $1.7 million, compared to $1.8 million for the third quarter of 2015.

Net loss for the third quarter of 2016 was $6.9 million, or $0.37 per share, compared to a net loss of $6.1 million, or $0.57 per share, for the third quarter of 2015.