Good day, ladies and gentlemen, and welcome to Kura Oncology Incorporated Fourth Quarter 2017 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be provided at that time. [Operator Instructions] As a reminder, this conference call is being recorded. Now I'd like to introduce your host for today's conference, Pete De Spain, VP of Investor Relations. Sir?

Thank you, James. Good afternoon, and welcome to Kura Oncology's conference call. Joining me on the call from Kura are Dr. Troy Wilson, our President and Chief Executive Officer; Heidi Henson, our Chief Financial Officer; and Dr. Antonio Gualberto, our Chief Medical Officer. Before I turn the call over to Dr. Wilson, I would like to remind you that today's call will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today, and may involve risks and uncertainties that could cause actual results to differ materially from expected results. Please refer to Kura's filings with the SEC, which are available from the SEC or on the Kura Oncology website for information concerning risk factors that could affect the company. I'd also like to point your attention to the latest version of our corporate presentation which is now available on our website. With that, I will now turn the call over to Dr. Troy Wilson, President and CEO of Kura Oncology.

Thank you, Pete. At Kura, we're committed to realizing the promise of precision medicines for the treatment of cancer. Our pipeline of small molecule drug candidates target signaling pathways and other drivers of cancer where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Our goal is to help patients with cancer lead better longer lives. I'm pleased to report, we recently took another step closer towards achieving that goal with a successful and a Phase 2 meeting with the FDA regarding a registration directed trial of our lead drug candidate tipifarnib, more on that in a moment. We enlicensed tipifarnib, a potent, selective and orally bioavailable inhibitor of the farnesyl transferase enzyme from Janssen in December 2014. Using advancements in cancer genetics and new molecular diagnostic tools such as next-generation sequencing, we at Kura Oncology are evaluating tipifarnib in multiple solid tumor and hematologic indications. Our most advanced indication is in patients with head and neck squamous cell carcinoma's or HNSCC that carry specific mutations in the HRAS gene. Last month, we reported updated results from our Phase 2 trial of tipifarnib in patients with HRAS mutant, HNSCC at the Multi-Disciplinary Head and Neck Cancer Symposium in Scottsdale. The update presented by Dr. Alan Ho of Memorial Sloan Kettering Cancer Center showed that 5 of the 6 valuable patients achieved a confirmed partial response. 2 of these patients achieved durable responses beyond 18 months. The 1 valuable patient who did not achieve a response based on standard resist criteria experienced tumor shrinkage and prolonged disease stabilization. 3 additional patients were enrolled in the trial, however none of these 3 was valuable as of the February 8, data countries-off date. Unfortunately, one patient passed away shortly after joining…

Thank you, Troy and good afternoon, everyone. Hopefully you've all had a chance to review our press release this afternoon. For more detailed information I invite you to review our 10-K filed today. Now let's get started with a quick overview of our financial results. Total operating expenses for the fourth quarter of 2017 were $11 million compared to $7.5 million for the fourth quarter of 2016. For the full year 2017, total operating expenses came in at $36.1 million compared to $28.4 million for the prior year. Now let me break that down for you. R&D expenses for the fourth quarter of 2017 were $8.1 million compared to $5.5 million for the fourth quarter of 2016. The increase in R&D expenses for the fourth quarter was primarily due to increases in clinical development activities related to tipifarnib offset by a decrease in research expense related to our other preclinical stage programs. Research and development expenses for the full year of 2017 were $26.4 million compared to $20.4 million for the previous year. G&A expenses for the fourth quarter of 2017 were $2.9 million compared with $2 million for the fourth quarter of 2016. The increase in G&A expenses was due to increases in non-cash share-based compensation, personnel costs and professional fees. For the full year 2017, G&A expenses were $9.7 million compared to $8 million for 2016. The net loss for the fourth quarter of 2017 was $10.7 million or $0.37 per share compared to a net loss of $7.3 million or $0.38 per share for the fourth quarter of 2016. Net loss for the full year 2017 was $35.4 million or $1.52 per share compared to a net loss of $27.6 million for 2016 or $1.47 per share. As of December 31, 2017, we had 93.1 million in cash, cash equivalents and short-term investments. Subsequently in January 2018 we sold an aggregate of approximately 3.1 million shares of our common stock under an ATM facility for net proceeds of 57.4 million. We expect that our current cash, cash equivalents and short-term investments will be sufficient to fund current operations into the first half of 2020. With that, I will now turn the call back over to Troy.

Thanks, Heidi. In just over 3 years since we enlicensed tipifarnib, we've confirmed it's clinical activity, validated our biomarker hypothesis and optimized dose and schedule in HNSCC and we're now on the verge of our first registration directed study, that's the power of our precision medicine approach. We're very pleased with the progress we've made and are particularly encouraged by the FDAs feedback on the regulatory path forward for tipifarnib and HRAS mutant, HNSCC. We look forward to providing additional updates regarding the design and execution of the study in the months ahead. With that operator, we're now ready for questions.

[Operator Instructions] Our first question comes from Constantino [ph] with JMP Securities. Your line is now open.

So you mentioned that as currently design the AIM-HN trial may be adequate to support accelerated approval for [indiscernible] HNSCC; have you discussed with the agency the specifics of what would be required for full approval of TP in the setting? And then I've got a quick follow-up after that.

Let me let Antonia address that question for you.

Yes, certainly they can see prerogative to consider the final outcome of the study. So currently they are no specific discussion of anti-type of approval that sound impact obviously will be discussed when the totality of the data is available.

So just to be clear; if let's say the response rate and the durability of response is above a certain threshold, you could still get full approval on this read out, is that accurate like from AIM-HN alone?

What I can say is that the agency will consider anything that will be transformative. And obviously that will take into account not just the greater response but also the quality of the responses. The agency did not discard any type of approval.

And then, just a related question -- have you guys -- do you have plans or are you in the process of pursuing any regulatory designations like breakthrough therapy to sort of expedite development? Are those part of the discussions?

As we've said in the past, we're going to avail ourselves of any and all avenues to try to accelerate development. So we're not able to give any sort of specific update but certainly we want to take advantage of everything available to us and -- if and when there are appropriate updates, we'll give them.

These label expansions or the broader squamous cell cancer population you've alluded to in the past, I'm just wondering what steps do you think you have to take there to realize that sort of broader opportunity outside of just head and neck?

Certainly the indications that we are referring to the squamous, cutaneous and particularly the non-small cell cancer; molecularly they are very similar to head and neck. And we have already mentioned in the past, the prior technical data, so the expectation is that we will have an encouraging signal from these studies.

[Operator Instructions] Our next question comes from Jo [ph] with Citi. Your line is now open.

The first one is on the design of the screening and outcome study in HRAS, head and neck patients. Could you tussle over above that and also with the FDA consider that? And if so, how in the filing?

We actually are quite encouraged by the fact that the FDA was eager to receive this data and consider the totality of the data, not just only the study but only the sequencing and outcomes of the study as part of the process of the decision making regarding the type of approval and the approval consideration.

The Phase 3 study that's planned for the 59 patients, are you able to get a sense of how long those patients might take to enroll?

We're not yet in a position to give guidance on enrollment in the AIM-HN study. We've been very focused on screening, and as Antonia mentioned, an important development is that we're looking forward to initiating the SEQ-HN study. In addition, as he mentioned to providing -- to characterizing the natural history of HRAS mutations, we're optimistic that that's going to provide patients for enrollment in the AIM-HN study since the former is a non-interventional and the latter is a treatment study. We're also going from a Phase 2 proof-of-concept setting in 20 or so sites to multi-center global trail which is a very different undertaking. So, I think we'll be in a better position a little later when we have a better idea. The final thing I'll say is, we're -- we are finalizing both feasibility testing as I indicated in our prepared remarks and the final protocol with the FDA. So we need to get through this site feasibility testing on a worldwide basis, we want to get through that. We're going through this exact analysis internally.

The lung study that's planned for Europe, could you tell us a little bit about how that could be used to help explore the potential to be fine of a net setting?

Obviously our expectation is that similarly to our Phase 2 in head and neck, this study will be able to provide proof-of-concept in this as squamous non-small cell lung cancer indication. Where we go from there, obviously will depend on the review of the data.

Thank you. This concludes our question-and-answer session. So I'd like to turn the conference back over to Dr. Wilson for closing remarks.

Thank you all again for participating in our call today. For those of you keeping track of our progress, here are potential milestones we're anticipating in the year ahead. For tipifarnib, preclinical data in HRAS mutants, squamous non-small cell lung tumor models at AACR, initiation of our SEQ-HN trial, a screening and outcome study in the first half, initiation of the AIM-HN trial in the second half, additional updates from our ongoing Phase 2 study in HRAS mutant HNSCC in the second half, initiation of a proof-of-concept study in HRAS mutant squamous non-small cell lung cancer through the Spanish Lung Cancer Group, and additional clinical data in hematologic malignancies in the second half. For KO-947, preclinical biomarker data in squamous cell carcinomas at AACR and data from Phase 1 dose escalation trial in the second half. And for KO-539, submission of an IND application in late 2018 or early 2019. Thank you once again for participating in today's call. I invite you to join us via webcast for my presentation at the Cowen Healthcare Conference tomorrow at 8:40 AM Eastern Time, 5:40 AM Pacific Time. If you have any additional questions, please feel free to contact Pete, Heidi or myself. Thank you and have a good evening, everyone.

Thank you, ladies and gentlemen, that does conclude today's conference. Thank you very much for your participation. You may all disconnect and have a wonderful evening.