Good day, ladies and gentlemen, and welcome to the 2018 Kura Oncology second quarter financial results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct question-and-answer session and instructions for how to participate will follow that time. [Operator Instructions]. As a reminder, this conference call is being recorded. I would now like to introduce your host for today's conference, Mr. Pete De Spain, Vice President of Investor Relations. Sir, you may begin.

Thank you, operator. Good afternoon and welcome to Kura Oncology's second quarter conference call. Joining me on the call from Kura are Dr. Troy Wilson, our President and Chief Executive Officer; and Dr. Antonio Gualberto, our Head of Development and 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. With that, I will now turn the call over to Dr. Troy Wilson, President and CEO of Kura Oncology.

Thank you, Pete, and thank you all for joining us this afternoon. I'd like to start by introducing the newest members of our leadership team Dr. Marc Grasso and John Farnam. Marc comes to us after 20 years in healthcare investment banking where he focused on strategic advisory services and capital raising for leading biotechnology and pharmaceutical companies, most recently as lead banker at Stifel for West Coast biopharma. Marc earned a Doctorate in Medicine from the Johns Hopkins University School of Medicine and an undergraduate degree in molecular biology from Princeton University. With his deep knowledge of corporate finance, history of strategic transactions, and significant exposure in our space, Marc is the ideal person to step into this expanded role as Kura's chief financial officer and chief business Officer. He'll start with us on August 21. John Farnam joined us last month in the newly created position of chief operating officer. He spent the past three years as head of operations at Celgene Receptos where his responsibilities included clinical operations, quality assurance, finance, facilities and professional leadership development. Previously, he had a distinguished career as an officer in the Marine Corps, which included services commanding officer of Miramar Air Station where he oversaw operations of the installation and its 2,500 personnel. John's core strength in leadership, operations, personnel, and program management will help to ensure that all functions at Kura are working seamlessly together. Marc and John are valuable additions to our leadership team as we prepare for our first registration-directed trial and I want to welcome both of them to Kura. I also want to take this opportunity to thank Heidi Henson and to express my sincere appreciation for her hard work and dedication as Kura's CFO since the company's inception. On behalf of the entire board and…

Understood. [Operator Instructions]. Our first question comes from Joel Beatty with Citigroup. Your line is now open.

Hi, guys. This is Sean [ph] calling in for Joel. Thank you for taking my call and my questions. So, at ESMO, how large of a data package can we expect to see and will that data package be similar in scope to previous data readouts?

Sean, thanks for the question. We can't get into the specific number of patients that you can expect. What we can tell you is both the cohort in HRAS mutant HNSCC and the additional cohort in other squamous cell carcinomas are open and enrolling patients. The other thing that we've said is that currently the HRAS mutant HNSCC cohort is enrolling patients at a rate of approximately two patients per month. And as of ESMO, we'll give an update on whatever patients at that point are currently on study, we’ll give the sort of full parameters as we've given in the past. But we don't want to front run either the abstract or the presentation with more specifics on numbers or what to expect.

Sure. That makes sense. Thank you. And just for the brief follow-up, I'm not sure if you can provide any additional color, but have you disclosed what other indications you've enrolled in the exploratory study?

No. We haven't disclosed the specifics of the additional patients that are being enrolled in that third cohort of other squamous cell carcinomas. We'll be in a position to provide additional information at the oral presentation at ESMO, which we're looking forward to.

Great. Thank you, Troy. And then, lastly, can you give us a sense of how your retrospective analyses in the HemOnc indications frame your threshold for success in those programs?

I'm sorry, Sean. Can you ask that question again? I want to make sure I understand what you're asking.

Yeah, absolutely. I'm just trying to gauge how your retrospective analyses of the HemOnc indications frame your thresholds for success in the upcoming readouts in the end of 2018.

Sure. Okay, I understand it. If I may, Sean, let me ask Antonio if he can answer that question for you.

What I will say is that the importance of this data is the ability to reproduce similar –equal or similar markers across several indications. So, the fact that we can potentially select responders in lymphoma indications using CXCL-12 that we are able to reproduce that data retrospectively in AML patients, and we can take that data and now look at our ongoing CMML patients and see that we can identify also patients that are receiving clinical benefits from tipifarnib. So, I think that's quite important because it's telling us that we are on the right track. So, this is the track that was studied many years ago. There's a number of patients that do very well, but the subset, you know outside the oncogene breeding [pj] HRAS, these subsets of patients with responses, they could not be identified in the past and now we have now independent indications that we are in the right path for the definition of that population.

Thank you, Antonio and Troy. Appreciate it.

Thanks, Sean.

Thank you. And our next question comes from Joe Pantginis with H.C. Wainwright. Your line is now open.

Hi, guys. Good afternoon. Thank you for taking the question. First, just a relatively quick question with regard to the HNSCC program. You've expanded your sites. You're enrolling about two patients per month, which is great. Just curious, with regard to the enrollment for AIM-HN, you said take about two years to enroll, the approximately 59 patients based on the growing database of patients that you have from RUN-HN as well as the patients you expect from SEQ-HN, or identification, I should say. Do you anticipate or is there a potential that this two-year timeframe could be conservative?

Joe, thanks for the question and also thanks for the initiation report that you put out, it was fun to read. With respect to your question, yes, there is the potential that the two-year timeline that we're projecting for enrollment of AIM-HN may be conservative. It's our preference to be conservative at this point. And then, we can adjust our estimates as it's appropriate. You correctly point out that currently where we stand today with 25 clinical sites open, we're enrolling approximately two patients per month. And there is – as we've indicated in the past, there is the potential both for the enrollment timeline to be shorter than we're projecting and for the trial to meet its primary efficacy endpoint prior to the completion of enrollment, as was what happened with RUN-HN. It's just we prefer to be conservative, so we're continuing to give that guidance on approximately two years for full enrollment because we're expecting that we're going to go through a period of bringing the sites online, and that's going to take time. Even though there are 25 sites currently – approximately 25 sites open in the Phase II, you still go through a sort of sigmoidal curve as you're bringing sites online. But I think we're pleased at the current rate of enrollment and we think that that bodes well for the conduct of the pivotal trial.

No, that's really helpful. Thank you. And if I could just switch quickly to hem indications for tipifarnib, this might be a multipronged question, so bear with me. I'm just curious, obviously, we're looking forward to the data for PTCL and potentially others later this year. Just curious, now that you have a very strong balance sheet, what the potential wish list might look like. Obviously, dependent on the data. With regard to, one, biomarker test readiness for additional studies that are upcoming and how quickly you might be able to ramp up these studies? And then third, any potential combos you might be considering based on the mechanism of action of CXCL-12? Thanks.

Sure. Thanks for the question. So, we're certainly encouraged at continuing to evaluate tipifarnib both in the context of HRAS mutant solid tumors. And in addition to providing the data update in RUN-HN, pointing people toward the initiation of AIM-HN, you notice that we did draw your attention to the lung squamous cell carcinoma trial that is currently open for enrollment with the Spanish Lung Cancer Group. That as well as the other HRAS mutant solid tumors, we think represents kind of the most immediate opportunity just given the strength of the data that we've shown thus far in the ongoing Phase II study. With respect to the hem malignancies and other diseases, that's where, as Antonio mentioned in his response to Sean's question, we're looking forward to providing an update around the end of the year, likely at ASH, that we hope will reinforce this notion that the CXCL-12 pathway gives us an independent means of patient enrichment that is independent of HRAS. The significance of that is, as Antonio indicated, you've got a class of agents with farnesyl transferase inhibitors that have anecdotal reports of activity, but really no molecular mechanism of action that was ever assigned to them. If the CXCL-12 represents a therapeutic target and a way of enriching patients, that has implications potentially in both the hematologic malignancies – and we're starting with the ones where Janssen and then we have the most data, but other indications as well. And we're looking forward to continuing to be very data-driven and to providing that data update later in the year. With respect to the strength of the balance sheet, we really appreciate the strong support. I think we continue to evaluate sort of how we prioritize our pipeline opportunities. And we'd like to continue to be in a position where we can look forward for places where we can spend additional resources to create more value for patients.

Great. Thanks a lot, Troy. I appreciate it. Yeah, I'm sorry. Go ahead.

So, you asked about combinations, that also is going on preclinically. So, there's no currently clinical trials on combination studies with tipifarnib, but we continue to conduct a number of preclinical studies. And more data potentially on those to come in the months ahead.

Great. Thanks again.

Sure.

Thank you. And the next question comes from Konstantinos Aprilakis with JMP Securities. Your line is now open.

Hey, guys. Thanks very much for taking my questions. I was wondering if I could get your thoughts on the recent readout for pembro and first-line HNSCC, suggesting a significant survival advantage versus cetuximab plus platinum. Does this alter your development plans for tipi in any way and what impact you expect these data to have on clinical practice, if any, assuming checkpoint inhibitors establish themselves in the frontline.

Sure. Konstantine, thank you for the question. Let me let Antonio answer your question.

Hi, Konstantine. So, obviously, positive data combination therapies that will be beneficial to patients is good for everybody. And certainly, we congratulate our colleagues. In a way, it may seem easier for us. You saw, obviously, the data about the markers. So, the fact that the immune therapy may require the identification of susceptible population, it can only favor other targeted therapies. Also, you have to take into account the recurring standard of care with platinum based followed by immune therapy. And those therapies were to be combined in the frontline that actually – the only thing that it does is cement our initial position on a second line. So, there's a number of benefits both in how we position tipifarnib and also in the fact that one of the main drivers of the expansion of a potential HRAS franchise is to have many patients tested as possible. So, if patients are going to be tested for – you will imagine the pathology departments that will test only for IO compounds, but for any other possible targeted therapy that the patient may receive. So, that only increased the opportunities for other targeted therapies such as tipifarnib.

Got it. Thank you. So, in a post cetuximab setting, there's reason to believe that HRAS plays a role in driving resistance to therapy, and so tipi certainly has a part to play there. Anything you can say in a post sort of checkpoint inhibitor setting?

Well, what I can tell you is that – you have seen these data that patients with head and neck recurring HRAS mutation, they're fairly resistant not only to cetuximab, but also to the checkpoint inhibitors. And we have shown anecdotal, but remember patients that did not experience a response. So, in an initial step, yes, we are in the post setting. And once the patient has the – sorry, post IO setting. And once the patient progress from that therapy, they will be ideal candidates with tipifarnib. But in the future, obviously, physicians will have to determine what is the therapy for the patients that carry the HRAS mutation. But there's some work to do. We will have to initially show what is the depth, the duration of our responses initially in this post firs line setting.

Okay, fantastic. Thank you, Antonio.

Sure.

Thank you. And our next question comes from Chris Shibutani with Cowen. Your line is now open.

Thanks very much. Perhaps if you could just provide us with a little bit more color on the lung study that's being done with the Spanish cooperative group. You mentioned that the study has been initiated. Can you give us a sense for perhaps the number of patients you're expecting the group to enroll and then perhaps maybe some timeline upon which we might consider getting some initial data on that?

Sure. So, Chris, the study is very similar in design to the other proof of concept studies that we've used in the past. So, approximately 18 patients and you're looking for a certain response rate of interest. In terms of timeline, that's more difficult. This is, obviously, a cooperative group study. It's not at all under Kura's control. One of the reasons that we went with the Spanish lung cancer group is with the frequency of this mutation estimated at between 1% and 3% of squamous lung cancer, you need a number of sites actively screening patients. And we thought that the Spanish lung cancer group was well positioned to be able to do that. We're providing some support in terms of supporting diagnostic testing. But I think it's probably premature to give guidance on what we might expect the enrollment to be. As with ISTs, these studies are a very efficient way or cost-efficient way of generating proof-of-concept data, but they're largely in the control of the cooperative group. And I don't know that we'll be able to give you much more in this near-term on any kind enrollment expectations or updates.

Got it. And then, with the data that we're coming up at ESMO, we'll look forward to that. You did provide some context for a response rate. Can you help us as well with what you think would be reasonable to think about in terms of durability? And then, to follow-up on that, I think when you and I spoke earlier in the quarter, there was a possibility of having a presentation at the triple meeting as well. Is that no longer in the table with the focus being ESMO? Thank you.

So, let's take your second question first, Chris. Our intent was that we would like to see the data presented either at ESMO or the triple meeting. Just to give folks an update, since the last data update was in February, so we're very excited. We're also excited with the fact that we've got an oral presentation at ESMO. So, I think that speaks to the excitement around targeted therapies in what is otherwise a sea of immune therapy. With respect to durability, it's our expectation that the agency would want to see a median duration of approximately six months across the patient population. So, given the high unmet need and the relatively low response rate and short PFS among the approved second line agents, it seems like six months is sort of a reasonable proxy. So, that's what we're shooting for in terms of durability.

Got it. And then, a final question. And I realize you're bringing a CFO on board at the end of the month, but with your cash balance presently and your comment about having runway into 2021, when I look out at consensus estimates, it's kind of a range with the denominator of maybe four or five analysts. But can you help me understand what you think would get you to 2021? I see, for instance, according to my sources, that the operating expense burn in 2019 and 2020 from consensus comes out to over $200 million. So, are you comfortable with where consensus is or should the Street view be a little bit more tempered to spending during that period? If you could help us out with that, to get us to 2021, that would be great. Thank you.

So, just to clarify, Chris, as I said in the prepared remarks, we're anticipating that the $200 million will take us through 2021. That includes the anticipated enrollment of the pivotal trial and the anticipated six months of durability data needed. And so, we don't give forward guidance on our quarterly spend. What we do give guidance on and we've been consistent, and I hope conservative is, is how far we expect the runway to last. And we feel confident that we have cash through 2021 at this point, which should take us through the requirements for the pivotal trial and give us a number of other opportunities with the pipeline. So, hopefully, that clarifies the situation for you.

Great. Appreciate it, Troy, and look forward to meeting your team members. Thanks.

Thanks.

Thank you. [Operator Instructions]. Our next question comes from Jonathan Chang with Leerink Partners. Your line is now open.

Hi. This is John Barrett on for Jonathan Chang. Thanks for taking my questions. How are you thinking about a companion diagnostic strategy for tipifarnib in HRAS mutant cancers?

Sure. So, we – sort of several answers to your question. We are developing a companion diagnostic. It's a PCR-based test that will accompany the NDA as part of the existing regulatory framework. And those activities are ongoing and in good shape for the initiation of the pivotal trial. That being said, the pivotal trial doesn't require us to use that companion diagnostic to enroll patients. The agency was actually – we were very pleasantly surprised that the agency allows us to use any approved test to identify HRAS mutant patients. So, in the US, next gen sequencing FoundationOne is the current standard of care. Ex-US, there are a number of approaches. That's why we highlighted the new relationship with OncoDNA. That's an NGS platform we've had very good success with in Europe, as well as now looking toward the rest of the world. So, we would expect that a majority of the patients on the AIM-HN trial will likely be identified using next-generation sequencing. And to our standpoint, as long as patients are being screened by whatever method, that's good for targeted therapy. We will, however, be prepared to have satisfied the regulatory requirements in terms of the ultimate companion diagnostic. And that effort is ongoing.

Great, thank you.

Thank you. And I'm showing no further questions at this time. I'd like to turn the call back over to Troy Wilson, CEO, for any closing remarks.

Great. Well, thank you for the questions. And thank you all once again for participating in our call today. Next week, we'll be at the Wedbush conference in New York. We look forward to seeing many of you there. And in the meantime, if you have any additional questions, please feel free to contact Pete or myself. Thank you again. And have a good evening, everyone.

Ladies and gentlemen, thank you for participating in today's conference. This concludes your program and you may all disconnect. Everyone, have a great day.