U.S. Markets open in 4 hrs 15 mins

Edited Transcript of FPRX earnings conference call or presentation 7-Aug-19 8:30pm GMT

Q2 2019 Five Prime Therapeutics Inc Earnings Call

San Francisco Aug 16, 2019 (Thomson StreetEvents) -- Edited Transcript of Five Prime Therapeutics Inc earnings conference call or presentation Wednesday, August 7, 2019 at 8:30:00pm GMT

TEXT version of Transcript

================================================================================

Corporate Participants

================================================================================

* Aron Marc Knickerbocker

Five Prime Therapeutics, Inc. - President, CEO & Director

* David V. Smith

Five Prime Therapeutics, Inc. - Executive VP & CFO

* Helen Louise Collins

Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer

* Martin Forrest

Five Prime Therapeutics, Inc. - VP of IR & Corporate Communications

================================================================================

Conference Call Participants

================================================================================

* Charles Anthony Butler

Roth Capital Partners, LLC, Research Division - MD, Senior Equity Analyst & Head of Biotechnology Research

* Chris Shibutani

Cowen and Company, LLC, Research Division - MD & Senior Research Analyst

* Eric William Joseph

JP Morgan Chase & Co, Research Division - VP & Senior Analyst

* Maryana Ilya Breitman

Goldman Sachs Group Inc., Research Division - Research Analyst

* Nicholas M. Abbott

Wells Fargo Securities, LLC, Research Division - Associate Analyst

* Timur Ivannikov

Raymond James & Associates, Inc., Research Division - Senior Research Associate

* Wei Ji Chang

SVB Leerink LLC, Research Division - MD of Emerging Oncology & Senior Research Analyst

* Yue-Wen Zhu

Guggenheim Securities, LLC, Research Division - Associate

================================================================================

Presentation

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

Welcome to the Five Prime Therapeutics Second Quarter 2019 Earnings Call. As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Martin Forrest, Vice President Investor Relations and Corporate Communications. You may begin.

--------------------------------------------------------------------------------

Martin Forrest, Five Prime Therapeutics, Inc. - VP of IR & Corporate Communications [2]

--------------------------------------------------------------------------------

Thank you, Sarah. Good afternoon, everyone, and thank you for joining us. A press release with the company's second quarter financial results was issued earlier today and can be found on our company website.

Joining me today are Aron Knickerbocker, our Chief Executive Officer; Dr. Helen Collins, Chief Medical Officer; and David Smith, our Chief Financial Officer. Today's conference call will include forward-looking statements under the Private Securities Litigation Reform Act of 1999, including statements regarding our research and development programs and financial outlook. Actual results may differ from those indicated by these forward-looking statements due to numerous factors, including those discussed in the Risk Factors section of our SEC filings. Our expectations and assumptions could change. While we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so even if our views change.

I'll now turn the call over to Aron.

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [3]

--------------------------------------------------------------------------------

Thank you, Martin. Good afternoon, and thanks for joining us today to review our achievements from the second quarter and preview upcoming milestones. I'm pleased to say that all clinical programs are on track, and we are entering a period where upcoming data events will allow us to make disciplined data-driven decisions to prioritize pipeline investments.

For the Five Prime controlled assets, our current priorities are: one, the bemarituzumab and the FIGHT trial; two, advancing the most promising FPA150 opportunities; and three, safety in dose-finding for FPT155.

Okay. Let me start by recapping why we remain confident about bema's potential to be an important new medicine for patients with gastric cancer. Bema is a targeted agent that binds specifically to FGFR2b, which is a protein that is frequently overexpressed in gastric cancer and is associated with poor prognosis. The bema Phase I study demonstrated clear monotherapy activity in heavily pretreated gastric and gastroesophageal junction cancer patients. For patients in the monotherapy Phase I study who achieved the trough plasma concentration that the dosing regimen used in FIGHT also achieves, the monotherapy objective response rate was an impressive 31% and the disease control rate was 84%. That was without chemotherapy.

Now we are combining bema with modified FOLFOX6 chemotherapy in the FIGHT trial, which we know to be additive in efficacy in FGFR2b overexpressing tumor models. No overlapping toxicities were identified from the safety lead-in to the FIGHT trial, and validated molecular diagnostic tests have been developed to reliably identify patients who potentially would derive benefit from bema and standard-of-care chemotherapy.

Additionally, a relevant analog, Herceptin, has proven that targeted therapies work in gastric cancer, and the ToGA trial that resulted in Herceptin's approval for use as a frontline therapy in combination with chemotherapy was quite similar in design and power to the FIGHT trial. Herceptin also works by binding to a surface protein overexpressed on gastric cancer cells, much the same way that bema binds to FGFR2b. And Herceptin relies on ADCC as one of its mechanisms of action. However, unlike bema, Herceptin is not believed to have much monotherapy activity in gastric cancer.

With respect to the clinical operations of the FIGHT trial, we are pleased that the enrollment continues ahead of plan, and we are disclosing today that we have reached the milestone of dosing the first patient in Japan, which has a large population of patients with gastric cancer. While we remain confident about bema, we plan to conduct an early futility analysis in the FIGHT trial, that Helen will discuss further. This is consistent with our emphasis on portfolio prioritization and given the higher-than-expected enrollment rate, we will pause enrollment in the FIGHT trial when sufficient patients have been enrolled to support the planned futility analysis. We expect the pause and enrollment to occur during the fourth quarter of 2019. This pause will conserve resources while we generate data from the bema, FPA150 and FPT155 programs to make data-driven decisions to prioritize pipeline investments.

Assuming we pass the futility analysis in FIGHT, we will have adequate bema drug supply to resume enrollment promptly. As a reminder, if we move forward, we believe 1 in 3 gastric cancer patients will be eligible for treatment with bema, which represents a substantial increase in the bema commercial opportunity in the United States, Europe and Asia regions versus our original expectations. Altogether, we continue to be excited about the potential for bema to be an important new medicine for patients with gastric cancer.

Turning to FPA150, ESMO has accepted our abstract, and we will present data at the upcoming annual meeting in September. We expect to present data from the monotherapy Phase Ib expansion cohorts at the 20-milligram per kilogram dose in patients with breast, ovarian and endometrial cancers overexpressing B7-H4. While monotherapy data will be the focus at ESMO, we believe, based on preclinical data that FPA150 holds significant potential in combination with other checkpoint inhibitors or chemotherapeutic agents.

On that front, we're approaching completion of the safety lead-in for the combination of FPA150 with KEYTRUDA and expect to open the ovarian expansion cohort later this month. If we identify efficacy in the breast or endometrial monotherapy cohorts, we may also begin additional chemo and our checkpoint combination studies in those indications.

Turning to FPT155, enrollment is proceeding according to plan in the dose escalation portion of the Phase I trial with 6 dose-level cohorts enrolled and dose escalation continuing. We have submitted an abstract to present dose escalation safety and pharmacokinetic data from this program at SITC in November.

For our partner programs, completion of enrollment in the randomized Phase II trial of cabira and Opdivo in second-line pancreatic cancer is imminent, and we expect BMS to have actionable data by next year. BMS is the trial sponsor and will determine when it's appropriate to disclose data and next steps for this program.

And finally, BMS-986258, a fully human antibody targeting TIM-3, an immune checkpoint receptor, continues to advance in the Phase I/II clinical trial and is now being studied by BMS in combination with Opdivo.

As I mentioned earlier, we are preparing for several upcoming data events that will allow us to make disciplined data-driven decisions to prioritize pipeline investments. And with that, I'll turn the call over now to Helen.

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [4]

--------------------------------------------------------------------------------

Thank you, Aron. Let's begin with bema. Building on Aron's earlier comments, the reason to add an early futility analysis to the FIGHT trial is to ensure the trial is adequately powered to detect an overall survival benefit of full enrollment. I'd like to remind you the FIGHT trial is a double-blind, placebo-controlled trial, which means we don't see the unblinded data. There is an independent DMC, which does review the unblinded data, and at our last meeting with them, they recommended continuation of the trial without modification.

The trial continues to enroll very well, and we continue to see globally a prevalence of FGFR2b in the frontline setting of over 30%. In light of rapid enrollment and our desire to manage our resources wisely, we're planning to pause enrollment in the FIGHT trial during the fourth quarter. We estimate that by the fourth quarter, we will have enrolled approximately 25% of the total planned patients, which should be sufficient to generate the number of events needed to conduct the futility analysis in the first half of 2020.

The futility analysis is a crucial derisking event for the FIGHT trial. As once we know the outcome of this analysis, we will be able to make a data-driven decision to either resume enrollment, amend the trial or discontinue it. Bema is a well-tolerated, targeted, monoclonal antibody was demonstrated single-agent activity being used in a biomarker-selected patient population, and we remain optimistic about the potential for bema to improve the survival of patients in frontline FGFR2b overexpressing gastric cancer.

Moving on to FPA150, which is our first-in-class B7-H4 antibody, this antibody is designed to target tumor cells through 2 mechanisms of action by enhancing killing of B7-H4 overexpressing tumors through enhanced ADCC, and by blocking B7-H4 from sending an inhibitory signal to CD8 T cells. We plan to present preliminary data at ESMO from approximately 30 patients preselected for B7-H4 tumor over-expression across the ovarian, breast and endometrial monotherapy expansion cohorts. This will be early data as most of these patients will have had a single scan and only a handful will have been on study long enough to have had their second scan. We also anticipate having safety data from the first 4 patients enrolled in the combination cohort of, KEYTRUDA and FPA150.

Our preclinical data for FPA150 demonstrate synergy with anti-PD-1, additivity with chemo and modest activity as a single agent. For this reason, we believe the ultimate development path for FPA150 will be as a component of combination regimens, similar to how other monoclonal antibodies directed to solid tumor targets are used. For example, Herceptin and Perjeta are used in combination with chemotherapy.

In May, we initiated the combination dosing in a B7-H4 selected ovarian cohort with full doses of both FPA150 and KEYTRUDA. We anticipate completing the safety lead-in and opening the KEYTRUDA combination expansion later this month, which should generate efficacy data to make a go, no-go decision in 2020 for the FPA150 KEYTRUDA combination in ovarian cancer.

Turning to FPT155, the dose escalation is proceeding according to plan, and we expect to present the first available safety and pharmacokinetic data from the initial dose escalation cohorts at SITC in November. As you may recall, an antibody that activate T-cells through CD28 resulted in super-agonism and severe cytokine release syndrome. By contrast, preclinical data demonstrates that FPT155 requires co-stimulation for T-cell activation and, therefore, should not trigger super-agonism. So reporting early safety, tolerability and lack of cytokine release syndrome at early dose levels will support the key differentiating features of FPT155.

Aron has already provided you with an update on the partner programs, so I will now turn the call to our CFO, David Smith.

--------------------------------------------------------------------------------

David V. Smith, Five Prime Therapeutics, Inc. - Executive VP & CFO [5]

--------------------------------------------------------------------------------

Thank you, Helen. The complete details of our financial results for the quarter can be found in the press release that we issued earlier this afternoon and in our company website. We ended Q2 with a strong balance sheet. Cash, cash equivalents and marketable securities totaled $214.1 million on June 30, 2019, compared to $237 million on March 31, 2019. This expected decrease over the prior quarter reflects operating and other expenses during the quarter that exceeded revenues. The net loss for the quarter was $34.4 million or $0.99 per basic and diluted share. This was flat with the prior year. Collaboration and license revenue was $3.3 million for the quarter. This is a decrease from last year's second quarter revenue of $7.6 million and was expected. It is primarily related to lower collaboration revenues from Bristol-Myers Squibb as a result of the completion of the research term under the immuno-oncology discovery collaboration in March 2019.

Research and development expenses were $29.4 million for the second quarter of 2019 compared to $33.4 million in the second quarter of 2018. This decrease was primarily related to lower compensation costs as well as lower manufacturing costs related to FPT155 drug production and lower diagnostics costs related to the FIGHT trial. These cost reductions were partially offset by higher CRO costs that were related to strong patient enrollment and the opening of new clinical trial sites. G&A expenses totaled $9.7 million, which were essentially flat year-over-year.

Looking ahead, we continue to expect full year 2019 net cash used in operating activities to be in the range of $117 million to $122 million. We estimate ending 2019 with approximately $148 million to $153 million in cash, cash equivalents and marketable securities.

In closing, we have the resources that will take us not just through but beyond go, no-go decisions for the FIGHT trial, FPA150 and FPT155.

Now I'll turn the call back to the operator for Q&A.

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

(Operator Instructions) Our first question comes from the line of Jonathan Chang with SVB Leerink.

--------------------------------------------------------------------------------

Wei Ji Chang, SVB Leerink LLC, Research Division - MD of Emerging Oncology & Senior Research Analyst [2]

--------------------------------------------------------------------------------

First question, can you provide more color on the rationale for pausing enrollment in the FIGHT trial when you've enrolled enough patients to support the futility now?

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [3]

--------------------------------------------------------------------------------

Yes, Jonathan. This is Helen. Yes, absolutely. I mean I think, we'd -- at the last quarter call, we talked about adding futility based on seeing such a high number of patients qualifying for the trial and wanting to make sure that while we thought all patients have a scientific rationale to benefit from bema, obviously, we need to make sure that the trial is powered such that when we complete enrollment, we will be -- the trial will be successful. So -- and at that point, we were a little bit vague as to when it would happen because we didn't -- we were still ramping up sites in Europe and really hadn't had any event yet.

So now we feel like we're at a point where we know when we want that futility or when that futility can occur. And then again, because enrollment is so quick, we think it's prudent for our company that we end up pausing enrollment, observing -- read out the futility and then resuming enrollment presuming that we pass. So I think it's really a matter of -- maybe, Aron, you would like to add to this about also all of our -- the rest of our portfolio.

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [4]

--------------------------------------------------------------------------------

Yes. That is the other element here is fiscal discipline we're exercising with respect to the portfolio. And I think once we see whether this event becomes a derisking event if we pass, then we would be in a position to rapidly resume enrollment. We have drug supply ready to go. And I think we have investigator enthusiasm if we pass futility.

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [5]

--------------------------------------------------------------------------------

Yes. And you can imagine, Jonathan, your patients you enroll, say, after Q4 and until you read out that futility aren't going to contribute to the futility. So of course, yes, it would be nice to have those patients when we resume, but everything's -- the trial is open at essentially all the sites you want to be open at. It's enrolling very quickly, and we feel confident we can resume things quickly.

--------------------------------------------------------------------------------

Wei Ji Chang, SVB Leerink LLC, Research Division - MD of Emerging Oncology & Senior Research Analyst [6]

--------------------------------------------------------------------------------

Got it. And second question, can you provide more granularity on how enrollment in the FIGHT has progressed versus your initial projections? If I heard you correctly, you indicated 25% enrollment in the fourth quarter. How does that compare to your initial plans?

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [7]

--------------------------------------------------------------------------------

Yes. We didn't ever give exact projections publicly about our enrollment. We made analogy to the ToGA trial, and you may recall that where if you go back and look at the ToGA trial, which is now 8, 10 years ago, that it took them 36 months to enroll a trial that was fairly similarly sized. And of course, there's a lot more competition out there, but then we also have access to China through our Zai partnership. So that was kind of the vague guidance that we gave previously. And I could just tell you that we're ahead of that schedule.

--------------------------------------------------------------------------------

Operator [8]

--------------------------------------------------------------------------------

Our next question comes from the line of Steve Seedhouse with Raymond James.

--------------------------------------------------------------------------------

Timur Ivannikov, Raymond James & Associates, Inc., Research Division - Senior Research Associate [9]

--------------------------------------------------------------------------------

This is Timur Ivannikov on for Steve Seedhouse. So we have a couple of questions about bema. So in terms of this potential futility analysis, have you settled on the hazard ratio threshold that will be used? And could you talk about some of the factors and how you will be choosing that ratio?

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [10]

--------------------------------------------------------------------------------

Yes. So this is, again, Helen, I can start with that and then Aron can jump in. So we haven't said what it is. This is obviously a few -- we have a recommendation that we'll be making to our DMC, but there is a conversation that has to occur there. What we do definitely want to do and plan to do, and there should not be an issue in doing is making sure that, that hazard ratio was less than 1. So sometimes you may see trials designed where an early futility, the hazard ratio is set at 1, and essentially, what they're trying to do is very early on, just to make sure the drug isn't worse than placebo. We're not concerned about that, like what we really want to do is make sure that we're on track to show benefit. So -- and to make sure that this trial, again, with its 540 -- 550-or-so planned patients is powered to achieve its endpoint. So I don't know if, Aron, you want to add to that?

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [11]

--------------------------------------------------------------------------------

I think that answers it. Thanks, Helen.

--------------------------------------------------------------------------------

Timur Ivannikov, Raymond James & Associates, Inc., Research Division - Senior Research Associate [12]

--------------------------------------------------------------------------------

And our next question, I guess, could you talk a little bit more about the process that informs you about the enrolled patient characteristics in this bema trial? I mean, it sounds like you have a prespecified plan, and it sounded like you had another check-in recently. And could you talk about the proportion of Asian population that you see now versus what you saw in the first 100 patients? I believe it was 100 patients that you looked at originally.

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [13]

--------------------------------------------------------------------------------

Yes, I can't off the top of my head tell you what proportion of patients are China, ex-China, Asian, U.S. or European. I can say that just like we saw back and talked about at our Q1 call that we are seeing a FGFR2b overexpression prevalence in this front-line setting that is similar globally, so there's no difference in the different geographic areas. So -- and then, as you may recall, what we talked about at that point was that we were seeing -- we had originally designed a trial where patients would be enrolled based on being overexpressing FGFR2b on their tumors. And then as a proxy for that overexpression, we had added ctDNA because we were concerned that biopsies might miss patients.

And what we're finding is that we are capturing more patients than we actually thought based on just the overexpression alone. And again, based on the mechanism of action of this drug that it requires protein on the surface of the cell, this is what we would want to see. So -- but it is different than the patient population that we saw in our late-line Phase I study.

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [14]

--------------------------------------------------------------------------------

I would just add that the way that the sites have come on in terms of the country and site activation is sort of an East to West pattern. So the first sites were opened in China, and then South Korea, later in North America and most recently in Europe. And so now we're up to 18 countries with sites open. And as noted, today, the most recent is Japan. So whereas in the early days of the trial, most of the patients would have been coming from South Korea and China. That's now skewing downward as we get more patients entering from North America and Europe is now contributing a number of patients. So that ratio is going to continue to change as more European patients come into the trial. But as we said, this positivity rate is holding at over 30% and seems to be relatively consistent around the globe.

--------------------------------------------------------------------------------

Timur Ivannikov, Raymond James & Associates, Inc., Research Division - Senior Research Associate [15]

--------------------------------------------------------------------------------

Okay. And I guess, we do have a quick question on FPT155. So in terms of the type of data presentations that you'll have at SITC, I think for FPA150, you talked about presenting safety data. But then obviously, you also included some efficacy data. Is that kind of the performance we should expect at SITC?

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [16]

--------------------------------------------------------------------------------

No, because we were further along with dose escalation with FPA150 at the time of the ASCO presentation. We're still in the midst of dose escalation. As I noted earlier today on the call, we're in the sixth dose level. But it's our plan to present whatever safety and pharmacokinetic data we have from those early dose levels, but we're still continuing dose escalation.

We do feel that it's important, though, as Helen noted, just given the way that this molecule acts, by signaling through CD28 and acting as a T-cell co-stimulator to show safety and given the history with monoclonal antibody directed to CD28, which is not safe because it induced new super-agonism. And as a result, cytokine release syndrome that was very severe. We have not seen that at all. Preclinically, we've benchmarked against that very antibody. So we are confident about that going into the clinic, but we also recognize that we need to establish a safe dose in humans. And so we think this is a very important set of data for derisking (inaudible)

--------------------------------------------------------------------------------

Operator [17]

--------------------------------------------------------------------------------

Our next question comes from the line of Michael Schmidt with Guggenheim Securities.

--------------------------------------------------------------------------------

Yue-Wen Zhu, Guggenheim Securities, LLC, Research Division - Associate [18]

--------------------------------------------------------------------------------

This is Charles Zhu on for Michael Schmidt. I had a -- let's start off with a couple of clarifying questions on the bemo FIGHT trial. On the FGFR2 positivity, I was just kind of wondering if you could provide any incremental detail around the percentage of patients that may have tested positive by ctDNA alone, positive by ctDNA and negative by IHC or positive for both.

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [19]

--------------------------------------------------------------------------------

Yes, we haven't shared that publicly yet. It's -- the ctDNA rate of positivity is consistent with our expectations going into the study based on published data and what's been seen previously. So that's holding up. What's interesting, though, is the IHC rate in these previously untreated patients is higher than we expected, and that is now holding up as well, consistently with many more patients now on study.

--------------------------------------------------------------------------------

Yue-Wen Zhu, Guggenheim Securities, LLC, Research Division - Associate [20]

--------------------------------------------------------------------------------

Got it. Okay. And then next clarifying question for the -- it looks like there was some kind of dose modifications that may have taken place to try to maintain certain levels of plasma concentrations. I just want to clarify when this modification occurred. And how many Phase III patients, if any, may have received the prior dosing scheme?

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [21]

--------------------------------------------------------------------------------

Yes. Just to be clear, what's in the modification was a dosing scheme we tested and the safety lead-in. And Helen can describe the dose levels that were tested there and what we took forward in the Phase III portion.

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [22]

--------------------------------------------------------------------------------

Yes. So I can say in our phase -- actually monotherapy Phase I, patients were dosed every 2 weeks. And you may recall that we did not have any dose-limiting toxicity, so that the dose eventually was chosen based on obviously efficacy being observed in the single agent. And then also at a dose that we had predicted there would be efficacy based on murine models.

And so what we did when we went to our Phase III -- excuse me, our safety lead-in of chemotherapy plus bema is we realized what we wanted to do is hit our target [C] trough faster. And of course, you can do that one or 2 ways. You can either have a higher loading dose on day 1 or you can add a single dose on day 8 so that patients are treated every 2 weeks. Except when they're in their first cycle, they also get one extra dose on day 8. So we chose to do this the latter way, demonstrated in that safety lead-in that essentially all patients achieved the target trough by day 15.

And we think this is important because it's what we saw, retrospectively, when we looked at our Phase I data is only if patients achieved that target trough did they actually have efficacy. And I think that's what Aron you'd mentioned here on the earnings call that when you actually look at that subgroup, you have a response rate that's almost 30%, again, this being retrospective. So we think it's important to hit the target trough. We think the monotherapy data supports that. And every patient on the Phase III trial from the beginning has received this dosing schema.

--------------------------------------------------------------------------------

Yue-Wen Zhu, Guggenheim Securities, LLC, Research Division - Associate [23]

--------------------------------------------------------------------------------

Got it. That makes sense. And then the last question from me, shifting gears a bit now to FPA150 via B7-H4. Recall, you guys mentioned very briefly early on the call that a go/no-go decision may occur in 2020 after you guys finished the safety lead-in with the KEYTRUDA-FPA combination. Just kind of wondering, what kind of benchmarks are you thinking about regarding around this go/no-go decision? And how much efficacy would you hope to see in order to continue?

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [24]

--------------------------------------------------------------------------------

Well, again, I'll start with this. I mean, as you know, these are 3 tumors with a narrow exception in triple-negative breast cancer, but for ovarian endometrial and all the rest of breast cancer, there are no checkpoint inhibitors approved. The single-agent activity is maybe anecdotally up to sort of 12%, 15% or less than that. So obviously, we want to see higher. The reason I'm a little bit vague because again, it's always a risk benefit. And I think one of the properties we're seeking about FPA150 is that there's very little toxicity. So again, I don't know if Aron, we really showed that there's a benchmark. I think we've been talking. Sometimes we ask these questions, saying you want to see double what you might expect with a PD-1 alone. But again, it's really -- it's a whole totality of the data in terms of how well it's tolerated. And particularly with drugs that have checkpoint activity, durability of response is obviously really important as well. It's really more the overall survival in PFS arguably at times that can be more important than response rate.

--------------------------------------------------------------------------------

Operator [25]

--------------------------------------------------------------------------------

Our next question comes from the line of Chris Shibutani with Cowen.

--------------------------------------------------------------------------------

Chris Shibutani, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [26]

--------------------------------------------------------------------------------

Apologies, if I missed part of the beginning of the call. So hopefully, I can raise the topic that hasn't already been addressed. If so, please do let me know. Looking to see with regard to your thinking around business development, the overall strategy. In particular, you had described continued efforts to explore that. How are you feeling about that relative to some of the decisions that you've had to make to sort of narrow your focus a little bit earlier this year? What's your outlook?

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [27]

--------------------------------------------------------------------------------

Yes. Thanks, Chris, for the question and for calling in. So business development is an ongoing focus of ours. We have discussions ongoing now that are active, spanning multiple assets. We don't provide guidance on those. But we do feel that it will be an important part of our strategy going forward as it has been historically as we look to collaborative relationships to access non-dilutive capital but also other things as well. So that can be broader development programs, combination agents, for example, global manufacturing and commercial reach. All of those sorts of things are important elements to us as we seek to advance these programs and Five Prime. So it is an active area for us. We don't guide on any business development activities, but it is core to the strategy for how we intend to advance these programs and discussions are active.

--------------------------------------------------------------------------------

Chris Shibutani, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [28]

--------------------------------------------------------------------------------

Great. No, I've always thought that the (inaudible) platforms wouldn't be a valuable asset in terms of figuring out how to further leverage that. During this year, you've also announced previously that your Chief Scientific Officer was moving on to another opportunity. Can you update us on the status of your efforts to recruit someone to replace that important role?

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [29]

--------------------------------------------------------------------------------

Yes. So we have hired a search firm -- retained search firm. Their efforts are ongoing. They've identified a number of interesting candidates. But in the meantime, we have assigned the duties of the former Chief Scientific Officer to 2 very capable Vice Presidents here at Five Prime. So each has responsibility for roughly half of the research organization. One group focused on discovery and the late-stage research programs. The other are focused on our biotherapeutics and molecule biology areas. And so they've risen to the task nicely, and none of the programs have really suffered as a result of the departure, and they are still progressing as we'd hope. But the search is ongoing, and we'll update you further.

--------------------------------------------------------------------------------

Chris Shibutani, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [30]

--------------------------------------------------------------------------------

Great. And then you provided some updates on some shifting of the components of your board members. Can you just help us understand what you're thinking about in terms of those decisions that you've made in terms of what the relative distribution and capabilities or insights that you're hoping to gain at this stage for the company?

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [31]

--------------------------------------------------------------------------------

Sure. Yes, we strive to have a Board that's composed of people with diverse backgrounds, experiences and capabilities. And I think if you take note of the 2 recent additions, what you see there is we've added, in the case of Carol Schafer, who was most recently at Wells Fargo and Equity Capital Markets, somebody who's a very experienced person with respect to capital markets and financing biotech companies. She's also been in an operational role at Lexicon Pharmaceuticals in her past. And so she brings a lot of depth in terms of financial acumen and awareness of capital markets and has worked with a number of companies like ours in getting them financed and capitalized. So that was the rationale for adding Carol Schafer.

And then we're also -- we're happy to have welcomed Lori Lyons-Williams. She brings a different profile. She is a commercial leader and is currently in that capacity at Dermira in the dermatology space and Allergan before that and other companies as well. But a very experienced and capable commercial leader who's launched important brands, built out commercial groups, and I think brings real depth and current acumen about how drugs are brought to market, commercialized and reimbursed. So that's why we have chosen to add those 2 members to our Board. I think with those additions, we have a well-rounded and diverse Board. And they were really intentionally selected just given their backgrounds and capabilities.

--------------------------------------------------------------------------------

Chris Shibutani, Cowen and Company, LLC, Research Division - MD & Senior Research Analyst [32]

--------------------------------------------------------------------------------

Great. And then one last one, and I'll try to laser down to one of our assets. It is a partnered asset, but the TIM-3, I noticed in the release, you mentioned that the expected trial size has increased from 308 to 383. What should we take that to mean? And apology, again, if you've already brought this up.

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [33]

--------------------------------------------------------------------------------

No, that's why we just mentioned it briefly. And it's a significant program. It's a Phase I/II trial and it has multiple components. So initially, there was dose escalation with monotherapy anti-TIM-3 and then BMS is combining it both with Opdivo as well as recombinant hyaluronidase for potential subcu administration. I think it signifies continued investment in this program. We are pleased with what BMS is doing with the TIM-3 asset. We can't obviously divulge anything confidential about the nature of the trial, so I have to leave it at that. But we're pleased with their commitment to this program.

--------------------------------------------------------------------------------

Operator [34]

--------------------------------------------------------------------------------

Our next question comes from the line of Tony Butler with Ross Capital Partners.

--------------------------------------------------------------------------------

Charles Anthony Butler, Roth Capital Partners, LLC, Research Division - MD, Senior Equity Analyst & Head of Biotechnology Research [35]

--------------------------------------------------------------------------------

Helen or Aron, just apologies for sticking with the FIGHT trial, but just 3 really brief questions. When you had a conversation with the sites or how -- or I guess, the question is, how did you communicate to them that you would have that interim pause and which will be around the fourth quarter. And the reason I asked this is because this is actually question 2. You asked about the hazard ratio on this call, but I did recall before that you were going to put the futility or you wanted to put the futility analysis hurdle having a ratio clearly less than 1, so there would be clearly some activity. And I want to know if that's still the case, because importantly, would you communicate what that number is back to those sites once that analysis has occurred? Importantly, because you alluded also to their excitement to reenroll. And I wondered if they may go hand-in-hand.

And then the last question is -- and you may have said this, forgive for missing it, but is enrollment ramping at all sites, not just the ones that you had previously enrolled but also with the newer sites which have just opened.

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [36]

--------------------------------------------------------------------------------

So again, I'll start and then Aron will jump in with those things that I forget. So first, in terms of the communication, the pause, we are in the process of doing that. That needs to be done in conjunction with when we're going public with you. So the investigators won't hear about that until over the next 24 hours. We obviously did communicate to them about the findings in terms of the prevalence of FGFR2b. And so that's probably -- and as we think that's contributed to the fast enrollment and the enthusiasm of the study. In terms of the hazard ratio, you're absolutely correct. And I think that is still our intent is to have a hazard ratio less than 1.

I'll remind you that when you're looking at futility, what you're doing is you're looking at the ability of your trial to demonstrate the benefit of the drug. You're not looking at the drug's benefit, per se. So futility, the actual bar is usually not something that's communicated publicly. What is communicated, obviously, is after our discussion with the DMC is that we have passed futility and that the trial is appropriately sized and designed to demonstrate the benefit that we think we need to get approval of the drug. So obviously, the investigators do hear outcomes of DMC. They will hear that the futility has been passed, but they will not know what that bar is.

And then finally, I guess, for the question about enrollment. So yes, we have not seen greater interest or less interest anywhere. I think, as Aron said earlier, and I thought that was very nice. So you said that we've opened sites going from East to West, and that's just more a regulatory, how long it takes to open trials in various countries. But whatever sites have opened, they're enrolling at approximately the same rate. China, obviously, has more gastric cancer. They're a bit higher proportionately for their patients enrolled per site, but otherwise, there's not really a geographic difference in terms of enrollment.

--------------------------------------------------------------------------------

Operator [37]

--------------------------------------------------------------------------------

Our next question comes from the line of Salveen Richter with Goldman Sachs.

--------------------------------------------------------------------------------

Maryana Ilya Breitman, Goldman Sachs Group Inc., Research Division - Research Analyst [38]

--------------------------------------------------------------------------------

This is Maryana Breitman on for Salveen. I had a couple on the FTP155. It's in monotherapy right now, but it looks like combinations will make sense. Are you thinking about combinations going forward and what those will be? And also in which indications.

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [39]

--------------------------------------------------------------------------------

So for 155 for the CD80-Fc protein, is that what you're talking about or the B7-H4 antibody?

--------------------------------------------------------------------------------

Maryana Ilya Breitman, Goldman Sachs Group Inc., Research Division - Research Analyst [40]

--------------------------------------------------------------------------------

Yes.

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [41]

--------------------------------------------------------------------------------

Yes. Okay. So 155, certainly, preclinical data suggests that a combination -- I think we presented that at AACR last year. And there's excellent preclinical data to suggest that a combination may work better than the single agent. Right now, we're concentrating on the single agent. And so as we've said, we think it's really important to show that there's a therapeutic window here for this particular mechanism of action. But we're certainly keeping the idea of a combination in mind.

--------------------------------------------------------------------------------

Maryana Ilya Breitman, Goldman Sachs Group Inc., Research Division - Research Analyst [42]

--------------------------------------------------------------------------------

Got it. But do you have any idea for the indications like -- I mean, right now, it's a basket trial, but like what are you thinking? Or you just want to see what the data shows?

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [43]

--------------------------------------------------------------------------------

We've had lots of conversations about this. I mean, I think as we do a dose escalation, to some extent, it will depend what we see. I mean, the mechanism of action, obviously, what we're hoping to do is to see a much broader response than what we see with the CTLA agonist alone, for example, because we're doing -- we're inhibiting that mechanism as well as directly stimulating the T-cells. But at the same time, obviously, the tumor has to have T-cells there. So we do have some thoughts about this, but we have not made those public.

--------------------------------------------------------------------------------

Maryana Ilya Breitman, Goldman Sachs Group Inc., Research Division - Research Analyst [44]

--------------------------------------------------------------------------------

Got it. Got it. And another one, I just wanted to get some commentary on Bristol has expanded the cabira program. It looks like they keep bringing new indications. And I was just wondering, what is the dialogue about that? And what do you see from them, like why they -- I mean, what do they see that they keep bringing more indications on that?

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [45]

--------------------------------------------------------------------------------

Yes. I mean, yes, our teams -- we -- well, our teams do work some together. Again, BMS is developing the drug now. But I think we're really pleased by the amount of resources that they're putting towards it, the number of trials, the broad indications that they're looking at. And unfortunately, I can't say more than that other than it's clear that BMS is not winding down their efforts there to the contrary.

--------------------------------------------------------------------------------

Operator [46]

--------------------------------------------------------------------------------

Our next question comes from the line of Eric Joseph, JPMorgan.

--------------------------------------------------------------------------------

Eric William Joseph, JP Morgan Chase & Co, Research Division - VP & Senior Analyst [47]

--------------------------------------------------------------------------------

I just want to clarify on the futility analysis for FIGHT that that's based strictly on the primary endpoint of overall survival or whether you get the opportunity to look at some of the secondary endpoints of PFS or objective response rates.

And I guess, secondarily, I guess, given the surprise in the proportion of high expressors for FGFR2b and the obvious implications of that as a prognostic indicator, is there any reason to think that FGFR2b would function differently as a therapeutic target by line of therapy?

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [48]

--------------------------------------------------------------------------------

Yes. So I think the easier question is the second one. So no, there's absolutely no reason to think that it would be by line of therapy. I mean, there are clear growth factors that stimulate the cell to divide, and so it's going to be blocking that growth factor. And then the second mechanism of the ADCC, that's going to be regardless of line of therapy. In terms of the futility, again, as we said, we have a proposal that we'll be talking about with our DMC, so we haven't said specifically what will -- what endpoints will be using or whether it will be a composite.

--------------------------------------------------------------------------------

Eric William Joseph, JP Morgan Chase & Co, Research Division - VP & Senior Analyst [49]

--------------------------------------------------------------------------------

Got it. And maybe just a strategy, clarification question as it relates to FPA150. Is the expectation at this point that the monotherapy program will not be advanced and really a go/no-go decision will be based on the data that you're seeing in combination with KEYTRUDA?

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [50]

--------------------------------------------------------------------------------

So now I'm really glad you asked that question. So that's absolutely not the case. I think what happened to us, we were really excited at ASCO because what we felt that the data represented was just how much -- how enthusiastic again the investigators were, how easy it was to find these patients, how safe the drug was. Our goal at ESMO is some of those same things now that we're going to have approximately, as you said, 30 patients who've been dosed at the full dose of 20 milligrams per kilogram. And again, an early sense of the efficacy.

Now I think we are trying to temper expectations in that we do not expect, based on the mechanism of action and our preclinical data, that this is something where you're going to see a 70% response rate. We do not expect that. We expect what we might see, and that's why we used those analogies of like a Herceptin alone or something which are drugs -- Perjeta that are very successful drugs have some single-agent activity, but really their greatest benefit has been in combination. And because of the ubiquitous nature of this B7-H4 overexpression, its homogeneity, its lack of expression on normal cells, the lack of us seeing toxicity, that, that is very likely where we'll end up developing this drug as it also allows you to move earlier into lines of therapy. So you should expect to see some single-agent something though. But I think what we're trying to do is just to make sure don't go out there thinking it's going to be a 70% response.

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [51]

--------------------------------------------------------------------------------

Yes. And let's try to stay consistent about this point. As we've talked about this program since they went into the clinic, which is we do want to see single-agent activity. We're demanding that. It does not mean the ultimate use will be as a single agent [but a lot] like Herceptin, which gets combined with chemotherapy. We think that's, again, an analogous setup here. So we are not saying no to monotherapy activity, and we are also saying that we think the more likely maximization of patient benefit will be in combination.

--------------------------------------------------------------------------------

Eric William Joseph, JP Morgan Chase & Co, Research Division - VP & Senior Analyst [52]

--------------------------------------------------------------------------------

Got it. That's very helpful. I guess, maybe just in setting the stage for ESMO a bit more in here. Can you just talk about sort of the distribution of those 30 patients across the different histology cohorts that you're accruing here across breast, ovarian and endometrial? And sort of how to think about duration of follow-up as well?

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [53]

--------------------------------------------------------------------------------

Well, I think, as we're saying, that we've enrolled about -- we will have data on about 30 patients who have had one scan. So again, it's going to be early, right? And if the handful have had been on long enough to have had a second scan. In terms of the distribution, well, you can imagine breast and ovarian is a little more common than endometrial, so it's a bit more of those than there are in endometrial. But it's not a huge difference between the different arms.

--------------------------------------------------------------------------------

Operator [54]

--------------------------------------------------------------------------------

(Operator Instructions) Our next question comes from the line of Jim Birchenough with Wells Fargo.

--------------------------------------------------------------------------------

Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [55]

--------------------------------------------------------------------------------

It's Nick on for Jim. First, just going back to the bema trial. Since you made this discovery of the IHC positive and of double positive patients, have you screened the literature to look for instances where this has occurred in other targets? And what's your theory on why this is occurring in these front-line patients but not the chemotherapy-treated patients? And then secondarily, does a futility allow for analysis of both a double positive and a single positive patient? And then I have a follow-up.

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [56]

--------------------------------------------------------------------------------

So I think your first question really, in some ways, has to do with the assay, and then you have to recall that we're the first company to have a drug that is geared to FGFR2b overexpression. There are drugs out there tyrosine kinase inhibitors for FGFR2 mutation, but that's completely different. So one of the difficulties with looking at the literature is we're the first people to work with Ventana to come up with a high-quality I/O assay. So if you comb through the literature, you'll find variations and overexpression depending on what assay they're using from, I don't know, a low of, I would say, 7% up to 60% to 80%. Probably those 60% to 80% is because the assay is probably not very good. So even our 30% that was falling into what you might see out there if you hunt around.

In terms of your second question, which has to do with the futility. So again, a futility is, again, really is something that we are choosing to do, right? Which is why it's not -- you don't have to pre specify that in the protocol, because again, what we're trying to do is to make sure the trial is designed appropriately. Certainly, the DMC will have the information about patients, whether they're IHC-positive, ctDNA positive or both. But again, we haven't disclosed how we're going to ask them to look at that. So yes, but I'm being reminded, but our goal, again, is for the purpose of the trial that because the inclusion criteria are either, one, ctDNA or IHC, that, that would still be -- how this trial is designed right now. But you are speaking to whether or not the outcome of the futility could be some change in the trial design or size?

--------------------------------------------------------------------------------

Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [57]

--------------------------------------------------------------------------------

Yes, yes.

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [58]

--------------------------------------------------------------------------------

And Nick, let go back to your earlier question on literature data. We've dug into the findings from the ToGA trial, which again, is the Phase III study of Herceptin plus chemo versus placebo plus chemo. And there, you can see that it was overexpression that predicted the survival benefit from Herceptin, not gene application. So in patients that were lowered -- that were low overexpressers, there was no benefit. So if they're IHC1, for instance. There was no hazard ratio benefit seen even if they were gene amplified. But in the patients who are IHC2 or IHC3 status, whether or not they were amplified, in this case by FISH, there was a significant benefit and the hazard ratio was 0.65. Again, we think that's a relevant analog and makes a lot of sense for an antibody that works on the cell surface and blocks growth factors and engages NK cells. It shouldn't matter so much whether there's multiple copies of the gene as far as the target is there and you can prevent the growth factor signaling in the engaged NK cells. So that seems to be what happened with Herceptin in the ToGA trial. We think that's instructive and germane for the FIGHT trial as well.

--------------------------------------------------------------------------------

Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [59]

--------------------------------------------------------------------------------

It's very helpful. And then moving to FDA150. The patient characteristics for these expansion patients that we see at ESMO, are they different enough from those enrolled in the dose escalation and early biomarker-positive patients? And I fully acknowledge that the doses that you're testing in those patients is below the 20 milligrams, that we should expect the data to be different from ASCO?

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [60]

--------------------------------------------------------------------------------

So you're right. The main difference is going to be the dose. I mean, again, ASCO had a proportion of patients who are B7-H4 positive and had a proportion that were negative and only a couple that were at a dose level, you might have expected to see something for B7-H4 positive. So I think this is going to be a larger number of some patients, obviously, 30, but again, early. So I think the hardest thing is going to be, how do you judge patients who have stable disease when they've only had one scan, right? Is it going to be stable disease on the way to a PR or a stable disease on the way to a progressive disease? And it's going to be too early for those patients, right?

--------------------------------------------------------------------------------

Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [61]

--------------------------------------------------------------------------------

Okay. But stable disease, at least to me, they're getting some benefits, one assumes. But I just don't know how long, right?

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [62]

--------------------------------------------------------------------------------

Yes.

--------------------------------------------------------------------------------

Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [63]

--------------------------------------------------------------------------------

And then can you remind me a bit -- roughly how many patients you want to enroll in each of these cohorts and whether you're employing [on] 2-stage design?

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [64]

--------------------------------------------------------------------------------

Yes, we have a in 2-stage design so -- and up to 30 is how the cohorts are written right now.

--------------------------------------------------------------------------------

Nicholas M. Abbott, Wells Fargo Securities, LLC, Research Division - Associate Analyst [65]

--------------------------------------------------------------------------------

Okay. And then the last one for me on 155, I mean, given the nature of this target, I'm assuming that the dose that you had to start out was very much a therapeutic dose. You're at additional 6 now. How many dose levels have you planned? Or maybe another way to ask the question is, when do you get to a dose level where the pharmacodynamics that you're seeing is similar to what you needed to see in preclinical models?

--------------------------------------------------------------------------------

Helen Louise Collins, Five Prime Therapeutics, Inc. - Senior VP & Chief Medical Officer [66]

--------------------------------------------------------------------------------

Yes. I mean, obviously, you have to have that to go into the clinic, right? And that is a big discussion that you have with regulatory agencies because that determines to some extent where you start. So -- and I realize I'm avoiding answering your question because we haven't made that public. So we're getting close. Maybe we're there, maybe we're close, maybe we'll be there in a little while, but yes.

--------------------------------------------------------------------------------

Operator [67]

--------------------------------------------------------------------------------

Thank you. This concludes today's question-and-answer session. I would now like to turn the call back to Aron Knickerbocker for closing remarks.

--------------------------------------------------------------------------------

Aron Marc Knickerbocker, Five Prime Therapeutics, Inc. - President, CEO & Director [68]

--------------------------------------------------------------------------------

Thanks. As I said at the beginning of the call, all of our clinical programs are on track. And just to restate the near-term priorities, those are, one, the bemarituzumab and the FIGHT trial; two, advancing the most promising FPA150 opportunities; and three, safety and dose-finding for FPT155. And as I mentioned, we're committed to making data-driven decisions and also exercising tight fiscal discipline. We've got the resources to act on data from the FIGHT futility analysis, FPA150 studies and the ongoing trial of FPT155 and beyond.

So with that, I'd like to thank you all for joining us today. I'd also like to thank the patients and the investigators participating in our clinical trials, our Five Prime employees and our strategic collaborators who all contribute to the continued advancement of our programs. Thank you very much.

--------------------------------------------------------------------------------

Operator [69]

--------------------------------------------------------------------------------

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