ARRY Q4 CC Transcript

Q4 2017 Array Biopharma Inc Earnings Call BOULDER Aug 10, 2017 Edited Transcript of Array Biopharma Inc earnings conference call or presentation Wednesday, August 9, 2017 at 1:00:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Andrew R. Robbins Array BioPharma Inc. - COO * Jason Haddock Array BioPharma Inc. - CFO * Ron Squarer Array BioPharma Inc. - CEO and Director * Tricia Haugeto * Victor Sandor Array BioPharma Inc. - Chief Medical Officer ================================================================================ Conference Call Participants ================================================================================ * Anupam Rama JP Morgan Chase & Co, Research Division - VP and Analyst * Edward Andrew Tenthoff Piper Jaffray Companies, Research Division - MD and Senior Research Analyst * Hiroshi Shibutani Cowen and Company, LLC, Research Division - MD and Senior Research Analyst * James William Birchenough Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst * Kyung Yang Jefferies LLC, Research Division - MD and Senior Equity Research Analyst * Mara Goldstein Cantor Fitzgerald & Co., Research Division - Director of Research, Head of U.S. Healthcare Research & Senior Analyst * Peter Richard Lawson SunTrust Robinson Humphrey, Inc., Research Division - Director * Stephen Douglas Willey Stifel, Nicolaus & Company, Incorporated, Research Division - Director ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good day, ladies and gentlemen, and welcome to the Q4 2017 Array BioPharma Inc. Earnings Conference Call. (Operator Instructions) As a reminder, this conference call may be recorded. I would now like to introduce your host for today's conference, Ms. Tricia Haugeto from Array. Ma'am, you may begin. -------------------------------------------------------------------------------- Tricia Haugeto, [2] -------------------------------------------------------------------------------- Thank you. Good morning, and welcome once again to Array BioPharma's conference call to discuss our financial results for the fourth quarter and full year of fiscal 2017. You can listen to this conference call on Array's website at arraybiopharma.com. Also, we are using slides today to accompany our remarks. The slides can be downloaded on the Investor Relations homepage of our website. In addition, a replay of the conference call will be available as a webcast from our website. I'd like to introduce Array's Chief Executive Officer, Ron Squarer; and our Chief Financial Officer, Jason Haddock, who will lead the call today. In addition, Dr. Victor Sandor, our Chief Medical Officer; and Andy Robbins, our Chief Operating Officer, will be available to answer questions as needed. But before I hand over the call to Ron, I will read the following safe harbor statement. The matters we are discussing today include projections or other forward-looking statements about the future results, research and development goals of Array and its collaborators and future financial performance of Array. These statements are estimates based on management's current expectations and involve risks and uncertainties that could cause them to differ materially from actual results. We refer you to risk factors discussed in our filings with the SEC, including our annual report filed on Form 10-K for the year ended June 30, 2016, and in other filings Array makes with the SEC. These filings identify important risk factors that could cause actual results to differ materially from those in our projections or forward-looking statements. Now I'd like to turn it over to Array's CEO, Ron Squarer. -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [3] -------------------------------------------------------------------------------- Thank you, Tricia, and good morning to everyone who's called in. I'm starting on Slide 3 of our presentation. We are very pleased that encorafenib and binimetinib new drug applications and marketing authorization applications have been filed with the FDA and EMA, respectively. Based on the strength of data from Part 1 and Part 2 of our global Phase III COLUMBUS trial in BRAF-mutant melanoma patients. We announced the NDA on July 5 and the MAAs were also filed in July. Part 1 results were presented at the Society of Melanoma Research Congress or SMR, this past November. And top line results from Part 2, which I'll review shortly were shared in May. We plan to share the full results of Part 2 at ESMO in September. Now in May, we announced that we selected Ono Pharmaceuticals as our partner for development and commercialization of bini and enco in Japan and South Korea. We also initiated 2 exciting nonexclusive clinical trial collaborations, 1 with Merck and 1 with Bristol-Myers Squibb to investigate the safety and efficacy of our MEK inhibitor binimetinib with anti-PD-1 therapy in metastatic colorectal cancer patients with microsatellite stable tumors or MSS CRC. Now separately, we continue to enroll our Phase III BEACON CRC trial, and based on an attractive safety profile and with early encouraging activity observed in a triple combination safety lead-in, the randomized portion of the trial is well under way. Results from the safety lead-in will also be presented at ESMO in September. Novartis continues to substantially fund all ongoing trials with binimetinib and encorafenib that were active or planned as of the close of the Novartis agreement in 2015, including the COLUMBUS Phase III trial. Reimbursement revenue from Novartis was approximately $107 million for the previous 12 months. And we estimate that eventually Novartis will have contributed over $400 million in payments to Array related to binimetinib and encorafenib. So I'm moving to Slide 5. We're pleased to have in place strong global partnerships to maximize the potential of binimetinib and encorafenib worldwide. Here in the U.S., we continue to build our commercial infrastructure, salesforce and medical affair teams. Substantial key talent is already in place across functions. In Europe, PF who has a strong legacy in oncology with over 1,000 employees dedicated to this therapeutic area, including commercial, research and development capabilities has made binimetinib and encorafenib a top priority for their team. And in Japan, our new partner Ono, actually invented Opdivo, partnered it with BMS and they've delivered nearly USD 1 billion in local Opdivo's Japanese sales over the past 12 months. So if you look at the deal terms we negotiated with PF and Ono, in aggregate we received over $60 million in upfront payments with nearly $600 million in potential milestone payments, and the potential that over half of future development costs will be offset by contributions from our partners. In Europe, in other territories, PF will deliver up to 35% royalties on net sales, when the products combined deliver over EUR 100 million of sale. And in Japan and South Korea, Ono will provide up to 25% royalties on net sales, when the products combined deliver over JPY10 billion. So now on Slide 7, I'll review the COLUMBUS trial design. The trial is a 2-part global Phase III study involving more than 900 patients. Part 1 is a 3-arm randomization of BRAF-mutant melanoma patients, between the combination of binimetinib plus 450 milligrams of encorafenib, which I'll refer to as COMBO450, vemurafenib and encorafenib monotherapy at a dose of 300 milligrams daily. Now in earlier Phase I/II trial, the maximum tolerated dose of encorafenib monotherapy was found to be 300 milligrams, whereas in combination with binimetinib, 450 milligrams of encorafenib was well tolerated, and this was the dose taken forward and evaluated in Part 1 of COLUMBUS. Now to further inform the FDA combination rule, we designed COLUMBUS Part 2 to assess and characterize the contribution of binimetinib to the contribution -- to the combination by holding the dose of encorafenib to 300 milligrams daily in the combination arm, allowing for a comparison to the same dose used as a monotherapy in the comparator arm. Now the primary endpoint of the entire COLUMBUS trial is Part 1, comparison of progression-free survival or PFS between COMBO450 and vemurafenib. So moving to Slide 8. As I mentioned, the results of the COLUMBUS trial were in our view quite remarkable and exceeding our expectations, not only in treatment effect size but also in the tolerability profile. In the analysis of the primary endpoint, the median PFS for patients treated with the combination was 14.9 months versus 7.3 months for patients treated with vemurafenib. It has a ratio was 0.54 and the P value was 0.001. The VEM result is consistent with historical pivotal trials in which VEM was used as a standard for reference, which is important as a validation of our results. COLUMBUS is the only pivotal trial with a dose of the RAF inhibitor was increased above it's single agent maximum tolerated dose, because of the tolerability improvements achieved by the addition of the MEK. We believe this design contributed to an impressive PFS result at nearly 15 months, whether you look at blinded independent central review or local review. By protocol, we use central review, although, local review has most commonly been used in historic pivotal trials conducted in this phase. As secondary endpoint of the trial was PFS for COMBO450 versus encorafenib alone. On Slide 9, we show the PFS result from the central and local reviews. Under central review, the medium PFS for patients treated with COMBO450 was 14.9 versus 9.6 months for patients treated with encorafenib. The COMBO450 also demonstrated an improvement and confirmed ORR shown on Slide 10. We demonstrated a 75% response rate by local review, 63% by central review for the combination. Vemurafenib demonstrated response rates of 49% by local review and 40% by central review, which are also consistent with historical pivotal trials in which vemurafenib was used as a standard for reference. Now as mentioned, local review has most commonly been used in the historical pivotal trials conducted in this space. So moving to Slide 11, COMBO450 was well tolerated and reported adverse events or AEs, we are overall consistent with previous bini/enco combination clinical trial results in BRAF-mutant melanoma patients. Grade 3/4 AEs, which occurred in more than 5% of patients, and have receiving COMBO450 included increased GGT, increased blood CK and hypertension. The incidence of selected NE Grade AEs of special interest and including toxicities commonly associated with commercially available MEK+BRAF-inhibitor treatments for patients receiving COMBO450, included, pyrexia at only 18%, retinal pigment epithelial detachment at only 13% and photosensitivity at only 5%. Now full safety results of COLUMBUS Part 1 were presented at the 2016 SMR Congress. Now on Slide 12, we show the median duration of exposure was approximately 51 weeks for patients receiving bini/enco versus 31 weeks and 27 weeks for the ENCO and VEM monotherapy arms respectively. And we are pleased to see the median dose intensity for both binimetinib and encorafenib, was approximately 100% for patients treated with COMBO450, which was impressive since we increased the dose of encorafenib in a combination 50% above its single agent MTD. Now moving to Slide 13. We show the top line results for Part 2 of COLUMBUS. The Primary Analysis of Part 2 compared to PFS and patients treated with COMBO300, to patients treated with encorafenib as a single agent. The median PFS for patients treated with COMBO300 was 12.9 months compared with 9.2 months for patients treated with single agent encorafenib with a p-value of 0.029 for the comparison. COMBO300 was generally well tolerated with dose intensity and reported adverse events consistent with the COMBO450 results in COLUMBUS Part 1. In addition to these results from the PFS analysis, we look forward to presenting full results from Part 2 at ESMO in September. The presentation will include PFS, ORR, dose intensity, safety and tolerability, all of which are consistent with the Part 1 results and top line Part 2 results. BEACON CRC, continues to be a critically important part of our development strategy. On Slide 15, we provide the details of the study, which is a global Phase III clinical trial in patients with BRAF colorectal assessing the efficacy of encorafenib and cetuximab with or without binimetinib in comparison to cetuximab and irinotecan-based therapy. The primary endpoint of the trial is overall survival or OS of the triplet therapy compared to the control arm and of the triplet therapy to the doublet therapy. The setting includes the 30 patients safety lead-in phase to establish combined ability of the agents in the triplet therapy. As mentioned earlier, based on an attractive safety profile, and with early encouraging clinical activity observed in the safety lead-in, the randomized portion of the trial is well underway. The results from the safety lead-in, which will be presented at ESMO in September could provide insight into the potential performance of the triplet therapy arm of the randomized portion of BEACON CRC. So as ESMO approaches, it may be useful to review certain recent historic benchmarks in BRAF CRC treatment in the patient population who are relevant to BEACON CRC. These are patients who have failed at least 1 prior therapy. By way of background, CRC patients with a BRAF [drive] mutation have in particularly poor (inaudible) assistant limited treatment options. So as recently at ASCO in June of this year, the SWOG cooperative group published results from a study that included a control arm of 50 patients with BRAF and CRC, treated with cetuximab+irinotecan and reported a 4% ORR rate. Now this result along with other separate historic benchmarks provides insight to the potential performance of the BEACON CRC control arm. At ASCO 2016, we reported a 22% confirmed ORR in 50 patients, treated with a combination of encorafenib and cetuximab in 1 arm of the Phase II study. This result provides insight to the potential performance of the BEACON CRC doublet therapy arm. This Phase II also contained a triplet arm of 52 patients, where a PI3K alpha inhibitor was added to the doublet regimen. As previous announced, Array is not pursuing this triplet regimen as the PI3K alpha added minimal activity and substantial toxicity. Now 2 additional separate triplet data sets have been published recently. First with the experimental arm of the SWOG trail presented at ASCO 2017, which included 50 patients with BRAF and CRC, who received the triple combination of VEM, cetuximab, and irinotecan, a RAF, EGFR+irinotecan. While there were significant tolerability challenges associated with this regimen, 16% ORR rate was reported, including both confirmed and unconfirmed responses. The second was the experimental arm of a trial presented at ESMO 2016 of 83 BRAF CRC patients, who received the triplet combination of the dabrafenib+panitumumab+trametinib, which is a RAF+EGFR+MEK. The confirmed overall response rate to that triplet arm was 21%. Now these past results, represent directional benchmarks for this population leading up to our ESMO presentation. Improving upon our own Phase II doublet result of 22%, with the addition of binimetinib, would be encouraging. So now on Slide 16. As a reminder, the primary endpoint of the BEACON CRC study is OS in the encorafenib, cetuximab arm of our prior Phase II trial, we were pleased to report a median OS of greater than 1 year, which is more than double several separate historical standard of care published benchmarks for this population. And the recent SWOG group result is indicated in the first bar, which has a median OS of 5.9 months for patients on the cetuximab and irinotecan control arm of the study. These results taken together provide a directional benchmark for overall survival in our control arm and BEACON CRC. So finally, on Slide 17, we show separate -- certain separate historical standard of care benchmarks for both overall response rate and median PFS in patients with BRAF and mutant CRC. In the encorafenib+cetuximab arm of our prior Phase II trial, as previously mentioned, the ORR was 22%. Now historical benchmarks in this population range between 4% to 8%. The median PFS of encorafenib+cetuximab from our prior Phase II trial was greater than 4 months, whereas listed historical median PFS benchmarks fall between 1.8 and 2.5 months, including the recent SWOG trial control arm result of 2 months median PFS using cetuximab and irinotecan. Now on Slide 18. We look forward to hosting an investor reception and webcast during ESMO on September 9. Dr. Scott Kopetz from MD Anderson, Dr. Axel Grothey from the Mayo Clinic, will be reviewing results from the BEACON CRC safety lead-in. The presentation will include details on the safety and tolerability profile of the triplet therapy as well as preliminary measures of efficacy including ORR, and available durability results. These event details are also found in the quarterly press release. So next on Slide 20. We were excited to initiate in May, clinical research collaborations with Merck and Bristol-Myers Squibb to study binimetinib+anti-PD-1 therapy in patients with microsatellite stable metastatic CRC or MSS CRC. The incidence of microsatellite stability is found in the vast majority of the colorectal cancer population. These new studies have the potential to strengthen our position both on the I/O front and in the CRC field. In the trial with Merck, we'll investigate the safety and efficacy of binimetinib with Merck's Keytruda. The trial with BMS will investigate the safety and efficacy of binimetinib in combination with BMS's Opdivo, and Opdivo+Yervoy regimen. The trial design for each study is unique, and we will provide more details when the trials are posted on clinicaltrials.gov. These collaborations are based on the synergistic activity we've seen with binimetinib, when combined with anti-PD-1 therapy in preclinical models and based on emerging clinical data. Phase I/II studies are expected to establish recommended dose regimens for further study and explore the preliminary antitumor activity of the combination. The results from these studies, which are anticipated to begin in the second half of 2017, will be used to determine optimal approaches to further clinical development of these combinations. Under the Merck agreement, Merck will act as the sponsor of the clinical trial, and Array will supply Merck with binimetinib for use in the trial under the BMS agreement. Array and BMS will jointly support the study with Array acting as the sponsor. Now on Slide 22. We describe 3 characters of the global melanoma and colorectal cancer market opportunities. On the left, it's estimated that approximately 50% of advanced melanoma patients, and 10% to 15% of advanced colorectal cancer patients have activating BRAF mutation. Due to the relative sizes of these populations, the BRAF CRC and the BRAF melanoma patient populations are actually similar in size. On the right, we can see, that over 229,000 individuals to come to colorectal cancer or melanoma combined each year across the U.S., Europe and Japan. The unmet need in advanced CRC and melanoma remains very high. And with advancement of our BEACON CRC study, and NDA for COLUMBUS, Array is working towards potentially bringing new treatment options to these patients. Both Merck and BMS have recently been granted FDA approvals for their PD-1 therapies for the treatment of CRC patients, with microsatellite instability high or MSI-high -- MSI-H, I should say. The MSI-H population is estimated to be relatively small at roughly 5% of metastatic CRC patients, and the overlap of this population with roughly 10% to 15% of patients with BRAF CRC is also estimated to be small. In the pie chart, we depict this estimated overlap. I'll now turn the call over to Jason to review our financial highlights. -------------------------------------------------------------------------------- Jason Haddock, Array BioPharma Inc. - CFO [4] -------------------------------------------------------------------------------- Thank you, Ron. Good morning, everyone. Slide 24 depicts our financial performance for the fourth quarter as well as the full year for fiscal 2017. As you see, our revenue for fourth quarter is $33.8 million compared to $33.3 million for the prior quarter. We earned additional milestones in the quarter from Genentech and Loxo, totaling $4 million and recognized a portion of the $31.5 million upfront payment from Ono received for the bini/enco Japan rights. These increases were partially offset by lower Novartis reimbursement. Reimbursement revenue from Novartis for Q4 is $21.8 million, bringing full year to $107.2 million, which is relatively flat to 2016. Other transitioned activity continues to trend down in recent quarters. 2016 represented a partial year of Novartis reimbursement. This brings our full year 2017 revenue to $150.9 million, up $13 million from 2016, driven by milestones earned on partnered assets. You can see in our cost of partner programs for the fourth quarter of fiscal 2017 is $10.1 million, which is up $2.7 million from previous quarter. Full year 2017 expenses were $35.4 million, up $12.2 million from 2016. These increases in the quarter and the full year are driven by BEACON expenses, as we continue to advance that program. Research and development expense for the quarter is $39.1 million, which is almost $7 million lower than the prior quarter. Novartis reimbursed activity has continued to trend down, as I mentioned in the revenue above, and our full year R&D spend is $178.2 million, up $17.5 million from full year 2016. And this is driven by our increased expense on our proprietary programs as well as nonreimbursed bini/enco expenditures we moved to commercialization. G&A for the fourth quarter is $10.9 million, which is down from last quarter by $0.8 million, driven by slightly decreased activity in legal and commercial expenses. Full year 2017 G&A expenses is $39.3 million, up $3.1 million from 2016, driven by increased commercial expenses as we build that capability. This brings our loss from operations from Q4 to $26.3 million compared to $31.9 million from the previous quarter, driven by the higher milestone revenue and slightly lower expenses. Our total loss from operations for 2017 is $102.1 million compared to $82.2 million in 2016. This increase is driven by higher spend on proprietary programs and commercial capability, partially offset by increased earned milestones for the year. Other expenses totaled $3.3 million for the quarter, bringing the full year to $14.7 million. This represents a $4.1 million increase from 2016, largely driven by noncash fair value expense on notes payables. Net loss for the quarter is $29.6 million, and for the full year is $116.8. Finally, we closed the quarter with a balance of $235.1 million in cash, cash equivalents and marketable securities. Our balance represents an increase of $27.7 million from previous quarter, driven primarily by receipt from Ono of $31.2 million upfront as well as earned milestones from Loxo Morati offset by our normal operational burn. Excluding onetime operational items, our quarterly burn rate was approximately $26 million, which is slightly lower than previous quarter. We expect our burn to increase in future quarters, as we continue to advance our proprietary programs and build our commercial capability. Now I'd like to turn the call back to Ron. -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [5] -------------------------------------------------------------------------------- Thank you, Jason. So on Slide 25, I'd like to end our presentation this morning with our top headline. And we're pleased to share with you the great progress we've made over the past several months with binimetinib and encorafenib. NDAs and MAAs were filed for BRAF-mutant melanoma with the FDA and EMA. And we look forward to working with them and other global revelatory authorities in the coming months. We also look forward to sharing further results from COLUMBUS Part 2 at ESMO in September. Also, we initiated collaborations with Merck and BMS to combine binimetinib with other I/O therapies and MSS CRC. Enrollment is well underway with the randomized portion of the BEACON CRC trial, it's Phase III trial, and we'll share a first look from the triplet therapy safety lead-in at ESMO. As we signed on Ono as our Japanese partner, we rounded out our global footprint for how we plan to take BINI and ENCO to market. And with that, I'm now going to open up the call to Q&A. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) And our first question comes from the line of Anupam Rama from JPMorgan. -------------------------------------------------------------------------------- Anupam Rama, JP Morgan Chase & Co, Research Division - VP and Analyst [2] -------------------------------------------------------------------------------- Maybe a quick question here on -- can you help us work through the various scenarios with AstraZeneca and selumetinib? I'm also trying to understand a little bit better how and if one falls outside as a scope of kind of the collaboration that was announced? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [3] -------------------------------------------------------------------------------- Anupam, thanks for the questions. So regarding selumetinib, we've put the details into our press release. And the way we look at it is we remain entitled to the same royalties and milestones that we had always been entitled to under the previous agreement with -- between Array and AstraZeneca. And so now we have the possibility of not only AstraZeneca exploring uses of selumetinib, but also Merck exploring potential uses of selumetinib, not to mention, they may collaborate ultimately on our commercialization. And so, essentially, we see this is as the possibility in any case of expanded activity and support for selumetinib going forward. Regarding NF1 specifically, all I can say is we've announced in our press release that we are in a dispute regarding the topic and that its probably inappropriate to say anything, anything more than not. Although, the field is stated as a treatment palliation and prevention of cancer. -------------------------------------------------------------------------------- Operator [4] -------------------------------------------------------------------------------- And our next question comes from the line of Ted Tenthoff from Piper Jaffray. -------------------------------------------------------------------------------- Edward Andrew Tenthoff, Piper Jaffray Companies, Research Division - MD and Senior Research Analyst [5] -------------------------------------------------------------------------------- What are your plans with respect to preparing for potential ODAC for the COMBO, with the FDA. And just walk us through sort of a little bit more detail on what some of the commercial drop is in the United States as well as with your partners in Europe and Japan for -- entering into the BRAF melanoma market? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [6] -------------------------------------------------------------------------------- Great. Ted, I think regarding ODAC, I think, we don't have any awareness at the moment of whether there would be an ODAC or frankly if there wouldn't be an ODAC. And we are coming up in the next weeks on hopefully some clarity on the review, the review process and presumably some insight as to what -- whether or not the review process would include an ODAC. You know that we are very pleased with the results of both Part 1 and Part 2, in terms of treatment effect size, tolerability and as a sort of a very clean addressing of the combination through with Part 2. But it's not up to us, it's up to the FDA. So I think, we don't -- we can't say anything more about ODAC or potential ODAC at this time. We'll let you know when we know. Regarding preparation for commercialization, I think, it's best if Andy Robbins, our Chief Operating Officer to answer that question. -------------------------------------------------------------------------------- Andrew R. Robbins, Array BioPharma Inc. - COO [7] -------------------------------------------------------------------------------- This is Andy. Just kind of recap where we are at with commercialization. As we've said previously, we plan to build out our own commercial infrastructure here in the U.S., that will entail about 40 to 60 new Array employees across several functions, obviously, sales but in addition marketing and medical affairs. As we speak now, we already have, medical science liaisons in the field. And their primary activity is to build relationships with both national and regional level key opinion leaders. And that work is already under way. In addition from a market access perspective, we already have Array strategic account managers out in the field, and they are meeting with the strategic portion of the market as you might imagine, payers, IDNs, GPOs, et cetera, to introduce them to Array, introduce them to binimetinib and encorafenib in preparation for a launch should the FDA approve. The drug's out of the COLUMBUS trail. And then, we already have several of the senior-level marketing, market access, market analytics and sales folks onboard in the home office. We are looking towards hiring up the salesforce closer to when we expect regulatory action. So from a calendar perspective, that's probably going to come in the early to spring time part of calendar 2018. But certainly, much of the strategic work has been completed and now we are moving into essentially the tactical execution of preparing for that eventuality. -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [8] -------------------------------------------------------------------------------- So I will just add at a strategic level, Ted. I think we've said this before, but we always were very impressed with the safety and tolerability profile of this combination. We are also impressed that we were able to actually increase the dose of encorafenib. And so we continue to be pleased with the overall tolerability profile. And we'll be able to share another cut of that or look at that at ESMO from Part 2. And while in a completely different population, and with another drug, even in BRAF CRC with cetuximab, we'll have another sort of data set to look at tolerability. I think, what I can say, exceeded our expectations was the absolute treatment effect size. And so, going to market, we're pleased to have a very attractive tolerability profile. And what appears to be from in an absolute term a robust activity profile. So it's a good way to go to market. -------------------------------------------------------------------------------- Edward Andrew Tenthoff, Piper Jaffray Companies, Research Division - MD and Senior Research Analyst [9] -------------------------------------------------------------------------------- And how do you ultimately plan for the eventuality of triplet therapy in BRAF melanoma? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [10] -------------------------------------------------------------------------------- Yes. So Ted, I'm assuming you are talking about the potential for PD-1. And our position here or I should say, immunotherapy approaches. So our position remains the same. First of all, BRAF melanoma continues to be an area with limited treatment options. I know, that sounds strange given the great progress, that I/O and MEK/RAF combinations have offered, but in reality that -- those are essentially the available therapies an I/O regimen and a MEK/RAF regimen and many other diseases. Of course, there are many, many additional options. So we believe that all available options ultimately will be used. We are exploring both sequencing options and combination options through a study called SECOMBIT and another study called IMMU-TARGET. But our view from talking to KOLs and time will tell, is that it's unlikely that sort of all available treatment options will be given at once sort of upfront and that it's more likely we think that they'll be sequenced over time. But our messages we think ultimately where ever -- in whatever order MEK/RAF will be used in those patient, of course, that are eligible. So that's our view there. -------------------------------------------------------------------------------- Operator [11] -------------------------------------------------------------------------------- And our next question comes from the line of Chris Shibutani from Cowen. -------------------------------------------------------------------------------- Hiroshi Shibutani, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [12] -------------------------------------------------------------------------------- With the BEACON 30 patients lead-in, we're looking for to that ESMO update. Can you remind us when you completed enrollment of that 30 patient, a leading cohort and get a sense for what potential ability to assess durability. We might be able to see at ESMO based upon kind of rough timing and I realize that there are data cut-off aspect to it as well. -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [13] -------------------------------------------------------------------------------- Yes. Chris, I appreciate it -- the question. And we have Victor and Andy on the line. But I -- and I think, there we could probably give you a general answer on when we complete enrollment. But the message here is, I think it's safe to focus on overall response rate as, let's call it, the more robust portion of what we're able to share. We spent some time today providing benchmarks not just for response [his], separate historic standard of care benchmarks for response rates in PFS and OS. But I think, the more sort of robust data presentation is going to be on response rates. But certainly, we intend to share what we can about durability but it's going to be early. And certainly that's what you hope for. You hope for the fact that it is still early in order to call that. And so Victor or Andy, if you would like to comment on what you can say about when we finished enrollment? -------------------------------------------------------------------------------- Victor Sandor, Array BioPharma Inc. - Chief Medical Officer [14] -------------------------------------------------------------------------------- I think you covered it. I think that we announced last time that we had completed enrollment. And to give the sense of the timing and I think that, what we'll be able to present at ESMO is as Ron pointed out, mature objective response rate data together with a good sense of the durability of those responses. -------------------------------------------------------------------------------- Hiroshi Shibutani, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [15] -------------------------------------------------------------------------------- Great. Then for BEACON, obviously, with the safety lead-in, you've created optionality for you to be able to study a doublet as well as the triplet. And so just for clarification, can we understand what would be sufficient for you to be able to win in either of these? Is it that you have to have a positive readout in the doublet or the triplet for BEACON to be positive? Obviously, there is the end possibility. But if that's the case, then does the triplet have to show statistically significant benefit versus the doublet? If you could just help us with understanding the path for (inaudible)? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [16] -------------------------------------------------------------------------------- Sure. So Just from a timeline point of view, we initiated this study without having triplet experience. And so, that was -- obviously, we were very impressed with the performance of encorafenib and binimetinib. And so, we were optimistic. And as a result, all what we really knew was results from 100 patients that had all received at least -- I'm sorry, at least -- they all received at least encorafenib and cetuximab in our prior Phase II. And we were -- we reported the overall survival rates there at over 1 year compared to, which is sort of double to more of the historic standards -- standards of care. So that the message there is, I'm not knowing exactly how the triplet might perform and the study is designed with the possibility of getting both approved. And the way it works is, primary endpoint is triplet versus control, and then doublet versus control and then triplet versus doublet. And so, the way you think about it is, we think it's unlikely or hard to imagine that if the doublet separates from control that the triplet would not. So essentially, as long as the doublet separates from control, and the triplet does as well, we have the doublet approved. And then, the standard for getting the triplet approved is for there to be a clinically meaningful difference between the triplet and the doublet. And of course, that could come in the form of activity, but it could also come in the form of improved tolerability and our history with the combination of our MEK and RAF is that tolerability can sometimes be quite important. So let me just check with Victor, if he would add anything or correct anything on that? -------------------------------------------------------------------------------- Victor Sandor, Array BioPharma Inc. - Chief Medical Officer [17] -------------------------------------------------------------------------------- I think that's all good. I think, there's a bottom like though. The important part is that the way the study is designed and the way the study has been agreed with the agency is that, we have the possibility of getting either the triplet or the doublet approved under the circumstance where either the triplet or -- well, the triplet and the doublets both meet the control. So it's really designed in order to be able to get either one of those approved depending on the outcome. -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [18] -------------------------------------------------------------------------------- And now strategically Chris, I want to make it clear. We -- our goal is to get the triplet approved if the data supports that. And the reasons are obvious that I'll state them. We expect enhanced activity and you know at ESMO, we'll have an early look at this, and that's unique when you are running a trial, just have an early look at your sort of primary endpoint arm. But also because -- so patients would benefit, of course, and durability could be improved over the doublet. But also, as you can imagine, we'd offering 2 separate drugs, which we have rights to outright in the U.S. and successful royalties in other parts of the world. So from a patient care perspective and certainly from a commercial point of view, the triplet is the goal here. -------------------------------------------------------------------------------- Operator [19] -------------------------------------------------------------------------------- And our next question comes from the line of Peter Lawson from SunTrust Robinson Humphrey. -------------------------------------------------------------------------------- Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [20] -------------------------------------------------------------------------------- Just thinking about selumetinib. How does the Astra drug deal around selumetinib? How does that kind of impact Merck's view around bini and CRC, just trying to triangulate those kind of relationships? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [21] -------------------------------------------------------------------------------- Yes, sure. So Peter, thanks for the question. We are in constant contact with Merck regarding our trials, as you can assess from our previous announcement. This is something -- they're sponsoring and that we're essentially -- they're carrying the weight on this one, let's put it that way. And we continue to work with them. They remain committed to that study. And so, we look forward to running it with them. At the end of the day, I think, it's all going to be data-driven as it should be. We are not aware of any specific plan for selumetinib and Merck's PD-1 and I don't think, it's early days. But we are very aware of the existing collaborations that's moving forward with binimetinib. And as I said earlier, this is more -- these are more Array invented MEKs are being used with important standards of care. And so over time, we'll see where the data lands. -------------------------------------------------------------------------------- Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [22] -------------------------------------------------------------------------------- Got you. And then, just around BINI plus I/O combinations, other ones being on CRC. what are the driving factors for you or what do you think other partners could be waiting for? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [23] -------------------------------------------------------------------------------- Right. So beyond CRC. There are -- there's -- I think there is a little doubt that the single largest opportunity is MSS CRC. In that, it's not only a very large population, but it's population where essentially I/O has been cold and maybe turned hot. And so that is the leading opportunity. But there are a number of other life cycle opportunities that we may explore and explore together with partners or other companies may explore over time. I'll ask -- both Victor and Andy, have done some life cycle planning work on that. The only other thing I'll mention is that there is a possibility in emerging thoughts about combining MEK not just with I/O but with other mechanisms. We continue to explore those opportunities. But as a company our size launching -- is according to our plans anyway 2 drugs soon in a very large commercial opportunity, we're laser-focused on that. And at the same time in parallel pursuing these life cycle opportunities. But we have to prioritize and CRC takes the largest location. So Victor or Andy, if you want to talk about other potential applications for I/O MEK outside of colorectal? -------------------------------------------------------------------------------- Victor Sandor, Array BioPharma Inc. - Chief Medical Officer [24] -------------------------------------------------------------------------------- Andy, you want me to start? I think that there are multiple other potential applications as everyone is probably aware of. Lung cancer is probably high up on the list. But there are many others, where PD-1s are approved. And so we are constantly scanning and looking for opportunities where we can combine our drugs in any of these areas. There are also a number of cold tumors where the idea would be to try to make them into hot tumors than like pancreatic cancer that would represent other opportunities. I think that there are other opportunities and we are certainly looking at these very, very carefully and prioritizing it. -------------------------------------------------------------------------------- Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [25] -------------------------------------------------------------------------------- Right. And just a follow-up. What do you think is the motivation for using kind of, I guess, earlier or first generation mix versus these kind of [mirror] MEK inhibitors like binimetinib? What do you think drove, let's say, for the decision for Astra and Merck? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [26] -------------------------------------------------------------------------------- So I can't speak for either of those companies. I will direct you to the fact that, it's likely that it was really about the perk that is driving this decision. And -- but there is no question that there is an emerging school of thought that, MEKs can be immuno enhancers and the industry has been very -- I think very, very productive in seeking to explore many different combinations, many different settings with many different molecules looking for the best outcomes. So I think, we're pleased with that. Beyond that, that's a question probably more for Pascale and Merck than for us. I would just, just because the U.S. earlier, I'd point out that, in the past regarding the questions about MEK, I/O combinations, we've actually put out some animal data historically both in colorectal, but we actually have some animal data, we looked at combining binimetinib with immunotherapy or checkpoint inhibitors in pancreatic tumors. So hence, Victor's reference to those. And that, of course, is a tough population, but one we are trying to plan for in the future. -------------------------------------------------------------------------------- Peter Richard Lawson, SunTrust Robinson Humphrey, Inc., Research Division - Director [27] -------------------------------------------------------------------------------- And there is nothing in the existing binimetinib data that kind of would make a potential partner really to a different MEK? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [28] -------------------------------------------------------------------------------- Peter, I think what we are saying is that we have a collaboration with Merck with binimetinib and Keytruda that is active and we are looking forward to pursuing it. What we are not saying here today is that, we think that anything has changed with regards to our collaboration with binimetinib. So I don't think there is reason to read anything certainly negative into this about binimetinib. We continue to pursue that collaboration and we look forward to seeing results in the future. -------------------------------------------------------------------------------- Operator [29] -------------------------------------------------------------------------------- And our next question comes from the line of Jim Birchenough from Wells Fargo. -------------------------------------------------------------------------------- James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [30] -------------------------------------------------------------------------------- Just following up on NF1. We know that there is a trail opening at University of Alabama that you're helping to cosponsor. You've spoken about the NF1 opportunity before. So is this the NF1 strategy? Or should we look for more trials in that disease? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [31] -------------------------------------------------------------------------------- Yes, so I am assuming you're talking about our NF1 industrial sponsored program, is that right? -------------------------------------------------------------------------------- James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [32] -------------------------------------------------------------------------------- Yes, yes, you're right. -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [33] -------------------------------------------------------------------------------- So yes, we -- first of all, this is a demonstrating disease, that historically has had essentially no pharmaceutical intervention and is deeply disabling to children and young adults. So -- and I think that based on published data, the prospect of the MEK in this disease is quite exciting. And that it's to be expected that they would be interested in studying additional agents in that population. But to the extent that, the historic data holds and that MEKs can have a dramatic impact in that disease. We think the more options for patients the better. -------------------------------------------------------------------------------- James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [34] -------------------------------------------------------------------------------- So just to be clear, Ron, I mean, if this trial looks like readout end of 2019, through relatively small, is this -- do you think this is just for publication? Or this actually allow you to potentially pursue registration? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [35] -------------------------------------------------------------------------------- So the way I'd describe it is, I think, that we will observe the data that emerges from the study and sort of make those directional decisions as they come. Based on what we are seeing, obviously, registration would require some expansion of effort and publication, of course, would be a lower level intervention. So I think it's early to say. Maybe, Andy, is sort of a person, who's spearheads our life cycle planning from a commercial strategic point of view. Do you want to add anything, Andy? -------------------------------------------------------------------------------- Andrew R. Robbins, Array BioPharma Inc. - COO [36] -------------------------------------------------------------------------------- No, I think it's fair to characterize that that's not currently designed as a FDA registration trial. But it is -- we will have the benefit of seeing the data as they emerge. We don't have to wait for a final blinded -- unblinding of a randomized study in 2019. So as Ron mentioned, we will be prepared to pivot and act accordingly depending on how the earlier trends look. -------------------------------------------------------------------------------- James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [37] -------------------------------------------------------------------------------- Okay. That makes sense. And in terms of 382, can you provide us with an update on how that trial is going in combination with pembro? And when we might see some data and what that data might be? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [38] -------------------------------------------------------------------------------- Yes. Sure. So where we are is that we were pleased to complete the dose escalation with pembro. And we're at the point now where we're in the -- we're entering these expansions in both lung cancer and melanoma. And we'll continue to pursue those. But as I said in the past, we really are kind of looking to the industry to provide some new insight about this program. Now that doesn't mean, we're going to change our approach, certainly in the current study, we are going to continue to explore this combination in these select patient population. But around now or maybe later this year or early next few, we would hope to see some results from other CSF-1R approaches, as you know, mainly, let's call it, the leading CSF-1R approaches, that we are benchmarking against or antibodies, I think it's safe to characterize our small molecule approach as, probably the one with an attractive profile, let's just say, how they're selective with a good tolerability profile from data we presented in single agent studies. So we've heard competitive intel and I don't know what to make of that suggesting that there may be, let's call it, molecule specific or antibody specific, let's call it, tolerability or compatibility challenges. And so we'll see and we have no way to validate that. But we do think that the kind of issues that we've heard again can't tell us they are true or not, might be facing the antibodies or items which we have not observed with our program to-date. But this is in the realm of speculation. So the message is the world should help us understand the importance of CSF-1R now hopefully, where are program continues and we see ourselves having a differentiated, very clean, very potent small molecule approach and this -- the program will emerge over time. -------------------------------------------------------------------------------- James William Birchenough, Wells Fargo Securities, LLC, Research Division - MD and Senior Biotechnology Analyst [39] -------------------------------------------------------------------------------- Great. And just 1 for me, and that's really on the BEACON running data. So reading between the lines, you are highly encouraged with the run-in, assuming that the data are strongly positive. Do you think this affects the timeline for the study? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [40] -------------------------------------------------------------------------------- So I think you're referring to the potential benefit to recruitment. I think that any time any clinical program is in a position to share positive data and, again, we'll be talking about that data in, let's say, a few weeks. And so we'll let folks judge it then. It certainly can't help with recruitment. And this is such a -- we spent time today talking about just how devastating the disease is and how limited the current and frankly, ineffective the current treatment options are, the ones that are actually used, standards of care, irinotecan and EGFR containing regimens. But that even, the progress has been made with sort of experimental approaches has been, I'd argue, disappointing. So there is a tremendous need here, that's going to drive recruitment. But certainly, any data that would be encouraging, I think, will help to drive recruitment as well. So we'll be in a better position to talk about it in Madrid. And if you are there, we'll see you in the afternoon. -------------------------------------------------------------------------------- Operator [41] -------------------------------------------------------------------------------- And our next question comes from the line of Mara Goldstein of Cantor Fitzgerald. -------------------------------------------------------------------------------- Mara Goldstein, Cantor Fitzgerald & Co., Research Division - Director of Research, Head of U.S. Healthcare Research & Senior Analyst [42] -------------------------------------------------------------------------------- Just on the NDA (inaudible). Do you think that you will be able to have some unique language around dosing in your label given the experience with the RAF dosing that you've observed in the pivotal trials? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [43] -------------------------------------------------------------------------------- Mara, thanks for the question. So we're under regulatory review right now. As you know, Part 1 is the primary endpoint, that's the, what we call, COMBO450 versus standard of care. And so, I mean, that's the kind of dosing that we designed to study for and that we expect to ultimately prevail. But we're in regulatory process. We're early days. We're not in any way near the label negotiations yet. Hopefully, those will be part of our future. So until that -- until we are through that, it's difficult to comment any further. -------------------------------------------------------------------------------- Mara Goldstein, Cantor Fitzgerald & Co., Research Division - Director of Research, Head of U.S. Healthcare Research & Senior Analyst [44] -------------------------------------------------------------------------------- Okay. And if I could just ask quickly, I know we discussed the selumetinib, AstraZeneca issue. But what exactly is the procedural process from this point on to remedy this dispute? You've delivered to them. Certainly they dispute. So what happens from here? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [45] -------------------------------------------------------------------------------- Yes. So just maybe to give you some color there. It's our goal to be transparent with investors so that every thing you need to know in order to assess and value the company. And so our goal was to simply inform folks that we are disputing as a sizable financial consideration and some issues related to development what -- that what we consider to be outside of the field. And the ultimate tactics or a future of that dispute isn't something we can or should comment on. At this time, we are simply letting people know that this dispute exists to the extent that things occur in the future that affect -- and that will materially affect us, we'll be sure to share that information. So that's all I can say at this time. -------------------------------------------------------------------------------- Operator [46] -------------------------------------------------------------------------------- And our next question comes from the line of Stephen Willey from Stifel. -------------------------------------------------------------------------------- Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division - Director [47] -------------------------------------------------------------------------------- I was just maybe wondering if you could confirm that the next update we'll be getting from COLUMBUS will be when you guys, I guess, trigger the requisite data that are needed to unblind OS data? Is that, essentially the gating factor to the next COLUMBUS update from a data perspective? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [48] -------------------------------------------------------------------------------- Well, Steve, I would just say that this COLUMBUS Park 2, where we're going to do a full readout, which is another sort of look at the combination, granted now that its what we consider to be its primary endpoint dose, that's a COMBO300 versus COMBO450, which is the primary endpoint -- that will be additional information. But yes, certainly, the goal ultimately is to analyze OS in Part 1 at the right time and share that data. And so look, so far the profile we've seen with regarding -- with regards to response rates and durability in a PFS, have been, as I said, impressive and has exceeded our expectations, we can't speculate on OS. But I can say we look forward to seeing the results. And as to when that may occur, I don't think Victor can add much more. But I'll see what he wants to add about timing for OS events and analysis, Victor? -------------------------------------------------------------------------------- Victor Sandor, Array BioPharma Inc. - Chief Medical Officer [49] -------------------------------------------------------------------------------- Yes. No, I don't think I can add much more. I mean, it really is dependent on the events and there is a wide potential range of timing. So I think that we'll wait for the number of events and do the analysis at the appropriate time. -------------------------------------------------------------------------------- Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division - Director [50] -------------------------------------------------------------------------------- Okay. Is it safe to assume that you guys are seeing the event accruals in real time? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [51] -------------------------------------------------------------------------------- Victor? -------------------------------------------------------------------------------- Victor Sandor, Array BioPharma Inc. - Chief Medical Officer [52] -------------------------------------------------------------------------------- Yes. So we do see event accruals in real-time. However, as you probably know, when you get these data, some sites are, obviously, better than others at entering data into database. So there is a cleaning process. So we are always a few weeks behind real-time. But yes, we do get it in in real-time. -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [53] -------------------------------------------------------------------------------- We don't know, which arm they're from but we do (inaudible). -------------------------------------------------------------------------------- Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division - Director [54] -------------------------------------------------------------------------------- Got it. And then, I guess, just going back to the PD-1 MEK discussion. How much of the decision-making within these collaborative arrangements evaluating PD-1 MEK will be driven, I guess, by both of the Phase Ib data that's generated within each of the arrangements. But also from the Phase III atezo Cotellic data, that we're going to be getting from Roche presumably in the next 6 to 12 months. And I guess, I ask the question, one, because we're getting close to sort of end. But then two, there's, I guess, a little bit more chatter regarding perhaps the inferiority of something like Atezo relative to (inaudible) or a pembro? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [55] -------------------------------------------------------------------------------- Yes. So it's difficult to answer that question. There's clearly 2 potential outcomes. One is that, that the drugs matter. Meaning that, you're going to get different outcomes with different drugs, that's been the history of drug development. That's been the history of the pharmaceutical industry and certainly been in [tumor] cancer. In which case we are -- we're very pleased with the profile of binimetinib and it was designed, let's call it, to be a sort of a newer generation and -- or improved product, with it's profile selectivity, potency, half license what not. And so that's some -- there's always a promise that there will be a real difference between the molecules. But if not, you really want to have your drug at least validated in a world where people are going to pick their favorite MEK and their favorite PD-1 and combine them, you want to make sure that there is at least some data out there to support it. But my personal assumption, which is a complete guess at this point is that, I think there will be differences, and I think that our molecules have the potential to show a difference. -------------------------------------------------------------------------------- Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division - Director [56] -------------------------------------------------------------------------------- Okay. And maybe just lastly, can you remind us what the IP on selumetinib is and the composition of (inaudible) patent that I think is dictating the exclusivity of that asset? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [57] -------------------------------------------------------------------------------- Yes, Andy, as a commercial lead, he usually find the words for this. So why don't we let you answer that? -------------------------------------------------------------------------------- Andrew R. Robbins, Array BioPharma Inc. - COO [58] -------------------------------------------------------------------------------- I play a lawyer, when I stay at Holiday Inn Express. I think our position on both selumetinib and binimetinib is that, they're a composition of [matter] plus the Hatch-Waxman extensions would give us protection from generic entry till the end of the 2020s or the late part of the 2020s without providing a more specific pinpoint date. -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [59] -------------------------------------------------------------------------------- Yes. We have time just for 1 more. I think, we've actually crossed the hour. So we'll take 1 last call. I appreciate the questions, but we'll take 1 more. -------------------------------------------------------------------------------- Operator [60] -------------------------------------------------------------------------------- And our last question comes from the line of Eun Yang from Jefferies. -------------------------------------------------------------------------------- Kyung Yang, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [61] -------------------------------------------------------------------------------- This is Kyung Yang on for Eun. And could you talk a little bit about the leading factors to beginning the Phase III trial of ARRY-797? -------------------------------------------------------------------------------- Ron Squarer, Array BioPharma Inc. - CEO and Director [62] -------------------------------------------------------------------------------- Sure. So with ARRY-797, our position has been that we do -- we are working towards initiating the Phase III. And I think, we've also stated and we're continuing to state that, we are -- we've had substantial and productive interactions with FDA and regulators on appropriate endpoints and study designs. And, of course, there is discussions, never really end, but we've learned a lot from them to-date. And so we're pleased with that. So essentially, we are in that mode now, where we're on a traditional registration start timeline. You've got to get your drug supply, your clinical supply in place, your protocols and your sites in place and move forward. And so we are on a traditional -- registration trial starts with that program. And all I'll say is that, we continue to explore the sort of strategic path forward with the program that hasn't changed and certainly, can and are in a position to and are capable, enable to pursue it on our own. But we are also exploring possibility of a stand-alone entity or spinout of the asset as well as, of course, at anytime licensing our interest from strategic third parties. But I think the message is -- and unless one of those things happen, we will continue the program and initiate the Phase III later this year. And we'll keep you posted as things emerge. And so with that, I'd like to close the call and thank our employees here (inaudible) for their commitment, ingenuity and diligence that continues to fuel our success. I also want to thank our patients, partners and shareholders for their continued confidence and support. And we'll now close the call. Thank you all very, very much. -------------------------------------------------------------------------------- Operator [63] -------------------------------------------------------------------------------- Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. And you may all disconnect. Everyone, have a great day.