Loxo Oncology's (LOXO) CEO Josh Bilenker on Q4 2017 Results - Earnings Call Transcript

Loxo Oncology (NASDAQ:LOXO) Q4 2017 Earnings Conference Call March 1, 2018 8:00 AM ET

Executives

Jacob Van Naarden - CBO

Josh Bilenker - CEO

Jen Burstein - SVP of Finance

Analysts

Eric Schmidt - Cowen and Company

Matthew Harrison - Morgan Stanley

Stephen Willey - Stifel

Yigal Nochomovitz - Citigroup

Raju Prasad - William Blair

Operator

Good day, ladies and gentlemen, and welcome to the Loxo Oncology fourth quarter and year end 2017 conference call. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to turn the conference over to Jacob Van Naarden, Chief Business Officer. Sir, you may begin.

Jacob Van Naarden

Thank you, operator. Thank you for joining us today. Before we get started, I'd like to remind you that during this conference call, Loxo Oncology will make certain statements that are considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including our business plans and objectives and timing and success of our clinical trials.

Such forward-looking statements are not guarantees of future performance, and therefore, you should not put undue reliance upon them. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. I refer you to our SEC filings for a discussion of risk factors that could cause our actual results to differ materially from those discussed today.

During this call, the financial metrics unless otherwise noted will be presented on a GAAP basis and include collaboration revenue recognized and stock-based compensation. You will find reconciliations of non-GAAP measures discussed today to the most comparable GAAP measures in our earnings release.

All comparisons made in the course of this call are against the same period in the prior year unless otherwise stated.

With that, we will turn the call over to our CEO, Dr. Josh Bilenker.

Josh Bilenker

Good morning and thanks to everyone for joining us. With me today are Jake Van Naarden, our Chief Business Officer and Jen Burstein, our SVP of Finance. This is a very exciting time for Loxo Oncology. We are nearing completion of the NDA submission for larotrectinib and getting closer to becoming a commercial company. As we prepare for launch, we are working closely and diligently with our colleagues at Bayer, activities that we’ll comment more on later. There are of course other upcoming milestones to acknowledge today. Like new data for LOXO-292 at a Spring Cancer Meeting and a clinical start for LOXO-305 in the second half.

Before we discuss these near term milestones, I would like to take a moment to remind you of our larger company vision, including how we got to where we are and where we hope to go in the future. Every drug that we commit to can be explained in the following way. We believe it will have a high likelihood of helping patients in the near term with differentiated effects. That sounds like what all biotech companies should be doing, but what might be a little different about us are the many paths we're willing to take to get there.

We're happy to do discovery in collaboration with great partners like Array Biopharma. We're happy to acquire or license compelling compounds like we did in the Redx transaction and now we're also happy to build molecules internally. In the fourth quarter, we opened a discovery facility of our own in Boulder, Colorado. For any given program, we seek to choose the path that we believe will best optimize timeline estimates, competitive considerations, success likelihoods, cost and feasibility of execution.

It's such an unlikely thing to have conviction around an oncology target at least for us that it's useful to have multiple strategies available that could lead to a compelling clinical candidate. For us, it's all about hustling to the clinic with the best drug as fast as possible in the right population. We didn't have all these tools available to us in the very beginning, but in less than five years, we have put three compounds in the clinic, grown from a team of less than 10 people to a team of approximately 70 and we are now preparing hopefully for our first new drug approval with our partners at Bayer.

These activities have diversified our business and changed the scope of our operations. One of the things that I'm proud of is that I think we've maintained our culture, despite this rapid growth. We're a largely self-selected group and I hope a desirable destination for people who are looking for career acceleration, care more about outcome than title and care about developing drugs that actually are likely to work. You'll see our team continue to grow this year and there's no activity more important to me than maintaining the excellence and attention to detail that has gotten us this far.

Next, I'd like Jake to walk us through an update of the Bayer collaboration before I provide a clinical and regulatory update on larotrectinib and LOXO-195 as well as provide brief remarks on LOXO-292 and LOXO-305.

Jacob Van Naarden

Thanks, Josh. In November, we announced the collaboration with Bayer to develop and commercialize larotrectinib and LOXO-195, our highly selective TRK inhibitor franchise. As we said then, we believe this is a great opportunity to reach more patients more quickly, while also enhancing the risk adjusted value of the programs for shareholders. We know that this is going to be a difficult launch due to the extreme rarity of the patient population and the current state of the relevant diagnostics.

So in addition to helping us bring laro and 195 more effectively to patients, the partner allowed us to monetize half of the assets and therefore significantly diversify the equity story for shareholders ahead of this launch. As a reminder, the deal terms include a $400 million upfront payment, of which 250 million was received in the fourth quarter of 2017 and the remaining $150 million is due later this month. We're eligible for an additional 1.15 billion in milestones if earned in the future, of which we expect to receive 275 million in 2018 and 150 million in 2019. These are based on larotrectinib regulatory and first commercial sale events in certain major markets.

In the United States, Loxo and Bayer will co-promote the products and share commercial costs and profits on a 50-50 basis. As we've mentioned previously, our field team will primarily focus on the lab and pathology audiences, providing an opportunity to build relationships and a strategic framework that will be critical, not only for larotrectinib, but also for other medicines in our pipeline. We are currently finalizing our go to market plans for the United States with Bayer.

These plans will shape the size and nature of our respective field organizations as well as the non-personnel budget. We plan to update investors on these plans when they are finalized, closer to a potential approval and launch. It is also worth pointing out that Loxo provides clinical and regulatory leadership in the United States, while Bayer has final say in matters relating to sales, marketing and pricing.

In this pre-launch phase, two activities are key. First, we have to increase the level of target awareness among physicians and pathology lab directors. The speed at which this program has moved has not provided a lot of time for doctors to have heard about TRK fusions as targets worth looking for and treating. Most oncologists haven't even heard of TRK fusions, and if they have, they heard about it for the first time less than a year ago at last year’s ASCO meeting.

Furthermore, even though our development program was tissue agnostic, most oncologists still practice according to subspecialties based on tumor type. And with our partners at Bayer, we are devising a strategy to reach as many of these physicians as efficiently as possible. For instance, we have started to present subsets of laro clinical data at cancer meetings dedicated to specific tumor types.

Second, we have to help lab directors learn about the diagnostic tests out there capable of identifying TRK fusions. We continue to make progress with the standalone IHC test in collaboration with Ventana. We hope this test will be available as a class one test later this year. Class 1 means that the test can be sold as a research tool that an individual lab can choose to set up under clear regulations. We anticipate that this test will be useful to some pathology audiences as a screening tool.

Increasingly though, we have been turning our focus to next generation sequencing or NGS. We think NGS represents the most viable path to full commercial realization for larotrectinib, LOXO-195 or any other drug that addresses the so-called long tail of actionable biology that has been uncovered by comprehensive genomic profiling. NGS tests are by their very nature multiplex. They test for many things, dozens or hundreds of things at once. When these tests include pros with robust TRK fusion sensitivity, the physician has an opportunity to make the TRK fusion diagnosis alongside numerous other actionable diagnoses.

Given their inherent rarity, TRK fusions are probably best found when they come along for the ride in this sense. Screening for rare genetic alterations, one at a time, doesn't make a lot of sense cost wise, leads to exhaustion of small and scarce quantities of tumor tissue and could lead to testing fatigue as ordering physicians become dispirited over continued negative results.

2017 was an exciting year for comprehensive genomic profiling. There were NGS FDA approvals for multiplex tests. Medicare extended a preliminary national coverage determination for NGS testing and created a pathway for any test manufacturer out there who wishes to step forward. Academic labs also have a path forward for reimbursement under the national coverage determination.

We are working with many of the key players across the NGS landscape and plan to announce formal collaborations as they are realized. We're excited about these recent developments, but they are of course recent and don't afford much lead time ahead of a potential commercial launch. We think these developments will provide benefits eventually, but we are cognizant that for the initial launch, we still will have to contend with the relatively low NGS utilization and assays with varied and generally poor TRK fusion coverage.

We'll be doing our best with Bayer and our colleagues to impact these trends and we hope that our clinical data and publications like our recent New England Journal of Medicine article will help positively influence the various stakeholders involved.

I'll now turn it back to Josh for a clinical and regulatory review.

Josh Bilenker

Now, let's review where things stand on the clinical and regulatory fronts for larotrectinib, to our highly selective TRK inhibitor, which has shown efficacy across adult and pediatric patients with TRK fusion cancers, regardless of tumor type. We announced in December that we initiated a rolling NDA submission to the FDA. We are pleased to report that the submission continues to go as planned and we expect it to be completed this month. Should FDA agree to file the NDA and grant priority review, as we hope and expect, a PDUFA date would be expected sometime this fall.

Our colleagues at Bayer have responsibility for and are leading the MAA submission in Europe. Those committees remain on track to enable a submission this calendar year. We announced last week the publication of the laro pivotal dataset in the New England Journal of Medicine. It was an honor to be included in a journal of this caliber. Hopefully, the publication helps inspire and accelerate the adoption of comprehensive genomic profiling with TRK fusions illustrating what is possible when the right patient receives the right drug.

The publication also provides three additional months of patient follow-up from the data presented at ASCO, employing a July 17, 2017 data cutoff. I should mention that this July data cutoff also supported the initial NDA submission. The overall response rate was consistent with what that we reported in October. It was 75% by central review and 80% by investigator assessment. As of the data cutoff, 86% of the responding patients remained on treatment or had undergone surgery with curative intent and 71% of responses were ongoing at one year.

The safety profile of larotrectinib remained consistent with previous data readouts with a very low incidence of grade 3 or 4 adverse events, few dose reductions and no discontinuations for adverse events. While the primary analysis for the NDA and the New England journal paper utilizes the first 55 consecutively enrolled TRK fusion patients across three studies, we have continued to enroll additional TRK fusion patients. We expect to present data for these patients at a medical meeting in the second half of the year. That update will also include additional durability data for the primary 55 patients.

Before we move on, let's recap what we expect coming up for larotrectinib in the coming months. Number one, completion of the NDA submission this month, leading to a potential PDUFA date in the fall. Number two, Bayer’s submission of the EU marketing authorization application in 2018. And number 3, a presentation of updated TRK fusion clinical data in the second half of the year that will include updated durability data and patients enrolled beyond the first 55.

Now, moving on to LOXO-195, which is our second generation TRK inhibitor designed to treat and address patients who initially respond, but then develop resistance to larotrectinib, entrectinib or other TRK inhibitors. LOXO-195 can work against mutations of the TRK fusion protein such as solvent from mutations, which make other drugs lose their potency. LOXO-195 was rationally designed to be a selective TRK inhibitor and avoid problematic off targets that can cause toxicity.

Unfortunately, LOXO-195 won't work in every patient who progresses on a prior TRK inhibitor. Some patients get too sick too quickly at the time of progression, while others, though we think a minority, will develop resistance mutations that cause problems for lots of 195 as well. Nevertheless, we continue to believe that LOXO-195 can extend durable disease control for patients with TRK fusion cancers with time being added on to the back end of the duration they hopefully achieve with larotrectinib.

It makes sense to develop this drug concurrently with laro’s development. As such, LOXO-195 was part of the collaboration agreement with Bayer. Our Phase 1/2 trial continues to enroll patients and to open additional sites. As we have talked about previously, it is challenging to provide details on timelines since enrolment depends on patients relapsing on other programs. However, we are currently planning to present interim clinical data at a medical meeting in the second half of this year.

Now, moving on to LOXO-292. It's an important year for LOXO-292. LOXO-292 is a rationally designed and highly selective inhibitor of RET, a protein that is subject to both activating fusion events and activating mutations. RET fusions have been described in 2% of patients with lung cancer, 10% to 20% of patients with papillary thyroid cancer and they've also been described as a fusion partner in a variety of other tumor types such as colon, breast, pancreatic and even brain cancers at very low frequencies.

RET is also involved in a type of activating mutation present in 60% of patients with medullary thyroid cancer. With our LOXO-292 program, we are interested in understanding the drug’s activity in all of these patient populations. Just counting late line patients across lung cancer and the two thyroid cancer populations, we estimate that there are approximately 5,000 patients per year in the United States with RET activated cancers.

Importantly, many doctors and lab directors today know that it is important to test for RET fusions and mutations, especially in lung and thyroid cancer. In other words, target awareness is generally pretty good for RET today and getting better. For example, RET fusion testing was included in the 2017 National Comprehensive Cancer Network or NCCN guidelines for lung cancer, even before an FDA approval of a drug specifically targeting RET.

We expect LOXO-292 will be the subject of a Phase 1 update at a medical meeting in the first half of 2018, either AACR or ASCO. We will provide details on the specific meeting once we have an accepted abstract and the meeting allows us to talk about it. If you recall, we dosed the first patient in May of 2017. The study has a dose escalation design that would provide some flexibility and that it allows us to expand enrolment to patients with RET alterations in response to the patient demand.

You may also recall that we shared some evidence of -- early preliminary evidence of activity at the World Lung Meeting in October of 2017, which included information regarding two patients with limited follow-up. Since then, we have of course continued to enroll the trial. We're actively learning about many issues that could impact the development of LOXO-292. For example, does exposure to a prior kinase inhibitor affect response to LOXO-292? Does the RET fusion partner such as KIF5B affect response to LOXO-292? And what is the best way to develop LOXO-292 in medullary thyroid cancer, given that there are already FDA approved drugs for this indication?

Our Phase 1 update should shed light on many of these key questions. A brief remark about LOXO-305 now. And with this, I’ll close the clinical and regulatory update. LOXO-305 is a highly selective, non-covalent BTK inhibitor that we expect to have a role in treating acquired resistance in patients with B-cell malignancies who had progressed on a covalent BTK inhibitor such as ibrutinib or acalabrutinib. The covalent BTK inhibitors are an impressive class of drugs that tens of thousands of patients depend on.

However, some patients are now starting to relapse while on these drugs. We think LOXO-305 can help many of these progressing patients. We are completing our IND-enabling studies and expect a clinical start in the second half of 2018.

Now with that, let me turn it over to Jen Burstein, our SVP of Finance for a review of the financials.

Jen Burstein

This morning, we issued a press release, which included our quarterly financials. We will be filing our 10-K after the close today. To briefly summarize the financials, net loss for the fourth quarter was 20.6 million on a GAAP basis and 37.2 million on a non-GAAP basis. This difference was primarily driven by excluding revenue recognized related to the Bayer upfront payment and partially offset by exclusion of share-based compensation expenses.

Our total operating expenses decreased by 31 million quarter-over-quarter from Q3 to Q4, primarily due to the 40 million asset acquisition of the BTK inhibitor program from Redx incurred in Q3, partially offset by expanded development activities across the pipeline, commercial preparedness activities and new hiring. On a non-GAAP basis, our expenses increased by 9.5 million quarter-over-quarter from Q3 to Q4.

As of December 31, 2017, we had 626.2 million in cash, cash equivalents and investments. As Jake mentioned, we received 250 million of the 400 million upfront payment related to the Bayer collaboration in the fourth quarter of 2017 and the remaining 150 million is payable in the first quarter of 2018. As you can see in our earnings press release, we recorded revenue for the first time this past quarter associated with the Bayer upfront payment.

We will be accounting for that upfront payment using a calculation based on quarterly research and development spending associated with larotrectinib and LOXO-195 relative to cumulative and forecasted research and development spending in these programs over the course of the collaboration agreement. As a result, the quarterly revenue recognized for the upfront payment will vary from quarter to quarter.

We plan to exclude revenue recognized related to the upfront payments from our non-GAAP operating loss going forward as well as other milestones received. As we enter the new year, we are finalizing how we plan to present our Bayer co-promotion financials going forward. More to come on that in the coming quarters, but for those who are looking to get a head start, we are looking at financial presentations similar to what Onyx did with its co-promotion agreement with Bayer from Nexavar.

So for instance, reporting the total collaboration revenue as one line item in the P&L and using a supporting schedule to show investors how we arrive to that number, starting with larotrectinib net sales as reported by Bayer and ending with the result of the 50-50 financial split, which we expect will be negative initially. We will revisit in future quarters so that folks can update their models accordingly.

Josh Bilenker

So thanks to everyone for joining the call today. We’ll now open the line for your questions.

Question-And-Answer Session

Operator

[Operator Instructions] Our first question comes from Eric Schmidt with Cowen and Company.

Eric Schmidt

Maybe a couple of quick ones on 292 for Josh. I know you're going to be limited in what you can say, but have you commented on whether you're in the RET cohort expansion phase of the phase 1/2?

Josh Bilenker

We haven't commented on that.

Eric Schmidt

And you mentioned in terms of the upcoming presentation that we should get a flavor for how the drug might be acting in fusion partner patient populations, patients who had seen prior therapies. It sounds like we're going to get at least a fair number of patients presented in that case. Can you at least give us an estimate of roughly how many patients we’ll see?

Josh Bilenker

We haven't guided specifically of course. Just to remind, of course, in September, we had enrolled 28 patients during the dose escalation. Again, given the target awareness for RET, we are seeing preferential referrals of patients with RET altered cancers generally, which is bigger than just lung cancer, but we expect this update to have sufficient sample to be interpretable.

Eric Schmidt

Maybe a quick one on larotrectinib. I noticed that a few patients have stuck in to your pivotal Phase 2s who actually didn't have TRK fusions at least per IHC testing and wondering therefore whether you still think there's a role for IHC testing and how you deal with this issue potentially in the commercial setting, maybe that’s better for Jake.

Jacob Van Naarden

Sure. Happy to take it, Eric. Yeah. I think you're alluding to the commentary in The New England paper where the authors talk about some of the non-responders and the potential that maybe there was sort of false positives test result. Interestingly, those were patients who actually enrolled to our program based on NGS results. And so -- and IHC was used retrospectively to understand whether or not the NGS result was actually a true positive or not. And so, it was a bit of a surprise, but I think it alludes to the fact that there is generally not a standardization of these assays across the world.

And I think as you know, we rolled out our clinical trial program, allowing diverse assays to enroll patients and this is one of the things that happened and it's just a real world phenomenon. We think the IHC assay is going to be useful as a screening tool for some pathology audiences who want to be able to take a broad swath of patients and narrow it down to a smaller amount that can therefore be run on a molecular assay like an NGS assay. For the most part, the false positive rate on NGS assay is exceedingly low, but you're right, there were a handful that seemed to be of that flavor in the 55.

Operator

Our next question comes from Matthew Harrison with Morgan Stanley.

Matthew Harrison

I guess two for me, maybe just following up on the assay question. Can you just update us specifically on what else needs to happen to have the IHC assays specifically the Ventana assay certified and available prior to launch and just give us a little bit of background there on the timing and expectations around that? And then I have a follow up.

Josh Bilenker

Yeah. Sure. There was a series of very standard analytical studies that have to be done. So, what lab work that is being done at Ventana right now to enable the commercial release of a class 1 assay. Remember, as you may or may not recall, a class 1 assay that the manufacturer sell certifies for release. It’s essentially a research reagent that is sold to CLIA labs for the detection of TRK protein that the CLIA lab can then validate to their own CLIA standards and utilize. So there's not a lot of risk inherent to that process right now for that class 1 availability later this year.

Matthew Harrison

And then on, just on 292, maybe just a clarification about AACR versus ASCO. I mean AACR titles are available except for late breakers, so should it be our assumption that the only way it shows up at AACR is through a late breaker or is there just something on this in there?

Josh Bilenker

Yeah. I think there's a nuance to how AACR is doing its disclosures this year. So there is the regular abstracts which are largely pre-clinical, which is the titles you see online now. Then there's late breakers and clinical trials that are lumped together and those have not yet been disclosed.

Operator

Our next question comes from Stephen Willey with Stifel.

Stephen Willey

Maybe just a follow up on Eric's question. Can you maybe just talk a little bit about the genetic representation of the RET patients that you’ve enrolled thus far and should we expect to see a pretty good cross-section of fusion partners in activating mutations within this patient update.

Josh Bilenker

Right. I mean just based on the enrollment math or pace that I alluded to in referencing the fall meeting, with the data cutoff that actually preceded that meeting, enrollment has gone pretty well across that phase 1 dose escalation and allowed us to enroll a cross-section of patients, some of whom were not selected for RET alterations, some of whom have RET alterations in the setting of thyroid cancer and other cancers and some of whom of course have known RET fusion lung cancer. So, we expect the denominators to be sufficient, again to be interpretable with respect to the impact of fusion partner on effect or any other genetic nuance as it relates to effect.

We're enrolling mutations as well as fusions for example. We’re enrolling patients who have had prior exposure to lots of kinase inhibitors with anti-RET activity for example. So this is, in contrast, the TRK when we enroll the patient on to the laro program. Most of those patients had never seen a drug with any anti TRK activity. That's not the case in our rep population. These patients are more beat up. Many of them have been pre-treated with drugs like alectinib or cabozantinib or vandetanib or other experimental RET inhibitors that aren’t approved and they have access to those clinical trials. So it's a much more diverse heterogeneous group, both biologically as well as clinical course.

Stephen Willey

And then just the BTK question actually. So, I think you’ve talked a little bit about 305 and the development path there might -- the path forward there may be in primary refractory and intolerant patients. But just wondering if there is also some kind of development path here worth exploring I guess in either responding or stable patients that have some level of a detectable [indiscernible]. I’m just wondering if that’s an opportunity that you think you might be able to carve out of the clinic.

Josh Bilenker

It’s an insightful question. I can tell you I’ve been reading. We're not in phase 1 yet. So, we're starting to pay attention to these issues. Love your thoughts offline, but I think it's a little too early to comment on the development path.

Stephen Willey

And then just a quick financial question, should we see the impact of the R&D cost sharing arrangement with Bayer in Q1 or should we just assume I guess that R&D is going to kind of continue as is and there will be some reimbursement that shows up as collaborative revenue on top line?

Jacob Van Naarden

Right now, the plan is that the cost sharing on the R&D spending will be netted in our R&D line. So not as a separate reimbursement line.

Stephen Willey

Okay. And can you provide us with some level of guidance around what proportion of 4Q spend was attributable to laro and 195?

Jacob Van Naarden

Well, just to clarify, the cost sharing doesn't start until January 1 of 2018.

Stephen Willey

Understand. But I'm just trying to extrapolate from the proportion of 4Q spend that was laro and 195 related such that when Bayer steps in, you might see a little bit of a downstroke in terms of R&D spend in ’18?

Jacob Van Naarden

Got it. Okay. Yeah. I don't think we've broken that out, but the 10-K that we're filing later today does have expenses on a full year basis broken out by program. So that may be directionally helpful.

Operator

Our next question comes from Yigal Nochomovitz with Citigroup.

Yigal Nochomovitz

Hi, Josh and Jake. Thanks for taking the question. Just more of a conceptual one, sort of on the broader strategy for the company in terms of prioritization of RET versus TRK. Obviously, Josh, you mentioned that RET is a more established market and that it's better appreciated already by oncologists. So in the early days, what was the initial thinking regarding moving into the TRK development first, which is more unproven at least on a commercial basis versus RET. Just curious there, was that something to do with this, the order of operations at the Array kinase facility?

Josh Bilenker

Yeah. I mean, a truth that cuts across a lot of our decision making is -- we’re really driven first and foremost by clinical and biologic expediency above all else. We had a compelling drug candidate in hand in early 2014 to file an IND with through the Array collaboration targeting TRK fusions. Not only was less known commercially about TRK fusions, but it could be argued that there really wasn't clinical proof of principle. That's also not true of RET of course. We have clinical proof of principle from these multi-kinase inhibitors. So really, it reflected chemical readiness and RET actually, LOXO-292, Array had had a track record and commitment to discovery in TRK for years before the Loxo-Array collaboration existed.

So we benefited from that medicinal chemistry that was existing. LOXO-292 is the first compound that Loxo and Array discovered de novo together through the collaboration agreement, starting with high throughput screening and early hit. So, it just took a while longer for LOXO-292 to become a clinical candidate. But you can see us continue to pursue the same logic. Some of our programs have more med-chem risk, some of our programs have more clinical biology risk and some of our programs have more commercial risk or flavors thereof and again, we think of the blend more than prioritizing, probably commercial is the one we put least, begets great drugs beget great markets over time and we've seen that before with other programs.

Yigal Nochomovitz

And then you mentioned that there's going to be an update under your ability for the NDA dataset sometime, I think you said in the second half of the year. What is the expectation on the additional amount of duration for that update?

Jacob Van Naarden

Yes. So that update will actually have sort of two components to it, essentially all blended together, but it will have later data cuts in the mid-July, data cut that was used for the initial NDA submission in the New England journal paper, but it will also have data that you've not yet seen about all the additional patients that we've enrolled after the 50 – the primary 55 and all of that data will be subject to the same data cut, which will be, I believe, sometime in the spring, because it's the same data cut that we’ll be supporting the ongoing regulatory.

Josh Bilenker

So just to underscore that, July 17 was the New England Journal data cut and Jake just alluded that the next one will be in the spring. So that’s a meaningful delta of months.

Yigal Nochomovitz

And then, one more thing, you mentioned Josh that you do -- you have invested in a discovery facility in Boulder. Could you just clarify, is that a wholly-owned facility, independent of Array or have you sourced any of the chemists from Array in putting that together?

Josh Bilenker

It's an independent entity from our Array collaboration. We've just been developing a nexus of talent in the Denver, Boulder area. One of our lead clinical development professionals is also in that geography. We've rented some lab space. We intend to do both biology validation as well as early medchem out of that facility. It's not a big facility in terms of human footprint today, but it is slated to grow.

Operator

[Operator Instructions] Our next question comes from Raju Prasad with William Blair.

Raju Prasad

Can you just help us to understand some of the nuances in the RET 292 development that gives you confidence on the prior TKI group in particular?

Josh Bilenker

I mean, ultimately, it’s a data driven answer I should provide, which I hope to provide at a medical meeting. There is a lot of ways patients progress. They could have had their targets of optimally inhibited by a prior multi-kinase, in other words, it turns out that tumor needed deeper inhibition of the RET pathway to respond. They could have actually developed acquired resistance to a RET inhibitor prior or they could have activated the tertiary pathway that has nothing to do with the RET and therefore shouldn't respond the single agent RET and I think we just have to answer your question with data.

Raju Prasad

Great. And then I saw that the FDA is going to be hosting that workshop in May on tissue agnostic therapies. Can you just talk about maybe this FDA push towards doing this and what you think could come out of this maybe a potential push towards basket trials or maybe an expedited pathway for some of these follow-on products you have like 305 and 292?

Josh Bilenker

Look, I think FDA has had a leadership position. When you think about the different constituents who have an impact, that important impact on drug development, whether it's academia industry, government FDA, I’d argue that FDA has had a leadership position in thinking about this. FDA approved Keytruda in MSI-high cancers for the first tissue agnostic approval anywhere ever in that fashion. So, I think this is a theme that they're committed to thinking through from a regulatory science standpoint. We're obviously grateful for that investment of intellectual capital. I can't really speculate on a larger policy agenda for a meeting that hasn't happened, but we’re eager to hear about it and we’ll students, we’ll hope to be continued students of their ideas.

Operator

Thank you. And I'm currently showing no further questions at this time. I would like to turn the call back over to Josh Bilenker for closing remarks.

Josh Bilenker

So again, we’ll let you have a lot of your morning back. We're excited to have this time with you. It's an important year for the company and we can appreciate your support, thoughtful questions and as you know, we're always available for more. Thank you.

Operator

Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day.