Array BioPharma's CEO Discusses F3Q 2014 Results - Earnings Call Transcript

| About: Array BioPharma (ARRY)

Array BioPharma, Inc. (NASDAQ:ARRY)

F3Q 2014 Results Earnings Conference Call

April 29, 2014 09:00 AM ET


Tricia Haugeto - Director, Corporate Communications and IR

Ron Squarer - Chief Executive Officer

Mike Carruthers - Chief Financial Officer

Mike Needle - Chief Medical Officer

Andy Robbins - SVP of Commercial and Strategy


Michael Schmidt - Leerink Partners

Eileen Flowers - Jefferies

Matt Lowe - JP Morgan

Matthew Andrews - Wells Fargo Securities


Welcome to the Third Quarter 2014 Array BioPharma, Inc. Earnings Conference Call. My name is Christine and I will be the operator for today’s call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note that this conference is being recorded.

I will now turn the call over to Ms. Tricia Haugeto. You may begin.

Tricia Haugeto

Thank you, Christine. Good morning and welcome once again to Array BioPharma’s conference call to discuss our financial results for the third quarter of 2014. You can listen to this conference call on Array’s website at 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, Mike Carruthers who will lead the call today. In addition, our Chief Medical Officer, Mike Needle and Andy Robbins, our Senior Vice President of Commercial and Strategy will be available to answer questions as needed.

But before I hand over the call to Ron, I would like to read the following Safe Harbor statements. 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, 2013 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 Array’s CEO, Ron Squarer.

Ron Squarer

Thank you, Tricia and good morning to everyone. I’d like to open the call by recognizing a new director on Array’s Board; Dr. Chuck Baum. Chuck has an ideal background to complement the expertise of our Board. His track record of building successful development teams and bringing drugs to market in oncology including Sutent, Inlyta and Xalkori will be invaluable as we focus our efforts in oncology and continue our evolution towards late stage development and commercialization.

So, I’m on slide 3 of our supporting deck. And as we head into ASCO, which occurs in about a month we’re very excited about the progress that continues to be made with the two Array-invented MEK inhibitors. And we also look forward to near-term catalyst with a long list of promising development stage programs. Both of our MEK partners have received quite a bit of attention in the past week with the news that Pfizer has expressed an interest in acquiring AstraZeneca and Novartis’ planned acquisition of GSK’s oncology business. Of course, I’ll be drilling down on both of these developments in just a bit.

Regarding our wholly-owned filanesib program in multiple myeloma, we are currently enrolling randomized Phase 2 trial, exploring the combination of filanesib and Kyprolis. This trial is a smaller version of our planned Phase 3 trial which will have a similar design.

During this quarter, we initiated a new single agent filanesib Phase 2 trial, which is designed to measure objective response rates in refractory patients with low levels of the patient selection marker AAG.

We believe these patients with lower AAG will receive greater benefits than those with high levels of AAG. You’ll recall that we estimated that approximately 70% of patients fall into this category. This study will fulfill several regulatory requirements and with positive results could also enhance future product label in refractory melanoma.

Several of our earlier stage programs continue to make important progress with ARRY-797 enrolling LMNA-related dilated cardiomyopathy patients in the Phase 2 proof of concept trial. ARRY-380, our highly selective oral HER2 inhibitor is now being studied in three separate proof-of-concept combination trials in metastatic breast cancer. And just last week, Loxo Oncology announced that Loxo-101 and Array invented PAN TRK inhibitor is initiating its first clinical trial, details of which have been posted to

We believe that each of these programs are supported by exciting scientific rationale and early data. And encouraging results with any of these programs could generate significant upside for Array. For clarification, the current ARRY-380 and Loxo-101 trials are partner funded, allowing Array to focus our resources on our currently enrolling trials for our wholly owned filanesib and ARRY-797 programs. So, as we disclosed this morning already, we have $110 million in cash as of the end of March which positions us well to execute on our current plans.

So turning to slide 4, as I just mentioned, our binimetinib partner, Novartis announced that they have entered into a definitive agreement with GlaxoSmithKline pending antitrust review. Now if their planned transaction closes, Novartis will acquire GSK’s oncology franchise including GSK’s MEK inhibitor known as Mekinist. So following this announcement, Array issued a Novartis approved press release which is summarized on this slide to clarify the implications for binimetinib.

So first, Novartis has indicated that it will continue to honor its obligations under the Array-Novartis agreement related to binimetinib, including obligations related to support for ongoing clinical trials as specified in the agreement. And this includes the three Phase 3 trials NEMO and COLUMBUS, which are being conducted by Novartis and MILO, which is being conducted by Array.

Second, Novartis reaffirmed the potential timing for the first binimetinib regulatory filing in NRAS melanoma which is in 2015. The GSK Novartis deal remains subject to government approval. And importantly our agreement prevents Novartis from assigning or licensing all binimetinib rights to a third party. So in the event that Novartis’s binimetinib development and commercialization rights were to be returned to Array, Novartis must provide support for ongoing clinical studies as specified in our agreement. We believe that the possible return of all rights for binimetinib to Array could represent a substantial upside scenario and could be transformative to our company, but would be in addition to our existing and robust internal portfolio.

Moving on to slide 5. Pfizer publically announced yesterday their continued exploration of a possible merger with AstraZeneca. Pfizer’s press release specifically highlighted their interest in a combined portfolio of targeted medicines for lung cancer and specifically called out novel agents for KRAS sub types.

So, we have been informed by AstraZeneca that selumetinib clinical development is advancing according to plan with patient enrollment continuing in three pivotal trails in KRAS non-small cell lung cancer, in thyroid cancer and in uveal. These are the pivotals in addition to a great number of additional trials underway.

In the event that AstraZeneca were to assign our agreement to Pfizer upon being acquired, Pfizer will assume all of AZ’s rights and obligations regarding selumetinib. This includes but not limited to potential future milestones and double-digit royalties that would come to Array.

Now uveal melanoma represents the first potential indication for selumetinib and we are pleased that AZ announced last week for the first time that they expect to file this indication with regulatory authorities in 2015 as part of their public disclosure.

So on slide 6, both Array invented MEK inhibitors will be featured at ASCO in June. There will be an oral presentation on binimetinib, in combination with Novartis’ experimental CDK inhibitor, LEE011 in NRAS melanoma. The ongoing Phase III binimetinib NRAS melanoma trial I mentioned earlier is a randomized single agent trial. So, it will be interesting to see these MEK, CDK combination results. And as the title states, it appears there are early encouraging clinical activities observed.

Novartis will also be sharing data on a combination with binimetinib and their experimental PI3K Alpha selective inhibitor, known as BYL719 in selected solid tumors.

Preliminary results will be provided from the Phase 2 combination trial with selumetinib and temsirolimus and mTOR inhibitor in patients with soft tissue sarcoma as well as two Phase 1 trials in pediatric patients. The first trial is in neurofibromatosis type 1 or NFI and plexiform neurofibroma or PN. And the second trial is in gliomas.

We're particularly excited to see that additional data will in fact be presented on NF1 since the data shared last year in NF1 focused Congress was very promising.

So, I'm now turning to slide 8, and here we provide the details of the three ongoing registration trials for binimetinib, an NRAS-mutant melanoma, BRAF-mutant melanoma and low-grade serous ovarian cancer.

Now while NEMO and COLUMBUS are being conducted by Novartis, Array actually initiated and continues to conduct the low grade ovarian cancer trial and [notice] MILO. This 300 patients study is a multi-national randomized Phase III trial with sites in the U.S., Canada, Europe and Australia. The trial is covered by the Novartis Array to development agreement where overall cost to Array are capped annually and in total at a reasonable level.

NRAS mutant melanoma will likely be the first indication for binimetinib as I mentioned and Novartis is currently projecting and has just reiterated their expectation for regulatory filing in 2015.

On slide nine, we list a subset of the 17 ongoing or initiated Novartis sponsored, company sponsored binimetinib trials. It’s our expectation that all of these trials are currently continuing according to plan and we're particular interested in the combination of binimetinib and panitumumab in colorectal cancer as KRAS mutations drive at approximately 35% of that tumor.

Also not listed on this chart is a new NTI trial with binimetinib and full fox in patients with metastatic colorectal cancer, who have failed prior standard therapy. Patients with colorectal cancer represent a large population and it continues to be a very high unmet need disease.

Now on slide 10, regarding, selumetinib we continue to be encouraged by AstraZeneca’s progress. They are currently three pivotal trials in rolling patients with selumetinib KRAS non-small cell lung cancer thyroid cancer and uveal melanoma. As AstraZeneca announced during their quarterly results last week uveal melanoma will like to be the first indication for selumetinib with the projected regulatory filing in 2015.

So we see the possibility of revenue from selumetinib to Array by 2016. In addition we're delighted to see last week AstraZeneca publicly stated some tension to potentially start a first line KRAS with non-small cell lung Phase 3 study to complement their ongoing second line KRAS non-small cell lung cancer Phase 3 study, the potential for either of these trials of course is very large.

On slide 11, we list just a example of the 52 ongoing selumetinib trials, 32 of which are either Phase 2 or 3, of note all the multiple ongoing studies exploring combinations of selumetinib with traditional first line and non-small cell lung cancer chemotherapy for this GEM, CYST, CARBO, PACK and pemetrexed. And we expect that the results of these studies will inform the new potential first line KRAS non-small cell lung cancer Phase 3 study which AZ discussed in their disclosures last week.

So turning now to filanesib on slide 13, I just like to review our global development plans for filanesib. At the top, you'll see the Phase 3 trial now named FACTOR in combination with Kyprolis which is designed to support full regulatory approval in the U.S. and Europe, the factor trail will enroll several hundred patients with relapsed refractory multiple myeloma. The primary endpoint will be progression free survival. There are more than 70,000 patients with relapsed refractory multiple myeloma in developed countries and if successful this could represent the first drug combination for Kyprolis in patients who have previously been treated with Rev and Velcade.

Now separately from the FACTOR trial, we are conducting a two Phase 2 trial design to support -- it provides us supportive data for full approval along with other benefits. Now the first Phase 2 which continues to enroll patients is a study of filanesib and Kyprolis compared to Kyprolis around. Prior to initiating the FACTOR Phase 3 study we will have the benefit of reviewing combinability data from this Phase 2. In addition the study will help us validate the use of AAG as a patient selection marker and generate data for publication to support enrollment of the Phase 3 trial.

The other Phase 2 which is now named AfFIRM has been posted to it is a single agent single arm study of filanesib in 160 heavily pre-treated relapsed refractory multiple myeloma patients. So eligible patients will have received at least [two] prior lines of therapy have received prior bortezomib and lenalidomide and have disease refractory to carfilzomib and/or pomalidomide and we believe this represents a very high unmet need population. In addition to providing important safety and pharmacology data necessary for regulatory filing this trial will help us validate AAG as a patient selection marker and if successful could support broader labeling in conjunction with a Phase 3 trial.

On slide 14 we are moving to ARRY-797 in our trial in LMNA related dilated cardiomyopathy or LMNA related DCM, a rare genetically linked cardiovascular disease. And as we have said patients with this disease they say a very poor prognosis with a nearly 70% experiencing major cardiac event, heart transplant or death by age 45.

On slide 15 the study we’re currently enrolling is a 12 patient proof of concept study of ARRY-797 in patients with LMNA related DCM. The primary endpoint is change from base line in a six minute walk test at 12 week, other endpoints include left and right in ventricular functions, quality of life, safety and pharmacokinetics. Preliminary results from this trial are expected by the end of this year.

And now I would like to turn the call over to Mike Carruthers, who will provide a summary of our financial performance during the quarter.

Mike Carruthers

Thank you, Ron. I am pleased to share with you the financial results for the quarter. Starting on slide 17. Our revenue for the third fiscal quarter was $8 million. This was fairly evenly split between collaboration revenue and recognition of milestone or license payments which were received in prior periods but recognized currently.

Our revenue is down by approximately $2 million from the same period last year, largely because our new ongoing Celgene collaboration is focused on a single target while a year ago we are working on the original multi target Celgene agreement. Our R&D spend increased from the prior sequential quarter as the Phase 3 and single agent Phase 2 studies for Filanesib are in preparation mode.

However compared to the same period of last year, the $14.1 million spend this quarter remains below the same quarter of last year and was also below the overall average of last year. We ended the quarter with a solid cash position of $110 million.

Moving to our slide 18, for guidance for the fiscal year. There is no change to the full year guidance for loss per share, although the revenue guidance is several million lower. This is because we expect revenue and loss per share in the final fiscal quarter to be pretty similar to the quarter just ended.

And with that, I would like to turn it back over to Ron.

Ron Squarer

Thank you, Mike. Concluding now on slide 19, here we provide a summary of key upcoming catalysts for Array. It is our expectation at this time that all clinical trials with binimetinib will continue to advance according to current development plan. In the event that Novartis’s binimetinib development and commercialization rights are in fact returning to Array. And Novartis must provide support for ongoing clinical studies as specified in our agreement.

Given a potential 2015 filing for NRAS melanoma, we believe that the possible return of all rights for binimetinib to Array could represent a substantial upside scenario and be transformative to our company and this of course would be an addition to our -- to the remainder of our robust portfolio.

During this year, we will continue to collect data from multiple ongoing filanesib clinical trials including the Phase 2 randomized combination trial with Kyprolis, which will inform the factor Phase 3 trial.

With selumetinib, which is partnered with AZ, three pivotal trials are ongoing including the SELECT-1, Phase 3 KRAS non-small cell lung cancer trial. We look forward to AZ’s investment decision this year on a new Phase 3 trial in first line KRAS non-small cell lung cancer and to a potential 2015 filing for uveal melanoma.

We remain on track to have preliminary results from a proof-of-concept study of ARRY-797 in a rare cardiovascular disease by the end of this year and look forward to seeing ARRY-380 and LOXO-101 advanced in clinical trials.

And at this time, I'd like to turn the call back to the operator for Q&A.

Question-and-Answer Session


Thank you. We will now begin the question-and-answer session. (Operator Instructions). Our first question comes from Michael Schmidt from Leerink Partners. Please go ahead.

Michael Schmidt - Leerink Partners

Hi, good morning. Thanks for taking my questions. My first question is on the Astra collaboration on selumetinib. So you said they are very excited and enthusiastic about the product, talking about potentially a new Phase 3 study in non-small cell lung cancer. But I was really wondering with regards to potential change of control, do you have a similar class and place that you have in Novartis regarding the continued support for the trials in case of potential control?

Ron Squarer

Yes. So, Mike thanks for the question. So, let’s parse this a bit, in the AZ agreement if AstraZeneca is acquired by Pfizer it’s our belief that they will be able and entitled to assign rights and obligations on to Pfizer. Now I think all we can say about, we think that AZ and Pfizer are very, would be very interested in continuing to support this trial. I mentioned at the open that in the press release issued by Pfizer, they didn’t call out a whole lot, but they did call out KRAS-mutant disease as one of their rationales for being interested in AstraZeneca.

So we think there is a great deal of, there would be a great deal of natural interest in maintaining that plan. Of course uveal melanoma, which they are saying now would be finally in 2015 presumably would be unaffected and represent a quick path to market. And then there is a thyroid pivotal that is ongoing.

There are provisions related to diligent development and commercialization, but I really do believe that the interest of these companies either when -- either AZ on its own or as part of Pfizer would provide a tremendous motivation to move forward. And what's very impressive about the selumetinib program is that there are so many exploratory trials running with it, 52 trials in total over, almost three dozen that are Phase 2 or 3. And so, there is a lot of data that’s already been created or is in the process of being created to support forward plans for AZ and Pfizer.

Michael Schmidt - Leerink Partners

Got it, great. And then one on 797, you have LMNA-related DCM data at the end of the year. I was just wondering with regards to the six-minute walk test, this matter is notoriously noisy in my view for some indications at least with the high degree of variability. And I was wondering how meaningful that endpoint really is and then also what the approvable endpoint would be in that indication?

Ron Squarer

Yes. We do get questions on the six-minute walk test and I think at this point what’s best is first to collect our data and continue to discuss it with opinion leaders and regulators. What I can say from precedence is that six-minute walk has in fact been used on multiple occasions to achieve approval in high unmet need for ultra-orphan disease. And following our conversations with FDA prior to starting the study, it is our impression that six-minute walk at the functional test is one that would be quite important to regulators.

As I mentioned, there are other endpoints being measured even in this proof-of-concept study, a quality of life which you could suggest is another measure of improved function, but there will be many traditional technical endpoints studied as well. And so, I think at this time to speculate on exactly what the regulatory hurdle is, it might be inappropriate only to say that six-minute walk test has been used in the past. Does that answer the question?

Michael Schmidt - Leerink Partners

Yes. Thank you so much.


Thank you. Our next question comes from Eun Yang from Jefferies. Please go ahead.

Eileen Flowers - Jefferies

Hi, it’s actually Eileen Flowers dialing in for Eun this morning. So, based on your discussions with Novartis, can you give us a projected probability for the likelihood that Novartis returns binimetinib to Array?

Ron Squarer

Right. Eileen good morning. So, I think at this time all we can really go on is the fact that Novartis has stated they expect their deal to close in 2015 I think they’re saying first half I think that’s just an estimate on their part. And so, it’s very early for us to speculate on what will exactly happen with binimetinib. And so, I think it’s best that we allow events to progress until such point as we’re able to give more insight.

There is the current agreement which is in place with all of its provisions. And then as I mentioned, a deal of this size will have a government review and regulators frankly around the world will have their opinions as to what an appropriate outcome is for this drug going forward. So, I know that’s not a very specific answer, but I think at this time it’s the appropriate one.

Eileen Flowers - Jefferies

Great. And then can you talk about Novartis’ plan to the second generation MEK inhibitor ARRY-300?

Ron Squarer

No, you are talking Novartis?

Eileen Flowers - Jefferies

Yes, correct.

Ron Squarer

So, you know at this point, we are not aware of any activity which is ongoing regarding a second MEK inhibitor. So, at this point I think it’s safe to say that it is not advancing. And frankly there has been so much progress with binimetinib now in three pivotal trials seemed to be filed. And that the product as far as we can see and at ASCO there will be even more data, is performing quite well. And with the key hallmark really being our ability to combine and both Array-invented MEKs are absolutely different programs, but thus far they do appear to have the ability to combine well in the case of Novartis where they’ve tested mostly with innovative targeted agents, we’ve seen their ability to combine.

As you know, AstraZeneca has taken a very different approach to development really not one that overlaps with Novartis and has looked at a lot of cytotoxic combinations in there as well, we see good combine-ability. So, the need I think for a follow on MEK is not great. And so at this point I’d say it’s not advancing.

Eileen Flowers - Jefferies

Thanks. And then if could ask a quick one on ARRY-520; if the Kyprolis focus study there that’s coming out this year fails, how do you think that would impact enrollment in your ongoing trials with ARRY-520?

Ron Squarer

So, we’re talking about the Phase 2, the ongoing Phase 2 combination trial -- I am sorry. Okay, I apologize. If the data emerges with Kyprolis with a FOCUS trial specifically that is in some way a less than ideal, how would it affect us? And what I would say is FOCUS is a very specific study with a design that may not be as relevant to the current labeled indication for Kyprolis. All indications we have is that the uptake of Kyprolis has been very rapid and very healthy and that there is a lot of enthusiasm forward. I know that Amgen, Onyx now are continuing to study a different dosing regimens and looking to seek in fact evidence for even greater efficacy.

And so, in total, I would say there doesn't seem to be any reason to think that the FOCUS result in particular would affect uptake and hence affect our studies which are really more focused currently on the U.S. approved patient population. I’ll ask Andy to comment on the landscape a bit.

Andy Robbins

Yes, the only thing I'll add there is from a FOCUS perspective, it's certainly European focused [partner fund] designed to get approval as a single agent. I think the general perception in the key opinion leader community is whether or not that trial is positive; Kyprolis remains an important agent in the treatment of myeloma. So, whether or not the trial reads out and gets them an approval in Europe, I think the enrollment of our [claim’s] trial should proceed unaffected.

Eileen Flowers - Jefferies

Great. Thanks for taking my questions.


Thank you. Our next question comes from Cory Kasimov from JP Morgan. Please go ahead.

Matt Lowe - JP Morgan

Hi, there. It’s actually Matt Lowe in for Cory today. Just to come back quickly to the Novartis GSK situation, could you be a bit more specific on Novartis’ obligations relating to the four ongoing trials in that context too, if indeed that asset is returned to Array?

Ron Squarer

Right. So, at this point, I think we need to stick to the language that is approved from Novartis. We very much respect our obligation to maintain any confidential data, they’re confidential. And while the agreement is publicly posted, there are sections that are redacted. And so what I’ll just restate that there are in fact obligations within our current agreement that would be related to continued support for ongoing trials if in fact in the event that binimetinib is returned to Array. And that’s separate from any kind of government review that might come into play here.

So that’s sort of almost in a business as usual setting. And then particularly with respect to it and what government authorities would seek in order to ensure that there are no sort of anti-competitive effects to the MEK landscape. So perhaps there will be more news over time, but we do respect the confidentiality of our agreement.

Matt Lowe - JP Morgan

Okay. And then just a quick follow-up 797 for DCM, I guess is there anything more you can say about what specifically you are looking to show in that 12 patients Phase 2 trial to be able to move the program forward into Phase 3? I’m talking about what kind of increase in the six-minute walk test would kind of be the line in the sense you to progress that program, what would you also want to see certain things on the secondary end-point?

Ron Squarer

Yes. Matt, I appreciate the question, and this question has come up in the past. And I think what, while they are out there, general sort of perceptions of what a clinically meaningful change in a six-minute walk would be, we also know the [providence] of approval in ultra-orphan, we’ve seen drugs approved with relatively minor changes in six-minute walk, but with overall picture or totality of data that looks compelling. And so this is an exploratory. Of course we would like to see not just meaningful improvement in function but we’d like to see it broadly in this patient population. But we are as I said, examining also laboratory type test. And it is our perception that it is sort of totality of data that would influence decision in an ultra-orphan setting where you have a number of patients.

I think that we’ll be in a much better position to explain both the results and the hurdles when we have them. And I’m concerned at this point to put sort of lines in the sand. I think it's preliminary for that. Does that help at all, Matt?

Matt Lowe - JP Morgan

Yes, that was helpful. Thank you.


Thank you. Our next question comes from Matthew Andrews from Wells Fargo Securities. Please go ahead.

Matthew Andrews - Wells Fargo Securities

Hey, good morning. Thanks for talking the questions, a couple for me. Ron, would you assume that the Phase 3 randomized study starts in the back half of the year, because of the reduction in R&D for fiscal 2014 like (inaudible) [$12 million]? Second question, can you just define sort of the main duration you're looking for relative to the combinability data from the Phase 2? And then for Mike Needle, what's the updated thoughts related to an interim on response rates in Phase 3?

Ron Squarer

Al right.

Matthew Andrews - Wells Fargo Securities

Is there any change?

Ron Squarer

Yes. So, I’ll let Mike talk about the interim results on the, for ORR in the Phase 3, just describe what we think our plans are likely to be. But I think you are asking if our guidance reflected some change to the filanesib plan. Matt, I believe that was your question, is that what you are talking about?

Matthew Andrews - Wells Fargo Securities

Yes. It looks R&D guided for $12 million less this year versus prior guidance; I was just wondering if that reflects pushing out initiation in the randomized Phase 3 to the back half of the calendar year?

Mike Carruthers

This is Mike Carruthers, no it doesn’t. A year ago, just year-on-year comparison, there are two things: I mean one, we were running the Phase 2 asthma study last year which was a significant in costly study that’s long over but did impact the entire year last year. And in addition, as you know we have the goal and have been pretty successful in our research efforts, discovery efforts being cost neutral working with collaborators to achieve that.

Ron Squarer

Right. And I think the second question, Matt, it had to do with are we going to be looking, what are we going to be looking at from our ongoing Phase 2 trial. And currently the plan remains exactly as we stated when we initiated this program, the primary objective of what we are going to be looking at for the phase -- the ongoing Phase 2 is in fact combinability, and first of all look at everything that we see in order inform the Phase 3 study. But the real focus of that study was in fact to look at combinability. And so you had a question about the plans or the potential plans for an interim ORR in Phase 2, so let me let Mike Needle address that and tell you where we are with that thinking.

Mike Needle

Yes. So, what we are currently looking at, and we haven’t fully finalized the plans is A, look, we would call an interim look if you look, but it will obviously be fairly late in the study where we will attempt to compare response rates between the experimental line of plus carfilzomib to the control one carfilzomib. And potentially, if the results are convincing enough, it’s possible that we could bring that for a discussion to the FDA for accelerated approval. As I am sure you are well aware, the FDA is less enthusiastic about uncontrolled trials than perhaps they were 10 years ago. And they have proposed that this is a possibility; this is a possibility, there is a couple of things that make it just a little -- notes what taking into account. And when the agency in our conversations with them was pretty clear, they didn’t want to see any such analysis prior to completion of enrollment because they always would be concerned, as a result influence to the completion of the trail and they are concerned about that.

And then secondly again, remember or not remember, but you should know that our current thinking is that we would do that analysis in the AAG low population, specifically as opposed to the overall population. So, we haven’t fully finalized our plans but that’s what our current thinking is.

Ron Squarer

And I would just add that our focus remains obviously on completing the trial for -- would be on completing trial for PFS. And there is always some statistical questions, are we are going to apply the vast, vast majority of the power to the PFS endpoint, wouldn’t want to risk that. As we post this trial in the future, ideally will be able to share a lot more details about it. Alright?

Matthew Andrews - Wells Fargo Securities

Yes. Just one last one for Mike, were there any ATM sales in the quarter, and if so, how much?

Mike Needle

Yes, there were. There was approximately $5 million worth of ATM sales.

Matthew Andrews - Wells Fargo Securities

Okay. Thank you.


Thank you. I will now turn the call back over to Ron Squarer for closing remarks.

Ron Squarer

Great. Well, thank you very much. Thanks to everyone. Certainly an exciting time for Array. And we look forward, of course to be able to provide more detail regarding binimetinib, as it becomes clear. But it could represent an important upside scenario, that's one possibility, in addition to our robust existing portfolio. And we'll be providing more insight on and how we're prioritizing that portfolio over time. And so, at this point, I'd like to thank our employees here at Array for their commitment, ingenuity, and diligence that continues to fuel our success. Also, I want to thank our patients, partners and shareholders for their continued confidence and support. And with that, we will close the call. Thank you all very much.


Thank you. And thank you ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.

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