Synta Pharmaceuticals' Management Discusses Q4 2013 Results - Earnings Call Transcript

Synta Pharmaceuticals Corp. (SNTA) Q4 2013 Earnings Conference Call March 11, 2014 10:00 AM ET

Executives

Steve Bernitz - Senior Vice President, Corporate Development

Keith Gollust - Chairman, Board of Directors and Executive Committee

Vojo Vukovic - Chief Medical Officer

Iman El-Hariry - Vice President, Clinical Research

Keith Ehrlich - Chief Financial Officer

Analysts

Brian Klein - Stifel

Graig Suvannavejh - MLV

George Zavoico - H.C. Wainwright

Nick Abbott - BMO Capital Markets

Operator

Good day, and welcome to the Synta Pharmaceuticals Fourth Quarter and Year End 2013 Earnings Conference Call. Today’s conference call is being recorded and webcast. At this time for opening remarks, I will turn the call over to Steve Bernitz, Senior Vice President of Corporate Development at Synta Pharmaceuticals. Please go ahead, sir.

Steve Bernitz - Senior Vice President, Corporate Development

Hello and thank you all for taking the time to join us today. With me are Keith Gollust, Chairman of the Board of Directors and Executive Committee; Vojo Vukovic, Chief Medical Officer; Iman El-Hariry, Vice President, Clinical Research; and Keith Ehrlich, Chief Financial Officer. This morning, we issued a press release that reported results for the fourth quarter and year end 2013. This release can be found on our website at www.syntapharma.com.

Before we begin, I would like to point out that we will be making forward-looking statements based on our current intent, belief and expectations, which are subject to certain risks and uncertainties. Additional detail can be found in related SEC filings also available through our website.

I will now turn the call over to Keith Gollust.

Keith Gollust - Chairman, Board of Directors and Executive Committee

Thank you, Steve and thank you all for joining us today. I want to begin this call by addressing the news that was announced last week. By way of context, several months ago, the Board of Directors made a decision to strengthen the company’s decision-making capabilities. We began at the Board level and retained the services of an executive search firm. Our goal was to add directors with executive experience in drug development, regulatory interactions and commercialization.

As you know from last week’s news, this process has already resulted in the addition to our board of Dr. Paul A. Friedman, the recently retired CEO of Incyte Corporation. Dr. Friedman has already begun to contribute to Synta and will continue to do so through his active participation as a member of the executive committee, which was formed to oversee company affairs while we conduct a careful search for a new CEO.

At some point in the Board’s process of self-examination, we came to the conclusion that in order to best serve our many constituencies, we needed to make an executive change. This in turn led to the news of Safi Bahcall’s departure. This was a difficult decision which was carefully considered over an extended period of evaluation. It was also an emotional decision since we and the Board have worked closely with Safi and consider him a friend. I want to take this opportunity to express my gratitude and the gratitude of the Board to Safi for the personal commitment he made to the company over many years.

I also want to emphasize that the decision was not based on any lack of confidence in the current status of our development programs. On the contrary, it is the increasing scope and complexity of our programs that contributed to the Board’s belief that recruiting an executive with experience in the areas critical to the successful execution of a complex development program was essential.

This morning’s announcement that ganetespib was selected for inclusion in the I-SPY 2 trial brings to five the number of randomized investigator-sponsored trials that have been announced this year, which collectively are targeted to enroll over 1,000 patients and have the potential to validate the clinical benefit of ganetespib in multiple indications. Importantly, these trials are sponsored by and paid for by cooperative groups and government bodies, which required independent objective determinations that the clinical data and safety profile that has been compiled to-date justifies the significant commitments being made.

Synta’s Board of Directors believes that the ganetespib development program provides compelling evidence of clinical activity. The challenge is to conduct a successful Phase 3 trial that leads to regulatory approval in commercial operations. That challenge can best be met with a properly designed and well executed clinical trial. The GALAXY-2 protocol amendment that was announced earlier this morning addresses that challenge and represents a renewed and expanded commitment by Synta’s board. It is well known that over 35% of the outstanding shares are owned by members of the board. That makes us highly motivated to commit resources carefully. The dilution caused by partnering or by issuing equity is felt by all of us proportionately.

We are well aware that the GALAXY-2 trial will take longer and cost more than originally anticipated, but the modifications we have made are consistent with the goal of maximizing our probability of success. This leads to the final point I would like to make before Vojo provides greater detail on the clinical programs. Together with strengthening the executive function, the Board is making a commitment to provide investors with an increased level of candor and to build conservatism into the guidance we provide. I personally have been an investment professional for over 40 years and I understand the importance of the word credibility. We have set a goal of establishing credibility and earning your trust by the actions we take and the guidance we provide.

With that I will turn the call over to Dr. Vojo Vukovic.

Vojo Vukovic - Chief Medical Officer

Thank you, Keith. As we announced this morning based on an evolving standard of care and regulatory feedback, we are amending the protocol of our pivotal Phase 3 GALAXY-2 trial. As you may know GALAXY-2 is a randomized multinational study of ganetespib and docetaxel versus docetaxel alone for the second line treatment of patients with non-small cell lung adenocarcinoma. This trial is being amended to strengthen the provision for testing patients for ALK translocations and EGFR mutations from strongly encouraged to mandatory. Only those patients who have demonstrated progressive disease following one prior platinum-based combination therapy for advanced non-small cell lung adenocarcinoma a diagnosis of advanced disease greater than six months prior to study entry known as chemo-sensitive and whose tumors test negative for both ALK and EGFR status will be enrolled. We believe this amendment is necessary to reflect real growth clinical practice particularly in the U.S. where ALK and EGFR patients are now commonly treated with inhibitor specific to these targets.

We are sure that there are at least 700 patients with ALK, EGFR double negative status the trial size has been increased to 850 patients. As this study size, the GALAXY-2 trial has an 87% power to detect the hazard ratio of 0.75 at a time with the final overall survival analysis. Based on these study amendments and current projections Synta expects the two interim efficacy analysis of GALAXY-2 to be conducted by the independent Data Monitoring Committee in the second half of 2015 and the final analysis to be conducted in the first half of 2016.

As Keith also mentioned ganetespib is now a part of five other large randomized studies. These include the I-SPY 2 trial, a standing Phase 2 randomized controlled multi set of trial for women with newly diagnosed locally advanced breast cancer. The study is designed to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone in the neo-adjuvant setting. This is a highly regarded study which has already yielded promising new findings such as those announced for investigational agents veliparib and neratinib.

Enrollment in the ganetespib arm of I-SPY 2 is expected to begin in 2014. It will initially be available to patients with HER2 negative disease, with the intent to expand its eligibility to all breast cancer subtypes including HER2 positive after safety testing with trastuzumab is completed. The I-SPY 2 trial employs a unique adaptive trial design to match experimental therapies with patients and predict regimens likely to succeed in Phase 3. Genetic or biological markers from individual patients’ tumors are used to screen promising new treatments identifying which treatments are most effective in specific patient subgroups. This study allows the identification of the right drug for the right patient in the most expeditious fashion.

I-SPY 2 adds to the AML-LI-1, AML-18 and AML-19 trials in acute myeloid leukemia and High Risk Myelodysplastic Syndrome, which we announced in January. These multi centered randomized trials supported by the Leukemia & Lymphoma Research Fund and Cancer Research UK will evaluate ganetespib in combination with chemotherapy and the first line treatment of these diseases. Among them, the AML-LI-1 trial is currently ongoing. This study looks at the combination of ganetespib and low-dose cytarabine versus low-dose cytarabine alone in patients who are not eligible for intensive chemotherapy and are traditionally not included in most trials. Up to 50 patients are being enrolled in the ganetespib arm, after which an interim analysis will be conducted to evaluate whether to proceed into a Phase 2 trial. This interim analysis is expected to be conducted in mid-2014.

We also announced in January the selection of ganetespib for the GANNET53 trial in ovarian cancer. GANNET53 is a Seventh Framework Program or FP7 research project funded by the European Commission. This pan-European randomized trial is designed to evaluate the combination of ganetespib and paclitaxel versus paclitaxel alone in over 200 patients with metastatic, p53 mutant, platinum-resistant ovarian cancer. The study’s consortium consists of national clinical trial groups in gynecological oncology and high-volume university centers as well as noted p53 scientists. The safety lead-in Phase 1 portion of GANNET53 is expected to begin enrollment in mid-2014. All these programs are part of the over 2000 clinical trials sponsored by investigators, cooperative groups or patient foundations that are ongoing or planned for 2014. These programs are supported by significant number of research studies conducted at leading institutions.

To that end, we look forward to seeing results presented at the ACR Annual Meeting in April looking at in vitro, in vivo or clinical results with ganetespib in lungs, pancreatic, ovarian, colorectal, glioma, renal and breast cancers exploring combinations with radiation, chemotherapy and targeted agents. We also look forward to presenting in vivo pre-clinical results from our HDC program. As a reminder, HDCs are conjugate molecules that link ganetespib or other Hsp90 inhibitors with small molecule cancer drugs using the accumulation of Hsp90 inhibitors and tumors through improved delivery of those drugs to tumors. The most advanced of these HDCs are our HDC SN-38 and HDC docetaxel conjugates. We look forward to presenting additional data surrounding this platform at upcoming scientific conferences.

I will now turn the call over to Keith Ehrlich for financials.

Keith Ehrlich - Chief Financial Officer

Thank you, Vojo and good morning everyone. There were no revenues recognized in the fourth quarter of 2013 or 2012. In the fourth quarter of 2013, our research and development expenses were $20 million as compared to $14.4 million for the same period of 2012. Our fourth quarter general and administrative expenses were $3.5 million as compared to $3.4 million for the comparable period in 2012. Our net loss in the fourth quarter of 2013 was $24.2 million or $0.31 per basic and diluted share as compared to a net loss of $18.1 million or $0.29 per basic and diluted share in the same period of 2012.

As of December 31, 2013, we had approximately $91.5 million of cash resources on hand. Based on our current operating levels, we expect our cash resources will be sufficient to fund operations at least through the end of 2014. Certain new or expanded activities contemplated for 2014 will be conducted subject to the availability of sufficient financial resources.

I will now turn it back over to Steve.

Steve Bernitz - Senior Vice President, Corporate Development

Thank you, Keith. This concludes our prepared remarks. Operator, we will now open the call to questions.

Question-and-Answer Session

Operator

Thank you, Mr. Bernitz. We will now be conducting a question-and-answer session. (Operator Instructions) Thank you. Our first question is coming from the line of Thomas Wei of Jefferies. Please go ahead with your question.

Unidentified Analyst

Hi guys. This is Shawn (indiscernible) filing in for Thomas. I just had a couple of questions for you. First, I want to know the decision to modify the GALAXY-2 trial, how much of this was driven by like FDA feedback versus an internal company decision?

Vojo Vukovic

Hey, Shawn. The GALAXY-2 modification, the amendment that we announced this morning was driven by really two key factors, one is as you pointed out the regulatory feedback and the other is really the changes in non-small-cell lung cancer landscape. We are in ongoing discussions and have been in ongoing discussions with both major regulatory agencies since before the trial was started and we continue these discussions today. So we have carefully listened to the regulatory feedback and as appropriate to incorporate in design and that’s really the path that you saw today, namely the definition of the patient population to ALK and EGFR negative.

Unidentified Analyst

Okay. And then just on the ENCHANT-1 trial, I am just curious how many more patients do you expect to present to ASCO and what would you see is like a positive or favorable look at the data at that point?

Iman El-Hariry

Hi, Thomas, this is Iman here. We actually at ASCO we are not planning for any scientific presentations. However, we are having an update on ENCHANT trial in two weeks’ time at the European Breast Cancer Conference.

Unidentified Analyst

Okay. And then just on the I-SPY 2 trial, I was curious like about how long do you think the safety testing with Herceptin will take? And in terms of actually succeeding and achieving this like high basing and predictive probability like what is actually the threshold for success there?

Iman El-Hariry

Okay. In terms of the combination with trastuzumab, this is – it’s a Phase 1 combination, which is done not under the hospices of the I-SPY consortium, but it’s done on a different study. So, this study would be initiated hopefully soon. In terms of the probability of success, the ongoing protocol in the I-SPY has predicted modeling, which looks at least 85% of chance to succeed in Phase 3. So, it’s the next drug based on activity in the certain subgroup or biomarker out of the same biomarkers in this setting.

Unidentified Analyst

Okay. And just one last thing just curious about how long will it take to fully enroll the minimum 60 patients or maximum 120 patients? And when would you expect to see some data from this trial?

Iman El-Hariry

We are expecting the study to start in the second half of the year. However, as I mentioned earlier, the study has an adopted design based into it, which means then if it looks at enrolling the 60 or up to 120 patients, based on the adaptive design and how soon the level of activity is demonstrated and that’s difficult to actually give any estimate at this point.

Unidentified Analyst

Great. Thanks for taking my questions.

Operator

The next question comes from the line of Brian Klein with Stifel. Please proceed with your question.

Brian Klein - Stifel

Hi, thanks for taking my questions. Good morning. First for Vojo, regarding the GALAXY-2 amendment, I guess I still don’t understand the rationale because in the past you have seen activity with ganetespib in both of those mutant populations, ALK and EGFR. So, I don’t understand why you are now excluding those patients? Can you give a little bit more of an explanation, I understand that in the U.S. at least there is a change in the underlying treatment paradigm, but it’s certainly in the rest of the world those patients should still be eligible?

Vojo Vukovic

Hi, Brian. It’s a very good question. The rationale is really entirely driven by regulatory reasons. As you know, GALAXY-2 is a global program. And when executing this program, we are aiming at global registration strategy. So we need to make sure that the trial will be acceptable for approval of ganetespib globally. For that reason, we do consult with all major and also national regulatory authorities as appropriate. The decision to restrict the patient population I think it’s a regulatory component because of the availability of appropriate targeted treatments for these two patient populations and the evolving landscape and we have to project this obviously over not just today but we have to project it over the anticipated timeline to approval. And finally from a medical perspective it makes a lot of sense to strive to what’s having a more homogenous patient population that makes the evaluation of the drug much easier. And as you know patients with ALK and EGFR may carry different prognosis compared to other patients.

Brian Klein - Stifel

Right. Thank you. You give us a sense of where you are in patient enrollment now and how that patient population would be impacted by these changes in terms of the final analysis and the I guess the mITT population you’re looking at now?

Vojo Vukovic

Yes. So as you know traditionally we have not provided operational updates in terms of status updates on enrollment. What we provided instead is our guidance towards the data read-out. Just to reiterate we’re currently planning for two interim analysis to be conducted by the independent Data Monitoring Committee in the second half of 2015 and the final analysis is currently scheduled for first half of 2016.

Brian Klein - Stifel

Okay. Are you still committed to enrolling the majority of the patients in the U.S. and Western Europe?

Vojo Vukovic

We have implemented operational changes to enable the amendment to be successfully implemented. The trial is a global trial and will have a very significant component of patients from the West including Western Europe and North America.

Brian Klein - Stifel

Great. Alright. Thank you for taking my question.

Operator

Thank you. Our next question is from the line of Graig Suvannavejh of MLV. Please go ahead with your question.

Graig Suvannavejh - MLV

Great. Good morning. And thank you for taking my questions. I had several on multiple fronts, but first just if I could just go back to the original topic of the conversation which was the change in leadership. I’m just wondering well it sounded like you’re looking for someone that had in particular commercial and or regulatory expertise and I was curious if that necessarily meant that you needed to have someone who already has been a CEO or someone who might not have been the CEO but has been very senior in the company and so on to get your thoughts on maybe the profile of the person that you’re looking for?

Keith Gollust

Well, Graig this is Keith Gollust. You described well what an ideal Chief Executive for a company like ours, what the qualifications would be. We know from work we’ve done that there are some – there are many well qualified people available generally at any given point in time that meet the criteria we’ve established. And we’re optimistic that we’re going to be able to meet several of them and make trade-offs as necessary. It isn’t the case that we know we can find somebody who gets a 10 in every one of the categories we’d like to focus on. But one thing I can tell you is that we’re not in a hurry, we’re going to take our time, we’re going to meet with multiple candidates and in the end the Board will determine the individual who we think can best assist in achieving our goals.

Graig Suvannavejh - MLV

Okay, great. Thank you so much for that. Just having been relatively new to this story, it seems if this is the second major kind of amendment to the GALAXY-2 trial? And I was just wondering just off the top of my head, is there any reason to believe that there might not be yet another change or as far you’re concerned this is the final change to the trial size and the protocol?

Vojo Vukovic

This changed the amendment too. It reflects our current thinking, obviously it’s very difficult to predict what may happen in the future, but this current amendment reflects our aggregate thinking and the aggregate regulatory feedback we received so far. We believe the program will be very well positioned for the rest of the development timeline but again this is something that’s difficult to predict. If necessary we’ll do more changes but the changes we’re doing today position drug to grow all the way to the finish line.

Graig Suvannavejh - MLV

Okay. And maybe follow-up to that as how often do you get regulatory feedback that would make you internally at least think about making any potential changes?

Vojo Vukovic

As we said before, we started the regulatory consultations before we opened the Phase 2 trial. We have been in communication with the global major international and national regulatory authorities in a continuous fashion and we continue to do so if necessary.

Graig Suvannavejh - MLV

Great. And maybe I will ask one more question just about the HDC program, I think as of your – the company’s last call, there was a statement that an IND might have been within 12 to 14 months of filing, I was wondering if now that we are three months past that, is it fair to assume that an IND for any of your HDCs might be 9 to 11 months away or are there any guidance around timing of INDs?

Vojo Vukovic

We believe and continue to believe that our HDC platform is a very exciting scientific concept. I think that the discussions externally we have thus far seem to confirm that. Many people will share the enthusiasm we feel about this platform and it’s because of that if you want to make the best efforts to put the best possible molecule or molecules into the clinic. And I think the board continues to support the strategy. So, at this point in time, we do not, I think want to provide the very specifics down to one month plus-minus type of guidance. We anticipate being entering to the clinic in the next year.

Graig Suvannavejh - MLV

Okay, thank you for taking my questions.

Operator

Thank you. Our next question is coming from the line of George Zavoico of H.C. Wainwright. Please go ahead with your question.

George Zavoico - H.C. Wainwright

Hi, everyone. Good morning. Thank you for the update, Keith and everyone. A first question regards – is in regard to the UK in the Cardiff trials, you presented in the press release today that the LI-1 trial was a new trial, but in fact it’s been going on since November 2012 and it also includes other drugs like cyclacel, capecitabine, and Sunesis’ vosaroxin, which didn’t make the cut. And the LI-1 is a fluid trial, in other words, Dr. Burnett can choose to add various other drugs in the trial if he sees fit. But so far the track record for that hasn’t been very successful. It seems that Ara-C – low-dose Ara-C seems to be the sort of the win. I know vosaroxin hasn’t worked. Can you tell me how many patients are actually in LI-1 right now with ganetespib and what your outlook for that whole patient population, the elderly very difficult to treat population is for ganetespib?

Vojo Vukovic

Sure. Hi, George.

George Zavoico - H.C. Wainwright

Hey, Vojo.

Vojo Vukovic

So the AML-LI-1 trial has been ongoing for a while as correctly stated since end of 2012. And Dr. Alan Burnett, the scientific and medical leads of this program and his colleagues have, as correctly stated, put several drugs into this multi-drug protocol and some of the other drugs did not make the cuts. The challenge that you also correctly been cited has been in this patient population is to create the combination that will be both safe and effective, because these are elderly patients who cannot tolerate intense chemotherapy. And so far we encouraged with the way how ganetespib did in the study, because it went on and enrolled approximately 50 patients we are approaching the enrollment of the 50th patient in the LI-1 trial, 50th patient on the ganetespib arm, which means that we are approaching the time of the first interim analysis, which will be a go/no-go decision point for Phase 3. This interim analysis will be conducted by the independent Data Monitoring Committee and that committee time for midpoint of this year so around mid 2014.

I think another point to mention is as you – as we have announced the same group, Dr. Burnett and his colleagues have decided to put ganetespib into the other trials under their stewardship such as the AML-18 and AML-19 trials, which combined ganetespib with more intense chemo regimens in different patient populations in first line, of these trials in first line, which I think is the another, I think not to ganetespib and its potential and promise and justification.

George Zavoico - H.C. Wainwright

Thanks, Vojo. Next speaks to my next question which is the safety aspect of ganetespib, I mean, from what I have following this ganetespib for a while now, one of the things that stands out is it’s safety and that’s probably why Burnett is adding it with daunorubicin and I am not sure if it’s been combined with daunorubicin before and the same thing goes for I-SPY and for the GANNET. Are these – are there any safety lead in trials need to be done for these before it goes into the sort of the full enrollment period or are these folks that are putting these – putting ganetespib into their sponsored trials overall satisfied with the safety?

Vojo Vukovic

Yes. So to answer your question directly for both AML trials, the AML-18 and AML-19, the new trials, there is a safety lead in component, which was actually successful completed for AML-18. And on the basis of this data and we assume also performance in the AML-LI-1 trial the consortium is moving the drug forward into the randomized stage.

George Zavoico - H.C. Wainwright

Great. So that’s good news. And in that regard, I mean, you are dropping the getting back to GALAXY-2, you are dropping the crizotinib and the erlotinib portion, patients that are on those drugs, but that doesn’t as Brian said you are seeing activity in those patient populations. This doesn’t preclude adding ganetespib to crizotinib and the erlotinib in those populations and in other trial perhaps, does it – are you thinking about what might be in that regard?

Vojo Vukovic

Absolutely. And as I mentioned before, the intention of modifying the patient population making this more narrow in GALAXY-2 is not driven by the lack of activity in these two patient populations, it is just our desire and also the regulatory view that our GALAXY-2 patient population should be as homogenous as possible to ensure optimal analysis of the data and then increase the probability of success. And we intend – we and others shared the opinion and the view that ganetespib will be a very effective drug in the EGFR and ALK-positive patient population, but that’s a separate question that can and will be explored in separate trials.

George Zavoico - H.C. Wainwright

Great. And finally last question regarding partnering and capital raising you have less than $100 million or about $100 million or slightly less and you guided to having cash through the end of 2014. We have heard multiple times on these calls that partnership is coming we expected within a year that sort of thing. Can you sort of give an overview of whatever you can say obviously not to show your hand, what your philosophy is going forward to make sure that you can take this trial to the end in 2016 when GALAXY-2 is going to play out?

Vojo Vukovic

Sure. Well, we have a cash budget for 2014, which calls for approximately the same level of expenditure that we saw in 2013. And it’s likely to expect that a similar number will apply in 2015 and we are taking into consideration our cash requirements right through final analysis of GALAXY-2. Given the level of cash that we need to maintain, it suggests we will have to do – find sources of cash in the future, including this year approximately to what it has been in the past. And we will be considering a normal combination of proceeds from partnerships and financings either equity or debt in order to meet those needs.

In response to your observation that we have made statements in the past about partnerships that might be or likely to be completed, I would say that we have an active partnering program, it’s led by our Senior Vice President, Steve Bernitz at any point in time where in discussions that are at various stages of development. And all I want to say is that in the future if we complete a partnering transaction, we will announce it at the time of completion. I don’t think you can expect to hear from us statements about what we think might happen in the future.

George Zavoico - H.C. Wainwright

That’s terrific, I am glad you made that clear. Thank you very much.

Operator

Our next question is from Nick Abbott with BMO Capital Markets. Please go ahead with your question.

Nick Abbott - BMO Capital Markets

Good morning, thanks for taking my question. My question really been frmed by the previous question is and it’s really a strategic question sort of at the highest level almost which is you have this GALAXY-2 trial ongoing, the size have increased fairly dramatically presumably the spend has increased, I think scientifically many of us have questioned the scientific basis of the trial in this era of biomarker led trials and yet you have a compound that appear to be exquisitely active in certain biomarker populations, so was there ever a Board level discussion of is really the best use of capital GALAXY-2 or should we really take a long hard look at the data we have accumulated and see if there is faster market strategy in a biomarker led population? Thank you.

Keith Gollust

That’s a good question. The most direct answer to your question is, yes, of course the Board in consultation with the senior management of the company is continually evaluating strategic options. As you would expect there are always trades-offs pros and cons and but ultimately we take responsibility for the strategic direction of the company. I just want to refer back to a statement I made in my opening comments which is that the in addition to being Directors of the company, the Directors are major shareholders of the company and we have every motivation to allocate our scarce resources as carefully as possible. We rely very heavily on the senior management of the company and their evaluation of our programs, but that’s something we consider on a continuous basis and what – when strategic trade-offs are required we focus and we make those decisions.

Nick Abbott - BMO Capital Markets

And maybe as a follow-up then in terms of this – is the other data that’s out there you have had a number of trials a CHIARA trial which started long time ago albeit in a frontline ALK positive population but there have been a number of investigator-sponsored studies in your patients with advanced disease who failed targeted therapies, can you give us a quick summary of what the latest observations are from some of these other studies that you haven’t talked about recently?

Vojo Vukovic

Alright, I will try to do that briefly and concisely. Yes, we certainly have expanded the ganetespib program very early on several years ago into a number of indications to evaluate its safety and efficacy profile both as monotherapy and in combination with other drugs, improving positive drug score with radiation. As Keith mentioned in answer to your previous question, we are continuously evaluating the results. We are continuously evaluating our environment and trying to see what is the best strategy for ganetespib moving forward. Obviously, there is multiple choices which is a good thing because the drug is active in molecularly profiled patient populations in oncology driven diseases.

But we think a number of factors including competition, treatment’s landscape and also the drug profile to make best choices but also to evaluate and reevaluate the choices that we make. And I think the GALAXY strategy, we remain very confident it’s the right strategy because of the multitude of mechanisms that are affected by ganetespib which facilitate the activity of chemotherapy and improve on it’s ability to prolong life in lung cancer we think that it’s a very interesting concept that can be evaluated in other indications as well. And I think this is something that’s been reaffirmed and confirmed by the commitments that outside institutions investigators make particularly in the domain of those large randomized trials which require significant resources that we have announced today.

Nick Abbott - BMO Capital Markets

Okay, thank you. And then do you have any specific comments on the CHIARA trial?

Keith Gollust

The CHIARA trial just to remind everybody is a monotherapy trial in patients with ALK-positive non-small cell lung cancer. This trial has actually terminated enrollments. And the reason for that is it changes strategic priorities. This was part of the process if I try to briefly describe that we continuously look, evaluate and reevaluate our strategic priorities and try to make the best choices for the program and for the company.

Nick Abbott - BMO Capital Markets

Okay, thank you.

Operator

Thank you. That concludes the question-and-answer session. I will now turn the conference back over to Mr. Gollust for closing remarks.

Keith Gollust - Chairman, Board of Directors and Executive Committee

I want to thank you all for your time today. I want you to know that if you have any follow-up questions, I along with the team here are available to take your calls. I look forward to speaking with many of you in the future. Thank you.

Operator

Ladies and gentlemen that does conclude today’s call. You may now disconnect.

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