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Executives

George Farmer - Vice President of Corporate Development

Safi R. Bahcall - Co-Founder, Chief Executive Officer, President and Director

Keith S. Ehrlich - Chief Financial Officer, Principal Accounting Officer and Vice President of Administration & Finance

Vojo Vukovic - Chief Medical Officer and Senior Vice President of Clinical Research & Regulatory Affairs

Analysts

Thomas Wei - Jefferies & Company, Inc., Research Division

Jim Birchenough - BMO Capital Markets U.S.

Gene Mack - Brean Capital LLC, Research Division

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

George B. Zavoico - MLV & Co LLC, Research Division

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

Robin Davison - Edison Investment Research Limited

Ryan Martins - Lazard Capital Markets LLC, Research Division

Michael G. King - JMP Securities LLC, Research Division

Nicholas Abbott - BMO Capital Markets U.S.

Synta Pharmaceuticals (SNTA) Q1 2013 Earnings Call April 30, 2013 10:00 AM ET

Operator

Good day, and welcome to the Synta Pharmaceuticas First Quarter 2013 Earnings Conference Call. Today's conference is being recorded and webcast. At this time, for opening remarks, I will turn the call over to George Farmer, Vice President of Corporate Development at Synta. Please go ahead, sir.

George Farmer

Hello, and thank you, all, for taking the time to join us today. With me are Dr. Bahcall, our Chief Executive Officer; Vojo Vukovic, our Chief Medical Officer; and Keith Ehrlich, our Chief Financial Officer. This morning, we issued a press release that reported results for the first quarter of 2013. This release can be found on our website at 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 Dr. Bahcall. After which, we will open the call to questions. Safi?

Safi R. Bahcall

Thanks, George, and thank you, all, for joining us this morning. Today, I'll provide quick updates on our ganetespib program and then turn it over to Keith for a financial update. We'll then open the call for questions.

Ganetespib, our lead oncology drug candidate, is being evaluated in a number of different clinical trials, including our 300-patient GALAXY-1 trial and our 500-patient GALAXY-2 trial in second line non-small cell lung cancer.

Last September, we reported promising interim results from the first 172 patients enrolled with GALAXY-1. And last October, we completed our target trial enrollment of 240 adenocarcinoma patients. An analysis to the overall survival from this trial was prespecified for 6 months from the last patient enrolled. This analysis will be conducted in May, and we expect those results will be presented at ASCO in June.

At this point, given the proximity to the medical meeting, as I'm sure you understand, we can't comment on any aspect of the trial until after the ASCO presentation. Earlier this month, we announced the first patients who enrolled in our GALAXY-2 Phase III trial, a 500-patient global randomized trial evaluating the same regimens as the GALAXY-1 trial with overall survival as a primary endpoint. This study population is very similar to GALAXY-1 but excluding outright progressors to first-line therapy, meaning those patients who experienced disease progression within the first 6 months of being diagnosed and treated for metastatic disease.

With respect to our other trials, we continue to enroll patients in the ENCHANT breast cancer trial and we'll be evaluating data from both that trial and our monotherapy trial in now positive patients later this year. As we have mentioned before, our strategic focus has shifted to combination therapy as the most efficient path to ganetespib registration. And we currently have no further plans for monotherapy development.

The ENCHANT trial protocol has recent been amended to treat HER2 negative patients with ganetespib in combination with paclitaxel as a means to enable future clinical development with either taxin [ph], docetaxel or paclitaxel, both of which are commonly used in breast cancer.

I'll now turn the call over to Keith who will review our first quarter 2013 financial results. Keith?

Keith S. Ehrlich

Thank you, Safi, and good morning, everyone. There were no revenues in the first quarter of 2013 as compared to $0.1 million of grant revenues in the same period of 2012.

In the first quarter of 2013, our research and development expenses were $16.4 million as compared to $12.1 million for the same period of 2012. Our first quarter general and administrative expenses were $3.9 million as compared to $2.6 million for the comparable period of 2012.

In the first quarter of 2013, our net loss was $20.7 million or $0.30 per basic and diluted share, as compared to a net loss of $15.1 million or $0.27 per basic and diluted share in the same period of 2012.

Based on our current operating levels, we expect our cash resources of approximately $90.4 million will be sufficient to fund operations into the second quarter of 2014. This estimate assumes no additional funding from new partnership agreements or equity financing events and that the timing and nature of activities contemplated for 2013 and 2014 will be conducted subject to the availability of sufficient financial resources.

I will now turn the call back over to Safi for concluding remarks. Safi?

Safi R. Bahcall

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

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from the line of Thomas Wei with Jefferies & Co.

Thomas Wei - Jefferies & Company, Inc., Research Division

Just wanted to ask a couple of things. First, on the GALAXY update at ASCO. I know 240 was -- is the target population to analyze, but you were going to enroll the study to a higher number to be able to do some of the prespecified subgroup analyses. Is the data that we're going to see at ASCO only on those first 240 or are you just going to include whatever data you have on all of the patients, including the access patients who have been enrolled?

Safi R. Bahcall

It's the former, it's only on the approximately 240 patients who completed enrollment in -- the final patient was enrolled in November. And the total number when that phase of the primary enrollment phase was closed was 254 patients.

Thomas Wei - Jefferies & Company, Inc., Research Division

254. And what is the total enrollment in GALAXY in the end, and when was the last of those patients enrolled for the subgroup analyses?

Safi R. Bahcall

Right. So as you mentioned, there's an extension phase specified in the protocol to keep enrolling the biomarker population until you achieve a prespecified number, 80 in one of the groups and 120 in the other group. And we're very close to done. In the end, it'll be probably an incremental 70 patients or so.

Thomas Wei - Jefferies & Company, Inc., Research Division

Okay. That's helpful. And then just a clarification on CHIARA. I guess, I wanted to ask, have you looked at that data yet? And is that what is shaping this development strategy as a combination?

Safi R. Bahcall

No, actually. Data is still not mature from that trial. It's really more about understanding the landscape and the opportunities for the drug.

Operator

Our next question comes from the line of Jim Birchenough with BMO Capital Markets.

Jim Birchenough - BMO Capital Markets U.S.

And just on the GALAXY-2 study, could you remind us what number of events trigger the first 2 interim analyses and the final analysis of overall survival? And what the powering is around those interims? And related, just -- is there a futility analysis in one of the interims? And I've got a follow-up.

Safi R. Bahcall

Sure. Let me just check with George. I know we disclosed a certain level of detail, I can't remember the exact level of detail on number of events or so. But, George?

George Farmer

Yes, Jim, we haven't disclosed the number of events require to hit those interim analyses. The trial is powered to see a hazard ratio of 0.7, it's 87% powered to show that. So we have said it back in our previous corporate presentations that if the treatment effect is in fact manifested at 0.7, we're probably around 40-some percent powered to stop the trial up to the first interim. And then somewhere in the order of 60% to 70% at the second. The final will be about 87% or at least 87% for the final.

Jim Birchenough - BMO Capital Markets U.S.

And then just bigger picture, as you think about the initial effort of focusing on certain oncogenic proteins that might be clients of Hsp90 and now it seems like maybe it's more complex and you're looking at targeting phenotypes. Can you maybe just provide a broad comment on what you've learned about the role of Hsp90? And should we expect in the future that you will still target markers like ALK or is -- are you just discovering that it's more complex than that and you need to go after phenotypes and that's the better yield?

Safi R. Bahcall

Jim, great question. We've had many ad boards and interactions with many of the top medical oncologists in lung cancer field in U.S. and Europe over the last few months. And those kind of questions have been top of mind. There's very high interest in the lung cancer community over the last few years since the development of EGFR inhibitors and now the ALK inhibitors and growing interest in ROS, RED neck inhibitors in agents that target one specific oncogene, one specific pathway. And so we are seeing -- we're very interested in that. We'll be measuring -- and of course, KRAS for many years before that. So we're looking at that very actively, both in our GALAXY-1 and our GALAXY-2 trial. Some of those subpopulations are very small. In the Caucasian population, ALK and EGFR and ROS and RED are pretty small percentages. KRAS is, of course, quite a bit bigger. So we're actively looking specifically at KRAS within both GALAXY-1 and GALAXY-2 because it's the largest mutation that's known today. And there's -- but we are looking at what you call exploratory biomarkers. We have a very large gene panel that we're getting both in GALAXY-1 and we'll get in GALAXY-2 as well that will help identify maybe some novel biomarkers. So those are of very high interest. We're seeing very high interest among investigators and cooperative groups for a combination approach. Since ganetespib has a -- it's very different mechanism or way of targeting those driver oncogenes. And then you can think of the ALK inhibitors, the EGFR inhibitors coming and hitting ALK or EGFR in one particular point. But ganetespib takes out the stabilizer for ALK and EGFR and other critical functions. So what we've seen in the many discussions we've had over the last several months is a lot of interest in a combination, a therapy approach to either ALK or EGFR or KRAS populations. And that's something that's under active discussion. And in addition, we've had discussions with folks in the -- who are working on the PD-1 and PD-L1 programs. Based on the broader tumor biology effects of ganetespib on the angiogenic effects, on the effects on metastatic pathways but also effect on the immune suppression pathways. So I think what you could expect as things develop over the coming year or 2 is a growing combination approach in certain targeted areas.

Operator

Our next question is coming from the line of Gene Mack with Brean Capital.

Gene Mack - Brean Capital LLC, Research Division

Safi, I hate to beat this sort of dead horse but the 240 patients -- the 70 incremental patients that you talked about earlier, that was incremental to the 172 or so that were added, right? Not to the 240 that will be at ASCO, is that right?

Safi R. Bahcall

No, not quite. So if you go back to September of last year when we locked the database for the presentation at ESMO in September of last year, there were 172 analyzable patients. That was all within the primary enrollment phase. So that's all within the 240 primary enrollment phase. So we finished the primary enrollment phase by November of last year. So all of that stuff gets subsumed in the primary enrollment phase. After we closed enrollment and the primary informant phase in November, we opened enrollment in the extension phase, which is just for biomarker populations. So after November, there's an incremental 70 biomarker defined patients that are the subject of a biomarker analysis. Is that helpful?

Gene Mack - Brean Capital LLC, Research Division

Yes, that's perfect. And then I just wonder if you could comment at all on -- so I guess, Memorial Sloan-Kettering is starting trial combining ganetespib with crizotinib. It looks as though some of those patients may be front line, some of those patients may be second line. Any ideas on where assuming, I guess -- that trial -- is there any idea of when they may be able to or may be ready to present any data from that trial and where it may go from there?

Vojo Vukovic

All right. So to answer your first question, this trial is in front line patients only. So these are patients with ALK on to lung cancer. And they're getting crizotinib for the first time and at that time, the combination is given to the patients. It’s an investigative-driven trial, so investigator-sponsored trial by Memorial Sloan-Kettering. Obviously, they're in control of the trial, it's not in our control, it has dose escalation, dose filing component. So we really can't really speculate on when exactly the trial will be completed or the first data will be presented.

Gene Mack - Brean Capital LLC, Research Division

Okay. And then just finally, Safi, you had mentioned, I think, earlier in the year, something about some new publications on HIF-1alpha that may make it into publication sometime this year, I wonder if you all have got any update on that, if there's anything interesting you think would be useful at ASCO for investors to be looking at?

Safi R. Bahcall

Sure. There were results on anti-angiogenic effects of ganetespib, including inhibition of HIF-1alpha and the secretion of VEGF production or secretion from cells, as well as other anti-angiogenic factors. And do we do this pancreatic models that was presented at AACR by collaborators who work in pancreatic. There's a publication in colorectal that was submitted to a journal. I'm not sure of the latest updates since it's been accepted. But I would estimate they would out this year. And then there are a number of other collaborations that are ongoing that I would expect to be presented later this year on the anti-angiogenic effects of ganetespib.

Operator

Our next question is coming from the line of Brian Klein with this Stifel.

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

So I know it's early days in terms of enrollment for GALAXY-2, but can you give us a sense of how many sites are open for enrollment? And whether the past few weeks, your enrollment is consistent with your expectations?

Safi R. Bahcall

Yes, you're right. It's probably too early days to get commenting on GALAXY-2. I think what we have said -- I think what we can say is that we have -- of the 15 playing countries, we will simply now open our regulatory clearance in 11 of the 15 countries, which is quite good progress.

Brian Klein - Stifel, Nicolaus & Co., Inc., Research Division

Great. And then on the upcoming ASCO presentation, just to clarify, the analysis has not yet been conducted? Is that correct?

Safi R. Bahcall

That's correct. The analysis for ASCO has not yet been conducted.

Operator

Our next question comes from the line of George Zavoico with MLV & Co.

George B. Zavoico - MLV & Co LLC, Research Division

A question about your ASCO. It looks like you -- the aspect title, as you know, have come out, and you've got a couple of IST presentations there. So is this a sort of preview what's to come regarding the announcements of outcomes of ISTs? I know you don't have a whole lot of control over what and when it said in theirs, but this looks pretty promising at ASCO?

Safi R. Bahcall

Our focus has really been on the GALAXY program and then our next focus is on the breast program. As you say, it's up to the investigators, show what they choose to present on some of the ISTs, and I don't think we have yet seen from them what they plan to present.

George B. Zavoico - MLV & Co LLC, Research Division

Okay, good. Look forward to seeing at those presentations, for sure. Regarding the design of GALAXY-2 then, there are couple of interesting elements to the design that I wanted to ask about. One is this stratification in the patient population to bounce 3 key subgroups. Like in GALAXY-1, you're doing it kind of as a Phase II or a second phase of enrollment, as you say. Is that -- first question is whether that's going to be the same for GALAXY-2, whether you're going to enroll the overall number, I guess, 400, 500 patients and then look and see if you've got stratification -- I mean, balance and then add more? That's the first part of the question. And then the second part is the element that allows you to continue treating patients with ganetespib after a discontinuation of docetaxel. Do you have any -- and in the prior trials, if you've done that, do you have any evidence of that -- provides additional benefit or prolongation of survival or PFS?

Safi R. Bahcall

Sure. On the first part of your question, what we have is fairly routine stratifications in GALAXY-2 for 3 factors that are well-known, prognostic factors, and that's entirely based on the standard reason sponsors do these and -- for larger trials, which is to ensure balance. So you don't get sicker patients in one arm or the other arm. And these are not expected to be -- they're not put in there to be specific biomarkers, and there's no extension phase. It's just the standard balance of prognostic factors between arms. Your second question, does the -- allowing the treatment of -- treatment with ganetespib following completion of chemotherapy, do we have definitive evidence of clinical benefit? The answer is it's too early to say. We'll probably have more to say about that later in this year when we have more data. Vojo, anything you want to add?

Vojo Vukovic

Yes, sure. Doing maintenance therapy is a part of the drugs, it's something that's fairly routine. For example, [indiscernible] the first time also continues after the combination with chemo. And you treat generally until progression because these types of drugs, by definition, fit to be better tolerated and it allows for longer unique control longer treatment of patients, and that's what we're going doing here.

Operator

Our next question comes from the line of Joe Pantginis with Roth Capital Partners.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

Maybe just a quick couple of questions on GALAXY-2. I know we just mentioned that with George about the stratification. Maybe can you just go back and review for us the rationale for continuing to stratify for the LDH status in that study? And then secondly, just going off an earlier question as well and not looking for sort of enrollment update but set of any commentary you can provide with regard to how smooth the transition has been going from GALAXY-1 to GALAXY-2?

Safi R. Bahcall

Sure. LDH is a highly prognostic variable, not only in lung cancer but in many tumor types. It's one of the most prognostic. LDH, ECOG performance status in response to first-line therapy are probably 3 of the most prognostic variables when you look to impact on hazard ratio. So we want to make sure that they're balanced. Does that answer the first part of your question?

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

It does.

Safi R. Bahcall

Okay. And then the second part, I will -- sorry, could you repeat the second part of your question?

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

Sure. Just wanted to -- not looking for enrollment updates on GALAXY-2, just sort of any commentary you could provide as to how smooth the transition was going in between the 2 studies and the ability for sites to come on board? Any hurdles you might be experiencing still they need to overcome?

Vojo Vukovic

Okay. Yes. So the transition from the GALAXY-1 probably to GALAXY-2 has been very smooth. As Safi mentioned, we obtained regulatory clearance in 11 out of the 15 playing countries. The transition is as expected, when we open a new country for the Phase III component of the program, we call it a down for Phase II as we plan. And so far, it's been going very smooth. We are incorporating the vast majority of the centers that we work with in the study GALAXY-1 study. And that's a tremendous, I think, advantage because not only are these centers up and running and experienced with the drug, but it also breaks even [ph], it can also can fit in. So that's really helping the transition.

Operator

Our next question comes from the line of the Robin Davison with Edison Investment Research.

Robin Davison - Edison Investment Research Limited

I just -- I know it's a little too discuss the material that's scheduled to be presented at ASCO. But I wondered, was it -- would it be reasonable to presume that it would be the same analysis that you have done in terms of subpopulations and so on as was presented at ESMO? Or is it quite possible it could be different factors you're looking at?

Safi R. Bahcall

Obviously, it's up to the investigators of the study but our expectation, this is a standard medical meeting presentation just like the ESMO and will feature the standard tables and graphs that you see. In this case, not only for the ITT, meaning the all comers, but also because we have a Phase III trial that has started and we've select a population, you'll see the full analysis for the ITT and then you'll also see the full analysis for the patient population that we've chosen for advancement into Phase III. That's our expectation.

Robin Davison - Edison Investment Research Limited

Yes, great. Also, just a sort of small financial quick one. I just noticed that the R&D expenditure in the first quarter, is that a good guide to the expenditure over the course of the year? Now we've got like sort of GALAXY-2 study underway? Or is there other -- some sort one-off setup costs that might give that a sort of misleadingly high figure?

Keith S. Ehrlich

Well, I think that these costs can vary from period to period, depending upon the ebb and flow of the trial. So I think it's a good starting point.

Operator

Our next question is coming from the line of Ryan Martins with Lazard Capital Markets.

Ryan Martins - Lazard Capital Markets LLC, Research Division

So for the ASCO analysis, I guess, that's going to be done in May, it's not yet done. So the abstract is going to have data presumably from just orders presented at ESMO or will that be something between -- or was presented to ESMO and what's going to be presented in ASCO?

Safi R. Bahcall

I think what you're asking about -- when you talk about the abstract, are you talking about when abstracts get publicly released before ASCO? Maybe, George, you want to just comment on the process there?

George Farmer

Yes. So, Ryan, our abstract will be released on the day of the presentation, the GALAXY-1 abstract and that will be on June 3, the morning-of.

Ryan Martins - Lazard Capital Markets LLC, Research Division

Okay. And then just on GALAXY-2. You are excluding the rapid progresses there. I did not see that in the inclusion/exclusion in the trial listed on some trials. How that's going to be operational-ized into the trial? How is that going to work?

Vojo Vukovic

Sure. So one of the key eligibility criteria as was mentioned before, we mean the fast progressors to first time therapy. And to make it operationally smooth and consistent globally, we've chosen to do the cutoff by looking at data prognosis of advanced disease, and that's set to 6 months. So patients who were diagnosed less than 6 months before study entry, those patients will be excluded. And patients will be included that were diagnosed more than 6 months prior to study entry.

Operator

Our next question is coming from the line of Mike King with JMP Securities.

Michael G. King - JMP Securities LLC, Research Division

A lot of my questions have been answered. But I was curious to know, will you -- in GALAXY-1, if you had an EGFR activating mutation in the first line setting and then progress, are you eligible for GALAXY-1? And will you be able to break out that subpopulation in the ASCO presentation?

Safi R. Bahcall

The answer is yes.

Michael G. King - JMP Securities LLC, Research Division

Okay. And is that part of the entry criteria for GALAXY-2 as well?

Safi R. Bahcall

No, we're really looking for wild type patients. I mean, as you know, we're not in a Caucasian population. So at the end, EGFR patients are relatively small percent. And in addition, because there's so many drugs targeting new EGFR patients, now they're -- those patients are being identified and going into other trials. So it ends up being a relatively small percent. And so what we're looking for is a wild type, meaning not EGFR mutation.

Nicholas Abbott - BMO Capital Markets U.S.

Not having any -- prior history of an EGFR activating mutation?

Safi R. Bahcall

Correct.

Operator

Our next question is a follow-up from the Gene Mack with Brean Capital.

Gene Mack - Brean Capital LLC, Research Division

So let me -- a quick -- a couple of follow-ups. First, just on GALAXY-2, maybe George can comment. What's the level of overlap you're expecting with the centers that enrolled patients for GALAXY-1? And then on GALAXY-1, just a follow-up to the earlier question on abstract content. Would your protocol have permitted any sort of incremental update between September 2012 when the ESMO data was cut and the February submission of the ASCO abstract? So I'm asking you, what you put in the abstract, just if the protocol would have allowed for any additional incremental being put in an abstract submission if you had so chosen to do so?

George Farmer

Yes, we can't get into the micro-details of abstracts, the technical stuff of what will be presented at ASCO until after the ASCO presentation. Maybe I'll turn it over to Vojo for the third point.

Vojo Vukovic

Yes. So there's a good amount of overlap between study centers in GALAXY-1 versus GALAXY-2. As I mentioned before, we are incorporating most of the centers that we work with GALAXY-1, ones that have very good experience with. And we're incorporating those centers all in GALAXY-2, and in addition to that, it's significantly expanding to be able to reach the required target number of patients in the specified timeline.

Operator

Our next question comes from the line of Nicholas Abbott with the BMO Capital Markets.

Nicholas Abbott - BMO Capital Markets U.S.

A non-GALAXY question, you'd probably be relieved to know. And it really is about the strategy for ISTs. You've been very generous supporting numerous ISTs with ganetespib. And they've covered a wide variety of settings, metastatic, neoadjuvant. Do you have an internal priority list of the ISTs that you are most excited about? And going forward, are there any IST programs that you're considering that have you had the resources, you would have run those studies internally?

Safi R. Bahcall

I think -- a great question, Nick. We do, in fact, have a prioritization plan, and the Medical Affairs team works very closely with clinical and the rest of the executive team to create a prioritization list. It starts with the main therapeutic areas that we're focused in, the main indications, which is lung and breast cancer. And because we're very active in interacting with the lung and breast cancer medical community and because there's quite a bit of data that has been generated in the past and it's accumulating both preclinical and clinical, we are seeing a lot of interest and that fits very closely with what we call, our core focus. So that gets very high priority internally. And then there are kind of the next indications, and we prioritize based on a number of criteria, how closely they fit with our development plans, how well they complement our development plans, our views on as -- as well as investigative views on probability of success and of course, the economics. If we have a large group, as has happened recently and we'll have more to say about later, that's come with a several hundred-patient randomized trial that they're willing to finance. And we think it's a high unmet medical need, and there's real benefit for patients there, that becomes -- and it's -- we think the safety questions are addressable, so that it doesn't raise any undue safety concerns. Then that also rises in the priority. So that's kind of a rough sense of how we think about it. Do you want to anything, Vojo?

Vojo Vukovic

Yes, absolutely. In addition to that, we also look at certain indications, questions whether they're very strong molecular or scientific rationale in high unmet medical needs to explore the potential indications for the drug.

Nicholas Abbott - BMO Capital Markets U.S.

So how many ISTs do you think will be started this year?

Safi R. Bahcall

Our plans are after the ASCO presentation to get into more detail about the overall clinical development plans for ganetespib.

Operator

That concludes the question-and-answer session. I will now turn the conference back over to Dr. Bacall for closing remarks.

Safi R. Bahcall

Thank you, all, for your time and attention today. That ends our call.

Operator

Ladies and gentlemen, this does conclude today's teleconference. You may now disconnect.

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