Daniel Cole - Investor Relations Chen Schor - Chief Executive Officer Vojo Vukovic - Chief Medical Officer Marc Schneebaum - Chief Financial Officer.

Christopher James - FBR Capital Mike King - JMP Securities George Zavoico - Jones Trading.

Good day. And welcome to the Synta Pharmaceuticals Second Quarter 2015 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 Daniel Cole of Synta Pharmaceuticals. Please go ahead, sir..

Hello, and thank you all for taking the time to join us today. With me are Chen Schor, Chief Executive Officer; Vojo Vukovic, Chief Medical Officer; and Marc Schneebaum, Chief Financial Officer. This morning, we issued a press release that reported financial results for the second quarter 2015.

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 intents, beliefs and expectations, which are subject to certain risks and uncertainties.

Additional details can be found in related SEC filings and are also available through our website. I will now turn the call over to Chen..

Thanks, Dan. Good morning to everyone. And thank you for joining our call today. The first half of 2015 has been a productive period for us, both for now very broad ganetespib program and our HDC platform. Ganetespib, as you know, is our novel, potent, small molecule inhibitor of heat shock protein 90, or Hsp90.

Hsp90 has been recognized as an important target for cancer therapy, yet drugging this target has proven challenging until now. Ganetespib is 10 to 100-fold more potent than first-generation Hsp90 inhibitors. Its chemical structure does not have the moiety associated with liver toxicity observed with first-generation Hsp90 inhibitors.

And its rapid clearance from the retina is associated with near-absence of even mild to moderate visual disturbances. The ganetespib program is approaching the first Interim Analysis of our pivotal GALAXY-2 trial in second line non-small cell lung adenocarcinoma which is expected by the end of 2015.

The study follows the large randomized Phase 2 GALAXY-1 trial which supported the design and patient selection for GALAXY-2.

Assuming GALAXY-2 demonstrates an overall survival benefit and profile similar to that seen in GALAXY-1, we believe ganetespib will be differentiated and become a valuable option in the evolving non-small cell lung cancer landscape.

Like others, we believe the recently introduced immunotherapies represent a significant advance in the treatment of patients. What we can say today, based on available data, is that the PD-1 and PD-1 based therapies appear to work best in select non-small cell lung cancer patient, specifically in patients who express significant level of PD-L1.

However, a consistent theme from recent reports and trials is that immunotherapy doesn’t cure cancer, improve survival only for a subset of patients and unmet medical need for novel agents such as ganetespib remains.

For example significant opportunity exists for ganetespib in patients who are negative or who cells express low level of PD-L1 or in patients who progress on immunotherapies or as part of a combination therapy with the immuno-oncology agents.

A recently published review article in Cancer Immunology Research highlights the rational for combining ganetespib and immune checkpoint inhibition. And this is something we look forward to exploring in future clinical studies.

Our clinical experience with ganetespib in over 1,400 patients today and the broad level of support from independent investigators, indicates that the opportunity for ganetespib is certainly not limited to non-small cell lung cancer.

Ganetespib holds significant potential to benefit patients and improve outcome across the number of different indications. Activity has been observed with ganetespib as both as single agent and in combination with other treatment.

Its tolerability profile allows for combination with a wide range of therapeutic approaches including chemotherapy, targeted therapy, radiation therapy and immunotherapy. We believe ganetespib can potentially serve as a backbone for many therapeutic approaches and fits well within a future where novel combinations will remain -- will gain traction.

As I mentioned earlier, the ganetespib clinical program is quite extensive. In addition to GALAXY-2, five large investigator sponsored randomized trials are ongoing or soon to initiate and nearly two dozen more studies are ongoing or in the planning stage.

Following ganetespib in our pipeline is STA-12-8666, the first clinical candidate coming out of our Hsp90 inhibitor Drug Conjugate or HDC platform, which is also progressing well. 8666 is an Hsp90 inhibitor conjugated to SN-38, which is the active form of irinotecan.

8666 has demonstrated profound preclinical anti-tumor activity in a number of tumor models including those resistant to other therapies. And we are very excited to see this program progressing into the clinic. We continue to be on track to file an IND for 8666 in the first quarter of 2016.

We remain encouraged by our progress and look forward to the important milestones ahead. We continue to retain rights to ganetespib and our HDC platform, which provides us with a significant opportunity to create value in the coming quarters. I’ll now turn the call over to Vojo to provide a clinical update.

Vojo?.

Thank you, Chen. We are indeed encouraged by the continued progress of our programs, in particular the GALAXY-2 Phase 2 trial, the large randomized ganetespib ISTs and the strides we’re making with 8666. First, let’s touch on ganetespib and GALAXY-2.

GALAXY-2 is an ongoing Phase 2 trial, evaluating ganetespib and docetaxel versus docetaxel alone in upto 850 patients for the second-line treatment of patients with non-small cell lung cancer with adenocarcinoma histology. Overall survival is the primary endpoint of the study.

As Chen mentioned, the study design in patient population being evaluated is supported by the results from our large randomized exploratory Phase 2 study GALAXY-1, which was published Annals of Oncology in the second quarter of this year.

Furthermore, the conduct and execution of GALAXY-2 has been greatly refined, thanks to what we learned from our GALAXY-1 experience. We continue to be pleased by the rate of enrollment in our pivotal Phase 3 study and continue to remain on track regarding the timing of data analysis.

Based on our current projections, we expect that the first interim analysis will occur by the end of this year. At a time of the first interim analysis, the independent data monitoring committee can recommend that the study be stopped for efficacy, stopped futility or continue to the second interim analysis.

We expect that the second interim analysis and the final data analysis will take place in 2016. Assuming positive interim results from this trial and pending regulatory consultation, we plan to file for regulatory approval of ganetespib for non-small cell lung cancer in 2016.

As Chen noticed, the interest in ganetespib extends beyond the GALAXY-2 trial in non-small cell lung cancer. We continue to see important progress in our investigator sponsored studies, particularly the larger unmet studies that are potential registration enabling.

Of note, this past quarter, we announced the enrollment of the first patient in the Phase 2 portion of the GANNET53 trial. GANNET53 is a randomized pan-European trial sponsored by Innsbruck Medical University in Austria and founded by the European Commission.

The study is evaluating the combination of ganetespib and paclitaxel versus paclitaxel alone in over 200 patients with metastatic, predominantly p53 mutant, platinum-resistant ovarian cancer.

The rational for evaluating ganetespib in p53 mutant driven malignancies is supported by recent Nature obligation where the treatment of mice having tumors with p53 mutations with Hsp90 inhibitors including ganetespib led to improved tumor control and prolonged survival.

Enrollment in the Phase 2 portion of GANNET53 follows the successful completion of Phase 1, the results of which were recently presented at ASCO 2015. Next are the AML-LI-1, AML-18 and AML-19 trials.

Three separate randomized trials evaluating ganetespib in combination with chemotherapy for the treatment of patients with acute myeloid leukemia and high-risk myelodysplastic syndrome. The AML-LI-1 trial is the most advanced trial in the series, having moved into the Phase 3 extension after meeting pre-specified efficacy criteria in July 2014.

Passing this efficacy hurdle is important. As to our acknowledge, another drug in this study has achieved successfully. And finally, the ongoing I-SPY 2 TRIAL evaluating ganetespib as a neoadjuvant therapy for women with newly diagnosed, locally advanced triple-negative breast cancer.

Recruitment into the ganetespib arm of this began in the fourth quarter of 2014 and is ongoing. We expect results from the studies in our I-SPY program to emerge in 2016 and 2017 which will help shape our understanding of ganetespib’s potential in multiple indications in the relatively short period of time.

Additional clinical trials of ganetespib are also being considered. Chen has mentioned combinations with immune checkpoint inhibitors. We’re exploring this along with other ganetespib combinations in various settings and look forward to providing more detail on this front in the future.

Moving to our HDC program, we are also encouraged by the continued progress with our lead candidate 8666. 8666 has demonstrated activity in multiple preclinical models, including patient-derived tumor models of pancreatic cancer and small-cell lung cancer.

In addition, pre-clinical results for 8666 in pediatric sarcoma were also highlighted in the poster discussion session at this year ASCO meeting. 8666 has also demonstrated improved tolerability compare to irinotecan in preclinical models. The 8666 program is on track for IND submission by the first quarter of 2016.

We look forward to providing updates on this and other HDC candidates as they move towards the clinic. I will now turn the call over to Marc Schneebaum for a financial review.

Marc?.

Thanks, Vojo, and good morning, everyone. As of June 30, 2015, the company had $98.3 million in cash, cash equivalents and marketable securities, compared to $97.7 million as of December 31, 2014. This includes $41.8 million in net proceeds from an underwritten public offering that closed in April 2015.

We expect that our cash resources will be sufficient to fund our operations, at least through the first half of 2016. This estimate assumes no additional funding from new partnership agreements, equity financings or further sales under our ATM facility.

The timing and nature of certain activities we’ve planned for through 2016, will be conducted subject to the availability of sufficient financial resources. Now, moving on to our results of operations. We didn’t recognize any revenue in the second quarter of either 2015 or 2014.

Research and development expenses were $16.4 million for the second quarter of 2015 compared to $18.8 million in the second quarter of 2014. This net decrease of 2.4 million was primarily the result of lower costs in our ganetespib program, specifically for the Phase II GALAXY-1 study and other earlier stage company-sponsored clinical studies.

General and administrative expenses were $3.1 million for the second quarter in 2015 compared to $2.9 million for the same period in 2014.

Overall, the company reported a net loss of $19.8 million or $0.15 per basic and diluted share in the second quarter of 2015 compared to a net loss of $22.3 million or $0.24 per basic and diluted share for the same period in 2014. With that, operator, you can open the call for questions..

Thank you. [Operator Instructions] Our first question is coming from the line of Christopher James with FBR Capital. Please proceed with your question..

Congrats on the progress this quarter.

Just going back to something you said earlier, given the evolving landscape with the PD-1 inhibitors, when do you think you will be able to start testing ganetespib with one of the checkpoint inhibitors? And have you done any preclinical work with ganetespib?.

Very good question. We have certainly two collaborations and also internally conducted a number of preclinical studies to evaluate the feasibility of combining with different immunotherapies, including checkpoint inhibitors.

These collaborations have produced the encouraging results which have generated a lot of interest and enthusiasm with investigators. And we’re currently in discussions, multiple discussions about potential studies in the clinic, and we’ll provide updates as soon as we can..

And when do you think you’ll be able to share some of those data and sort of in what forum will that be; at a medical meeting or do you think some sort of publication?.

Preclinical data has been already presented in multiple meetings earlier this year. As the data evolves, we’ll continue to present. There is also a paper that’s been recently published with the checkpoint inhibition. So, some of the data is in the public domain. We will continue generating new data and continue presenting at scientific meetings.

And again, once we are ready to discuss specifics about the clinical studies, will be certainly doing so..

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

This may sound like the previous question from C.J.

If you guys really do have this effect on presentation, it seems like you could do collaborative deals along the line of what inside is done with our IDO inhibitor; is that the way we ought to be thinking about this?.

So just provide maybe, just a little more background and then what I can obviously answer your question directly, I can give you a sense of what we’re thinking.

So first I’ll mention that we invested quite a lot of efforts into understanding the biology and preclinical activity of Hsp90 inhibition in general and ganetespib specifically when it comes to the tumor or the tumor environment and learned a couple of things, a couple of angles that are related to the mechanism of action.

One is that ganetespib and Hsp90 inhibition eventually leads to down regulation of PD-1 in the tumor; two, we’ve seen localized induction of T-Cell recruitment factors and indeed more T-Cell that can access the tumor. And the third angle is production and presentation of tumor neo-antigens.

So, I think this really provides the potential benefit in combination, either with PD-1 or PD-L1s or also with other T-Cell therapies. We have one slide in our corporate presentation that summarizes that, at least some of the data that we have. But we continue to generate a lot more data about the mechanism of action.

So that’s at the preclinical setting. When we look at the tolerability of ganetespib and we try to compare it to some of the side effects of other clinical stage immunotherapies, we do see the potential of a combination.

And it’s not only us, it’s other investigators that have also approached us with very high level of interest in moving to the clinic with different combinations with immuno-oncology. So, we’re not there yet, but as Vojo mentioned, we continue to progress towards this direction.

And at the right point in time, obviously we’ll share and we’ll update and our path forward in the clinic. So, I know I didn’t give you a direct response, but I think I gave you a little more background on where we stand and hopefully it’s helpful..

Yes, it is, obviously until we see publications and such. I just wonder, you mentioned tumor microenvironment and down regulation of PD-1. I am wondering also if there is anything that you can say about ganetespib ability to effect antigen presentation..

Mike, in some of our preclinical studies, we have seen that treatment with ganetespib increases the presentation of tumor associated or tumor specific antigens on soft surface and that can potentially play nicely with tumor vaccine based programs or even with T-Cell based mechanisms.

And we have also functionally looked that in appropriate models we can clearly see synergy with for example of T-Cell based immunotherapy..

Our next question is coming from the line of George Zavoico with Jones Trading. Please proceed with your question..

First one is regard to 8666. I can’t wait to see an IND and going forward on that. But in the same light, when you were working on this program before you made a lot of analogs.

And I am wondering if you might be thinking about moving any others forward or partnering or how do you plan to advance all the other assets you’ve developed in that program?.

This is Chen. And I’ll try to give you a little more background. So indeed, when you think about our IP and the different payloads that we have tested with our HDC platform, we have tested more than 40 different payloads. And the first one that we select that is the SN-38 payload and that’s one we’re moving into the clinic.

And we do have really phenomenal I believe preclinical data in a couple of indications. We are working on a few other payloads. And pretty consistent with how we addressed sharing more information about 8666 with investors and analysts, we expect to follow the same path.

And until we have something that we believe is close to a clinical candidate and is really ready to IND enabling toxicology studies, we think it’s probably a little premature to share it with investors.

And not only -- mainly because every point in time we continue to optimize the different efforts that we have in research and we may prioritize one program versus another. And once we progress something we’ll share. Regarding partnerships, we do see some interest in the different programs that we have.

And as you know, these type of discussions are -- there is lot of factors that we need to take into account, whether it’s economics; whether it’s shares of vision about the future; development plan and what’s the right thing for shareholders at any point in time.

And as discussions mature and once we have something to share with you and with investors, obviously we intend to do that..

Okay, I look forward to hearing more about that in the next year or two then. You mentioned the LI-1 trial in AML going forward. Can you provide any guidance -- I know it’s run by the UK group.

But can you provide any guidance on when that might complete enrollment, when you might see some data perhaps by ASH of this year?.

George, I’ll try to answer your question. As you pointed out, this trial is sponsored by European cooperative group. It’s under their control including timelines. We know they are actively recruiting. For a period of time there was halt in this trial as the data monitoring board has evaluated the other drugs that are part of this protocol.

And once it was clear that only ganetespib succeeded in meeting the pre-specified efficacy criteria, the trial resumed and the other drugs were eliminated. And I believe that they identified potential new drugs for the Phase 2 of the program. But now the Phase 3 component of the trial is fully recruiting.

We need to recruit a total of 200 patients into the ganetespib arm. That effort is ongoing. And based on information that we have indirectly, we would expect this trial start producing some results in the time frame that is specified earlier, 2016-2017..

And you mentioned there were two others, the AML-18 and AML-19. .

Exactly right. So, 18 is now in the randomized phase that completed successfully the Phase 1 pilot which was designed to evaluate the feasibility. And so the combination is feasible. This induction chemotherapy. And now the randomized trial is ongoing. And then finally, the AML-19, we believe that’s waiting for some additional approvals.

And we expect the recruitment into this trial to start by the end of this year..

And final question regarding GALAXY-2 and it’s pretty far along. Are pretty much all those sites now recruiting patients? And I’m wondering how that might impact looking forward to next couple of quarters in terms of clinical trial expenses.

Unless I’m wrong, I don’t see too much additional expenses with regard to GALAXY-2 because you’re kind of -- if I’m correct, you might try to be at cruise control now, monitoring the recruitment and monitoring the activity in the trial..

Well, I can certainly speak to some of the operational aspects. You are absolutely right, we are active in all sites. As we previously guided, we have over 200 active sites in this trial. Recruitment is holding up very, very good. We are very pleased with recruitment.

And we remain firmly on track for the guidance regarding the output, regarding the first interim analysis and of course the second interim and the final for next year. So, we’re very pleased with that. When it comes to cost, obviously the GALAXY-2 trial is still costing some money because we’re conducting the trial, we’re recruiting new patients.

So, I don’t Marc, do you want to comment on anything financial regarding this question?.

George, I think that you hit right on the head. We’re more or less on cruise control with GALAXY-2. And the change, the reduction in our overall R&D expenses had more to do with other earlier stage programs, not GALAXY-2..

[Operator Instructions] If there are no further questions, I’ll turn the conference back over to Mr. Schor for any additional concluding comments..

Thank you all for joining. We look forward to sharing more with you in the coming quarters. And if you would like to know more about our progress, please feel free to reach out to us directly. Thank you and have a great day..

Ladies and gentlemen, this concludes today’s call. You may now disconnect..