Daniel Cole - IR Anne Whitaker - President and CEO Keith Ehrlich - CFO Vojo Vukovic – SVP and Chief Medical Officer.

Joe Pantginis - Roth Capital Partners Mike King - JMP Securities Brian Klein - Stifel George Zavoico - MLV & Company Jim Birchenough - BMO Capital Markets Robin Davison - Edison Group.

Good day, and welcome to the Synta Pharmaceuticals Third Quarter 2014 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; Anne Whitaker, Chief Executive Officer; Vojo Vukovic, Chief Medical Officer; and Keith Ehrlich, Chief Financial Officer This morning, we issued a press release that reported financial results for the third quarter 2014.

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

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

Thanks Dan and good morning, everyone. Thank you all for joining us on today's call. This is very exciting time for all of us here at Synta as we're making good progress with our lead asset ganetespib and the GALAXY-2 program and preparing the company for moving forward toward a registration phase.

Today we'll share some updates on the progress of the GALAXY-2 program, but first I thought I would share a bit of my perspective including some insight for you all into why I joined Synta, some initial observations in my first 60 days in the job and how I am viewing our future as a pharmaceutical company focused on discovery, development and commercialization of medicines.

So to start I came to Synta primarily for three reasons; first, the strong science behind the impact that the heat shock protein 90 has on the growth and resistance of a variety of cancers, by serving as a chaperone protein for more than 200 proteins.

Hsp90 is a target that's long been studied, yet is the newest generation of inhibitors of which ganetespib is the leader that are now showing the promise of this target and there appears to be a real resurgence of interest in Hsp90 among investigators and a growing risk of drug developers, which brings me to the second reason I came to Synta.

I believe ganetespib has a late stage Phase III asset, holds promise as an impactful therapy for patients with non-small cell lung cancer and potentially a number of other cancer types and while there have been some ups and downs along the development path with this asset, I believe the fundamentals of the GALAXY program, including a robust Phase II dataset going into Phase III support a high probability of demonstrating a significant improvement in overall survival in a population with limited treatment option.

I am also encouraged by the level of investigator support for ganetespib.

In my experience it is not only unusual to see so many large randomized potentially registration enabling studies being conducted by cooperative for preregistration assets, it's almost unprecedented to see the sheer number of almost entirely investigator funded studies, either ongoing or in planning.

The third reason I came to Synta is because of the opportunity to build a leading pharmaceutical company that can make a real difference for patients fighting cancer. Here at Synta I found a passionate, committed, talented team with strong discovery and development capabilities.

With my background in organizational development, leadership and general management and commercial operations, I felt it was a place that I can make a real difference for patients, our employees here at Synta and our shareholders.

My interactions in the first two months with the team investigators and key opinion leaders have given me even more confidence that I made the right decision in joining Synta. Along with my clinical development and operations team, I've been on the road at GALAXY-2 investigator meetings in both Europe and the U.S. the past few weeks.

With the addition of a hundred sites in the West in recent months, these meetings were key to creating momentum with existing investigators and to on-boarding new sites.

During these meetings I had the chance to hear first hand from investigators about the broad unmet need in second line lung cancer and this is even with the recent approvals of targeted therapies for certain patient populations.

I also spent some time in the field with our head of medical affairs to visit with investigators who have initiated or are initiating their own trials with ganetespib and I heard their view on the science behind Hsp90 and in its role supporting tumor growth and resistance to existing therapies.

Their interest in our support, which is often just limited to providing drug is really focused in three areas, additional studies in lung cancer, which I believe are a testament to our clinical result and this disease and in the GALAXY program.

Studies that combine ganetespib with radiation therapy, a treatment that is frequently geared toward curative intent and rare diseases or cancers that affect small population and that as a result have very few treatment options.

I think it's important to note for all of you that through all of these interactions, I have had out in the field I have seen the strength of the Synta team and the work they've done in building strong relationships and credibility within the academic and community settings really come to life and I would like to commend the team for the work they've done so far with ganetespib.

Now I am very much a realist, so I recognize that we currently have an will have in the future our challenges as a company as we work toward our goal of becoming a leading pharmaceutical company. Based on what I've seen from the team so far, I am confident that we can pull together and overcome the challenges that we face.

I am very clear that as the CEO, it's my primary job to start the course -- to really charge the course for the company and then to navigate successfully along that course. I feel my over 20 years of experience in the industry has prepared me well for this role and I am very excited about the future before us.

Now over the next couple of months, we'll be working as a team along with the Board to refresh our corporate identity as well as our business and financial strategy and while it's clear that is the anchor program for us, we've seen encouraging data across a number of tumor types and we'll need to make strategic decisions around how to advance additional registration enabling development programs that support commercialization, yet are efficient and sensitive to the financial realities of a development stage company like ours.

We'll also need to make strategic decisions on how to unlock the value of our other assets including the HDC platform and Elesclomol and we want to unlock that value for both patients and for our shareholders.

As we move the organization through GALAXY and other potential pivotal trials, I expect that our core strategic capabilities will shift from where we've been in the past, which was focused solely on discovery and development.

We'll need to infuse the organization with some new talent that has extensive experience in filing NDAs, completing business transactions and working in partnership. I have -- search is currently underway and plan to add these capabilities within the coming months.

As we make changes to the organization, you have my commitment that we will do so in an informed, thoughtful and transparent way to ensure that our Synta colleagues, our stakeholders and shareholders understand the rational for the strategic path we're taking.

So to summarize my initial commentary, we have a strong foundation in science, clinical strategy, external support and people.

We are intensely focused on executing GALAXY-2 to the very highest standard of clinical practice and we will continue to evaluate our strategic options for shifting to a commercial pharmaceutical company and unlocking the value of ganetespib and our other key assets. Let's now move forward with the agenda for the call today.

Vojo will provide you with an update on where we are GALAXY and our other development programs. Keith will provide you an overview of the third quarter financials and then we'll open up the call for any questions and comments that all of you may have. So Vojo, over to you..

Thank you, Anne. Since the beginning of this year, ganetespib has reached several important clinical milestones across studies in tumor types.

GALAXY-2, our Phase III study in non-small cell lung adenocarcinoma, remains on track to meet our anticipated data readout timelines in 2015 and 2016, in addition to which a number of investigator sponsor studies are ongoing and in planning including five large proof of concept and in some cases potentially registration-enabling trials in three cancers including AML, breast and ovarian.

Let me begin with GALAXY-2. This study is our central focus internally. As many of you know, it is based on the encouraging result seen in the GALAXY lung study.

As an exploratory study, which is held as trial with setup and executed, GALAXY-1 was designed to find the right population to carry forward into Phase III and as such, included a variety of pre-specified and exploratory analysis.

Because ganetespib targets the Hsp90 chaperone protein and consequently hits so many dependent oncogenic pathways, the challenge has always been to find the right patient population.

The unique mechanism affection is what makes ganetespib such a potentially important drug as it achieves the best of targeting a single target in that there is less safety compromise and the best of targeting multiple pathways simultaneously, in that it heals high anti cancer activity.

In GALAXY-1, we found that treatment with ganetespib had the best efficacy in patients who were diagnosed more than six months prior to study entry. Ongoing pre clinical work is seeking to decipher the molecular mechanisms of increased activity in this patient population.

In parallel, we're conducting translational research studies and looking for specific genetic signature as predicted biomarker for ganetespib activity. GALAXY-2 is evaluating ganetespib and docetaxel versus docetaxel alone for the second-line treatment of these patients.

It's a robust, well designed and well powered trial who conduct and execution has been greatly refined, thanks to what we've learned in GALAXY-1. Total enrollment is expected to be 850 patients.

At this study size the trial has a 92% power to detect the 35% reduction in risk of death that has a ratio of 0.75 at the time of the final overall survival analysis.

Following the agreement with the FDA on the statistical analysis plan, the primary endpoint analysis will be based on an evaluation of overall survival in the intent to treat population and the pre-specified analysis of overall survival in ALK and EGFR negative patients will be conducted as a supportive analysis.

Based on the pace of enrollment and our statistical assumptions, we remain on track to meet our data readout timelines. We continue to expect two interim efficacy analysis to be conducted by an independent data monitoring committee in the second half of 2015, followed by the final data analysis in the first half of 2016.

Our belief in ganetespib is shared by many others in the oncology community.

While we place more emphasis on the larger, in some potentially registration-enabling trials that are ongoing or near initiation, the proliferation of smaller investigational studies are ongoing in planning or under discussion as a testament to the enthusiasm for this drug within the oncology community.

Many of these studies are being conducted without any financial support from Synta other than supplying drug.

As to the larger investigator studies, we recently announced the initiation of the I-SPY2 TRIAL evaluating ganetespib in combination with [test] (ph) therapy for the treatment of breast cancer to the treatment of breast cancer in the new adjuvant setting.

I-SPY2 is well known standing Phase II randomized controlled multi center trail sponsored by QuantumLeap Healthcare and in collaboration with the NCI. The readout from I-SPY2 can happen one between 1620 patients have been evaluated.

The goal of the trial is to identity regimes that have a high probability of showing clinical benefit in the future 300-patient Phase II confirmatory trial. The first patient in the ganetespib arm of the I-SPY2 trial was enrolled in late October and we look forward to updates from our colleagues at QuantumLeap as the trial progresses.

We also announced the launch of the AML-18 trial, which is one of three large randomized Phase 2/III studies of ganetespib in the first line treatment of AML, sponsored by the Lymphoma Research Fund and Cancer Research UK.

AML-18 evaluates ganetespib plus standard daunorubicin and ara-C in patients over 60 years old who can tolerate intensive chemotherapy versus treatment with standard daunorubicin and ara-C therapy alone. The trial is expected to enroll up to 300 patients in the ganetespib arm.

AML-18 follows the AML-18 follows the AML-LI-1 study, which recently graduated the ganetespib arm into the Phase III expansion portion of the study. We were very pleased to see ganetespib pass this hurdle as it is one which few therapies in this study has done successfully.

AML-LI-1 is evaluating the combination of ganetespib with low dose ara-C in newly diagnosed elderly patients with acute myeloid leukemia or high-risk myelodysplastic syndrome who are not eligible for intensive chemotherapy. The flip trial in the EML series, AML-19, is expected to launch in the first half of 2015.

It will evaluate ganetespib in combination with daunorubicin and ara-C versus chemotherapy alone in younger patients with AML. The trial is expected to enroll more than 500 patients in the ganetespib arm in a two-to-one randomization and will be conducted by the U.K. NCRI Group, a network of over 100 institutions.

As we mentioned last quarter, the GANNET53 in ovarian cancer is also underway. This is a pan European randomized trail evaluating ganetespib and paclitaxel versus paclitaxel alone in 200 patients with metastatic, platinum resistant ovarian cancer, in which the vast majority of tumors have limitation to P53 gene.

Enrollment of the safety lead-in Phase 1 portion of GANNET53 opened in July 2014 with the randomized portion scheduled to open in the first quarter of 2015. We expect that in the next one to three-year period, these trials have the potential to generate a large amount of important data that will help set our future clinical direction.

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

Keith?.

Thank you, Vojo, and good morning, everyone. There were no revenues recognized in the third quarter of 2014 and 2013. Research and development expenses were $16.2 million for the third quarter of 2014 compared to $17.6 million for the same period in 2013.

General and administrative expenses were $3.2 million for the third quarter of 2014 compared to $4.2 million for the same period in 2013. The company reported a net loss of $20 million or $0.19 per basic and diluted share in the third quarter of 2014 compared to a loss of $22.5 million or $0.33 per basic and diluted share for the same period in 2013.

During the third quarter of 2014, we raised $28.1 million in net proceeds from the sale of our common stock under our ATM agreement. Approximately $27 million remains available under the ATM.

As of September 30, 2014, we had $119.3 million in cash, cash equivalents and marketable securities compared to $91.5 million in cash, cash equivalents and marketable securities as of December 31, 2013. Based on our current operating levels, we expect our cash resources will be sufficient to fund operations at least into the fourth quarter of 2015.

This estimate assumes no additional funding from new partnership agreements, equity financing events or further sales under our ATM and that the timing and nature of certain activities contemplated for the remainder of 2014 and 2015 will be conducted subject to the availability of sufficient financial resources. Let me now turn the call back to Anne.

Anne?.

Thanks Keith. While as I said earlier, I am very excited about the opportunities at Synta including ganetespib, our ACC platform and earlier stage programs. Over the next few months, we will be carefully evaluating our strategic option with the goal of positioning the company for long-term growth and maximizing shareholder value.

We are committed to the successful execution of the GALAXY-2 trial and we look forward to facilitating investigator sponsored trials in a strategic, efficient manner to expand the development of ganetespib in areas beyond our core focus on lung cancer.

We will also seek to leverage our ACC platform in earlier stage programs and build our organization to support ganetespib as we approach the registration phase. We look forward to providing you all with an update on our strategic direction in the near future. With that, let's now open the call for questions.

Operator, are you there?.

Thank you, Ms. Whitaker. At this time, we will be conducting a question-and-answer session. (Operator Instructions) Our first question is coming from the line of Joe Pantginis with Roth Capital Partners. Please proceed with your question..

Hi, good morning Anne. Hey, guys. And welcome again Anne to Synta and thank you for the vision you shared today.

Two questions, first, maybe can you provide a little more color on how the company will look to leverage the various ISTs that you discussed and also the potential for even more ISTs to drive new studies versus starting new internal programs?.

So maybe I'll start and then Vojo can jump in and give his color on this as well.

First of all just to reiterate, we're very excited about the number of ISTs that are going on and as I came in to the company, I was quite surprised honestly to see the number of investigator initiated studies and the interest in ganetespib and it was very much a pleasant surprise and so we're going to be going through the strategic process as I mentioned to really look out where we want to focus the efforts around ganetespib and with that, we will be also looking at where we want to focus the ISTs that we will be supporting.

So maybe Vojo, you can give a little more color as well on your thoughts around the ISTs..

Sure. I would like to pretty much echo some of the same sentiment that Anne mentioned.

We're very excited about the continuing and actually growing the interest of investigators, I think which is evidenced by the fact that our early IST program was really composed of small studies aimed at attracting potential signals of activity in different cancer types.

Nowadays more recently much of that interest has increased to the point where corporate groups and large associations are able and willing to make commitments to evaluating ganetespib in large randomized trials that certainly help us better understand the potential for activity in different indications, but in certain cases also have the potential to expand the approvals in the future..

That's very helpful. Thank you. And then I guess that's almost a good a bit -- good segue with regard to -- obviously put some news out with regard to the upcoming FDA meeting regarding the pediatric potential for the drug.

Obviously, we need to wait to see what the committee discusses but maybe you could discuss a little bit about the importance of the potential expansions around pediatrics not just say patent extension or further exclusivity and what do you look for additional studies in new pediatric indications? Thanks a lot..

So I think, I'll let Vojo start and I'll probably have some comments to add there, so Vojo?.

Sure, and as part of our ISD program, we've relatively we've relatively recently initiated a combination study for ganetespib and mTOR inhibitor nhibitor in a patient population with the rare sarcomas and the prevalence of that is also present in younger or pediatric patients.

We believe that this ISD study has piqued the interest of the FDA and I think that was the reason why we got the invitation to present in front in front of the [indiscernible] committee and provide additional information to the committee, so they can potentially recommend a path forward for this drug in this indication or perhaps some other pediatric indications.

So we think that this discussion, which will take place in early December will really help us set the strategy and charge of course for development of ganetespib in the pediatric indications..

And I would just add Joe, my view on this as I think it further validates ganetespib as a potential treatment in cancer when you have the FDA making this request to you to present and especially in a pediatric indication and certainly there is a clear unmet need here.

So I think it validates the interest in ganetespib and also speaks to the safety of the product as well.

And we know ganetespib is a fairly benign treatment with the side effects predominately being GI but manageable in the trails as we've done in our program for GALAXY-2, so I am very encouraged by the interest here and of course we will be assessing as this ODAC finalizes how we might go forward if it's appropriate to go forward, but it does certainly extend the value of ganetespib as an agent..

Okay. Thank you very much..

Thanks Joe..

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

Thanks for taking my questions. Couple of quick ones, first Anne for you.

Just curious, I don't expect you to give up your sources or anything like that but I'm just curious if you could talk about sort of the types of folks you went to when you were or you turn to when you were doing your due diligence on decision whether to accept a offer at joint center or not.

It's hard to find anybody these days so it is a nice thing to say about Hsp90 inhibitors, despite all the progress you guys have made. So, perhaps you could give us a little bit of color on that.

I know you've talked about why you joined, but just maybe if you go into a little more detail about sort of the folks you turn to get comfortable with the opportunity..

Thank you, Mike for the question and I certainly did my due diligence as part of making the decision to come to Synta. I had a very good job and had a long career -- successful career in Big Pharma. So it was a big step for me but as I've told a number of people, I feel like my career has been building for this.

But I did my due diligence and I had oncology experience throughout my careers scattered throughout my career. So I've built a close relationship with a number of oncologist across the U.S. and even into Europe and other parts of the world.

So I had some close oncologists friends really I consider them and mentors that I turn to and in all honesty I ask him to tell me the good, the bad, the ugly that they thought around both Hsp90 and even the company and the programs.

And so I heard all the sort of pros and cons, but what I heard consistently through those individuals that I spoke with, these oncologists who had familiarity with the Hsp90 pathway was that there was real promise with Hsp90 and there was frustration because of the number of products that had dropped down because of the ocular toxicity and liver toxicity, but there was really a real hope that ganetespib because of it being the next generation Hsp90 inhibitor would finally prove that this pathway is one that can really have an impact on a broad range of tumors.

So I haven’t asked those folks if I could give up their name, so I wouldn’t do that, but I think they would names that many people on the line would recognize.

And then I also went to my mentors in the industry who have really guided my career some who I've worked for directly, some who many of levels above me and act as more mentors for me around my decision to leave Big Pharma and go to really the biotech organization, the discovery, development stage and they pushed me to do my due diligence, but I felt good that my sort of Board of Advisors supported me with this step because it was one that I've been building my career towards and they knew that.

If you look at my background, I am someone who comes in and builds organizations, some might characterize me as sort of a turnaround person. I think I am more accurate term for my leadership approach is I am a big of a change agent and so I felt that this was the perfect match for me. So hopefully that answers your question..

Yes. Great. No I appreciate the candor. And then separate from that, I am just wondering where you stand with the ATM. I feel like Synta shares have missed out on a great biotech rally for 2014, because of the added dilution.

So, I just wonder how you feel about your current capital position and what needs you have or not going forward as far as maintaining your capital reserves. Thank you..

Thanks Mike and I'll let Keith start and then maybe I'll add a few comments on..

Sure. So Mike, as you know I think you have a fair point I think this was a year where the ATM worked very well for us.

We raised $95 million this year and that puts us in a great position to sustain the company pretty much through 2015 and we believe that that positions us well to see a number of inflection points that allow us to consider other alternatives. The Board does have a strategy.

It knows it has a variety of options for raising capital including partnerships, equity debt, hybrids there again depending on the situation and they will select the ideal fund raising mechanism based on the circumstances at the time.

So I think we're very confident in our ability to raise capital and we're confident in our ability to fund these programs to fruition..

Yes and I would just add just a little bit, I wasn’t here when the decisions were made to do the ATM, but I can tell you I am sure I am glad that we have money in the bank to take us through at least through and through 2015 and as we work with the Board in the coming weeks and couple of months, we'll be looking at our business strategy and refreshing that and we'll also be taking into account our financing strategy to be able to execute on the business strategy.

And as Keith said, we have a lot of options. We'll be exploring those and be opportunistic about the timing of executing on those.

But I want to emphasize we will very good that we are in a strong cash position to run through at least the end of 2015 and we'll look at other ways to fund the additional strategies that we'll consider as we lay the path for the company over the next three to five years..

Thank you..

Thanks Mike..

Thank you. The next question is coming from the line of Brian Klein with Stifel. Please proceed with you question..

Hi. Good morning. And thanks for taking my questions..

Hi Brian..

Hi Anne. So, I wanted to circle back to some of your preliminary commentary where you suggested you were considering pivoting the company towards a more commercial focus and thinking about adding new employees.

And my question really is, isn't it a little bit too premature to start thinking about a commercial strategy when you're still in the midst of a Phase III where you won't even have any real data readout until a year from now and a number of trials that are just starting, but certainly it seems that you're quite a ways away from any commercial opportunity and so is it too premature to start thinking about that now?.

Well thank you, Brian. Thanks for your question and certainly a fair one. So I'll kind of step back and just remind you of kind of where I come from. So I come from Big Pharma and certainly I know Big Pharma is different than Biotech, but I found a number of experiences in launching products.

And what I can tell you is that it's really important to start your commercial planning anywhere between two and three years advance of a potential launce.

And so it's not about spending a lot of money because we are not going to be spending a lot of money and hiring a lot of people and so we have assurance that we have a product that is launchable within a short timeframe.

But doing that thinking around how you are going to position the product, really the sort of distribution approach, pricing strategies all of these things have to be thought about well in advance and as we sit today at Synta, I would say that this is not a criticism for the organization in anyway, but I am one of the few if not the only that has a depth of commercial experience and so we will be looking for additional people to come in over the next year to really add to our commercial capability..

Okay.

I guess I find it a little difficult to reconcile that with the fact that you still don't even know the full characteristics of the drug given that you don't have the data in hand so I'm not sure how you can start thinking about distribution and pricing strategies when it's unclear where the drug would even fit in within a treatment paradigm that's evolving and in which you might wind up being relegated to a smaller portion of a commercial opportunity..

Well I think it's a fair point that we don't know exactly what the label will be for the product and how the product will be positioned in the market and that's true for any company until you have the label and quite honestly until you have payer discussions, but you can't start to develop a target patient or sort of target profile for the drug target product profile, we call them TPPs that you then start to position and do market research and such around.

So it's never a 100% my experience and in the industry we never got it a 100% right, but if you base it on your Phase III trial GALAXY-2, then we have a good sense of what the target product profile would be and we also have a good sense of how products are coming into the market over the next two to three years, so how the standard of care could evolve and what are the potential scenarios for standard of care.

So your point around we don't have the precision of exactly how this product is going to be used in the market we can start to work on the ranges of that now and get more precise as we come closer to the time. And I can add just one other point, Brian, just I am sorry to talk so much about it, but I should tell, I am pretty passionate about this.

I also think about as a small company the types of partnerships that we may do with bigger organizations whether they are Big Pharma midsized Pharma or whatever, and having been on the other side of those discussions, I know how important it is to the company, the potential partner to smaller company to have done at least some initial work that they can base is what the initial sort of market research, initial product positioning so that they know how they're valuing the asset.

So I am certainly in no way, we're going to do all the kind of work that Big Pharma organization could do. One, because you don't need to do that in this situation, but we need to do enough so that we're in -- we have a position of strength when we are actually discussing partnerships going forward..

Okay. Got it. Thank you. Now that's very helpful. And then just one final question off of what you commented earlier in regards to the capital that you have available to yourself, given that what -- at least appears to me the next major data readout will be the interim analyses in the second half of 2015.

It looks like you will be approaching a very minimal cash position at that point in time. And so I'm just wondering beyond all the potential opportunities in terms of partnership, should we expect that you will fully utilize your ATM and are considering additional equity raises to continue operations through that data point? Thanks..

So as I said earlier and you just summarized, we're confident we have the funds to run through the end of 2015 and so as we look at really developing our business strategy for the company we're going to also look at what's our financing strategy to go along with that.

And we will be looking at exploring all options and the timing of executing on sort of those tactics as we talk more and gain further confidence around our strategy as an organization. So we do have the ATM but I don't think there is any indication that we plan to only use an ATM going forward.

We'll explore and be pretty excuse me, opportunistic about our financing strategy.

Keith, would you like to add anything else?.

No, I think you got it pretty much covered there..

Okay. Thanks for taking my questions..

Thanks Brian..

Thank you. Our next question is coming from the line of George Zavoico with MLV & Company. Please proceed with your question..

Hi, good morning everyone and welcome Anne again. I have two questions, one regarding the AML program that is being managed out of the U.K. The LI-1 result was clearly very good and it looks like it's moving forward now into these subsequent trials.

Vojo, could you describe what the potential path forward with AML-18 and AML-19 will -- will the responsibility for perhaps the registrational trial shift over to Synta eventually or what's the outlook there?.

Sure, so as you know George there is lot of precedence in oncology to where corporates and group trials have led to approvals of drug including first or initial approvals, but certainly a lot of secondary approvals came to that path and we believe there is a possibility for that with ganetespib AML.

The entire program all three large randomized studies in AML are Phase II/ Phase III did the step up essentially from a data readout perspective as a Phase III and they have sufficient power to detect what the investigators believe is a meaningfully improvement in survival.

So what we plan to do as a company is really engage further in discussions with the sponsors of the studies to understand what is that what we as a company can do to further support those trials and increase overall the robustness of the studies and robustness of the data to more likely to meet registration standards.

So in other words that's going to be our primary strategy and we believe that that strategy could potentially lead to approvals to the AML..

Is the trial expanded? I think it's expanded beyond the U.K.

now right? And what obligations, since they basically carried most of the times, what obligations would you have to them, if any, upon approval if and when that happens?.

So the operationally the trials are running in Europe and U.K. and several European countries. There is even some plans outside of Europe as well to facilitate recruitment.

In terms of obligations, our only obligation for the contract is really to provide study drug so unless we engage further to support the robustness of the studies and that's our choice really, we do not have any major significant responsibilities towards the sponsors..

Okay. Thank you for that Vojo and one more question about the predictive biomarker plans that you outlined, that's ongoing right now is GALAXY-2. It seems to me that these are still exploratory in the sense that it's not prospective for GALAXY-2 because your inclusion criteria really has already been defined as in clinicaltrials.gov.

These predictive biomarkers I presume, part of the reason it's not only to inform future trials and other indications perhaps, but for the GALAXY-2 and non-small lung cancer, how would they reflect back as a prospective study in perhaps registrational application to the NDA, assuming for GALAXY-2 is successful..

Okay. So the translational research programs we're currently conducting is based on clinical outcomes and patient samples from GALAXY-1. So we're using basically that study to -- the test signals and formulate hypothesis which subsequently can be verified in an independent data set which is the GALAXY-2.

That's the standard approach to what's biomarker validation that has also passed the regulatory approval. So we could pursue one of the strategies going forward. We could pursue strategies similar to what BMS did with KRAS and ERBITUX where after the fact you introduced biomarkers on to your label. So that's one possibility.

The other possibility is when we think about lung cancer and earlier treatments of things, those biomarkers could be potentially used as a selection criteria for first time trials or new adjuvant trials. And of course the third possibility is we can explore this in a pilot session in other indications.

So we could utilize some of the knowledge gained in the GALAXY program to optimize development of ganetespib indications..

Okay. That's very helpful Vojo. Thank you very much and look forward to the next data point..

Thanks George..

Thanks George..

Thank you. Our next question is coming from the line of Jim Birchenough with BMO Capital Markets. Please proceed with your question..

Good morning for making this morning and thanks for taking my questions. Anne, first I would like to compliment you on what I felt was a very strong introduction, well done. And I think you seem like you're going to be a pretty no-nonsense leader there at Synta.

I'm wondering if you consider their GALAXY program, whether you've considered what happens if GALAXY-2 fails and how can you position the company to continue in that event or perhaps more likely what happens in a world that becomes dominated by these program death inhibitors and can you consider looking at evaluating ganetespib activity in patients who are failing these anti-PD1s since it seems more than likely that those kinds of products are going to change the landscape in lung cancer.

And then I have a couple of follow-up questions as well. Thank you..

Okay. We'll thanks Jim. Thanks for your questions and I think you're probably accurate in your first assessment. I think most people would characterize me as pretty no-nonsense or pretty candid. So I hope I continue to live up to that type of interaction we can have.

So I think your question around what really happens if GALAXY-2 doesn’t work out that we don't have positive data and I think there are a lot of factors in that. It could be that what does the FDA ask us to do additionally? What does that data actually look like.

But that is a major part of what I am working on with the team here at Synta and the Board.

As we look at what our strategic options are for the company, I was brought here to build a sustainable organization that could commercialize again ganetespib and continue to build a sustainable leading pharmaceutical company and so we're exploring what our options are there.

We're exploring what additional tumor types we could consider for ganetespib. We're exploring how should we support the HDC program a variety of different things that we wouldn’t want to lay out here today.

All of the strategic choices that we're considering quite honestly because I haven’t had that full conversation with our Board, but I want to give you confidence that we're thinking about that, that very strongly. How do we prepare for success and that is the main focus, but we also need to have a plan B.

Your question around the PDIs and PDI-1 and that sort of new products coming in and where are they going to be positioning, where they'll be positioned and could ganetespib -- how will ganetespib be positioned around them? As we're doing forecast for ganetespib, by tumor type, we're looking at how the standard of care could change over the next three to five to seven years because a lot of the immunotherapy will be coming out even later than the next three to five years and how my ganetespib be used in combination with those products or around those products and so I don't think anyone can predict with precision exactly what the standard of care is going to look like by line of treatment in a few years.

But what does give me confidence, I'll take you back to some of the comments I made initially from some of the investigators that we talked with about the GALAXY-2 and even once we're doing ISTs, what they're continuing to see was these products that are coming out in immunotherapy phase, it's not going to be for all products.

There is a subset of patients that we'll work for and there is still tremendous unmet need in the space with lung cancer and so I feel confident there will be a place for ganetespib. So that I guess that what I would sort of leave it at, at that point..

Okay. Thank you. And then just one quick follow-up and I know you've not been in the hot seat for that long. But the data we've seen so far on HDC program has been particularly striking. Obviously I'm sure what's coming out of the labs is being filtered so that the best data gets presented. But it really has been very striking.

And so do you think you have the ability to push that program forward, given conservation of resources to GALAXY or can you look at other creative ways to fund that. Thank you..

Thank you for the question around HDC, the HDC platform because that is one of the things since I was doing my own evaluation of coming to the company that I saw as quite promising and so what I can share with you at this point is we're considering what other options to really maximize the HDC platform and we're considering how would we take assets that are coming out of the HDC platform ourselves and what would be the investments required there and the time to get return on an asset like that.

How we would leverage that platform for partnerships but protecting our IP. So I'll give you a little indication of sort of my view on it that it's not going to be one single pathway that we're going to take with the HDC platform.

We will certainly leverage it as a partnering strategy because we've already to date come up with 450 compounds there, but we will also consider as we have capital available how might we fund assets coming out of that program or that platform as well..

Excellent. Thank you very much and good luck to you..

Thank you..

Thank you. Our next question is coming from the line of Robin Davison with Edison Group. Please proceed with your question..

Preaching from London. The biggest strategic question to me anyway at least is would seem to be whether you try to partner ganetespib ahead of the GALAXY-2 data or do so afterwards.

And I appreciate you've really been in the position for a short amount of time, but I'm just wondering what your thoughts are on that? I think, do you think that that is the biggest issue facing the company? What is your inclination? It seems that you've come into and you are not so burdened by the previous decisions, so you might actually bring a different perspective to that question..

Thank you, Edison for the question and you might have notice I mentioned partnership a few times in sort of my opening comments because I think when you have an asset like ganetespib that is active, appears to be active across a number of tumor types, we have to be thinking strategically about how we might leverage partnership to really develop the asset across those multiple tumor types.

And your point around whether we partner before we have data or after we have data, I think we will know more about that really as we engage further with potential partners over the coming months. My approach to partnership is perhaps a little different than the previous leader of the organization.

I plan to take a very strategic and targeted approach to partnering.

I think it's really important that we think about who might be the best partner for us in each region or as a global partner and that partner would be committed to helping us develop the asset more fully once we have data available showing that it is -- proving that the effect in non-small cell lung cancer.

So we will be preparing in the first half of the year first of all to really identify who might be the right partners for us and region by region and then globally and what those partnerships might look like.

So when we have data and whether that's in the fall or second half of 2015 or early 2016, we're ready to move quickly with appropriate partnerships because once you get to that point after you have data, you have to move quickly to prepare for commercialization and as I said earlier, we will have done work that will help make it easier for those partners that we might consider to really move to help us together to move to commercialization.

But as time will tick off pretty fast once we have data and are ready to file the NDA. So hopefully that answers your question..

Yes that was helpful. I have a quick follow-up actually.

It seems that in the GALAXY-2 study, one of the sort of more controversial decisions was around the six months greater diagnosis, I am just -- you're coming into the organization you have to see that that's a suitable way to identify the patients that would work in the commercial world, you're confident of that?.

First of all, I would sort of back up and I think GALAXY-1, certainly did its job of really identifying the patient population that ganetespib could have the greatest impact on overall survival and so I am pleased that it identified that population that we could really focus on and GALAXY-2.

And my experience from a commercial side is that, this is something greater than six months of being diagnosed with advance disease, it's something that physicians can easily sort of determine.

It's not something they have to run a test for right, that is they can determine that in clinical practice and I know there have been a number of other products that have that in their label or something similar that the product has failed treatment and it's been six months since they were on that treatment or even in cases nine months since treatment.

So I think it will be easy for physicians whether they are an academic institution or in a community practice to actually be able to determine what the right patient is for ganetespib from that definition. I do want to emphasize that we are not stopping there.

As Vojo said earlier, we hope to really find through additional work that we're doing even the more definitive terms of the patient that could benefit form ganetespib, but I think we would be able to commercialize around this type of -- this for our label very easily..

Great. Thanks very much..

Thank you..

Thank you. That concludes our question-and-answer session. I will now turn the conference back over to Ms. Whitaker for any additional concluding comments..

Well thank you all again for joining the call this morning, I've enjoyed the conversation, the dialogue with you all. We look forward to sharing more with you in the coming quarters and if you would like to know about our progress, please feel free to reach out to us directly. So hope you all have a wonderful day. Thanks.

Thank you. Ladies and gentlemen, this concludes today's call. You may now disconnect..