Merrimack Pharmaceuticals, Inc.
Q4 2014 Earnings Call Transcript

Published: 26 Feb 2015

[Operator:]

Good day ladies and gentlemen and welcome to the Merrimack Pharmaceuticals Fourth Quarter 2014 Investor Call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder, this conference call maybe recorded. I would now like to introduce your host for today’s conference Geoff Grande of Investor Relations. Please go ahead.

[Geoff Grande:]

Good morning everyone and thank you for joining us. Today, we'll review our fourth quarter 2014 financials and provide an update on our clinical progress. A press release detailing this information issued a short while ago as well as slides accompanying this call can be found in the investor section of our website at www.merrimackpharma.com. This call is being broadcast live and will be archived on our website for six weeks. I'm joined today by Bob Mulroy, our President and CEO and Bill Sullivan, our CFO. We’ll end the formal portion of the call with time for Q&A. Before we begin, I need to remind you that during this call, we will be making forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These may include statements about our future expectations and plans, clinical development timelines, the potential success of our product candidates, and financial projections. These statements involve risks and uncertainties which are described in the risk factors section of our most recent Form 10-Q and the other reports we filed with the SEC, which are available online at sec.gov. While these forward-looking statements represent our views as of today, they should not be relied upon as representing our views in the future. We may update these statements in the future; we are not taking on an obligation to do so. With that, I'll turn the call over to Bob.

[Bob Mulroy:]

Well thank you, Geoff and good morning everyone. Thank you for joining us it's a pleasure to update you today on Merrimack's recent progress. Let me start off by touching on the headlines that we plan to cover in today’s call. First we want to revise our cash run rate guidance into 2016. Second we want to confirm that we are on track to complete our MDA submission as stated. Third we want to review the recent announcements that we have launched our first prospectively selected trial for MM-121 and lung cancer. Fourth we want to discuss our decision to stop enrollment in the 111 gastric studies and to focus our resources on other programs. And last we want to confirm that we are on track to execute business development to support our development efforts that are planned for 2015. For those of you who are new to the company Merrimack is a fully integrated cancer company built on a scientific foundation, systems engineering to better understand the dynamics to drive multifaceted diseases and to design and to deliver on the promise of precision medicine to integrated therapeutic and diagnostic solutions to the challenges of treating cancer. On primary note the company has the mix of an exciting transition to be in commercializing. In 2014 our lead program MM-398 achieved the primary overall survival end point in a Phase 3 trial in metastatic pancreatic cancer in patients who have received prior treatment with gemcitabine. Based on that data we have initiated a rolling MDA submission under an FDA granted Fast Track Designation. We are also building out our commercial organization as we prepare for launch. During 2014 we also entered a $970 million partnership agreement with Baxter to the ex-U.S rights to MM-398 that will drive the expansion of 398 into multiple additional cancer indication. In addition to 398 we have a substantial pipeline of additional novel therapeutics all paired with contingent diagnostics and clinical development. All are derived from our systems biology engine. Most excitingly during 2014 we culminated the analysis of data readouts from a transitional Phase 2 program studying MM-121 our monoclonal antibody targeting ErbB3 in lung, breast and ovarian cancer. MM-121 and its companion diagnostic has a potential to identify patients in advance who would be resistant to the standard of care and then restore their response. In those trials we saw significant benefit in the 128 heregulin positive patients who are treated with MM-121 and achieved a progression free survival [hazard] ratio in the range of 0.26 to 0.37. We also recently laid out a path to registration for 121 in both lung and breast cancer targeting more than 300,000 patients worldwide. For MM-302 our HER2-targeted nanoliposomal encapsulation of doxorubicin. We initiated a Phase 2 trial in metastatic breast cancer designed to support an application for accelerated approval. Last year we also reported Phase 1 data for both MM-141, our tetravalent bispecific antibody designed to inhibit the signaling of the IGF pathway and MM-151 our oligoclonal EGFR inhibitor as we discussed plans with both of those programs in the Phase 2 trials in 2015. Dealing of this progress 2015 is shaping up to a very important and exciting year for the company. Now let me turn to some more specific updates on a few programs namely MM-398, MM-121, MM-111 and our business development progress. First 398, most recently in January at the ASCO GI conference in San Francisco we presented additional analysis of the Phase 3 NAPOLI-1 data. This data appear of Slide 6 of the slides posted on our website. In our initial top-line analysis last year from the intent to treat population the overall survival was 6.1 months for the MM-398 combination arm versus 4.2 months for the control of 5FU/Leucovorin. The un-stratified hazard ratio in this ITT population was 0.67. At ASCO GI we provided a stratified hazard ratio for the ITT population of 0.57. Stratified hazard ratio accounts for the pre-specified prognostic factors that are included in the study randomization. We also provided an expanded analysis of the protocol population for the study which has the finest patients who are able to remain on treatment for more than six weeks. In this population the median overall survival for patients 398 plus 5-FU/Leucovorin was 8.9 months versus 5.1 month on the control. The stratified hazard ratio seen in this population was 0.47. Overall this data continue to demonstrate the robustness of the overall benefit of 398 and the potential for provide a benefit to patients. Moving to the future, most importantly our NDA is on track for filing. We initiated a rolling submission in late 2014 and expect to completed in the weeks ahead consistent with our previous guidance of late Q1 and early Q2. In terms of regulatory timelines we have received Fast Track designation for 398 and will request priority review which could put us on schedule for a potential approval in Q4 of 2015. With our NDA filing underway our commercial preparations are accelerating. At our analyst day in December we outlined in detail our view of the commercial opportunity for 398, this includes the opportunity to create a standard of care and an indication were not exist, the geographical concentration of pancreatic cancer treatment centers which allows us to prepare for a field team of individuals and a favorable view of 398 by treating oncologist going to third-party market research that we conducted. We look forward to keeping you updated on these developments in the months ahead. With respect to our development plans for 398 as we outlined in December our initial expansions plan will focus on two primary indications front-line pancreatic cancer and gastric cancer we anticipate initiation of both of those programs this year. During our last quarter’s conference call we stated that our cash [flow] guidance did not include any of the potential milestones for the Baxter partnership. Essentially we had just closed the transaction and our joint plans on regulatory and development strategies were early in their formation. Since that call we have had the pleasure to work with our partners at Baxter and confirm our plans for the regulatory and development efforts in 2015 allowing us to include some of the milestones from our partnership that we expect to receive this year. The initial milestones allow us to extend our runway guidance from the second half of 2015 now into 2016. Bill Sullivan will talk more about that in a moment. Now let me move to the recent news for MM-121. Last week we announced that we had initiated a new trial in lung cancer. It will be our first study to prospectively select patients based on our internally developed [biomarker hypothesis]. This is the trial we are very excited about. The trial designed to enroll a 120 heregulin positive patients where we randomized 221 to receive MM-121 plus or minus the investigators choice of docetaxel or pemetrexed. We believe this study has the potential to address significant medical needs over half of the non-small cell lung patients. This study is based on biomarker data we generated in the Phase 2 program, MM-121 which will see on Slide 11, that confirmed our hypothesis of heregulin as a prognostic for core patient outcome and 121 promise to treat and reverse this drug result. Given the unmet need we expect the trial to enroll quickly. Primary endpoint of the study is progression free survival with overall as a secondary end. We are also continuing to plan to prepare to launch MM-121 two registration seeking trials in breast cancer triple negative and estrogen-receptor positive as discussed our plan is to launch those additional studies for 121 only after we have gained additional fundings through business development. Now let me turn to an update on MM-111 the fourth product in our clinical portfolio. As you may recall we have been running a single Phase 2 trial investigating MM-111 in combination with Trastuzumab and Paclitaxel which was the control arm of Trastuzumab and Paclitaxel in patients with second line HER2 positive gastric and gastroesophageal cancer. This study was designed with two co-primary end points progression free survival in the overall population and in a biomarker positive heregulin high population. Most recently the database in [monitoring board] overseeing the trial met and recommended the closure of the study to further patient accrual due to shorter progression free survival on the experimental arm relative to the control arm in the overall unselected patient population. As a result we have stopped new patient enrollment on this trial. Although we're still analyzing that data there are a few insights we can make at this time. In some of the preliminary analysis for the biomarker data the heregulin biomarker levels across the entire patient population in this study were significantly lower than expected. MM-111 was designed to treat patients with high levels of HER2 and high levels of heregulin. Unfortunately despite the existing body of research and our own clinical research that indicated otherwise we found that a vast majority of the patents in this trial were well below the threshold of heregulin levels identified previously as necessary to benefit from an ErbB3 inhibitor such as MM-111. This indicates the expression of heregulin gastric cancer is not as high as anticipated and the second line HER2 positive gastric cancer is not an indication but we will consider further development of MM-111. As a result we have decided to halt our investment in the further development of 111 at this time. Given the breadth and depth of the opportunities across our entire pipeline we intend to focus our existing efforts on the planned studies and conserve our resources that had been allocated to 111. We sincerely want to thank all the patients that participated in the study as well as the physicians and medical practitioners that made the trial possible. Well the results are disappointing we are sure we had to the wrong indication and are unable to get a reading on 111 itself. Over the weeks ahead we will be executing the full analysis from the complete biomarker data from the studies to learn as much as possible about the value of heregulin as potential prognostic biomarker and we look forward to sharing our findings with you once that analysis is complete. Last let me touch on our ongoing business development efforts. Last year we stated that we were seeking to gain a partnership to secure funding to launch the registration effort for MM-121 in breast cancer in 2015, we continue to be very pleased with the steady progress we are making in those discussions and based on the strong interest want to confirm our strategy to complete the business development deal as our next source of capital to fund development. Given we're not in complete control of the completion date we cannot be more specific on the timing of the completed deal but we're working to gain a new partner as soon as possible and remain confident in our ability to close and launch additional studies in 2015. We look forward to updating you on all of our progress on these programs in the months ahead. Now let me turn the call over to Bill Sullivan to discuss our financial results. Bill?

[Bill Sullivan:]

Thanks, Bob and good morning everyone. Our fourth quarter 2014 and full year 2014 financials were included in our press release, which was distributed a short while ago. Net loss for the fourth quarter of 2014 was 9.5 million and consisted of 33.9 million in collaboration revenues, 39.0 million in operating expenses and a 4.4 million loss from other expenses. The 33.9 million in collaborations revenues primarily consisted of 23.4 million in MM-121 revenue under our collaboration with Sanofi and 10.5 million in MM-398 revenue under our collaboration with Baxter. We do not expect any further MM-121 revenue from Sanofi due to the termination of our collaboration in December 2014. In 2015 we expect to recognize approximately 59 million of revenue under our Baxter collaboration. Moving onto operating expenses, 30.7 million, or 79% of operating expenses consisted of research and development expenses. Of this, 20.8 million or 68% related to our clinical stage programs, the remaining 9.9 million related to stock option expenses, pre-clinical expenses and general expenses that are not directly related to clinical stage programs. The other 8.3 million or 21% of operating expenses consisted of general and administrative expenses. The 4.4 million loss from other expenses was primarily related to interest expense from our term loan with Hercules Merrimack convertible senior notes. Approximately 2.1 million of this interest expense was imputed non-cash expense related conversion feature of the senior notes. Looking at our balance sheet, cash and cash equivalence available for sale securities increased 29.7 million from the third quarter to the fourth quarter of 2014. Additionally yesterday we entered into an amendment to our loan agreement with Hercules. Under the amendment we agreed to extend the interest only period on the 40 million term loan by 16 months the principal payment is now beginning on June 1, 2016 and continuing through the maturity date of November 1, 2018. In addition if we receive FDA approval for MM-398 by a certain date the interest rate on the loan will decrease by 1.1%, we will have the option to extend the interest only period by an additional six months and we will have the option to borrow up to an additional 15 million by August 1, 2016. Turning to our financial guidance. As Bob mentioned since our last quarterly conference call we have quickly formed a strong working relationship with our new partner Baxter. We now have greater clarity into our development and regulatory plans for MM-398 and therefore the milestones that we expect to receive in 2015 from Baxter. As a result of this clarity we have extended our cash runway guidance. Specifically Merrimack expects to be able to fund operations into 2016 to unrestricted cash and cash equivalence in available for sale securities of 124 million of as of December 31st 2014, anticipated cost sharing reimbursements from Baxter and the anticipated receipt of 66.5 million of net MM-398 milestones from Baxter in 2015 after offsetting payments to PharmaEngine. Any payments received from additional business development which remains a priority would further extend our cash runway. At this point I will turn the call back over to Geoff.

[Geoff Grande:]

Thanks Bill, I mentioned briefly that we will be presenting the Cowen and Company 35th Annual Health Care Conference on Monday March 02nd in Boston as well as the Barclays Global Healthcare Conference on Tuesday, March 10 in Miami. We hope to see you at one of these events. And with that we would like to open the line for any questions.

[Operator:]

Thank you. [Operator Instructions]. Our first question comes from the line of Peter Lawson, Mizuho Securities. Your line is open.

[Peter Lawson:]

Bob I just wonder if you could talk through 398 to the front-line pancreatic, when could we see that I guess same for the gastric cancer when can we see data for those? And are these post potentially registration of Phase 1, Phase 2, Phase 3, Phase 2 Phase 3 trials?

[Bob Mulroy:]

Hey Peter, thanks for the question. So I think at this point where we stand with those studies is we work with Baxter to have a consensus on the plans for those studies and we need to work through a series of external audiences in terms of the investigators and RVs and all those things to be a final protocol before we can be more specific about the study design and when we might see the finish, but I think our intent with both gastric and with pancreatic cancer is designed studies that can support registration. So we are working on those. And as we work with our partner Baxter to sort of build the external consensus around that design and the trial we will be able to provide more detail on start and when we expect to complete them and the rest of your question.

[Peter Lawson:]

And then just on 111, just so the low heregulin levels in gastric cancer, does that [gives] any concern around under the diagnostic test or other pipeline molecules that you have? And what other indications could you potentially explore with 111?

[Bob Mulroy:]

So that’s a great question. I think at this point it’s a little bit early to speculate on the source of the disconnect here, I mean obviously there is a disconnect between what we expected to find in this indication and what we are actually seeing. And what I can say is there really is no impact on the rest of our pipeline that 111 was designed to treat a very specific biology, a different patient population than our other therapy. And the short story here is we didn’t see a failure in 111 we saw a failure to get it into patients that 111 was designed to treat. If you go back to why, what we saw with the 111 is we did a lot of pre-clinical research. We took a lot of patient samples from different studies and were able to come up with estimates of what we thought the prevalence would be in ovarian and breast and lung and those estimates turned out to be pretty precisely accurate for half of all the patients in those study. In the case of 111 we used very much comparable procedure of existing literature, looking at tumor surveys of existing patients in the field and in this indication the patients did not turn up. And I think whether that’s specific to -- at this point that seems to be specific to gastric and well that’s specific to the way historically the heregulin was determined, I think that our confidence in our existing asset today are that they are the most robust that have been used. And so our confidence that today’s data is the right data, is right, the question is really more historically existing literature the samples that we acquired to take a look at the nature of those data what we are investigate, but I think the confidence in our asset today is robust is clearly the best asset that didn’t use heregulin and the most robust. And so our confidence in today’s date is high. It’s really historical about the preclinical data that led us to believe there were patients in this indication sort of the thing we have to investigate. But different biology, no impact on our programs, with 121 we've done the Phase 3 studies, we know the patients are there from real clinical data now, in this case the gastric cancer situation is not to the design of 111 and that's what we learnt.

[Operator:]

Our next question comes from the line of Daniel Brims with Cantor. Your line is open.

[Daniel Brims:]

Thanks for taking the question. I guess now with 111 being halted, are you going to -- you’ve not really talked much about moving 151 forward, will you probably be potentially initiating that study in 2015?

[Bob Mulroy:]

So I think we've talked generally about our excitement about moving 151 into colorectal cancer at the end of last year. And that we will have more specifics through 2015 as we get closer to sort of getting something underway, but again at this point we're in a phase we're working with the external parties to get things ready -- we're not quite ready to be specific on the trial, the design, things like that. But we are very excited about the opportunities for 151, we've put out some very exciting Phase 1 data showing our ability to treat patients who have progressed on Erbitux at ESMO this past fall. And so we're excited about the opportunity there. We're also excited about the opportunity with 141 that we will be moving into a front line pancreatic cancer study in IGF positive patients in the first half of this year. So I think the situation at 111 is really just prioritization I mean unfortunately we don't have a negative signal that it doesn't work but relative to our resources and the other opportunities in our pipeline at this point it just doesn't cross the hurdle for something we're going to invest in at this point.

[Daniel Brims:]

Okay. And with 121 you have -- you’ve initiated probably haven't really seen what the enrollment rates are yet. Do you have any estimate on when we might be seeing that proof of concept data?

[Bob Mulroy:]

So we don’t -- we have not put an estimate out yet as in all our studies we love to see what the enrollment looks like, I think we're pretty optimistic that the 120 study 121 study alone will enroll pretty quickly given the data we saw from our prior studies that was 55% of the patients were heregulin positive, so it's a very large population to start in lung cancer and then it's a very large percentage of those patients that would actually be positive in the biomarker and you have a very large unmet need. And so our expectation and our desire to enroll that study as quickly as possible and have data but again once we see what enrollment looks like in the sites we will be able to provide a more specific estimate.

[Operator:]

Our next question comes from the line of Yigal Nochomovitz with Oppenheimer.

[Yigal Nochomovitz:]

Bob you mentioned some of the third-party marker research you had around the 398's profile. Kind of wondering if you had done that before or after the protocol data had come out as obviously it would be interesting to recall the physician community with the improved OS signature from the protocol data? Thanks.

[Bob Mulroy:]

So the short story is that that research was done last summer and it was based solely on the topline data that we had put out. And so one of the things that’s very exciting about that data is the very, very enthusiastic response of physicians based on the topline when we hadn't presented at least in the pancreatic cancer a lot of the very important data points to physicians look to and that include stratified and has a ratio that accounts, so the potential differences in the patient populations and the protocol data which gives them a sense if they have the right patient, they get them on drug what could really be the power of the drug. So given the strength of that data based on just the un-stratified topline that was a very positive signal. We are in constant engagement with the physicians and continuing to do additional research and so to your point we will provide an update at some point appropriate based on feedback from this most recent and we think really exciting data for 398.

[Yigal Nochomovitz:]

And then Bob you have mentioned obviously that the guys had fast tracked and requested priority review for 398, wondering if you had any additional thoughts or expectations on whether you expect FDA to convene a panel, I mean obviously it's irinotecan which is a known entity. What's your -- any thoughts there?

[Bob Mulroy:]

So we have been gaining fast track status and technically the application for priority review is submitted coinciding when you have completed your submission and so technically that will go in when everything is done in the weeks ahead. With respect to the advisory panel that’s up to the FDA and we can't comment on that. I think we feel very confident that we have an exceptionally robust study, that is robust across all dimensions and that with respect to the entire filing that we put it together it's our hope that our extensive work with the FDA in the past year clarify that questions and to deliver a fuller complete package will hopefully lead to a speedy review but I think at this point in time we can't comment on any advisory panels they may seek.

[Yigal Nochomovitz:]

And I just wanted to ask one question on 111. I mean did you actually get any data back from the [SMB], it be interesting if there was a PFS benefit I know there weren't a lot of higher heregulin patient but if there were some I assume did you see a benefit in that small group on PFS?

[Bob Mulroy:]

So one is we're still analyzing the full data from the study and I think the second thing is that there are so few patients that enrolled in the lines and I don't think there would really be any meaningful data. I think that is really the headline from this study which is again the disappointment that not that we've got a small end it's really the heregulin levels were both much lower than we expected in general and even those patients who seem to cross the line were basically on the threshold. So it was just not I guess the question of prevalence but just overall heregulin levels were just much lower than we or prior research or our advisors expected. So I don’t think that there will be the opportunity to get a readout on 111. That being said there will be an opportunity to look at the overall heregulin levels across all the control and understand if there is any valuable data in that that supports what we have seen with 121 about ErbB3 activity or its prognostic value. We will look at all that data, as a dataset but the clear data at this point basically says this is not an indication with patients who are suitable for treatment with 111.

[Yigal Nochomovitz:]

And then just real fast. Just going back to 398 -- at the analyst day, you outlined the strategy for the [indiscernible] Phase II to lead into the Phase III and the pancreatic front-line settings. And then actually you mentioned some specific regimens there that you might be looking at to combine with 398 and 5-FU/Leucovorin. Can you provide any kind of update as to whether you refined that list or the list that you discussed then is what you're going with that would include [indiscernible] and maybe a few other ones. Thanks.

[Bob Mulroy:]

So we have Peter Laivins our Head of Development to touch on that.

[Peter Laivins:]

Hi thanks very much for the question. Yes we are continuing to look at that, and we have multiple combinations that are being evaluated and the design we believe we permitted to maximize the number of different combinations that we could look at, at that time. So that helps us really make great use of that initial phase of that program.

[Operator:]

[Operator Instructions]. Our next question comes from the line of Eric Schmidt with Cowen and Company. Your line is open.

[Eric Schmidt:]

Good morning, thanks for taking my questions. Maybe Bob first on and then 121, I think you have been a little bit more specific on this call about saying you are not going to start the breast cancer potential pivotal studies until you find a partner. Anything we should be reading into on that comment?

[Bob Mulroy:]

No, I think the breast cancer studies are just outside of our existing resources right now. And we need to support those resources and I think from the perspective of 121 we are able to launch and execute on the lung cancer study which we are excited about, and we wanted to get that underway based on the data we have given the -- just the size of the breast cancer studies in that program, we just need the financial support to pursue those indications. So I think we have stated that previously but we are just reinforcing that today.

[Eric Schmidt:]

And then Bill on the guidance for 2015, I think you mentioned that it includes about $59 million in revenue from your partners. Can you be a little bit more granular about what contributions are associated with that revenue, what milestones and any timing you can provide?

[Bill Sullivan:]

Sure Eric, so one thing to keep in mind is that the revenue we are recognizing is there is timing differences between that and the cash we collect. Focusing on the revenue we are using an accounting model in which we are using a service base proportional performance revenue recognition model and under that model we are expecting to recognize about 59 million in revenue next year. That's completely separated for the most part from the cash inflows that I have mentioned. We are expecting net cash inflows this coming year of 66.5 million. And then really what happens is the timing difference between when we receive cash when we recognize revenue. So I think we are really focusing on the cash number.

[Eric Schmidt:]

I think that’s right, what’s implied in the cash guidance for milestones.

[Bill Sullivan:]

Net inflows from Baxter less with PharmaEngine is 66.5 million, and that’s included in our cash runway guidance.

[Eric Schmidt:]

Is that all associated with this specific milestone such as filing Ex-U.S. or timing of that or any -- again more granularity you can provide?

[Bill Sullivan:]

It’s just associated with moving MM-398 through future development.

[Eric Schmidt:]

So you can’t be more specific?

[Bill Sullivan:]

Correct.

[Eric Schmidt:]

Can you say whether Baxter intends to file in any Ex-U.S. countries this year?

[Bob Mulroy:]

Eric this is Bob. So Baxter has publically stated that their intent is to initiate their filing process in Ex-U.S. markets, but has not provided any more specific guidance than that at this point but that they will be starting that process. And I think to your question the milestones we expect to receive this year are mix of those that are for continued development of 398 and those that are for regulatory process of 398. So -- but we can’t be more specific about where the dollars [indiscernible].

[Operator:]

Our next question comes from line of Jonathan Aschoff with Brean Capital. Your line is open.

[Jonathan Aschoff:]

Bob unless you said all you can about the 121 potential partnership to Eric before, is there anything else you can help us with more in terms of how the talks have been evolving over the few months. Is there any kind of granularity we can get on that?

[Bob Mulroy:]

I think the short answer is, no. I mean I think the key on business development is that there is a significant interest in the program. I think from a global point of view we've got three studies that had a pre-hypothesis that heregulin would identify patients who were not going to respond to Standard of Care. The data validated that finding and provides the evidence that 121 could correct that resistance. And looking at a patient population that's between 30 to 50% of three very large indications, that indication from the research that we have done that this spans all the solid tumor space. So there is significant interest in the data set, there is significant interest in the indication of the program. It'd be really the industry's first drug to treat resistance in a major way and that would provide a really sort of first in class advantage and in addition to that we really the first mover in this space. So it's very attractive we have had a lot of interest in the program I think we're working through the process of getting the program lined up with hopefully the right partner and the right program and we look forward to discussing it with you in the future.

[Jonathan Aschoff:]

Would it be fair to ask for the number of people on the other side of the table has evolved over the last few months?

[Bob Mulroy:]

We can't be specific about any of those conversations and I think as we did in the 398 process we will have to discuss a little bit more of the global specifics when it's over but as we go through the process we are not comfortable revealing any more detail about that.

[Operator:]

And our next question comes from the line of Anupam Rama with JPMorgan. Your line is open.

[Eric Joseph:]

Hi guys this is Eric Joseph in for Anupam. I just had a couple of questions about the frontline pancreatic trials. First with 398 -- I know that you’ve been a little hesitant to provide more detail, but I know that in the past you talked about looking at it and looking at 398 [quite a few] background in combination with [investments] just wondering if you could kind of maybe discuss what some of the combinations regimens might be and whether you can also maybe give us an idea on the size of the Phase 2 study you are going to look at to get a good idea on activity and whether also [general] vaccine will be looked at as a comparator arm in this Phase 2 portion of that study? Thanks.

[Peter Laivins:]

Hi yes its Peter Laivins, thanks again. I think with the -- as we -- to reiterate what we discussed at the Analyst Meeting we basically were looking at a strategy that engages the multiple combinations including some of the component drugs that you talked about and with a design that permits us to flexibly evaluate as many of those potential combinations as possible and then move quickly to advance those into registration trials, so that's pretty much the detail we can give you on it. We'll try and be flexible and fast in our approach.

[Eric Joseph:]

Okay. Any greater granularity around timing of when those -- when the front line trial with 398 or with 141 might begin in 2015?

[Unidentified Company Representative:]

So I think with 141 we've said that we plan to get that launched in the first half of this year. We haven't provided any more specific guidance in 2015 for the frontline program for 398 but we [certainly] will update that in the not too distant future.

[Operator:]

And we are now done with the question and answer portion of today’s conference. I'd like to turn the call back over to management for closing remark.

[Geoff Grande:]

Great, well thank you everyone for joining us. We look forward to updating you again next quarter.

[Operator:]

Ladies and gentlemen thank you for participating in today’s conference. This does conclude the program and you may all disconnect. Everyone have a good day.