Jack Henneman - CFO Charles Link - Chairman, CEO, & CSO Nicholas Vahanian - President & CMO.

Stephen Willey - Stifel Peter Lawson - Mizuho Securities Biren Amin - Jefferies Kenan Turnacioglu - PointState Capital Mara Goldstein - Cantor.

Good day, ladies and gentlemen, and welcome to the NewLink Genetics Second Quarter 2015 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions]. As a reminder, this call will be recorded.

I would now like to introduce your host for today's conference Mr. Jack Henneman, Chief Financial Officer of NewLink Genetics. Please go ahead..

Thank you. Good morning and thank you for joining Dr. Charles Link, Chairman, Chief Executive Officer, Chief Scientific Officer; Dr. Nicholas Vahanian, President and Chief Medical Officer; and me; for the NewLink Genetics second quarter 2015 financial conference call.

Earlier this morning, we issued two press releases announcing our financial results for the quarter and some clinical trial results. Certain statements made during this call are forward-looking and actual results might differ materially from those projected in any forward-looking statements.

Additional information concerning factors that could cause actual results to differ is contained in our periodic reports filed with the SEC. Forward-looking statements are made only as of the date hereof and the company undertakes no obligation to update or revise the forward-looking statements. I will now turn the call over to Dr. Link..

Thank you, Jack. Thank you for joining us today to discuss our second quarter results and progress in our clinical and business development programs.

In pursuit of bringing better treatment options to patients with cancer, we have developed two complementary immuno-oncology platforms, HyperAcute Immunotherapy technology, which features a whole cell vaccine approach to cancer immunotherapy, and IDO pathway inhibitors which focus on disrupting mechanisms by which tumors evade the immune system.

At our first ever Analyst Day, held on July 14, in New York City, our management team outlined and detailed our clinical programs and our vision to develop products in these two platforms either alone or in combination. A webcast of the company's presentation can be found on the Investor Relations page of our website. Today, Dr.

Vahanian and I will review our corporate accomplishments for the quarter, and provide an update on our proprietary, late-stage clinical trial in the HyperAcute immunotherapy, IDO pathway inhibitor programs. Finally, Jack, will provide an operational and financial update.

Our primary focus continues to be bringing our seven clinical candidates from our two immuno-oncology platforms through clinical development and to patients.

We are excited about the potential for algenpantucel-L, to be the first product on the market with an FDA approved indication for the adjuvant treatment of patients with surgically resected pancreatic cancer.

We continue to hire talented people in key areas to support activities required by manufacturing, clinical development, regulatory filing, and commercialization of algenpantucel-L. NewLink Genetics now employs more than 180 people across Ames, Iowa, Austin, Texas, and Devens, Massachusetts offices.

Our other immune-oncology clinical candidates are also advancing. Our collaboration efforts with Genentech are moving forward well with our chemistry co-development teams working on developing additional IDO and IDO/TDO inhibitors and our clinical development teams are engaged in production.

Nick, will discuss the expanding clinical trials for GDC-0919 in a minute. In addition, we continue to work with Merck, with whom we have partnered since November 2014, and other governmental agencies to develop an Ebola vaccine candidate. That vaccine was originally developed by the Public Health Agency of Canada.

I'm sure many of you have seen by now the good news out this morning regarding our Ebola vaccine. They have been released by the consortium and Merck regarding this as well as our own and interim data on our Ebola vaccine that was published by The Lancet this morning -- or in The Lancet this morning.

We are pleased to play an important role in the global health crisis of Ebola and believe this advancement is an important potential validation of our vaccine expertise. NewLink appreciates the tremendous support for the studies from many collaboration partners, including Merck, the Government of Canada, U.S.

Department of Health and Human Services which include the Centre for Disease Control, the National Institute of Health, and the Biomedical Advanced Research and Development Authority. Especially the U.S.

Department of Defense which provided funding for the development to manufacturers of vaccine that was used in the current clinical trial that was reported this morning.

The World Health Organization and many other organizations have stepped forward in the crisis to support the development of this vaccine in this study and other clinical studies in Africa.

We hope that the interim data published today may contribute to the successful registration of our vaccine candidate which might be able to play an important role in diminishing the threat of Ebola but a lot more work still needs to be done.

Because of the Ebola crisis, a large team was assembled, which includes scientists, physicians, epidemiologists, and other experts from the World Health Organization, Norway, Canada, Guinea, Doctors without Borders, Universities of Florida, Maryland and Bern, the London School of Hygiene & Tropical Medicine.

Funding for the trial came from the Wellcome Trust, Norway, Canada, World Health Organization, Doctors without Borders, NewLink Genetics, and Merck. NewLink Genetics and Merck one of the world's leading vaccine and pharmaceutical companies provided the vaccine.

Scientists from NewLink Genetics and Merck also gave detailed technical support on the vaccine and its administration to field staff.

The international partnership's statement can be found in a joint announcement of the Wellcome Trust, the London School of Hygiene & Tropical Medicine, the Norwegian Institute of Public Health, Doctors without Borders, the Public Health Agency of Canada, the Lancet, and Ministère of l'Hygiène Publique de Guinée. Now, I would turn the call over to Dr.

Vahanian to provide more details about our clinical programs..

Thank you, Chuck. We continue to believe that our HyperAcute immunotherapy program has the potential to improve treatment options across multiple cancer indications.

Our most advanced program, algenpantucel-L, currently is being studied in two Phase 3 trials, IMPRESS for the adjuvant treatment of patients with resected pancreatic cancer; and PILLAR, for patients with locally advanced or borderline resectable pancreatic cancer.

The company has announced that at the time of the second interim analysis, the estimated blended median overall survival in the trial from the time of the randomization was 28.5 months for all patients. Median time from surgery to randomization was approximately 1.5 months.

Therefore, median survival from surgery was estimated to be approximately 30 months for all patients in our study. We believe that the median months for overall survival from randomization in the control arm is in the low 20s. The trial remains under SPA with the FDA and has open drug and fast track status.

The initial data had given us confidence to extend our manufacturing capabilities and to proceed with our commercialization plans for algenpantucel-L. Our expectations for the PILLAR trial remain unchanged.

We anticipate that the trial will be fully enrolled during the second half of 2015 and we will provide an update on the timing of preliminary results, as we have additional insight into events, rates, and completion of enrollment.

Our HyperAcute candidate for non-small cell lung cancer, Tergenpumatucel-L is being tested in a randomized Phase 2b study in patients with advanced non-small cell lung cancer. It remains open syndrome.

Additionally, we are initiating a second Tergenpumatucel-L trail evaluating the combination of this HyperAcute Immunotherapy with our IDO pathway checkpoint inhibitor, Indoximod, and chemotherapy potrations with advanced non-small cell lung cancer.

We are particularly pleased about this trial and will use a treatment option that combines for the first time our HyperAcute Immunotherapy and IDO inhibitor platforms to move forward our vision of using combination therapies to treat patients with cancer. We expect to enroll patients in this trial during 2015.

We also have other Phase 1 and Phase 2 trials open up trials of product using HyperAcute Immunotherapy platform, including currently enrolling studies where patients with melanoma and renal cell cancer. We will provide updates on these studies as they progress.

On the IDO pathway inhibitor front, we continue to make progress in our studies of our proprietary compound Indoximod across multiple cancer indications. There are four ongoing Indoximod studies that we expect to complete enrollment within the next 12 to 15 months.

First one of these is NLG2101, our global randomized Phase 3 trial testing Indoximod in combination with docetaxel or paclitaxel in patients with metastatic breast cancer with full enrollment expected by the end of 2015. We expect to present pulmonary data at a medical meeting later in 2015. This is a largest randomized trial in Indoximod today.

Next, is NLG2102, a Phase 2 trial testing Indoximod in combination with temozolomide in patients with progressive or refractory glioblastoma. We presented the results from the Phase 1b portion at a post representation during the American Society of Clinical Oncology Meeting on June 1.

The results showed that the combination was well tolerated with preliminary evidence of efficacy. We are enrolling the Phase 2 portion of the trial. Then, there is NLG2103, a Phase 2 trial testing Indoximod in combination with the checkpoint inhibitors ipilimumab, nivolumab, or temozolomide, in patients with advanced melanoma.

We expect to report top-line results from the Phase 1b portion at the Cancer Poster Session of ESMO/ECC meeting in Vienna on Saturday, September 26. And finally, NLG2104 is a Phase 1b2 trial testing Indoximod in combination with gemcitabine plus vaccine in patients with metastatic pancreatic cancer. Top-line Phase 1b results are expected in 2016.

NewLink Genetics has also entered into an exclusive worldwide license and collaboration agreement with Genentech, a member of the Roche Group, for the development of the IDO inhibitor GDC-0919.

Based on pre-clinical data presented at ASCO by our partner, GDC-0919 demonstrated decreases in plasma kynurenine levels and regulatory T-cells as well as anti-tumor efficacy when combined with anti-PD-L1 and anti-CTLA4.

This product candidate is currently in Phase 1 clinical development in patients with advanced solid tumors, and Phase 1 data on GDC-0919 is expected to be presented in at the ESMO/ECC meeting in Vienna on Sunday, September 27.

In addition, a Phase 1 clinical trial, with a planned enrollment targeting 224 patients, will study GDC-0919 in combination with Genentech's PD-L1 inhibitor MPDL3280A for patients with locally advanced or metastatic solid tumors. An additional study is planned for GDC-0919 in combination with an OX40 inhibitor.

Now, I will turn the call over to Jack, for a brief discussion of our financial results and expectations for the coming year.

Jack?.

Thank you, Nick. Before we move to the Q&A, I want to provide a quick overview of key financials this quarter. We finished the quarter with $207.6 million in cash and equivalents, compared to $202.8 million at the end of 2014.

Research and development expenses in the second quarter of 2015 were $16.1 million compared to $6.5 million during the comparable period in 2014.

The increase is primarily due to increases in clinical trial expenses related to NewLink's broad pipeline product candidates as well as expenses for manufacturing and research related to the Ebola vaccine candidate. Most of the Ebola related expenses are subject to reimbursement under government contracts.

NewLink Genetics reported a net loss of $14.1 million or $0.49 per diluted share for the second quarter of 2015, compared to a net loss of $9.2 million or $0.33 per diluted share for the comparable period in 2014. We are currently expecting to end the year with more than $160 million in cash and equivalents.

And now, I will turn the call over to the operator for questions..

Thank you. [Operator Instructions]. And our first question comes from Stephen Willey with Stifel. Your line is now open..

May be just an Ebola question, first I guess. Just kind of curious if you guys can maybe outline what some of the next steps are here.

I understand that there is a couple of additional studies that are ongoing and then I guess may be when might we find out, kind of what the longer-term economic path forward here may be, in terms of what NewLink may be entitled to in terms of any kind of distribution agreements that Merck may secure with various governmental entities?.

Thanks for the question, Steve. I think that this study would be one component; a whole series of studies that deal with the safety immunogenicity and efficacy of the vaccine. So it's one component.

There are a series of contracts that we've been working on with Merck and there is a deep development plan that's underway with Merck that really focuses on getting the most complete dataset that we can on the safety immunogenicity and this efficacy trial data complements that. I think that there is still a lot of work to be done.

And the Merck collaboration has been going very well. They've been an excellent partner in developing and working on this. It will probably be quite some time before we provide much financial guidance as to what the financial results might be at this.

We are really focused on doing everything we can to contribute and help in any material way that we can for the crisis in Africa, and that is really our sole focus. And those other things will follow.

We are obviously very grateful to the wide number of collaborators who participate in this project, basically all around the world; many of which I listed on the -- I think all of which I listed on the call.

And so, it's really been a remarkable thing to see so many different people from so many different parts of the world work together and pull in the right direction and really an unprecedented way to get as far as we have with the project, but there's still a lot of work to do.

We are very pleased with the terrific performance at Merck with many of our collaborators; Department of Defense has been particularly helpful for us in funding the vaccine supply that was actually used here in the clinical trial in Guinea. And so, it's a significant step forward, I think today, but it's one of many steps we will need to accomplish..

Okay. And may be just to clarify I believe in other BARDA contracts and I’m not sure this is actually falls under the jurisdiction of BARDA. But I know that stockpiling decisions don't necessarily hinge upon any kind of formal FDA approval.

So would you expect that to potentially be the case here as well?.

Yes, I really wouldn't want to speculate the answer to that question. I think that these large government agencies have very thoughtful groups of people; we've had now a longstanding relationship with BARDA, we're doing very strong collaborative work with the BARDA teams.

The Merck team, the NewLink team, are also working with BARDA to plan additional future studies or potential work that has to be done to move the vaccine forward and it's really not my place to sort of speculate what some large government agency may or may not do..

Fair enough.

And then may be just one question with respect to the upcoming ESMO presentations, the Phase 1b Indoximod ipi combo that's going to be the dose escalation portion of that study, correct?.

Yes..

Is there any kind of commentary that you can provide just with respect to patient numbers and I guess whether or not you've seen the same phenomena that we saw I think with the Incyte compound when combined with ipi whereby the single-dose data kind of proved to be relatively obsolete once combined with an immunotherapeutic agent..

Sure. Hi, Steve, thanks for the question. As you know, we've been quite excited with our Indoximod IDO pathway inhibitor molecule bringing to clinic, and in particular, combining with vaccines, as I referred during my discussion. And one of those trials was also with another checkpoint inhibitor in this case, ipilimumab.

We are very excited about this combination going forward. But to stick with the scientific, as you know, with the rules and regulations of these meetings, I'm going to stick with reserving the data to the meeting itself, but we are excited about the combination..

Thank you. Our next question comes from Peter Lawson with Mizuho Securities. Your line is now open..

Good morning, Peter..

Good morning, and congrats on the results from the Ebola trial. Could you remind us about the commercialization royalty structure and the cost in that part of the business, how they're going to change in the next year or so.

And then, any additional benefits do you think you get from developing that vaccine either for other infectious diseases or the cancer vaccine that would be great. Thank you..

Yes, as I said previously that our primary focus has been to develop the vaccine and support the development of the vaccine for answering the call to try to help in the crisis in Africa, and so that's where these large international consortiums have been working together sort of fast and furious towards those goals.

I think that beyond the current crisis the agreements that we have with Merck when you license the vaccine to them we've been working very closely with Merck.

Merck is responsible for the research, development, and manufacturing the vaccine, and we have coordination groups that work virtually every day with them on all aspects of this and that includes involvement in the Department of Defense and border contracts.

The agreement contemplates that in the future there is a significant royalty to NewLink that occurs sort of in environments outside of Africa and the third world.

So it's not our intention to make any significant or any all I guess is the best way to say it, profit in the third world, and we're focused on the crisis, and the other things will follow down the line should they materialize..

Thank you.

And then just the data at ESMO, I'm just wondering if you could frame it up in the terms of the matrix that we essentially see for the two presentations and response rates et cetera?.

You're referring to the --.

ESMO trial..

ESMO trial for the Indoximod plus ipi..

Yes, yes exactly..

Yes, it's a Phase 1b study primarily safety and dose escalation as I responded to Steve earlier. I will wait -- we will wait for the actual presentation to release more data to stick with the rules and regulation of the conference itself that we can go within any more detail of the data itself..

But we would see kind of initial response rates?.

It's a Phase 1b -- it's a Phase 1 study dose escalation primarily safety study..

Thank you. [Operator Instructions]. Our next question comes from Biren Amin with Jefferies. Your line is open..

Thanks for taking my question. Maybe question on Ebola, there is a Wall Street Journal article this morning that has a statement saying that U.S. FDA had some critical commentary on this trial in particular, there were some protocol changes to the study.

Can you maybe just elaborate on that?.

I really can't comment on anything that regulatory authorities either in United States or overseas are going to say about this as any comments related to those sorts of things would really be Merck as the head of the consortium -- development consortium to respond to.

I think that, I would characterize that there is a whole series of studies there are, some of which are done, some of which are being executed, but there will be an ongoing series of studies to try to study further characterize the safety and immunogenicity the potential efficacy of the vaccine.

So I think that this piece of data from this preliminary trial results are one sort of plank and sort of building that deck, if you will..

Got it, okay. And then maybe I had some questions on the IMPRESS.

I note that you continue to reiterate expectations for overall survival and control on in the low-20s, what I guess continues to give you confidence in that statement?.

I think that we have assessed a lot of the literature as you have.

And the large study RTOG-9704 as far as you are aware that was published few years back showed median overall survival in post resected pancreatic cancer in the United States of a little over 19 months and that figure was also supported by retrospective analysis that was done in large series of patients over the last three decades with the John Hopkins study which I know you're familiar with.

We do think that the impact of Abraxane's approval in the setting of metastatic patients in the more expanded use of FOLFIRINOX in metastatic patients is going to have an impact. We don't know what the level of that impact will be since we're blinded completely to which arm of the study is performing in what manner.

We really can't speculate with certainty about what we and how we think the consortium will perform other than looking to the literature for how those patients have performed in the United States over the years that have gone on..

And does the company have an update with regards to when it expects final events to reach?.

No, what we said at our Investor Day two weeks ago we would reiterate today which is as we follow the data through this year we will try to make better estimate at some point down the line to give the market some idea of when that's going to happen. But our current statement is we believe that it will occur in 2016..

Got it. And then may be a last question on Indoximod.

What was the rationale to combining with TMZ versus may be combining with a vast and refractory relapse GPM?.

Again in our -- hi Brien, good morning. Our initial rationale for GPM which continues to be supported based on the data of chemo combination of Indoximod there is a lot of pre-clinical data that we produced would be very scientifically very rationale to combine it for the best effect.

So you keep temozolomide being the only chemo treatment in that setting we thought it would be the best result, and so for limited number, but having temozolomide refractory patients in combination with Indoximod with a late response showing objective partial response was a quite impressive in the Phase 1 albeit it's a limited data we think it's a right path to follow based on our initial scientific rationale now..

Okay. And may be just a last question on GPM.

I noticed there is a pre-clinical study that was recently published with Indoximod in combination with PD-1 and CTLA4, is that a combination that you might evaluate?.

Absolutely, checkpoint inhibitor is in combination with Indoximod, Indoximod with our vaccines and other vaccines, and Indoximod with chemotherapy is we believe scientific rationale is behind it and we will -- our efforts will go forward in clinical trials to prove those hypothesis yes..

Thank you. We have a follow-up question from Peter Lawson with Mizuho Securities. Your line is open..

Just on cash.

How long a runway do you have?.

Well we haven't given guidance beyond the end of this year. As we've said, we expect cash in excess of $160 million at the end of this year. I think you also know that while this company is certainly as a higher expense level today than it did a year ago, we've been very careful over the years.

We actually have more cash on our balance sheet today than all the equity that we've raised since the beginning of time. So in that sense, I think we're quite well financed, I think we're well financed compared to other companies. So we have a good runway. We also have an awful lot going on as you've seen.

So we are balancing our ambitions, if you will, for all this clinical work with our seven immuno-oncology candidates with our continuing desire to use our capital efficiently..

Great, thank you. And then, Nick, just on the thoughts around the combination trials for HyperAcute Indoximod, I mean, you've got a lot of options there.

Just wonder how you navigate through that and how you're thinking through the selection of molecules in particular trials?.

Sure. First, having the HyperAcute platform in-house and having access to Indoximod, one of the first things that we're going forward with, as you know, we will enroll patients in 2015 Tergenpumatucel plus Indoximod plus docetaxel trial as I mentioned earlier.

So that was the low hanging fruit from our perspective to prove that hypothesis in that combination.

As we mentioned in our Analyst Day couple of weeks ago as well, which was we are in active discussions with other combination trials because again scientific rationale for all these combinations are there but clinical data should convince for the -- after the exploratory combinations to go which direction.

And I believe in different clinical settings depending on stage of the disease or the particular malignancy different combinations will make more sense but more data is need and that's we're going to find out in different clinical trials maybe PD-L1 or PD-1 or CTLA4. All these combinations are considered as we go forward..

Yes. I think as Biren just mentioned the preclinical data in particular our CTLA4 blockade in blocking the PD-1 pathway show remarkable synergy in preclinical model. So they're obviously strong candidates.

I think people underestimate significantly the fact that IDO blockade for sure can be synergistically a number of different types of chemotherapy agents, there was a really nice Nature Medicine paper that was originally published George Prendergast and his group showing that in a number of observations by David Munn and his group with Andrew Mellor showing very nice synergies between chemotherapy blockade and the IDO pathway blockade.

So we think all of those are very rationale. We try to get as much preclinical data as we can to make rational decisions and then figure out subsets of patient that really are approachable in the clinic to realistically execute the studies..

Thank you. Our next question comes from Kenan Turnacioglu from PointState Capital. Your line is open..

Listen, as it sounds like the Ebola vaccine is not going to be moving the needle on the revenue line anytime soon. But just as a shareholder and I'd just as a human I'm very impressed with the amount of advancement you guys have done being such a small company and potentially really changing lives.

Let's see what happens, but it's an important first step. So I want to just lead off by saying congratulations. It's pretty amazing..

Thank you, Kenan..

Thank you, Kenan..

Then on PILLAR, what can you talk a little bit about how many patients would fit into that as a percentage of pancreatic patients into that description of borderline resectable and give us a sense of when that might report out?.

Sure. Thank you, Kenan. I'll pronounce your name a little bit, Kenan Turnacioglu. With my background I --.

It was a brace effort. It was a brave effort..

Yes, brave effort. I think I'm entitled to live with my background. Thanks for the questions, Kenan. PILLAR trial, as you know, is our expansion of Algenpantucel program. We're quite excited.

The initial efforts to this trial actually came from a lot of principal investigators in our Phase 3 trial, and then later on in Phase 3 to more forward with this trial because of some of the observations that was made and potential chemo-sensitization of Algenpantucel. That trial was 280 -- up to 280 patients trial was enrolling very nicely.

As we said, we believe enrolment will be completed 2015. When you look at the literature and there is no clear data, NewLink team as we're building our commercial team in Austin, one of our efforts being in fact being spent on the market and market size in resected pancreatic cancer, locally advanced metastatic understanding these better.

Best available data, historical references has been about 15% to 20% of these patients are resected, about 20% to 30% are locally advanced, and the remaining being in the metastatic setting.

However, those numbers are dynamic; they're changing, because there are more patients who are borderline resectable patients, now are being through new adjuvant treatment going into more the resected population. Those are even higher risk patients.

So numbers between locally advanced, borderline unresectable patients not going into resectable population, that number is changing. We believe today between resectable patients and borderline and locally advanced patients the numbers is around 40% to 50%, if you combine both of those populations to go into which one more data is needed.

And treatments like Algenpantucel will in fact affect if we prove that our Phase 3 trial is an effective treatment more patients, more higher risk patients will probably go into surgery from the border-line unresectable patients now..

I guess is there anything coming longer-term, so a long-term question but companies like Luminar talk a lot about liquid biopsies or a blood marker that would help earlier detection of pancreatic cancers and may be reduce the amount of metastatic and increase their pool of locally advanced in resectable?.

I think that's really important question, Kenan. I think these new technologies or earlier diagnosis in detecting not just pancreatic cancer, but any cancer in a much smaller disease state, I think are going to eventually be breakthroughs in helping increase to cure number of disease.

I think that if you look at -- well, if we think about the pancreatic cancer was resected and given what we've learned about immunobiology where there are so many overlapping checkpoint molecules that are blocking the immuno and destroying the tumors, the smaller the tumors are the less checkpoint defense they have, and they tend -- smaller tumors tend to have less time involved.

As you know a lot of these solid malignancies may be in the body for 5, 10, 15 years prior to diagnosis. The key of course is sensitivity and specificity in cost effectiveness of mass screening. But I do believe that as these sort of types of markers continue to evolve that they're going to be huge important part of clinical care.

Most of them however are still early and up to development and nobody really knows how you use them in a broader screening. So we're, now if you look at the enrolment of the patients in the IMPRESS trial 70% of the patients being node positive in the last national U.S. trial being 68% node positive.

That the change or impact of those types of markers are not reflected in our trail because they're simply not being used in any broad scale clinically yet. But I do think its coming. I do think that you're right in thinking about that's going to be an important part in future..

Thank you. Our next question comes from Mara Goldstein with Cantor. Your line is open..

I apologize if you've covered this already. I signed on a bit late. But with respect to Ebola we're obviously seeing some early data, which is great.

But can you characterize sort of how data may come out from this particular series of trial, like what would be the next kind of data point we could see?.

Hey Mara. Good morning..

Hi, Charles..

I'm good. How are you? I think that the current environment in Africa is that the rate of Ebola has been dropping dramatically because of the terrific work by the people on the ground in the public health agencies of those countries; I'm sure with organizations like Doctors without Borders, by the World Health Organization.

And the vast majority of the outbreak has already evaded by these public health efforts, which are really unprecedented for an outbreak of this scope in magnitude.

Because of that, the number of additional patients overtime that will be available in that case either doing vaccination studies or other randomized efficacy studies and the current outbreak are quite limited as noted by both Dr. Douchy [ph] had provided today from the NIH on this exact issue.

So I think that there is a limited ability in the current crisis to continue to generate new and expanded efficacy data. The study this morning, I think does show evidence, potential evidence with efficacy as a vaccine, it's a important study.

I think that we will have to see and there will have to be a lot of discussion about the relative weight of this data with the relative weight of lot of the other immunogenicity data and safety data that's being generated on a number of different trials.

As you know the original Phase 1 trials were published in internal medicines a few weeks back both from the European and WHO consortium from the U.S.-based consortium, Department of Defense, and National Institute of Health.

So there is a whole series of studies that are ongoing and are rolling hundreds and hundreds of patients looking at immunogenicity and toxicity and getting a better feel for dosing. As you change and evolve, your CMC standards in manufacturing there is obviously potential confirming studies that have to be done.

So this study is part of a very large, broad effort and series of studies that are being developed, try to move the vaccine forward to its ability to be licensed at some point. That's probably the best answer I can give you right now..

Thank you. I'm showing no further questions at this time. I would now like to turn the call back over to Dr. Charles Link for any closing remarks..

All right. Thank you everyone for joining us on this call this morning. Thanks again to all the international collaborators and encouraging news on the Ebola vaccine this morning. We are making really good progress we believe in our cancer oncology, immuno-oncology programs.

You can see there's a huge number of clinical trials within our pipeline and hopefully there will be sort of a continuous flow of data from a lot of those projects. Everybody have great day..

Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program. You may all disconnect. Everyone have a great day..