Jack Henneman - Chief Financial Officer Charles Link - Chairman, Chief Executive Officer and Chief Scientific Officer Nicholas Vahanian - President and Chief Medical Officer.

Mara Goldstein - Cantor Fitzgerald Peter Lawson - SunTrust Stephen Willey - Stifel Biren Amin - Jefferies Eric Criscuolo - Mizuho Securities.

Good day, ladies and gentlemen, and welcome to the NewLink Genetics Corporation Fourth 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 conference is being recorded.

I would now like to introduce your host for today's conference Mr. Jack Henneman, Chief Financial Officer. Sir, you may begin..

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

Earlier this morning, we issued a press release announcing financial and operational results and outlining business priorities for 2016 to support the development of the Immuno-Oncology pipeline. Dr. Link will discuss key takeaways from 2015 and business priorities for 2016. Dr.

Vahanian will highlight 2015 and 2016 clinical programs and I will wrap up with the fourth quarter and year end 2015 financial results. Certain statements made during this call are forward-looking statements under U.S. Federal Security Laws.

These statements are subject to risks and uncertainties that could cause actual results to differ materially from the experience or present expectation. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports filed with the SEC.

Forward-looking statements made during this call speak only as of the date hereof and the company undertakes no obligation to update or revise the forward-looking statements.

Information presented on this call is contained in the earnings release we issued this morning and in our Form 8-K dated February 29, 2016 which may be accessed from the Investors page of this company website. I will now turn the call over to Chuck..

Thank you, Jack. Thank you all for joining us today to discuss our fourth quarter and year end 2015 results. We had an exceptional year during which we made significant progress in our clinical and pre-commercial programs.

With this progress, we are now closer to facilitating our mission of bringing patients with cancer better treatment option from our two immuno-oncology platforms. During the past year, we achieved clinical milestones across our pipeline and made investments in building commercial and manufacturing infrastructure.

NewLink Genetics primarily is focused on advancing immuno-oncology therapy. We have two complementary immuno-oncology platforms, HyperAcute Cellular Immunotherapy, which feature a whole cell immune activation approach the cancer; and IDO pathway inhibitors, which disrupt the mechanisms by which tumors evade the immune system.

Our vision in the immerging consensus in the immune-oncology world is that immune based combination therapy will become the new standard of care. We are well positioned to execute our vision by combining cellular immunotherapy and checkpoint inhibitors proprietary work partner.

With seven product candidates in clinical development from Phase I to Phase III, our pipeline addresses multiple cancer types including pancreatic, non-small cell lung, kidney, breast and brain cancer as well as melanoma.

I will now recap the key accomplishments from 2015 and outline our business priorities for 2016 then Nick will provide an update of our clinical programs including the two Phase III trials for patients with pancreatic cancer. Lastly, Jack will provide an operational and financial update.

The IMPRESS and PILLAR Phase III trials of algenpantucel-L for patients with pancreatic cancer are progressing according to plan. We remain on track to report top line results from the IMPRESS trial this year. We reported the completion of enrollment in the PILLAR trial in December 2015.

Patient enrollment continues to progress across Phase I and Phase II trials for additional HyperAcute Cellular Immunotherapy in advanced melanoma, non-small cell lung cancer and kidney cancer. We will provide updates on these trials in 2016 as they advance.

NewLink Genetics has made great progress in 2015 with our two distinct ideal pathway inhibitors in clinical development, Indoximod and GDC-0919 which we partnered with Genentech. The Genentech collaboration continues to be very productive with a strategic focus and the commitment of people.

In mid-2015, the Phase 1b study combining our GDC-0919 with Genentech’s PD-L1 inhibitor atezolizumab, the enrolling patients with advanced solid tumors. In addition, the Genentech collaboration is working toward a pipeline of IDO and TDO inhibitors. In 29015, we doubled our additional chemistry group to support our efforts in this area.

While NewLink Genetics is primarily focused on immuno-oncology, we also have developed a potential vaccine for Ebola which we originally licensed from the Public Health Agency of Canada and then partnered with Merck in 2014.

In 2015, we achieved several key clinical milestones in the development of the rVSV-ZEBOV Ebola vaccine candidate and released interim data showing potential efficacy that was published in the July 2015 issue of The Lancet.

In fact this team has gained considerable experience from our Ebola work and we are now leveraging that experience in our development product for Zika Virus vaccine. Another important development in 2015 is the expansion of our Board of Directors from six to eight members with the appointment of Dr. Nicholas Vahanian and Mr. Paolo Pucci.

Both have built strong carriers in development of cancer therapy and Mr. Pucci brings deep experience in the commercialization of oncology product. Additionally, we promoted Brian Wiley, the Chief Commercial Officer a newly created position. Brian had been with NewLink Genetics for more than three years.

And he has demonstrated both the leadership and the expertise to build our commercial organization. We have recruited top biotech team to support commercial manufacturing and our pre-commercialization efforts related to the algenpantucel-L and the expansion of our clinical trials program.

Now, looking ahead to 2016, one our main priority is to report top line results to algenpantucel-L from the IMPRESS trial. If we meet trial endpoint, we will execute on our regulatory strategy with the FDA continue to build our U.S. commercialization plan as well as explore the partnering strategy outside the U.S.

IMPRESS is the largest corporate sponsored trial, the patients with resected pancreatic cancer fully enrolled today. Pancreatic cancer remains a very difficult clinical problem and we hope to bring out algenpantucel-L to market so that improves the life of patients with pancreatic cancer. We eagerly await the results of IMPRESS.

Another 2016 business priority is the validation of our IDO pathway inhibitor with potential data readouts for Indoximod and GDC-0919. In 2015, we began reporting preliminary safety in evidence with clinical activity across a number solid tumor. We look forward to continued progress in these programs in 2016.

Nick will provide more detail on our IDO pathway inhibitor program. In 2016, we also work to advance our Ebola vaccine candidate partnered with Merck towards regulatory approval. We recently announced our Zika Virus development program which is being led by Dr.

Thomas Monath, Chief Scientific and Operating Officer of our Infectious Disease Group that is based in Devens, Massachusetts. Now, I turn the call over to Nick to update you on our clinical programs including our expectations for data of our IMPRESS Phase III trial and other clinical programs..

Thank you, Chuck. In 2015, we continue to move forward with our HyperAcute cellular immunotherapy, including algenpantucel-L for pancreatic cancer, tergenpumatucel-L for Lung cancer, tergenpumatucel-L for melanoma and HyperAcute Renal.

We are excited that we will report the top line results from the primary analysis of the pivotal registration Phase III IMPRESS study in 2016. We completed enrollments of our pivotal trial studying efficacy of algenpantucel-L for patients with locally advanced pancreatic cancer in December 2015. Total enrollment exceeded 300 patients.

The primary endpoint of this Phase III trial is overall survival. And this study designed additional algenpantucel-L for study of Cellular Immunotherapy regiments for these patients. We expect to report on the timing of the PILLAR study this year.

Additionally, in 2016, we have recently begun enrollment in a triple combination trial of algenpantucel-L, Indoximod and Docetaxel for patients with advanced non-small cell lung cancer.

As for our review [ph], IDO inhibitor, pathway inhibitor program in 2015, we presented preliminary data from our studies in metastatic breast cancer, refractory malignant brain tumors, advanced melanoma, in just last, month metastatic pancreatic cancer.

In these studies, our ideal pathway inhibitor Indoximod chose an exceptional safety profile in evidence of clinical activity of the combined treatment with various chemotherapeutic and immunotherapy agents. In conjunction with our partners at Genentech, Phase I results from GDC-0919 represented ESMO.

The Phase 1b dose-escalation study of GDC-0919 in combination with atezolizumab for patients with advanced solid tumors is underway. We anticipate continued progress in our ideal pathway inhibitor program in 2016.

First, we expected update from our clinical trialed validated addition of Indoximod to Gemcitabine for patients with metastatic pancreatic cancer.

Additionally, we expect opportunity provide an update and preliminary data from our clinical trials evaluating Indoximod in combination with improve the immunotherapy for advanced melanoma as well as Indoximod in combination with chemotherapy for refractory malignant brain tumors.

Our randomized placebo control Phase III trial evaluating Indoximod in combination with chemotherapy for metastatic breast cancer is full enrolled. The endpoint of this trial is event driven, so we expect to be able to provide more guidance as the timing of result before the end of the year.

We also anticipate an update on the progress of GDC-0919 from our partner Genentech. To sum up, in 2016, we anticipate potential value creating milestones in both our HyperAcute Cellular Immunotherapy and our proprietary IDO pathway inhibitor programs.

We are building an extreme commercial oncology team an anticipation of registration and commercialization of algenpantucel-L. If approved, this an oncology product will be the first treatment for patients with resected pancreatic cancer. Now, I’d like to turn the call back to Jack..

Thank you, Nick. Before we move to the Q&A, I want to provide a quick overview of our cash position. We will not review the P&L on detail on the call. Please see the press releases we issued this morning and the 10-K that we will file at the end of the day today. We are well capitalized.

We finished the year with a 198 million in cash and equivalents compared to 203 million at the end of 2014. We have however increased our spending.

We are anticipating and therefore preparing for the success of the IMPRESS trail, the commercial manufacturing of algenpantucel-L, the filing of the BLA and the commercialization of algenpantucel-L in at least the United States.

We’ve also significantly increased our clinical programs, especially with regard to Indoximod and we are building our pipeline of new opportunities in both oncology and infectious disease. We currently have over 200 employees, about 100 of these employees in research and development and one capacity or another and over 40 PhDs and MDs.

Notwithstanding all this progress, our philosophy has been to managed spending it carefully as possible for the period before the readout of top line data from the IMPRESS trial.

The potential for combinations of HyperAcute Cellular Immunotherapy candidates with other cancer treatments including checkpoint inhibitors as well our infectious disease initiative represent exciting future opportunity. We want to have the resources to maximize their potential.

With that in mind, our goal and expectation is to finish 2016 with two years of cash on hand. We expect to provide you with an update once we have reported top line data from the IMPRESS trial. With that we’ll open up to questions..

[Operator Instructions] Our first question comes from the line of Mara Goldstein with Cantor Fitzgerald. Your line is now open..

Hello, thanks very much. So I just have two questions..

Good morning, Mara..

Good morning.

First is really around IMPRESS and I know that this is top of mind for everybody, but I am just wondering if we can try and triangulate a little bit to understand the thought process behind what the timing of the readout for this year might look like?.

So Mara, we are going to sort of stick with that we will announce the top line results in 2016 and we are not going to be providing more specificity at this time. But honestly everybody is working hard in the trial that all 70 sized mixture of capturing data in real time and coming with data as we move forward.

So all we are going to say on that subject matter is that we will be announcing top line results in 2016..

Okay. And then just with respect to this last statement I having, cash two years versus cash runway. Just a point of clarification there, is that an absolute two years with this cash of is that dependent on I am just trying to understand if the readout of IMPRESS goes one way that cash can go last different time.

So if you can just help us to understand from a sort of capital perspective..

Jack, why don’t you answer that question?.

Sure. So historically we’ve given cash guidance and this year we obviously have a major inflection point in the middle of the year. And as you suggest, we will have what we hope as a positive results and end up spending more money or not in which case we will substantially reduce our spending.

So I think we feel that there are two scenarios going forward. In the both case if you will, we’ll grow the company and we will have the opportunity to raise money if need. And in the bare case if you will, we will substantially cut our spending and pivot towards other opportunities that we have as we discussed in the script..

Okay, thank you. I’ll hop in and get back online. Thanks a lot..

Our next question comes from the line of Peter Lawson with SunTrust. Your line is now open..

Hey Nick.

Just talk about the tripe comport trial and it’s mostly - I deeply understand that you accelerated the enrollment or you expect to see enroll faster?.

We started - we recently started the trial and naturally it’s accelerating its enrollments, it’s not -.

Gotcha, thank you.

And then just kind of on IMPRESS, kind of a compete, could we see IMPRESS still you’ve seen or potentially PILLAR, I am just trying to work out the timing of those two?.

Because of the timing of the enrollment in PILLAR, we expect that the IMPRESS results will readout sometime this year. Again we are not predicting what time range that might happen, but the - we still believe that PILLAR readout will occur after that.

Our intention is to get an update of what the pillar timing is during the year, try to just give a little bit of guidance on that study, but since it’s an event driven study and it’s based on overall survival that will obviously take a significant portion of time.

But our current release is regardless how late in the year the IMPRESS trial result we still anticipate that will readout somewhat after that..

Great and then Jack just around the cash flow, I am wondering if you could give us some color around where you seeing R&A and SG&A spend are heading?.

Well, our R&D and SG&A spending as I said, they really both have increased in recent quarter and will continuing to increase at least until the point of IMPRESS data and thereafter if data are positive, it will continue to increase, if not we’ll obviously have to take a real look..

And the guidance of two years of cash to the end of the year?.

That’s the guidance, yes..

Perfect, okay. Thanks so much. I hop back into the queue..

I think it’s important to understand that there are number of potential additional revenue things that may be options for NewLink. Hopefully things related to the Genentech collaboration and some other is relative data support the company financially..

Our next question comes from the line of Stephen Willey with Stifel. Your line is now open..

Good morning, Steve..

Yeah, good morning, guys. Thanks for taking my question. Good morning.

Just I think maybe one of IMPRESS and I guess I am wondering if you guys could provide a little bit of color characterization with respect to kind of where this stand with FDA regarding statistics at this point? And then I guess maybe second to that, you know as we think about you guys issuing a press release here at some points going forward with top line data, I just kind of curious if you’ve kind of crystallize your strategy around what the content of that might look like.

And I mean obviously we should be expecting the log rank analysis correspond, I am guessing you know that the depending the regulatory discussions we could be seeing a couple of additional analysis.

But I guess with respect to other items like mark analysis three year survival, four year survival, I am just kind of curious is to how you guys are thinking about communicating the totality of that date to show a press release? Thanks..

See, we really appreciate the question. We are going to explain everything that was done with the trial at the time that we release the top line results. And as you know and we discussed with regulatory agencies are fairly confidential, so we are really going to make any other commentary regard to that.

Anticipation would be that we would make a press release as a top line result when they become available later this year and then we would anticipate presenting the data at a scientific conference before we actually you know release the content of all the scientific outcome. And that’s sort of the process we’re going to go through..

Okay. And then I guess my thought would be, I guess development to the confidentiality that you just spoke to, so just leave it that. And then Jack, just quick question, I know that there has been some focus on the two year cash run rate guidance by year end.

Does that include or assume any additional milestones are there from both with Genentech or I guess other collaborations that could materialize?.

I think it’s a total assessment of the verity of scenarios that can fright us both in terms us our spending rate, inflection points, opportunities for milestones, we’ve also as you know gone to great trouble of the years and had great success in getting federal financing for some of the work.

So the guidance is really a reflection of all these scenarios and we feel pretty confident on that..

Great, thanks a lot and congrats on a productive year..

Thank you..

Thanks Steve..

Our next question is from the line of Biren Amin with Jefferies. Your line is now open..

Hey guys..

Good morning, Biren..

Hey morning, Chuck. Thanks for taking my questions. Maybe I’ll just start with IMPRESS, I think in the past the company disclose with the integrative survival was in the trial.

Can you update us on that?.

All I can say is that we haven’t done any formal data analysis since the interim in terms of the projected media in overall survival, but our general impressions are certainly that that’s not - that number is not going down, so we don’t have a formal analysis to be able to say more than that..

Okay.

And the on PILLAR, I just want to clarify, can we expect data from that trial this year and can you also maybe just give us some color on how many patients in the trial are administered for FOLFIRINOX versus Gem-abraxane?.

So we’re not releasing any details of that trial yet as we’re beginning to assemble all the demographics in total, so our plan is do an update there on this year to give more guidance as the timing. And we may or may not release the patient characteristic that in that process..

Okay. And then on the triple combo -.

I can say that our experience has been that there is a substantial number of universities and the centers and that’s were stuff that use. FOLFIRINOX is also another substantial number that, with abraxane is a significant variation in which course is used and which age group this patient.

So there is a fair amount of variability which is really why we design the trial and it could be you know whatever therapy was choosing at the university..

Got it.

And then - so when you release the data from that trial or you stratify according to what therapy they received?.

Again - well the patient’s experience to allow us to the time to unfold that next to the update on the trial..

Got it.

And then on the triple combo, is there a controller in this study that you just started?.

Yes.

I am sorry, which one?.

So with the triple combo with Indoximod?.

It’s a single-arm study, Biren..

Okay, great, thank you..

Thanks, Biren..

Our next question comes from the line of Eric Criscuolo with Mizuho. Your line is now open..

Good morning, Eric..

Yeah, good morning.

So just on the commercial build out, I was wondering if you could just comment on where you think you are as far as what inning or percentage of reps that you want to add that are onboard right now?.

What, inning, I am more of a football fan than a baseball fan..

Make it a quarter then that’s fine..

Yeah, yeah, I would say the way I characterize it, the game is progressing nicely in our favor. We’ve done a lot of build out, the essential elements of the pre-commercialization team, team members that are dealing with reimbursement, marketing, logistics. So a number of the key hires are in place there. So that’s going well.

And Brian Wiley now appointed now as Chief Commercial Officer and with the addition Paolo Pucci and Paul Edick already on our board. We have quite a commercialization main trust I would say that really is focused on developing these programs. We are reinventing the wheel there.

We’re using a number of well-established national vendors with expertise in commercial launches to help us with the various aspects of those programs. In addition, on the manufacturing side, we have expanded the manufacturing capability at NewLink in our Ames facility which will really be used as a source of the product at the time of launch.

And secondarily, we have developed a relationship with the contract manufacturer that can supply additional capacity should launch exceed expectations that will be ready.

And one of the goals is to position ourselves that there could be potential for really access programs and certainly recognize that this is a potential lifesaving therapy, should the IMPRESS trial resolves turn favorable later this year.

And so we believe that we are sort of filling, and are very focused on all the elements will be necessary to launch. I do think you have to understand that we’re a young company and so this is the large challenge for us and it’s going to take a lot more work for us to put ourselves into position to be fixed us with this.

This also represent new category of therapy with a new specific method of administration in terms of the way that the whole-cell active immunotherapy is administered.

It’s important to understand that this type of immunotherapy is an active for cell, so we can really consider in active cellular immunotherapy, they requires intact living cells to signal the immune system inside the people and it’s quite different in technology than the vaccine that people are used to thinking about in cancer, they ask you a peptide injection and that sort of thing.

But it really does require signaling from a live cell. I hope that gives you some color..

Thank you for that.

And then just getting back to the IMPRESS and PILLAR studies, are there any scientific rational or thinking that that may indicate or be a reason why HyperAcute could work in one of these settings better than the other setting?.

So it was always our belief when we went after pancreatic cancer initially that one of the key scientific elements in terms of a new defense is the number of overlapping checkpoint blockade pathways that are activated.

And what people are finding other tumor types and certainly in pancreatic cancer as well is that larger tumors have more and varied checkpoint blockage inhibitors being over expressed. And so in general, we would think that larger solid tumors are going to have more immune defense than smaller tumors.

In the post resection setting, you can sort of think that a completely resected at least as determined by a CT scan a month or more after surgery that a completely resected tumors below tumor volume also reflects a method of controlling checkpoint blockage because you are greatly reduce the tumor.

We started the PILLAR trial because a lot of the investigators that were involved in the IMPRESS trail felt that have the impression that this could be an active therapy.

And because of those impressions and their request, we started the PILLAR trial and that’s why the enrollment on the trial went so rapidly as many of the same size that we conducted the IMPRESS trial.

So I personally believe that the film indication when you have a larger bulkier tumor, it going to be a little bit tougher, so the magnitude of benefit might be less than in a situation where you have a minimal disease setting.

Long term, there are number of minimal disease settings where after surgery, you have a significant cancer recurrence and death. In many of those situations, it’s a minority of the total population that has the change of recurrence and death.

I would think of top of my head about resected renal cancer for incidence we’ve been identified high risk subset of patients.

In those studying that may be difficult to use some of the current checkpoint blockade drugs because it would be too expensive or you might have side effect in patients that were otherwise be cured by surgery but because of the favorable toxicity profile of this class of therapeutic meaning the HyperAcute Active Cellular Immunotherapy, we believe that there are number of post-surgical settings where this is a great risk of - a significant risk of tumor occurrence are maybe not in the majority of patients with this type of therapy might be applied.

So earlier in stage at setting with this minimal disease setting, we think is probably the optimal scenario in a minimal checkpoint blockade scenario to try to incorporate this type of active cellular immunotherapy..

Eric, this Nick, if I may add to that, as you recall from our Phase II study of algenpantucel-L on pancreatic cancer, one of the key observations we made patients with progressed after resection a dramatic responses to follow-on chemotherapy.

So the PILLAR study for locally advanced pancreatic cancer, partly was inspired and designed with DPIs to explore that observation which is when you vaccinate the patient first and they follow with chemotherapy locally advanced, dramatic responses in multi-tumors and further immunizing the patients to increase to response, Erik.

So in a local advanced pancreatic cancer, part of that study design came from the observations from the recycle trial as the patients recurred. So we are excited about both for different reason, but at the underlying hypothesis is activated immune system, immune response will sustain those responses in addition to chemotherapy..

Great, thank you very much..

Alright, thank you, Eric..

This does conclude our Q&A session for today’s call. I would now like to turn the conference back to Dr. Charles Link for any further remarks..

Thank you, everyone for joining us in the call this morning. We are making good progress across the business and look forward to updating you on additional achievements over the coming months and we also appreciate all the nice solid questions from our analysts. Have a great day..

Thank you..

Ladies and gentlemen, thank you for your participation in today’s conference. This does conclude the program. You may now disconnect. Everyone have a great day..