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

Stephen Willey - Stifel Peter Lawson - SunTrust Mara Goldstein - Cantor Fitzgerald Biren Amin - Jefferies.

Good day, ladies and gentlemen, and welcome to the NewLink Genetics Corp. First Quarter 2016 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 like to introduce your host for today's conference Mr. Jack Henneman, Chief Financial Officer. Sir, please 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' first quarter 2016 earnings conference call.

Earlier this morning, we issued a press release announcing financial results for the first quarter and summarizing operational progress toward our 2016 goals. On our call this morning, Dr. Link will discuss the operational clinical and scientific progress we've achieved during the first quarter. Dr.

Vahanian will provide an update on our clinical programs and I will wrap up with a summary of first quarter financial results. Certain statements made during this call are forward-looking pursuant of the U.S. Federal Security Laws.

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

The 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 10-Q which we expect to file at the end of the day.

I will now turn the call over to Chuck..

Thank you, Jack. Thank you all for joining us today for our review of the first quarter financial results and operational performance. We had a productive quarter and made solid progress in achieving our mission of bringing better treatments options to patients with cancer.

The pivotal IMPRESS trial for patients with resected pancreatic cancer is moving rapidly towards final analysis. And, we are preparing for multiple updates from both our IDO pathway inhibitor clinical programs at key scientific meetings during 2016.

You will recall from our fourth quarter and year end 2015 call that we established several business priorities for 2016 and I'm pleased to say that we are on track to achieve our goals.

We are fortunate to be in a position to significantly increase our clinical and preclinical programs including our IDO and P10 [ph] programs respectively and to build our pipeline across immune-oncology and infectious disease. Our first priority for 2016 is to report top line results for the IMPRESS Phase 3 trial.

The IMPRESS Phase 3 trial is moving rapidly towards final analysis and we are updating our guidance on the timing of reporting top line results. We expect to report these results during this quarter. That is all we are going to disclose on this call and we do not expect to say anything more until we announce the results.

We remain blinded to the results of the IMPRESS trial. As we have said before, we are anticipating and therefore preparing for the success of the IMPRESS trial, so we continue to advance our plans for the commercial manufacturing of Algenpantucel-L, the filing of the BLA and if it is approved the commercialization of Algenpantucel-L.

If we meet the IMPRESS trial endpoints we will execute our regulatory strategy with the FDA, continue to build our U.S. commercialization plans and explore partnering Algenpantucel-L outside the U.S. Pancreatic cancer remained a disease with a significant unmet need.

We hope to bring Algenpantucel-L to market so that it potentially improves the lives of patients with pancreatic cancer. We eagerly await the results of IMPRESS.

In addition to IMPRESS, our PILLAR Phase 3 trial for patients with locally advanced pancreatic cancer completed enrollment in December 2015 and we expect to report later this year on the timing for the completion of this study.

Our other HyperAcute Cellular Immunotherapy programs continue to move forward with progress in our non-small cell lung cancer, melanoma and kidney cancer trials. Our second 2016 business priority is the clinical validation of our IDO pathway inhibitors.

There is growing evidence supporting our belief that the IDO pathway is a key checkpoint in the immune system. IDO inhibitors in the clinic have been shown to enhance immune response against many types of cancer.

The role of IDO inhibition in cancer control continues to attract the attention of clinical research as illustrated by the large number of clinical trials currently underway studying IDO inhibitors in combination with chemotherapy, checkpoint inhibitors and immune system modulators.

NewLink Genetics is well-positioned to target IDO and develop therapies for IDO inhibition. The most advanced drug candidates from our IDO pathway inhibitor program are indoximod which is wholly-owned and GDC-0919 which we partnered with Genentech.

We anticipate continued clinical progress in our IDO pathway inhibitor program and expect a number of trial updates during 2016.

This will include clinical trial updates evaluating indoximod in combination with temozolomide for refractory malignant brain tumors as well as indoximod in combination with taxane chemotherapy for patients with metastatic breast cancer. The refractory malignant brain tumor trial is a Phase 2 single arm trial that is currently enrolling.

We will provide a mid trial update before the end of the year. As for the metastatic breast trial, it is one of our most advanced IDO clinical programs. This randomized placebo controlled Phase 2 trial evaluating indoximod in combination with chemotherapy for breast cancer is now fully enrolled.

It is an event driven trial, so we expect to provide more guidance as to the timing of trial results before the end of the year. We also anticipate an update on the progress of GDC-0919 later this year.

Our partner, Genentech-Roche has announced that it will provide an update at the European Society of Medical Oncology this October on GDC-0919 in combination with their checkpoint inhibitor atezolizumab, which is an anti-PD-L1 monoclonal antibody across a number of solid tumors.

The Genentech collaboration continues to be very productive and we believe that it both validates the NewLink's IDO pathway inhibitor program and maximizes the probability of clinical success for our IDO program.

For those of you new to the story, in 2014 we entered into an exclusive license agreement for GDC-0919 with Genentech-Roche that has potential milestones of over $1 billion along with double-digit royalties. Both the preclinical research collaboration and the clinical development are proceeding according to plan.

We believe this partnership with one of the leaders in the oncology space not only validates our IDO platform, but also provides us access to Genentech-Genentech's expertise in checkpoint inhibition, biomarkers, medicinal chemistry and global clinical development which cumulatively we believe positions our IDO program for success.

We look forward to continue progress of these programs in 2016 and Nick will provide an update on potential data readouts we expect this year..

Thank you, Chuck. As Chuck mentioned, we are excited and anxiously awaiting top line results from the primary analysis of the pivotal registration patient [ph] IMPRESS study during this quarter. We are part of this program and its contribution to the pancreatic cancer community and the field of immune-oncology.

The trial will generate important new data about patients with resected pancreatic cancer. We also anticipate continued progress in our IDO pathway inhibitor programs in 2016. We expect to provide a clinical update at ASCO on the following programs.

An interim data update from the Phase 2 trial with the target enrollment of 80 patients evaluating the addition of indoximod to gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer.

And our mid trial and safety data update from our Phase 2 trial of indoximod and ipilimumab or PD-1 inhibitors for patients with stage 3 or stage 4 melanoma.

We also expect initial data updates updates in the second half of 2016 including mid trial updates from our Phase 3 trial of indoximod in combination with temozolomide for patients with refractory malignant brain tumors.

Guidance from timing of preliminary results and a Phase 2 trial of indoximod in combination with taxane chemotherapy for patients with metastatic breast cancer and progress with GDC-0919 combined with an anti-PD-L1 antibody and anti-OX40 therapies from our partner.

As you know, Genentech is responsible for the clinical development and communication updates from this program. We remain confident about this clinical approach and believe that using checkpoint inhibitors in combination with other therapies may show benefit across multiple therapeutic areas.

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 experienced commercial oncology team in anticipation of registration and commercialization of Algenpantucel-L.

It is important to note, if approved this immune-oncology program would be the first FDA approved treatment for patients with resected pancreatic cancer. Now, I would like to return the call back over 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 and detail on this call. Please see the press release we issued this morning and the 10-Q that we will fill at the end of the day today.

As we have talked about before, we are well capitalized and have the advantage of having partner programs with both Genentech and Merck and substantial cash on the balance sheet. We finished the quarter $178 million in cash and equivalents compared $197.8 million at the end of 2015.

As you know, our spending has increased as we move towards final IMPRESS results. We plan to finish 2016 with two years of cash on hand. We expect to provide you with an update after we have reported top line data from the IMPRESS trial.

Since the beginning of the year we have presented at several investor conferences including SunTrust Orphan Drug Day, RBC Capital Markets Healthcare Conference, Citi's Immunotherapy Bus Tour, Jeffries Immuno-Oncology Summit and the Needham Healthcare Conference.

In the upcoming quarter we expect to present at the Bank of America Healthcare Conference on May 12, the Jeffries Healthcare Conference in June, and the Cantor Fitzgerald Annual Healthcare Conference in July. With that, we'll open up for questions.

Operator?.

[Operator Instructions] And our first question will come from the line of Stephen Willey from Stifel. Your line is open..

Good morning guys, thanks for taking the questions..

Good morning, Steve, good to hear you..

Hi Steve..

Good morning. So, I guess just a question around the nature of the communication that will be issued when you guys reveal the IMPRESS data.

I'm just wondering it if you had come to a conclusion as to what is going to be included in the press release because it is obviously the primary stat analysis, but we've, you've talked obviously of potentially looking at additional methodologies and there could also be some mention of a landmark analysis within the press release as well.

So just kind of curious as to if you guys have come to the conclusion as to what is going to be contained in the press release and if you can elaborate what that might be?.

Steve I appreciate the question. As we stated on the call we are blinded to the results. So not knowing the results our intention is to report the top line results, but I really can't give more guidance at this time. So we're just going to say that the top line results will be reported this quarter..

Okay, that's fair and then a question on the indoximod melanoma trial, just curious if you are going to have any biopsy data from that study and whether or not if you can remind us if that study also looks at the impact of sequencing either the checkpoint inhibitor agent or indoximod? Thanks..

Thanks for the question Steve. We are going to present additional data from the combination study of ipilimumab and indoximod as well as PD-1 and indoximod. As you know, now these are standard of care in advanced metastatic melanoma. We will not comment any further about the nature of the [indiscernible] standard regulations for the [indiscernible].

But as you know the trial was designed as such that patients upfront could get DP [ph] or PD-1 that is their choice and so there will be additional information that we will gain from this trial which is one of our primary interests with ipilimumab plus indoximod or PD-1 plus indoximod was followed by one of the other agents.

So we're interested in that data. As the trial matures we will get that knowledge, but at this point we cannot comment any further about the nature of the data we will be presenting..

Can you say if this study at least allows for the collection of biopsies during treatment to look for a baseline?.

Again, we will give more update on this at the upcoming meetings Steve..

Okay. I'll get back in the queue. Thanks..

Thank you. Our next question will come from the line of Peter Lawson from SunTrust. Your line is open..

Thanks for taking my question.

Just maybe Nick [indiscernible] just on the 0919 is there any other color you can give us around that data, the number of patients or I guess we get to see initial efficacy and what was that full [indiscernible] PFS or response rates or duration?.

This trial has been enrolling for quite some time. It began enrolling in July of last year and it is large trial that involves well over 100 patients, I think the target is over 200 patients.

It is designed to have concentrated groups of 20 patients across a number of histologies, so it is basically trying to get Phase 1B data sets that are large enough for specific histologies to get clinical signals.

Genentech has stated that they intend to present the Phase 1B data from this larger scale trial at ESMO, but they haven’t released any information about how many patients that will entail, about how many patients of which histology or any other details.

And the way that our agreement with them works is that we are only allowed to disclose publicly even we know stuff privately that they have disclosed publicly. So we sort of at their behest in terms of what we can say and I really can't say much more than that..

Got you, thank you and just going back to the IMPRESS question around what would be in the press release, I guess we'd get to see OS and the P values, is that how we should think about it is the minimal amount of data we get?.

So I think that in terms of minimal about of data that's probably a safe assumption. In terms of what the global to tell you that data it is we have to, you know we have to analyze and look at data before we make that final determination..

Got you, thank you so much, I'll jump back into the queue..

Thank you. Our next question will come from the line of Mara Goldstein from Cantor Fitzgerald. Your line is open..

Thanks so much.

So I have two questions and the first is around IMPRESS but more so on the remainder of the HyperAcute pipeline and when you have the results of IMPRESS in hand do you have the ability as we look at sort of trials in place to make adjustments to those trials as that's something that is being – could be contemplated?.

So certainly we believe that the IMPRESS trial being such a large data set with 724 patients enrolled in the trial the fact that we have serum and cells over time from those patients who we can correlate with survival as an example or progression free survival for that matter is such a large data set that we certainly anticipate that we're going to learn a lot from the trial and we're going to have a much more complete sense.

As you know the trial is stratified for nodal status that is an important characteristic of how immunotherapy works in lower volume disease versus higher volume stage 1 disease it is stratified for Ca 19-9.

As you know a lot of the other adjuvant trials excluded Ca 19-9 patients because they are considered too poor prognosis patients and there is a small minority of patients we anticipate based on national trends which show about 10% of patients getting new adjuvant therapy.

And finally, the difference in stratification because of radiation therapy or not which is still an open question.

So there is a whole series of scientific questions that we have lined up that we believe we're going to be able to interrogate this database for that really will be probably one of the most comprehensive trials, data sets with scientific correlates that's every been developed in post resection pancreatic cancer.

I think that you can imagine that there is a bunch of different questions and they are fundamental to the biology of the disease, a bunch of different questions that are fundamental to if you induce immune response that are tumor specific how long does it last, how durable they are and obviously the shape and scope of the survival curve is going to be fascinating I think.

As you know, this trial is showing remarkably unexpected projected overall median survival by Kaplan-Meier analysis that was seen on the first and second analyses where we estimate that the survival was 30 months from the time of surgery and the trial as a whole which did a great deal longer than has ever been observed in a U.S. trial before.

So obviously our belief currently and given the investments that we're making in preparation for commercialization, preparation for extended manufacture and all the things that we're doing because we intend to commercialize it ourselves in the United States, we're doing that because we have a strong belief the trial is going to be positive.

But we are blinded to the results, we don't know what the control arm is doing versus the treatment arm. No one knows for sure, right now about that the data and so we're really excited to get in there and dig in this data and obviously since we've announced it is going to occur this quarter, that's on a fairly short event horizon right now..

Okay, thanks and then I wanted to ask a question, I respect that there is limited information that you can provide with respect to 919 and the Genentech agreement, but I'm just curious as to the data release or the expectation of an updated data that will occur at ESMO when would you be able to disclose what is essentially a milestone opportunity event for the company?.

So again, when the milestones are achieved that will trigger a material event to NewLink Genetics so that at that point we will disclose what the milestone was and what the financial payment was. The process of working with Genentech continues to advance.

As you guys saw we put out the actual license agreement with Chugai to also GDL [ph] license, in Japan [ph] we were excited about that. And so I think there a lot of momentum behind the project obviously Genentech and Roche are making large investments in the project.

It is being conducted much the way the CTLA-4 and anti-PD-1 anti-PD-L1 trials have been conducted with these very large Phase 1b trials to get signals with significant populations 20 or more patients with specific disease histologies and clinical scenarios to get signals and then move into Phase 2.

So it is our current anticipation that things will continue to develop with this project, but we can't and we're obviously tremendously excited about it and there's tremendous opportunities for big time additional payments to NewLink in this agreement I said earlier on as we've stated before..

That's what I was getting at. Yep Mara, I appreciate the question as you know we are limited to be able to comment on this, details of the Genentech agreement.

However, as we pointed out earlier, we are very excited about this work that we continue to do with the Genentech team, but also as we've pointed out through after the signing of the contract that it is not a back loaded agreement. We are pleased with the fact that milestones along the way to clinical development.

So we and I think at this point that's all we can say..

Okay, well thank you..

[Operator Instructions] Your next question will come from the line of Biren Amin from Jefferies, your line is open..

Yes, thanks guys for taking the questions..

Hi Biren..

Hey, how are you? So just on IMPRESS are we going to see different cuts based on, you know you've talked about alternative statistical methodologies previously into the second interim, so are you going to cut the data based on different methodologies? That will be my question..

Biren I appreciate the question, but we really are going to just report the top line results and when we are able to in this quarter and we're not looking to make any further detailed commentary.

We obviously had very detailed prolonged discussions with the regulatory bodies and we're very comfortable with where we are right now in the planning, but we're not going to make any further comment until we actually release the information..

And it is important to point out Biren, first I appreciate the question it is the main question I think around this trial right now in people's minds given the history over the last seven years how we came here, so I appreciate the question.

I just wanted to remind that we are completely blinded to the results and along the way as Chuck mentioned, we continue to communicate with all the proper agencies and bodies and internally as well and when we get through the results as we also mentioned on this call in the second quarter of 2016 we will report the results.

That's all we're going to say at this point..

Okay, and since you have tremendous experience in the IDO/TDO research space I wanted to get your….

Thanks for acknowledging that..

I wanted to get your impressions of ACR poster [ph] with RG 70099 [ph], this is IDO/TDO inhibitor and I think Roche presented some data IDO 1 positive tumor model showing high error inhibition of [indiscernible] with this compound. So I just want to get your thoughts on this preclinical data set with this compound..

Yes, so I really can't comment on data on some compounds from other companies. I can tell you that one of the factors about GDC-0919 and we published this previously that it has both IDO inhibitor effect and TDO inhibitor effects in animal concentration.

So I know that there has been a lot of discussions about combined IDO/TDO inhibitors or a single IDO inhibitor or single TDO inhibitor.

Obviously we're doing a lot of other medicinal chemistry work under this very large collaboration with Genentech-Roche that is one of the three major committees that comes out of the agreement that we have with the partnership with Genentech-Roche. So we are very comfortable that the lead drug that is in the clinic.

Of course trial that is still preclinical you know would be several years behind where we are in clinical development now with GDC-0919 given this large expansive Phase 1B trial for several hundred patients that's being conducted.

But on the issue of IDO versus TDO or IDO/TDO combinations GDC-0919 are characterized as having activity against both targets..

And if I can add one thing to that Biren, as you know we've stated previously in the absence of a better PD marker I guess it is a tool to assess serum [ph] levels, but at the end of their multiple factors contributing to that including person's diet and liver activity.

So it is not the best way we've always said to be able to measure potency of a compound, but in the absence of other better solid markers it is something that people should look at, but at the end general microenvironment and what happens in the general microenvironment the potency of the potential IDO inhibitor or IDO/TDO inhibitor you see a lot more complex than simply measuring [indiscernible].

It is not a high priority, but nevertheless, in the absence of any better [indiscernible] marker it is something that people can look at..

Okay, thanks..

Thank you..

Thanks Biren..

Thank you. And we do have a follow up from Stephen Willey from Stifel. Your line is open..

Thanks for taking the followup. Just a quick question regarding some of the work you guys are starting to do on P10.

It is obviously a target that's starting to get a little bit more interest in terms of its role on Tregs, I guess specifically and I know you just entered into the licensing agreement with Georgia region, so just kind of curious if you can maybe talk a little about where that compound is in terms of development may be how quickly you might be able to get to an IND? Thanks..

Well, as you know, David Munn [ph] and Andrew Miller [ph] were the original team from Georgia that discovered the role of IDO in immune protection in the womb, in the uterus and subsequently identified its importance as a checkpoint inhibitor in cancer biology.

And so that laboratory group has been one of the fundamental driving groups in the immune-oncology world. We've had a great relationship with David Munn [ph] in the university over, boy it must be 10 years by now.

And when David came upon this new discovery of this important role of P10 as potentially a critical checkpoint blockade pathway that also contributes to the control of tregs and interacts with these other pathways as he published in his science translational research paper just a few months ago now.

We had actually been in touch with him for some time and we're very interested in his work and so we're looking forward to working with him on this project which has been underway for some time. We are not at this time making any projections about when we will be in the clinic on this project.

The preclinical development project right now, but we are devoting considerable resources and we're really excited about this collaboration..

All right, I appreciate the color thanks..

Thank you. And we do have a question from the line of Peter Lawson from SunTrust. Your line is open..

Just a quick followup just around PILLAR is that's still like to second half 2016 event that we see data has been pushed out by any chance?.

We haven’t made any specific guidance around PILLAR.

As we've mentioned in several of our prior discussions that one of the reasons we are not giving any details or information around PILLAR or focusing on the data is we're right now our attention is devoted to IMPRESS and any potential implications about gaining knowledge about potential cures or any responses we defer that to later in the year.

So once we, as we mentioned in this call our focus on IMPRESS and we will have the opportunity to report on that data in this quarter and once we're through that process we will give more guidance around PILLAR..

Thank you, and then just a really quick question for Jack, how should we think about the ground and licensing revenue is that kind of $5 million to $6 million range for the rest of the year for each quarter since you have kind of done that?.

Yes, that's not bad, it depends on what else comes in, it is good as any. It basically matches our, not necessarily in every single quarter, but it basically matches our expenses on the infectious disease side. So in that sense it is relatively neutral subsidy.

It will go up and down by quarter as we pass through billing, get collections and everything else..

Since you mentioned infectious disease, I guess I just want to mention one word about the Ebola program which is the recent announcement of the additional $30 million is obviously hitting some of the, what we believe are some of the final trials will have to be conducted that might allow that drug to be filed to register the drug, although we don't have timing projections on that, that's really up to Merck to disclose with us.

The grant actually before that or the contracts actually before that which was the smaller of several million dollars, I think $4 million or $5 million option on top of it is actually pretty interesting grant for us, because that was the first large scale grant support that we got for the multivalent vaccine.

You probably need on the order of three strains of Ebola and Marburg, to cover all the various strains of those diseases and our ultimate goal for that project is to have a solution that vaccine that will work for all the strains with one vaccination.

And so that was really the next stage in that technology being developed in some ways as important or more important than the funding that was five or ten times its size..

Got you. Thank you so much, thanks for the color..

Thank you, Peter..

Thank you. At this time, I am showing no further questions. I'd like to turn the call back over to Dr. Charles Link for any closing remarks..

Well, we thank you all for dialing in today and listening to the call. We appreciate everyone's support and we really are excited about our opportunity to be able to report results this quarter. Everybody have a great weekend..

Thank you..

Ladies and gentlemen, thank you for participating in today conference. This concludes the program. You may now disconnect. Everyone have a great day..