Jack Henneman – Chief Financial Officer Charles Link – Chairman, Chief Executive Officer, Chief Strategic Officer Nicholas Vahanian – President & Chief Marketing Officer.

Mara Goldstein – Cantor Fitzgerald Stephen Willey – Stifel Mike Ulz – Baird.

Good day, ladies and gentlemen, and welcome to the NewLink Genetics First Quarter 2017 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. As a reminder, this conference call is being recorded.

I would now turn the call over to Mr. Jack Henneman, Chief Financial Officer..

Good morning, and thank you for joining Dr. Charles Link, Chairman, Chief Executive Officer and Chief Scientific Officer, Dr. Nicholas Vahanian, President and Chief Medical Officer and me for the NewLink Genetics' First Quarter 2017 Financial Conference Call.

Earlier this morning, we issued a press release announcing our financial and operational results and clinical guidance. Dr. Link will review our clinical and scientific priorities for 2017; Dr. Vahanian will highlight our clinical progress and our IDO programs; and I will wrap up with the first quarter 2017 financial results.

Certain statements made during this call are forward-looking statements under U.S. Federal Securities 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 as contained in the earnings release this morning in our Form 8-K dated May 4, 2017, which may be accessed from the Investor's page of the Company website. I will now turn the call over to Dr. Link..

the continuing maturation of the clinical data to give us increased confidence that indoximod acts effectively on the IDO pathway and formulation worked to improve the patient experience in our intellectual property position. We have substantially advanced both.

The first with clinical data published at AACR and more to be published later this year; and the second with the development of our commercial formulation of indoximod. Accordingly, we will be in a position to launch a large-scale adaptive randomized trial by the end of this year that could be used to register indoximod.

We entered the quarter with a strong balance sheet and have resource to initiate by year-end the large randomized trial. Now I turn the call over to Dr. Vahanian to update you on our clinical programs and publication guidance..

randomized placebo-controlled Phase 2 data for the combination of the cancer vaccine Provenge plus indoximod for patients with metastatic castration-resistant prostate cancer will be presented at ASCO on June 5. The data will be presented on 46 patients. In that study, please pay attention to radiographic progression-free survival.

These data may impose our overall confidence in indoximod and its potential motility [ph] in a number of different clinical combinations.

For pancreatic cancer, our Phase 2 study for Indoximod plus chemotherapy has a -- vaccine as a primary endpoint of overall survival with an anticipated presentation at an upcoming medical meeting in the second half of 2017.

Our trial evaluating division of indoximod to standard of care chemotherapy for newly diagnosed AML will have initial data from the Phase 1B portion of the study available later this year. On June 4 at ASCO, Genentech-Roche will report preliminary results of the Phase 1B dose escalation study of navoximod and to centric in patients with solid tumors.

Of note, the design of the trial includes an initial dose exclusion phase in heavily pretreated patients followed by disease-specific expiration covers. Any updates for this study will be reported by Genentech-Rosche. Finally, as Chuck said, we expect NLG802 to enter the clinic by the end of the third quarter.

This next-generation IDO pathway inhibitor is a key component of our life cycle strategy for indoximod and has the potential to enhance the long-term economic value of indoximod franchise.

To sum up, we are extremely encouraged by our indoximod combination data and believe it has the potential to enhance the outcomes for existing therapies such as PD-1 inhibitors, vaccines and chemotherapy without compromising tolerability. We look forward to more data readouts from indoximod studies and from Genentech for navoximod.

And again with the confidence in our significant clinical data in melanoma, we are excited to announce our intention to initiate a large adoptive randomized trial of indoximod in combination with anti-PD-1 therapy. We look forward to updating the investment community on our clinical programs as the year progresses.

Now, I'd like to turn the call back over to Jack..

Thank you, Nick. Before we move to the Q&A, I want to provide a quick overview of key financials for Q1 2017 and guidance for the rest of 2017. We continue to remain well-capitalized with a solid balance sheet.

NewLink Genetics ended the first quarter with cash and cash equivalents totaling $118.2 million compared to $131.5 million for the year ending December 31, 2016. We expect to end 2017 with approximately $75 million in cash and equivalents which excludes any cash that may be received from financings or milestones.

We believe we have the resources to proceed with our business plans including the initiation of a large randomized trial of indoximod announced today. Research and development expenses were $15.7 million in the first quarter of 2017 compared to $21.9 million in the first quarter of 2016.

As noted on our press release, the decrease was due primarily to a $4.6 million decrease in clinical trial manufacturing spend, a decrease in personnel-related spend at $1.4 million and a decrease in licensing and consulting fees $1 million offset by an increase in stock compensation expense of $822,000.

General administrative expenses in the first quarter of 2017 were $8.2 million compared to $9.2 million in the first quarter of 2016. The decrease was due to a decline of $700,000 in consulting and legal fees, a decrease of $700,000 in personnel-related spend, offset by an increase in stock compensation expense of $437,000.

NewLink Genetics reported a net loss of $20.9 million or $0.72 per diluted share for the first quarter of 2017, compared to a net loss of $23.7 million or $0.82 per diluted share for the first quarter of 2016. With that, we'll open up for questions..

Thank you. [Operator Instructions] Our first question comes from Mara Goldstein from Cantor Fitzgerald. Your line is open..

I'm wondering and I apologize if I missed this, but in the press release you speak to an adapted portion of the Phase 3 indoximod trial.

I'm wondering if you can give us a little bit more color on that?.

Yes. Because we have a new commercial formulation of the drug and the preclinical evidence shows that that may increase absorption of the drug, we have a brief run-in of dose escalations that will then be followed by the large-scale randomization portion of the trial..

Sorry, Nick, I didn't hear you..

Basically it's referring to the fact that we have to do a brief dose ramp up portion of the study. That's why it's adaptive study..

And how many patients do you anticipate in that?.

We will give further details of the study in the future..

Okay.

But just to be clear, the adaptive applies only to the dose escalation, not to changing the number of patients in the trial?.

Correct..

That is correct..

Okay. All right. Thank you very much..

Sure..

Thank you..

Our next question comes from Stephen Willey from Stifel. Your line is open..

Good morning, guys. Thanks for taking the questions..

Good morning, Steve..

Good morning. Just to follow up, I guess on Mara's question.

Does the adaptive part of the plan Phase 3 now proclude you from having to do any single agent bridging work prior to the initiation of this study?.

We don't believe that we need to do any single agent work prior to the study, given the tolerability profile of the drug as a single agent and given the fact that in the Phase 1B combination of pembrolizumab and indoximod in advanced melanoma at the Phase 2 portion of that and the Phase 1B portion, they were very well-tolerated in combination and the profile looks to be very similar to the toxicity of the pembrolizumab in the single agent.

As you know, nothing is final until everything is finalized with the regulatory authorities, but there are anticipation that that would not be required..

Understood. I guess just from a strategic perspective, are you guys still considering some kind of collaborative set up here with either maybe some kind of cost sharing arrangement or are you thinking about still going in alone? Just kind of curious as to where you are from those strategic standpoints around how the study gets executed..

Thank you, Steve, for the question. We're under CDA with a number of large cap pharmaceutical companies that has potential interest in combination of checkpoint blockade and we're excited about some of those potential opportunities. I won't comment further until anything is decided or finalized of that nature..

Got it. And then just lastly, I guess post indoximod data that was presented last month at AACR, has there been any thought as to a potential venue that might allow you to provide an update of the Phase 2 data? Thanks..

We haven't made any projections yet about when update for Phase 2 data. We believe the enrollment in the study will complete over the next year and we'll be interested in seeing what the long-term follow-up is given, how durable a lot of the responses look.

The initial data set obviously represented about 60 out of the total 100 patients in the trial roughly, so I appreciate that. We haven't made any projection about what we're going to do on another update..

Understood. Thanks for taking the questions..

Thank you..

Your next question comes from Mike Ulz from Baird. Your line is open..

Hi, guys. Thanks for taking the question. Good morning. Maybe I can just ask the follow up on the Phase 3 melanoma study in terms of the design.

At this point, do you have a preference for a particular PD1 inhibitor?.

I think there are different strategies about how you might incorporate a PD-1 inhibitor into the trial and this can be one or more than one. So again, the final design will really depend upon our input from the regulatory agencies and we don't really want to make any announcement about that. We have the regulatory review..

Got it. And then maybe just sort of a more strategic question around indoximod and now that you've sort of committed to starting the first pivotal, can you just share some of your thoughts about potentially starting additional pivotals and some of the triggers around that? Or any constraints around that? Thanks..

As you know, we own all of the proprietary rates to indoximod. That's completely carved out of our deal with Genentech and Rosche on navoximod. We don't have any limitations in terms of what trials we can do. As you know, we have been doing combinations of indoximod with other agents outside of just checkpoint blockade.

So the size of the PD-1 combination study, we're doing combinations with chemotherapy and pancreatic cancer and we intend to do an update later on this year to firm up that data with harder numbers.

We recently increased the enrollment of that trial from 100 to 140 and we're adding 40 patients that we'll get biopsies pre and post treatment to try to get a sense of the immune environment in the tumor before and after treatment of the combination of [indiscernible] and indoximod. We think that's interesting.

The other combination that we're going to be presenting data on is the ASCO data related to Provenge which was really the first cancer vaccine that was approved in preclinical models – indoximod can enhance the effects of vaccine that are blocked through checkpoint blockade.

I think that people tend to think of IDO inhibitors as a combination for our PD1 access therapy and we think about them in having potential across the spectrum.

In some of the discussions that we're having with potential large cap pharmaceutical clinical partners in terms of partnering through clinical projects, other alternatives are being discussed as well..

Got it. Thank you..

Thank you..

Thank you, Michael..

I'm not showing any further questions at this time. I will now like to turn the call back over to Dr. Charles Link for closing remarks..

Thank you. NewLink Genetics remains focused on advancing immuno-oncology therapies in order to improve the lives of the patients with cancer. In summary, our IDO pathway inhibitors disrupt the mechanisms by which tumors evade the immune system and we are in the clinic across multiple cancer types.

Our long standing vision and the consensus in the immuno-oncology world that immune-based combination therapies are becoming the standard care for patients suffering from a wide range of cancer indication. We are excited to be a part of realizing that vision. Thank you everyone for joining us on the call this morning.

We hope to see you May 18 at the Bank of America Merill Lynch and Healthcare Conference in Las Vegas, at ASCO in Chicago or on June 8 at the Jefferies Global Healthcare Conference in New York City. Please follow up with us if you have further questions..

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