Operator: 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.

Jack Henneman: 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.

Charles Link: Thank you, Jack. Thank you for joining us today. As we have stated previously, 2017 is an important year for NewLink Genetics. As many of you heard on our Investor Day in October 2016 and on our last quarterly earnings call, 2017 is also a big year for the clinical validation of the IDO pathway as the key immuno-oncology target. More recently, data presented at AACR by our investigators and others confirm IDO pathway inhibitors has the potential to enhance the outcome for patients with cancer when used in combination with currently available therapies. To review the science, the IDO pathway plays a key role in normal immune function by appropriately regulating immune response. Many cancers hijack the IDO pathway as a means of immune escape and thereby are unchecked by the immune system. The IDO pathway is interrelated with a number of immune checkpoints and therefore combining IDO pathway inhibitors with antibodies to PD-1 and PD-L1 as a potential to improve outcomes for those therapies. There's also an increasing body of evidence that suggest adding an IDO pathway inhibitor to additional anti-cancer agents such as chemotherapy, vaccines and others may also provide improved benefit for patients. In addition to our abstracts presented AACR and now accepted for ASCO, we hope to publish additional data in 2017 that will validate this theme. Dr. Vahanian will give more detailed guidance on our clinical development and publication plan in a few minutes. NewLink has two separate and distinct types of IDO pathway inhibitors. That includes two currently in clinical development and the third which will enter the clinic soon. Navoximod is our direct enzyme inhibitor of IDO that we have partnered in the collaboration with Genentech-Rosche. Indoximod is our proprietary IDO pathway inhibitor to which we have retained all rights. Evolving data suggest that indoximod inhibits the IDO pathway by blocking or having an impact on multiple immune functions otherwise influenced by IDO. Thus, although both navoximod and indoximod target the IDO pathway, they appear to have separate indistinct mechanism action and therefore represent two different opportunities for us. Finally, NLG802 is our noble pro-drug of Indoximod, a new chemical entity subject to a new IND [ph] and development program. We believe that NLG802 as a next generation molecule will target the IDO pathway in a similar manner to Indoximod. Let me next discuss our clinical development strategy at a high level. Genentech-Rosche has expanded the enrollment target to 305 patients for the Phase 1B study of navoximod GDC-0919 in combination with this anti PD-L1 antibody to centric atizolizumab [ph] for patients with solid tumors. As you recall, the design of the trial includes an initial dose escalation phase followed by disease-specific expansion cohort. As Genentech-Rosche has reported, an initial abstract for this Phase 1B dose escalation study will be presented by their investigator at ASCO next month. Any other news on the progress of this program must come from Genentech. Indoximod is a multiple Phase 2 trials for patients with various malignancies including melanoma, prostate cancer, pancreatic cancer and AML. As most of you are aware an abstract was presented recently at AACR showing promising data for a Phase 2 study of indoximod in combination with the anti-PD1 antibody pembrolizumab in advanced melanoma. In addition, in abstract for a randomized placebo-controlled Phase 2 study of indoximod with the vaccine Provenge in metastatic castrate resistant prostate cancer will be presented at ASCO next month. We expect further readouts for studies of indoximod in combination with other therapies in pancreatic cancer, in AML later this year. Finally, we expect our indoximod prodrug NLG802 to enter clinical trials by the end of the third quarter. We hope this next-generation molecule will lead to new opportunities in the clinic in the future and further expand our indoximod franchise. Our IDO pathway programs are following the clear plan we described at our Investor Day back in October. First, we discussed the central role of Genentech-Rosche in the development of navoximod. That program is firmly in Genentech's hands and we hope they expeditiously move it along in a way that is more visible to investors. Second, we said we are basing our decision to advance indoximod on two considerations: 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.

Nicholas Vahanian: Thank you, Chuck. I will start by reviewing the highlights of the data we presented with indoximod recently at AACR and then we'll give an update on what we expect for the rest of 2017 because as Chuck described, our indoximod program is making great progress against the plan we outlined last year. As noted previously, interim Phase 2 data were presented at an AACR plenary session on the combination study of indoximod plus pembrolizumab for patients with advanced melanoma. These data provide additional clinical validation for advancing indoximod to Phase 3 clinical development. Specific response rates in the 51 non-occular melanoma patients were the following: 59% overall response rate; 12% complete response rate; and disease control rate of 80%. And as you can see on the water-plot [ph], the vast majority of the patients appear to be achieving clinical benefit from the combination of indoximod plus pembrolizumab. And you can also appreciate that the depth of response for both PRs and CRs is substantial for a number of patients. Despite the plot in the next slide further suggests that there's potential for both the overall and complete response rates to improve over time as the study matures. It is important to note that both early and delayed responses have been reported and that a number of patients are still on treatment as is represented by the lines with ours. The spinner-plot [ph] also provides a nice representation for the overall durability of the combination. The addition of indoximod to pembrolizumab was well-tolerated. The majority reported adverse events were Grade 1 and 2 events. There were a limited number of Grade 3 treatment rate events and the rate of Grade 3 events was not efficiently different from what is typically seen with pembrolizumab alone. Importantly, very few patients experience toxicity that require them to stop therapy. Of the 60 patients presented at AACR, only three have treatment-related toxicities that resulted in sensational therapy. There have been no treatment-related death in the study. These results have greatly increased our confidence that indoximod can succeed in a large-scale randomized trial in combination with anti-PD1 therapy and that such a trial might be suitable for regulatory approval. The trial was expected to use an adapted design that incorporates a brief dose-confirmation stage followed by a definitive randomized stage. We further believe that indoximod has the potential to succeed in various combinations for a number of different indications. Our top priority is to bring indoximod to market as quickly as possible. In addition to our progress in melanoma, the indoximod clinical program includes numerous other indications. Guidance for other indoximod trials is as follows: 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.

Jack Henneman: 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.

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

Mara Goldstein: 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?

Charles Link: 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.

Mara Goldstein: Sorry, Nick, I didn't hear you.

Nicholas Vahanian: 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.

Mara Goldstein: And how many patients do you anticipate in that?

Nicholas Vahanian: We will give further details of the study in the future.

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

Nicholas Vahanian: Correct.

Charles Link: That is correct.

Mara Goldstein: Okay. All right. Thank you very much.

Nicholas Vahanian: Sure.

Charles Link: Thank you.

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

Stephen Willey: Good morning, guys. Thanks for taking the questions.

Charles Link: Good morning, Steve.

Stephen Willey: 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?

Charles Link: 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.

Stephen Willey: 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.

Charles Link: 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.

Stephen Willey: 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.

Charles Link: 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.

Stephen Willey: Understood. Thanks for taking the questions.

Charles Link: Thank you.

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

Mike Ulz: 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?

Charles Link: 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.

Mike Ulz: 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.

Charles Link: 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.

Mike Ulz: Got it. Thank you.

Charles Link: Thank you.

Nicholas Vahanian: Thank you, Michael.

Operator: 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.

Charles Link: 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.

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