Good afternoon, ladies and gentlemen and welcome to the NewLink Genetics First Quarter 2019 Earnings Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded..

I will now turn the call over to Ms. Lisa Miller, Director of Investor Relations. .

Thank you. I would like to remind everyone that 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 report 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 afternoon and in our Form 8-K, which may be accessed from the Investors page of the company's website. .

I will now turn the call over to Dr. Link. .

Thank you, Lisa. Good afternoon, and thank you for joining us. With me on today's call are Dr. Eugene Kennedy, Chief Medical Officer; and Mr. Carl Langren, Chief Financial Officer. .

After the market closed, we issued a press release reviewing clinical highlights and financial results for the first quarter of 2019. On this call, I will provide an overview of these programs, corporate activities and goals, Dr. Kennedy will review highlights of our clinical development program, and Mr.

Lundgren will wrap up with the financial results and comments on our cash position. .

indoximod, NLG802 and NLG207, and anticipate presenting additional data from these programs throughout the rest of this year. .

NLG802 is the prodrug of indoximod engineered to significantly increase drug exposure for patients. To date, results from our Phase I dose-escalation trial of NLG802 demonstrated significant drug exposure in humans while maintaining a benign safety profile.

Later this month, we will present updated results from this trial at the Immuno-Oncology World Congress in Barcelona, Spain, which corroborates earlier promising findings at additional dosing levels. .

The established data demonstrating the differentiated mechanisms of action of indoximod, plus the significantly increased exposure demonstrated to date with NLG802, provide a solid basis for further clinical development..

In diffuse intrinsic pontine glioma, or DIPG specifically, earlier results with indoximod were encouraging, and we anticipate presenting updated data from that Phase I trial in the second half of 2019 as data mature. .

In addition, NLG207, a nanoparticle formulation of the topoisomerase 1 inhibitor camptothecin, has broadened our portfolio of investigational therapeutic agents and the cancer indications they address.

We are encouraged by Phase II results evaluating NLG207 in recurrent ovarian cancer presented at AACR last month and are assessing the role of NLG207 as a therapeutic agent in gynecologic malignancies. .

Finally, Merck recently announced that the European Medicines Agency had accepted the marketing authorization application for our partnered Ebola vaccine. In addition, Merck has previously announced that the rolling BLA for the FDA was initiated last fall with anticipated completion of that filing in 2019.

Should the FDA approve this vaccine candidate, NewLink Genetics holds a significant interest in a priority review voucher that will be issued in conjunction with the approval. .

We continue to be encouraged by results to date across our clinical programs and believe that our data support further trials in pursuit of a path to potential registration in the difficult-to-treat indications NewLink is targeting.

Through prudent corporate restructuring and careful strategic use of capital, NewLink has maintained our strong financial position which we believe will support our clinical program through the end of 2021. In addition, we're actively engaged in evaluating a range of opportunities to expand our pipeline. .

Now I will turn the call over to Dr. Kennedy who will discuss our clinical programs in greater detail.

Gene?.

Thanks, Chuck. I will begin with an update from our NLG207 program. Ovarian cancer remains an indication with a significant unmet need, particularly in the relapse setting. Preclinical data suggested that NLG207 has strong, single-agent anticancer activity matched with less bone marrow toxicity.

These findings supported subsequent clinical trials and were corroborated by results presented at AACR from a completed Phase II study of NLG207 for patients with recurrent ovarian cancer. .

That's the single arm Phase II study conducted in conjunction with the Gynecologic Oncology Group Foundation evaluated 30 patients treated with NLG207 every 2 weeks in combination with weekly paclitaxel in 28-day cycles until progression or toxicity. The primary objective was overall response via RECIST criteria.

Progression-free survival, duration of response and safety were also assessed..

The results from this Phase II study presented at AACR demonstrated confirmed responses in 8 out of 30 patients for an overall response rate, or ORR, of 26.7%, including 1 complete response. The ORR for platinum-resistant patients was 23.5% with the best response rate, including unconfirmed responses, equal to 41.2%.

The ORR for platinum-sensitive patients was 30.8%. .

The treatment was well tolerated with grade 3, 4 adverse events relatively consistent with paclitaxel as a single agent. We are encouraged by these results particularly given the fact that many enrolled patients were platinum-resistant and acceptable toxicities were observed..

Turning to our indoximod program. We continue to evaluate indoximod in combination studies targeting frontline DIPG recurrent pediatric brain tumors and frontline AML and are currently evaluating NLG802, our indoximod prodrug, in a dose-escalation trial. .

Frontline DIPG is a distinct subtype of pediatric brain tumors with the most dire prognosis and significant unmet need.

Currently, for DIPG, radiotherapy represents the only standard of care therapy used in the frontline setting and prognosis for this indication is especially poor, with approximately 20% survival at 2 years and 1% survival at 5 years. .

To date, neither radiotherapy nor any experimental therapeutic approach has been shown to meaningfully prolong survival for these children, but radiotherapy does provide some degree of symptomatic relief. .

NewLink is evaluating standard-of-care radiotherapy combined with indoximod immunotherapy, followed by indoximod plus maintenance chemotherapy for DIPG patients in a single-arm Phase I study.

Standard-of-care therapy has not changed significantly for many decades, and we therefore believe historical data may serve as an appropriate comparison to evaluate the potential for indoximod to improve patient outcome in this setting. .

Data from our trial last presented at ISPNO in July 2018 demonstrated symptomatic improvement in all patients in the cohort, an evidence of deep radiographic responses. We anticipate presenting updated results from the DIPG cohort later in 2019 as the dataset matures. .

Finally, NewLink continues to develop NLG802, a prodrug of indoximod engineered to significantly increase drug exposure for patients currently in a dose-escalation Phase I trial. Preclinical data showed four to sixfold increased drug exposure for NLG802 compared to a similar per-molar dosing of indoximod.

Initial Phase I data from our first-in-human dose-escalation trial were presented at SITC in November of 2018. .

These clinical data were promising with a confirmation of a similar four to sixfold increase in exposure in human subjects, and the drug was well tolerated at these levels. We will present additional encouraging data from this trial later this month at the Immuno-Oncology World Congress 2019 in Barcelona, Spain. .

In summary, recent results from trials evaluating NLG207 in ovarian cancer, indoximod in frontline DIPG as well as NLG802 in a dose-escalation trial for patients with solid tumors are encouraging, and we look forward to disclosing more data across our clinical programs this year. .

Now I'll turn the call over to Carl to discuss the financial results for the quarter and our cash forecast. .

Thank you, Gene. Before we move to the Q&A, I will comment on our cash guidance and provide an overview of key financials for Q1 2019. .

We ended Q1 2019 with cash and equivalents of $113.2 million compared to $120.7 million at the end of 2018. We anticipate a cash use of approximately $10 million per quarter, which allows our cash runway to extend through 2021.

This excludes any additional financing, new partnerships or the impact of a priority review voucher, which we expect to be granted in conjunction with the potential approval of our partnered Ebola vaccine candidate. .

As a reminder, in 2014, we entered into a license agreement with Merck to develop, manufacture and commercialize our Ebola vaccine candidate. Merck recently announced that the European Medicines Agency, or EMA, had accepted a marketing authorization application for this vaccine which we find encouraging. .

As previously reported, Merck began a rolling BLA submission with the FDA in late 2018 with expected completion of a filing in 2019. Should the FDA approve this Ebola vaccine, that approval would trigger the issuance of a priority review voucher owned by Merck and in which NewLink Genetics has a substantial economic interest.

Thereafter, NewLink would have the right to monetize its interest in the voucher. .

While we can't forecast the value of priority review vouchers in the future, the most recent open market transaction value these vouchers at around $100 million. Given the clinical efficacy data to date, we believe that there is substantial clinical value in this vaccine and look forward to its potential near-term approval. .

NewLink Genetics reported a loss of $10 million or $0.27 per diluted share for the first quarter of 2019 compared to a net loss of $18.3 million or $0.49 per diluted share for the first quarter of 2018. The company ended Q1 2019 with approximately 37.28 million shares outstanding.

Please refer to the press release we put out this afternoon for more detail on financial results. .

Looking ahead, we hope to see many of you at the Bank of America Merrill Lynch Healthcare Conference next week and other investor conferences throughout the year. .

Now I'd like to turn the call back over to Chuck before we open up the call to questions.

Chuck?.

Thank you, Carl. In summary, we continue to make progress across our clinical development pipeline from a position of considerable financial strength.

We expanded our clinical programs to include NLG207, which is being evaluated for patients with recurrent ovarian cancer who have failed multiple lines of therapy, and we are pleased with the Phase II results that our investigator presented at AACR in April. .

Results for clinical trials for indoximod and NLG802 have been encouraging, and we look forward to presenting updated data from those trials throughout the rest of 2019. We also continue to evaluate potential acquisitions or in-licensing opportunities to broaden our pipeline. .

We are deeply grateful to the patients, physicians and other health care professionals who have participated in our clinical programs. Their contribution has enabled us to work relentlessly towards our goal of discovering therapies with the potential to improve the lives of individuals with cancer. .

With that, we will open up the call to questions.

Operator?.

[Operator Instructions] Our first question comes from the line of Ying Huang from Bank of America. .

This is Alec on for Ying. So the first one is on indoximod in DIPG, which we'll be seeing later this year.

Could you give us a little bit more color in terms of the kinds of clinical data that will be presented? How many patients will have data at that point? And also, what kind of avenue you're planning for data release, for example, would it be a PR or at a scientific conference in the second half?.

Sure. So I think as we've indicated before, we think that the meaningful milestones for these children is overall survival, and that's why we're waiting for that data to mature. We haven't disclosed the exact number in our cohort, but we have had patients enrolled since our presentation last July in 2018.

As to the nature of the presentation, it's been our long-standing preference to present data at appropriate academic meetings. But with each data that we receive, obviously we make a decision appropriate to the circumstances. But we do look forward to having an opportunity to share that data with investors later this year. .

Great.

And then what are your plans for NLG207 in ovarian cancer? Do you plan to initiate a Phase III study based on the GOG data presented at AACR? Or will you -- do you want to wait for the Mass Gen study plus bev to readout as well?.

So we haven't made public any plans for what the next step is for the NLG207. We are working in line with them to expanding drug supply and other gynecologic malignancies where topoisomerase 1 inhibitor has not been effective. It's potentially one with a better toxicity profile might be useful, but we haven't made these plans public as yet. .

Our next question comes from the line of Steve Willey from Stifel. .

This is actually [ Steve Klass ] on for Steve Willey. I guess just with respect to NLG207, I know you -- there's a couple of other investigator-sponsored trials in progress. I think with Avastin and then with olaparib in relapsed/refractory SCLC. I was wondering if you could just give us an idea of where these trials currently stand. .

So the trials are enrolling patients, but we haven't made any projections about when first data would be available. We don't anticipate that there will be data from those trials available this year in my current best understanding.

Do you agree with that, Gene?.

Yes. I think with the -- if it's Mass General's trial with Avastin, that trial -- they're working to sort of aggregate that data. But the second trial you mentioned, the trial with the PARP inhibitor, is run through NCI. That -- those data are being aggregated and we hope to have them available soon.

I'm working with the investigators there to find the appropriate setting for that. .

Thank you. I'm showing no further questions in the queue at this time. I now hand the call back to Dr. Link for closing remarks. .

We thank you for your interest and we look forward to seeing some of you next week. Have a great rest of the week, everyone. .

Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day. You may all disconnect..