On March 1, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) today reported consolidated financial results for the fourth quarter and year ended 2017, as well as progress in its clinical development programs (Press release, NewLink Genetics, MAR 1, 2018, View Source [SID1234524320]). The Company also outlined key 2018 business priorities related to the clinical programs for indoximod, its IDO pathway inhibitor drug candidate.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"NewLink Genetics has produced encouraging data supporting indoximod in several indications and looks forward to presenting additional data in 2018, further validating IDO pathway inhibition as a key target in immuno-oncology," said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer. "In addition, Indigo301, our pivotal trial for patients with metastatic melanoma, and Indigo201, our randomized Phase 2 trial in collaboration with AstraZeneca for patients with metastatic pancreatic cancer, are our core clinical priorities for 2018."
Anticipated 2018 Highlights
•
Initiate randomization portion of Indigo301, a pivotal Phase 3 trial for patients with advanced melanoma, in Q2-Q3 2018
•
Full Phase 2 results of indoximod plus checkpoint inhibitors in metastatic melanoma in 1H:2018
•
Initiate Indigo201, a randomized Phase 2 trial for patients with metastatic pancreatic cancer, in 1H:2018
•
Full Phase 2 results from the single-arm trial of indoximod plus gemcitabine nab-paclitaxel in metastatic pancreatic cancer in 1H:2018
•
Two abstract presentations at AACR (Free AACR Whitepaper) Annual Meeting 2018 include data from a Phase 1 study of indoximod for pediatric patients with malignant brain tumors and data providing additional characterization of the differentiated mechanism of action of indoximod
•
Continued evaluation of indoximod in additional oncology indications
2017 Highlights
•
Presented updated Phase 2 data of indoximod plus pembrolizumab in advanced melanoma at the Third Annual International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) with encouraging overall and complete response rates and progression-free survival
•
Commenced dose determination portion of Indigo301
•
Entered into a collaboration with AstraZeneca on Indigo201
•
Presented Phase 2 data from a randomized, double-blind study of indoximod plus cancer vaccine for patients with metastatic castration-resistant prostate cancer at ASCO (Free ASCO Whitepaper) Annual Meeting, indicating statistically significant improvement in median progression-free survival compared to monotherapy
Exhibit 99.1
•
Presented Phase 1b data of indoximod plus chemotherapy in newly diagnosed AML suggesting the potential for indoximod in treatment regimens beyond PD-1
•
Successfully raised $74.3 million, net of offering costs, and ended 2017 with $158.7 million cash and equivalents
Update on Current Clinical Timeline and Financial Guidance
NewLink Genetics reported an update of its clinical timeline and now expects to initiate Indigo301 randomization in Q2 to Q3 2018 and complete enrollment in 2019. The Company expects to end this year with approximately $75 million in cash. The shift in the timeline arises from an increased number of trial sites planned for Indigo301 and additional work related to manufacturing.
Financial Results
Cash Position: NewLink Genetics ended the year on December 31, 2017, with cash and cash equivalents totaling $158.7 million compared to $131.5 million for the year ending December 31, 2016. The Company’s cash position is sufficient to fund operations in the near and medium term.
R&D Expenses: Research and development expenses were $17.5 million and $69.9 million in the fourth quarter and year ended December 31, 2017 compared to $19.5 million and $93.3 million during the comparable periods in 2016. The decrease year-over-year was due primarily to higher restructuring charges of $11.1 million incurred in 2016, including a non-cash charge of $4.0 million related to impaired assets, as compared to $600,000 of charges incurred in 2017. Remainder of the decrease was due to decreases of $6.2 million in clinical trial costs, $4.4 million in supplies, equipment and licensing, $3.6 million in personnel-related expense, and $200,000 in manufacturing expense. Decreases were offset by increases of $1.0 million in stock compensation expense and $600,000 in legal and consulting.
G&A Expenses: General and administrative expenses in the fourth quarter and year ended December 31, 2017 were $6.7 million and $31.7 million compared to $7.2 million and $33.2 million during the comparable periods in 2016. The decrease was primarily due to a $2.3 million reduction in personnel-related spend and $1.2 million reduction in legal and consulting, offset by increases of $700,000 in stock compensation expense, $700,000 in supplies and equipment, and $600,000 in restructuring charges incurred in 2017.
Net Loss: NewLink Genetics reported a net loss of $13.7 million or $0.37 per diluted share for the fourth quarter of 2017 and a net loss of $72.0 million or $2.30 per diluted share for the year ended December 31, 2017, compared to a net loss of $13.5 million or $0.46 per diluted share for the fourth quarter of 2016 and a net loss of $85.2 million or $2.94 per diluted share for the year ended December 31, 2016.
NewLink Genetics ended 2017 with 37,109,556 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss the results and to give an update on clinical and business development activities. NewLink Genetics’ senior management team will host the call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.
Access to the live conference call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. The conference call will be webcast live and a link to the webcast can be accessed through the NewLink Genetics website at www.NewLinkGenetics.com in the "Investors & Media" section under "Events and Presentations" or by clicking here. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 9466627. The replay will be available for two weeks from the date of the call.
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, cancer vaccines, and chemotherapy across multiple indications such as melanoma, pancreatic cancer and other malignancies.