NewLink Genetics Reports Second Quarter 2016 Financial Results
- Management to Host Conference Call Today at
- Analyst Day to be held on
"We have streamlined our operations and focused development efforts on the clinical validation of indoximod, our proprietary IDO pathway inhibitor program, which is being studied in multiple cancers," said
"We have the financial resources to realize the potential of our product development pipeline as well as opportunities for the development of other potentially synergistic therapies that could provide benefit to patients with cancer," commented
Program Updates
Indoleamine 2,3-Dioxgenase (IDO) Checkpoint Inhibitor Programs
The IDO pathway regulates immune response by suppressing T cell function and enabling local tumor immune escape.
Indoximod
- Updates on Phase 1b/2 trial of the IDO pathway inhibitor, indoximod, plus checkpoint inhibitors for the treatment of unresectable stage 3 or 4 melanoma. The trial design allows for the combination of indoximod with
either ipilimumab or one of the PD-1 checkpoint inhibitors, pembrolizumab or nivolumab. The combination of indoximod with other checkpoint inhibitors has been well tolerated thus far with no increase in toxicity noted in this Phase 1b/2 study. Overall, 40 patients had been enrolled in the combined Phase 1b/2 study long enough to have response data available at the time of data cut off. The poster data presented at ASCO were based on data via site reported RECIST criteria available from 28 subjects, the objective response rate, comprised of complete response plus partial response, for these patients is 36 percent (10 of 28) with three complete responses. Interestingly, the subset of 15 patients who received indoximod in combination with pembrolizumab had an objective response rate of 53 percent (8 of 15) with two complete responses (13 percent). The trial continues to enroll, with 55
patients currently enrolled in Phase 2.
- Interim analysis on a Phase 2 trial of the IDO pathway inhibitor, indoximod, plus gemcitabine/nab-paclitaxel for the treatment of metastatic pancreatic cancer. The combination of indoximod and gemcitabine/nab-paclitaxel continues to be well tolerated by patients with metastatic pancreatic cancer. These data come from the Phase 1/2 trial in which treatment-naïve patients with metastatic pancreatic cancer were treated with the combination therapy in continuous four week cycles. As of the data cut off for the analysis, a total of 45 patients (Phase 1 and 2) were enrolled in the trial long enough to potentially have cycle 4 imaging available by the ASCO presentation. Data via site reported RECIST criteria were available on 31 patients. At the time of this analysis, objective response rate was 45 percent (14 of 31) and multiple durable responses ≥6 months were observed. Two patients achieved a complete response (6 percent), both at Cycle 8, showing delayed kinetics that may indicate an immune based mechanism. The trial continues to enroll patients and a biopsy cohort expansion is underway.
"These promising data continue to demonstrate the potential of combination therapies with other checkpoint inhibitors and with chemotherapies for different cancers," added
Restructuring
The company also announced that it has implemented a significant restructuring program following the May results of the IMPRESS Phase 3 study of algenpantucel-L. The objective of the restructuring is to focus the company's financial resources on the following priorities:
- Progress and accelerate the development of indoximod;
- Continue the alliances with
Genentech (GDC-0919) and Merck (Ebola vaccine candidate); - Advancing other drug discovery programs, including both PTEN and Zika virus; and
- Evaluate external opportunities to expand our pipeline.
The restructuring includes the following initiatives:
- Winding down HyperAcute Cellular Immunotherapy clinical trials that do not include a checkpoint inhibitor combination;
- Winding down commercial manufacturing capacity for algenpantucel-L;
- Consolidating the Company's facilities footprint from 133,000 square feet to approximately 66,000 square feet;
- Reducing headcount from approximately 230 to approximately 130; and
- Focusing capital spending to primarily support drug discovery and development.
We recorded
Financial Results for the Three-Month Period Ended
Cash Position: NewLink Genetics ended the quarter on
R&D Expenses: Research and development expenses in the second quarter of 2016 were
G&A Expenses: General and administrative expenses in the second quarter of 2016 were
Net Loss: NewLink Genetics reported a net loss of $32.4 million or (
NewLink Genetics ended the quarter with 28,962,296 shares outstanding.
Financial Guidance and Upcoming Investor Meetings
NewLink Genetics' goal and expectation remains to finish 2016 with two years of cash on hand and the capacity to make incremental investments.
We expect to present at the
Conference Call Details
The Company has scheduled a conference call for 8:30 a.m. ET today to discuss the results and to give an update. 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 (
About NewLink Genetics Corporation
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
Condensed Consolidated Statements of Operations | |||||||||||||||
(unaudited) | |||||||||||||||
(In thousands, except share and per share amounts) | |||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||
2016 | 2015 | 2016 | 2015 | ||||||||||||
Grant revenue | $ | 1,262 | $ | 3,280 | $ | 5,600 | $ | 12,929 | |||||||
Licensing and collaboration revenue | 750 | 4,165 | 2,120 | 33,711 | |||||||||||
Total revenue | 2,012 | 7,445 | 7,720 | 46,640 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 27,410 | 16,130 | 49,347 | 34,111 | |||||||||||
General and administrative | 9,130 | 7,257 | 18,294 | 15,623 | |||||||||||
Loss from operations | (34,528 | ) | (15,942 | ) | (59,921 | ) | (3,094 | ) | |||||||
Other income, net | 60 | 22 | 99 | 33 | |||||||||||
Net loss before taxes | (34,468 | ) | (15,920 | ) | (59,822 | ) | (3,061 | ) | |||||||
Income tax benefit | 2,079 | 1,829 | 3,713 | 160 | |||||||||||
Net loss | $ | (32,389 | ) | $ | (14,091 | ) | $ | (56,109 | ) | $ | (2,901 | ) | |||
Basic and diluted loss per share | $ | (1.12 | ) | $ | (0.49 | ) | $ | (1.94 | ) | $ | (0.10 | ) | |||
Basic and diluted average shares outstanding | 28,891,827 | 28,661,588 | 28,874,385 | 28,408,474 |
Condensed Consolidated Balance Sheets | |||||||
(unaudited) | |||||||
(In thousands) | |||||||
2016 | 2015 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash, cash equivalents and certificates of deposit | $ | 160,527 | $ | 197,800 | |||
Prepaid expenses and other current assets | 7,228 | 10,342 | |||||
Income tax receivable | 4,259 | — | |||||
Total current assets | 172,014 | 208,142 | |||||
Property and equipment, net | 7,435 | 10,400 | |||||
Total assets | $ | 179,449 | $ | 218,542 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 21,380 | $ | 12,422 | |||
Unearned revenue | 838 | 892 | |||||
Other current liabilities | 327 | 667 | |||||
Income taxes payable | — | 859 | |||||
Total current liabilities | 22,545 | 14,840 | |||||
Long-term liabilities: | |||||||
Royalty obligation payable | 6,000 | 6,000 | |||||
Notes payable and obligations under capital leases | 395 | 368 | |||||
Deferred rent | 1,109 | 1,153 | |||||
Unearned revenue | 56 | 407 | |||||
Total long-term liabilities | 7,560 | 7,928 | |||||
Total liabilities | 30,105 | 22,768 | |||||
Stockholders' equity: | |||||||
Common stock | 290 | 288 | |||||
Additional paid-in capital | 286,300 | 276,610 | |||||
(784 | ) | (771 | ) | ||||
Accumulated deficit | (136,462 | ) | (80,353 | ) | |||
Total stockholders' equity | 149,344 | 195,774 | |||||
Total liabilities and stockholders' equity | $ | 179,449 | $ | 218,542 | |||
Corporate Contact:Source:Jack Henneman Chief Financial Officer (515) 598-2561 Investor@linkp.com Investor & Media Contact:Beth Kurth LaVoieHealthScience 617-374-8800, ext. 106 bkurth@lavoiehealthscience.com
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