NewLink Genetics Corporation Provides Operational Update and Reports Third Quarter 2016 Financial Results
"We continue to focus our clinical developmental efforts targeting the IDO pathway. We have two distinct IDO pathway inhibitors advancing in the clinic, GDC-0919 with our partner
The Company hosted an investor day on
"As described at our investor day, we believe 2017 will be an important year in the development of both GDC-0919 and indoximod and we look forward to providing further updates and results," added
The program featured leaders in the field of immuno-oncology and pioneers in the science of IDO: George
Key takeaways from the Investor Day included:
1. Validation of IDO as a Target. The IDO pathway can allow cancer to escape the immune system. Many cancers have developed the ability to employ IDO to evade immune attack. We believe clinical results are increasingly validating the IDO pathway as a target for cancer therapies. Just as scientists discovered the role of PD-1/PD-L1 expression and the usefulness of PD-1/PD-L1 blockade, there is an increasing body of research into the role of the IDO pathway in cancer.
2. NewLink's Two IDO Pathway Inhibitor Clinical Candidates. NewLink Genetics is engaged in clinical trials for two IDO pathway inhibitor product candidates, each with its own distinct mechanism of action.
- GDC-0919, a direct IDO enzymatic inhibitor, is being developed in partnership with Genentech. GDC-0919 is currently in a Phase 1b trial, in combination with atezolizumab in solid tumors. In October, 2014, NewLink and Genentech entered in to a license and collaboration agreement with an upfront payment of $150 million, more than $1 billion in potential milestones, and substantial royalties.
- Indoximod, an IDO pathway inhibitor, is proprietary to NewLink Genetics. Indoximod is being tested in the clinic in multiple indications including melanoma, pancreatic cancer, malignant brain
tumors, breast cancer, acute myeloid leukemia, and non-small cell lung cancer.
3.
4. Future R&D. NewLink also discussed its program targeting the PTEN pathway in regulatory T cells (Treg cells) as a central driver of tumor immunosuppression. NewLink Genetics is an early leader in the field of PTEN research, just as it was in developing IDO as a potential pathway for immune suppression in cancer.
Financial Results for the Three-Month Period Ended
Cash Position:
R&D Expenses: Research and development expenses in the third quarter of 2016 were
G&A Expenses: General and administrative expenses in the third quarter of 2016 were $7.7 million compared to $7.4 million during the comparable period in 2015. The increase was due primarily to an increase of
Net Income/Loss:
Financial Guidance and Upcoming Investor Meetings
We have presented at seven investor meetings and conferences since the beginning of the year, including our own investor day held last week. We expect to present at three upcoming conferences in
Conference Call
The Company has scheduled a conference call for
About
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements of NewLink that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "target," "potential," "will," "could," "should," "seek" or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about NewLink Genetics' financial guidance for 2016; results of its clinical trials for product candidates; its timing of release of data from ongoing clinical
studies; its plans related to moving additional indications into clinical development; NewLink Genetics' future financial performance, results of operations, cash position and sufficiency of capital resources to fund its operating requirements; and any other statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink makes due to a number of important factors, including those risks discussed in "Risk Factors" and elsewhere in NewLink Genetics' Annual Report on Form 10-K for the year ended
| Condensed Consolidated Statements of Operations | |||||||||||||||
| (unaudited) | |||||||||||||||
| (In thousands, except share and per share amounts) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| 2016 | 2015 | 2016 | 2015 | ||||||||||||
| Grant revenue | $ | 14,457 | $ | 13,365 | $ | 20,057 | $ | 26,294 | |||||||
| Licensing and collaboration revenue | 888 | 844 | 3,008 | 34,555 | |||||||||||
| Total revenue | 15,345 | 14,209 | 23,065 | 60,849 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 24,463 | 22,508 | 73,810 | 56,619 | |||||||||||
| General and administrative | 7,749 | 7,384 | 26,043 | 23,007 | |||||||||||
| Loss from operations | (16,867 | ) | (15,683 | ) | (76,788 | ) | (18,777 | ) | |||||||
| Other income (expense), net | 19 | (63 | ) | 118 | (30 | ) | |||||||||
| Net loss before taxes | (16,848 | ) | (15,746 | ) | (76,670 | ) | (18,807 | ) | |||||||
| Income tax benefit (expense) | 1,308 | (160 | ) | 5,021 | — | ||||||||||
| Net loss | $ | (15,540 | ) | $ | (15,906 | ) | $ | (71,649 | ) | $ | (18,807 | ) | |||
| Basic and diluted loss per share | $ | (0.54 | ) | $ | (0.55 | ) | $ | (2.48 | ) | $ | (0.66 | ) | |||
| Basic and diluted average shares outstanding | 28,983,561 | 28,734,768 | 28,911,042 | 28,518,503 | |||||||||||
| Condensed Consolidated Balance Sheets | |||||||
| (unaudited) | |||||||
| (In thousands) | |||||||
| 2016 | 2015 | ||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash, cash equivalents and certificates of deposit | $ | 148,276 | $ | 197,800 | |||
| Prepaid expenses and other current assets | 25,683 | 10,342 | |||||
| Income tax receivable | 5,197 | — | |||||
| Total current assets | 179,156 | 208,142 | |||||
| Property and equipment, net | 7,188 | 10,400 | |||||
| Total assets | $ | 186,344 | $ | 218,542 | |||
| Liabilities and Stockholders' Equity | |||||||
| Current liabilities: | |||||||
| Accounts payable and accrued expenses | $ | 39,626 | $ | 12,422 | |||
| Unearned revenue | 693 | 892 | |||||
| Other current liabilities | 326 | 667 | |||||
| Income taxes payable | — | 859 | |||||
| Total current liabilities | 40,645 | 14,840 | |||||
| Long-term liabilities: | |||||||
| Royalty obligation payable | 6,000 | 6,000 | |||||
| Notes payable and obligations under capital leases | 333 | 368 | |||||
| Deferred rent | 1,089 | 1,153 | |||||
| Unearned revenue | — | 407 | |||||
| Total long-term liabilities | 7,422 | 7,928 | |||||
| Total liabilities | 48,067 | 22,768 | |||||
| Stockholders' equity: | |||||||
| Common stock | 291 | 288 | |||||
| Additional paid-in capital | 290,772 | 276,610 | |||||
| (784 | ) | (771 | ) | ||||
| Accumulated deficit | (152,002 | ) | (80,353 | ) | |||
| Total stockholders' equity | 138,277 | 195,774 | |||||
| Total liabilities and stockholders' equity | $ | 186,344 | $ | 218,542 | |||
Corporate Contact:Jack Henneman Chief Financial Officer,NewLink Genetics 515-598-2561 Investor@linkp.com Investors:Donna LaVoie LaVoieHealthScience 617-374-8800, ext. 107 dlavoie@lavoiehealthscience.com Media:David Connolly LaVoieHealthScience 617-374-8800, ext. 108 dconnolly@lavoiehealthscience.com
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