CORRECTED: NewLink Genetics Reports Third Quarter 2018 Financial Results and Announces Abstracts to Be Presented at Upcoming Medical Meetings
“NewLink Genetics continues to produce encouraging data supporting indoximod in targeted cancer indications. We remain confident in the advancement of our clinical programs as we strive to develop novel therapies addressing areas of great unmet need,” said
Data to be Presented at Upcoming Medical Meetings
- Abstract accepted for oral presentation at the ASH Annual Meeting,
December 1-4, 2018
• Abstract 332: Indoximod combined with standard induction chemotherapy is well tolerated and induces a high rate of complete remission with MRD-negativity in patients with newly diagnosed AML: results from a Phase 1 trial, Emadi, A., et al. - to be presented during the oral session, 616 entitled “Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Combination Therapy” Sunday, Dec 2, 2018, 9:30-11:00 AM PT . Data indicate that a high percentage of newly diagnosed AML patients treated with indoximod plus standard-of-care (SOC) chemotherapy achieved complete response (CR) and showed no evidence of minimal residual disease (were MRD-negative). Indoximod was well tolerated. - Abstracts accepted for poster presentation at the SITC Annual Meeting,
November 7-11, 2018
• Abstract 11213: A phase 1a clinical trial ofNLG802 , a prodrug of indoximod with enhanced pharmacokinetic properties, Rixe, O., et al. (Poster #P331)
• Abstract 10294: The immunogenomic impact of indoximod on the tumor microenvironment of melanoma patients, Yu, J., et al. (Poster #P142)
• Abstract 10304: Effects of indoximod plus gemcitabine/nab-paclitaxel on tumor microenvironment of patients with metastatic pancreatic cancer, Yu, J., et al. (Poster #P706)
• Posters are being presented onFriday, November 9 th, andSaturday, November 10 th, from8 AM to 8 PM , in Exhibition Hall E of theWalter E. Washington Convention Center .
Outlook for 2019
- Updated results from Phase 1 trial of indoximod plus radiotherapy for pediatric patients with recurrent malignant brain tumors including initial survival data expected to be presented 1H 2019
- Updated data from Phase 1 trial of indoximod plus radiotherapy in DIPG anticipated in 2019
- Data from Phase 2 trial of
NLG207 (CRLX101), a nanoparticle formulation of the topoisomerase 1 inhibitor, camptothecin, plus paclitaxel in recurrent ovarian cancer anticipated in 2019
Clinical Update
A Phase 2 study evaluating
Board Changes
Financial Results for the Three-Month Period Ended
Cash Position:
R&D Expenses: Research and development expenses for the third quarter of 2018 were
G&A Expenses: General and administrative expenses for the third quarter of 2018 were
Net Loss:
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.
Access to the live conference call is available by dialing (855) 235-8286 (U.S.) or (267) 753-2161 (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 10 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 1753698. 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, suppressing immune response and allowing for immune escape by degrading tryptophan with the resultant production of kynurenine. Indoximod reverses the immunosuppressive effects of low tryptophan and high kynurenine through mechanisms that include modulation of the AhR-driven transcription of genes that control immune function. This results in increased proliferation of effector T cells, increased differentiation into helper T cells rather than regulatory T cells, and downregulation of IDO expression in dendritic cells. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications including recurrent pediatric brain tumors, DIPG, and AML.
About NewLink Genetics Corporation
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of NewLink that involve substantial risks and uncertainties. All statements contained in this press release are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words "guidance," "upcoming," "will," "plan," “intend,” "anticipate," "approximate," "expect," 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 2018; 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; the effects of its organizational realignment; 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 December 31, 2017 and other reports filed with the U.S. Securities and Exchange Commission (
Investor Contact & Media Contact:
Director of Investor Relations
515-598-2555
lmiller@linkp.com
NewLink Genetics Corporation | |||||||||||||||
Condensed Consolidated Statements of Operations | |||||||||||||||
(unaudited) | |||||||||||||||
(In thousands, except share and per share amounts) | |||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Grant revenue | $ | — | $ | 5,379 | $ | 11,268 | $ | 18,279 | |||||||
Licensing and collaboration revenue | 120 | 103 | 1,004 | 334 | |||||||||||
Total operating revenues | 120 | 5,482 | 12,272 | 18,613 | |||||||||||
Operating expenses: | |||||||||||||||
Research and development | 7,570 | 18,480 | 39,972 | 52,405 | |||||||||||
General and administrative | 7,588 | 7,907 | 23,792 | 25,038 | |||||||||||
Total operating expenses | 15,158 | 26,387 | 63,764 | 77,443 | |||||||||||
Loss from operations | (15,038 | ) | (20,905 | ) | (51,492 | ) | (58,830 | ) | |||||||
Other income and expense: | |||||||||||||||
Miscellaneous income (expense) | (18 | ) | 12 | 16 | (101 | ) | |||||||||
Interest income | 664 | 151 | 1,510 | 353 | |||||||||||
Interest expense | (2 | ) | (3 | ) | (51 | ) | (116 | ) | |||||||
Other income (expense), net | 644 | 160 | 1,475 | 136 | |||||||||||
Net loss before taxes | (14,394 | ) | (20,745 | ) | (50,017 | ) | (58,694 | ) | |||||||
Income tax benefit | 6,991 | 119 | 6,991 | 429 | |||||||||||
Net loss | $ | (7,403 | ) | $ | (20,626 | ) | $ | (43,026 | ) | $ | (58,265 | ) | |||
Basic and diluted loss per share | $ | (0.20 | ) | $ | (0.69 | ) | $ | (1.16 | ) | $ | (1.98 | ) | |||
Basic and diluted average shares outstanding | 37,214,363 | 29,939,823 | 37,178,542 | 29,462,226 | |||||||||||
NewLink Genetics Corporation | |||||||
Condensed Consolidated Balance Sheets | |||||||
(unaudited) | |||||||
(In thousands) | |||||||
Year Ended | |||||||
September 30, | December 31, | ||||||
2018 | 2017 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 122,061 | $ | 158,708 | |||
Prepaid expenses and other current assets | 4,920 | 6,226 | |||||
Income tax receivable | 7,398 | 356 | |||||
Other receivables | 700 | 10,176 | |||||
Total current assets | 135,079 | 175,466 | |||||
Property and equipment, net | 4,096 | 5,091 | |||||
Income tax receivable | 140 | $ | 140 | ||||
Total non-current assets | 4,236 | $ | 5,231 | ||||
Total assets | $ | 139,315 | $ | 180,697 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,238 | $ | 9,256 | |||
Accrued expenses | 8,736 | 12,467 | |||||
Current portion of unearned revenue | — | 56 | |||||
Current portion of deferred rent | 84 | 92 | |||||
Current portion of notes payable and obligations under capital leases | 74 | 160 | |||||
Total current liabilities | 10,132 | 22,031 | |||||
Long-term liabilities: | |||||||
Royalty obligation payable to Iowa Economic Development Authority | 6,000 | 6,000 | |||||
Notes payable and obligations under capital leases | 59 | 111 | |||||
Deferred rent | 929 | 998 | |||||
Total long-term liabilities | 6,988 | 7,109 | |||||
Total liabilities | 17,120 | 29,140 | |||||
Stockholders' equity: | |||||||
Blank check preferred stock, $0.01 par value: Authorized shares - 5,000,000 at September 30, 2018 and December 31, 2017; issued and outstanding shares - 0 at September 30, 2018 and December 31, 2017 | — | — | |||||
Common stock, $0.01 par value: Authorized shares - 75,000,000 at September 30, 2018 and December 31, 2017; issued 37,305,626 and 37,168,122 at September 30, 2018 and December 31, 2017, respectively, and outstanding 37,216,892 and 37,109,556 at September 30, 2018 and December 31, 2017, respectively | 373 | 372 | |||||
Additional paid-in capital | 403,674 | 389,786 | |||||
Treasury stock, at cost: 88,734 and 58,566 shares at September 30, 2018 and December 31, 2017, respectively | (1,409 | ) | (1,142 | ) | |||
Accumulated deficit | (280,443 | ) | (237,459 | ) | |||
Total stockholders' equity | 122,195 | 151,557 | |||||
Total liabilities and stockholders' equity | $ | 139,315 | $ | 180,697 | |||
Source: NewLink Genetics Corporation