NewLink Genetics Reports First Quarter 2019 Financial Results and Provides Clinical Activities Update
“We continued to make progress across our clinical programs this year. We look forward to presenting additional encouraging data later this month on
Clinical Update and Anticipated Upcoming Milestones
The Company has had an abstract accepted, and plans to present updated data from a Phase 1 dose-escalation study of
The Phase 2 study of
Updated results from the cohort of patients with DIPG in the efficacy portion of a Phase 1b study of indoximod for the treatment of pediatric patients with recurrent malignant brain tumors are anticipated later in 2019.
In reference to NewLink Genetics’ partnered Ebola vaccine candidate, Merck recently announced that the
Financial Results for the Three-Month Period Ended
Cash Position:
R&D Expenses: Research and development expenses for the first quarter of 2019 were
G&A Expenses: General and administrative expenses in the first quarter of 2019 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 its financial results and to give an update on clinical and business development activities. There will also be a question and answer session following management’s prepared remarks.
Access to the live conference call is available five minutes prior to the start of the call by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) and using the conference ID 8457627. 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 conference ID 8457627. 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 DIPG, recurrent pediatric brain tumors, and AML.
About
About
About NewLink Genetics Corporation
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of NewLink Genetics 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 2019 and beyond; results of its clinical trials for product candidates; its timing of release of data from ongoing clinical studies; its plans related to execution of clinical trials; 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 December 31, 2018 and other reports filed with the U.S. Securities and Exchange Commission (
Investor & Media Contact:
Director of Investor Relations
515-598-2555
lmiller@linkp.com
NewLink Genetics Corporation | |||||||
Consolidated Statements of Operations | |||||||
(unaudited) | |||||||
(In thousands, except share and per share amounts) | |||||||
Three Months Ended March 31, |
|||||||
2019 | 2018 | ||||||
Operating Revenues: | |||||||
Grant revenue | $ | — | $ | 9,384 | |||
Licensing and collaboration revenue | 106 | 516 | |||||
Total operating revenues | 106 | 9,900 | |||||
Operating expenses: | |||||||
Research and development | 5,203 | 20,314 | |||||
General and administrative | 5,567 | 8,292 | |||||
Total operating expenses | 10,770 | 28,606 | |||||
Loss from operations | (10,664 | ) | (18,706 | ) | |||
Other income and expense: | |||||||
Miscellaneous income | 5 | 24 | |||||
Interest income | 624 | 385 | |||||
Interest expense | (1 | ) | (13 | ) | |||
Other income, net | 628 | 396 | |||||
Net loss before taxes | (10,036 | ) | (18,310 | ) | |||
Income tax benefit | — | — | |||||
Net loss | $ | (10,036 | ) | $ | (18,310 | ) | |
Basic and diluted loss per share | $ | (0.27 | ) | $ | (0.49 | ) | |
Basic and diluted average shares outstanding | 37,275,459 | 37,155,082 | |||||
NewLink Genetics Corporation | |||||||
Condensed Consolidated Balance Sheets | |||||||
(unaudited) | |||||||
(In thousands) | |||||||
March 31, | December 31, | ||||||
2019 | 2018 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 113,184 | $ | 120,738 | |||
Prepaid expenses and other current assets | 4,447 | 5,536 | |||||
Income tax receivable | 341 | 339 | |||||
Other receivables | 305 | 459 | |||||
Total current assets | 118,277 | 127,072 | |||||
Property and equipment, net | 3,520 | 3,727 | |||||
Right-of-use asset | 7,334 | $ | — | ||||
Income tax receivable | 140 | $ | 140 | ||||
Total non-current assets | 10,994 | $ | 3,867 | ||||
Total assets | $ | 129,271 | $ | 130,939 | |||
Liabilities and Stockholders' Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 896 | $ | 555 | |||
Accrued expenses | 6,950 | 8,139 | |||||
Current portion of deferred rent | — | 92 | |||||
Current portion of lease liability | 963 | ||||||
Current portion of notes payable | 63 | 61 | |||||
Total current liabilities | 8,872 | 8,847 | |||||
Long-term liabilities: | |||||||
Royalty obligation payable to Iowa Economic Development Authority | 6,000 | 6,000 | |||||
Notes payable | 27 | 43 | |||||
Lease Liability | 7,353 | ||||||
Deferred rent | — | 906 | |||||
Total long-term liabilities | 13,380 | 6,949 | |||||
Total liabilities | 22,252 | 15,796 | |||||
Stockholders' equity: | |||||||
Blank check preferred stock, $0.01 par value: Authorized shares — 5,000,000 at March 31, 2019 and December 31, 2018; issued and outstanding shares — 0 at March 31, 2019 and December 31, 2018 | — | — | |||||
Common stock, $0.01 par value: Authorized shares — 75,000,000 at March 31, 2019 and December 31, 2018; issued 37,387,876 and 37,343,547 at March 31, 2019 and December 31, 2018, respectively, and outstanding 37,276,102 and 37,251,220 at March 31, 2019 and December 31, 2018, respectively | 373 | 373 | |||||
Additional paid-in capital | 409,143 | 407,199 | |||||
Treasury stock, at cost: 111,774 and 92,327 shares at March 31, 2019 and December 31, 2018, respectively | (1,449 | ) | (1,417 | ) | |||
Accumulated deficit | (301,048 | ) | (291,012 | ) | |||
Total stockholders' equity | 107,019 | 115,143 | |||||
Total liabilities and stockholders' equity | $ | 129,271 | $ | 130,939 | |||
Source: NewLink Genetics Corporation