NewLink Genetics Reports Second Quarter 2017 Financial Results and Updates Indoximod Program
"We continue to focus on indoximod, our leading drug candidate, as it advances into late-stage clinical development," said
NewLink Geneticsrecently completed a successful face-to-face meeting with the FDAto review the proposed design for the pivotal trial with indoximod for patients with advanced melanoma.
- First patient dosed
in the Phase 1 study of
NLG802, a novel prodrug of indoximod. NLG802is a distinct investigational agent targeting the IDO pathway and represents an important step in the Company's product life-cycle planning.
- A Notice of Allowance (NOA) by the US Patent and Trade Office (USPTO) was received in early July for our patent application covering indoximod salts and prodrugs. When issued, this patent will provide exclusivity until 2036 and cover both the formulation of indoximod to be used in the pivotal trial and
- Phase 2 data from a randomized trial of indoximod in combination with the cancer vaccine, PROVENGE® (sipuleucel-T), for patients with metastatic castration resistant prostate cancer (mCRPC) were presented at the
American Society of Clinical Oncology(ASCO) Annual Meeting on June 5th. These data showed a statistically significant improvement in radiographic progression-free survival (rPFS) of 10.3 months compared to 4.1 months in the placebo arm, with no difference in adverse events between the two arms.
- Phase 1b data from a trial of indoximod in combination with standard of care chemotherapy for patients with newly diagnosed Acute Myeloid Leukemia (AML) were presented at
European Hematology Association(EHA) Annual Congress on June 23rd. These early data showed that after one cycle of induction therapy, 7/7 patients who achieved complete response (CR) were seen to have no evidence of minimal residual disease (MRD-neg), suggesting that the addition of indoximod has the potential to reduce the proportion of patients with evidence of leukemia after initial therapy.
Guidance for remainder of 2017:
- First patients dosed with novel salt formulation of indoximod.
- Updated data from Phase 2 trial of indoximod plus gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer to be presented at an oncology meeting in late 2017 or early 2018.
- Initiation of a pivotal trial of indoximod in combination with PD-1 checkpoint blockade for patients with advanced melanoma, with the goal of full enrollment by end of 2018.
Financial Results for the Three-Month Period Ended June 30, 2017
Cash Position: NewLink Genetics ended the second quarter with cash and cash equivalents totaling $107.8 million compared to $131.5 million for the year ending December 31, 2016.
R&D Expenses: Research and development expenses were $18.2 million in the second quarter of 2017 compared to $27.4 million in the second quarter of 2016. The decrease was due primarily to a $1.8 million decline in clinical trial spend, a decrease in supplies and other expense of
G&A Expenses: General and administrative expenses in the second quarter of 2017 were $8.9 million compared to $9.1 million in the second quarter of 2016. The decrease was due to a decline of $1.0 million in personnel-related spend, offset by an increase of
Net Loss: NewLink Genetics reported a net loss of $16.7 million or (
NewLink Genetics ended the quarter with 29,281,301 shares outstanding.
Financial Guidance and Upcoming Investor Meetings
We expect to end 2017 with approximately
We look forward to presenting at the Baird Healthcare Conference and the
Conference Call Details
The Company has scheduled a conference call for 8:30 a.m. ET today to discuss the results and to give an update.
Access to the live conference call is available by dialing (855) 469-0612 (
About NewLink Genetics Corporation
NewLink Genetics is a late-stage biopharmaceutical company focusing on discovering, developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer. NewLink Genetics' IDO pathway inhibitors are designed to harness multiple components of the immune system to combat cancer. Indoximod is being evaluated in combination with treatment regimens including PD-1 checkpoint blockade, cancer vaccines, and chemotherapy across multiple indications such as melanoma, prostate cancer, acute myeloid leukemia, and pancreatic cancer. For more information, please visit http://www.newlinkgenetics.com
PROVENGE® is a registered trademark of
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended||Six Months Ended|
|Licensing and collaboration revenue||56||750||231||2,120|
|Total operating revenues||10,370||2,012||13,131||7,720|
|Research and development||18,200||27,410||33,925||49,347|
|General and administrative||8,897||9,130||17,131||18,294|
|Loss from operations||(16,727||)||(34,528||)||(37,925||)||(59,921||)|
|Other income (expense), net||1||60||(24||)||99|
|Net loss before taxes||(16,726||)||(34,468||)||(37,949||)||(59,822||)|
|Income tax benefit||—||2,079||310||3,713|
|Basic and diluted loss per share||$||(0.57||)||$||(1.12||)||$||(1.29||)||$||(1.94||)|
|Basic and diluted average shares outstanding||29,255,386||28,891,827||29,219,469||28,874,385|
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$||107,777||$||131,490|
|Prepaid expenses and other current assets||4,916||5,921|
|Income tax receivable||6,287||5,975|
|Total current assets||130,238||167,912|
|Property and equipment, net||5,886||6,835|
|Liabilities and Stockholders' Equity|
|Accounts payable and accrued expenses||$||25,822||$||37,192|
|Other current liabilities||314||322|
|Total current liabilities||26,303||37,905|
|Royalty obligation payable||6,000||6,000|
|Notes payable and obligations under capital leases||173||285|
|Total long-term liabilities||7,218||7,376|
|Additional paid-in capital||306,556||295,535|
|Total stockholders' equity||102,603||129,466|
|Total liabilities and stockholders' equity||$||136,124||$||174,747|
Lisa MillerDirector of Investor Relations NewLink Genetics(515) 598-2555 firstname.lastname@example.org Media Contact: Andrew MastrangeloAVP, Public & Media Relations LaVoieHealthScience 617-374-8800, ext. 108 email@example.com
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