NewLink Genetics Reports Third Quarter 2017 Financial Results and Updates Indoximod Program
"We are pleased with the progress we have made advancing indoximod into our pivotal trial in melanoma. Additionally, the clinical collaboration with AstraZeneca in pancreatic cancer represents a significant step toward expanding the opportunity for indoximod beyond melanoma," said
- Established the design of our pivotal trial for patients with advanced melanoma. The Phase 3 trial will evaluate indoximod in combination with both approved PD-1 checkpoint inhibitors, KEYTRUDA
® (pembrolizumab) and OPDIVO® (nivolumab), in approximately 600 patients with advanced melanoma. Co-primary endpoints of the study are Progression Free Survival (PFS) by RECIST criteria and Overall Survival (OS).
- Phase 2 data for indoximod plus PD-1 checkpoint inhibitor KEYTRUDA (pembrolizumab) updated for the original 51-patient advanced melanoma cohort first presented at AACR in April demonstrated improvement in complete response rates. The Complete Response (CR) improved to 20% from 12% as the data matured, and the 12-month PFS by RECIST criteria was 56% with a median PFS (mPFS) of 12.9 months.
- Entered a clinical collaboration agreement with AstraZeneca to evaluate the combination of indoximod and IMFINZI™ (durvalumab), AstraZeneca's anti-PD-L1 monoclonal antibody, along with standard of care chemotherapy in a
randomized, placebo-controlled Phase 2 trial for patients with metastatic pancreatic cancer.
- Indoximod was granted Orphan Drug Designation by the
FDAfor patients with Stage IIb-IV melanoma.
- Dosed the first patients with the novel salt formulation of indoximod. As planned, this was done in the ongoing Phase 1b study of indoximod in combination with standard of care chemotherapy for patients with newly diagnosed Acute Myeloid Leukemia (AML). All subsequent trials will utilize the new formulation of indoximod.
$55.2 millionnet of expenses in underwritten public offering led by Bank of America Merrill Lynchand Stifelsubsequent to the third quarter. During the third quarter, we raised an additional $19.3 millionnet of expenses in an "at-the-market" facility, with Cantor Fitzgeraldas agent.
Guidance for remainder of 2017 and 2018:
- Initiate the Pivotal trial of indoximod in combination with PD-1 checkpoint blockade for patients with advanced melanoma, with the goal of enrollment by end of 2018.
- Present final results of Phase 2 trial of indoximod plus checkpoint inhibitors for patients with advanced melanoma during 2018.
- Present final results of Phase 2 trial of indoximod plus gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer at an oncology meeting 1H 2018.
- Initiate the randomized Phase 2 trial of indoximod plus durvalumab plus gemcitabine/nab-paclitaxel for patients with metastatic pancreatic cancer 1H 2018.
Financial Results for the Three-Month Period Ended September 30, 2017
Cash Position: NewLink Genetics ended the third quarter with cash and cash equivalents totaling $120.7 million compared to $131.5 million for the year ending December 31, 2016.
R&D Expenses: Research and development expenses were $18.5 million in the third quarter of 2017 compared to $24.5 million in the third quarter of 2016. The decrease of
G&A Expenses: General and administrative expenses in the third quarter of 2017 were $7.9 million compared to $7.7 million in the third quarter of 2016. The increase of
Net Loss: NewLink Genetics reported a net loss of $20.6 million or $0.69 per diluted
share for the third quarter of 2017 compared to a net loss of $15.5 million or
NewLink Genetics ended the quarter with 31,319,751 shares outstanding.
Financial Guidance and Upcoming Investor Meetings
We expect to end 2017 with approximately
We look forward to presenting at the Stifel Healthcare Conference in
Conference Call Details
The Company has scheduled a conference call for 8:30 a.m. ET today to discuss the results and to give an update.
Access to the live conference call is available by dialing (855) 469-0612 (
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is one of the key immuno-oncology targets involved in regulating the tumor microenvironment and immune escape.
KEYTRUDA® is a registered trademark of Merck, Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
OPDIVO® is a registered trademark of
IMFINZI™ is a registered trademark of AstraZeneca.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
Director of Investor Relations
AVP, Public & Media Relations
617-374-8800, ext. 108
|Condensed Consolidated Statements of Operations|
|(In thousands, except share and per share amounts)|
|Three Months Ended||Nine Months Ended|
|Licensing and collaboration revenue||103||888||334||3,008|
|Total operating revenues||5,482||15,345||18,613||23,065|
|Research and development||18,480||24,463||52,405||73,810|
|General and administrative||7,907||7,749||25,038||26,043|
|Loss from operations||(20,905||)||(16,867||)||(58,830||)||(76,788||)|
|Other income (expense), net||160||19||136||118|
|Net loss before taxes||(20,745||)||(16,848||)||(58,694||)||(76,670||)|
|Income tax benefit||119||1,308||429||5,021|
|Basic and diluted loss per share||$||(0.69||)||$||(0.54||)||$||(1.98||)||$||(2.48||)|
|Basic and diluted average shares outstanding||29,939,823||28,983,561||29,462,226||28,911,042|
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$||120,702||$||131,490|
|Prepaid expenses and other current assets||2,701||5,921|
|Income tax receivable||114||5,975|
|Total current assets||134,187||167,912|
|Property and equipment, net||5,527||6,835|
|Liabilities and Stockholders' Equity|
|Accounts payable and accrued expenses||$||25,692||$||37,192|
|Other current liabilities||287||322|
|Total current liabilities||26,091||37,905|
|Royalty obligation payable||6,000||6,000|
|Notes payable and obligations under capital leases||138||285|
|Total long-term liabilities||7,159||7,376|
|Additional paid-in capital||331,036||295,535|
|Total stockholders' equity||106,464||129,466|
|Total liabilities and stockholders' equity||$||139,714||$||174,747|
News Provided by Acquire Media