On May 4, 2017 NewLink Genetics Corporation (NASDAQ:NLNK), reported consolidated financial results for the first quarter 2017, as well as progress in its clinical development programs (Press release, NewLink Genetics, MAY 4, 2017, View Source [SID1234518856]).

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Recent Highlights:

Presented promising interim Phase 2 data of the IDO pathway inhibitor, indoximod, in combination with KEYTRUDA (pembrolizumab) for patients with advanced melanoma at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) plenary session on April 4, 2017
Presented a poster on NLG802, "A novel prodrug of indoximod with enhanced pharmacokinetic properties," at AACR (Free AACR Whitepaper) on April 4, 2017
Abstract accepted for presentation at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) for a randomized double-blind, placebo-controlled Phase 2 study of indoximod in combination with the vaccine, PROVENGE (sipuleucel-T), for patients with metastatic castration resistant prostate cancer
Abstract accepted for presentation at the 2017 ASCO (Free ASCO Whitepaper) Annual Meeting submitted by our partner on a Phase 1b dose-escalation study of navoximod (GDC-0919) in combination with TECENTRIQ (atezolizumab) in multiple solid tumors
"We believe that the emerging clinical data from NewLink Genetics and other companies are validating the fundamental hypothesis that the IDO pathway is central to immuno-suppression in cancer," said Charles J. Link, Jr. MD, Chairman, Chief Executive Officer and Chief Scientific Officer. "We have two distinct IDO pathway inhibitors advancing in the clinic, indoximod – which is wholly-owned by NewLink Genetics – and navoximod (GDC-0919), which is partnered to Genentech/Roche. In addition, we have a next-generation compound, a novel prodrug of indoximod, NLG802, which we expect to enter the clinic by the end of Q3 this year."

Guidance for remainder of 2017:

Metastatic castration resistant prostate cancer: Randomized, placebo-controlled Phase 2 clinical trial data to be presented at ASCO (Free ASCO Whitepaper) on Monday, June 5, 2017
Metastatic pancreatic cancer: Indoximod in combination with gemcitabine + ABRAXANE (nab-paclitaxel) Phase 2 trial to be presented at an upcoming medical meeting in the second half of 2017
Acute Myeloid Leukemia (AML): Interim data from a Phase 1b dose-escalation study of indoximod in combination with standard of care chemotherapy for patients with newly diagnosed AML to be presented second half of 2017
The Company announced that it intends to initiate a pivotal trial of indoximod plus anti-PD-1 inhibitors for patients with advanced melanoma by the end of 2017. The trial is expected to use an adaptive design that incorporates a brief dose confirmation stage followed by a definitive randomized stage.

"The clinical data for indoximod in advanced melanoma establishes the basis for this pivotal trial," said Nicholas N. Vahanian, MD, President and Chief Medical Officer.

Financial Results:

Cash Position: NewLink Genetics ended the first quarter with cash and cash equivalents totaling $118.2 million compared to $131.5 million for the year ending December 31, 2016.

We expect to end 2017 with approximately $75 million in cash and equivalents, which excludes any cash that may be received from financings or milestones.

R&D Expenses: Research and development expenses were $15.7 million in the first quarter of 2017 compared to $21.9 million in the first quarter of 2016. The decrease was due primarily to a $4.6 million decline in clinical trial and manufacturing-related spend, a decrease in personnel-related spend of $1.4 million, and a decrease in licensing and consulting fees of $1.0 million, offset by an increase in stock compensation expense of $822,000.

G&A Expenses: General and administrative expenses in the first quarter of 2017 were $8.2 million compared to $9.2 million in the first quarter of 2016. The decrease was due to a decline of $700,000 in consulting and legal fees, a decrease of $700,000 in personnel-related spend, offset by an increase in stock compensation expense of $437,000.

Net Loss: NewLink Genetics reported a net loss of $20.9 million or loss of $0.72 per diluted share for the first quarter of 2017 compared to a net loss of $23.7 million or loss of $0.82 per diluted share for the first quarter of 2016.

NewLink Genetics ended Q1 2017 with 29,219,661 shares outstanding.

On May 4, 2017 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported financial results for the first quarter ended March 31, 2017, and provided a business update (Filing, Q1, Corvus Pharmaceuticals, 2017, MAY 4, 2017, View Source [SID1234518836]).

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"We are continuing to make significant progress in our Phase 1/1b trial, which is designed to rapidly identify the diseases where our lead product candidate, CPI-444, has the greatest potential both as a single agent and in combination with atezolizumab," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "This strategic design has allowed us to identify four cohorts for expansion based on the demonstration of anti-tumor activity in renal cell cancer and non-small cell lung cancer, especially in patients that are resistant or refractory to prior treatment with anti-PD(L)-1 antibodies, and whose tumors are PDL-1 negative, an extremely difficult to treat patient population. We look forward to presenting additional clinical data from these cohorts in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2017."

Recent Achievements and Upcoming Milestones
Clinical & Preclinical Development

Expanded four cohorts from 14 to 26 patients in the ongoing disease-specific expansion part of the Phase 1/1b clinical study of the Company’s lead oral checkpoint inhibitor, CPI-444. The expanded cohorts include treatment with both CPI-444 as a single agent and in combination with atezolizumab (Tecentriq), an anti-PD-L1 antibody, in renal cell cancer (RCC) and non-small cell lung cancer (NSCLC).
Presented interim safety data on 113 patients and efficacy data for 96 patients enrolled the Company’s Phase 1/1b study at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017. The data showed that treatment with CPI-444 was well tolerated, provided disease control and induced tumor regression in a number of patients with extensive disease, especially in patients who were resistant/refractory to prior treatment with anti-PD(L)-1 antibodies.
Plan to present clinical data from the four disease expansion cohorts in both RCC and NSCLC at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2017.
Continued to progress anti-CD73 antibody and ITK inhibitor programs toward Phase 1 study initiation in 2018.
Corporate Development

On May 1, 2017, Corvus expanded its collaboration agreement with Genentech, a member of the Roche Group. Under the new agreement, CPI-444 administered in combination with atezolizumab (Tecentriq) will be evaluated in a Phase 1b/2 randomized, controlled clinical study as second-line therapy in patients with non-small cell lung cancer (NSCLC) who are resistant/refractory to prior therapy with an anti PD(L)-1 antibody. It is anticipated that the study will enroll up to 65 patients in the treatment arm. Genentech will manage study operations for the Phase 1b/2 trial, which is expected to begin enrolling patients in the second half of 2017. Corvus retains global development and commercialization rights to CPI-444.
Financial Results

At March 31, 2017, Corvus had cash, cash equivalents and marketable securities totaling $122.1 million. This compared to cash, cash equivalents and marketable securities of $134.9 million at December 31, 2016.

Research and development expenses for the three months ended March 31, 2017 totaled $13.5 million compared to $5.4 million for the same period in 2016. The increase of $8.1 million was primarily due to an increase of $2.1 million in outside costs for the Phase 1/1b clinical trial for CPI-444, an increase of $1.7 million in drug manufacturing costs for our anti-CD73 antibody program, an increase of $0.8 million in personnel and related costs associated with higher headcount and a $3.0 million milestone payment made to Vernalis plc pursuant to our license agreement.

General and administrative expenses for the three months ended March 31, 2017 totaled $2.7 million compared to $1.0 million for the same period in 2016. The increase of $1.7 million was primarily due to an increase of $0.9 million in personnel and associated costs, primarily due to an increase in headcount and a $0.5 million increase in legal and accounting costs.

The net loss for the three months ended March 31, 2017 was $16.0 million compared to $6.4 million for the same period in 2016. Total stock compensation expense for the three months ended March 31, 2017 was $1.5 million compared to $0.4 million for the same period in 2016.

MacroGenics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Myriad Genetics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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vTv Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, vTv Therapeutics, 2017, MAY 3, 2017, View Source [SID1234521347]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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