On July 30, 2019 NewLink Genetics Corporation (NASDAQ:NLNK) ("NewLink Genetics" or the "Company") reported financial results for the second quarter ended June 30, 2019 and provided an update on clinical and corporate developments, including a transition of management (Press release, NewLink Genetics, JUL 30, 2019, View Source [SID1234537880]). Charles J. Link, Jr, M.D. has chosen to retire from his posts as Chairman, Chief Executive Officer and Chief Scientific Officer, and has also resigned from the Board, effective August 3, 2019. Dr. Link cofounded NewLink Genetics in 1999 and served as the Company’s Chief Scientific Officer until his additional appointment to CEO and Chairman in 2003.

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NewLink Genetics’ Board of Directors has established an Office of the CEO. Effective August 3rd, members of the Office of the CEO will lead the company to advance its strategic goals. The Board of Directors has elected Carl Langren, Chief Financial Officer; Eugene Kennedy, M.D., Chief Medical Officer; Brad Powers, General Counsel; and Lori Lawley, Vice President, Finance and Controller to the Office of the CEO. Reporting to the Board of Directors, the members of the Office of the CEO have been given full executive authority and will oversee the execution of the Company’s operations and strategic initiatives.

"I am grateful and deeply honored to have had the opportunity to lead NewLink Genetics and work alongside some incredibly talented people on projects dedicated to patients with great unmet medical need," said Charles J. Link Jr, M.D. "I have confidence that the company and its leadership have the resources to move forward and succeed and I look forward to watching the company’s progress. I plan to enjoy spending more time with my family as well."

"NewLink Genetics is grateful to our co-founder, Charles Link, for his 20 years of service in building the Company," said Thomas A. Raffin, M.D., Lead Independent Director of NewLink Genetics. "The Board of Directors and Company are thankful to Chuck for his many contributions and for fostering our mission of improving the lives of patients and their families. Moving forward, we are fully confident that the leadership team in the Office of the CEO is positioned to advance the Company’s goals following Chuck’s retirement."

NewLink Genetics ended the second quarter with $105.4 million in cash. The Company continues to evaluate potential acquisition, in-licensing, or other opportunities to broaden its pipeline, assist patients, and create value for shareholders.

Clinical Update

The Company presented updated data from a Phase 1 dose-escalation study of NLG802, a prodrug of indoximod, at the Immuno-Oncology 2019 2nd World Congress in Barcelona, Spain, May 23-24, 2019.

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 licensing application for this vaccine, V920 (rVSV∆G-ZEBOV-GP), is under review at the FDA, the European Medicines Agency (EMA), the World Health Organization (WHO), and African countries. Should this vaccine be approved by the FDA, a Priority Review Voucher (PRV) would be issued, in which NewLink Genetics owns a substantial financial interest.

Financial Results for the Three-Month Period Ended June 30, 2019

Cash Position: NewLink Genetics ended the quarter on June 30, 2019, with cash and cash equivalents totaling $105.4 million compared to $120.7 million on December 31, 2018. The Company projects its cash position is sufficient to fund planned operations through the end of 2021.

R&D Expenses: Research and development expenses for the second quarter of 2019 were $5.2 million, a decrease of $6.9 million from $12.1 million for the same period in 2018. The decrease was primarily due to reductions of $2.4 million in contract research and manufacturing spend, $2.0 million in clinical trial expense, $1.8 million in personnel-related and stock compensation expense, $400,000 in supplies and licensing, and $300,000 in legal and consulting expense.

G&A Expenses: General and administrative expenses in the second quarter of 2019 were $5.6 million, a decrease of $2.3 million from $7.9 million for the same period in 2018. The decrease was due primarily to reductions of $1.9 million in personnel-related and stock compensation expense and $400,000 in supplies.

Net Loss: NewLink Genetics reported a net loss of $(10.1) million or $(0.27) per diluted share for the second quarter of 2019 compared to a net loss of $(17.3) million or $(0.47) per diluted share for the second quarter of 2018.

NewLink Genetics ended the second quarter of 2019 with 37,300,960 shares outstanding.