On May 3, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported consolidated financial results for the first quarter 2018 and reviewed recent highlights and upcoming milestones (Press release, NewLink Genetics, MAY 3, 2018, View Source [SID1234526083]).
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"NewLink Genetics continues to produce encouraging data supporting the differentiated mechanism of action of indoximod, its IDO pathway inhibitor, and the potential for indoximod in multiple therapeutic combinations to improve patient outcomes across a broad range of cancer indications," said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer.
Highlights
Abstracts accepted for presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting, June 2018
Abstract 4015 – Phase 2 trial of the IDO pathway inhibitor indoximod plus gemcitabine / nab-paclitaxel for the treatment of patients with metastatic pancreas cancer – to be presented during the discussion session, "Gastrointestinal (Noncolorectal) Cancer," Sunday, June 3, 2018, 4:45 PM – 6:00 PM CT
Abstract 9512 – Phase 2 trial of the IDO pathway inhibitor indoximod plus checkpoint inhibition for the treatment of patients with advanced melanoma – to be presented during the discussion session, "Melanoma/Skin Cancers," Monday, June 4, 2018, 4:45 PM – 6:00 PM CT
Abstracts presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 2018
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Abstract 3753 – Indoximod modulates AhR-driven transcription of genes that control immune function
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Abstract 10973 – Front-line therapy of DIPG using the IDO pathway inhibitor indoximod in combination with radiation and chemotherapy
Abstract, Radio-immunotherapy using the IDO pathway inhibitor indoximod for children with newly-diagnosed DIPG, to be presented at the 18th International Symposium on Pediatric Neuro-Oncology (ISPNO), Poster Session 1, Sunday, July 1, 2018, 5:00 PM – 6:30 PM MT
Data from Phase 1b trial of indoximod plus standard-of-care chemotherapy for patients with acute myeloid leukemia (AML) intended to be presented in the second half of 2018
Finalized the novel formulation of indoximod
Update on Clinical Programs and Financial Guidance
NewLink Genetics previously reported that it was undertaking a review of its clinical programs and determined it will not initiate its Phase 3 study of indoximod in combination with PD-1 inhibitors for patients with advanced melanoma. In addition, we have deprioritized pancreatic cancer and have mutually agreed with AstraZeneca not to proceed with the Phase 2 trial.
Clinical opportunities under consideration include high quality randomized studies of indoximod in one or more target disease states for which we have developed promising single-arm data over the last few years. Indoximod has demonstrated encouraging clinical data in a number of cancer indications including AML in combination with chemotherapy, DIPG in combination with radiation and chemotherapy, and melanoma in combination with checkpoint
Exhibit 99.1
blockade. When we complete the review of our clinical programs, we expect to have substantially reduced the rate at which the Company will be using cash. We intend to update our financial guidance when we report results for the second quarter.
Financial Results
Cash Position: NewLink Genetics ended the quarter on March 31, 2018, with cash and cash equivalents totaling $143.9 million compared to $158.7 million for the year ending December 31, 2017.
R&D Expenses: Research and development expenses for the three months ended March 31, 2018 were $20.3 million, an increase of $4.6 million from $15.7 million for the same period in 2017. The increase was due primarily to an increase of $8.4 million in contract research and manufacturing spend, an increase of $670,000 in clinical trial and legal and consulting expense, offset by a $2.1 million decrease in supplies, a $1.2 million decrease in personnel-related and stock compensation expense, and a $1.2 million decrease in licensing expenses.
G&A Expenses: General and administrative expenses for the three months ended March 31, 2018 were $8.3 million, an increase of $58,000 from $8.2 million for the same period in 2017. The increase was due to an increase of $733,000 of legal and consulting and other expense, offset by a decline of $675,000 in personnel-related and stock compensation.
Net Loss: The net loss for the three months ended March 31, 2018 was $18.3 million compared to net loss of $20.9 million for the same period in 2017. The basic and diluted weighted average common shares outstanding for the three months ended March 31, 2018 were 37,155,082, resulting in a basic and diluted loss per share of $0.49. For the three months ended March 31, 2017, the basic and diluted weighted average common shares outstanding were 29,213,488, resulting in basic and diluted loss per share of $0.72.
NewLink Genetics ended Q1 2018 with 37,165,098 shares outstanding.
Conference Call and Webcast Details
The Company has scheduled a conference call and webcast for 4:30 p.m. ET today to discuss the financial results and to review its clinical activities. NewLink Genetics’ senior management team will host the call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.
Access to the live call is available by dialing (855) 469-0612 (U.S.) or (484) 756-4268 (international) five minutes prior to the start of the call. The conference call will be webcast live and a link can be accessed through the NewLink Genetics website at View Source To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast. A replay of the call will be available for two weeks from the date of the call and can be accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and using the passcode 6768809.
About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as AML, DIPG and melanoma.