MIRATI THERAPEUTICS REPORTS THIRD QUARTER 2017 FINANCIAL RESULTS

On November 1, 2017 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage oncology biotechnology company, reported financial results for the third quarter 2017 (Press release, Mirati, NOV 1, 2017, View Source [SID1234521440]).

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“We are excited by the momentum we have created our programs, including sitravatinib as both a single agent and in combination with nivolumab (OPDIVO) where we reported promising clinical data in non-small cell lung cancer patients at medical conferences in September and October,” said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. “We remain on track to provide program updates on glesatinib, mocetinostat and KRAS by the end of the year.”


Third Quarter 2017 Financial Results

Cash, cash equivalents, and short-term investments were $75 million at September 30, 2017, compared to $56.7 million at December 31, 2016.

Research and development expenses for the third quarter of 2017 were $13.5 million, compared to $16.1 million for the same period in 2016. Research and development expenses for the nine months ended September 30, 2017 were $42.8 million, compared to $52.5 million for the same period in 2016. The decrease in research and development expenses for both the three and nine months ended September 30, 2017 is primarily due a decrease in third party research and development expense, including a reduction in glesatinib manufacturing expenses. In addition, share-based compensation expense decreased in the nine months ended September 30, 2017 compared to the same period of 2016 due to lower exercise prices for options granted during the last half of 2016 and most of 2017. These decreases in expenses are partially offset by increases in expenses associated with our ongoing sitravatinib Phase 1b clinical trial and early discovery costs.

General and administrative expenses for the third quarter of 2017 and 2016 were $3.1 million and $3.5 million, respectively. General and administrative expenses for the nine months ended September 30, 2017 were $10.5 million, compared to $11.4 million for the same period in 2016. The decrease in general and administrative expense is primarily due to a decrease in share-based compensation expense, which is due to lower exercise prices for options granted during the last half of 2016 and most of 2017.

Net loss for the third quarter of 2017 was $16.4 million, or $0.65 per share basic and diluted, compared to net loss of $19.4 million, or $0.97 per share basic and diluted for the same period in 2016. Net loss for the nine months ended September 30, 2017 was $52.5 million, or, $2.12 per share basic and diluted, compared to net loss of $63.4 million, or $3.21 per share basic and diluted for the same period in 2016.

Regeneron to Share Clinical Progress of REGN1979 and Cemiplimab (REGN2810) in B-Cell Lymphomas at the 2017 ASH Annual Meeting

On November 1, 2017 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that data from two Phase 1 clinical trials of REGN1979 and cemiplimab (REGN2810) in patients with different forms of B-cell lymphoma will be presented at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, December 9-12, 2017, in Atlanta, GA(Press release, Regeneron, NOV 1, 2017, View Source [SID1234521403]).

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Regeneron’s clinical presentations will include new safety and activity results from a Phase 1 study of cemiplimab alone or in combination with REGN1979, as well as updated results from a Phase 1 study of REGN1979 monotherapy. Collectively, the two studies enrolled patients with B-cell non-Hodgkin lymphoma (B-NHL) or Hodgkin lymphoma (HL) previously treated with at least one prior therapy and for whom no standard-of-care options exist.

REGN1979 is an investigational bispecific monoclonal antibody that binds to CD3 on immune system T-cells and to CD20 on B-cell malignancies to help trigger tumor killing. Cemiplimab is an investigational human, monoclonal antibody targeting PD-1 (programmed cell death protein 1).

The studies will be presented as posters during the 2017 ASH (Free ASH Whitepaper) Annual Meeting as follows:

Safety and Preliminary Antitumor Activity of the Anti-PD-1 Monoclonal Antibody REGN2810 Alone or in Combination with REGN1979, an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Patients with B-Lymphoid Malignancies
Abstract # 1495
Saturday, December 9, 5:30 – 7:30 p.m. ET

Safety and Preliminary Clinical Activity of REGN1979, an Anti-CD20 x Anti- CD3 Bispecific Antibody, in Patients with B-NHL Previously Treated with CD20-Directed Antibody Therapy
Abstract # 1550
Saturday, December 9, 5:30 – 7:30 p.m. ET

The FDA granted orphan drug designation to REGN1979 for diffuse large B-cell lymphoma (DLBCL) and breakthrough therapy designation status to cemiplimab for metastatic or locally advanced and unresectable cutaneous squamous cell carcinoma (CSCC) earlier in 2017. Cemiplimab is being developed jointly with Sanofi under a global collaboration agreement.

REGN1979 and cemiplimab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

New Data of Emicizumab Presented at The American Society of Hematology 2017

On November 1, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that oral and poster presentations will be given with regard to emicizumab at The American Society of Hematology (ASH) (Free ASH Whitepaper) 2017 in Atlanta, Georgia, United States. Emicizumab is a bispecific antibody under development for hemophilia A (Press release, Chugai, NOV 1, 2017, View Source [SID1234521451]).

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Data from additional six-month follow-up of global Phase lll studies in hemophilia A with inhibitors to factor VIII, HAVEN 1 study (NCT02622321) and HAVEN 2 study (NCT02795767), will be shown at the conference. The HAVEN 2 will be presented at 7:30 EST on December 9 as part of the official Press Program at ASH (Free ASH Whitepaper). Both studies have been conducted in collaboration with Roche and Genentech, while HAVEN 1 is for adults and adolescents and HAVEN 2 is for children.

In addition, preliminary data from HAVEN 4 study (NCT03020160), a Phase lll study with hemophilia A patients with or without inhibitors which examines emicizumab prophylaxis administered subcutaneously once every four weeks, and real-world data from a non-interventional trial in children under 12 years of ages with hemophilia A with inhibitors will be presented.

10-Q – Quarterly report [Sections 13 or 15(d)]

Momenta Pharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Momenta Pharmaceuticals, 2017, NOV 1, 2017, View Source [SID1234521397]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Geron has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Geron, 2017, NOV 1, 2017, View Source [SID1234521492]).

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