On May 10,2018 Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing next generation DNA Damage Response (DDR) therapeutics for the treatment of patients with cancer, reported its financial and operational results for the first quarter ended March 31, 2018 (Press release, Sierra Oncology, MAY 10, 2018, View Source [SID1234526417]).
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"In late February 2018, we provided a comprehensive update on the development program for our Checkpoint kinase 1 (Chk1) inhibitor, SRA737. We also announced planned amendments to our SRA737 Monotherapy Phase 1/2 trial that are now being implemented, which include expanding the overall size of the trial and adding a sixth cohort targeting CCNE1-driven high grade serous ovarian cancer (HGSOC). This cohort is of high interest to us given mounting evidence for the role that CCNE1 amplification has in driving replication stress in cancer and the corresponding reliance on Chk1 in order to manage this replication stress. Analogous to poly ADP-ribose polymerase (PARP) inhibitors, which first exhibited robust activity in patients harboring BRCA mutations, emerging evidence suggests that Chk1 inhibitors such as SRA737 may prove effective in defined genetic backgrounds of high replication stress, such as CCNE1 amplification," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We are also pleased to report that we have advanced our Phase 1/2 Low-Dose Gemcitabine Combination trial into the Cohort Expansion Phase 2 portion, which is targeting enrollment of 80 genetically-selected patients across four indications, with a comparable biological orientation based on both exogenous (low-dose gemcitabine) and intrinsic genetic drivers of replication stress. An update from this trial and preliminary data from the Monotherapy trial are anticipated in the fourth quarter of 2018."
During the first quarter, Sierra reported signing a supply agreement with Janssen Research & Development, LLC pursuant to which they will supply TESARO’s ZEJULA (niraparib), an orally administered PARP inhibitor, facilitating the initiation of a combination trial of niraparib with SRA737 in patients with prostate cancer in the fourth quarter of 2018. The trial is to be led by Professor Johann de Bono, Regius Professor of Cancer Research, Head of the Division of Clinical Studies and Professor in Experimental Cancer Medicine at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust.
Subsequent to the end of the quarter, Sierra presented preclinical results for SRA737, including late-breaking data, in two posters at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting, demonstrating that SRA737 has anti-tumor activity across a broad range of settings, including as monotherapy in aggressive CCNE1-driven HGSOC patient-derived xenografts and in combination with a PARP inhibitor in tumor cells that have acquired resistance to PARP inhibitors and/or platinum therapy.
Sierra is also currently designing a clinical study evaluating SRA737 in combination with immuno-oncology agents, which potentially could be submitted to regulatory authorities in the fourth quarter of 2018.
In addition to SRA737, Sierra is also advancing SRA141, a potent, selective, orally bioavailable small molecule inhibitor of cell division cycle 7 kinase (Cdc7). SRA141 is currently undergoing preclinical research in preparation for an Investigational New Drug Application (IND) submission to the U.S. Food and Drug Administration (FDA) expected in the second half of 2018.
First Quarter 2018 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $8.3 million for the first quarter of 2018, compared to $8.0 million for the first quarter of 2017. The increase was primarily due to an increase of $1.7 million in clinical trial costs partially offset by decreases of $0.9 million in third-party manufacturing costs related to SRA737 and SRA141, and $0.5 million in research, preclinical and other support costs. Research and development expenses included non-cash stock-based compensation of $1.0 million for both the first quarter of 2018 and of 2017.
General and administrative expenses were $3.4 million for the first quarter of 2018, compared to $3.1 million for the first quarter of 2017. This increase was primarily due to an increase in personnel-related costs and professional fees. General and administrative expenses included non-cash stock-based compensation of $0.5 million for both the first quarter of 2018 and of 2017.
Net loss was $11.5 million for the first quarter of 2018, compared with a net loss of $11.1 million for the first quarter of 2017.
Cash and cash equivalents totaled $133.8 million as of March 31, 2018, compared to $100.3 million as of December 31, 2017. This increase was due to an underwritten public offering of 21,850,000 shares of common stock in March 2018, pursuant to which the company raised net proceeds of $46.0 million, net of underwriting discounts, commissions and offering expenses. The company believes that its existing cash and cash equivalents will be sufficient to fund current operating plans through approximately mid-2020. At March 31, 2018, there were 74,309,681 shares of common stock issued and outstanding and stock options to purchase 10,202,831 shares of common stock issued and outstanding.