On November 8, 2017 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 third quarter ended September 30, 2017 (Press release, Sierra Oncology, NOV 8, 2017, View Source [SID1234521764]).
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"During the quarter, we continued to aggressively drive the clinical program for SRA737, expanding the number of sites recruiting patients into our Monotherapy trial from three to eight leading centers across the United Kingdom. With growing investigator interest for evaluating our Chk1 inhibitor, we anticipate further expanding this trial into additional sites over the coming months. We plan to provide an update on the SRA737 development program in February 2018 and remain on track to report interim clinical results at a medical conference in the second half of 2018," said Dr. Nick Glover, President and CEO of Sierra Oncology.
"Subsequent to the end of the quarter, we presented a poster at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) reporting on preclinical data demonstrating that sub-therapeutic, non-cytotoxic doses of gemcitabine induce replication stress and hence potentiate the anti-tumor activity of SRA737. These data support the design of our second ongoing Phase 1 clinical trial which is specifically evaluating this combination and is also proceeding as planned," added Dr. Glover. "As we advance our two trials, we are also preparing for a potential clinical study of SRA737 in combination with a PARP inhibitor, where we see a strong biological rationale to expect synergy with Chk1 inhibition. We are also excited about the emerging evidence of biological synergy between immune checkpoint blockade and Chk1 inhibition, and we are currently designing a potential clinical study for this combination as well."
"We continue to advance SRA141, our potent, selective, orally bioavailable small molecule inhibitor of Cell division cycle 7 kinase (Cdc7), an emerging DDR target with exciting potential in cancer. SRA141 is currently undergoing preclinical research in preparation for an Investigational New Drug (IND) filing. Given our near-term focus on broadening the development program for our lead asset SRA737, we are evaluating when best to advance SRA141 into the clinic within the context of our current operational and capital resources," added Dr. Glover.
"Our development program for SRA737 continues to be strongly supported by our collaboration with Cancer Research UK and the Institute of Cancer Research, the originators of SRA737. During the quarter, we also announced the formation of our new DDR Advisory Committee, consisting of leading experts in the DDR field. We recently held two Key Opinion Leader (KOL) events which featured members from our Advisory Committee who shared their insights on emerging DDR biology and the potential of Chk1 inhibition in oncology, providing further support for our programs," concluded Dr. Glover. Recordings of the Sierra’s recent KOL events are accessible at www.sierraoncology.com/events-and-webcasts.
Third Quarter 2017 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $7.4 million for the three months ended September 30, 2017, compared to $12.3 million for the three months ended September 30, 2016. The decrease is primarily due to fees incurred in 2016 in accordance with the license agreement for SRA737: a $7.0 million upfront license fee for the exclusive license of SRA737, and a $2.0 million fee related to the successful transfer to the company of the two ongoing clinical trials of SRA737. These decreased costs were partially offset by a $3.5 million increase in clinical trial costs, third-party manufacturing costs and research and other costs related to SRA737 and SRA141. Research and development expenses included non-cash stock-based compensation of $1.0 million and $0.9 million for the three months ended September 30, 2017 and 2016.
Research and development expenses were $22.6 million for the nine months ended September 30, 2017, compared to $28.1 million for the nine months ended September 30, 2016. The decrease is primarily due to expenses incurred in 2016, including fees related to the SRA737 license agreement, a $0.9 million upfront payment for the exclusive license of SRA141, and a $2.4 million restructuring charge related to close-out expenses for PNT2258. These decreases were partially offset by increases of $4.4 million in third-party manufacturing costs and $2.4 million in research and other costs related to SRA737 and SRA141. Research and development expenses included non-cash stock-based compensation of $3.0 million and $2.6 million for the nine months ended September 30, 2017 and 2016.
General and administrative expenses were $2.8 million for the three months ended September 30, 2017, compared to $3.0 million for the three months ended September 30, 2016. General and administrative expenses were $9.2 million for the nine months ended September 30, 2017, compared to $10.8 million for the nine months ended September 30, 2016. The decrease for the nine months ended September 30, 2017 compared to the prior period was primarily due to a $1.0 million decrease in business development expenses and a $0.4 million decrease in restructuring costs as compared to 2016. General and administrative expenses included non-cash stock-based compensation of $0.5 million and $1.5 million for the three and nine months ended September 30, 2017, and $0.4 million and $1.4 million for the three and nine months ended September 30, 2016.
For the three months ended September 30, 2017, Sierra incurred a net loss of $10.0 million compared to a net loss of $15.2 million for the three months ended September 30, 2016. For the nine months ended September 30, 2017, Sierra incurred a net loss of $31.4 million compared to a net loss of $38.6 million for the nine months ended September 30, 2016.
Cash and cash equivalents totaled $107.8 million as of September 30, 2017, compared to $116.7 million as of June 30, 2017, and $109.0 million as of December 31, 2016. The company believes that its existing cash and cash equivalents will be sufficient to fund current operating plans through approximately mid-2019.
At September 30, 2017, there were 52,268,443 shares of common stock issued and outstanding, and stock options to purchase 7,685,449 shares of common stock issued and outstanding.