On August 10, 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 second quarter ended June 30, 2017 (Press release, Sierra Oncology, AUG 10, 2017, View Source [SID1234520143]).

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"During the quarter, we reported encouraging initial progress from our novel synthetic lethality-oriented Phase 1 Monotherapy trial of SRA737, demonstrating that our Chk1 inhibitor was well-tolerated to date and that patients were now receiving doses of drug above the minimum concentration projected to be therapeutically active," said Dr. Nick Glover, President and CEO of Sierra Oncology. "Following the clinical success of PARP inhibitors by several companies, enthusiasm has grown within the scientific and medical community for the potential to treat cancers by exploiting the DDR network, and there is increasing attention being placed on the limited number of novel DDR agents like ours that are currently in clinical trials. Our focus for the balance of 2017 is on driving patient enrollment into our two trials with the objective of providing a preliminary update from these studies in early 2018."

Highlights from the second quarter:
Sierra Oncology’s collaborator, The Institute of Cancer Research (ICR), reported preclinical synthetic lethality data for SRA737 at AACR (Free AACR Whitepaper) 2017, supporting the use of SRA737 in certain genetically defined tumors and in combination with chemotherapy.

Secured patents in the United States and Europe explicitly covering SRA737 and extending its protection out to 2033 in the United States before any patent term extensions.

Received regulatory clearance to enhance the two ongoing Phase 1 clinical trials for SRA737 to incorporate the prospective enrollment of patients with genetically-defined tumors (determined using Next-Generation Sequencing) that harbor genomic alterations hypothesized to confer sensitivity to Chk1 inhibition via synthetic lethality.

Presented these innovative clinical trial enhancements in two posters at the ASCO (Free ASCO Whitepaper) 2017 Annual Meeting.

Reported encouraging initial progress from the ongoing Phase 1 SRA737 Monotherapy trial, including:

The Dose Escalation Phase of the trial, which employs an accelerated titration design, had rapidly advanced through several 100% dose escalations.

SRA737 had been well-tolerated and the maximum tolerated dose (MTD) had not been reached. No Grade 2 or higher SRA737-related Adverse Events had been reported.

Pharmacokinetic (PK) parameters for SRA737 had been generally linear across the dose range tested.

Several cohorts had surpassed the proposed minimum efficacious plasma concentration for SRA737 based on preclinical modelling. This enabled the commencement of the parallel Cohort Expansion Phase of the trial, which is enrolling prospectively-selected genetically-defined patients into five indication-specific cohort expansions at potentially active dose levels.

Transitioned the Phase 1 Chemotherapy Combination trial to Stage 2, which is evaluating SRA737 in combination with low-dose gemcitabine. Once an MTD and dosing schedule have been determined, the study will also evaluate the preliminary efficacy of the combination in an indication-specific cohort of prospectively-selected, genetically-defined subjects.

Second Quarter 2017 Financial Results (all amounts reported in U.S. currency)
Research and development expenses were $7.2 million for the three months ended June 30, 2017, compared to $9.1 million for the three months ended June 30, 2016. Research and development expenses were $15.2 million for the six months ended June 30, 2017, compared to $15.8 million for the six months ended June 30, 2016. The decreases were due to a $2.8 million restructuring charge related to close-out expenses for PNT2258 and a $0.9 million upfront license payment for the exclusive license of SRA141 that were incurred in the second quarter of 2016. There was also a decrease in clinical trial costs as compared to the prior period, due to the discontinuation of PNT2258 clinical trials. These decreased costs were partially offset by an increase in third-party manufacturing and research costs related to SRA737 and SRA141. Research and development expenses included non-cash stock-based compensation of $1.0 million and $2.0 million for the three and six months ended June 30, 2017, and of $0.8 million and $1.8 million for the three and six months ended June 30, 2016.

General and administrative expenses were $3.3 million for the three months ended June 30, 2017, compared to $3.8 million for the three months ended June 30, 2016. General and administrative expenses were $6.4 million for the six months ended June 30, 2017, compared to $7.8 million for the six months ended June 30, 2016. The decreases were due to a $0.3 million restructuring charge incurred in the second quarter of 2016 and a decrease in business development expenses. General and administrative expenses included non-cash stock-based compensation of $0.5 million and $1.0 million for the three and six months ended June 30, 2017, and $0.5 million and $0.9 million for the three and six months ended June 30, 2016.

For the three months ended June 30, 2017, Sierra incurred a net loss of $10.3 million compared to a net loss of $12.9 million for the three months ended June 30, 2016. For the six months ended June 30, 2017, Sierra incurred a net loss of $21.4 million compared to a net loss of $23.4 million for the six months ended June 30, 2016.

Cash and cash equivalents totaled $116.7 million as of June 30, 2017, compared to $125.0 million as of March 31, 2017, and $109.0 million as of December 31, 2016. The company raised net proceeds of $27.4 million in February 2017 from an underwritten public offering of common stock. The company believes that its existing cash and cash equivalents will be sufficient to fund current operating plans through approximately mid-2019.

At June 30, 2017, there were 52,268,443 shares of common stock issued and outstanding, and stock options to purchase 7,716,043 shares of common stock issued and outstanding.