Sierra Oncology Reports Third Quarter 2018 Results
- Momelotinib regulatory pathway clarity anticipated in H1 2019 - VANCOUVER, Nov. 8, 2018 /PRNewswire/ - Sierra Oncology, Inc. (Nasdaq: SRRA), a clinical stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, today reported its financial and operational results for the third quarter ended September 30, 2018. "During the third quarter, we fundamentally transformed Sierra with the addition of momelotinib to our portfolio, a differentiated, demonstrably active and well-tolerated Phase 3 drug candidate for the treatment of myelofibrosis. We are currently preparing for discussions with regulators to determine the registration path for momelotinib and anticipate reporting next steps in the first half of 2019. Our anticipated registration strategy envisions a single Phase 3 trial in second line myelofibrosis patients, a population for which no approved therapies currently exist, to recapitulate the meaningful clinical benefits observed in the two previously completed SIMPLIFY Phase 3 trials, with a particular emphasis on reinforcing momelotinib's differentiated anemia benefits," said Dr. Nick Glover, President and CEO of Sierra Oncology. "We also continue to advance our DNA Damage Response (DDR) drug candidates, SRA737 and SRA141. During the quarter, we made substantial progress enrolling genetically-selected patients into the indication specific cohorts of our two SRA737 trials, with a focus on recruiting patients with High Grade Serous Ovarian Cancer (HGSOC). We plan to report preliminary efficacy results from these trials in the first half of 2019. We also prepared for the initiation of a trial of SRA737 in combination with a PARP inhibitor in prostate cancer and for our first clinical trial with SRA141 for the treatment of colorectal cancer. We are currently evaluating the optimal timing of these trials within the context of our recently expanded portfolio." Highlights for the Third Quarter of 2018:
Third Quarter 2018 Financial Results (all amounts reported in U.S. currency) Research and development expenses were $30.0 million for the nine months ended September 30, 2018, compared to $22.6 million for the nine months ended September 30, 2017. The increase was primarily due to a $3.0 million upfront fee paid to Gilead for the acquisition of our lead product candidate momelotinib, an increase of $5.4 million in clinical trial costs and a $1.4 million increase in personnel-related costs, partially offset by decreases of $1.5 million in third-party manufacturing costs related to SRA737 and SRA141, and $0.9 million in research, preclinical and other support costs. Research and development expenses included non-cash stock-based compensation of $3.3 million and $3.0 million for the nine months ended September 30, 2018 and 2017, respectively. General and administrative expenses were $3.1 million for the three months ended September 30, 2018, compared to $2.8 million for the three months ended September 30, 2017. This increase was primarily due to increases in personnel-related costs, professional fees and allocated overhead. General and administrative expenses included non-cash stock-based compensation of $0.7 million and $0.5 million for the three months ended September 30, 2018 and 2017, respectively. General and administrative expenses were $10.7 million for the nine months ended September 30, 2018, compared to $9.2 million for the nine months ended September 30, 2017. This increase was primarily due to a $1.3 million increase in personnel-related costs, professional fees and allocated overhead and a $0.2 million increase in business development costs. General and administrative expenses included non-cash stock-based compensation of $1.8 million and $1.5 million for the nine months ended September 30, 2018 and 2017, respectively. For the three months ended September 30, 2018, Sierra incurred a net loss of $15.6 million compared to a net loss of $10.0 million for the three months ended September 30, 2017. For the nine months ended September 30, 2018, Sierra incurred a net loss of $39.1 million compared to a net loss of $31.4 million for the nine months ended September 30, 2017. Cash and cash equivalents totaled $116.1 million as of September 30, 2018, compared to $100.3 million as of December 31, 2017. At September 30, 2018, there were 74,364,165 shares of common stock issued and outstanding, with another 10,793,266 issuable upon exercise of stock options and warrants, and a term loan of $4.9 million. Equity Inducement Plan The 2018 Equity Inducement Plan is used exclusively for the grant of equity award to individuals who were not previously an employee or non-employee director of Sierra (or following a bona fide period of non-employment), as an inducement material to such individual's entering into employment with Sierra, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. The options have an exercise price of $1.73 per share, which is equal to the closing price of Sierra's common stock on the date of grant. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient's start date, and then will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee's continued employment with Sierra on such vesting dates. The options are subject to the terms and conditions of Sierra's 2018 Equity Inducement Plan, and the terms and conditions of the stock option agreement covering the grant. About Sierra Oncology Sierra is also advancing SRA737 and SRA141. SRA737 is a potent, highly selective, orally bioavailable small molecule inhibitor of Checkpoint kinase 1 (Chk1), a key regulator of cell cycle progression and the DNA Damage Response (DDR). SRA737 is currently being investigated in two Phase 1/2 clinical trials primarily focused on patients with ovarian cancer: SRA737-01, a monotherapy study, and SRA737-02, a drug combination study evaluating SRA737 potentiated by low dose gemcitabine. Sierra is also preparing for a potential clinical study of SRA737 in combination with a PARP inhibitor. SRA141 is a potent, selective, orally bioavailable small molecule inhibitor of Cell division cycle 7 kinase (Cdc7). Cdc7 is a key regulator of DNA replication and is involved in the DDR network, making it a compelling emerging target for the potential treatment of a broad range of tumor types. For more information, please visit www.sierraoncology.com. Cautionary Note on Forward-Looking Statements
View original content:http://www.prnewswire.com/news-releases/sierra-oncology-reports-third-quarter-results-300744943.html SOURCE Sierra Oncology |
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Company Codes: NASDAQ-NMS:SRRA |