SRA737 Monotherapy trial prioritized for ovarian cancer; targeting enrollment of 65 patients with preliminary data anticipated in H1 2019
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VANCOUVER, Aug. 9, 2018 /PRNewswire/ - 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, today reported its financial and operational results for the second quarter ended June 30, 2018. "We continue to advance our lead drug candidate, SRA737, across three distinct clinical development strategies; as a monotherapy, in combination with low dose gemcitabine, and in combination with a PARP inhibitor. During the second quarter, we further refined our monotherapy study to focus on high grade serous ovarian cancer (HGSOC), supported by emerging data in the field that provides clinical validation for Chk1 inhibition in this indication. Accordingly, we are prioritizing the enrollment of approximately 65 genetically defined HGSOC patients into this trial, while continuing to enroll patients into the trial's other indications, although with lower priority," said Dr. Nick Glover, President and CEO of Sierra Oncology. "However, given that this amendment will require time to operationalize, we anticipate preliminary data from our monotherapy trial will be reported in the first half of 2019." "Drug resistance to current therapies, including the recently licensed PARP inhibitor class, is almost inevitable in patients with advanced ovarian cancer, driving an acute need for novel and innovative approaches to treat these patients," said Dr. Rebecca Kristeleit, Senior Clinical Lecturer in Experimental Therapeutics, Cancer Institute, University College London. "A study examining the therapeutic benefit of an oral Chk1 inhibitor in patients with HGSOC is a promising approach and Sierra's commitment to prospectively selecting patients with the genetic contexts most likely to synergize with Chk1 inhibition is particularly compelling. I am very pleased to be actively involved in this clinical effort and able to provide this trial option for patients." Sierra is now also planning to include and prioritize for ovarian cancer patients in its combination trial of SRA737 potentiated by low dose gemcitabine. The company recently reported having commenced the Cohort Expansion Phase 2 portion of this trial, which is targeting enrollment of 80 patients across four indications. Sierra plans to modify this study to add and prioritize enrollment for a cohort of 20 genetically defined HGSOC patients, replacing an originally proposed cohort of urothelial cancer patients. Preliminary data from this trial is now also anticipated to be reported in the first half of 2019. Sierra is also continuing to prepare for the planned initiation of a combination trial of SRA737 with the PARP inhibitor niraparib (TESARO's ZEJULA®), which is being supplied under a previously announced agreement with Janssen Research & Development, LLC. The multicenter Phase 1b/2 study will evaluate this combination in subjects with metastatic castration-resistant prostate cancer (mCRPC) and is expected to initiate in the fourth quarter of 2018, 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. Sierra is also advancing SRA141, a potent, selective, orally bioavailable small molecule inhibitor of cell division cycle 7 kinase (Cdc7). The company has completed all gating preclinical research for SRA141 and plans to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) in the second half of 2018 in order to commence clinical trials with this drug candidate. Second Quarter 2018 Financial Results (all amounts reported in U.S. currency) Research and development expenses were $17.1 million for the six months ended June 30, 2018, compared to $15.2 million for the six months ended June 30, 2017. The increase was primarily due to an increase of $3.4 million in clinical trial costs for SRA737 and a $0.7 million increase in personnel-related and overhead costs, partially offset by decreases of $1.5 million in third-party manufacturing costs related to SRA737 and SRA141, and $0.7 million in research, preclinical and other support costs. Research and development expenses included non-cash stock-based compensation of $2.2 million and $2.0 million for the six months ended June 30, 2018 and 2017, respectively. General and administrative expenses were $4.2 million for the three months ended June 30, 2018, compared to $3.3 million for the three months ended June 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 $0.6 million and $0.5 million for the three months ended June 30, 2018 and 2017, respectively. General and administrative expenses were $7.6 million for the six months ended June 30, 2018, compared to $6.4 million for the six months ended June 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 $1.1 million and $1.0 million for the six months ended June 30, 2018 and 2017, respectively. For the three months ended June 30, 2018, Sierra incurred a net loss of $12.0 million compared to a net loss of $10.3 million for the three months ended June 30, 2017. For the six months ended June 30, 2018, Sierra incurred a net loss of $23.5 million compared to a net loss of $21.4 million for the six months ended June 30, 2017. Cash and cash equivalents totaled $125.4 million as of June 30, 2018, compared to $100.3 million as of December 31, 2017. This increase was due to an underwritten public offering completed 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 June 30, 2018, there were 74,334,181 shares of common stock issued and outstanding and stock options to purchase 10,569,959 shares of common stock issued and outstanding. About Sierra Oncology Sierra Oncology is also advancing SRA141, a potent, selective, orally bioavailable small molecule inhibitor of Cell division cycle 7 kinase (Cdc7) undergoing preclinical development. 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
SIERRA ONCOLOGY, INC.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
June 30, December 31,
2018 2017
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ASSETS
CURRENT ASSETS:
Cash and cash
equivalents $125,425 $100,348
Prepaid
expenses and
other current
assets 2,423 1,377
Total current assets 127,848 101,725
Property and equipment, net 121 154
Other assets 578 319
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TOTAL ASSETS $128,547 $102,198
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LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accrued
liabilities $6,774 $6,133
Accounts
payable 1,122 1,339
Total current liabilities 7,896 7,472
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TOTAL LIABILITIES 7,896 7,472
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STOCKHOLDERS' EQUITY:
Common stock 74 52
Additional paid-in capital 768,139 718,751
Accumulated deficit (647,562) (624,077 )
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TOTAL STOCKHOLDERS' EQUITY 120,651 94,726
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TOTAL LIABILITIES AND
STOCKHOLDERS' EQUITY $128,547 $102,198
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SIERRA ONCOLOGY, INC.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share data)
Three Months Ended Six Months Ended
June 30, June 30,
-------- --------
2018 2017 2018 2017
---- ---- ---- ----
Operating expenses:
Research and
development $8,785 $7,194 $17,119 $15,202
General and
administrative 4,178 3,283 7,598 6,429
Total operating expenses 12,963 10,477 24,717 21,631
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Loss from operations (12,963) (10,477) (24,717) (21,631)
Other income 582 185 854 281
--- --- --- ---
Loss before provision for (benefit from)
income taxes, net (12,381) (10,292) (23,863) (21,350 )
Provision for (benefit from) income
taxes, net (421) 37 (378) 71
---- --- ---- ---
Net loss $(11,960) $(10,329) $(23,485) $(21,421)
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Net loss per common share,
basic and diluted $(0.16) $(0.20) $(0.35) $(0.45)
====== ====== ====== ======
Weighted-average shares used in
computing net loss per common
share, basic
and diluted 74,320,415 52,268,443 67,061,904 47,459,428
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Company Codes: NASDAQ-NMS:SRRA |
