Plan to Open Expansion Cohorts in Phase 1 Trial of SY-1365 in Fall of 2018; Expansion to Focus on Ovarian and Breast Cancer Patient Populations as Single Agent and in Combination
Expect to Report Initial Clinical Data from Combination Arms of Phase 2 Trial of SY-1425 and Dose Escalation Portion of Phase 1 Trial of SY-1365 in Fourth Quarter of 2018
EMA Grants SY-1425 Orphan Drug Designation for Treatment of AML
Management to Host Conference Call at 8:30 AM ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes, today reported financial results for the quarter ended June 30, 2018 and provided an update on recent accomplishments and upcoming events.
“The second half of 2018 promises to be an important time for Syros,” said Nancy Simonian, M.D., Chief Executive Officer of Syros. “Over the next several months, we plan to report initial clinical data from our Phase 2 trial evaluating the safety and efficacy of SY-1425 in combination with standard-of-care and targeted agents in genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome. We plan to open expansion cohorts in the ongoing Phase 1 trial of SY-1365 in multiple patient populations with ovarian and breast cancers, as well as report data from the dose-escalation portion of the trial. Notably, we expect this to be the first-ever reported human clinical data on a selective inhibitor of CDK7, which is gaining increased recognition as an important new drug target in oncology. Together, we believe these clinical results will provide important insights into these programs and hopefully bring us closer to our vision of translating our leadership in gene control into medicines that provide profound benefit for patients.”
- Syros plans to report initial clinical data in the fourth quarter of 2018 from cohorts in its Phase 2 trial evaluating the safety and efficacy of SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive patients with newly diagnosed acute myeloid leukemia (AML) who are not suitable candidates for standard chemotherapy, and in combination with daratumumab in biomarker-positive patients with relapsed or refractory AML and higher-risk myelodysplastic syndrome (MDS).
- Syros plans to open expansion cohorts in the fall of 2018 in its Phase 1 trial of SY-1365. These expansion cohorts will evaluate SY-1365 as a single agent and in combination with standard-of-care therapies in multiple patient populations with ovarian and breast cancers.
- Syros plans to report clinical data in the fourth quarter of 2018 from the dose escalation portion of its Phase 1 trial of SY-1365 in patients with advanced solid tumors.
- Syros plans to select a new development candidate from its preclinical pipeline by the end of 2018.
Recent Pipeline Highlights
- In July 2018, the European Medicines Agency (EMA) granted SY-1425 orphan drug designation for the treatment of AML. The EMA orphan drug designation is granted to medicines being developed for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition with a prevalence of not more than five in 10,000 people in the European Community. EMA orphan drug designation benefits include protocol assistance, access to the EU centralized authorization procedure, reduced EU regulatory filing fees and 10 years of market exclusivity.
In June 2018, Syros presented on the design of its Phase 1 clinical
trial of SY-1365 at the American Society of Clinical Oncology (ASCO)
Annual Meeting. Based on preclinical data, which showed robust
anti-tumor activity in ovarian and breast cancers, Syros designed the
expansion phase of its trial to initially focus on these tumors.
Expansion cohorts will evaluate the safety, tolerability and
preliminary clinical activity of SY-1365 in:
- Three ovarian cancer patient populations in earlier- and later-stages of disease, as either a single agent or in combination with carboplatin;
- Hormone receptor-positive, CDK4/6 inhibitor-resistant breast cancer patients, in combination with fulvestrant;
- Patients with solid tumors of any histology to evaluate pharmacodynamic endpoints and measures of biological activity in paired tumor biopsies.
Recent Corporate Highlights
- In June 2018, Syros announced the appointment of Michael W. Bonney, Chief Executive Officer of Kaleido Biosciences, to its Board of Directors.
Second Quarter 2018 Financial Results
Cash, cash equivalents and marketable securities as of June 30, 2018 were $124.4 million, compared with $72 million on December 31, 2017. During the second quarter, Syros sold $16.6 million in common stock under its at-the-market sales facility.
For the second quarter 2018, Syros reported a net loss of $14 million, or $0.43 per share, compared to a net loss of $13.4 million, or $0.52 per share, for the same period in 2017.
- Revenues were $0.4 million for the second quarter of 2018, which relate entirely to Syros’ collaboration with Incyte. Syros did not record revenues in the second quarter of 2017.
- Research and development (R&D) expenses were $11.1 million for the second quarter of 2018, as compared to $10 million for the same period in 2017. This increase was primarily attributable to an increase in costs associated with Syros’ Phase 1 clinical trial of SY-1365 and increased headcount.
- General and administrative (G&A) expenses were $3.8 million for the second quarter of 2018, as compared to $3.5 million for the same period in 2017. This increase was primarily attributable to an increase in employee-related costs.
Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into 2020.
Conference Call and Webcast:
Syros will host a conference call today at 8:30 a.m. ET to discuss these second quarter 2018 financial results and provide a corporate update.
The live call may be accessed by dialing (866) 595-4538 for domestic callers or (636) 812-6496 for international callers and referencing conference ID number: 8675009. A live webcast of the conference call will be available online on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 90 days.
About Syros Pharmaceuticals
Syros is pioneering the understanding of the non-coding region of the genome to advance a new wave of medicines that control expression of genes. Syros has built a proprietary platform that is designed to systematically and efficiently analyze this unexploited region of DNA in human disease tissue to identify and drug novel targets linked to genomically defined patient populations. Because gene expression is fundamental to the function of all cells, Syros’ gene control platform has broad potential to create medicines that achieve profound and durable benefit across a range of diseases. Syros is currently focused on cancer and monogenic diseases and is advancing a growing pipeline of gene control medicines. Syros’ lead drug candidates are SY-1425, a selective RARα agonist in a Phase 2 clinical trial for genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome, and SY-1365, a selective CDK7 inhibitor in a Phase 1 clinical trial for patients with advanced solid tumors. Led by a team with deep experience in drug discovery, development and commercialization, Syros is located in Cambridge, Mass.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the Company’s ability to advance its clinical-stage programs, including the reporting of clinical data from the combination cohorts of the ongoing Phase 2 clinical trial of SY-1425 and the dose escalation phase of the SY-1365 clinical trial in the fourth quarter of 2018, and the initiation of expansion cohorts of SY-1365 in ovarian and breast cancers in the fall of 2018; that the reporting of data from the SY-1365 clinical trial will be the first-ever reported clinical data of a selective CDK7 inhibitor; the selection of a development candidate for IND-enabling studies during 2018; the Company’s ability to fund its planned operations into 2020; and the benefits of Syros’ gene control platform and product development pipeline. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including Syros’ ability to: advance the development of its programs, including SY-1425 and SY-1365, under the timelines it projects in current and future clinical trials; demonstrate in any current and future clinical trials the requisite safety, efficacy and combinability of its drug candidates; replicate scientific and non-clinical data in clinical trials; successfully develop a companion diagnostic test to identify patients with the RARA and IRF8 biomarkers; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; obtain and maintain necessary regulatory approvals; identify, enter into and maintain collaboration agreements with third parties, including its ability to perform under the collaboration agreement with Incyte; manage competition; manage expenses; raise the substantial additional capital needed to achieve its business objectives; attract and retain qualified personnel; and successfully execute on its business strategies; risks described under the caption “Risk Factors” in Syros’ Annual Report on Form 10-K for the year ended December 31, 2017, as updated in its Quarterly Reports on Form 10-Q for the quarters ended March 31 and June 30, 2018, each of which is on file with the Securities and Exchange Commission; and risks described in other filings that Syros makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Syros expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.
Syros Pharmaceuticals, Inc.
|June 30, 2018||December 31, 2017|
|Cash, cash equivalents and marketable securities||$||124,366||$||72,049|
|Working capital (1)||109,272||60,746|
|Total stockholders’ equity||108,712||65,324|
(1) The Company defines working capital as current assets less current liabilities. See the Company’s condensed consolidated financial statements for further details regarding its current assets and current liabilities.
SYROS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Research and development||11,082||10,041||22,198||19,669|
|General and administrative||3,841||3,472||7,916||6,558|
|Total operating expenses||14,923||13,513||30,114||26,227|
|Loss from operations||(14,548||)||(13,513||)||(29,369||)||(25,126||)|
|Other income, net||501||145||859||243|
|Net loss per share - basic and diluted||$||(0.43||)||$||(0.52||)||$||(0.90||)||$||(1.02||)|
|Weighted-average number of common shares used in net loss per share - basic and diluted||32,892,712||25,584,147||31,621,303||24,511,205|
Source: Syros Pharmaceuticals
Released August 7, 2018