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Initiated Phase 1 Clinical Trial for SY-1365, Its First-in-Class CDK7 Inhibitor, Adding a Second Clinical-Stage Program to Syros’ Pipeline
Presented Preclinical Data Supporting Rational Combination Strategy for SY-1425, Including Ongoing Clinical Development in Combination with Standard-of-Care Therapy and Planned Future Development in Combination with Anti-CD38 Therapy
Announced Cancer Discovery Publication Highlighting Platform as New Approach for Stratifying Patients with Potential to Lead to Improved Treatment
On Track to Present Initial Phase 2 Clinical Data for SY-1425 in Fourth Quarter of 2017
Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, today reported financial results for the quarter ended June 30, 2017 and provided an update on recent accomplishments and upcoming events.
“Syros made significant progress during the second quarter by dosing the first patient in our Phase 1 clinical trial of SY-1365 and driving toward the planned initial data readout from our Phase 2 trial of SY-1425 in the fourth quarter,” said Nancy Simonian, M.D., Chief Executive Officer of Syros. “We presented data at key medical meetings supporting our rationale for the ongoing and planned future development of SY-1425 as both a monotherapy and combination agent in defined subsets of AML and MDS patients. We also presented data on our identification of 14 new drug targets for triple negative breast cancer and our discovery of key genes controlling the autoimmune response in lupus. The depth of our programs, from discovery to development, is a testament to the promise of our gene control platform to generate a sustainable pipeline across a range of diseases to support our long-term goal of building an enduring company that makes a profound difference for patients.”
Syros also announced that Kyle Kuvalanka, Chief Operating Officer, has resigned effective September 22, 2017. Syros has initiated a search to appoint a chief financial officer.
“Kyle has been instrumental in charting our strategic course and maturing Syros into a publicly-traded entity with robust investor support and sufficient funding to enable operations through key inflection points,” said Dr. Simonian. “The Syros team and our board of directors thank Kyle for his many contributions, and we wish him much success in the future.”
Recent Platform and Pipeline Highlights
Recent Corporate Highlights
Second Quarter 2017 Financial Results
Cash, cash equivalents and marketable securities as of June 30, 2017 were $91.5 million, compared with $83.6 million on December 31, 2016. The increase in cash is primarily due to gross proceeds of approximately $35.0 million from the April 2017 private placement of our common stock, partially offset by cash used to fund operations during the six-months ended June 30, 2017.
For the second quarter 2017, Syros reported a net loss of $13.4 million, or $0.52 per share, compared to a net loss of $12.0 million, or $5.42 per share, for the same period in 2016. The change in net loss per share reflects the significant increase in shares of common stock outstanding in July 2016 relating to the Company’s initial public offering and the conversion of the Company’s convertible preferred stock into common stock. Stock-based compensation included in the net loss was $1.2 million for the second quarter 2017, compared to $1.1 million for the same period in 2016.
Syros expects that its operating expenses for 2017 will be approximately $55.0 million. This amount includes approximately $5.0 million in non-cash expenses, primarily consisting of stock-based compensation and depreciation, resulting in an estimated cash burn of approximately $50.0 million for the year.
About Syros Pharmaceuticals
Syros Pharmaceuticals is pioneering the understanding of the non-coding region of the genome to advance a new wave of medicines that control expression of disease-driving 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 immune-mediated 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, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers. 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 timing for presentation of initial clinical data for SY-1425 and SY-1365; plans for future clinical development of SY-1425 in combination with an anti-CD38 antibody; the ability to replicate pre-clinical data of Syros’ product candidates in clinical trials; the ability to identify inhibitors of CDK12 and CDK13 suitable for clinical development, the ability of drug targets identified by Syros to result in product candidates; Syros’ anticipated operating expenses and cash burn for the year ended December 31, 2017; the ability to recruit a chief financial officer; and the promise of Syros’ gene control platform. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘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; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; 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 biomarkers associated with the RARA super-enhancer; obtain and maintain necessary regulatory approvals; identify, enter into and maintain collaboration agreements with third parties; 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’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, 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.
Selected Condensed Consolidated Balance Sheet Data
|June 30, 2017||December 31, 2016|
|Cash, cash equivalents and marketable securities||$||91,521||$||83,593|
|Working capital (1)||86,174||75,941|
|Total stockholders’ equity||91,081||80,602|
(1) The Company defines working capital as current assets less current liabilities. See the Company’s condensed consolidated financial statements for further details regarding its current assets and current liabilities.
Syros Pharmaceuticals, Inc.
Condensed consolidated statements of operations
(in thousands, except share and per share data)
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Research and development||10,041||9,525||19,669||17,790|
|General and administrative||3,472||2,540||6,558||4,911|
|Total operating expenses||13,513||12,065||26,227||22,701|
|Loss from operations||(13,513)||(12,065)||(25,126)||(22,701)|
|Other income, net||145||44||243||92|
|Accrued dividends on preferred stock||—||(1,823)||—||(3,560)|
|Net loss applicable to common stockholders||$||(13,368)||$||(13,844)||$||(24,883)||$||(26,169)|
|Net loss per share applicable to common stockholders - basic and diluted||$||(0.52)||$||(5.42)||$||(1.02)||$||(10.57)|
|Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted||25,584,147||2,553,146||24,511,205||2,475,576|
(2) Under a research agreement we entered into with a multinational pharmaceutical company, we recognized revenue of $1.1 million during the six months ended June 30, 2017. The research agreement expired on March 31, 2017, and we do not expect to recognize revenue from this agreement in the future. We did not earn any revenue during the six months ended June 30, 2016.
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