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 September 30, 2017 and provided an update on recent accomplishments and upcoming events.
“Syros made significant progress in the third quarter, driving toward an initial clinical data readout at ASH from our ongoing Phase 2 clinical trial of SY-1425 as well as adding a combination arm with SY-1425 and an anti-CD38 therapy to the trial, and continuing to execute efficiently on the dose escalation phase of our Phase 1 trial of SY-1365,” said Nancy Simonian, M.D., Chief Executive Officer of Syros. “We presented key data on both programs, showing favorable PK and evidence of target engagement in patients from the clinical trial of SY-1425, as well as a significant correlation between the biomarker status of patients screened for the trial and differentiation of their cells treated ex vivo with SY-1425, supporting our platform’s ability to identify patients we believe may be most likely to respond to gene control therapies such as SY-1425. For SY-1365, we presented PK and PD data showing substantial anti-tumor activity in preclinical models of multiple cancers using a twice weekly dose consistent with the initial dosing regimen being used in the Phase 1 trial. We are at an exciting time in the company’s evolution, with multiple clinical data readouts for SY-1425 and SY-1365 expected between now and the end of 2018, a rich preclinical pipeline, and a leading gene control platform that we believe will continue to fuel our pipeline and fulfill our mission of improving patients’ lives.”
Upcoming Milestones
Recent Platform and Pipeline Highlights
Third Quarter 2017 Financial Results
Cash, cash equivalents and marketable securities as of September 30, 2017 were $81.9 million, compared with $83.6 million on December 31, 2016. The decrease in cash, cash equivalents and marketable securities is primarily due to cash used to fund operations during the nine-months ended September 30, 2017, partially offset by gross proceeds of approximately $35.0 million from Syros’ April 2017 private placement.
For the third quarter of 2017, Syros reported a net loss of $13.8 million, or $0.53 per share, compared to a net loss of $14.2 million, or $0.65 per share, for the same period in 2016. Stock-based compensation included in the net loss was $1.1 million for the third quarter of 2017, compared to $1.7 million for the same period in 2016.
Financial Guidance
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 reporting of initial clinical data from the ongoing Phase 2 clinical trial of SY-1425 at the ASH Annual Meeting; the presentation of additional clinical data on SY-1425 and initial clinical data on SY-1365; the percentage of AML and MDS patients who have the RARA or IRF8 biomarker; the benefits of CDK7 inhibition; the ability to discover and develop drugs in the immuno-oncology field that can reactivate the immune system; anticipated operating expenses and cash burn for the year ended December 31, 2017; and the benefits 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. Moreover, there can be no assurance that PK and PD data and ex vivo differentiation data generated to date in the ongoing Phase 2 clinical trial of SY-1425 are predictive of the ability of such trial to meet any of its endpoints. 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; 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 September 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. |
||||||||
September 30, 2017 | December 31, 2016 | |||||||
Cash, cash equivalents and marketable securities | $ | 81,948 | $ | 83,593 | ||||
Working capital (1) | 73,928 | 75,941 | ||||||
Total assets | 88,677 | 91,323 | ||||||
Total stockholders’ equity | 78,592 | 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. |
||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Revenue (2) | $ | — | $ | — | $ | 1,101 | $ | — | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 10,447 | 11,584 | 30,116 | 29,374 | ||||||||||||
General and administrative | 3,593 | 2,633 | 10,151 | 7,544 | ||||||||||||
Total operating expenses | 14,040 | 14,217 | 40,267 | 36,918 | ||||||||||||
Loss from operations | (14,040 | ) | (14,217 | ) | (39,166 | ) | (36,918 | ) | ||||||||
Other income, net | 215 | 48 | 458 | 140 | ||||||||||||
Net loss | $ | (13,825 | ) | $ | (14,169 | ) | $ | (38,708 | ) | $ | (36,778 | ) | ||||
Accrued dividends on preferred stock | — | (121 | ) | — | (3,681 | ) | ||||||||||
Net loss applicable to common stockholders | $ | (13,825 | ) | $ | (14,290 | ) | $ | (38,708 | ) | $ | (40,459 | ) | ||||
Net loss per share applicable to common stockholders - basic and diluted | $ | (0.53 | ) | $ | (0.65 | ) | $ | (1.54 | ) | $ | (4.44 | ) | ||||
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted | 26,259,216 | 22,012,743 | 25,100,278 | 9,110,993 |
(2) Under a research agreement we entered into with a multinational pharmaceutical company, we recognized revenue of $1.1 million during the nine months ended September 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 nine months ended September 30, 2016.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171108005367/en/
Media Contact:
Syros Pharmaceuticals
Naomi Aoki,
617-283-4298
[email protected]
or
Investor
Contact:
Stern Investor Relations, Inc.
Hannah
Deresiewicz, 212-362-1200
[email protected]