On August 1, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended June 30, 2019, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, AUG 1, 2019, View Source [SID1234538098]).
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"This is an exciting time for Syros as we continue to advance our clinical-stage programs toward multiple data readouts this year and next that have the potential to validate our fundamental approach to drug development and catalyze change in the treatment landscape for cancers with high unmet needs," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We plan to report updated clinical data for SY-1425 and SY-1365 in the fourth quarter, which we expect will provide additional insights into the safety and clinical activity of both drug candidates and further inform our development plans. We are particularly pleased to announce that we recently began enrolling relapsed or refractory AML patients in a new cohort in our Phase 2 trial of SY-1425 in combination with azacitidine. With this accomplishment, we now have three ongoing trial cohorts with potential for proof-of-concept data in 2020 that, if positive, bring us closer to our vision of providing much-needed therapies for patients."
Upcoming Milestones:
SY-1425
Syros plans to complete enrollment in the second half of 2019 in the Phase 2 trial cohort evaluating the safety and efficacy of SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive patients with newly diagnosed AML who are not suitable candidates for standard chemotherapy.
Syros plans to report updated data on SY-1425 in combination with azacitidine in the fourth quarter of 2019 in newly diagnosed patients with AML who are not suitable candidates for standard chemotherapy.
Syros plans to report potential proof-of-concept data from the ongoing cohort evaluating SY-1425 in combination with azacitidine in biomarker-positive patients with relapsed or refractory (R/R) AML in 2020.
SY-1365
Syros plans to report initial clinical data in the fourth quarter of 2019 from the expansion portion of its Phase 1 trial, including: initial efficacy and safety assessments from the cohort evaluating SY-1365 as a single agent in high-grade serous ovarian cancer patients who have had three or more prior lines of therapy; initial safety and pharmacokinetic data from the cohort evaluating SY-1365 in combination with carboplatin in high-grade serous ovarian cancer patients who have had one or more prior lines of therapy; and initial safety, efficacy and mechanistic data from the cohort evaluating SY-1365 as a single agent in patients with advanced solid tumors accessible for biopsy.
Syros plans to report additional data from these cohorts, including potential proof-of-concept data from the ongoing cohort in high-grade serous ovarian cancer patients who have had three or more prior lines of therapy, in 2020.
Syros also plans to report potential proof-of-concept data from an ongoing cohort evaluating SY-1365 as a single agent in patients with relapsed ovarian clear cell cancer and initial data from an ongoing cohort in hormone receptor (HR)-positive CDK4/6 inhibitor-resistant breast cancer patients in 2020.
SY-5609
Syros plans to present new preclinical data on SY-5609, including pharmacokinetic and pharmacodynamic data and assessments of anti-tumor activity in patient-derived xenograft models of multiple cancers, in the fourth quarter.
Syros plans to complete investigational new drug (IND)-enabling studies of SY-5609 in 2019 to support the initiation of a Phase 1 oncology trial in early 2020.
Recent Pipeline Highlights:
In May 2019, Syros opened for enrollment the new Phase 2 trial cohort evaluating the safety and efficacy of SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive patients with R/R AML.
In May 2019, Syros published a new manuscript, Discovery and Characterization of SY-1365, a Selective, Covalent Inhibitor of CDK7, in the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s journal Cancer Research. The publication highlighted the discovery, mechanism of action and promise of SY-1365 as a new targeted approach to treat a range of difficult-to-treat cancers.
Recent Corporate Highlights:
In June 2019, Syros appointed Alice Shaw, M.D., Ph.D., Director of the Center for Thoracic Cancers at Massachusetts General Hospital and a Professor of Medicine at Harvard Medical School, to its Board of Directors. Dr. Shaw is a highly respected oncologist and recognized leader in translational medicine and the development of targeted cancer therapies.
Second Quarter 2019 Financial Results:
Syros had cash, cash equivalents and marketable securities of $121.7 million as of June 30, 2019, as compared with $99.7 million in December 31, 2018. This increase in cash reflects aggregate net proceeds of approximately $65.0 million from Syros’ two concurrent underwritten public offerings, which closed in April 2019.
For the second quarter of 2019, Syros reported a net loss of $19.5 million, or $0.47 per share, compared to a net loss of $14.0 million, or $0.43 per share, for the same period in 2018.
Revenues were $0.5 million for the second quarter of 2019, as compared to $0.4 million for the second quarter of 2018. Revenues in both the second quarter of 2019 and the second quarter of 2018 were earned under Syros’ collaboration with Incyte Corporation.
Research and development (R&D) expenses were $15.5 million for the second quarter of 2019, as compared to $11.1 million for the same period in 2018. This increase was primarily attributable to continued advancement of the Company’s existing clinical trials and advancement of its preclinical programs, including SY-5609 into IND-enabling studies.
General and administrative (G&A) expenses were $5.2 million for the second quarter of 2019, as compared to $3.8 million for the same period in 2018. This increase was primarily attributable to an increase in employee-related expenses.
Financial Guidance:
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 to the end of the first quarter of 2021.
Conference Call and Webcast:
Syros will host a conference call today at 8:30 a.m. ET to discuss these second quarter 2019 financial results and provide a corporate update.
To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international), and refer to conference ID 7254685. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the call.