On May 7, 2020 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended March 31, 2020 and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, MAY 7, 2020, View Source [SID1234557356]).
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"While COVID-19 has created tremendous uncertainty across the globe, it has also reminded us of the critical importance of medical innovation," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "Over the last few months, we have focused on ensuring the safety and well-being of our employees and our community, while continuing to advance our ongoing clinical trials and critical earlier-stage research. There is no playbook for what we are going through, and I am extremely proud of the dedication, creativity and flexibility our team has shown during this time. Thanks to their efforts, we recently completed enrollment in our Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory AML patients. We remain on track to report data from this cohort and mature data on SY-1425 from our cohort in newly diagnosed AML patients, as well as initial dose-escalation data from the Phase 1 trial of SY-5609, all in the fourth quarter. While these are difficult times, we have a strong foundation and a strong team, and I am confident we will adapt to the challenges ahead as we pursue our mission of delivering medicines that provide a profound benefit for patients."
Anticipated Milestones:
SY-1425
Report potential proof-of-concept data in the fourth quarter of 2020 from the ongoing, fully enrolled Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory acute myeloid leukemia (AML) patients.
Report mature data in the fourth quarter of 2020 from the ongoing, fully enrolled Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy.
SY-5609
Present new preclinical data on the anti-tumor activity of SY-5609 in models of colorectal cancer, as well as details on the design of its ongoing Phase 1 trial, at the Virtual 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Report initial safety, tolerability, pharmacokinetic and pharmacodynamic data in the fourth quarter of 2020 from the dose-escalation portion of the ongoing Phase 1 trial evaluating SY-5609 in patients with breast, colorectal, lung and ovarian cancers, as well as in patients with solid tumors of any histology that harbor Rb pathway alterations.
Report additional dose-escalation data, including clinical activity data, in mid-2021.
Preclinical Pipeline
Nominate next development candidate by the end of 2021.
First Quarter 2020 Financial Results:
Cash, cash equivalents and marketable securities as of March 31, 2020 were $121.9 million, compared with $91.4 million on December 31, 2019. This increase reflects the $20 million upfront payment received in connection with Syros’ entry into a collaboration with Global Blood Therapeutics, Inc. (GBT) in December 2019, the $20 million that Syros drew down from its senior secured loan facility with Oxford Finance, LLC in February 2020, and $12.3 million from the sale of common stock under Syros’ at-the-market sales facility in the first quarter.
For the first quarter of 2020, Syros reported a net loss of $17.2 million, or $0.39 per share, compared to a net loss of $16.5 million, or $0.49 per share, for the same period in 2019.
Revenues were $2.4 million for the first quarter of 2020, compared to $0.5 million for the same period in 2019. In the first quarter of 2020 $2.2 million in revenue was recognized under Syros’ collaboration with GBT and $0.2 million was recognized under its collaboration with Incyte Corporation (Incyte). All revenues recognized in the first quarter of 2019 were under Syros’ collaboration with Incyte.
Research and development (R&D) expenses were $14.6 million for the first quarter of 2020, as compared to $12.6 million for the same period in 2019. This increase was primarily attributable to continued advancement of Syros’ existing clinical trials and preclinical programs, including its sickle cell disease program.
General and administrative (G&A) expenses $5.1 million for the first quarter of 2020, as compared to $4.9 million for the same period in 2019. This increase was primarily attributable to an increase in employee-related costs, including salary, benefits and stock-based compensation due to our increased headcount.
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 expenditures requirements into 2022, beyond key milestones expected for both SY-1425 and SY-5609.
Conference Call and Webcast:
Syros will host a conference call today at 8:30 a.m. ET to discuss these first quarter 2020 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 1585949. 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.