Analyst Conference Summary

biotechnology

conference date: May 7, 2020
for quarter ending: March 31, 2020 (first quarter, Q1)

Forward-looking statements

Overview: Continues to progress pipeline.

Basic data (GAAP):

Revenue was $2.4 million, up sequentially from $0.5 million, and up from $0.5 million year-earlier.

Net income was negative $17.2 million, up sequentially from negative $19.7 million, down from $16.5 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.39, up sequentially from negative $0.46, and up from negative $0.49 year-earlier.

Guidance:

Believes cash sufficient into 2022.

Conference Highlights:

Nancy Simonian, M.D., CEO said "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." So far there has been no substantial impact on the clinical trials from the pandemic.

Syros specializes in using small molecules to control gene regulation.

SY-1425 completed enrollment in April 2020 in the ongoing Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory acute myeloid leukemia patients. Also same combination for newly diagnosed AML in patients who are not candidates for chemo. Should report data in Q4 2020. There is still high unmet medical need in AML. SY-1425 is an oral agent.

SY-5609, a oral CDK7 agent, is due to report safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data in Q4 2020 from the dose-escalation portion of Phase 1 trial evaluating SY-5609 in patients with breast, colorectal, lung and ovarian cancers, and in patients with solid tumors of any histology that harbor Rb pathway alterations. The first patient was dosed in January 2020.

In January 2020, Syros presented preclinical data showing that inhibiting cyclin-dependent kinase 7 and CDK12 result in different transcriptional effects at the 2020 Keystone Symposia Cancer Epigenetics: New Mechanisms and Therapeutic Opportunities.

In December 2019, Syros presented preclinical data demonstrating its discovery and validation of a novel fetal hemoglobin repressor, Nuclear Factor I X (NFIX) at the ASH Annual Meeting. Data showed that, when knocked down in primary cells and an erythroid cell line expressing adult hemoglobin, NFIX induced fetal hemoglobin in nearly 100% of cells and increased total fetal hemoglobin levels to 40%, exceeding levels that are associated with a functional cure in a subset of sickle cell disease patients.

In February 2020, Syros announced the closing of a $60 million senior secured loan facility with Oxford Finance, LLC. $20 million was drawn down at closing, and $40 million will be available across two tranches, subject to certain conditions and achievement of milest

In December 2019, Syros entered into a collaboration with Global Blood Therapeutics (GBT) for sickle cell disease and beta thalassemia. Under the agreement, Syros will identify therapeutic targets and discover drugs that induce fetal hemoglobin, and GBT will receive an option to obtain an exclusive worldwide license to develop, manufacture and commercialize products resulting from the collaboration. Syros received a $20 million upfront payment. GBT is obligated to fund up to approximately $40 million in research expenses for at least three years. Should GBT exercise its option under the agreement, Syros could receive up to $315 million in option exercise, development, regulatory, commercialization and sales-based milestones per product candidate resulting from the collaboration, in addition to mid- to high-single digit royalties on sales of products.

Cash and equivalents ended the quarter at $122 million, up sequentially from $91.4 million. During the quarter ended received a $20 million milestone from GBT and $20 million loan from Oxford, at $12 million from ATM sale of common stock.

Operating expenses were $19.7 million, comprised of $14.6 million for R&D and $5.1 million for administration. Loss from operations $17.3 million. Other income $0.1 million.

Q&A summary:

Study requirements, visits? Some visits involve procedures like a biopsy or CAT scan, so those would need to occur in the clinic. Check-in time visits may move to telemedicine, moving visits to closer labs.

5609 timeline? We believe it has best-in-class potential. So we are seeing enthusiasm, that helps keep the enrollment going. The patients have advanced cancers with signicant mortality, so they can't wait for the pandemic.

1425 azacitibine non-oral component? Most patients are going to specialized treatment centers. 1425 can be taken at home daily, aza needs to be given in clinics, or from visiting nurses

5609 if several cancers look promising? It has a breadth of activity. We selected types that can show early activity. Breast cancer, lung, ovarian, colorectal. Others with RB pathway problems. Just observing, characterizing tumors to see what correlates with activity. We foresee incorporating broad opportunities as early as possible.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: