Analyst Conference Summary

biotechnology

conference date: March 5, 2020
for quarter ending: December 31, 2020 (fourth quarter, Q4)

Forward-looking statements

Overview: Raised cash and continues to make pipeline progress.

Basic data (GAAP):

Revenue was $0.5 million, down from $0.9 million year-earlier.

Net income was negative $19.7 million, down from $18.0 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.46, up from negative $0.54 year-earlier.

Guidance:

Believes cash sufficient into 2022.

Conference Highlights:

Nancy Simonian, M.D., CEO said "We are entering 2020 in a position of strength. Following the recent initiation of our Phase 1 trial of SY-5609, we are advancing two oral investigational medicines through development in multiple cancer patient populations that we believe are most likely to respond to these targeted agents, both with meaningful data readouts expected in the fourth quarter. Meanwhile, our gene control platform continues to fuel a robust preclinical and discovery pipeline in oncology and monogenic diseases. We are committed to executing with excellence on our ongoing efforts and, longer term, to leveraging our deep understanding of the regulatory genome to deliver much-needed medicines that provide profound benefits for patients."

Syros specializes in using small molecules to control gene regulation.

SY-1425 is due to report potential proof-of-concept data in Q4 2020 from the ongoing Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory acute myeloid leukemia patients. Also data for same combination for newly diagnosed AML in patients who are not candidates for chemo in Q4. There is still high unmet medical need in AML.

SY-5609, a 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 $91.4 million. After the quarter ended received a $20 million milestone from GBT and $20 million loan from Oxford.

Operating expenses were $20.2 million, comprised of $14.3 million for R&D and $6.4 million for administration. Loss from operations $20.2 million. Other income $0.4 million.

Q&A summary:

Profile for 1425 R/R need to show? Significant unmet need. Efficacy and safety will be looked at. 16% respsonse and half-year overall survival for methylating agents; 20% to 30% shown for some recent approvals of targeted agents with four to eight month response ranges, that is the context.

IRS8 biomarker not as good of a predictor of response? Discovery platform looked for superenhancer. We made a novel discovery. RARA was the main target, but then we saw some effects for IRS8, so we broadened the work. Analysis did not support that, so we are now back to focusing on RARA.

5609, pathway alterations for tumor types? Started dosing in January. Q4 safety and other data. Various tumor types may have rich signals, as long as has an alteration in RB pathway. About one-third of basal breast cancers have these types of abnormalities. SCLC 75% to 90% have RB mutations. High grade ovarian is also common. After dose escalation we will make plans for expansion studies.

We are using the same platforms and technologies to attack non-cancer genetic diseases.

Cohorts to therapeutic level? Design for rapid results. Not specifying the transition point to standard 3 plus 3 dosing. We have uncovered novel CDK7 biomarkers that have been incorporated into the trail design.

Combination agent possibilities? There are many options.

MDS? We did some exploration, and saw evidence of activity, but the focus right now is AML.

We have some preclincal data for 1425 showing it may do well in combinations.

1425 partnering? Our goal is to build a fully integrated pharma company. We are always thinking strategically about creating value through partnerships.

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