Analyst Conference Summary

biotechnology

conference date: March 4, 2021 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2020 (fourth quarter, Q4)

Forward-looking statements

Overview: Continues trials of therapies.

Basic data (GAAP):

Revenue was $5.7 million, up sequentially from $3.8 million, and up from $0.5 million year-earlier.

Net income was negative $30.1 million, down sequentially from negative $19.5 million, and down from negative $19.7 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.62, down sequentially from negative $0.43, and down from negative $0.46 year-earlier.

Guidance:

Believes cash sufficient into 2023.

Conference Highlights:

Nancy Simonian, M.D., CEO said "2021 promises to be a pivotal year for Syros. We moved our lead program into our first registration-enabling study and continue to advance all three of our clinical-stage programs with the aim of setting new standards of care for targeted populations of patients with hematological malignancies and solid tumors. Following our recent financings, we are operating from a position of substantial strength, with capital to advance SY-1425, SY-2101 and SY-5609 through multiple expected data readouts while investing in our gene control platform to fuel our long-term pipeline."

Syros specializes in using small molecules to control gene regulation.

All revenue was from the Incyte or the GBT collaborations.

In December 2020, Syros acquired from Orsenix all assets related to SY-2101, a novel oral form of ATO (arsenic trioxide, oral). SY-2101 is a targeted clinical-stage drug candidate that has the potential to dramatically reduce the treatment burden of a standard-of-care regimen for newly diagnosed APL or acute promyelocytic leukemia. A dose confirmation study will start later in 2021, and a Phase 3 trial in 2022.

In February 2021 started a Phase 3 trail of SY-1425 combined with azacitidine in RARA positive high risk MDS. SY-1425 completed enrollment in May 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. Syros presented data for SY-1425 ASH in December 2020 showing a 67% overall response rate and composite CR of 61%. There is still high unmet medical need in AML. SY-1425 is an oral agent. Syros plans to initiate another SY-1425 trial in combination with venetoclax and azacitidine for RARA+ AML patients not suitable for standard chemo. Data is expected in 2022.

SY-5609, a oral CDK7 agent, reported Phase 1 safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data in October 2020. More data in Q3 2021 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. A second Phase 1 study started in June 2020, in combination with fulvestrant, for HR-positive metastatic breast cancer patients who progressed after CDK4/6 inhibitor treatment. Believes showed proof of mechanism and importance of polr2a biomarker.

Expects to move one candidate from preclinical to clinical in 2022.

Cash and equivalents ended the quarter at $174 million, up sequentially from $93 million. In December 2020 raised $90 million in a private financing. In January 2021 rasied $76 million in a public share offering.

Operating expenses were $34.9 million, comprised of $29.0 million for R&D and $5.9 million for administration. Loss from operations $29.2 million. Other expense $0.9 million.

Q&A summary:

Randomized Phase 2 primary endpoint? RARA+ unfit first-line AML combo, primary enpoint is composite complete response rate. There is a phenotype that corresponds to the resistance to the combo doublet the control group will receive.

Phase 3 high-risk MDS study powering? Not dislosed yet, but 190 patients randomized 2 to one, complete response is the primary endpoint, based on FDA discussion.

SY-5609 efficacy goal? EMA was early data. Dose escalation continues. Hope to advance as single agent or in combo in populations, depending on results.

SY-5609 breast cancer landscape? We are excited about that opportunity, including HR+ and triple negative. We will be considering unmet medical need including competition.

What data would be needed to change standard of care in MDS? There have not been new drugs approved except HMSs. Cytopenias are common. So an effective drug that does not exacerbate cytopenias and is convenient would be attractive. If successful could change teh standard of care for RARA+ MDS patients.

5609 expansion cohorts same as dosing cohorts? We hope to share data in Q3. Then hope to open expansions, choices will be data driven. But likely to hone in on one or more populations.

GBT collaboration is going well, not disclosing when or if data will be presented, but has been highly productive so far.

1425 diagnostic? We have a clinical trial assay, we are working on the companion diagnostic, which is progressing well.

We are seeing enthusiasm from KOLs for SY-2101.

Competition like Gilead trying to shift away from veneza backbone? 1425 is not mylo-suppressive. So do not anticipate additive toxicities. The AML space is dynamic, believe veneza will continue to be the standard of care, but 1425 should combine well if newer drugs emerge.

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