Analyst Conference Summary

biotechnology

conference date: November 5, 2021 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2021 (third quarter, Q3)

Forward-looking statements

Overview: Continues trials of therapies.

Basic data (GAAP):

Revenue was $5.7 million, flat sequentially from $5 million, and up from $3.8 million year-earlier.

Net income was negative $26 million, down sequentially from negative $22.5 million, and down from negative $19 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.41, down sequentially from negative $0.36, and up from negative $0.43 year-earlier. The share count increased sustantially y/y.

Guidance:

Believes cash sufficient into 2023.

Conference Highlights:

Nancy Simonian, M.D., CEO said "We executed on important milestones across our portfolios in targeted hematology and CDK inhibition as well as strengthened our leadership team with the additions of Conley Chee as Chief Commercial Officer and Jason Haas as Chief Financial Office. In September we dosed the first patient in our SELECT-AML-1 Phase 2 trial of tamibarotene, as well as in our dose confirmation study of SY-2101 in APL."

Syros specializes in using small molecules to control gene regulation.

All revenue was from the Incyte or the GBT collaborations.

In Q3 2021 presented encouraging Phase 1 clinical data for SY-5609 at ESMO for a variety of solid cancers. Expects to initiate an expansion cohort in pancreatic cancer in Q4 and a Phase 1b trial in mantle cell lymphoma in the first half of 2022. On August 5, 2021 announced an agreement with Roche to explore SY-5609 in combination with atezolizumab (Tecentriq) in colorectal cancer patients. This will be part of the ongoing Phase 1 trying multiple therapy combinations. No rights are being sold, Roche will pay for the study and share the data with Syros.

In Q3 2021 initiated SY-2101 for APL in a Phase 3 trial. Dose confirmation data from the earlier trial should be reported in 2022.

A Phase 3 trial of tamibarotene (SY-1425) combined with azacitidine in RARA positive high risk MDS continued. Data is expected in 2022. Potential NDA in 2024. In Q3 2021 Syros initiated another SY-1425 trial, in combination with venetoclax and azacitidine, for RARA+ AML patients not suitable for standard chemo.

SY-5609, a oral CDK7 agent, reported Phase 1 safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) data in October 2020. More Phase 1 data to be released in Q3 2021 at ESMO 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. Believes showed proof of mechanism and importance of polr2a biomarker. Expects to start the expansion portion of the Phase 1 trial later in 2021.

Expects to move one candidate from preclinical to clinical in 2022. Also working on nucleotide repeat disorders.

Cash and equivalents ended the quarter at $167 million, down sequentially from $195 million.

Operating expenses were $33 million, comprised of $27 million for R&D and $5 million for administration. Loss from operations $27 million. Interest expense $1 million. Gain from change in warrant liability was $2 million.

Q&A summary:

SY-5609 data implications? We believe it has broad potential, but want to focus on three populations we identified as high value. We are opening to partnering.

AML data new next year? Trial is enrolling, starting with a safety lead in. That will be the basis of any data released in 2022.

SY-2102 study will do a single dose in the fasted state and the fed state, then compare the PK. We will also compare between the infused and oral doses for PK. There are single dose and multiple dose modules.

Pancreatic cancer expansion cohort begins with second line disease. Our preclinical data support synergy with gemcitabine. The data readout should have clear next steps. Only then might we move into frontline disease. The greatest unmet medical need is in second-line disease.

CDK12 preclinical program is most advanced, but we still have not selected the program to take into human trials in 2022.

Nature of SY-1425 in 2022? Tamibarotene combo has great potential. Data in 2022 will be safety with perhaps some clincial activity.

We like both solid and blood tumor opportunities for SY-5609.

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