Analyst Conference Summary

biotechnology

conference date: March 15, 2022 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2021 (fourth quarter, Q4)

Forward-looking statements

Overview: Continues trials of therapies. Plenty of cash.

Basic data (GAAP):

Revenue was $8 million, up sequentially from $6 million, and up from $6 million year-earlier.

Net income was negative $24 million, up sequentially from negative $26 million, and up from negative $30 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.38, up sequentially from negative $0.41, and up from negative $0.62 year-earlier. The sharecount increased y/y from approx. 49 million to 63 million.

Guidance:

Believes cash sufficient into Q1 2023.

Conference Highlights:

Nancy Simonian, M.D., CEO said "2021 was a pivotal year for Syros, marked by the initiations of three clinical trials and one expansion cohort across our targeted hematology and CDK inhibitor portfolios, promising data from our SY-5609 program, as well as the appointments of two key leadership team member. We believe we are well-positioned to build on this momentum in 2022. We expect three data readouts this year, including pharmacokinetic and safety data from our dose confirmation trial of SY-2101 in APL as well as clinical activity data from the safety lead-in portions of the SELECT-AML-1 Phase 2 trial and the expansion cohort of SY-5609 in pancreatic cancer. These results have the potential to deliver important insights into each of our investigational medicines as we continue to advance towards becoming a fully integrated biopharmaceutical company with the aim to make a profound difference for patients."

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. 5609 is an oral CDK7 agent with polr2a as a biomarker. Based on those outcomes, initiated an expansion cohort in pancreatic cancer in Q4 2021 with safety portion data in late 2022. Expects to initiate Phase 1 trial evaluating SY-5609 in relapsed/refractory hematologic malignancies in the second half of 2022, with initial data expected mid-2023. In August 2021 announced an agreement with Roche to explore SY-5609 in combination with atezolizumab (Tecentriq) in Bras mutant 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. Roche plans to open the colorectal cancer arm in 1H 2022.

In Q3 2021 initiated SY-2101 for APL in a Phase 2 trial. Dose confirmation data from the earlier trial should be reported in mid 2022. The Phase 3 trial is expected to initiate in Q1 2023. Agreed with FDA on endpoints.

A Phase 3 trial of tamibarotene (SY-1425) combined with azacitidine in RARA positive high risk MDS continued. Data is expected in late 2023 or early 2024. Potential NDA in 2024. In Q1 2022 received orphan drug designation from the FDA. In 2H 2022 expects to report clinical activity data from safety lead-in portion of ongoing SELECT-AML-1 Phase 2 trial, combined with azacitidien and venetoclax, in newly diagnosed unfit RARA-positive AML patients. In March 2022 agreed with Qiagen for RARA biomarker.

Expects to move one candidate from preclinical to clinical in 2022, a CDK12 inhibitor. Preclinical data is encouraging. Also working on nucleotide repeat disorders.

Cash and equivalents ended the quarter at $143 million, down sequentially from $167 million.

Operating expenses were $33 million, comprised of $27 million for R&D and $6 million for administration. Loss from operations $25 million. Interest expense $1 million. Gain from change in warrant liability was $3 million.

Q&A summary:

Tamibarotene AML trial thresholds, next steps? For AML first data will be safety plus efficacy, looking for something north of 61% complete response rate of Phase 2 results. Because it is oral and relatively safe, and venetoclax has a low response rate, we are hoping to deliver value. Phase 3 AML trial size has not been determined.

Vaneza toxicities that could be worsened by tamibarotene? None anticipated.

The current patient APL population is largely cured by the current therapy, so getting the right dose for the new oral formulation is critical.

Mantle cell lymphoma with 5609? It is still a priority. But we had really high pancreatic cancer responses, so it we picked that to go forward with first. Will look at a variety of blood cancers before deciding on a specific one to move forward with.

We will leverage our solid cancer dosing knowledge as we do our blood cancer program. We will be adding 5609 to standard of care once dosing is determined.

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