Analyst Conference Summary

biotechnology

conference date: May 16, 2022 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2022 (first quarter, Q1)

Forward-looking statements

Overview: Continues trials of therapies. But delaying some trials until capital can be raised.

Basic data (GAAP):

Revenue was $5 million, down sequentially from $8 million, and flat from $5 million year-earlier. Revenue is from collaborations, not product sales.

Net income was negative $25 million, down sequentially from negative $24 million, and down from negative $14 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.40, down sequentially from negative $0.38, and down from negative $0.23 year-earlier.

Guidance:

Believes cash sufficient into Q2 2023.

Conference Highlights:

Nancy Simonian, M.D., CEO said "The first quarter of 2022 was very productive for Syros as our team focused on executing across our portfolio in preparation for three data readouts this year, including from the safety lead-ins of the SY-5609 trial in pancreatic cancer and of the SELECT-AML-1 Phase 2 trial of tamibarotene as well as from the dose confirmation study of SY-2101 in APL. Given the current market conditions, we will not be starting the Phase 3 trial of SY-2101 until we secure additional capital. In addition, at this time we are deprioritizing the evaluation of SY-5609 in hematologic malignancies. We are focusing our resources to continue our ongoing clinical trials in order to deliver benefit to patients as well as maximize value for our shareholders."

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. In August 2021 announced an agreement with Roche to explore SY-5609 in combination with atezolizumab (Tecentriq) in Kras mutant second-line 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 Phase 1b colorectal cancer arm in 1H 2022. Use for hematological is deprioritized as of Q2 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. Agreed with FDA on endpoints for Phase 3. But the Phase 3 trial is being delayed until additional capital is raised.

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. Believes tamibarotene has the potential to become the standard of care for its patient set.

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 $112 million, down sequentially from $143 million.

Operating expenses were $32 million, comprised of $25 million for R&D and $7 million for administration. Loss from operations $27 million. Interest expense $1 million. Gain from change in warrant liability was $2 million.

Q&A summary:

5609 strategic alternatives, or self-develop? Will make data-driven strategic decisions. Thinking about a variety of opportunities to raise capital to move forward.

Tamibarotene AML trial safety data, activity, expectations? Select AML is in newly diagnosed unfit AML Rara positive patients. Combination study. Intent to move into randomized part of trial. Primary endpoint is CR + CRi rate. Will look at other data as well. Rara positive have higher rate of monocytic features. CR rates of prior doublets have CR rates in the low 60% range. Looking for triplet responses north of that.

What prioritization if capital still constricted? Very committed to tamibarotene in MDS. Data end of 2023, early 2024. 5609 will have more data in 2022, which will inform capital allocation decision.

2101 delay purely financial? Not due to lack of confidence in the therapy. Strictly due to capital market conditions. Will move forward when we get the resources.

5609 pancratic strategy if positive data? Safety lead in data by end of year, will use that data to decide whether to move into expansion phase.

We are proactive about raising capital at the lowest cost possible. The reprioritizations announced extend our current cash into Q2 2023.

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