Analyst Conference Summary

biotechnology

conference date: March 2, 2023 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2022 (fourth quarter, Q4)

Forward-looking statements

Overview: Continues to advance pipeline of therapies.

Basic data (GAAP):

Revenue was negative $0.8 million, down sequentially from $3.9 million, and down from $7.8 million year-earlier. Revenue is from collaborations with GBT and Incyte, not product sales.

Net income was negative $5 million, up sequentially from negative $30.3 million, and up from negative $24 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.17, up sequentially from negative $3.21, and up from negative $3.80 year-earlier.

Guidance:

Now has a cash runway into Q2 2025.

Conference Highlights:

Nancy Simonian, M.D., CEO said "As evidenced by the FDA’s recent decision to grant Fast Track Designation to tamibarotene for HR-MDS, there is a clear need for new therapies that can address the needs of people living with this progressive and devastating disease and we are working with urgency, together with physicians around the world, to recruit and enroll the SELECT-MDS-1 trial. In addition, we have initiated the randomized portion of the SELECT-AML-1 Phase 2 trial and are actively screening patients. We expect to report initial data from SELECT-AML-1 in the fourth quarter of this year and to provide an update on the development path and timing for further evaluation of SY-2101 in a registration-enabling study in APL in the second half of this year." Believes funded through MDS Phase 3 trial data

The decrease in losses q/q and y/y were primarily due to a $30.8 million gain on change in fair value of warrant liability. The negative revenue reported was a true-up due to the contract extension.

In September 2022 closed the merger with Tyme Technologies. In July, Syros had announced that it plans to raise approximately $190 million through a merger with Tyme Technologies. This follows an oversubscribed private investment in public equity (PIPE) financing of $130 million. This gave the company $244 million in cash at the end of Q3 2022.

All revenue was from the Incyte or the GBT collaborations.

Initial positive data (83% cCR) from the safety portion of the Phase 2 trial of tamibarotene for AML was reported at ASH 2022 in December. A Phase 3 trial of tamibarotene combined with azacitidine in RARA positive high risk MDS continued. Data is expected in Q3 2024. Potential NDA in 2024. Believes tamibarotene has the potential to become the standard of care for its patient set. In AML additional Phase 2 data is expected in Q4 2023. FDA granted Fast Track for MDS in February 2023.

Syros reported preliminary encouraging SY-5609 data from the safety lead-in portion of the Phase 1 trial in pancreatic cancer patients in Q3 2022.

Based on preliminary data from the dose confirmation study of SY-2101 announced in August 2022, expects to initiate a SY-2101 Phase 3 trial in patients with APL in the second half of 2023. On August 8, 2022 reported positive prelimary data for this novel oral form of arsenic trioxide. Based on the pharmacokinetic data available to date, achieved exposures comparable to IV arsenic trioxide and demonstrated high oral bioavailability. Based on Q2 2022 feedback received from the EMA, Syros plans to conduct a singular registration trial for SY-2101 that could support approval in both the US and the EU.

In December 2022, Syros extended the research term under the collaboration agreement with Global Blood Therapeutics (GBT), now a part of Pfizer, for an additional year.

Cash and equivalents ended the quarter at $202 million, down sequentially from $244 million.

Operating expenses were $35 million, comprised of $28 million for R&D, and $7 million for administration. Loss from operations $36 million. Interest net $0 million. Gain from change in warrant liability was $31 million.

Full year 2022 results: revenue was $15 million. Net loss $95 million. EPS loss $7.49.

Q&A selective summary:

AML data to be released in Q4? Started randomized enrollment. Patient numbers not yet specified. Looking for triplet v. doublet in patients with Rara overexpression, and safety.

2101 registration path? No disclosures so far. We are the first to test oral v. IV availability. Essentially a dose confirmation study. Data is encouraging. Streamlining could mean fewer patients or quicker time to data. We should update later this year.

Select MDS1 futility analysis? Not guiding to a futility analysis. Looking to CR data in Q3 2024.

Share count? We do have 7.5 million prefunded warrants. Depends on that. Aggregate should stay near constant at 27.8 million

We are not selecting for a monocytic expression phenotype in the AML trial, but are for Rara overexpression. But we will be looking at that data.

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