Analyst Conference Summary

biotechnology

conference date: May 10, 2023 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2022 (first quarter, Q1)

Forward-looking statements

Overview: Continues to advance pipeline of therapies.

Basic data (GAAP):

Revenue was $3 million, up sequentially from negative $0.8 million, and down from $5 million year-earlier. Revenue is from collaborations with GBT and Incyte, not product sales.

Net income was negative $24 million, down sequentially from negative $5 million, and up from negative $25 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.85, down sequentially from negative $0.17, and up from negative $3.99 year-earlier. The number of common shares rose from about 6.3 million to about 27.8 million y/y.

Guidance:

Now has a cash runway into Q2 2025.

Conference Highlights:

Nancy Simonian, M.D., CEO said "2023 is off to a good start. We are focusing on clinical execution, with the goal of delivering tamibarotene and SY-2101 as new standards of care for the frontline treatment of hematologic malignancies. We are pleased that recent feedback from the FDA on our SELECT-MDS-1 trial continues to support the CR rate as an appropriate primary endpoint for either full or accelerated approval with supporting data on the durability of remission. We have amended our existing trial to add overall survival as a key secondary endpoint, allowing this single trial to efficiently serve as a confirmatory study if needed for full approval. We commenced the randomized portion of the SELECT-AML-1 Phase 2 trial and remain on track to report initial data in the fourth quarter, as well as to provide an update on the development path for SY-2101 in APL in the second half of this year. We are fortunate to operate from a robust financial position, with sufficient capital to fund our efforts into 2025, beyond pivotal CR data from the SELECT-MDS-1 trial and initial data from the randomized portion of SELECT-AML-1."

Syros announced that it has amended the protocol for its pivotal Phase 3 SELECT-MDS-1 trial by increasing the number of patients from 190 to 550 to evaluate overall survival (OS) as a key secondary endpoint. This will not affect the timing of the pivotal CR data from SELECT-MDS-1 which is expected in Q3 2024. If accelerated approval is achieved, the OS would allow for full approval. The FDA granted Fast Track for MDS in February 2023. Completed enrollment of 190 patients necessary to support complete response (CR) primary endpoint in Q4 2023 in the SELECT-MDS-1 Phase 3 trial in newly diagnosed HR-MDS patients with RARA gene overexpression. Will report pivotal CR data from the SELECT-MDS-1 Phase 3 trial in the third quarter of 2024.

The $3 million of revenue was from the Pfizer collaboration.

Initial positive data (83% cCR) from the safety portion of the Phase 2 trial of tamibarotene, in combination with standard of care, for RARA positive AML was reported at ASH 2022 in December. In AML additional Phase 2 data is expected in Q4 2023. Will also report additional Phase 2 data in 2024.

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. Currently is in a dose-confirmation trial, data will be updated later in 2023. Syros plans to conduct a singular registration trial for SY-2101 that could support approval in both the US and the EU.

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.

Cash and equivalents ended the quarter at $166 million, down sequentially from $202 million.

Operating expenses were $36 million, comprised of $29 million for R&D, and $7 million for administration. Loss from operations $33 million. Interest net $0.5 million. Change in warrant fair value $9 million.

Q&A selective summary:

Powering on the new OS endpoint? Focus is still on CR, over 90% powered. For OS is 80%. Survival is event driven, so no projected timeline yet. CR is on track for full 190 patient analysis by Q4 2023, with data on Q3 2024.

A timeline for the 2101 Phase 3 trial will be provided later this year after data from the current trial is reported.

Accerated v full approval criteria for first part of trial? We do not know the specifics, it depends on the data package, but CR usually is a good indicator of overall survival.

5609 will have two posters at ASCO, but we are looking for a partner for this program. We are not putting further capital into the development of this program.

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