Analyst Conference Summary

biotechnology

conference date: August 8, 2023 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2023 (second quarter, Q2)

Forward-looking statements

Overview: Continues to advance pipeline of therapies.

Basic data (GAAP):

Revenue was $3 million, flat sequentially from $3 million, and down from $6 million year-earlier. Revenue is from collaborations with GBT and Incyte, not product sales.

Net income was negative $36 million, down sequentially from negative $24 million, and down from negative $34 million year-earlier.

Earnings per Share (EPS), diluted, were negative $1.30, down sequentially from negative $0.85, and up from negative $5.40 year-earlier. The number of common shares rose from about 6.4 million to about 27.9 million y/y.

Guidance:

Has a cash runway into Q2 2025.

Conference Highlights:

Nancy Simonian, M.D., CEO said "In the second quarter and recent months, we continued to focus on clinical execution, enrolling patients in our SELECT-AML-1 and SELECT-MDS-1 trials and advancing both studies toward data readouts in the 4th quarter of 2023 and 3rd quarter of 2024, respectively. We look forward to sharing initial data from our SELECT-AML-1 trial in the 4th quarter, which will provide the first direct comparison of patients with RARA overexpression treated with the triplet regimen of tamibarotene, venetoclax and azacitidine compared to those treated with venetoclax and azacitidine alone. In parallel, we progressed our ongoing efforts with SY-2101. We are gathering pharmacokinetic data from our ongoing dose confirmation study and remain on track to provide an update on the next steps for a registration-enabling study in APL in the second half of 2023. In addition, we presented encouraging data for SY-5609 at the ASCO Annual Meeting in June. These data, which generated substantial enthusiasm from clinicians and key opinion leaders, further reinforce the potential of selective CDK7 inhibition and support our ongoing exploration of out-licensing opportunities to maximize the potential of this program."

Data from the pivotal Tamibaroten Phase 3 SELECT-MDS-1, with overall survival (OS) as a key secondary endpoint, and CR as the primary endpoint, 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.

The $2.7 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 (arsenic trioxide formulation) announced in August 2022, expects to initiate a SY-2101 Phase 3 trial in patients with APL (acute promyelocytic leukemia) 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 updated encouraging SY-5609 data from the Phase 1 trial in pancreatic cancer and other solid cancer patients in June 2023. Looking to license 5609 out.

Cash and equivalents ended the quarter at $144 million, down sequentially from $166 million.

Operating expenses were $37 million, comprised of $30 million for R&D, and $7 million for administration. Loss from operations $34 million. Interest net $1 million. Change in warrant fair value $3 million.

Q&A selective summary:

Partnering status? Our focus is on our late stage programs. We are in discussions with potential partners for 5609.

Tamibaroten in AML go/no go decision? Initial data in Q4. More data in 2024.

SELECT-MDS-1 futility analysis? Magrolimab (Gilead) failure? We have an interim futility analysis, will be blinded. Then a primary analysis of the CR rate. Adding patients for OS endpoint. We do not believe there is any implication for our program, since we have a different mechanism of action and a small molecule.

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