Analyst Conference Summary

biotechnology

conference date: May 14, 2024 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2024 (first quarter, Q1)

Forward-looking statements

Overview: Continues to advance pipeline of therapies.

Basic data (GAAP):

Revenue was $0 million, down sequentially from $0.4 million, and down from $3 million year-earlier. Revenue is from collaborations with GBT and Incyte, not product sales.

Net income was negative $3.7 million, up sequentially from negative $64.4 million, and up from negative $24 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.10, up sequentially from negative $2.18, and up from negative $0.85 year-earlier.

Guidance:

Has a cash runway into Q3 2025, after data updates.

Conference Highlights:

Conley Chee, CEO said "We are particularly pleased to share today that an independent data monitoring committee recently completed a pre-specified interim futility analysis on 50% of the patients enrolled in the SELECT-MDS-1 trial to support our primary endpoint analysis, and recommended that our study continue without modification. This recommendation, together with the FDA’s decision to grant Fast Track Designation to tamibarotene in AML, reinforces our confidence in the potential for our RARa agonist to offer improved clinical outcomes to HR-MDS and AML patients with RARA gene overexpression, supported by our belief that tamibarotene has a differentiated safety profile well suited for use in these patients. We have begun preparing for our first New Drug Application filing and subsequent launch in the United States. " In May 2024 the Oxford Financial loan agreement was increased to potentially $100 million from the prior $40 million, upon reaching certain milestones.

Data from the pivotal Tamibarotene (+ standard of care) Phase 3 SELECT-MDS-1, with overall survival (OS) as a key secondary endpoint, and CR as the primary endpoint, is expected in mid Q4 2024. If accelerated approval is achieved, the OS portion of the trial 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 Q1 2024 in the SELECT-MDS-1 Phase 3 trial in newly diagnosed HR-MDS patients with RARA gene overexpression. The trial will enroll up to 550 patients with overall survival (OS) as a key secondary endpoint.

Tamibarotene, in combination with standard of care, for RARA positive AML additional Phase 2 SELECT-AML data will be reported in Q3 2024. Was last reported in December 2023. In April,2024 the FDA granted Fast Track Designation to tamibarotene in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML with RARA overexpression, in adults who are over age 75 and who have comorbidities that preclude the use of intensive induction chemotherapy.

Syros has halted work on SY-2101 to focus on Tamibarotene. Based on preliminary data from the dose confirmation study of SY-2101 (arsenic trioxide formulation) announced in August 2022, had expected 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 wto be updated. 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 $108 million, down sequentially from $139.5 million.

Operating expenses were $31 million, comprised of $25 million for R&D and $6 million for administration. Loss from operations $31 million. Interest net $0 million. Change in warrant fair value up $27 million.

Q&A selective summary:

Interim analysis? Prespecified futility on 50% of patients, for complete response rates (CRs) and safety. Not sharing statistical bars.

AML pivotal development? After Q3 data, hard to project when we would make a go/no go decision.

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