Analyst Conference Summary

biotechnology

conference date: October 31, 2024 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2024 (third quarter, Q3)

Forward-looking statements

Overview: Crucial results expected November 2024.

Basic data (GAAP):

Revenue was $0 million, down sequentially from $0 million, and down from $3.8 million year-earlier.

Net income was negative $6.4 million, up sequentially from negative $23 million, and up from negative $40 million year-earlier.

Earnings per Share (EPS), diluted, were negative $0.16, down sequentially from negative $0.59, and up from negative $1.43 year-earlier.

Guidance:

Has a cash runway into Q3 2025.

Conference Highlights:

Conley Chee, CEO said "It is a very exciting time at Syros, as we approach a significant milestone in our efforts to establish tamibarotene as a potential new standard of care for higher-risk myelodysplastic syndrome (HR-MDS) patients with RARA gene overexpression. We expect to announce topline results from the pivotal SELECT-MDS-1 Phase 3 trial in mid-November, and if successful, we plan to file our first New Drug Application (NDA) and to launch tamibarotene in the U.S. We believe there is a tremendous opportunity for tamibarotene in the HR-MDS frontline setting. With approximately 9,000 newly diagnosed HR-MDS patients annually in the U.S. – approximately 50% of whom overexpress RARA – tamibarotene is uniquely positioned to address the unmet need, as no new therapies beyond hypomethylating agents (HMAs) have been approved in over a decade. Leveraging our own commercial capabilities and experienced leadership team, we are well-equipped to bring tamibarotene to patients." The potential market for tamibarotene is about $800 million.

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 November 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. Passed a futility analysis in Q1 2024. The trial will enroll up to 550 patients with overall survival (OS) as a key secondary endpoint. In Q3 enrollment continued to go very well.

Tamibarotene, in combination with standard of care, for RARA positive AML additional Phase 2 SELECT-AML-1 was discontinued. In August a prespecified interim analysis showed a low probability of success. Data was reported at the Society of Hematologic Oncology (SOHO) meeting in September 2024.

Syros has halted work on SY-2101 (arsenic trioxide formulation for APL (acute promyelocytic leukemia))to focus on Tamibarotene.

Cash and equivalents ended the quarter at $58 million, down sequentially from $79 million.

Operating expenses were $26 million, comprised of $21 million for R&D and $6 million for administration. Loss from operations $26 million. Interest net loss $0.5 million. Change in warrant fair value up $20 million.

Q&A selective summary:

AML results? ASA control data has an MDS complete remission rate of 17%, the regulatory benchmark. The AML trial was to see if we could leverage the MDS data on tamibarotene. The outcome was the achievement was maxed out by the two other drugs. We did see some good responses in the AML study, just not enough to go forward. Safety was good for a triple combination.

Data to be released for MDS? Tami + Aza vs. placebo + Aza. Will report CR rate on first 190 patients. We will not have overall survival in this report, but will have other secondary endpoints like duration of complete response, OR, safety, etc.

FDA filing? Routine regulatory interactions. Will file as efficiently as possible.

Commercial preparations? Preparing for last year, we have a detailed plan, we hope for broad access to the drug. Will have a market awareness campaign, build a field force. Working to have diagnostics and manufacturing capability at launch.

5609? It is a high potential asset. It is better suited for a larger pharma company.

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