Analyst Conference Summary

biotechnology

conference date: March 27, 2024 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2023 (fourth quarter, Q4)

Forward-looking statements

Overview: Continues to advance pipeline of therapies.

Basic data (GAAP):

Revenue was $0.4 million, down sequentially from $3.8 million, and down from $0.8 million year-earlier. Revenue is from collaborations with GBT and Incyte, not product sales.

Net income was negative $64.4 million, down sequentially from negative $40 million, and down from negative $5 million year-earlier.

Earnings per Share (EPS), diluted, were negative $2.18, down sequentially from negative $1.43, and up from negative $0.17 year-earlier.

Guidance:

Has a cash runway into Q2 2025, after data updates.

Conference Highlights:

Conley Chee, CEO said "We recently completed enrollment of the 190 patients necessary for our primary endpoint analysis in the SELECT-MDS-1 Phase 3 trial, and we remain on track to report pivotal CR data by the middle of the fourth quarter of this year. We are optimistic about this data, which we believe will further reinforce tamibarotene’s potential as a differentiated, biologically targeted approach for the approximately 50% of HR-MDS patients who are positive for RARA overexpression. We expect to report additional data from SELECT-AML-1 this year. In December, we shared initial results from a prespecified analysis of randomized patients, and we were highly encouraged by the 100% CR/CRi rate observed following treatment with the triplet combination of tamibarotene, venetoclax and azacitidine. We believe the triplet combination could alter the treatment paradigm in AML, with the potential to offer a more effective and well-tolerated option. Following our equity offering in the fourth quarter of 2023, we are well-positioned to execute on our upcoming clinical milestones, while beginning to prepare for our first new drug application filing and planned HR-MDS launch in the United States." Conley Chee took over as CEO on December 1, 2023. Nancy Nancy Simonian, former CEO, remains on the Board.

Data from the pivotal Tamibaroten (+ 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 data was reported in December 2023. Will also report additional Phase 2 data in 2024.

Syros has halted work on SY-2101 to focus on Tamibaroten. 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 $139.5 million, up sequentially from $112 million. In Q4 2023 raised $45 million gross with a near 5 million share equity offering.

Operating expenses were $27.5 million, comprised of $21.5 million for R&D, $6 million for administration, and restructuring of $0.1 million. Loss from operations $27 million. Interest net $0 million. Change in warrant fair value down $37 million.

Q&A selective summary:

Q4 data expectations? CR is very important and clinically meaningful. Correlates with OS. Primary endpoint was agreed with FDA and can support full or accelerated approval, depending on durability. Shortens timeframe from an OS endpoint. Recent duration of response based approvals have been around 6 months, depending on total data package. Safety is also critical. We have a good safety profile.

Cash burn run rate? Some lumpiness, but Q4 number should be approximate run rate.

Commercial prep? Medical affairs educating on the drug and data, including RARA overexpression. Investing in infrastructure, but most expense will be post data.

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