Analyst Conference Summary

biotechnology

conference date: November 14, 2023 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2023 (third quarter, Q3)

Forward-looking statements

Overview: Continues to advance pipeline of therapies.

Basic data (GAAP):

Revenue was $3.8 million, up sequentially from $3 million, and down from $3.9 million year-earlier. Revenue is from collaborations with GBT and Incyte, not product sales.

Net income was negative $40 million, down sequentially from negative $36 million, and down from negative $30 million year-earlier.

Earnings per Share (EPS), diluted, were negative $1.43, down sequentially from negative $1.30, and up from negative $3.21 year-earlier. There was extreme share dilution y/y.

Guidance:

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

Conference Highlights:

Nancy Simonian, M.D., CEO said "Syros is entering the fourth quarter well-positioned for its next phase of growth. We are laser-focused on advancing tamibarotene for the frontline treatment of hematologic malignancies and look forward to reporting initial data from the randomized portion of SELECT-AML-1 in early December, as well as pivotal data from SELECT-MDS-1 next year. This is precisely the moment we hoped for when we started Syros over a decade ago: our aim has always been to deliver profound benefit to people living with serious diseases. In transitioning leadership to Conley, Syros is taking a meaningful step toward achieving this vision, installing a CEO with extensive commercial expertise and the skill set necessary to effectively build and implement a successful pre-launch and launch strategy. I look forward to continuing to support Syros as a member of the Board of Directors, and to partnering with Conley and our dedicated team as we progress our clinical trials and, ultimately, work to establish tamibarotene as the standard of care for HR-MDS and AML patients with RARA overexpression." conley Chee, currently CCO, will take over as CEO on December 1, 2023. Nancy will remain on the Board.

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 Q4 2024. If accelerated approval is achieved, the OS would allow for full approval. The FDA granted Fast Track for MDS in February 2023. Will complete 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 $3.7 million of revenue was from the Pfizer collaboration. $0.2 million was from Incyte.

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 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, 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 $112 million, down sequentially from $144 million.

Operating expenses were $38 million, comprised of $28 million for R&D, $8 million for administration, and resturucing of $2 million. Loss from operations $39 million. Interest net $0.3 million. Change in warrant fair value $6 million.

Q&A selective summary:

AML and MDS landscapes that may affect tamibaroten? Some things have not changed: unmet need for high-risk MDS frail patients. New drugs have been put into development, with failure typical in Phase 3. We believe our mechanism of action differentiates us from the rest. In AML standard of care has changed with Venetoclax, but still room for improvement. There are other therapies in earlier stage trials.

SELECT AML initial data expectations? Randomized, all RARA positive, unfit AML. Combined with Veneza, compared to Veneza alone. Just 20 patiens, so just 10 with tamibaroten. Looking at CR/CRi rate.

SELECT MDS, a bit behind earlier estimate? Just hard to estimate enrollment rates.

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