SYRS Shareholder/Stockholder Letter Transcript:
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2023 ANNUAL REPORT
Dear Fellow Shareholders,
2023 was a transformative year for Syros, as we
made critical progress in advancing tamibarotene
through late-stage development for the frontline
treatment of higher-risk myelodysplastic syndrome
(HR-MDS) and acute myeloid leukemia (AML). We
believe we are now well on our way to becoming
a commercial biotech company. I am honored to
have the opportunity to lead Syros in this next stage
of growth and lucky to be supported by a team of
industry leaders, expert scientists, and company
builders in our pursuit of delivering tamibarotene to
the many people living with hematologic malignancies, who are in need of improved treatment options.
Together, we are well-prepared to build on our
momentum from 2023 and look forward to executing
on all our upcoming value-driving milestones in the
year ahead.
Advancing Tamibarotene: Key Milestones
We are approaching a critical step in achieving our
mission with pivotal data from the SELECT-MDS-1
Phase 3 trial on the horizon. We have completed
enrollment of the 190 patients necessary to support
the complete response (CR) rate primary endpoint
analysis in SELECT-MDS-1, and we expect to report
pivotal data by the middle of the fourth quarter of
this year. If successful, these data will allow us to
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deliver tamibarotene to patients, we have started
to build out our commercial plan and capabilities in
preparation for a potential launch in the U.S. with our
own specialty salesforce.
Clinical Progress and Promising Results
We are encouraged by the growing body of clinical
evidence that supports the potential for tamibarotene
to meaningfully augment the standard of care in
AML, particularly as AML and HR-MDS are closely
related diseases. In particular, we are excited by the
most recent initial results from the SELECT-AML-1
Phase 2 study, in which we observed a 100% CR/
CRi rate in patients treated with the triplet regimen of
tamibarotene, venetoclax and azacitidine, as compared to 70% among patients treated with venetoFOD[ DQG D]DFLWLGLQH DORQH 1RW RQO\ ZHUH WKHVH GDWD
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tamibarotene as it remains well-tolerated with no
additive toxicities, safety signals, or increase in myelosuppression being observed. These initial results
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potential to improve the standard of care in patients
with RARA overexpression, and we look forward to
sharing additional results from the SELECT-AML-1
study later this year.
Financial Strength and Capitalization
Importantly, we remain well-capitalized to fund the
continued development of tamibarotene and support planning of a commercial launch, buoyed by
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2023 that resulted in gross proceeds to Syros of
approximately $45.0 million. We believe that we
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operating expenses and expenditure requirements
into the second quarter of 2025, beyond our pivotal
Phase 3 data from the SELECT-MDS-1 trial and
additional data from the randomized portion of the
SELECT-AML-1 trial.
A Word of Thanks
We thank you for your continued support of Syros,
and to all the patients and their families who have
participated in our clinical trials. We look forward to
another productive year with important data in HRMDS and AML ahead. We are working diligently to
achieve our mission of developing new standards of
care for the frontline treatment of hematologic malignancies and delivering a novel therapeutic option for
the approximately 50% of MDS patients and 30% of
AML patients with RARA overexpression.
Sincerely,
Conley Chee
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Syros
4/23/2024 Letter Continued (Full PDF)