EQ Shareholder/Stockholder Letter Transcript:
Annual Report | 2024
Equillium is a clinical-stage biotechnology company leveraging a deep
understanding of immunobiology to develop novel therapeutics to treat severe
autoimmune and inflammatory disorders with high unmet medical need. The
company s pipeline consists of several novel immunomodulatory assets and
product platform targeting immuno-inflammatory pathways.
For more information, visit equilliumbio.com.
Dear Equillium Stockholders,
We are now in the fourth consecutive year of a
very challenging environment for small-cap
biotech, and the current financing market
remains very difficult. Yet we have made
considerable progress against these headwinds
in advancing our therapeutic candidates
through clinical studies, culminating in the
recent announcement of topline data from our
Phase 3 EQUATOR study of itolizumab in the
treatment of acute graft-versus-host disease
(aGVHD).
Based on the compelling data we observed in
longer-term clinical outcomes, we submitted to
the FDA a request for Breakthrough Therapy
designation and have been granted a meeting
with the FDA to review the potential pathway
for Accelerated Approval of itolizumab in the
first-line treatment of aGVHD a disease with
mortality in excess of 40% and no therapies
approved. We expect feedback from the FDA
during May 2025 that will set the future course
for the program and the company.
Over the last year, in addition to our focus on
the EQUATOR study, we supported our partner
Biocon Limited in completing a Phase 2 study
evaluating itolizumab in moderate to severe
ulcerative colitis (UC). Itolizumab demonstrated
clinical and endoscopic remission after 12
weeks of treatment comparable to
adalimumab, a global standard of care biologic
treatment for UC, and was generally well
tolerated consistent with prior clinical
experience.
We also advanced our multi-cytokine targeting
assets, announcing positive data from our
Phase 2 study of EQ101 (a tri-specific cytokine
inhibitor targeting IL-2, IL-9 and IL-15) in
alopecia areata, and that EQ302 (a bi-specific
cytokine inhibitor of IL-15 and IL-21) is ready for
IND enabling studies.
To conserve resources, we have paused much
of our pipeline investment outside of the
ongoing conduct of the EQUATOR study and
related itolizumab regulatory activities.
We look forward to our meeting with the FDA,
and to the potential this could unlock for
physicians and patients suffering from aGVHD.
If we receive positive FDA feedback, and subject
to additional capital, we plan to prepare a
biologics license application for submission in
the first half of 2026. We also remain engaged
in active business development discussions as
we continue to pursue strategic opportunities
that can extend our operational runway and
potentially allow us to realize maximum value
for our assets.
I would like to sincerely thank our employees,
our partners, and the physicians and patients
who participate in our clinical studies, all of
whom are invaluable to Equillium.
Best regards,
Bruce Steel
President and Chief Executive Officer, Equillium
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4/10/2025 Letter Continued (Full PDF)