GLYC 4/21/2023 Shareholder/Stockholder Letter Transcript:
Improving people s lives
through exceptional science
and resilient innovation
ANNUAL REPORT | 2022
GlycoMimetics is a late clinical-stage biotechnoloy company discovering and
developing glycobiology-based therapies for cancers and in ammatory diseases.
Additional information may be found at www.glycomimetics.com.
Letter from Our President and Chief Executive Of cer
Dear Shareholders and Friends,
In 2022, we demonstrated resilience in driving forward our organizational evolution, as we moved
toward becoming a commercial-stage company poised to deliver important medicines to patients with
signi cant unmet needs. This progress was led by the advancement of our pivotal Phase 3 study of
uproleselan in combination with chemotherapy in patients with relapsed/refractory (R/R) acute myeloid
leukemia (AML). Last fall, based on the slower accumulation of blinded pooled survival events needed
for the overall survival events trigger, we recognized an ethical need to address the possibility that this
slowdown in patient events may relate to bene t from uproleselan study therapy. Following consultation
with medical experts, we aligned with the U.S. Food and Drug Administration to conduct an interim
utility analysis at approximately 80% of planned survival events to our Phase 3 study protocol using a
conservative statistical threshold in order to preserve the statistical integrity of the originally planned nal
overall survival analysis.
The planned interim analysis was conducted in February 2023 by an independent Data Monitoring
Committee which recommended we continue the study to its originally planned nal analysis, while
noting there were no safety concerns. We are encouraged by this continued support of uproleselan s
strong safety pro le and the fact that patients are living longer than expected. As of March 2023, the
median follow-up was greater than 25 months, which is remarkable in AML studies. In fact, this study is
on track to have the longest follow-up of any study in R/R AML at the time of primary analysis at potentially
more than three years, far longer than the 6-7 month lifespan typically expected for these patients.
While there can be no guarantees, for these reasons and others, we remain optimistic about uproleselan
and its potential to improve overall survival in R/R AML. We are looking forward to the nal survival
event trigger which, based on our latest report and re ecting the longer follow-up duration, is expected
to occur within the rst half of 2024.
R/R AML continues to claim far too many lives, and I am incredibly proud to be part of the dedicated
team at GlycoMimetics working to transform outcomes and establish a new potential standard-of-care for
this patient population. Along with the strong momentum in our Phase 3 study, we have been pleased to
see the robust progress made by the clinical community in the ongoing investigator-sponsored studies of
uproleselan. At the American Society of Hematology (ASH) Annual Meeting in December, our investigator
partners at University of California-Davis and MD Anderson Cancer Center presented the rst clinical
continued
Letter from Our President and Chief Executive Of cer
continued
uproleselan data generated outside of the company-sponsored Phase 3 study, including data from R/R
and frontline t patients. Encouragingly, the results indicated a tolerable safety pro le for uproleselan and
showed promising evidence of disease activity. The results of these studies offer exciting opportunities to
potentially expand the clinical utility of uproleselan across AML disease indications and other hematologic
malignancies, if approved, and we are grateful to our clinical partners for their efforts.
Our collaborators at the National Cancer Institute (NCI) also remain on track with their Phase 2/3 study
in frontline newly diagnosed AML patients who are age 60 and above. The NCI completed enrollment
of the Phase 2 portion of the study in December 2021, and per protocol, they have suspended further
enrollment in anticipation of their planned interim analysis of event-free survival. We plan to share the
outcome of this interim analysis when available, and though the result is independent from that of our
own pivotal Phase 3 study, we welcome the opportunity to potentially expand the potential indications
for uproleselan to include frontline AML.
In 2021 we started adding key leaders, such as Dr. Lisa DeLuca as our Regulatory Affairs and Quality head,
to usher complementary skill sets to our organization that enhance our transformational journey towards
potential commercialization. As of 2022, I was delighted to welcome additional leaders including Bruce
Johnson as Chief Commercial Of cer, Edwin Rock, M.D., Ph.D., as Chief Medical Of cer and Chinmaya Rath
as Chief Business Of cer. At this crucial point in our company s life cycle, strong clinical and commercial
leadership is more essential than ever, and Bruce, Ed, and Chinmaya have each proven to be invaluable
leaders. Ed provides critical oversight, strategic guidance, and regulatory insights as we advance through
the late stages of clinical development, while Chinmaya applies his expertise from over two decades at
biotech and pharmaceutical companies to oversee our corporate strategy and early-stage pipeline programs.
In parallel, Bruce and his team remain hard at work educating the market on uproleselan s differentiated
mechanism of action, driving awareness of unmet medical needs in R/R AML and leading key commercial
readiness activities. As a result of these ongoing pre-commercial efforts, we are well-positioned to deliver
uproleselan, if approved, to patients in need.
I would like to express my sincere gratitude to our employees, clinicians, patients, partners, and shareholders
2023 is an important year for GlycoMimetics, and we deeply appreciate your continued support of our
mission to drive bene t for patients with cancers and in ammatory diseases.
Sincerely,
Harout Semerjian
President and CEO
4/21/2023 Letter Continued (Full PDF)