- FDA granted Breakthrough Therapy
designation to the Company’s drug candidate, GMI-1271, for
treatment of adults with relapsed/refractory acute myeloid leukemia
(AML)
- Company completed enrollment in the in
Phase 2 portion of its Phase 1/2 trial of GMI-1271 for the
treatment of AML
- Clinicians presented interim clinical
data from the Phase 1/2 trial of GMI-1271 for the treatment of AML
at the 2017 American Society of Clinical Oncology (ASCO) and
European Hematology Association (EHA) meetings
- Company completed public offering
raising gross proceeds of $92.6 million
GlycoMimetics, Inc. (NASDAQ: GLYC) today reported progress on
its clinical development programs and its financial results for the
second quarter and six months ended June 30, 2017.
“In the second quarter of 2017, GlycoMimetics achieved multiple
milestones for its GMI-1271 program, a highlight of which was the
FDA’s granting of Breakthrough Therapy designation to GMI-1271 for
the treatment of relapsed/refractory AML patients. This milestone
was coupled with the presentation of updated data from our ongoing
Phase 1/2 clinical trial at both the ASCO and EHA meetings and the
completion of a public offering of our common stock, from which we
raised gross proceeds of $92.6 million to significantly extend our
cash runway. We believe that these milestones provide evidence of
the opportunity residing in our GMI-1271 program and our drug
development platform more generally. The achievements during the
second quarter have importantly underscored the differentiated
potential of GMI-1271,” noted Rachel King, Chief Executive
Officer.
“The recent spotlight on our fast-progressing program in AML,
however, should not obscure the potential of our platform and broad
pipeline opportunities. In particular, GMI-1359, is a compound with
potential in multiple cancer indications and is now in Phase 1
trials in healthy volunteers. During 2018, we plan to identify the
initial patient population in which we will evaluate this compound.
In addition, our most advanced clinical development program to
evaluate GlycoMimetics’ drug candidate rivipansel for the treatment
of vaso-occlusive crisis of sickle cell diseases, is on track to
complete enrollment of the Phase 3 pivotal trial in the second half
of 2018, according to our collaborator Pfizer,” she added.
Key Operational Highlights for the Second Quarter of 2017:
- The company presented new data from its
Phase 1/2 AML trial of GMI-1271 at the June 2017 annual
meetings of ASCO and EHA. In the relapsed or refractory disease arm
of the trial, 66 patients had been enrolled. Of the 54
relapsed/refractory AML patients for whom data was available, the
CR/CRi rate was 41%. The mortality rate among this group at
60 days was 7%. We believe these results compare favorably to
what would be expected in this population, based on published
historical controls in similar patients. Researchers also observed
a median E-selectin ligand expression of 35% at baseline, with
higher rates among those patients in this cohort who achieved
remission. In the newly-diagnosed, treatment-naïve elderly arm of
the trial, 25 patients had been enrolled. Among these 25 patients,
the CR/CRi rate was 68%, with a 73% rate for patients with
de novo disease and 64% for patients with secondary AML.
- In May 2017, the company completed
enrollment of 91 patients in the Phase 1/2 trial of GMI-1271.
The Phase 2 portion of the trial included one cohort of 25 patients
over 60 years of age with newly diagnosed AML and a second
cohort of 44 patients with relapsed or refractory AML. Unlike in
the Phase 1 portion, some of the patients in the Phase 2
portion may be treated with multiple cycles of GMI-1271. We plan to
provide additional updates from this clinical trial in the second
half of 2017 and in 2018. We also intend to discuss with the FDA
the design of a potential Phase 3 pivotal trial that could
support an application for marketing approval for GMI-1271 for the
treatment of AML.
- In May 2017, GMI-1271 received
Breakthrough Therapy designation from the FDA for the treatment of
adults with relapsed/refractory AML. The FDA grants Breakthrough
Therapy designation to companies to help accelerate development and
review of drug candidates when preliminary clinical evidence
indicates that the drug may demonstrate substantial improvement
over existing therapies. The designation is designed to expedite
the development and review of designated therapies, without
changing FDA standards for new drug approval. In addition, in May
2017, the European Commission, based on a favorable recommendation
from the European Medicines Agency Committee for Orphan Medicinal
Products, granted orphan designation for GMI-1271 for the treatment
of AML.
Second Quarter 2017 Financial Results:
- Cash position: As of June 30, 2017,
GlycoMimetics had cash and cash equivalents of $119.1 million as
compared to $40.0 million as of December 31, 2016. The Company
raised $86.8 million in net proceeds from the public offering of
common stock completed in May 2017 and an additional $7.4 million
in net proceeds under an at-the-market equity facility that was
terminated in May 2017 in connection with the public offering.
- R&D Expenses: The company’s
research and development expenses decreased to $5.7 million for the
quarter ended June 30, 2017 as compared to $5.8 million for the
second quarter of 2016. The decrease was primarily caused by a
decrease in expenses related to non-clinical toxicology studies and
manufacturing and process development for its earlier-state drug
candidate, GMI-1359, partially offset caused by the on-going costs
associated with the ongoing clinical trials of GMI-1271 for the
treatment of AML and multiple myeloma (MM).
- G&A Expenses: The company’s general
and administrative expenses increased to $2.5 million for the
quarter ended June 30, 2017 as compared to $2.3 million for the
second quarter of 2016. These increases were primarily attributable
to annual salary adjustments and additional stock-based
compensation expense caused by 2017 equity awards to employees and
directors.
- Shares Outstanding: Shares of common
stock outstanding as of June 30, 2017 were 32,716,357.
About GMI-1271
GMI-1271 is designed to block E-selectin (an adhesion molecule
on cells in the bone marrow) from binding with blood cancer cells
as a targeted approach to disrupting well-established mechanisms of
leukemic cell resistance within the bone marrow microenvironment.
In a Phase 2 clinical trial which has now completed enrollment,
GMI-1271 is being evaluated in both elderly and relapsed/refractory
patients with acute myeloid leukemia (AML). In both populations,
patients treated with GMI-1271 together with standard chemotherapy
have continued to achieve higher than expected remission rates
based on historical controls, as well as lower than expected
induction-related mortality rates. Importantly, treatment in this
patient population has been well tolerated with minimal adverse
effects.
About GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin
and CXCR4. E-selectin and CXCR4 are both adhesion molecules that
keep cancer cells in the bone marrow. Preclinical studies indicate
that targeting both E-selectin and CXCR4 with a single compound
could improve efficacy in the treatment of cancers that involve the
bone marrow such as AML and MM or in solid tumors that metastasize
to the bone, such as prostate cancer and breast cancer. GMI-1359 is
currently in Phase 1 testing in healthy volunteers.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company
focused on the discovery and development of novel glycomimetic
drugs to address unmet medical needs resulting from diseases in
which carbohydrate biology plays a key role. GlycoMimetics' most
advanced drug candidate, rivipansel, a pan-selectin antagonist, is
being developed for the treatment of vaso-occlusive crisis in
sickle cell disease and is being evaluated in a Phase 3 clinical
trial being conducted by its strategic collaborator, Pfizer.
GlycoMimetics' wholly-owned drug candidate, GMI-1271, an
E-selectin antagonist, is being evaluated in an ongoing Phase 2
clinical trial as a potential treatment for AML and in a Phase 1
clinical trial for the treatment of multiple myeloma. The FDA
recently granted GMI-1271 Breakthrough Therapy designation
for the treatment of adult AML patients with
relapsed/refractory disease. GlycoMimetics has also recently
initiated a Phase 1 clinical trial with a third drug candidate,
GMI-1359, a combined CXCR4 and E-selectin
antagonist. GlycoMimetics is located in Rockville,
MD in the BioHealth Capital Region. Learn more
at www.glycomimetics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding
the clinical development of the company’s drug candidates,
including the expected timing of completion of clinical trials and
the presentation of clinical data. Actual results may differ
materially from those in these forward-looking statements. For a
further description of the risks associated with these statements,
as well as other risks facing GlycoMimetics, please see the risk
factors described in the company’s annual report on Form 10-K that
was filed with the U.S. Securities and Exchange Commission (SEC) on
March 1, 2017, and other filings GlycoMimetics makes with the SEC
from time to time. Forward-looking statements speak only as of the
date of this release, and GlycoMimetics undertakes no obligation to
update or revise these statements, except as may be required by
law.
GlycoMimetics, Inc. Condensed Statements of Operations (In
thousands, except share and per share data)
Three months ended June 30, Six months ended June 30,
(Unaudited) (Unaudited) 2017 2016 2017 2016 Revenue $ - $ -
$ - $ - Cost and expenses: Research and development expense
5,722 5,781 11,601 11,300 General and administrative expense
2,522 2,312 4,614 4,369
Total costs and expenses 8,244 8,093
16,215 15,669 Loss from
operations (8,244 ) (8,093 ) (16,215 ) (15,669 ) Other
income 102 22 142
42 Net loss and comprehensive loss $ (8,142 ) $
(8,071 ) $ (16,073 ) $ (15,627 ) Net loss per
share - basic and diluted $ (0.30 ) $ (0.41 ) $ (0.63 ) $ (0.80 )
Weighted average shares - basic and diluted 27,239,902 19,793,202
25,360,167 19,432,520 GlycoMimetics, Inc. Balance
Sheet Data (In thousands) June 30, December 31, 2017
2016 (unaudited) Cash and cash equivalents $ 119,148 $
40,042 Working capital 114,203 34,187 Total assets
121,622 42,388 Total liabilities 6,190 7,087
Stockholders' equity 115,432 35,301
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version on businesswire.com: http://www.businesswire.com/news/home/20170803005086/en/
GlycoMimetics, Inc.Investor Contact:Shari Annes,
650-888-0902sannes@annesassociates.comorMedia Contact:Jamie
Lacey-Moreira, 410-299-3310jamielacey@presscommpr.com
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