GlycoMimetics Reports Third Quarter 2016 Results and Progress in Clinical Development
November 04 2016 - 9:15AM
Business Wire
GlycoMimetics, Inc. (NASDAQ: GLYC) today reported progress on
its clinical development programs and its financial results for the
quarter ended September 30, 2016.
“For GlycoMimetics, the third quarter was highlighted by
continued achievements in our clinical development programs,
particularly with regard to GMI-1271, our clinical-stage E-selectin
antagonist. We announced initiation of a Phase 1 clinical trial of
GMI-1271 in multiple myeloma, expanding potential uses of the drug
candidate. We continue to enroll the Phase 2 portion of the
GMI-1271 AML trial in both newly diagnosed and relapsed/refractory
patients. We also announced the initiation of a Phase 1 clinical
trial of our next drug candidate, GMI-1359, in healthy volunteers.
After the close of the quarter, we announced the acceptance of
multiple abstracts for six posters and one oral presentation at ASH
in December 2016. With our new trial initiations and continued
enrollment in our ongoing trials, we expect to be in a position to
provide additional news on the clinical development of GMI-1271 and
GMI-1359 in late 2016 and throughout 2017,” said Rachel King,
GlycoMimetics’ Chief Executive Officer.
Key Operational Highlights:
- GlycoMimetics dosed the first patient
in a Phase 1 clinical trial of GMI-1271 for multiple myeloma (MM)
in September 2016. The multi-center, open-label dose escalation
trial, which has begun in Ireland, is designed to measure the
efficacy, safety and pharmacokinetics of GMI-1271 in combination
with bortezomib-based chemotherapy among patients who have been
diagnosed with MM and have not responded well to standard
chemotherapy.
- GlycoMimetics initiated dosing in a
Phase 1 clinical trial of its next drug candidate, GMI-1359, in
healthy volunteers. GMI-1359 is a small molecule drug candidate
that simultaneously inhibits both E-selectin and CXCR4. In this
first-in-humans trial, volunteer participants will receive a single
injection of GMI-1359, after which they will be evaluated for
safety, tolerability, pharmacokinetics and pharmacodynamics over 16
days. The randomized, double-blind escalating dose study is being
conducted at a single site in the United States.
- We continue to recruit and dose
patients in the Phase 2 portion of our clinical study evaluating
GMI-1271 in AML in both newly diagnosed and relapsed/refractory
patients at 8 active sites in the United States, Ireland and
Australia. Having recently been granted fast track status by the
FDA for GMI-1271 in this indication, GlycoMimetics plans to
continue to engage with the FDA to discuss clinical and
manufacturing planning as the program progresses.
- GlycoMimetics also recently announced
that six posters and one oral presentation on data from three of
the company’s clinical programs will be presented at the American
Society of Hematology’s Annual Meeting in December 2016.
Third Quarter 2016 Financial Results:
- Cash position: As of September 30,
2016, the Company had cash and cash equivalents of $45.3 million as
compared to $46.8 million as of December 31, 2015.
- Revenue: Revenue for the three-month
periods ended September 30, 2016 and 2015 was not material. There
were no milestone or royalty payments due from Pfizer during the
three months ended September 30, 2016 or 2015.
- R&D Expenses: The Company’s
research and development expenses increased to $5.9 million for the
quarter ended September 30, 2016 as compared to $5.0 million for
the third quarter of 2015. The increase was due to higher costs
associated with the clinical trials for GMI-1271 in AML and MM and
for GMI-1359 in healthy volunteers, partially offset by a decrease
in expenses related to manufacturing and process development for
GMI-1271.
- G&A Expenses: The Company’s general
and administrative expenses decreased to $2.0 million for the
quarter ended September 30, 2016 as compared to $2.1 million for
the third quarter of 2015. The decrease was related to slightly
lower legal expenses, patent fees and commercial research
fees.
- Shares Outstanding: Shares outstanding
as of September 30, 2016 were 23,063,430.
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.
Preclinical research points to the drug's potential role in moving
cancerous cells out of the protective environment of the bone
marrow where they hide and escape the effects of chemotherapy. In
preclinical studies using animal models of AML, the results of
which were presented at meetings of the American Society of
Hematology (ASH), GMI-1271 was also associated with a
reduction of chemotherapy-induced neutropenia and
chemotherapy-induced mucositis.
About GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin
and CXCR4. Since E-selectin and CXCR4 are both adhesion molecules
that keep cancer cells in the bone marrow, we believe that
targeting both E-selectin and CXCR4 with a single compound could
improve efficacy in the treatment of cancers that affect the bone
marrow such as AML and MM, as compared to targeting CXCR4 alone. In
December 2015 at the annual meeting of the American Society of
Hematology, we presented preclinical data suggesting that GMI-1359
may enhance the ability of chemotherapy to target and improve
survival rates in patients with a high-risk form of mutated
AML.
About Rivipansel
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.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company focused
on cancer and sickle cell disease. Using our expertise in
carbohydrate chemistry and knowledge of carbohydrate biology, we
are developing a pipeline of proprietary glycomimetics that inhibit
disease-related functions of carbohydrates, such as the roles they
play in inflammation, cancer and infection. We believe this
represents an innovative approach to drug discovery to treat a wide
range of diseases. 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 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
February 29, 2016, 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 September 30, Nine months ended September 30,
(Unaudited) (Unaudited) 2016 2015 2016 2015 Revenue $ 18 $ -
$ 18 $ 20,035 Cost and expenses: Research and development
expense 5,921 5,038 17,221 18,089 General and administrative
expense 1,984 2,133 6,352
5,844 Total costs and expenses 7,905
7,171 23,573 23,933
Loss from operations (7,887 ) (7,171 ) (23,555 ) (3,898 )
Other income 32 3 74
10 Net loss and net comprehensive loss
$ (7,855 ) $ (7,168 ) $ (23,481 ) $ (3,888 )
Net loss per share – basic and diluted $ (0.34 ) $ (0.38 ) $ (1.14
) $ (0.20 ) Weighted average shares – basic and diluted 23,049,347
19,025,623 20,638,129 18,999,705
GlycoMimetics, Inc. Balance Sheet Data (In thousands)
September 30, December 31, 2016 2015 (unaudited) Cash and
cash equivalents $ 45,283 $ 46,803 Working capital 41,104
39,497 Total assets 48,011 48,462 Total liabilities
6,259 7,991 Stockholders' equity 41,751 40,472
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GlycoMimetics, Inc.Investor Contact:Shari Annes,
650-888-0902sannes@annesassociates.comorMedia Contact:Jamie
Lacey-Moreira, 410-299-3310jamielacey@presscommpr.com
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