- Announced a Cooperative
Research and Development Agreement (CRADA) to collaborate with
the National Cancer Institute (NCI) and the Alliance for
Clinical Trials in Oncology to fund a planned pivotal Phase 3
trial to evaluate uproleselan (GMI-1271) in older, newly diagnosed
acute myeloid leukemia (AML) patients eligible for intensive
chemotherapy
- Continued to select new clinical sites
and ready previously-selected sites for the company’s sponsored
Phase 3 pivotal trial
- Presented preclinical research at the
American Association for Cancer Research (AACR) Annual Meeting
2018 in Chicago suggesting the potential anti-cancer activity
of two of GlycoMimetics’ drug candidates, uproleselan and GMI-1359,
as treatments for AML, metastasis in osteosarcoma and other
cancers
GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial
results for the second quarter ended June 30, 2018 and highlighted
recent company achievements. Quarter-end cash at June 30, 2018 was
$229.4 million.
“Our second-quarter 2018 accomplishments reflect significant
progress as we finalized our plans to conduct a comprehensive Phase
3 development program for uproleselan across the spectrum of AML.
With our announcement in May of an NCI CRADA, in addition to the
previously announced trial in Europe sponsored by the prestigious
HOVON consortium and our own sponsored registration trial, we are
now planning three separate randomized, controlled trials, which we
believe should provide clear efficacy and safety outcome measures
in each of settings being evaluated,” said Rachel King,
GlycoMimetics Chief Executive Officer. “The unique mechanism of
action of uproleselan allows for the potential treatment of not
only relapsed/refractory AML patients, but also older, newly
diagnosed AML patients who are considered to be either fit or unfit
for intensive chemotherapy. If successful, we believe that the
combination of these trials could position us to offer a new
standard treatment across the continuum of care in AML.”
Key Operational Highlights for the Second Quarter of
2018:
- The company’s agreement with the NCI,
part of the National Institutes of Health (NIH), provides
for GlycoMimetics to collaborate with both the NCI and
the Alliance for Clinical Trials in Oncology to conduct a
randomized, controlled clinical trial testing the addition of
uproleselan to a standard cytarabine/daunorubicin regimen (7&3)
in older adults with previously untreated AML who are eligible for
intensive chemotherapy. The trial will be funded by the NCI.
GlycoMimetics will provide uproleselan as well as financial support
to augment data analysis and monitoring. Geoffrey Uy, M.D.,
Associate Professor of Medicine, Bone Marrow Transplantation and
Leukemia, Washington University School of
Medicine in St. Louis, will lead this Phase 3 trial. The
primary endpoint will be overall survival, with a planned interim
analysis based on event-free survival (EFS) after the first 250
patients have been enrolled in the study.
- At the AACR annual meeting, the
company highlighted data from preclinical models of selected
cancers in which uproleselan and GMI-1359, a dual antagonist of
E-selectin and CXCR4, exhibited anti-cancer activity. Key findings
from the preclinical research include:
- Uproleselan could potentially be used
with a hypomethylating agent, such as 5-azacitidine, to treat AML
patients not healthy enough for intensive chemotherapy.
- GMI-1359 mobilized tumor-reactive
T-cells from bone marrow, which could enhance effectiveness of
treatments despite tumor resistance.
- Both tumor growth and metastasis of
osteosarcoma to lung tissue were reduced with GMI-1359
treatment.
- The company’s strategic partner Pfizer
continues to enroll individuals with sickle cell disease (SCD) in
its Phase 3 clinical study of rivipansel for the treatment of
vaso-occlusive crisis (VOC). Pfizer has advised GlycoMimetics that
enrollment is approximately 75% complete and is estimated to be
completed in early 2019, with top-line data expected to be
available in the second quarter of 2019.
Second Quarter 2018 Financial Results:
- Cash position: As of June 30, 2018,
GlycoMimetics had cash and cash equivalents of $229.4 million as
compared to $123.9 million as of December 31, 2017. In March 2018,
GlycoMimetics completed a public offering of 8,050,000 shares of
common stock, yielding net proceeds of $128.4 million.
- R&D Expenses: The Company’s
research and development expenses increased to $9.3 million for the
quarter ended June 30, 2018 as compared to $5.7 million for the
prior year quarter. The increase was primarily due to higher
manufacturing costs for uproleselan clinical supplies as the
Company prepares for our planned Phase 3 clinical trial and to meet
our supply obligations for clinical trials of uproleselan conducted
by or in collaboration with third parties. This increase was offset
in part by a decrease in clinical trial expenses as patient
enrollment for our Phase 1/2 clinical trial of uproleselan was
completed in May 2017.
- G&A Expenses: The Company’s general
and administrative expenses increased to $2.8 million for the
quarter ended June 30, 2018 as compared to $2.5 million for the
prior year quarter. The increase was primarily due to higher patent
and other legal expenses.
- Shares Outstanding: Shares outstanding
as of June 30, 2018 were 43,055,424.
The company will host a conference call and webcast tomorrow,
Friday, August 10, 2018, at 8:30 a.m. ET. The dial-in number for
the conference call is (844) 413-7154 (U.S. and Canada)
or (216) 562-0466 (international) with passcode 3876308. To access
the live audio webcast, or the subsequent archived recording, visit
the “Investors - Events & Presentations” section of the
GlycoMimetics website at www.glycomimetics.com. The webcast will be
recorded and available for replay on the GlycoMimetics website for
30 days following the call.
About Uproleselan (GMI-1271)
Uproleselan 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 1/2 clinical trial, uproleselan was
evaluated in both newly diagnosed elderly and relapsed/refractory
patients with AML. In both populations, patients treated with
uproleselan together with standard chemotherapy achieved better
than expected remission rates and overall survival compared to
historical controls, which have been derived from results from
third party clinical trials evaluating standard chemotherapy, as
well as lower than expected induction-related mortality rates.
Treatment in these patient populations was generally well
tolerated, with fewer than expected adverse effects. The FDA has
granted uproleselan Breakthrough Therapy designation for the
treatment of adult AML patients with relapsed/refractory (R/R)
disease. GlycoMimetics plans to implement a comprehensive
development program across the clinical spectrum of AML. This will
include a company sponsored Phase 3 trial in R/R AML and two
consortia-sponsored trials in newly diagnosed patients. One
consortium trial will be sponsored by the NCI and will enroll newly
diagnosed patients fit for intensive chemotherapy. The other trial
will be sponsored by the HOVON group in Europe and will enroll
newly diagnosed patients unfit for intensive chemotherapy.
About Rivipansel
Rivipansel, the most advanced drug candidate in the
GlycoMimetics pipeline, is a glycomimetic drug candidate that acts
as a pan-selectin antagonist, meaning it binds to all three members
of the selectin family – E-, P- and L-selectin. The first
potential indication for rivipansel is VOC of SCD, one of the
most severe complications of SCD which can result in acute ischemic
organ injury at one or more sites. By reducing cell adhesion,
activation and inflammation that are believed to contribute to
reduced blood flow through the microvasculature during VOC,
GlycoMimetics believes that rivipansel could be the first drug to
interrupt the underlying cause of VOC, thereby potentially enabling
patients to leave the hospital more quickly. Pfizer is conducting a
Phase 3 clinical trial for rivipansel in SCD.
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 multiple myeloma (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 has
three clinical-stage programs: rivipansel, uproleselan and
GMI-1359. In addition, the company is researching additional
pre-clinical stage compounds based on its specialized chemistry
expertise. 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 filed
with the U.S. Securities and Exchange Commission (SEC) on March 6,
2018, 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, 2018 2017 2018 2017
(Unaudited) (Unaudited) Revenue $ - $ - $ - $ - Cost
and expenses: Research and development expense 9,302 5,722 18,324
11,601 General and administrative expense 2,847
2,522 5,702 4,614 Total
costs and expenses 12,149 8,244
24,026 16,215 Loss from operations
(12,149 ) (8,244 ) (24,026 ) (16,215 ) Other income
870 102 1,234 142
Net loss and comprehensive loss $ (11,279 ) $ (8,142 ) $
(22,792 ) $ (16,073 ) Net loss per share -
basic and diluted $ (0.26 ) $ (0.30 ) $ (0.58 ) $ (0.63 ) Weighted
average shares - basic and diluted 42,809,840 27,239,902 38,982,965
25,360,167 GlycoMimetics, Inc.
Balance Sheet Data (In thousands) June 30,
December 31, 2018 2017 (unaudited) Cash and cash equivalents
$ 229,435 $ 123,925 Working capital 225,881 119,045
Total assets 235,696 128,583 Total liabilities 7,701 8,882
Stockholders' equity 227,995 119,701
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version on businesswire.com: https://www.businesswire.com/news/home/20180809005674/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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