GlycoMimetics Reports Operational Highlights and Financial Results for First Quarter 2020
May 01 2020 - 7:00AM
Business Wire
- Entered into an exclusive collaboration and license agreement
with Apollomics for development and commercialization of
uproleselan and GMI-1687 in the Greater China region
- Announced first patient dosing in Phase 1b clinical trial of
GMI-1359 in individuals with advanced breast cancer, led by
co-principal investigators from the Duke Cancer Institute
- Reiterated a commitment to determine what, if any, next steps
to take with respect to the rivipansel program following transfer
from Pfizer of the IND and the full Phase 3 RESET dataset
- To host conference call and webcast today at 8:30 a.m. ET
GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial
results for the first quarter ended March 31, 2020 and highlighted
recent company events. Cash and cash equivalents at March 31, 2020
were $154.8 million.
“During the quarter, patient enrollment continued on track in
GlycoMimetics’ Phase 3 registration program evaluating uproleselan
in relapsed/refractory acute myeloid leukemia (AML) as well as in
our collaboration with the National Cancer Institute (NCI) on a
multi-center clinical trial evaluating the drug candidate in newly
diagnosed patients fit for chemotherapy. Enrollment slowed in April
as a result of the COVID-19 pandemic, and we continue to actively
monitor the situation. At this time it is too early for us to
comment on the potential impact of the pandemic on completion of
enrollment in either trial, or the potential impact on cash burn.
In addition, we are working closely with Apollomics in the Greater
China region to initiate the Apollomics-funded third registration
trial for uproleselan,” commented Rachel King, Chief Executive
Officer.
“In early April, Pfizer transferred to us the rivipansel
investigational new drug application (IND) as well as the study
data set from its Phase 3 clinical trial evaluating the drug’s
clinical effect in sickle cell vaso-occlusive crisis,” continued
Ms. King. “We can now move forward to fully review the data to
determine the next steps, if any, to take with respect to the
rivipansel program now that we have worldwide development and
commercialization rights.”
Operational Highlights
Uproleselan
- GlycoMimetics’ pivotal Phase 3 trial in relapsed/refractory AML
continued to activate clinical sites and enroll patients in the
U.S., Australia and Europe through March 2020.
- The COVID-19 pandemic has resulted in slowed clinical site
initiation, patient recruitment and enrollment rates beginning in
April 2020, which we continue to closely monitor for any potential
material impact on our expected completion of enrollment.
Investigators continued to enroll patients in the NCI-sponsored
Phase 3 clinical trial designed to evaluate uproleselan in newly
diagnosed older adults with AML who are fit for chemotherapy,
through March 2020.
- GlycoMimetics and Apollomics announced an exclusive
collaboration and license agreement for the development and
commercialization of uproleselan and GMI-1687 in Mainland China,
Hong Kong, Macau and Taiwan (Greater China).
GMI-1359
- Duke University initiated a proof-of-concept Phase 1b study to
evaluate GMI-1359 in patients with advanced breast cancer with bone
metastases, and investigators dosed the first patient in January of
this year. The trial is evaluating safety and pharmacodynamic
biomarkers in individuals with hormone receptor positive metastatic
breast cancer.
- A new composition of matter and formulation patent was issued
in the United States for GMI-1359, and the U.S. Food and Drug
Administration (FDA) granted orphan drug and rare pediatric disease
designations for the drug candidate for the treatment of
osteosarcoma that may provide future development support and
marketing protections.
Rivipansel
- GlycoMimetics and Pfizer worked closely to prepare for the
transfer back to GlycoMimetics of the rivipansel program following
Pfizer’s April 2020 termination of the parties’ 2011 license
agreement for clinical development and commercialization of
rivipansel in sickle cell disease (SCD). The transfer, now
complete, includes the return of all rights and licenses previously
granted, as well as the rivipansel IND and the Phase 3 RESET study
data set.
- GlycoMimetics is committed to a detailed assessment of what, if
any, next steps to take with respect to the rivipansel program
after reviewing the Phase 3 clinical data.
First Quarter 2020 Financial
Results
- Cash position: As of March 31, 2020, GlycoMimetics had cash and
cash equivalents of $ 154.8 million as compared to $158.2 million
as of December 31, 2019. In January 2020, GlycoMimetics received an
upfront cash payment of $9.0 million from Apollomics pursuant to
the exclusive collaboration and license agreement for the
development and commercialization of uproleselan and GMI-1687 in
Greater China.
- R&D Expenses: The Company’s research and development
expenses increased to $12.7 million for the quarter ended March 31,
2020 as compared to $ 11.8 million for the first quarter of 2019.
Clinical development expenses increased by $2.4 million based on
the higher clinical costs related to the Company’s ongoing Phase 3
clinical trial of uproleselan in individuals with
relapsed/refractory AML and the Phase 3 clinical trial being
conducted by the NCI. In addition, personnel-related and
stock-based compensation expenses increased by $540,000 due to
annual performance adjustments processed in the quarter ended March
31, 2020. These increases were offset in part by a $2.1 million
decrease in manufacturing and formulation due to lower raw material
expenses in the first quarter ended March 31, 2020 as compared to
the first quarter ended March 31, 2019.
- G&A Expenses: The Company’s general and administrative
expenses increased to $4.4 million for the quarter ended March 31,
2020 as compared to $3.4 million for the first quarter of 2019.
Personnel-related expenses increased by $684,000 due to additional
general and administrative headcount and annual salary adjustments
awarded in the first quarter of 2020. Patent, legal fees,
consulting and other professional expenses, including director and
officer’s insurance premiums, increased by $373,000 for the quarter
ended March 31, 2020 as compared to March 31, 2019.
- Shares Outstanding: Shares of common stock outstanding as of
March 31, 2020 were 43,582,979.
The Company will host a conference call and webcast today at
8:30 a.m. ET. The dial-in number for the conference call is (844)
413-7154 for domestic participants and (216) 562-0466 for
international participants, with participant code 4567397.
Participants are encouraged to connect 15 minutes in advance of the
call to ensure that all callers are able to connect. A webcast
replay will be available via the “Investors” tab on the
GlycoMimetics website for 30 days following the call. A dial-in
phone replay will be available for 24 hours after the close of the
call by dialing (855) 859-2056 for domestic participants and (404)
537-3406 for international participants, participant code
4567397.
About Uproleselan and GMI-1687
Discovered and developed by GlycoMimetics, uproleselan and
GMI-1687 are investigational, first-in-class, targeted inhibitors
of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a
comprehensive Phase 3 development program in AML, has received
Breakthrough Therapy Designation from the U.S. FDA for the
treatment of adult AML patients with relapsed or refractory
disease. 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 or
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.
GMI-1687 is a rationally designed, innovative antagonist of
E-selectin that is potentially suitable for subcutaneous (SC)
administration. When given by SC injection in preclinical models,
GMI-1687 has been observed to have equivalent activity to
uproleselan, but at an approximately 1,000-fold lower dose.
GlycoMimetics believes that GMI-1687 could be developed as a
potential life-cycle expansion to broaden the clinical usefulness
of an E-selectin antagonist to conditions where outpatient
treatment is preferred or required. GMI-1687 is currently
undergoing IND-enabling studies.
About GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin
and CXCR4. E-selectin and CXCR4 are both adhesion molecules
involved in tumor trafficking and metastatic spread. 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 or in
solid tumors that metastasize to the bone, such as prostate cancer
and breast cancer, as well as in osteosarcoma, a rare pediatric
tumor. GMI-1359 has completed a Phase 1 clinical trial in healthy
volunteers. The Duke University Phase 1b clinical study in breast
cancer patients is designed to enable investigators to identify an
effective dose of the drug candidate and to generate initial
biomarker data around the drug’s activity. GMI-1359 has received
Orphan Drug Designation and Rare Pediatric Disease Designation from
the FDA for the treatment of osteosarcoma, a rare cancer affecting
about 900 adolescents a year in the United States.
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’ drug
candidate, uproleselan, an E-selectin antagonist, was evaluated in
a Phase 1/2 clinical trial as a potential treatment for AML and is
being evaluated across a range of patient populations including a
Company-sponsored Phase 3 trial in relapsed/refractory AML.
GlycoMimetics has also completed a Phase 1 clinical trial with
another wholly-owned 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.
Forward-Looking Statements
This press release contains forward-looking statements regarding
the Company’s strategy and the clinical development and potential
benefits and impact of its drug candidates. These forward-looking
statements include those relating to the planned clinical
development of the Company’s product candidates, including
expectations with regard to the enrollment of patients in its
ongoing Phase 3 clinical trial and the potential impact of the
ongoing global COVID-19 pandemic on the Company’s clinical
programs, operations and cash burn, the expected timing for
reviewing data from Pfizer’s Phase 3 clinical trial of rivipansel,
and its other plans for its current cash resources. 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 February 28, 2020, the updated risk factors
described in the Company’s quarterly report on Form 10-Q filed with
the SEC on May 1, 2020, 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 March
31,
2020
2019
(Unaudited)
Revenue
$
$ 9,000
$
—
Costs and expenses:
Research and development expense
12,668
11,773
General and administrative expense
4,440
3,360
Total costs and expenses
17,108
15,133
Loss from operations
(8,108)
(15,133)
Interest income
445
1,049
Net loss and comprehensive loss
$
(7,663)
$
(14,084)
Net loss per common share – basic and
diluted
$
(0.18)
$
(0.33)
Weighted-average common shares – basic and
diluted
43,575,590
43,166,967
GlycoMimetics, Inc.
Balance Sheet Data
(In thousands)
March 31,
December 31,
2020
2019
(unaudited)
Cash and cash equivalents
$
154,823
$
158,201
Working capital
146,269
151,577
Total assets
162,099
167,970
Total liabilities
13,609
13,769
Total stockholders' equity
148,490
154,201
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Investor Contact: Shari Annes Phone: 650-888-0902 Email:
sannes@annesassociates.com
Media Contact: Jamie Lacey-Moreira Phone: 410-299-3310 Email:
jamielacey@presscommpr.com
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