GlycoMimetics Reports Highlights and Financial Results for Fourth Quarter and Year-end 2019
February 28 2020 - 8:07AM
Business Wire
- Continued patient enrollment in both the Company-sponsored and
NCI-sponsored Phase 3 clinical trials of uproleselan in acute
myeloid leukemia (AML)
- Finalized an exclusive collaboration and license agreement with
Apollomics for development and commercialization of uproleselan and
GMI-1687 in the Greater China region
- Announced in early 2020 first patient dosing in Phase 1b
clinical trial of GMI-1359 in individuals with breast cancer, led
by co-principal investigators from the Duke Cancer Institute
- Upon receiving notice of Pfizer’s termination of license
agreement for rivipansel in early 2020, indicated we will work to
determine what, if any, next steps to take after more completely
reviewing Phase 3 clinical data in vaso-occlusive sickle cell
crisis
- To host conference call and webcast today at 8:30 a.m. ET
GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial
results for the year and fourth quarter ended December 31, 2019 and
highlighted recent company events including several accomplishments
reported to date in 2020. Cash and cash equivalents at December 31,
2019 were $158.2 million.
“GlycoMimetics ended 2019 with robust support from investigators
for our uproleselan Phase 3 registration program in
relapsed/refractory AML as well as 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. The two trials have raised awareness of our clinical
data to date suggesting that uproleselan may be clearly
differentiated from other drugs in development in AML. Endpoints
from the two studies have potential to demonstrate that uproleselan
could both extend survival and ameliorate the severe side effects
experienced by patients following standard treatment,” commented
Rachel King, Chief Executive Officer.
“Given our current cash position, we are confident that we can
move through key milestones in the uproleselan program, advance our
other pipeline programs, and continue to leverage our unique
glycochemistry platform to deliver important and potentially
game-changing treatments to patients and caregivers. With regard to
Pfizer’s recent decision to return rivipansel rights to us, we look
forward to reviewing the full Phase 3 clinical data set and will
work to determine what, if any, next steps to take,” she added.
Uproleselan
- GlycoMimetics’ pivotal Phase 3 trial of uproleselan in
relapsed/refractory AML continued to initiate and activate clinical
sites and to enroll patients in the U.S., Australia and in Europe,
with completion of enrollment expected to occur in the second half
of 2021.
- 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.
- GlycoMimetics and Apollomics announced in January 2020 an
exclusive collaboration and license agreement for the development
and commercialization of uproleselan and GMI-1687 in Mainland
China, Hong Kong, Macau and Taiwan.
- Clinical data shared at the Annual ASH Meeting showed that
uproleselan can potentially selectively break the underlying
environment-mediated drug resistance of AML bone marrow tumors and
prolong overall survival in high-risk patients with AML. Other
presentations highlighted E-selectin as a major extrinsic
contributor to chemoresistance in AML.
Rivipansel
- Pfizer announced in August 2019 that its Phase 3 clinical trial
evaluating rivipansel in sickle cell disease (SCD) failed to meet
the primary endpoint and key secondary endpoints.
- In February 2020, GlycoMimetics received written notice from
Pfizer of the termination of the parties’ 2011 rivipansel license
agreement, including the return of all rights and licenses
previously granted to Pfizer. This termination becomes effective in
April 2020, and GlycoMimetics will work to assess what, if any,
next steps to take with respect to the rivipansel program after
reviewing Pfizer’s Phase 3 clinical data more completely.
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 biomarkers of cancer
cell mobilization in individuals with hormone receptor positive
metastatic breast cancer.
- Shortly after the 2019 year-end, a new composition of matter
and formulation patent issued 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.
Fourth Quarter and Year-end 2019 Financial Results:
- Cash position: As of December 31, 2019, GlycoMimetics had cash
and cash equivalents of $158.2 million as compared to $209.9
million as of December 31, 2018.
- R&D Expenses: The Company’s research and development
expenses decreased to $11.5 million for the quarter ended December
31, 2019 as compared to $12.0 million for the fourth quarter of
2018. This decrease was due to a reduction in manufacturing
expenses in combination with an increase in clinical expenses in
the fourth quarter of 2019 as compared to the same quarter in 2018.
In the fourth quarter of 2018, the manufacturing expenses included
raw materials for the upcoming manufacturing batches that were
initiated in 2019. The clinical expenses increased in the fourth
quarter of 2019 due to the start-up clinical costs related to our
randomized, double-blind, placebo-controlled Phase 3 clinical trial
to evaluate uproleselan in individuals with relapsed/refractory
AML. Research and development expenses increased by $6.9 million to
$47.0 million for the year ended December 31, 2019, from $40.1
million in the year ended December 31, 2018. These increases were
primarily the result of increased clinical costs related to our
randomized, double-blind, placebo-controlled Phase 3 clinical trial
to evaluate uproleselan in individuals with relapsed/refractory AML
and costs associated with the Phase 2/3 randomized, controlled
clinical trial to evaluate uproleselan in older adults with
previously untreated AML who are suitable for intensive
chemotherapy which is being conducted by the NCI. The NCI trial
opened for enrollment in early 2019 and enrolled the first patient
in April 2019. Personnel-related and stock-based compensation
expenses increased due to an increase in clinical headcount and
annual stock option awards granted in 2019.
- G&A Expenses: The Company’s general and administrative
expenses increased to $3.9 million for the quarter ended December
31, 2019 as compared to $2.9 million for the fourth quarter of
2018. General and administrative expenses for the year ended
December 31, 2019 increased to $14.4 million as compared to $11.4
million in the prior year. These increases were primarily due to
higher legal and patent expenses as well as labor-related costs and
stock-based compensation expense. Patent expenses were higher due
to an increase in the number of patent applications filed in 2019
as compared to 2018. Personnel-related and stock-based compensation
expenses increased due to additional headcount in 2019, annual
salary adjustments and stock option and restricted stock unit
awards granted in 2019.
- Shares Outstanding: Shares of common stock outstanding as of
December 31, 2019 were 43,466,933.
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 4169765. 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
4169765.
About Uproleselan (GMI-1271) 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. Food and Drug
Administration (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 investigational new drug (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 acute myeloid leukemia (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 newly initiated
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’ wholly-owned
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 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, 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 December
31,
Year ended December
31,
2019
2018
2019
2018
(Unaudited)
Revenue
$
—
$
—
$
—
$
—
Costs and expenses:
Research and development expense
11,467
12,039
47,029
40,092
General and administrative expense
3,868
2,921
14,360
11,413
Total costs and expenses
15,335
14,960
61,389
51,505
Loss from operations
(15,335)
(14,960)
(61,389)
(51,505)
Interest income
609
1,053
3,497
3,231
Net loss and comprehensive loss
$
(14,726)
$
(13,907)
$
(57,892)
$
(48,274)
Net loss per common share – basic and
diluted
$
(0.34)
$
(0.32)
$
(1.34)
$
(1.18)
Weighted-average common shares – basic and
diluted
43,373,753
43,143,272
43,254,782
41,044,621
GlycoMimetics, Inc.
Balance Sheet Data
(In thousands)
December 31,
December 31,
2019
2018
Cash and cash equivalents
$
158,201
$
209,918
Working capital
151,577
203,506
Total assets
167,970
214,839
Total liabilities
13,769
9,375
Total stockholders' equity
154,201
205,464
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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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