GlycoMimetics today reported progress on its clinical development programs and its financial results for the quarter ended September 30, 2016.
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
- 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
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
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
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.
|Condensed Statements of Operations|
|(In thousands, except share and per share data)|
|Three months ended September 30,||Nine months ended September 30,|
|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||)|
|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||)||$||(0.20||)|
|Weighted average shares – basic and diluted||23,049,347||19,025,623||20,638,129||18,999,705|
|Balance Sheet Data|
|September 30,||December 31,|
|Cash and cash equivalents||$||45,283||$||46,803|