GlycoMimetics Reports Third Quarter 2016 Results and Progress in Clinical Development
"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
Key Operational Highlights:
GlycoMimeticsdosed 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.
GlycoMimeticsinitiated 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, Irelandand Australia. Having recently been granted fast track status by the FDAfor GMI-1271 in this indication, GlycoMimeticsplans to continue to engage with the FDAto discuss clinical and manufacturing planning as the program progresses.
GlycoMimeticsalso 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 Societyof 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 millionas compared to $46.8 millionas of December 31, 2015.
Revenue: Revenue for the three-month periods ended
September 30, 2016and 2015 was not material. There were no milestone or royalty payments due from Pfizer during the three months ended September 30, 2016or 2015.
R&D Expenses: The Company's research and development expenses
$5.9 millionfor the quarter ended September 30, 2016as compared to $5.0 millionfor 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
$2.0 millionfor the quarter ended September 30, 2016as compared to $2.1 millionfor 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, 2016were 23,063,430.
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.
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
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.
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
|Condensed Statements of Operations|
|(In thousands, except share and per share data)|
Three months ended
Nine months ended
|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||)||$||(0.20||)|
|Weighted average shares - basic and diluted||23,049,347||19,025,623||20,638,129||18,999,705|
|Balance Sheet Data|
|Cash and cash equivalents||$||45,283||$||46,803|
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