GlycoMimetics Reports Fourth Quarter and Year-End 2016 Results
Beyond this program, we initiated two new trials in 2016, a Phase 1
clinical trial of GMI-1271 in multiple myeloma (MM), and a Phase 1
clinical trial of our next drug candidate GMI-1359, a dual antagonist of
both E-selectin and CXCR4, in healthy volunteers. These accomplishments
position us for significant news flow in 2017. In addition, the Phase 3
trial of rivipansel being conducted by Pfizer continues to enroll sickle
cell patients with the goal of completion of enrollment in the second
half of 2018," said
Key Operational Highlights for the Fourth Quarter of 2016:
At the ASH Annual Meeting in
San Diegoheld in December 2016, GlycoMimeticspresented results from its Phase 1/2 clinical trial of GMI-1271, in which high rates of remission and favorable tolerability were observed among AML patients in both arms of the trial. In the Phase 1/2 clinical trial, clinicians are studying the use of GMI-1271 along with chemotherapy. For a total of 33 study participants with relapsed or refractory disease in one arm of the trial, the complete response (CR) rate was 45 percent. For 11 newly diagnosed study participants 60 or more years of age in the second arm of the trial, the CR rate was 73 percent. All study participants evaluated as of the ASH meeting who had responded had complete remissions; there were no patients observed who responded with incomplete count recoveries. In addition, in elderly, newly diagnosed patients evaluated as of the date of the ASH meeting, the 60-day mortality rate was zero for those receiving intensive induction chemotherapy plus GMI-1271.
GlycoMimeticscontinues to recruit and dose patients in the Phase 2 portion of its clinical study evaluating GMI-1271 in AML in both newly diagnosed and relapsed/refractory patients at eight active sites in the United States, Irelandand Australia. GMI-1271 has received fast track designation from the US Food & Drug Administration(FDA) for the treatment of AML, and GlycoMimeticsplans to continue to engage with the FDAto discuss clinical and manufacturing planning as the program progresses.
GlycoMimeticscontinues enrollment in a Phase 1 clinical trial of GMI-1271 for MM, which enrolled the first patient 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 chemotherapy among patients who have been diagnosed with MM and have not responded well to standard chemotherapy.
GlycoMimeticscompleted dosing in a Phase 1 clinical trial of 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-human trial, volunteer participants received a single injection of GMI-1359 and were evaluated for safety, tolerability, pharmacokinetics and pharmacodynamics over 16 days. The randomized, double-blind escalating dose study was conducted at a single site in the United States.
Fourth Quarter 2016 Financial Results:
Cash position: As of
December 31, 2016, GlycoMimeticshad cash and cash equivalents of $40.0 millionas compared to $46.8 millionas of December 31, 2015.
Revenue: The company's revenue for the year ended
December 31, 2016was not material. The revenue recorded in the year ended December 31, 2015was due to a $20.0 millionnon-refundable milestone payment from Pfizer triggered upon the dosing of the first patient in the Phase 3 clinical trial of rivipansel. There were no milestone or royalty payments from Pfizer during the year ended December 31, 2016.
R&D Expenses: The company's research and development expenses
$6.1 millionfor the quarter ended December 31, 2016as compared to $7.0 millionfor the fourth quarter of 2015. Research and development expenses similarly decreased by $1.8 millionto $23.3 millionfor the year ended December 31, 2016, from $25.1 millionin the year ended December 31, 2015. During the year ended December 31, 2016, there was an increase in the costs associated with the clinical development for GMI-1271 and GMI-1359, offset by a year-over-year decrease in expenses related to manufacturing and process development for GMI-1271.
G&A Expenses: The company's general and administrative expenses
$2.3 millionfor the quarter ended December 31, 2016as compared to $2.0 millionfor the fourth quarter of 2015. General and administrative expenses for the year ended December 31, 2016increased to $8.7 millionas compared to $7.8 millionin the prior year. These increases were primarily due to increased labor-related costs and stock-based compensation expense.
Shares Outstanding: Shares outstanding as of
December 31, 2016were 23,250,023.
GMI-1271 is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. Preclinical research points to the drug's potential role in moving cancerous cells out of the protective environment of the bone marrow where they hide and escape the effects of chemotherapy. In preclinical studies using animal models of AML, the results of which were presented at ASH meetings, GMI-1271 was also associated with a reduction of chemotherapy-induced neutropenia and chemotherapy-induced mucositis.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding the
clinical development of the company's drug candidates and the
presentation of clinical data. Actual results may differ materially from
those in these forward-looking statements. For a further description of
the risks associated with these statements, as well as other risks
|Condensed Statements of Operations|
|(In thousands, except share and per share data)|
Three months ended
|Costs and expenses:|
|Research and development expense||6,060||6,961||23,282||25,050|
|General and administrative expense||2,298||1,962||8,650||7,805|
|Total costs and expenses||8,358||8,923||31,932||32,855|
|Loss from operations||(8,358||)||(8,888||)||(31,914||)||(12,784||)|
|Net loss and net comprehensive loss||$||(8,329||)||$||(8,882||)||$||(31,810||)||$||(12,769||)|
|Net loss per common share - basic and diluted||$||(0.36||)||$||(0.47||)||$||(1.50||)||$||(0.67||)|
|Weighted average common shares - basic and diluted||23,110,862||19,043,234||21,256,312||19,010,587|
|Balance Sheet Data|
|Cash and cash equivalents||$||40,042||$||46,803|
|Total stockholders' equity||35,301||40,472|
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