GlycoMimetics Reports Second Quarter 2014 Results
The company recognized the full
The company's research and development expenses increased to
The company's general and administrative expenses increased to
"Our second quarter achievements reflect important progress in advancing
our lead drug candidate and our emerging clinical pipeline," said
Select Recent Corporate Highlights:
May 2014, Pfizer made a $15 millionpayment to GlycoMimeticsunder the terms of the parties' collaboration for the development of rivipansel (GMI-1070).
May 2014, data from a Phase 2 clinical trial of rivipansel in pediatric patients was presented at the American Society of Pediatric Hematology Oncology(ASPHO) 27th Annual Meeting. The presentation highlighted data from study participants aged 12 to 18 years, with findings similar to those observed among the adult population treated with rivipansel in terms of improving time to resolution of VOC, time to discharge, and time to reduction in pain. In these pediatric patients, researchers observed a greater than 50 percent reduction in time to transition to oral pain medications, as well as a reduction in time to hospital discharge, in each case compared to standard treatment for pain in pediatric subjects.
June 2014, the first healthy volunteer was dosed in a Phase 1 clinical study designed to evaluate the safety, tolerability and pharmacokinetics of GMI-1271, a novel and proprietary E-selectin antagonist in the company's pipeline. GlycoMimeticsis initially exploring the clinical use of the drug candidate to treat acute myeloid leukemia (AML) following preclinical studies of GMI-1271 for blood cancers and other cancers that are associated with elevated risk of metastasis and thrombosis.
July 2014, Pfizer reached agreement with the U.S. Food & Drug Administration(FDA) under an SPA for the planned Phase 3 trial for rivipansel.
Cautionary Note on Forward-Looking Statements
The statements in this press release that are not historical facts
constitute "forward-looking statements" that involve risks and
uncertainties and are made pursuant to the Private Securities Litigation
Reform Act of 1995. These forward-looking statements may be identified
by their use of terms and phrases such as "anticipate," "believe,"
"estimate," "expect," "intend," "may," "plan," "predict," "project,"
"target," "potential," "will," "would," "could," "should," "continue,"
and similar expressions, or the negative of such terms, and include, but
are not limited to, GlycoMimetics' expectations regarding potential
payments under its collaboration with Pfizer and its planned activities
with respect to the clinical development of GMI-1271. Actual results may
differ materially from those expressed or implied by these
forward-looking statements as a result of a number of important factors,
including the availability and timing of data from ongoing clinical
trials, the uncertainties inherent in the initiation of future clinical
trials, whether interim results from a clinical trial will be predictive
of the final results of the trial or results of early clinical trials
will be indicative of the results of future trials, expectations for
regulatory approvals, availability of funding sufficient for
GlycoMimetics' foreseeable and unforeseeable operating expenses and
capital expenditure requirements, other matters that could affect the
availability or commercial potential of GlycoMimetics' drug candidates,
and other factors discussed in the "Risk Factors" sections of the
company's Annual Report on Form 10-K for the year ended
|Condensed Statements of Operations|
|(In thousands except per share data)|
Three months ended
Six months ended
|Cost and Expenses:|
|Research and development||5,358||2,884||9,239||5,627|
|Selling, general and administrative||1,605||668||2,830||1,274|
|Total costs and expenses||6,963||3,552||12,069||6,901|
|Income (loss) from operations||8,064||(3,497||)||2,958||(3,038||)|
Income (loss) and comprehensive income (loss) before income taxes
|Income tax expense||77||-||77||-|
Net income (loss) and comprehensive income (loss)
|Net income (loss) per share - basic||$||0.42||$||(3.70||)||$||0.16||$||(3.24||)|
|Net income (loss) per share - diluted||$||0.39||$||(3.70||)||$||0.15||$||(3.24||)|
|Weighted average shares - basic||18,807,675||946,363||18,020,121||938,446|
|Weighted average shares - diluted||20,238,343||946,363||19,472,995||938,446|
|Balance Sheet Data|
|Cash and cash equivalents||$||66,217||$||2,311|
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