GlycoMimetics (GLYC) reported earnings on Tue 6 March 2018 (b/o)

• Also announces its design for a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate GMI-1271 in combination with MEC Mitoxantrone, etoposide and Ara-C or in combination with fludarabine, cytosine arabinoside and idarubicin in individuals with relapsed/refractory acute myeloid leukemia

** charts before earnings **

 

** charts after earnings **

 

GlycoMimetics misses by $0.02 

• Reports Q4 EPS of ($0.27) vs ($0.25) Capital IQ consensus; co reported no revs (as expected)
• Cash position: As of December 31, 2017, GlycoMimetics had cash and cash equivalents of $123.9 million as compared to $40.0 million as of December 31, 2016.
• Operations - In the Phase 3 trial of rivipansel, being conducted by our collaborator Pfizer, investigators are evaluating patients hospitalized for vaso-occlusive crisis of sickle cell disease. Pfizer reports that the study remains on track for completion in the second half of 2018.

GlycoMimetics announces its design for a randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate GMI-1271 in combination with MEC Mitoxantrone, etoposide and Ara-C or in combination with fludarabine, cytosine arabinoside and idarubicin in individuals with relapsed/refractory acute myeloid leukemia

• The design is aligned with guidance received from the FDA.
• The single pivotal trial is planned to enroll 380 adult patients worldwide and is expected to begin in the third quarter of 2018. The primary endpoint will be overall survival, and censoring for transplant in the primary efficacy analysis will not be required.
• Key secondary endpoints will include incidence of severe mucositis and remission rate, which will be assessed in a hierarchical fashion for potential inclusion in the product labeling, if GMI-1271 is approved by the FDA. In 2017, GMI-1271 received Breakthrough Therapy Designation.
• "Reaching alignment with the FDA on overall survival as the primary endpoint for the trial, without statistical censoring for transplant, positions GMI-1271 well for a potential successful outcome," said Rachel King, Chief Executive Officer of GlycoMimetics. "Getting more patients to transplant following treatment with GMI-1271 is one of our goals for this therapy. If we accomplish this, we hope GMI-1271 will contribute to prolonged overall survival for relapsed/refractory AML patients. We believe this is a rigorously designed Phase 3 trial that has the potential to bring us one step closer to meeting the significant unmet needs of this patient population. In addition, we believe that our trial design should streamline the path to data on overall survival, considered the 'gold standard' of clinical benefit, and that if this primary endpoint is achieved, it should position GMI-1271 optimally with U.S. and European regulatory agencies, as well as in the marketplace."