Analyst Conference Summary


conference date: November 8, 2017 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2017 (third quarter 2017, Q3)

Forward-looking statements

Overview: GlycoMimetics is planning to initiate a Phase 3 trial of GMI-1271 for AML in mid-2018.

Basic data (GAAP):

Revenue was $0, down from $18 thousand year-earlier.

Net loss was $8.0 million, less that the loss of $7.9 millon year-earlier.

EPS (diluted) was negative $0.24, more than negative $0.34 year-earlier. The improvement was due to the dilution of the stock.



Release & Conference Highlights:

“In the third quarter of 2017, we initiated productive discussions with the FDA to review data emerging from the ongoing Phase 1/2 clinical trial of our specific E-selectin inhibitor product candidate, GMI-1271, for the treatment of acute myeloid leukemia (AML) and to plan a mid-2018 start of the Phase 3 trial. The discussions reflect the FDA’s granting of Breakthrough Therapy designation to GMI-1271 for the treatment of relapsed/refractory AML patients. Our focus is on finalizing the design of the registrational trial in relapsed/refractory disease. While in the near term we are preparing to provide an update on the GMI-1271 program via two oral presentations at the ASH meeting, we also continue to make progress across our clinical pipeline and in the preclinical arena,” stated Rachel King, Chief Executive Officer.

In May GMI-1271 received Breakthrough Therapy designation from the FDA. There will be two data presentations at ASH in December, one clinical and one preclinical. The abstracts are available at the Glycomimetics web site. Unlike other current AML candidates, GMI-1271 appears to be broadly applicable across patient groups. ASH data remains very encouraging for both newly diagnosed and relapsing or refractory. Duration of response and survival are showing a signal [gave details]. 91 patients total treated. Not only safe, but were safer than chemo alone.

Registrational study for relapsed/refractory AML is being planned, and discussions are taking place with the FDA. Would like to start the Phase 3 trial in mid-2018.

Also plans to expand 1271 into the unfit-for-chemo AML setting.

Has been approached by independent consortia to explore expanded uses of 1271. A consortium sponsored trial could begin in 2018.

A European proof-of-concept trail of 1271 in multiple myeloma continued in Europe.

The Phase 3 rivipansel trial for VOC (vascular occlusive crisis) of sickle cell disease remains on track for completion in the second half of 2018. There is a special protocol agreement with the FDA. It is being conducted by partner Pfizer.

Cash balance ended at $112.9 million. During the quarter the company raised $106 million from a common stock offerning. Shares outstanding ended at 32.7 million.

A third therapy, GMI-1359, completed Phase 1 trial enrollment, and may be an improvement on GMI-1271 in treating bone marrow cancers.

Preclinical studies to move other candidates to the clinic continue.

Total cost of operations was $8.2 million, consisting of $5.8 million for R&D and $2.4 million for general and administrative expense.


ASH oral presentation, R/R good benchmark for survival? We will update on overall survival and disease-free survival. Historical controls matched for age & risk: OS has been between 5 and 5.5 months, and disease-free survival about 9 months. For the 7 + 3 chemo group, we also expect to update that at ASH.

Could there be an accelerated approval pathway given your breakthrough designation for 1271? We have had constructive discussions with the FDA. We are looking for the most expedited path to approval. For other companies' recent approvals in AML the FDA has shown flexibility in choice of endpoints.

Control arm in the pivotal trial? R/R AML, it would make sense to use MEC, which we have been using, but we are looking at using other agents as well.

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Disclaimer: My analyst call summaries may include both condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. These are my personal notes which I share with other investors and which I use as the basis of my blog and Seeking Alpha articles.

Copyright 2017 William P. Meyers