Analyst Conference Summary


conference date: May 2, 2019 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2019 (first quarter 2019, Q1)

Forward-looking statements

Overview: Waiting on rivipansel data, due late Q2. Plus other pipeline developments.

Basic data (GAAP):

Revenue was $0, up sequentially from $0, and down from $0 year-earlier.

Net income was negative $14.1 million, down sequentially from negative $13.9 million, and down from negative $11.5 million year-earlier.

EPS (diluted) was negative $0.33, down sequentially from negative $0.32, and flat from negative $0.33 year-earlier. The share count ended at 43.2 million, up from 35.2 million year-earlier.



Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "We continued to identify and initiate new sites and enroll participants in our company-sponsored Phase 3 trial in relapsed or refractory AML patients. We also worked closely with our two consortia partners to expand our late-stage uproleselan program, culminating in our announcement that the NCI consortium dosed its first patient in its trial in late April. During the same period, we worked with clinical collaborators at Duke Cancer Institute to plan our next trial for GMI-1359, a dual antagonist of E-selectin and CXCR-4, and defined individuals with breast cancer and bone metastases as our initial target study population,"

The Phase 3 rivipansel trial for VOC (vascular occlusive crisis) of sickle cell disease remains on track for completion in early 2019; enrollment is expected to complete at the "end of this week." Topline data is expected in 2019. There is a special protocol agreement with the FDA. It is being conducted by licensed partner Pfizer. Possible annual peak sales are greater than $1 billion, per Pfizer. Could get a milestone payment in 2019 on acceptance of an NDA. Royalties would be in double digits, and could receive up to $285 million in milestone payments; next milestone is upon FDA acceptance of the NDA. Highlighted superiority of rivipansel and the strong data pointing to likely Phase 3 success and commercial potential.

In addition to its own registrational trial, GlycoMimetics will collaborate with both the NCI and the Alliance for Clinical Trials in Oncology to conduct a randomized, controlled clinical trial testing the addition of uproleselan (GMI-1271) to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are eligible for intensive chemotherapy. Primary endpoint will be overall survival. The trial will be funded by the NCI. The trial is open for enrollment, with first patient dosing expected in Q2.

Uproleselan (GMI-1271) has Breakthrough Therapy designation from the FDA. Started the Phase 3 trial in Q4 2018 for relapsed/refractory AML, which will enroll 380 patients. Expanding the roster of clinical sites, with enrollment progressing as planned. Topline data should be available in Q4 2020. Overall survival (OS) will be the primary endpoint for the trial, and will not be censored for transplants, allowing more patients to receive transplants. Mucositis will be a secondary endpoint, as will CR. At ASH in December 2018 new data on clinical outcomes from the Phase 1/2 relapsed/refractory AML trial of uproleselan underscored opportunities to position this drug candidate, if approved, as a potential foundational therapy across the spectrum of AML.

Planning continues for the collaborative Haemato Oncology Foundation for Adults in the Netherlands (HOVON) European study of uproleselan in newly diagnosed patients unfit for chemotherapy with a goal of trial initiation in 2019.

Plans for 1271 for fit for chemo, newly diagnosed AML in the near future.

A European proof-of-concept trail of 1271 in multiple myeloma continued in Europe, with topline data expected in 2019. Also looking for a combination trial in the setting.

A third therapy, GMI-1359, Phase 1 trial of healthy volunteers was completed, and may be an improvement on GMI-1271 in treating bone marrow cancers. Preclinical data was presented at AACR. GlycoMimetics plans to initiate a proof-of-concept clinical trial of GMI-1359 in individuals with breast cancer whose tumors have spread to bone. It will evaluate safety and biomarkers of cancer cell mobilization in individuals with hormone receptor positive metastatic breast cancer. Data published in Nature Cell Biology strongly suggests that E-selectin is key to tumor growth and metastasis to bone and provides further support for the upcoming clinical trial of GMI-1359 in individuals with metastatic breast cancer

Current GlycoMimetics Board Member Tim Pearson will become Board Chair as of the close of the Company’s annual meeting on May 17, 2019.

Cash balance ended at $195.6 million, down sequentially from $210 million.

Total cost of operations was $15.1 million, consisting of $11.8 million for R&D and $3.4 million for general and administrative expense. Other income was $1.0 million.


GMI-1359, when will you announce the second tumor type? We will not announce a second tumor type. We do have a rich set of preclinical data. The Phase 1 study would determine what tumor type to address.

HOVON enrollment timeline? In HOVON's control, but hope for start of enrollment in 2H 2019. It is just a matter of logistics, there are no specific other challenges.

Potential rivipansel milestones? First we want to see topline data before we talk about a timeline.

Competition for AML trial patients? We are pleased with enrollment so far in the relapsed refractory patients, where there is still unmet medical need.

Sequential R&D expense decrease despite new trial? We had a lot of heavy spend in 2018 for manufacturing the clinical trials. But now Phase 3 trial expenses are ramping up, so an increase going forward.

Rivipansel demand given preventative drugs on or coming to market? There are about 100,000 crises per year in the US, so the acute setting will continue to be a need. Rivipansel is the only late stage drug for crisis.

GMI-1359 data from Phase 2 trial is expected in 2020. We will talk more about biomarkers in the future.

Phase 2 trial design for 1359? Right now we are focussed on dose escalation questions. We want to define a subset of breast cancer patients with biomarkers.

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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 2019 William P. Meyers