Analyst Conference Summary


conference date: November 6, 2020 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2020 (third quarter 2020, Q3)

Forward-looking statements

Overview: Waiting for AML trial enrollment and possible path for VOC approval.

Basic data (GAAP):

Revenue was $1 million, down sequentially from $9, and up from $0 year-earlier.

Net income was negative $13.7 million, up sequentially from negative $14.1 million, and up from negative $13.3 million year-earlier.

EPS (diluted) was negative $0.29, down sequentially from negative $0.32, and up from negative $0.31 year-earlier.


Cash is sufficient to reach key milestones for uproleselan, into 2022.

Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "During the third quarter, both late-stage trials of uproleselan, the Company-sponsored Phase 3 trial in relapsed/refractory AML patients as well as the NCI's study in newly-diagnosed AML patients fit for chemotherapy, progressed in the face of the COVID-19 pandemic, thanks in significant part to the dedicated efforts of clinicians, statisticians and sites. We continue to project completion of enrollment in our own Phase 3 trial in the second half of 2021. In sickle cell disease, new post hoc analyses of the rivipansel Phase 3 study provide additional perspective on the potential of our targeted E-selectin product candidates in early vaso-occlusive crisis. We have presented findings at multiple sickle cell congresses, and at the upcoming ASH meeting, we plan to share key secondary endpoint, subgroup and subset data. We believe these data provide a foundation for our ongoing evaluation of potential opportunities in our pipeline for the treatment of acute vaso-occlusive crisis, or VOC." The $1 million in revenue in the quarter was a milestone from Apollomics in China for codevelopment.

A post hoc analysis of the Phase 3 study evaluating the efficacy of rivipansel in acute vaso-occlusive crisis in sickle cell disease produced new efficacy data showing statistically significant improvements for patients treated early in crisis, in the primary efficacy endpoint of time to readiness for discharge v. placebo. Also for time of opoid use. A path forward is being discussed with the FDA, which granted rare pediatric disease designation. However, it is not clear if the rivipansel program will be taken forward.

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, but could be impacted by the pandemic. Completion of enrollment likely second half of 2021. 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 the ASH meeting in December 2020 GlycoMimetics will make an oral presentation of preclinical data from a study in an AML mouse model showing potential benefit of a combination therapy of uproleselan with venetoclax and HMA. At the SOHO meeting in September 2020, GlycoMimetics presented preclinical data showing a statistically significant prolongation of survival in a patient-derived xenograft (PDX) model.

In addition to its own registrational trial, GlycoMimetics is collaborating with both the NCI and the Alliance for Clinical Trials in Oncology conducting 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 is funded by the NCI. The first patient was dosed in Q2 2019 and enrollment continues. Could be used for applciation to FDA for its patient population.

GMI-1687 shows potential superiority for VOC to rivipansel. Preclinical data was presented at ASCAT in September 2020.

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

Cash balance ended at $143 million, down sequentially from $150 million.

Total cost of operations was $15 million, consisting of $11 million for R&D and $4 million for general and administrative expense. Loss from operations was $14 million. Other income was $0 million.

Q&A summary:

Rivipansel and 1687, decisions to advance? A year ago we were doing nothing in sickle cell. We should have our rivipansel data analysis by the ASH meeting. Both drugs data now look encouraging.

There will be a study in China of uproleselan, we will update when appropriate. In the main trial how long after completion of enrollment to data release depends on death rate.

1271? We have not yet defined the patient population, but will begin with safety and biomarker data.

Pace of AML enrollments unlikely to slow significantly due to the pandemic because of severe nature of the disease.

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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 2020 William P. Meyers