Analyst Conference Summary


conference date: November 2, 2018 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2018 (third quarter 2018, Q3)

Forward-looking statements

Overview: Open for enrollment of Phase 3 Uproleselan (GMI-1271) trial.

Basic data (GAAP):

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

Net income was negative $11.6 million, down sequentially from negative $11.3 million, and down from negative $8.0 million year-earlier.

EPS (diluted) was negative $0.27, down sequentially from negative $0.26, and up from negative $0.24 year-earlier.



Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "During the third quarter, we focused our activity on planning and initiating GlycoMimetics' comprehensive clinical program to evaluate uproleselan [formerly GMI-1271] across the spectrum of AML. We expect to announce enrollment of the first patient in our own Phase 3 pivotal study of "upro" in relapsed/refractory patients within a very short period of time, as initiation activity is well underway at many sites, and enrollment is now open. Support among investigators for this trial as well as for our two consortia-led trials is strong. We believe that the data contained in the abstracts selected for oral and poster presentations at the ASH meeting reinforce the benefits already shared at prior medical meetings and bolster our confidence in upro's potential to change the treatment paradigm in AML, whether patients have AML that is relapsed, refractory, or newly diagnosed"

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 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 protocol has been finalized.

Uproleselan (GMI-1271)has Breakthrough Therapy designation from the FDA. Will start the Phase 3 trial in Q4 2018, will enroll 380 patients. 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. Trial will be international to facilitate approvals in key EU countries. All geographic areas should have enrollment underway in early 2019.

Plans to expand 1271 into the unfit-for-chemo, newly diagnosed AML and high-risk MDS setting, in combination with HMA (hypomethylating agents). A trial was announced to be sponsored by the Hovon group. Could begin in first half of 2019.

Six abstracts for ASH have been released and are available at the company web site. Reviewed the data on this call. Supports hypothesis that e-selectin is a driver of resistance to AML. 8.8 month OS for uproleselan, with high level of minimal disease outcomes.

Hopes to announce 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 Q1 2019. Also looking for a combination trial in the setting.

The Phase 3 rivipansel trial for VOC (vascular occlusive crisis) of sickle cell disease remains on track for completion in early 2019; enrollment is 75% complete. Topline data could read out in Q2 2019. There is a special protocol agreement with the FDA. It is being conducted by licensed partner Pfizer. Possible peak sales are greater than $1 billion, per Pfizer. Could get a milestone payment in 2019. 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.

A third therapy, GMI-1359, Phase 1 trial continued, and may be an improvement on GMI-1271 in treating bone marrow cancers. Preclinical data was presented at AACR.

A paper to be presented at ASH indicates Uproleselan may facilitate stem cell procedures.

Cash balance ended at $219.8 million, down sequentially from $229.4 million.

Total cost of operations was $12.5 million, consisting of $9.7 million for R&D and $2.3 million for general and administrative expense. Other income was $0.9 million.


Mutations expected in Phase 3 trial? Flip3 (FLT-3) mutated patients did have higher levels of e-selectin ligand. We don't thing we need to screen for it. Would expect it to be more common in relapsed/refractory patients. We could at some point pair Uproleselan with Flip3 inhibitors. We see all patients have selectin ligands to some extent.

MRD assay in Phase 3? We will look at MRD with several different methods, including flow-based and DNA assay.

Rivipansel study differences, Phase 2 v. Phase 3? For Pfizer Phase 3 trial the endpoint is a checklist used for discharge, very similar to what we used in Phase 2. Also looking for about a day less of hospital time for patients. The Phase 3 endpoing is simple, standardized, and rigorously collected.

What do we need to see from Rivipansel for that blockbuster status? We are hearing from the community that a one-day reduction in hospital stays would be meaningful. Also opioid reduction.

We are not planning an interim analysis for our Phase 3 trial. There is an interim analysis in the NCI trial.


OpenIcon Analyst Conference Summaries Main Page



More Analyst Conference Pages:



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 2018 William P. Meyers