Analyst Conference Summary


conference date: March 6, 2019 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2018 (fourth quarter 2018, Q4)

Forward-looking statements

Overview: Waiting on rivipansel data, due late Q2.

Basic data (GAAP):

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

Net income was negative $13.9 million, down sequentially from negative $11.6 million, and down from negative $9.3 million year-earlier.

EPS (diluted) was negative $0.32, down sequentially from negative $0.27, and up from negative $0.27 year-earlier.



Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "We advanced our comprehensive clinical program for uproleselan that, if successful, could position uproleselan as a foundational therapy across the spectrum of AML. We believe this accomplishment reflects the enthusiasm of clinicians who have seen the Phase 1/2 uproleselan data at top oncology congresses and uproleselan’s impact on patient outcomes in clinical trials. In terms of our discovery and preclinical research during 2018, our team, utilizing our specialized chemistry expertise, produced new drug candidates to expand our pipeline opportunities into indications that go beyond sickle cell disease and hematologic cancers. Looking forward to 2019, we are in a strong financial position to pursue the clinical and preclinical opportunities ahead. Importantly, we look to the rivipansel top-line readout expected late in the second quarter that could represent both the first potential commercial success from our pipeline and a key financial resource going forward."

"We believe the Rivipansel study has a high probability of success." Believes the clinical data will strongly position the drug for approval, pricing, and acceptance in the market. Milestones could be up to $285 million, with the next milestone the acceptance by the FDA of Pfizer's NDA.

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 is expected late Q2 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. 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. 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.

Data released at ASH 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.

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. Also planning for a trial is solid cancers.

A paper was presented at ASH indicates uproleselan may facilitate stem cell procedures.

Cash balance ended at $210 million, down sequentially from $220 million.

Total cost of operations was $15.0 million, consisting of $12.0 million for R&D and $2.9 million for general and administrative expense. Other income was $1.1 million.


Uproleselan feedback on trial enrollment? We are getting enthusiastic responses from sites in the US and Australia. Sites will open soon in Europe. We are not seeing much competition for trial patients in the relapsed/refractory space.

Prioritization of early programs? 1687 is our next priority among pre-clinical candidates. It could follow up on upro in a self-administered setting, and possibly into other indications. The focus would be on potentially transformative targts. Galectin program has a broad range of possible indications.

Rivipansel v. the new prophylactic drug? We do not think crizanlizumab? would prevent treatment with rivipansel. Most sickle-cell therapies will be complementary. Prisolizomab data is similar to the well-established hydroxyurea, which has not prevented the need for a VOC treatment. Rivipansel is the only late-stage therapy to treat the crisis; the others are for prevention.

Solid tumor targets? Where the tumor has metastasized to the bone, not further details yet. Will look at biomarkers. Will have more later in the year.

Pfizer license includes the family of molecules. We are not continuing work on that family at GlycoMimetics. We are working on newer molecules for different indications from sickle cell.

The Pfizer trial is enrolling patients down to age 6. Our Phase 2 trial allowed for patients down to age 12. We think that is appropriate.

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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