Analyst Conference Summary


conference date: August 10, 2018 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2018 (second quarter 2018, Q2)

Forward-looking statements

Overview: GMI-1271 is now uproleselan.

Basic data (GAAP):

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

Net income was negative $11.3 million, up sequentially from negative $11.5 million, and down from negative $8.1 million year-earlier.

EPS (diluted) was negative $0.26, up sequentially from negative $0.33, and up from negative $30 year-earlier. The rise in EPS was due to dilution of the shares to raise cash.



Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "Our second-quarter 2018 accomplishments reflect significant progress as we finalized our plans to conduct a comprehensive Phase 3 development program for uproleselan across the spectrum of AML. With our announcement in May of an NCI CRADA, in addition to the previously announced trial in Europe sponsored by the prestigious HOVON consortium and our own sponsored registration trial, we are now planning three separate randomized, controlled trials, which we believe should provide clear efficacy and safety outcome measures in each of settings being evaluated. The unique mechanism of action of uproleselan allows for the potential treatment of not only relapsed/refractory AML patients, but also older, newly diagnosed AML patients who are considered to be either fit or unfit for intensive chemotherapy. If successful, we believe that the combination of these trials could position us to offer a new standard treatment across the continuum of care in AML." The extra trials could expand the label beyond what the main company trial will achieve.

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.

GMI-1271 (uproleselan) has Breakthrough Therapy designation from the FDA. Will start the Phase 3 trial in Q3 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.

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 second half of 2018.

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.

Preclinical studies to move other candidates to the clinic continue.

Cash balance ended at $229.4 million, down sequentially from $242.6 million.

Total cost of operations was $12.1 million, consisting of $9.3 million for R&D and $2.8 million for general and administrative expense. Other income was $0.9 million.


Rivipansel enrollment delay? It is challenging to enroll patients in the acute setting. Pfizer was confident in their forecast based on prior accruals.

1271 myeloma data? It is enrolling in Europe, data in 2019. The endpoint is a biomarker. We are seeing if it helps chemotherapy.

AML landscape, enrollment expectations? Consortia are voting with their feet. KOLs are very interested, which should bode well for accruals. Landscape is changing, supporting our using overall survival as the primary endpoint. If the data is good it will position us strongly for launch. We will support the trials so the data will be of registrational quality. MCI has not revealed the full size of the trial.

MCI trial transplant eligibility? The drug can be used with the standard of care, 7+3. The doctor will make any decisions about transplants.

In our trial we won't censor for transplant, so we should be able to capture that benefit.

Mechanistically the Novartis drug is a p-selectin antibody, ours is a pan-selectin antagonist. Theirs was studied in the context of prevention of crisis, our is treatment of crisis, on demand. There are other drugs being developed for prevention of crisis. There is a drug already on the market for prevention of crisis, has been for 15 years, but compliance is poor.

The Pfizer program does include an open label extension study allowing retreatment. That could support outpatient setting use.

1359 trial timeline? We are in a Phase 1 trial with healthy volunteers. We will look at one or more patient populations which we will describe by the end of the year.

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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 2018 William P. Meyers