Analyst Conference Summary

conference date: August 1, 2019 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2019 (second quarter 2019, Q2)

Forward-looking statements

Overview: Waiting on rivipansel data.

Basic data (GAAP):

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

Net income was negative $15.8 million, down sequentially from negative $14.1 million, and down from negative $11.3 million year-earlier.

EPS (diluted) was negative $0.37, down sequentially from negative $0.33, and flat from negative $0.26 year-earlier.

Guidance:

none

Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "In the second quarter of 2019, Pfizer completed enrollment in the pivotal Phase 3 trial of rivipansel and has recently given public guidance that it expects to report topline results in the third quarter of the year. We eagerly await those results, which will mark an important milestone for GlycoMimetics. In parallel, we continued to progress the late-stage clinical development of our uproleselan product candidate. Our Phase 3 trial in relapsed or refractory AML patients and the NCI-sponsored Phase 3 trial for newly diagnosed patients with AML both advanced during the quarter, with initiation of new sites and patient enrollment underway. During the same period, with our clinical collaborators at Duke Cancer Institute, we progressed our plans for a single center, proof-of-concept Phase 1b trial for GMI-1359, our dual antagonist of E-selectin and CXCR-4, in breast cancer patients with bone metastases."

The Phase 3 rivipansel trial for VOC (vascular occlusive crisis) of sickle cell disease completed enrollment; it is licensed by Pfizer. 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 low double digits up to low teens, 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 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 trial will be funded by the NCI. The first patient was dosed in Q2 2019.

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 completed, and may be an improvement on GMI-1271 in treating bone marrow cancers. Before the end of 2019 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 became Board Chair as of the close of the Company’s annual meeting on May 17, 2019.

Cash balance ended at $184 million, down sequentially from $195.6 million.

Total cost of operations was $16.8 million, consisting of $13.1 million for R&D and $3.8 million for general and administrative expense. Other income was $1 million.

Q&A:

Refractory/relapsed numbers of patients as originally assumed? In the Phase 3 trial we are enrolling a high-risk population. We are seeing a similar population to the Phase 2 trial, but we did refine the criteria. We are seeing a good balance of patients enrolling.

Phase 1/2 safety for sickle-cell disease? Safety and biomarkers have been consistently good throughout the program. Sickle-cell patients do have white blood cell variability, that did not seem to make a difference in our results. Pfizer has independent oversight for safety, proceeding with the trial is a signal of safety in the Phase 3 trial.

Novartis impact on rivipansel? There drug is a selective antagonist. So the target at least is well established. We don't see an impact on our market, the acute setting, but chronic therapy could cause some reduction in crisis.

Disclosure of Rivipansel, communication? It is the normal partner communication. We have an open communication channel.

Sevuparin failure? Heparin analog did not target e-selectin, so its failure should not be an indicator for rivipansel.

Genotype specific label for rivipansel? We expect no limitations by genotype.

1687 timeline? We are advancing it, but there is no guidance on when we will take it into the clinic. We are excited about its potential, it if far more potent.

Phase 3 AML consolidation cycle cap? We allow up to 3 cycles. Often patients go to transplant before cycle 3. Most of our patients get just on cycle.

ITT or modified ITT endpoint? Initial disclosure would be high level, but pivotal trials usually are based on an ITT analysis.

1359 timeline? Small trial, less than a dozen patients, readout by end of 2020.

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