Analyst Conference Summary


conference date: November 7, 2019 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2019 (third quarter 2019, Q3)

Forward-looking statements

Overview: After the failed rivipansel trial, focus is on the two Phase 3 AML trials.

Basic data (GAAP):

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

Net income was negative $13.3 million, up sequentially from negative $15.8 million, and down from negative $11.6 million year-earlier.

EPS (diluted) was negative $0.31, up sequentially from negative $0.37, and flat from negative $0.27 year-earlier.



Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "Our Company-sponsored 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. We are also working with the Duke Cancer Institute towards initiating a single center, proof-of-mechanism Phase 1b trial for GMI-1359, our dual antagonist of E-selectin and CXCR-4, in breast cancer patients with bone metastases. We are also very much looking forward to the ASH meeting in December, which has always been an important conference for us, and this year is no different. The key takeaway for us at this year's ASH meeting is that data from multiple preclinical and clinical settings show that E-selectin ligand expression on leukemic cells is correlated with poor survival in AML." Enrollment in both critical AML trials remains strong.

Rivipansel trial failure reported by Pfizer in Q3 2019 means that uproleselan is the main focus of the company.

The GlycoMimetics ASH abstracts have been published.

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 was discontinued for the collaborative Haemato Oncology Foundation for Adults in the Netherlands (HOVON) European study of uproleselan in newly diagnosed patients unfit for chemotherapy, in order to focus resources on the other trials.

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

Cash balance ended at $171 million, down sequentially from $184 million.

Total cost of operations was $14.1 million, consisting of $10.7 million for R&D and $3.4 million for general and administrative expense. Other income was $0.9 million.

Q&A summary:

Additional Phase 1 AML analysis at ASH, patient ratio? Low ligand group v. high ligand group do have differences. Generally the profile for risk is indeed high for the high E-selectin group.

Discontinued trial, impact on spending? Hovon spending had not been given, we want a focus on the registrational trial. The newly diagnosed, unfit for intensive chemo setting had a new drug approval, making it less attractive.

GMI-1359 data timeline? Data at end of 2020. It is a dose-escalation trial. We are considering a number of different types of cancer for the follow up Phase 2 trial.

NCI communications about trial? We would have a coordinated communication with them, including interim data. Interim is after 252 patients are enrolled.

Characterized the Phase 1 trial data as showing remarkable improvement in survival regardless of the patient type.

Company trial timeline still Q4 2020? Driving towards getting data by the end of 2020, but it does depend on accrual and number of events.

Cash runway? Burn will be about $5 million per month in 2019, then $6 million per month in 2020, so cash should last to 2022 under the current plan.

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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