Analyst Conference Summary

conference date: May 3, 2021 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2021 (first quarter 2021, Q1)

Forward-looking statements

Overview: Waiting for Phase 3 AML trial enrollment completion, expected by year-end 2021.

Basic data (GAAP):

Revenue was $1 million, up sequentially from $0 million, and down from $9 year-earlier.

Net income was negative $14,3 million, up sequentially from negative $15.6 million, and down from negative $7.7 million year-earlier.

EPS (diluted) was negative $0.28, up sequentially from negative $0.32, and down from negative $0.18 year-earlier.

Guidance:

Cash is sufficient to reach key milestones for uproleselan, into 2022.

Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "Our recent achievements, both in our collaboration with Apollomics and in data presentations at AACR, underscore the productivity of our pipeline. Working closely with investigators, regulators and collaborators, we are seeing great enthusiasm for our lead program, uproleselan, globally. The Chinese health agency's granting of a Breakthrough Therapy Designation as well as Apollomics' announcement of dosing of the first patient in Greater China support our outlook for this drug candidate. Complementing that achievement is our work with uproleselan in the U.S., namely, continued progress on our own Phase 3 AML trial and that of the National Cancer Institute, or NCI. Finally, with a focus on the early results from our GMI-1359 proof-of-concept trial and our preclinical work in the galectin-3 space, the AACR meeting added visibility for our pipeline opportunities that have the potential to address key unmet needs in hematology and beyond,"

In Q1 2021 Apollomics, the exclusive collaborator for development and commercialization of uproleselan in Greater China, received Breakthrough Therapy Designation from the Center for Drug Evaluation of the China National Medical Products Administration. In March, Apollomics reported the dosing of its first patient in a Phase 1 clinical trial that will bridge to a Phase 3 study in China.

GlycoMimetics is gathering data that would help in preparation for commercialization of uproleselan. Investigator-sponsored trials to expand the label are also in the works.

Uproleselan (GMI-1271) has Breakthrough Therapy designation from the FDA. The Phase 3 trial for relapsed/refractory AML completion of enrollment is likely late in 2021. 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 the ASH meeting in December 2020 GlycoMimetics made an oral presentation of preclinical data from a study in an AML mouse model showing potential benefit of a combination therapy of uproleselan with venetoclax and HMA.

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. Could be used for applciation to FDA for its patient population. The Phase 2 part of the trial could be complete before the end of 2021.

GMI-1687 shows potential superiority for VOC to rivipansel. Preclinical data was presented at ASCAT in September 2020. A Phase 1 trial is planned.

GMI-1359 showed evidence of biologic activity in the initial patients treated in a Phase 1b proof-of-concept trial of various tumors. The analyses, based on pharmacodynamic biomarkers, were reported at AACR in April 2021, showing it hit the targets.

A galactin 3 antagonist in a cancer model is encouraging, so preparing to move towards development.

Cash balance ended at $132 million, down sequentially from $137 million.

Total cost of operations was $15.3 million, consisting of $11.1 million for R&D and $4.2 million for general and administrative expense. Loss from operations was $14.3 million. Other income was $0 million.

Q&A summary:

Number of sites to open for R/R study? Its on clinical trials.gov, we have about 60 sites open, we are near the complete number of sites, just a small number more in Europe and a couple more in U.S.

Possible indications for GMI-1359? Whatever we choose will be for a targetted, focussed clinical trial. The data presented has been for bone involvement in both solid and liquid tumors. We have encouraging clinical data in osteosarcoma.

The investigator studies will be announced as the year goes forward. Many KOLs have expressed enthusiasm.

Galactins represent a new opportunity for GlycoMimetics. We believe our compounds are more potent and specific than those announced by competitors. Too early to describe indications.

Cash runway? Most spend is for uproleselan. Gets us through end of 2022. About $75 million in expenses in 2021, about $50 million in 2022.

NCI data readout is dependend on events (deaths), so will give more specific guidance at a later date.

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