Analyst Conference Summary

conference date: March 3, 2022 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2021 (fourth quarter 2021, Q4)

Forward-looking statements

Overview: Early 2023 still expected data readout from Phase 3 AML trial of uproleselan.

Basic data (GAAP):

Revenue was $0 million, down sequentially from $0.1 million, and down from $0.2 year-earlier.

Net income was negative $17.4 million, down sequentially from negative $17.3 million, and down from negative $15.6 million year-earlier.

EPS (diluted) was negative $0.33, up sequentially from negative $0.34, and down from negative $0.32 year-earlier.

Guidance:

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

Conference Highlights:

Harout Semerjian, Chief Executive Officer, said "During 2021, we focused on completing enrollment of our pivotal trial evaluating uproleselan in AML. Towards the end of the year, within two weeks of each other, GlycoMimetics completed enrollment of our Phase 3 trial and the NCI completed enrollment of the Phase 2 portion of its Phase 2/3 trial. This represents a significant achievement for our entire organization, particularly during a global pandemic that has negatively impacted enrollment rates for numerous clinical studies. The top-line data from these two trials of uproleselan in AML will undoubtedly be transformative for the organization. As the survival data matures, we are actively preparing for a potential regulatory submission and subsequent commercialization of uproleselan" Planning a path to commercialization, including production of commercial batches of uproleselan. Hired three new executives in late 2021 and early 2022 including Chief Commercial Officer.

The online journal Blood and other journals highlighted uproleselan in the fall of 2021.

Uproleselan (GMI-1271) has Breakthrough Therapy designation from the FDA. The Phase 3 trial for relapsed/refractory AML completed enrollment in November 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. The trial is event-driven, so the timeline for topline data vague, but currently estimated to be in early 2023.

Efficacy and safety data from a Phase 1/2 clinical study of uproleselan were published online September 16, 2021 in Blood. Investigators reported an MRD (minimal residual response) negative rate of 69 percent in evaluable trial participants with relapsed/refractory AML, indicating an increased response following addition of uproleselan to salvage therapy. Complete response rates were high.

GlycoMimetics is gathering data that would help in preparation for commercialization of uproleselan. Uproleselan drug product registration batches were completed in Q3 2021.

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 completed enrollment before the end of 2021. In Q2 2021 three additional investigator-sponsored trials were initiated for AML, bone marrow transplantation, and multiple myeloma. They could produce early data in 2021 and support uproleselan as a foundational treatment for AML. They include combination therapy with various regiments. One trial focusses on patients previously treated with HMAs; the number of patients who have failed HMA are accumulating.

The Phase 3 uproleselan trial in China is planned to initiate soon.

GMI-1687 shows potential superiority for VOC to rivipansel. Preclinical data was presented at ASCAT in September 2020. A Phase 1 trial IND submission is planned for the first half of 2022.

GMI-1359 showed evidence of biologic activity in the initial patients treated in a Phase 1b proof-of-concept trial of various tumors (breast cancer) in December 2021. The analyses, based on pharmacodynamic biomarkers, were reported at AACR in April 2021, showing it hit the targets. GlycoMimetics is evaluating further clincial developement and strategic options.

A galactin 3 antagonist GMI-2093 is preparing to move towards development. Preclinical data was presented at AACR in 2021.

GlycoMimetics is looking at possible collaboration deals for 1687, 1359, and the galactin antagonist.

Cash balance ended at $90 million, down sequentially from $102 million.

Total cost of operations was $17 million, consisting of $13 million for R&D and $5 million for general and administrative expense. Loss from operations was $17 million. Other income was $0 million.

Q&A summary:

2093 possible partering? Three critical factors: potent, selective, and oral. Most galectin 3 therapies are in fibrosis. We are looking for fibrotic setting partners with greater experience.

1687 VOC color? Benefits from what we learned with rivipansel, including importance of early intervention. So moving to IND, trial design not ready yet. Patients typically know a crisis is coming on, so that is when intervention is most likely to help.

It is possible for the NCI Phase 2 interim analysis data to mature in 2022. Then we will decide on the path forward, if there is one. If proceding to Phase 3, the NCI would do that.

For uproleselan our Breakthrough Designation status has allowed us to have multiple interactions with the FDA. We are doing the CMC (manufacturing) clearance work very quickly, so if the data is positive we will be ready for the launch.

We did not censored transplantations in the uproleselan trial, which does extend patient survival, which is why it will take more than a year to get even preliminary OS data. We will narrow the time range for reporting as we see the data evolve.

Expect 2022 burn to be about $60 millions.

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