Analyst Conference Summary

conference date: November 2, 2021 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2021 (third quarter 2021, Q3)

Forward-looking statements

Overview: Phase 3 AML trial very near completion of enrollment, topline data expected early in 2023.

Basic data (GAAP):

Revenue was $0.1 million, up sequentially from $0 million, and down from $1.0 year-earlier.

Net income was negative $17.3 million, down sequentially from negative $14.4 million, and down from negative $13.7 million year-earlier.

EPS (diluted) was negative $0.34, down sequentially from negative $0.28, and downp from negative $0.29 year-earlier.

Guidance:

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

Conference Highlights:

Harout Semerjian, Chief Executive Officer, said "I am excited about the strong momentum and opportunities we have in front of us. I am grateful for the dedication and perseverance of our employees and board of directors especially during my CEO transition period." Planning a path to commercialization, including production of commercial batches of uproleselan. Hired a commercialization leader.

On August 6, 2021, Harout Semerjian succeeded Rachel King as CEO. She remains on the board.

Uproleselan (GMI-1271) has Breakthrough Therapy designation from the FDA. The Phase 3 trial for relapsed/refractory AML completion of enrollment is likely soon 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. The trial is event-driven, so the timeline for topline data vague, but currently estimated to be in 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 should complete 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 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 April 2021. The analyses, based on pharmacodynamic biomarkers, were reported at AACR in April 2021, showing it hit the targets. The study will close by the end of 2021 and a new trial is being designed.

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

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

Cash balance ended at $102 million, down sequentially from $119 million.

Total cost of operations was $17.4 million, consisting of $13.3 million for R&D and $4.1 million for general and administrative expense. Loss from operations was $17.3 million. Other income was $0 million.

Q&A summary:

GMI-1359 prioritization, timeline? No changes in plan. We have the data we need from the current study. We will make an announcement when we have determined our future plans. The Duke trial was to demonstrate proof of concept in breast cancer. We acheived that.

R&D expense increase? That was a one-of for batch manufacturing

Cash runway? Into first half of 2023. Burn is about $15 million cash per quarter. Runway could be extended with cash from collaboration deals.

We have no FDA CMC issues at this time, we are working to be ready on an optimal timeline.

IST data in 2022? We could possibly add new cancer indications if there is positive data.

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