Analyst Conference Summary

conference date: March 29, 2023 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2022 (fourth quarter 2022, Q4)

Forward-looking statements

Overview:

Basic data (GAAP):

Revenue was $0 million, flat sequentially from $0.0 million, and flat from $0 year-earlier.

Net income was negative $ million, up sequentially from negative $8.5 million, and up from negative $ million year-earlier.

EPS (diluted) was negative $, up sequentially from negative $0.16, and up from negative $ year-earlier.

Guidance:

Cash runway to Q4 2023.

Conference Highlights:

Harout Semerjian, Chief Executive Officer, said ""

The Uproleselan (GMI-1271) 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 is vague, but currently estimated to be in Q4 2023. Released a table comparing types of patients in Phase 3 trial to those in Phase 2; populations are broadly similar. [Taking a long time to reach the OS reporting point is a good thing - WM]

GlycoMimetics asked to add an interim futility analysis, conducted by an Independent Data Monitoring Committee, to the trial. The FDA agreed. In Q1 2023 the results were that the trial was continued as planned.

Uproleselan market opportunity is based on its novel mechanism of action. 20,000 AML diagnoses annually in the U.S., with incidence increasing. 29% current 5-year survival rate. Current OS for our target R/R population is just 6 months. Remarked on potential market size.

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

At ASH (in December) initial data was presented, in posters, from the investigator-sponsored trials. 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 in November 2021. EFS is the endpoint. An interim analysis is planned before proceeding to Phase 3 enrollment. 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. Other investigator-sponsored trials are underway or planned that could lead to label expansion.

GMI-1687 shows potential superiority for VOC in sickle cell disease to rivipansel. Preclinical data was presented at ASCAT in September 2020. A Phase 1 trial IND submission was accepted by the FDA in June 2022. Currently there is no approved therapy for accute VOC. Looking for a partner.

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 $ million, down sequentially from $52 million.

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

Q&A summary:

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