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: After an interim utility analysis resulted in trial continuing, waiting for final results in 2024.

Basic data (GAAP):

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

Net income was negative $10.2 million, down sequentially from negative $8.5 million, and up from negative $17.4 million year-earlier.

EPS (diluted) was negative $0.19, down sequentially from negative $0.16, and up from negative $0.33 year-earlier.

Guidance:

Completion of some early-commercial and manufacturing activities for uproleselan enabled GlycoMimetics to project its cash runway to the end of 2024.

Conference Highlights:

Harout Semerjian, Chief Executive Officer, said "We aspire to become a commercial-stage company capable of delivering uproleselan to R/R AML patients in need of innovative new treatment options. Patients continue to live longer in our pivotal Phase 3 study of uproleselan, with duration of median follow-up for the blinded, pooled patient population now at a remarkable 25 months. Our Phase 3 AML trial projects to have the longest duration of median follow-up at time of primary analysis of any study, to our knowledge, previously conducted in this disease area. We remain optimistic and excited about the potential of uproleselan to improve overall survival in R/R AML." Glyc is encouraged by the results of the interim analysis.

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 to continue as planned. That was at 80% of events (deaths). The analysis utilized a very high statistical threshold to preserve the statistical integrity of the originally planned final overall survival analysis. The overall survival events trigger is now expected to occur in the first half of 2024. A deeper explanation of the high statistical threshold was presented on the call. It did show better results than the Phase 1 trial. Patients continue to live longer than expected.

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.

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 cleared by the FDA in June 2022, but trial start has been delayed. 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 $47.9 million, down sequentially from $52 million. After Q4 ended added raised an additional $28.7 million ATM.

Total cost of operations was $10.6 million, consisting of $5.9 million for R&D and $4.7 million for general and administrative expense. Loss from operations was $10.6 million. Interest income was $0.4 million.

Q&A summary:

NCI frontline data timeline? Phase 2/3. 267 patients enrolled, one year pause. But Glyc has not received any updates, perhaps because of slow death rate, but no official communication.

GMI 1687? Cleared IND, but focus is on uproleselan. [WM: so no trial start date]

How do you predict OS event timing, keep pushing it out? We have statistical external partners, taking into consideration all events and subgroups (transplant vs. not, etc.). At full enrollment in 2021, projected end of 2022. As events occur, we update our projection. Did data cleaning for the interim analysis, so have a very robust data base and updated our timeline. But it is possible it is the standard of care group that is extending the timeline, rather than uproleselan, since the data is blinded.

We are working to educate the medical community about the potential of uproleselan.

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