Analyst Conference Summary

conference date: November 9, 2022 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2021 (third quarter 2022, Q3)

Forward-looking statements

Overview: The good news is patients in the Phase 3 uproleselan AML trial are surviving longer. The bad news is because of that, the triggering event for data has been extended from mid-2023 to year-end 2023.

Basic data (GAAP):

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

Net income was negative $8.5 million, up sequentially from negative $13.3 million, and up from negative $17.3 million year-earlier.

EPS (diluted) was negative $0.16, up sequentially from negative $0.25, and up from negative $0.34 year-earlier.

Guidance:

Cash runway to Q4 2023.

Conference Highlights:

Harout Semerjian, Chief Executive Officer, said "Blinded pooled survival data in our pivotal Phase 3 study show patients living longer than what would be expected based on publicly available historical data. We approached the FDA as we felt an ethical obligation to conduct an interim analysis and have the independent DMC assess whether the prolonged survival observed is linked to treatment with uproleselan. We are pleased the FDA is aligned with our position. Whether the DMC recommends that we continue the study as originally planned or immediately unblind for full analysis, we remain confident and excited in the potential of uproleselan to improve outcomes in relapsed/refractory AML."

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. It will be after about 80% of survival events (or deaths). This will happen in Q1 2023. The change in timeline is the result of patients continuing to live longer than observed in the historical benchmarks used to design the study. Follow-up duration now projected at 30 months, an unprecedented amount, and considerably longer than other drugs that have received recent approvals.

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 will be 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 $52 million, down sequentially from $60.2 million.

Total cost of operations was $9 million, consisting of $5 million for R&D and $4 million for general and administrative expense. Loss from operations was $9 million. Other income was $0.2 million.

Q&A summary:

DMC meeting, timeline if positive? If compelling efficacy, they will recommend to stop and unblind the trial. We have fast track, break-through, and orphan designation. We will be ready to move forward if that happens.

Ex-US? Trial is well balanced in US v. ex-US enrollment. When we move forward in US, we will begin to move forward outside the US as well. Feedback so far is good, including with EU regulators. We are also looking at potential partnerships ex-US.

Investigator trials? We believe U has a role to play across all AML populations, from naive to multiple-lines. NCI trial is registrational grade. Investigator sponsored trials add to specific populations.

[surprising lack of more questions, given the value of the data]

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