Analyst Conference Summary


conference date: August 3, 2022 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2021 (second quarter 2022, Q2)

Forward-looking statements

Overview: Data from Phase 3 uproleselan AML trial expected mid-2023.

Basic data (GAAP):

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

Net income was negative $13.3 million, up sequentially from negative $14.7 million, and down from negative $14.4 million year-earlier.

EPS (diluted) was negative $0.25, up sequentially from negative $0.28, and flat from negative $0.28 year-earlier.


Cash runway to Q3 2023.

Conference Highlights:

Harout Semerjian, Chief Executive Officer, said "During second quarter, we made strides in advancing our transformation from a research company to a commercially focused organization and are encouraged by the continued progress of our pivotal Phase 3 trial of uproleselan in relapsed/refractory AML. Clearance by the FDA of the IND for GMI-1687 demonstrates our ability to create and advance innovative drug candidates for clinical development. GMI-1687 is now ideally suited for partnership and we are actively pursuing a licensing agreement for continued development of this novel molecule in sickle cell disease."

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 vague, but currently estimated to be in mid 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]

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.

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. 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 $60.2 million, down sequentially from $76.5 million.

Total cost of operations was $13.4 million, consisting of $8.0 million for R&D and $5.5 million for general and administrative expense. Loss from operations was $13.4 million. Other income was $0 million.

Q&A summary:

Phase 3 OS event tracking v. projections? Tracking in line with prior projections.

Uproleselan combo studies timelines? Principal investigators determine that, we do not have clear guidance, but could see as early as the coming ASH meeting.

Color on differences between Phase 2 and Phase 3 populations? Broadly similar, but not exact. Phase 3 used a lot more sites than 2. All are R/R, with prognosis in months. Also comparable to trials in market place.

NCI timeline? We will only get an update when they complete their analysis. EFS is the primary endpoint, full enrollment was in November 2021. So they could give us data in mid 2023.

Business development activity? That is a focus. 1687 is an exciting program. IND helps to find a partner. No timeline yet.

Workforce reduction? Already reduced in early research team. Not meant for significant cost reduction, just a shift in use. Burn has been about $15 million per quarter, impact of workforce reduction not material.

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Disclaimer: My analyst call summaries may include both condensations of statements made by company representatives and my own analysis. They are not covered by any warranty. I cannot guarantee anything said by company representatives is true. I try not to make errors, but it is possible. These are my personal notes which I share with other investors and which I use as the basis of my blog and Seeking Alpha articles.

Copyright 2022 William P. Meyers