Analyst Conference Summary

conference date: April 28, 2022 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2021 (first quarter 2022, Q1)

Forward-looking statements

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

Basic data (GAAP):

Revenue was $0 million, down sequentially from $0.0 million, and down from $1.1 year-earlier.

Net income was negative $14.7 million, up sequentially from negative $17.4 million, and down from negative $14.3 million year-earlier.

EPS (diluted) was negative $0.28, up sequentially from negative $0.33, and flat from negative $0.28 year-earlier.

Guidance:

Cash runway to Q3 2023.

Conference Highlights:

Harout Semerjian, Chief Executive Officer, said "During the first quarter, we advanced our transformation from a research company to a commercially-focused organization. Our clinical team continues to collect and confirm data and track events in real time from our Phase 3 trial in the relapsed/refractory patient population. Based on current projections, we now anticipate reaching our overall survival events trigger in mid-2023, with top line data disclosure shortly thereafter."

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. [Taking a long time to reach the OS reporting point is a good thing - WM]

In Q1 2022, to prepare for commercial launch, Bruce Johnson was hired as Senior Vice President and Chief Commercial Officer, and Deepak Tiwari as Vice President, Technical Operations. GlycoMimetics implemented a workforce reduction of 20% in April 2022, primarily in early-stage research and chemistry.

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.

GMI-1687 shows potential superiority for VOC to rivipansel. Preclinical data was presented at ASCAT in September 2020. A Phase 1 trial IND submission is planned for the first half of 2022, based on FDA guidance. Currently there is no approved therapy for accute VOC.

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 $76.5 million, down sequentially from $90 million.

Total cost of operations was $14.7 million, consisting of $9.6 million for R&D and $5.1 million for general and administrative expense. Loss from operations was $14.7 million. Other income was $0 million.

Q&A summary:

Uproleselan timing to submission following topline data? Preparing as data matures, should be able to communicate data within a few weeks of when it matures. Will get to FDA fast.

Sales strategy, market? 20,000 patients diagnosed with AML each year, 12,000 die each year. Not much for those who are fit for chemotherapy. We believe there is a lot of pent-up demand. There would be 8,000 patients to start with relapsed/refractory disease.

Op ex going forward, given headcount reduction? Had guided to $60 million spend, should be less than that. So cash runway to Q3 2023.

NCI study Phase 2 timeline? It is event based, event-free survival. We are not given details on the timeline. We will get their data when it is available. If data is positive, promising range would send to Phase 3, overwelmingly positive would likely proceed to submission for approval.

The longer it takes to get the Phase 3 OS data, the more likely the trial is a success. So would rather see the data later rather than earlier.

The reduction in force will not affect development of 1359, 2093, 1687. We can re-ramp early stage chemistry work when we are along the commercial path. Once 1687 is filed we will be open to partnerships.

Standard of care for AML, in newly-diagnosed setting, EFS is around 7 months best-case. We want to show 11+. Relapsed refractory OS has been 6 months.

Partnering 1359? Looking at strategic options.

GMI-2093? We now have an oral compound. Data is strong. We are in in partnering discussions.

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