Analyst Conference Summary

conference date: March 2, 2021 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2020 (fourth quarter 2020, Q4)

Forward-looking statements

Overview: Waiting for AML trial enrollment completion.

Basic data (GAAP):

Revenue was $0 million, down sequentially from $1 million, and flat from $0 year-earlier.

Net income was negative $15.6 million, down sequentially from negative $13.7 million, and down from negative $14.7 million year-earlier.

EPS (diluted) was negative $0.32, down sequentially from negative $0.29, and up from negative $0.34 year-earlier.

Guidance:

Cash is sufficient to reach key milestones for uproleselan, into 2022.

Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "During 2020, we remained on track to complete enrollment of our uproleselan pivotal trial in the second half of 2021. A data readout could be in 2022. Uproleselan continues to have strong support from collaborators working with us in the clinical and preclinical arenas. We believe this broad-based support for uproleselan reflects confidence in our approach to establish this product candidate as a potential foundational therapy across the spectrum of AML. In addition, the Chinese regulatory authority granted Breakthrough Therapy designation for uproleselan for the treatment of relapsed/refractory AML, complementing a prior designation by the FDA."

Rivipansel in acute vaso-occlusive crisis in sickle cell disease will not see further development. GMI-1687 will be brought to the clinic instead.

GlycoMimetics is gathering data that would help in preparation for commercialization of uproleselan.

Uproleselan (GMI-1271) has Breakthrough Therapy designation from the FDA. The Phase 3 trial for relapsed/refractory AML completion of enrollment is likely late in 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. At the ASH meeting in December 2020 GlycoMimetics made an oral presentation of preclinical data from a study in an AML mouse model showing potential benefit of a combination therapy of uproleselan with venetoclax and HMA.

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. The is funded by the NCI. The first patient was dosed in Q2 2019 and enrollment continues. Could be used for applciation to FDA for its patient population. Interim data could be available before the end of 2021.

GMI-1687 shows potential superiority for VOC to rivipansel. Preclinical data was presented at ASCAT in September 2020. A Phase 1 trial is planned.

GMI-1359 showed evidence of biologic activity in the initial patients treated in a Phase 1b proof-of-concept trial of various tumors. The analyses are based on pharmacodynamic biomarkers, and have been submitted for presentation at a major medical meeting.

Cash balance ended at $137 million, down sequentially from $143 million.

Total cost of operations was $15.7 million, consisting of $11.7 million for R&D and $4.0 million for general and administrative expense. Loss from operations was $15.6 million. Other income was $0 million.

Q&A summary:

Rivipansel decision factors? The treatment landscape for sickle cell has changed, with outpatient setting more common. 1687 would be better in the outpatient setting, and we would need a further trial for rivipansel approval.

GMI-1359? Data will be shared at a science meeting. We are looking at which specific tumors should be addressed going forward.

There is high interest from investigators for other uses of uproleselan. They will not be announced until the trial or trials begin.

Under the Breakthrough Therapy designation we have had ongoing dialog with the FDA about the uproleselan trials.

GMI-1359 is building up a data set in animal models that gives us confidence in going forward to human trials. It could also be used more broadly than just VOC.

In AML, in particular relapsed AML, despite the new drugs available there is still a large unmet medical need. Many venetoclax patients relapse or only have partial responses.

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