Analyst Conference Summary

conference date: May 1, 2020 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2020 (first quarter 2020, Q1)

Forward-looking statements

Overview: Waiting for trial results.

Basic data (GAAP):

Revenue was $9 million, up sequentially from $0, and up from $0 year-earlier.

Net income was negative $7.7 million, up sequentially from negative $14.7 million, and up from negative $14.1 million year-earlier.

EPS (diluted) was negative $0.18, up sequentially from negative $0.34, and up from negative $0.33 year-earlier.

Guidance:

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

Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "During the quarter, patient enrollment continued on track in GlycoMimetics' Phase 3 registration program evaluating uproleselan in relapsed/refractory acute myeloid leukemia (AML) as well as in our collaboration with the National Cancer Institute (NCI) on a multi-center clinical trial evaluating the drug candidate in newly diagnosed patients fit for chemotherapy. Enrollment slowed in April as a result of the COVID-19 pandemic, and we continue to actively monitor the situation. At this time it is too early for us to comment on the potential impact of the pandemic on completion of enrollment in either trial, or the potential impact on cash burn. In addition, we are working closely with Apollomics in the Greater China region to initiate the Apollomics-funded third registration trial for uproleselan."

Plans to do a full review of the failed Pfizer trial of rivipansel for sickle cell vaso-occlusive crisis, now that Glycomimetics has received the rights back.

GlycoMimetics and Apollomics announced in January 2020 a collaboration and license agreement for uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan. Received a $9 million upfront payment.

Uproleselan (GMI-1271) has Breakthrough Therapy designation from the FDA. Started the Phase 3 trial in Q4 2018 for relapsed/refractory AML, which will enroll 380 patients. Expanding the roster of clinical sites, with enrollment progressing as planned, but could be impacted by the pandemic. Completion of enrollment likely second half of 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. New data on the mechanism was published in late April 2020 indicating why it has a strong safety profile.

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 trial will be funded by the NCI. The first patient was dosed in Q2 2019. Could be used for applciation to FDA for its patient population.

Plans for 1271 for fit for chemo, newly diagnosed AML in the near future.

A third therapy, GMI-1359, Phase 1 trial of healthy volunteers completed i 2019, and may be an improvement on GMI-1271 in treating bone marrow cancers. Duke University initiated, in January 2020, a proof-of-concept clinical trial of GMI-1359 in individuals with breast cancer whose tumors have spread to bone. It will evaluate safety and biomarkers of cancer cell mobilization in individuals with hormone receptor positive metastatic breast cancer. Data published in Nature Cell Biology strongly suggests that E-selectin is key to tumor growth and metastasis to bone and provides further support for the upcoming clinical trial of GMI-1359 in individuals with metastatic breast cancer

Cash balance ended at $155 million, down sequentially from $158 million. In January recieved $9 million upfront payment from Apollomics.

Total cost of operations was $17.1 million, consisting of $12.7 million for R&D and $4.4 million for general and administrative expense. Loss from operations was $8.1 million. Other income was $0.4 million.

Q&A summary:

Rivipansel timeline? Probably in the coming months. No decision on next steps until review is complete.

1687 timeline? Preclinical data is compelling, as a follow up to uproleselan. No timeline at present.

We have no plans to lay off employees at this time. Cash should last at least into Q2 2022.

Enrollment is going well, with patients screened out of the trial at about the rate expected.

Nature Communications manuscript? We are excited about that. It is very specific about the mechanism of action for lowering chemo-resistance.

1359 enrollment? It is on hold for the pandemic.

Application to other hematological malignancies? We have preclinical data showing it is worth exploring.

Cash runway v. upro enrollment? Completion of enrollment guidance remains in place. We are managing cash carefully, we may have opportunities to add cash, so we think we can get to top line data with the cash we have.

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