Analyst Conference Summary

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

Forward-looking statements

Overview: Waiting for Phase 3 AML trial enrollment completion, expected by year-end 2021.

Basic data (GAAP):

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

Net income was negative $14.4 million, down sequentially from negative $14.3 million, and down from negative $14.1 million year-earlier.

EPS (diluted) was negative $0.28, flat sequentially from negative $0.28, and up from negative $0.32 year-earlier [due to a higher share count].

Guidance:

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

Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "There are now six trials underway evaluating our lead clinical candidate, uproleselan, including three registration trials and three ISTs, which we anticipate will provide clinical data flow beginning in 2022. Importantly, recruitment rates in both our Company-sponsored Phase 3 trial and the National Cancer Institute's Phase 2 portion of the Phase 2/3 trial support our expectation that enrollment in both studies can be completed by the end of this year. The support of clinicians who are enrolling patients in our global studies, and now the new ISTs, has made it possible to broaden the scope of our uproleselan clinical research to address unmet needs in AML and beyond."

Tomorrow, August 6, 2021, Harout Semerjian will succeed Rachel King as CEO. She will remain on the board.

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. The trial is event-driven, so the timeline for topline data will be announced after enrollment closes.

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

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 should complete enrollment before the end of 2021. 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.

In Q1 2021 Apollomics, the exclusive collaborator for development and commercialization of uproleselan in Greater China, received Breakthrough Therapy Designation from the Center for Drug Evaluation of the China National Medical Products Administration. In March, Apollomics reported the dosing of its first patient in a Phase 1 clinical trial that will bridge to a Phase 3 study in China.

GMI-1687 shows potential superiority for VOC to rivipansel. Preclinical data was presented at ASCAT in September 2020. A Phase 1 trial is planned for the first half of 2022.

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 April 2021. The analyses, based on pharmacodynamic biomarkers, were reported at AACR in April 2021, showing it hit the targets.

A galactin 3 antagonist in a cancer model is encouraging, so preparing to move towards development.

Cash balance ended at $119 million, down sequentially from $132 million.

Total cost of operations was $14 million, consisting of $10 million for R&D and $4 million for general and administrative expense. Loss from operations was $14 million. Other income was $0 million.

Q&A summary:

One time charges due to change in management? Costs going forward? Will see a non-cash, slight increase in SG&A in Q3. Same run rate going forward, cash good until 2023.

ISP data timelines? The investigators will release the data, generally at medical conferences.

1359 data timeline? More data perhaps at end of year.

1687 IND enabling? On track for Phase 1 initiation in 1H 2022. Derisked by data from the rivipansel trial.

Both new ISP AML studies are open-label, so they can be followed until meaningful enough for release. They have good potential to expand potential use of uproleelan.

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