Analyst Conference Summary

conference date: March 27, 2024 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2023 (fourth quarter 2023, Q4)

Forward-looking statements

Overview: Waiting for final uproleselan AML results in late Q2 2024.

Basic data (GAAP):

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

Net income was negative $9.1 million, up sequentially from negative $9.2 million, and up from negative $10.2 million year-earlier.

EPS (diluted) was negative $0.14, flat sequentially from negative $0.14, and up from negative $0.19 year-earlier. Share count 64.4 million, up from 53.0 million year-earlier.

Guidance:

Cash runway to the end of 2024.

Conference Highlights:

Harout Semerjian, Chief Executive Officer, said "With the time-based analysis imminent for our pivotal Phase 3 study of uproleselan in R/R AML, we are laser-focused on delivering the topline results in Q2 and excited about the possibility of submitting an NDA before year-end. This large, randomized, global trial now has a median follow-up of more than three years, which is remarkable in R/R AML, and could demonstrate the potential of uproleselan to become a new standard of care for a disease with limited treatment options and high unmet need. We are also pleased to announce our agreement with the ASH RC for GMI-1687, further validating the potential of this highly potent E-selectin antagonist for the treatment of sickle cell disease. We remain deeply committed to bringing life-changing treatments to patients and look forward to sharing more important updates in the coming months." Executing critical pre-launch activities. AML data cutoff is end of April.

AML has a high unmet medical need. 15% overall 5 year survival rate. Most AML patients do not have a specific gene to attack. 20,000 new cases per year. Believes the U.S. market opportunity is $650 to $850 million per year for r/r AML alone.

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 was event-driven, but the FDA allowed it to be amended to a time-based analsyis, so currently top line results should be in Q2 2024. If positive, hopes to file the NDA by the end of 2024. In Q2 2023 the FDA agreed to an initial Pediatric Study Plan, and the NCI (National Cancer Institute) to sponsor the pediatric Phase 1/2 study in AML. Also, the NCI again indicated data has not been released in its trial of seniors because of taking a long time for deaths to occur. [Taking a long time to reach the OS reporting point is a good thing - WM]

Updated clinical data from an investigator-initiated trial studying the use of uproleselan in combination with chemotherapy for patients with treated secondary AML has been accepted for poster presentation at the ASH Annual Meeting in December. In June, 2023, the first pediatric patient was treated with uproleselan in an investigator-initiated single arm, multi-center Phase 1/2 study to assess safety and tolerability, as well as determine a recommended phase 2 dose (RP2D) of uproleselan plus myeloablative, busulfan-based, pre-transplant conditioning for treatment of AML. This study, led by John Horan, MD, MPH, of the Boston Children’s Hospital and Dana Farber Cancer Institute, will enroll up to 28 patients (Age =12 months and = 30 years) and will also assess preliminary uproleselan efficacy at the RP2D. In addition the National Cancer Institute (NCI) plans an analysis of its Phase 2/3 trial of uproleselen in fit older AML patients.

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.

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. A Phase 1 trial first patient started in Q3 2023. Enrollment completed Q1 2024. Announced met primary and secondary endpoints. Full results later in 2024. 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 $41.8 million, down sequentially from $49 million.

Total cost of operations was $9.6 million, consisting of $5.3 million for R&D and $4.3 million for general and administrative expense. Loss from operations was $9.6 million. Other income was $0.5 million.

Q&A summary:

Results timing? NCI has not reached EFS trigger yet. Depending on timing of their results, we will likely do an sNDA.

Initial use of uproleselan? Initial use is adjunct to standard of care chemotherapy, including patients with mutations. ISPs are researching not-fit-for-chemo group.

End of Q2 or slightly earlier? Significant reduction in number of events over time. Slowdown continues. But data mature now from a time basis. Data cutoff is March 31. Then we have to do the data base cleanup and analysis. Then, hopefully, a positive press release in Q2.

ASH sickle cell new collaboration? Our goal is to eliminate vaso-occlusive events. But enrollment in this indication is difficult and will take time.

Other items needed for BLA? Most was incorporated into trial and data design, based on FDA discussions.

1687 collaboration costs, plan? There is a cost to us, but modest. Have not decided on collaboration strategy for commercialization.

Europe strategy? Our planning is underway and ongoing. Half the Phase 3 trial was done in Europe.

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