Analyst Conference Summary

conference date: May 3, 2023 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2023 (first quarter 2023, Q1)

Forward-looking statements

Overview: Waiting for final uproleselan AML results in 2024.

Basic data (GAAP):

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

Net income was negative $10.4 million, down sequentially from negative $10.2 million, and up from negative $14.7 million year-earlier.

EPS (diluted) was negative $0.17, up sequentially from negative $0.19, and up from negative $0.28 year-earlier.

Guidance:

Cash runway to the end of 2024.

Conference Highlights:

Harout Semerjian, Chief Executive Officer, said "Thanks to the outstanding work of our team preparing the clinical trial database and evaluating the data from the recent interim utility analysis of our Phase 3 study of uproleselan in R/R AML, GlycoMimetics is well positioned to expeditiously complete final trial analysis following the final survival events trigger, which is projected to occur within the first half of 2024,” said Harout Semerjian, Chief Executive Officer of GlycoMimetics. “We are optimistic and excited about the potential of uproleselan to improve overall survival in R/R AML and are fully focused on delivering on the potential of this important first-in-class therapy for patients in need of new, more effective treatment options." Glyc is encouraged by the results of the interim analysis.

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 is vague, but currently estimated to be in Q2 2024. [Taking a long time to reach the OS reporting point is a good thing - WM]

GlycoMimetics asked to add an interim futility analysis, conducted by an Independent Data Monitoring Committee, to the AML trial. The FDA agreed. In February 2023 the results were that the trial was to continue as planned. That was at 80% of events (deaths). The analysis utilized a very high statistical threshold to preserve the statistical integrity of the originally planned final overall survival analysis. The overall survival events trigger is now expected to occur in the first half of 2024. A deeper explanation of the high statistical threshold was presented on the call. It did show better results than the Phase 1 trial. Patients continue to live longer than expected.

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.

GlycoMimetics is gathering data that would help in preparation for commercialization of uproleselan. Uproleselan drug product registration batches were completed in Q3 2021.

At ASH (in December) initial data was presented, in posters, from the investigator-sponsored trials. 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. An interim analysis is planned before proceeding to Phase 3 enrollment. In Q2 2021 three additional investigator-sponsored trials were initiated for AML, bone marrow transplantation, and multiple myeloma.

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. Preclinical data was presented at ASCAT in September 2020. A Phase 1 trial IND submission was cleared by the FDA in June 2022, but trial start has been delayed. 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 $65 million, down sequentially from $47.9 million. During Q1 raised an additional $28.7 million via ATM.

Total cost of operations was $11 million, consisting of $5.4 million for R&D and $5.5 million for general and administrative expense. Loss from operations was $11 million. Interest income was $0.6 million.

Q&A summary:

Timeline based on what? Projections for overall survival. Robust analytical model. Final event trigger from model. We revise projections on an ongoing basis. It does depend on the number of events (deaths) over time.

Cash runway? Glycobiology platform on cusp of generating medicines, uproleselan first. We are not starting any new clinical programs while waiting for uproleselan results. We are burning about $10 million cash per quarter.

Data timing after last needed OS event? We had to get ready in case we passed the interim analysis. So now we are ready for a rapid analysis. Depends on when within H1, but will be a few weeks, so if event is towards the end of H1, topline data might come out beginning of Q3.

ISP data? Believes data reported at U. Davis is encouraging. Not disclosing numbers at this time. Similar responses so far in the other trial.

1687 partner interest? It is a solid second program. Ongoing partnership discussions.

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