Analyst Conference Summary

conference date: November 3, 2023 @ 5:30 AM Pacific Time
for quarter ending: September 30, 2023 (third quarter 2023, Q3)

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 $9.2 million, down sequentially from negative $8.2 million, and down from negative $8.5 million year-earlier.

EPS (diluted) was negative $0.14, down sequentially from negative $0.13, and up from negative $0.16 year-earlier.

Guidance:

Cash runway to the end of 2024.

Conference Highlights:

Harout Semerjian, Chief Executive Officer, said "We look ahead to 2024 with anticipation and excitement. Topline results for our pivotal Phase 3 study of uproleselan in relapsed/refractory AML remain on track by the end of Q2 and together with our potential NDA filing before the end of 2024 represent a transformational opportunity for patients, clinicians, and our company. Our progress toward these important milestones, along with the upcoming presentation of independent data on uproleselan at ASH and the expected initial results of our Phase 1a GMI-1687 study by end of Q1 2024, demonstrate our ability and ambition to deliver our development strategy and move closer to becoming a commercial stage company." Executing critical pre-launch activities.

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 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.

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 completion expected end of Q1 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 $49 million, down sequentially from $58 million.

Total cost of operations was $9.8 million, consisting of $5.3 million for R&D and $4.5 million for general and administrative expense. Loss from operations was $9.8 million. Other income was $0.6 million.

Q&A summary:

Likelihood of data by end of Q2 2024? We have seen a slowdown in the number of events twice. So now the FDA has given us a time-based trigger. That should mean data by the end of Q2. More rapid events could cause us to have data even earlier.

Any further work that would need finishing to file the NDA? We are in very good shape. We have had plenty of time to prepare, including for CMC, drug availability.

Dropout rate of your Uproleselan study? In Phase 2 had 31% transplant rate. Seeing north of that in the Phase 3 trial. 3% dropout rate.

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