Analyst Conference Summary

conference date: July 31, 2020 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2020 (second quarter 2020, Q2)

Forward-looking statements

Overview: Waiting for trial results.

Basic data (GAAP):

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

Net income was negative $14.1 million, down sequentially from negative $7.7 million, and up from negative $15.8 million year-earlier.

EPS (diluted) was negative $0.32, down sequentially from negative $0.18, and up from negative $0.37 year-earlier.

Guidance:

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

Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "The second quarter was quite productive as we noted strong enrollment in our company-sponsored pivotal trial of uproleselan in relapsed/refractory AML. Though we did see a slow down early in the COVID crisis, we were pleased to see enrollment pick back up later in the quarter. We are able to maintain prior guidance that we expect to complete enrollment in the second half of 2021. Also important were new data from a post hoc analysis of the rivipansel Phase 3 study that showed that patients treated with rivipansel within approximately 26 hours of the onset of pain in their crisis experienced statistically significant improvements in the primary efficacy endpoint of time to readiness for discharge compared to placebo. These data provide a foundation, we believe, for us to discuss with the FDA whether there may be a path forward for rivipansel in acute VOC." Scientists have returned to labs on a staggered basis.

Reviewed data from the failed Pfizer trial of rivipansel for sickle cell vaso-occlusive crisis. Glycomimetics has received the rights back. A post hoc analysis of the Phase 3 study evaluating the efficacy of rivipansel in acute vaso-occlusive crisis in sickle cell disease produced new efficacy data showing statistically significant improvements for patients treated early in crisis, in the primary efficacy endpoint of time to readiness for discharge v. placebo.

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 preclinical data on the mechanism of action was published in the April 27, 2020, issue of Nature Communications. The paper outlined how uproleselan can reduce chemoresistance in AML through the key mechanism of targeted E-selectin inhibition.

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 is funded by the NCI. The first patient was dosed in Q2 2019 and enrollment continues. 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.

An abstract that was accepted for oral presentation at the Foundation for Sickle Cell Disease (FSCDR) meeting and published online in June, disclosed data from a preclinical model of the E-selectin antagonist, GMI-1687, which is more potent than rivipansel and is being formulated for subcutaneous dosing. The data support development of GMI-1687 as a possible follow-on to rivipansel. 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.

A third therapy, GMI-1359, Phase 1 trial of healthy volunteers completed in 2019, and may be an improvement on GMI-1271 (uproleselan) 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 $150 million, down sequentially from $155 million. During Q2 issued common stock under its at-the-market facility with Cowen for aggregate net proceeds of $9.6 million.

Total cost of operations was $14.1 million, consisting of $9.9 million for R&D and $4.2 million for general and administrative expense. Loss from operations was $14.1 million. Other income was $0.0 million.

Q&A summary:

Preclinical development? 1687 is in IND enabling studies. We are working in the lab on galactins and other novel compounds prior to bringing them to advanced preclinical testing.

Rivipansel course? Will submit abstracts as data is available. No specifics yet.

1359 study had been halted? Was put on hold, should start enrolling patients soon. It is an outpatient trial, so elective.

1687 timing? Pfizer agreement precluded all sickle cell disease development. Now we can, no timeline yet.

Rivipansel timing of FDA meeting? Would not announce the specific date of the meetings, would announce guidance when available.

ATM facility remainder? $60 million.

Rivipansel 26.4 hour cutoff? Not prespecified, post-hoc, first quartile interval so not arbitrary.

Narrow window of opportunity, is it commercial? It is substantial. Current guidance is for patients to stay home. They could be encouraged to seek treatment more quickly, earlier in the crisis. So it would not be limited to a quarter of patients.

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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