Analyst Conference Summary

conference date: February 28, 2020 @ 5:30 AM Pacific Time
for quarter ending: December 31, 2019 (fourth quarter 2019, Q4)

Forward-looking statements

Overview: Focus is on the two Phase 3 AML trials.

Basic data (GAAP):

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

Net income was negative $14.7 million, down sequentially from negative $13.3 million, and down from negative $13.9 million year-earlier.

EPS (diluted) was negative $0.34, down sequentially from negative $0.31, and down from negative $0.32 year-earlier.

Guidance:

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

Release & Conference Highlights:

Rachel King, Chief Executive Officer, said "GlycoMimetics ended 2019 with robust support from investigators for our uproleselan Phase 3 registration program in relapsed/refractory AML as well as our collaboration with the National Cancer Institute (NCI) on a multi-center clinical trial evaluating the drug candidate in newly diagnosed patients fit for chemotherapy. The two trials have raised awareness of our clinical data to date suggesting that uproleselan may be clearly differentiated from other drugs in development in AML. Endpoints from the two studies have potential to demonstrate that uproleselan could both extend survival and ameliorate the severe side effects experienced by patients following standard treatment."

Rivipansel trial failure reported by Pfizer in Q3 2019 means that uproleselan is the main focus of the company. "With regard to Pfizer's recent decision to return rivipansel rights to us, we look forward to reviewing the full Phase 3 clinical data set and will work to determine what, if any, next steps to take. Will present the data at some point."

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.

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 trial will be funded by the NCI. The first patient was dosed in Q2 2019. Could be used for applciation to FDA for its patient population.

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. Completion of enrollment likely second half of 2021 [a delay from Q3 2019 statement]. 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 ASH in December 2018 new data on clinical outcomes from the Phase 1/2 relapsed/refractory AML trial of uproleselan underscored opportunities to position this drug candidate, if approved, as a potential foundational therapy across the spectrum of AML.

Planning was discontinued for the collaborative Haemato Oncology Foundation for Adults in the Netherlands (HOVON) European study of uproleselan in newly diagnosed patients unfit for chemotherapy, in order to focus resources on the other trials.

Plans for 1271 for fit for chemo, newly diagnosed AML in the near future.

A European proof-of-concept trail of 1271 in multiple myeloma continued in Europe, with topline data expected in 2019. Also looking for a combination trial in the setting.

A third therapy, GMI-1359, Phase 1 trial of healthy volunteers completed, and may be an improvement on GMI-1271 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 $158 million, down sequentially from $171 million.

Total cost of operations was $15.3 million, consisting of $11.5 million for R&D and $3.9 million for general and administrative expense. Other income was $0.6 million.

Q&A summary:

Osteosarcoma plans? It is early to talk about the market opportunity, but it has high unmet medical need and GMI-1359 has done well in preclinical studies. The breast cancer study should give an appropriate Phase 2 dose. After that we could expand it to osteosarcoma. Looking at biomarkers supportive of proof of mechanism of the molecule, including mobilization of the cells and disruption of microenvironment.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: