Glycomimetics Inc (GLYC) 10-Q Quarterly Report April 2022

Mid-year 2023 projected for events trigger of the GlycoMimetics-sponsored pivotal Phase 3 trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML).

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Investigational new drug (IND)-enabling 28-day toxicity studies and GMP manufacturing completed for GMI-1687 for treatment of acute vaso-occlusive crisis (VOC) of sickle cell disease; IND on track for first half 2022 submission.

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Conference call and webcast today at 8:30 a.m. ET

ROCKVILLE, MD – April 28, 2022-- GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial results and highlights for the first quarter ended March 31, 2022. Cash and cash equivalents at March 31, 2022 were $76.5 million.

“During the first quarter, we advanced our transformation from a research company to a commercially-focused organization. Our clinical team continues to collect and confirm data and track events in real time from our Phase 3 trial in the relapsed/refractory patient population. Based on current projections, we now anticipate reaching our overall survival events trigger in mid-2023, with top line data disclosure shortly thereafter. Beyond uproleselan, we reiterate our plan to submit an IND for GMI-1687 in sickle cell disease in the first half of 2022,” commented Harout Semerjian, Chief Executive Officer.

Operational Highlights

Uproleselan

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GlycoMimetics continued a focused effort to collect and confirm data received from the 70 sites in the U.S., Europe, Canada, and Australia that enrolled a total of 388 patients in the Company’s pivotal Phase 3 trial in relapsed/refractory AML. Based on current projections, GlycoMimetics now anticipates mid-year 2023 for the overall survival events trigger, with top line data disclosure shortly thereafter.

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In parallel, the National Cancer Institute (NCI), in its Phase 2/3 clinical trial evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, is preparing for its planned interim analysis of event free survival from its Phase 2 enrollment of 267 patients. The Company intends to share the outcome of the NCI’s analysis of the Phase 2 data.

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Investigator-sponsored clinical trials to evaluate expanded indications for uproleselan enrolled patients at the University of California-Davis, Washington University at St. Louis, MD Anderson Cancer Center, and the University of Michigan.

The following information was filed by Glycomimetics Inc (GLYC) on Thursday, April 28, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Glycomimetics Inc's 10-Q Quarterly Report:

Revenue - Product Highlight
Subject to the terms of the agreement, we will be eligible to receive potential further milestone payments totaling approximately $179.0 million, as well as tiered royalties ranging from the high single digits to 15%, as a percentage of net sales.

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Material Contracts, Statements, Certifications & more

Glycomimetics Inc provided additional information to their SEC Filing as exhibits

Exhibit 5.1: Opinion Regarding Legality

Exhibit 10.1: Material Contract

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Ticker: GLYC
CIK: 1253689
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-22-006260
Submitted to the SEC: Thu Apr 28 2022 4:01:14 PM EST
Accepted by the SEC: Thu Apr 28 2022
Period: Thursday, March 31, 2022
Industry: Pharmaceutical Preparations