Glycomimetics Inc (GLYC) SEC Filing 10-Q Quarterly Report for the period ending Friday, June 30, 2023

Glycomimetics Inc

CIK: 1253689 Ticker: GLYC



GlycoMimetics Reports Highlights and Financial Results for First Quarter 2023

Pivotal Phase 3 study of uproleselan combined with cytarabine-based chemotherapy in relapsed/refractory (R/R) acute myeloid leukemia (AML) continues to be projected to reach final survival event trigger within first half of 2024
Cash and cash equivalents expected to fund current operations into late 4th quarter of 2024
Conference call and webcast today at 8:30 a.m. ET

ROCKVILLE, Md.--(BUSINESS WIRE) – May 3, 2023-- GlycoMimetics, Inc. (Nasdaq: GLYC) a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers and inflammatory diseases, today reported its financial results and highlights for the first quarter ended March 31, 2023. Cash and cash equivalents as of March 31, 2023 were $65.0 million.

“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.”

Operational Highlights


In February 2023, GlycoMimetics announced that the independent Data Monitoring Committee for its ongoing Phase 3 trial of uproleselan in R/R AML had conducted an interim utility analysis (IA) and subsequently recommended the study should continue to the originally planned final overall survival events trigger. A statistical plan to add an IA to the Phase 3 study was cleared with the FDA in the fourth quarter of 2022, which enabled the DMC to review efficacy data from that study at around 80% of planned survival events. The IA utilized a very conservative threshold to preserve the statistical integrity of the originally planned final overall survival analysis. The overall survival events trigger is projected to occur within the first half of 2024.

The NCI Alliance for Clinical Trials in Oncology will conduct a planned interim analysis of event-free survival in 267 patients randomized to its Phase 2/3 clinical trial evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy. When available, the company will share these interim analysis results.

The following information was filed by Glycomimetics Inc (GLYC) on Wednesday, May 3, 2023 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:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Balance Sheets
Balance Sheets (Parenthetical)
Statements Of Cash Flows
Statements Of Operations And Comprehensive Loss
Statements Of Stockholders' Equity
Accrued Expenses
Accrued Expenses (Tables)
Accrued Expenses - Summary Of Accrued Expenses (Details)
Description Of The Business
Description Of The Business (Details)
Income Taxes
Leases (Details)
Leases (Tables)
Leases - Components Of Lease Expense (Details)
Leases - Maturities Of Lease Liability (Details)
Leases - Supplemental Information (Details)
License And Collaboration Agreements
License And Collaboration Agreements (Details)
Prepaid Expenses And Other Current Assets
Prepaid Expenses And Other Current Assets (Tables)
Prepaid Expenses And Other Current Assets - Summary Of Prepaid Expenses And Other Current Assets (Details)
Property And Equipment
Property And Equipment (Details)
Property And Equipment (Tables)
Significant Accounting Policies
Significant Accounting Policies (Policies)
Significant Accounting Policies (Tables)
Significant Accounting Policies - Fair Value Measurements (Details)
Significant Accounting Policies - Potentially Dilutive Securities (Details)
Significant Accounting Policies - Stock-Based Compensation (Details)
Stockholders Equity (Tables)
Stockholders' Equity
Stockholders' Equity - Company's Stock Option Activity (Details)
Stockholders' Equity - Equity Offerings (Details)
Stockholders' Equity - Incentive Plans (Details)
Stockholders' Equity - Inducement Plan (Details)
Stockholders' Equity - Inducement Plan - Stock Option Activity (Details)
Stockholders' Equity - Stock-Based Compensation Expense (Details)
Stockholders' Equity - Summary Of Rsu Activity (Details)
Stockholders' Equity - Weighted-Average Assumptions (Details)

Material Contracts, Statements, Certifications & more

Glycomimetics Inc provided additional information to their SEC Filing as exhibits

Ticker: GLYC
CIK: 1253689
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-23-012814
Submitted to the SEC: Wed Aug 02 2023 8:30:38 AM EST
Accepted by the SEC: Wed Aug 02 2023
Period: Friday, June 30, 2023
Industry: Pharmaceutical Preparations

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