Glycomimetics Inc (GLYC) SEC Filing 10-Q Quarterly Report for the period ending Friday, September 30, 2022

Glycomimetics Inc

CIK: 1007019 Ticker: GLYC



GlycoMimetics Reports Highlights and Financial Results for Third Quarter 2022

U.S. Food and Drug Administration (FDA) clears protocol amendment to conduct an interim utility analysis of pivotal Phase 3 study of uproleselan in relapsed/refractory acute myeloid leukemia (AML)
Blinded pooled survival data show patients in the Phase 3 study continue to live longer than historically expected; final survival events trigger now projected around year-end 2023
Independent Data Monitoring Committee (DMC) to determine by end Q1 2023 if the study should continue as planned or be immediately unblinded for full analysis if efficacy data is compelling
Cash runway extended to the end of 2023
Conference call and webcast today at 8:30 a.m. ET

ROCKVILLE, Md.--(BUSINESS WIRE) – November 9, 2022-- 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 third quarter ended September 30, 2022. Cash and cash equivalents as of September 30, 2022, were $51.6 million.

“Blinded pooled survival data in our pivotal Phase 3 study show patients living longer than what would be expected based on publicly available historical data. We approached the FDA as we felt an ethical obligation to conduct an interim analysis and have the independent DMC assess whether the prolonged survival observed is linked to treatment with uproleselan,” said Harout Semerjian, Chief Executive Officer. “We are pleased the FDA is aligned with our position. Whether the DMC recommends that we continue the study as originally planned or immediately unblind for full analysis, we remain confident and excited in the potential of uproleselan to improve outcomes in relapsed/refractory AML.”

The statistical plan cleared with FDA is for the independent DMC to review efficacy and safety data at around 80% of planned survival events. The company has initiated the required regulatory and Institutional Review Board (IRB) approvals to amend the protocol to conduct the interim utility analysis and share the data with the DMC by end of Q1 2023. The DMC is then expected to meet to review the data and recommend whether the study should continue as planned or should be immediately unblinded for full analysis, which could occur if the efficacy data from treatment with uproleselan in combination with standard chemotherapy is observed to be compelling.

As part of its ongoing monitoring of blinded pooled survival data within the Phase 3 pivotal study, the company is now projecting the final survival events trigger to occur around year-end 2023. This change in timeline is the result of patients continuing to live longer than observed in historical benchmarks used to design the study and was the primary rationale for the company to approach the FDA regarding conduct of an interim utility analysis.

The following information was filed by Glycomimetics Inc (GLYC) on Wednesday, November 9, 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.

View differences made from one quarter to another to evaluate Glycomimetics Inc's financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Glycomimetics Inc.


Assess how Glycomimetics Inc's management team is paid from their Annual Proxy

Definitive Proxy Statement (Form DEF 14A)
Screenshot example of actual Proxy Statement

Glycomimetics Inc's Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:

  • Voting Procedures
  • Board Members
  • Executive Team
  • Salaries, Bonuses, Perks
  • Peers / Competitors


SEC Filing Tools


Learn More
Bullish Bearish Neutral
Filter Sentiment:
Filter Category:
Filter Subcategory:
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
Going Concern
Going Concern (Details)
Income Taxes
Income Taxes (Details)
Leases (Details)
Leases (Tables)
Leases - Components Of Lease Expense (Details)
Leases - Maturities Of Lease Liability (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)
Risks And Uncertainties
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)
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: 0001558370-22-017036
Submitted to the SEC: Wed Nov 09 2022 8:30:54 AM EST
Accepted by the SEC: Wed Nov 09 2022
Period: Friday, September 30, 2022
Industry: Pharmaceutical Preparations

External Resources:
Stock Quote
Social Media

Bookmark the Permalink: