Glycomimetics Inc (GLYC) 10-Q Quarterly Report August 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 4^th 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

Uproleselan

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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:

Revenue - Product Highlight
Under the 2022 Sales Agreement, we may sell up to $100.0 million in shares of our common stock.
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 - Earnings Highlight
We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.
Other - Other Highlight
Factors that could cause or contribute to these differences include those below and elsewhere in this Quarterly Report on Form 10-Q, our Annual Report on Form 10-K, particularly in Part I - Item 1A, "Risk Factors," and our other filings with the Securities and Exchange Commission.
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We have financed our operations...Read more
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Interest Income During the three...Read more
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In May 2023, the FDA...Read more
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In March 2022, we filed...Read more
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We are advancing other preclinical-stage...Read more
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24 General and Administrative Expense...Read more
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If we raise additional funds...Read more
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Although it is difficult to...Read more
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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 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: 0001558370-23-012814
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