Glycomimetics Inc (GLYC) 10-Q Quarterly Report May 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.

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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 - Expense Highlight
The following table sets forth our results of operations: Research and Development Expense The following table summarizes our research and development expense by functional area for the three months ended March 31, 2023 and 2022: The following table summarizes our research and development expense by drug candidate for the three months ended March 31, 2023 and 2022: Our research and development expense for the three months ended March 31, 2023 decreased by $4.2 million compared to the same period ended March 31, 2022 primarily due to: decreased clinical development costs related to uproleselan as patient enrollment ended in our Phase 3 clinical trial; and decreased manufacturing and formulation costs related to uproleselan validation batches.

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.
Financial - Expense Highlight
In addition, our professional fees have increased with higher commercial readiness expenses for uproleselan and legal fees in the first quarter of 2023 as compared to 2022.
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In March 2022, we filed...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 10.2: Material Contract

Exhibit 10.3: Material Contract

Exhibit 10.4: Material Contract

Exhibit 10.5: 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: 0001558370-23-007744
Submitted to the SEC: Wed May 03 2023 8:34:35 AM EST
Accepted by the SEC: Wed May 03 2023
Period: Friday, March 31, 2023
Industry: Pharmaceutical Preparations