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

U.S. Food and Drug Administration (FDA) Clearance of Investigational New Drug (IND) application to study GMI-1687 in Sickle Cell Disease (SCD) received in June

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The Company previously disclosed and will continue to update its projection of mid-year 2023 for the survival events trigger for its pivotal Phase 3 trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML)

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Progress in data collection now enables the Company to share a comparison of the demographics of the pivotal Phase 3 study to those of the completed Phase 2 study

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Conference call and webcast today at 8:30 a.m. ET including discussion of AML landscape and uproleselan opportunity by Chief Commercial Officer Bruce Johnson

ROCKVILLE, Md.--(BUSINESS WIRE) – August 3, 2022-- GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial results and highlights for the second quarter ended June 30, 2022. Cash and cash equivalents as of the end of the quarter were $60.2 million.

“During second quarter, we made strides in advancing our transformation from a research company to a commercially focused organization and are encouraged by the continued progress of our pivotal Phase 3 trial of uproleselan in relapsed/refractory AML,” said Harout Semerjian, Chief Executive Officer. “Clearance by the FDA of the IND for GMI-1687 demonstrates our ability to create and advance innovative drug candidates for clinical development. GMI-1687 is now ideally suited for partnership and we are actively pursuing a licensing agreement for continued development of this novel molecule in sickle cell disease.”

Operational Highlights

Uproleselan

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GlycoMimetics continued efforts to clean the 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. Progress to date now enables the Company to share a comparison of the demographics of those 388 patients against the patient demographics from the Company’s completed phase 2 study with respect to age, severity of AML, prior stem cell transplantation rate, and distribution of relapsed and refractory patients (Table 1). The Company has previously disclosed and will continue to update its projection of mid-year 2023 for the overall survival events trigger, with disclosure of top-line data results shortly thereafter.

The following information was filed by Glycomimetics Inc (GLYC) on Wednesday, August 3, 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 - 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.
Revenue - Product Highlight
We have financed our operations primarily through private placements of our securities, up-front and milestone payments under our license and collaboration agreements and the net proceeds from public offerings of common stock, including sales of common stock under at-the-market sales facilities with Cowen and Company LLC, or Cowen.
Revenue - Product Highlight
Under the 2022 Sales Agreement, we may sell up to $100.0 million of our common stock.
Financial - Expense
We anticipate that our general...Read more
Financial - Income
Interest Income During the three...Read more
Other - Other
In March 2022, we filed...Read more
Financial - Expense
The duration, costs and timing...Read more
Other - Other
We are also advancing other...Read more
Revenue - Product
There was no revenue recognized...Read more
Other - Other
If we raise additional funds...Read more
Revenue - Product
Although it is difficult to...Read more
Financial - Expense
The capitalized amounts are expensed...Read more
Other - Other
We believe our expertise in...Read more
Financial - Expense
Outlook Based on our research...Read more
Other - Other
We will determine which programs...Read more
Financial - Expense
Funding Requirements Our primary uses...Read more
Other - Other
Our initial research and development...Read more
Financial - Expense
The increases were primarily due...Read more

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 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: 0001558370-22-011770
Submitted to the SEC: Wed Aug 03 2022 8:30:56 AM EST
Accepted by the SEC: Wed Aug 03 2022
Period: Thursday, June 30, 2022
Industry: Pharmaceutical Preparations