Glycomimetics Inc (GLYC) 10-Q Quarterly Report May 2021

●	Second half of 2021 remains the target for completion of enrollment of the GlycoMimetics-sponsored pivotal Phase 3 trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML)

●	Enrollment in 2021 is expected to support a planned interim analysis based on event-free survival in the National Cancer Institute’s (NCI) registration trial evaluating uproleselan in newly diagnosed AML patients over the age of 60 years and fit for chemotherapy

●	The Company announces plans to take GMI-1687 forward toward an investigational new drug (IND) filing, with acute treatment of acute vaso-occlusive crisis (VOC) in outpatient settings as one possible use. The Company discontinues development of rivipansel

●	Evidence of biologic activity in first patients treated in Phase 1b study of GMI-1359 in advanced breast cancer has been submitted to a scientific meeting for presentation

●	Hosting a conference call and webcast today at 8:30 a.m. ET

Rockville, MD — March 2, 2021

— GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial results for the fourth quarter and year ended December 31, 2020, and highlighted recent Company events, including several accomplishments reported to date in 2021. Cash and cash equivalents at December 31, 2020 were $137.0 million.

“During 2020, we remained on track to complete enrollment of our uproleselan pivotal trial in the second half of 2021. Uproleselan continues to have strong support from collaborators working with us in the clinical and preclinical arenas. We believe this broad-based support for uproleselan reflects confidence in our approach to establish this product candidate as a potential foundational therapy across the spectrum of AML. In addition, the Chinese regulatory authority granted Breakthrough Therapy designation for uproleselan for the treatment of relapsed/refractory AML, complementing a prior designation by the FDA. We will seek to demonstrate in both ongoing and new clinical trials that uproleselan in combination with standard treatments may both extend survival and ameliorate the severe side effects experienced by cancer patients,” commented Rachel King, Chief Executive Officer.

“December’s ASH meeting gave us an opportunity to share an in-depth understanding of the rivipansel Phase 3 and subsequent Open Label Extension (OLE) data demonstrating the key role of E-selectin and importance of early treatment in VOC. Nevertheless, based on input from the FDA with respect to rivipansel as well as input from key opinion leaders in sickle cell disease, we intend to focus development in this setting on our GMI-1687 product candidate,” she added. “We believe that development of GMI-1687 will be a better option than additional clinical work on rivipansel. This is particularly important since the care of

The following information was filed by Glycomimetics Inc (GLYC) on Tuesday, March 2, 2021 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
Research and Development Expense The following table summarizes our research and development expense by functional area for the three months ended March 31, 2021 and 2020: The following table summarizes our research and development expense by drug candidate for the three months ended March 31, 2021 and 2020: During the three months ended March 31, 2021, our research and development expense decreased by $1.5 million or 12%, compared to the same period in 2020 primarily related to lower clinical assay development and manufacturing expenses related to uproleselan.

Financial - Income Highlight
24 Interest Income During the three months ended March 31, 2021 interest income decreased by $439,000, or 98%, compared to the same period in 2020, due to lower average cash balances and lower interest rates on those balances.
Financial - Expense Highlight
General and Administrative Expense The following table summarizes the components of our general and administrative expense for the three months ended March 31, 2021 and 2020: During the three months ended March 31, 2021, our general and administrative expense decreased by $252,000, or 6%, compared to the same period in 2020 primarily due to lower stock-based compensation.
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
However, COVID-19 infection rates continue...Read more
Other - Other
Factors that could cause or...Read more
Revenue - Product
We have financed our operations...Read more
Revenue - Product
Under the 2020 Sales Agreement,...Read more
Financial - Cash Flow
Cash Flows The following is...Read more
Other - Other
While to date we have...Read more
Financial - Expense
22 The duration, costs and...Read more
Other - Other
We are also advancing other...Read more
Other - Other
If we raise additional funds...Read more
Financial - Expense
The capitalized amounts are expensed...Read more
Other - Other
The imposition of "lockdown," "social...Read more
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We expect our research and...Read more
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We will determine which programs...Read more
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Funding Requirements Our primary uses...Read more
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Our initial research and development...Read more

Financial Statements, Disclosures and Schedules

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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: 0001558370-21-005473
Submitted to the SEC: Mon May 03 2021 8:30:28 AM EST
Accepted by the SEC: Mon May 03 2021
Period: Wednesday, March 31, 2021
Industry: Pharmaceutical Preparations