Glycomimetics Inc (GLYC) 10-Q Quarterly Report November 2020

Enrollment in the Company-sponsored pivotal Phase 3 trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML) continued, and the company affirmed second half of 2021 as target for completion of enrollment

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A post hoc analysis of the Phase 3 RESET study evaluating the efficacy of rivipansel in acute vaso-occlusive crisis (VOC) in sickle cell disease (SCD) produced new efficacy data showing statistically significant improvements for patients treated early in crisis in the primary efficacy endpoint of time to readiness for discharge compared to placebo

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Pfizer completed the transfer to GlycoMimetics of all commercial and development rights and the Investigational New Drug Application (IND) for rivipansel

ROCKVILLE, MD, July 31, 2020 -- GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial results for the second quarter ended June 30, 2020, and highlighted recent company events. Cash and cash equivalents at June 30, 2020 were $149.8 million.

“The second quarter was quite productive as we noted strong enrollment in our company-sponsored pivotal trial of uproleselan in relapsed/refractory AML. Though we did see a slow down early in the COVID crisis, we were pleased to see enrollment pick back up later in the quarter. This was an important achievement in the face of the COVID-19 pandemic, and we are able to maintain prior guidance that we expect to complete enrollment in the second half of 2021. Also important were new data from a post hoc analysis of the rivipansel Phase 3 study that showed that patients treated with rivipansel within approximately 26 hours of the onset of pain in their crisis experienced statistically significant improvements in the primary efficacy endpoint of time to readiness for discharge compared to placebo. These data provide a foundation, we believe, for us to discuss with the U.S. Food and Drug Administration (FDA) whether there may be a path forward for rivipansel in acute VOC,” commented Rachel King, Chief Executive Officer.

The following information was filed by Glycomimetics Inc (GLYC) on Friday, July 31, 2020 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 tables summarize our research and development expense by functional area for the three and nine months ended September 30, 2020 and 2019: 27 The following tables summarize our research and development expense by drug candidate for the three and nine months ended September 30, 2020 and 2019: During the three and nine months ended September 30, 2020, our research and development expense decreased by $54,000, or 1%, and $2.4 million, or 7%, respectively, compared to the same periods in 2019.

Financial - Income Highlight
Interest Income During the three and nine months ended September 30, 2020 interest income decreased by $848,000, or 99%, and $2.4 million, or 83%, respectively, compared to the same periods in 2019, due to lower average cash balances and lower interest rates on those balances.
Revenue - Product Highlight
Subject to the terms of the agreement, 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 - Expense Highlight
Contract research services, consulting and other costs were lower in 2020 as research activities were affected at outside universities and travel by research and development personnel was largely eliminated due to the COVID-19 pandemic.
Financial - Cash Flow Highlight
30 Cash Flows The following is a summary of our cash flows for the nine months ended September 30, 2020 and 2019: Operating Activities Net cash used in operating activities for the nine months ended September 30, 2020 and 2019 was primarily the result of ongoing costs associated with our uproleselan clinical development programs which includes significant costs for project support, investigator site start-up costs and patient enrollment fees as well as clinical manufacturing costs.
Financial - Earnings
We cannot assure you that...Read more
Other - Other
However, COVID-19 infection rates continue...Read more
Other - Other
Pfizer terminated the Pfizer Agreement...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 - Expense
The higher clinical expenses were...Read more
Other - Other
While to date we have...Read more
Other - Other
Pfizer terminated the Pfizer Agreement,...Read more
Financial - Expense
25 The duration, costs and...Read more
Financial - Expense
Personnel-related expenses increased due to...Read more
Revenue - Geography
In 2017, the European Commission,...Read more
Other - Other
In August 2020, we entered...Read more
Other - Other
Impact of COVID-19 on Our...Read more
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Patent, legal fees, consulting and...Read more
Other - Other
If we raise additional funds...Read more
Financial - Expense
The capitalized amounts are expensed...Read more
Financial - Expense
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
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In December 2018, at the...Read more
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The shelf registration statement under...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: 0001558370-20-013021
Submitted to the SEC: Fri Nov 06 2020 8:02:43 AM EST
Accepted by the SEC: Fri Nov 06 2020
Period: Wednesday, September 30, 2020
Industry: Pharmaceutical Preparations