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GlycoMimetics Reports Highlights and Financial Results for Third Quarter 2023 Topline results from pivotal Phase 3 study of uproleselan in relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) on track to be reported by

Key Takeaway: GlycoMimetics reported its financial results for the third quarter of 2023, highlighting a net loss of $9.2 million and cash equivalents of $49.4 million as of September 30, 2023. The CEO expressed enthusiasm for the upcoming pivotal Phase 3 study results of uproleselan in relapsed/refractory AML, which are expected by the end of Q2 2024. The company is also advancing its GMI-1687 study, designed for treating sickle cell disease, further supporting its goal of becoming a commercial-stage biotech firm.

Market Sentiment Analysis

POSITIVE FACTORS

  • Topline results for pivotal Phase 3 study of uproleselan are on track.
  • CEO expresses strong optimism about 2024 and upcoming milestones.
  • Uproleselan has received Breakthrough Therapy and Fast Track designations.

CONCERNS & RISKS

  • The company reported a net loss of $9.2 million for the quarter.
  • Operational expenses are significantly high compared to revenue.

Full Press Release Details

GlycoMimetics Reports Highlights and Financial Results for Third Quarter 2023
ROCKVILLE, Md.--(BUSINESS WIRE) - November 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 third quarter ended September 30, 2023. Cash and cash equivalents as of September 30, 2023 were $49.4 million.
"We look ahead to 2024 with anticipation and excitement. Topline results for our pivotal Phase 3 study of uproleselan in relapsed/refractory AML remain on track by the end of Q2 and together with our potential NDA filing before the end of 2024 represent a transformational opportunity for patients, clinicians, and our company," said Harout Semerjian, Chief Executive Officer of GlycoMimetics. "Our progress toward these important milestones, along with the upcoming presentation of independent data on uproleselan at ASH and the expected initial results of our Phase 1a GMI-1687 study by end of Q1 2024, demonstrate our ability and ambition to deliver our development strategy and move closer to becoming a commercial stage company."
Operational Highlights
Third Quarter 2023 Financial Results:
The company will host a conference call and webcast today at 8:30 a.m. ET. To access the call by phone, please go to this registration link, and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.
A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.
Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class E-selectin antagonist. Uproleselan (yoo' pro le'se lan), currently in a broad development program including a late-stage Phase 3 trial in acute myeloid leukemia (AML), has received Breakthrough Therapy and Fast Track designations from the FDA and Breakthrough Therapy designation from the Chinese National Medical Products Administration for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin binding and stimulation of myeloid cells. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells confers a pro-survival effect. Uproleselan is intended to enable a novel approach to disrupting established mechanisms of leukemic cell resistance.
Discovered and developed by GlycoMimetics, GMI-1687 is a highly potent E-selectin antagonist that has been shown in animal models to be fully bioavailable following subcutaneous administration. This second-generation compound is currently being studied in a Phase 1a double-blind, single-center, randomized, placebo-controlled, sequential, single ascending dose trial in healthy adult volunteers. GMI-1687 is believed to have potential application in inflammatory diseases, and the company's initial development focus is treatment of sickle cell disease (SCD). E-selectin is believed to play a major role in vaso-occlusive crisis (VOC), the vascular clots and blockages that cause pain crises in people living with SCD. Administration of GMI-1687 via subcutaneous injection, if successfully developed in the clinic, may enable the drug to address current challenges of IV therapies for SCD as well as offer a potential point-of-care treatment option at the onset of VOC.
About GlycoMimetics, Inc.
GlycoMimetics is a late clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including AML, and for inflammatory diseases. The company's science is based on an understanding of the role that carbohydrates play in cell recognition. Its specialized chemistry platform is being deployed to discover small molecule drugs--known as glycomimetics--that alter carbohydrate-mediated recognition in diverse disease states, including cancers and inflammation. As a leader in this science, GlycoMimetics leverages this unique approach to advance its pipeline of wholly-owned drug candidates. The company's goal is to develop transformative therapies for diseases with high unmet medical need. GlycoMimetics is headquartered in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.
Forward-Looking Statements
This press release contains forward-looking statements. These forward-looking statements may include, but are not limited to, statements regarding the conduct of and data from clinical trials; planned or potential clinical development, regulatory interactions or submissions, and pre-commercialization activities; and the potential benefits and impact of the company's drug candidates. Actual results may differ materially from those described in these forward-looking statements. For a further description of the risks associated with these statements, as well as other risks facing GlycoMimetics, please see the risk factors described in the Company's Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 29, 2023, and other filings GlycoMimetics makes with the SEC from time to time. Forward-looking statements speak only as of the date of this release, and GlycoMimetics undertakes no obligation to update or revise these statements, except as may be required by law.
Public Relations Contact:
Condensed Statements of Operations
(In thousands, except share and per share data)
Three months ended September 30, Nine months ended September 30,
2023 2022 2023 2022
(Unaudited) (Unaudited)
Revenue from collaboration and license agreements $ - $ - $ - $ 75
Costs and expenses:
Research and development expense $ 5,292 $ 4,923 14,783 22,500
General and administrative expense 4,522 3,845 14,901 14,356
Total costs and expenses 9,814 8,768 29,684 36,856
Loss from operations (9,814) (8,768) (29,684) (36,781)
Interest income 611 244 1,864 336
Net loss and comprehensive loss $ (9,203) $ (8,524) $ (27,820) $ (36,445)
Net loss per common share - basic and diluted $ (0.14) $ (0.16) $ (0.44) $ (0.70)
Weighted-average common shares outstanding - basic and diluted 64,349,709 52,423,944 62,992,006 52,387,561
September 30, December 31,
2023 2022
(unaudited)
Cash and cash equivalents $ 49,408 $ 47,871
Working capital 45,619 41,834
Total assets 53,201 51,811
Total liabilities 6,653 8,881
Total stockholders' equity 46,548 42,930

Frequently Asked Questions

What financial results did GlycoMimetics report for Q3 2023?

GlycoMimetics reported a net loss of $9.2 million and cash equivalents of $49.4 million.

What is uproleselan used for?

Uproleselan is an investigational E-selectin antagonist for treating relapsed/refractory AML.

What is GMI-1687's primary focus in development?

GMI-1687 is primarily focused on treating sickle cell disease and its complications.

When are pivotal results for uproleselan expected?

Topline results for uproleselan's Phase 3 study are expected by the end of Q2 2024.

What notable designations has uproleselan received?

Uproleselan has received FDA Breakthrough Therapy and Fast Track designations.

Last updated: Nov 3, 2023