Full Press Release Details
GlycoMimetics Reports Highlights and Financial Results for Second Quarter 2023
ROCKVILLE, Md.--(BUSINESS WIRE) - August 2, 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 second quarter ended June 30, 2023. Cash and cash equivalents as of June 30, 2023 were $58.0 million.
"With the addition of a time-based analysis option to our pivotal Phase 3 study, we look forward to reporting topline uproleselan results in R/R AML by the end of Q2 2024. This readout will draw from a clinically mature dataset with more than three years of median follow-up and can potentially bring us closer to delivering this therapy to patients in need of new treatment options," said Harout Semerjian, Chief Executive Officer of GlycoMimetics. "We continue to execute our broad development strategy for uproleselan while we explore potential benefit in AML patients of all ages as evidenced by the FDA agreement on the pediatric study plan as well as the NCI sponsored, and investigator initiated pediatric studies. In addition to these advances, we are excited to expand our clinical pipeline and move GMI-1687, a novel, highly potent E-selectin antagonist into first-in-human studies. We look forward to initiating our Phase 1a study in the coming weeks."
Operational Highlights
Second 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 Phase 3 development program in acute myeloid leukemia (AML), has received Breakthrough Therapy and Fast Track designations from the U.S. 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. It is a second-generation compound that has potential application in inflammatory diseases with initial focus on 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. The administration of GMI-1687 via subcutaneous injection, if this treatment method is successfully developed in the clinic, may enable the drug to address certain 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, with the goal of developing 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 plans and submissions, 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.
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Condensed Statements of Operations
(In thousands, except share and per share data)
| Three months ended June 30, 2023 | Six months ended June 30, 2023 | |||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||
| (Unaudited) | (Unaudited) | |||||||||||
| Revenue from collaboration and license agreements | $ | - | $ | 75 | $ | - | $ | 75 | ||||
| Costs and expenses: | ||||||||||||
| Research and development expense | $ | 4,073 | $ | 7,973 | 9,491 | 17,577 | ||||||
| General and administrative expense | 4,857 | 5,455 | 10,380 | 10,511 | ||||||||
| Total costs and expenses | 8,930 | 13,428 | 19,871 | 28,088 | ||||||||
| Loss from operations | (8,930) | (13,353) | (19,871) | (28,013) | ||||||||
| Interest income | 671 | 86 | 1,253 | 93 | ||||||||
| Net loss and comprehensive loss | $ | (8,259) | $ | (13,267) | $ | (18,618) | $ | (27,920) | ||||
| Net loss per common share - basic and diluted | $ | (0.13) | $ | (0.25) | $ | (0.30) | $ | (0.53) | ||||
| Weighted-average common shares outstanding - basic and diluted | 64,276,184 | 52,407,347 | 62,313,155 | 52,369,369 |
| June 30, | December 31, | |||||
| 2023 | 2022 | |||||
| (unaudited) | ||||||
| Cash and cash equivalents | $ | 58,037 | $ | 47,871 | ||
| Working capital | 53,797 | 41,834 | ||||
| Total assets | 61,822 | 51,811 | ||||
| Total liabilities | 7,021 | 8,881 | ||||
| Total stockholders' equity | 54,801 | 42,930 |