ROCKVILLE, Md. / Mar 29, 2023 / Business Wire / 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 quarter and year ended December 31, 2022. Cash and cash equivalents as of December 31, 2022 were $47.9 million. After year-end, the company raised an additional $28.7 million in net proceeds from its “at-the-market” (ATM) sales facility.
“In 2022, we made great strides in our continued organizational evolution, strengthening our leadership team and financial position as we aspire to become a commercial-stage company capable of delivering uproleselan to R/R AML patients in need of innovative new treatment options,” said Harout Semerjian, Chief Executive Officer of GlycoMimetics. “Patients continue to live longer in our pivotal Phase 3 study of uproleselan, with duration of median follow-up for the blinded, pooled patient population now at a remarkable 25 months. Our Phase 3 AML trial projects to have the longest duration of median follow-up at time of primary analysis of any study, to our knowledge, previously conducted in this disease area. We remain optimistic and excited about the potential of uproleselan to improve overall survival in R/R AML.”
Operational Highlights
Uproleselan
GMI-1687
Corporate Update
Fourth Quarter and Year-end 2022 Financial Results:
Research and development expenses for the year ended December 31, 2022, decreased to $28.4 million as compared to $47.5 million in the prior year. The decrease in expenses was due to lower clinical development expenses related to the company’s ongoing global Phase 3 clinical trial of uproleselan, decreased manufacturing costs and decreased IND enabling activities related to GMI-1687.
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.
About Uproleselan
Discovered and developed by GlycoMimetics, uproleselan is an investigational first-in-class, E-selectin antagonist. Uproleselan (yoo’ pro le’se lan), currently in a comprehensive Phase 3 development program in acute myeloid leukemia (AML), has received Breakthrough Therapy designation from the U.S. FDA and 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 via NF-kB signaling. Uproleselan intends to provide a novel approach to disrupting established mechanisms of leukemic cell resistance.
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 with high unmet needs. The Company’s science is based on an understanding of the role that carbohydrates play in cell recognition and its specialized chemistry platform to discover small molecule drugs, known as glycomimetics, which alter carbohydrate-mediated recognition in diverse disease states, including cancer 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 need. GlycoMimetics is headquartered in Rockville, MD in the BioHealth Capital Region. Learn more atwww.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 submissions and commercialization activities, potential benefits and impact of the Company’s drug candidates, and the Company’s expected cash runway. 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.
GlycoMimetics, Inc. | ||||||||||||
Condensed Statements of Operations | ||||||||||||
(In thousands, except share and per share data) | ||||||||||||
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| Three months ended December 31, |
| Year ended December 31, | ||||||||
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| 2022 |
| 2021 |
| 2022 |
| 2021 | ||||
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| (Unaudited) |
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Revenue from collaboration and license agreements |
| $ | — |
| $ | 18 |
| $ | 75 |
| $ | 1,160 |
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Costs and expenses: |
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Research and development expense |
|
| 5,891 |
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| 12,896 |
|
| 28,391 |
|
| 47,492 |
General and administrative expense |
|
| 4,732 |
|
| 4,548 |
|
| 19,087 |
|
| 17,115 |
Total costs and expenses |
|
| 10,623 |
|
| 17,444 |
|
| 47,478 |
|
| 64,607 |
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Loss from operations |
|
| (10,623) |
|
| (17,426) |
|
| (47,403) |
|
| (63,447) |
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Interest income |
|
| 378 |
|
| 4 |
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| 715 |
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| 20 |
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Net loss and comprehensive loss |
| $ | (10,245) |
| $ | (17,422) |
| $ | (46,688) |
| $ | (63,427) |
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Net loss per common share – basic and diluted |
| $ | (0.19) |
| $ | (0.33) |
| $ | (0.89) |
| $ | (1.23) |
Weighted-average common shares outstanding – basic and diluted |
|
| 52,962,011 |
|
| 52,011,950 |
|
| 52,531,173 |
|
| 51,453,204 |
GlycoMimetics, Inc. | ||||||
Balance Sheet Data | ||||||
(In thousands) | ||||||
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| December 31, |
| December 31, | ||
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| 2022 |
| 2021 | ||
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| ||
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Cash and cash equivalents |
| $ | 47,871 |
| $ | 90,255 |
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Working capital |
|
| 41,834 |
|
| 78,964 |
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Total assets |
|
| 51,811 |
|
| 94,347 |
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Total liabilities |
|
| 8,881 |
|
| 12,743 |
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Total stockholders' equity |
|
| 42,930 |
|
| 81,604 |
Last Trade: | US$0.22 |
Daily Change: | 0.001 0.45 |
Daily Volume: | 38,312 |
Market Cap: | US$14.390M |
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