Full Press Release Details
GlycoMimetics Reports Highlights and Financial Results
for Fourth Quarter and Full Year 2021
ROCKVILLE, MD -- March 3, 2022-- GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial results and highlights for the fourth quarter and year ended December 31, 2021. Cash and cash equivalents at December 31, 2021 were $90.3 million.
"During 2021, we focused on completing enrollment of our pivotal trial evaluating uproleselan in AML. Towards the end of the year, within two weeks of each other, GlycoMimetics completed enrollment of our Phase 3 trial and the NCI completed enrollment of the Phase 2 portion of its Phase 2/3 trial. This represents a significant achievement for our entire organization, particularly during a global pandemic that has negatively impacted enrollment rates for numerous clinical studies. The top-line data from these two trials of uproleselan in AML will undoubtedly be transformative for the organization. As the survival data matures, we are actively preparing for a potential regulatory submission and subsequent commercialization of uproleselan," commented Harout Semerjian, Chief Executive Officer.
Operational Highlights
Executive Management Team
Fourth Quarter and Year-end 2021 Financial Results:
Research and development expenses for the year ended December 31, 2021 increased to $47.5 million as compared to $44.9 million in the prior year. The increase in expenses was due to higher clinical development expenses related to our ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML, increased manufacturing costs and increased IND enabling activities related to GMI-1687.
The Company will host a conference call and webcast today at 8:30 a.m. ET. The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 4048456. Participants are encouraged to connect 15 minutes in advance of the call to ensure they are able to connect. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, with participant code 4048456.
Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo' pro le' sel an), currently in a comprehensive Phase 3 development program in 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 (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment.
Discovered and developed by GlycoMimetics, GMI-1687 is a highly potent E-selectin antagonist that represents a potential life-cycle extension to uproleselan. GMI-1687 has been shown in animal models to be fully bioavailable following subcutaneous administration. As such, GMI-1687 is being positioned as a potentially self-administered drug to be used in the outpatient setting for the treatment of hematologic malignancies, such as AML and MDS, as well as inflammatory diseases such as acute vaso-occlusive crisis of sickle cell disease.
GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4 - both adhesion molecules involved in tumor trafficking and metastatic spread. Preclinical studies indicate that targeting both E-selectin and CXCR4 with a single compound could improve efficacy in the treatment of cancers that involve the bone marrow such as AML and multiple myeloma or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer, as well as in osteosarcoma, a rare pediatric tumor. GMI-1359 has received Orphan Drug designation and Rare Pediatric Disease designation from the FDA for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States.
GMI-2093 is a galectin-3 inhibitor discovered and being developed by GlycoMimetics. Available evidence indicates that the galectin-3 class may activate a variety of profibrotic factors, promote fibroblast proliferation and transformation, and mediate collagen production. Recent studies have defined key roles for galectin-3 in fibrogenesis in diverse organ systems, including liver, kidney, lung, and heart. Additionally, galectin-3 has been shown in preclinical models to be closely involved in tumor cell transformation, migration, invasion, and metastasis. GMI-2093 is being developed as a therapeutic strategy against tissue fibrosis and the treatment of certain cancers.
About GlycoMimetics, Inc.
GlycoMimetics is a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia (AML), and for inflammatory diseases with high unmet need. The Company's science is based on an understanding of the role that carbohydrates play on the surface of every living cell and applying its specialized chemistry platform to discover small molecule drugs, known as glycomimetics, which alter these carbohydrate-mediated pathways in a variety of disease states, including signaling in cancer and inflammation. As a leader in this space, GlycoMimetics is leveraging this unique targeted approach to advance its pipeline of wholly owned drug candidates, with the goal of developing transformative therapies for serious diseases. GlycoMimetics is located 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 include those relating to the planned or potential clinical development, regulatory interactions and submissions, and commercialization of the Company's product candidates, as well as the conduct of, and data from, preclinical studies and clinical trials, 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 3, 2022, 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.
Investor and Media Contact:
Email: sannes@annesassociates.com
Condensed Statements of Operations
(In thousands, except share and per share data)
| Three months ended December 31, | Year ended December 31, | |||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||
| (Unaudited) | ||||||||||||
| Revenue from collaboration and license agreements | $ | 18 | $ | 163 | $ | 1,160 | $ | 10,163 | ||||
| Costs and expenses: | ||||||||||||
| Research and development expense | 12,896 | 11,720 | 47,492 | 44,929 | ||||||||
| General and administrative expense | 4,548 | 4,011 | 17,115 | 16,743 | ||||||||
| Total costs and expenses | 17,444 | 15,731 | 64,607 | 61,672 | ||||||||
| Loss from operations | (17,426) | (15,568) | (63,447) | (51,509) | ||||||||
| Interest income | 4 | 5 | 20 | 482 | ||||||||
| Net loss and comprehensive loss | $ | (17,422) | $ | (15,563) | $ | (63,427) | $ | (51,027) | ||||
| Net loss per common share - basic and diluted | $ | (0.33) | $ | (0.32) | $ | (1.23) | $ | (1.12) | ||||
| Weighted-average common shares outstanding - basic and diluted | 52,011,950 | 47,995,898 | 51,453,294 | 45,721,139 |
| December 31, | December 31, | |||||
| 2021 | 2020 | |||||
| Cash and cash equivalents | $ | 90,255 | $ | 137,035 | ||
| Working capital | 78,964 | 125,845 | ||||
| Total assets | 94,347 | 142,832 | ||||
| Total liabilities | 12,743 | 14,613 | ||||
| Total stockholders' equity | 81,604 | 128,219 |