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Share Name | Share Symbol | Market | Type |
---|---|---|---|
GlycoMimetics Inc | NASDAQ:GLYC | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.005 | 1.85% | 0.275 | 0.275 | 0.2805 | 39,761 | 13:22:37 |
GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial results for the fourth quarter and year ended December 31, 2020, and highlighted recent Company events, including several accomplishments reported to date in 2021. Cash and cash equivalents at December 31, 2020 were $137.0 million.
“During 2020, we remained on track to complete enrollment of our uproleselan pivotal trial in the second half of 2021. Uproleselan continues to have strong support from collaborators working with us in the clinical and preclinical arenas. We believe this broad-based support for uproleselan reflects confidence in our approach to establish this product candidate as a potential foundational therapy across the spectrum of AML. In addition, the Chinese regulatory authority granted Breakthrough Therapy designation for uproleselan for the treatment of relapsed/refractory AML, complementing a prior designation by the FDA. We will seek to demonstrate in both ongoing and new clinical trials that uproleselan in combination with standard treatments may both extend survival and ameliorate the severe side effects experienced by cancer patients,” commented Rachel King, Chief Executive Officer.
“December’s ASH meeting gave us an opportunity to share an in-depth understanding of the rivipansel Phase 3 and subsequent Open Label Extension (OLE) data demonstrating the key role of E-selectin and importance of early treatment in VOC. Nevertheless, based on input from the FDA with respect to rivipansel as well as input from key opinion leaders in sickle cell disease, we intend to focus development in this setting on our GMI-1687 product candidate,” she added. “We believe that development of GMI-1687 will be a better option than additional clinical work on rivipansel. This is particularly important since the care of individuals with sickle cell disease has continued to shift to the outpatient setting, a trend which has accelerated during the pandemic. As a potentially subcutaneously available compound, GMI-1687 may be ideally suited to this changing landscape, and we have, therefore, initiated IND-enabling work with the compound. Our current cash position provides a runway into the fourth quarter of 2022 and through several key milestones in the uproleselan program, based on our current plan.”
Operational Highlights
Uproleselan
GMI-1687
Rivipansel
GMI-1359
Executive Management Team
Fourth Quarter and Year-end 2020 Financial Results:
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 or (216) 562-0466 for international participants, with participant code 1034166. Participants are encouraged to connect 15 minutes in advance of the call to ensure that all callers 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, participant code 1034166.
About Uproleselan
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 NMPA 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. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed or refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better-than-expected remission rates and overall survival compared to historical controls, which have been derived from results from third-party clinical trials evaluating standard chemotherapy, as well as lower-than-expected induction-related mortality rates. Treatment in these patient populations was generally well-tolerated, with fewer than expected adverse effects.
About GMI-1687
Discovered and developed by GlycoMimetics, GMI-1687 is a highly-targeted, highly-potent E-selectin antagonist. It has been shown in preclinical studies to be bioavailable via subcutaneous administration. During 2020, data from oral presentations at major scientific conferences pointed to the potential for a self-administered drug to treat VOC of sickle cell disease. Previously, GlycoMimetics has also demonstrated in preclinical models that GMI-1687 could be a potentially self-administered drug to be used in treatment of AML. The investigational drug also represents a potential life cycle extension opportunity for uproleselan.
About Rivipansel
Rivipansel, the Company’s wholly-owned glycomimetic drug candidate that binds to all three members of the selectin family (E-, P- and L-selectin), was GlycoMimetics’ first drug candidate to enter clinical development. Rivipansel has been granted a Rare Pediatric Disease designation for treatment of sickle cell disease in patients 18 years old and younger, and has also received Orphan Drug and Fast Track designations from the FDA. GlycoMimetics is discontinuing development of rivipansel as a treatment for VOC of sickle cell disease.
About GMI-1359
GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are 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 affecting about 900 adolescents a year in the United States. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. A Phase 1b clinical study is underway in breast cancer patients and is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug’s activity. GMI-1359 has received Orphan Drug designation and Rare Pediatric Disease designation from the FDA for the treatment of osteosarcoma.
About GlycoMimetics, Inc.
GlycoMimetics is a biotechnology company with a focus in hematology-oncology and a pipeline of novel glycomimetic drugs, all designed to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics' drug candidate, uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial as a potential treatment for AML and is being evaluated across a range of patient populations including in a Company-sponsored Phase 3 trial in relapsed/refractory AML. GlycoMimetics has an ongoing Phase 1b clinical trial evaluating GMI-1359, a combined CXCR4 and E-selectin antagonist, also a wholly-owned drug candidate,. 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 of the Company’s product candidates, as well as the presentation of data from preclinical studies and clinical trials, the potential benefits and impact of the Company’s drug candidates and the Company’s expectations regarding its 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 2, 2021, 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)Three months ended December 31,
Year ended December 31,
2020
2019
2020
2019
(Unaudited)
Revenue$
163
$
-
$
10,163
$
-
Costs and expenses: Research and development expense
11,720
11,467
44,929
47,029
General and administrative expense
4,011
3,868
16,743
14,360
Total costs and expenses
15,731
15,335
61,672
61,389
Loss from operations
(15,568
)
(15,335
)
(51,509
)
(61,389
)
Interest income
5
609
482
3,497
Net loss and net comprehensive loss
$
(15,563
)
$
(14,726
)
$
(51,027
)
$
(57,892
)
Net loss per common share – basic and diluted$
(0.32
)
$
(0.34
)
$
(1.12
)
$
(1.34
)
Weighted average common shares – basic and diluted
47,995,898
43,373,753
45,721,139
43,254,782
GlycoMimetics, Inc.Balance Sheet Data(In thousands) December 31,2020 December 31,2019 Cash and cash equivalents
$
137,035
$
158,201
Working capital
125,845
151,577
Total assets
142,832
167,970
Total liabilities
14,613
13,769
Total stockholders' equity
128,219
154,201
View source version on businesswire.com: https://www.businesswire.com/news/home/20210302005336/en/
Investor Contact: Shari Annes Phone: 650-888-0902 Email: sannes@annesassociates.com
Media Contact: Jamie Lacey-Moreira Phone: 410-299-3310 Email: jamielacey@presscommpr.com
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