Full Press Release Details
GLYCOMIMETICS REPORTS HIGHLIGHTS AND FINANCIAL RESULTS FOR
ROCKVILLE, Md. - November 6, 2020 - GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial results for the third quarter ended September 30, 2020, and highlighted recent company events. Cash and cash equivalents at September 30, 2020 were $142.9 million.
"During the third quarter, both late-stage trials of uproleselan - the Company-sponsored Phase 3 trial in relapsed/refractory AML patients as well as the NCI's study in newly-diagnosed AML patients fit for chemotherapy - progressed in the face of the COVID-19 pandemic, thanks in significant part to the dedicated efforts of clinicians, statisticians and sites. We continue to project completion of enrollment in our own Phase 3 trial in the second half of 2021," said Rachel King, Chief Executive Officer. "In sickle cell disease, new post hoc analyses of the rivipansel Phase 3 study provide additional perspective on the potential of our targeted E-selectin product candidates in early vaso-occlusive crisis. We have presented findings at multiple sickle cell congresses, and at the upcoming ASH meeting, we plan to share key secondary endpoint, subgroup and subset data. We believe these data provide a foundation for our ongoing evaluation of potential opportunities in our pipeline for the treatment of acute vaso-occlusive crisis, or VOC."
Operational Highlights
Third Quarter 2020 Financial Results:
The Company will host a conference call and webcast today at 8:30 a.m. ET. The conference call will be broadcast live in listen-only mode on the "Investors" tab of the Company's website at https://ir.glycomimetics.com/investor-relations. For those who wish to ask questions, 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 3073766. 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 3073766.
About Uproleselan (GMI-1271)
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 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.
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. After the Phase 3 RESET trial conducted by Pfizer, GlycoMimetics' former collaborator, did not meet its primary or key secondary efficacy endpoints in 2019, new efficacy data from a post hoc analysis of rivipansel were published in June 2020 and subsequently presented at the Foundation for Sickle Cell Disease Research Meeting in September 2020. GlycoMimetics is engaging with the FDA to identify what, if any, next steps to take, with a focus on determining if there is a potential streamlined path forward for this asset in sickle cell disease.
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. At the 2018 Annual Meeting of the American Society of Hematology, data presented in a poster about GMI-1687 pointed to the potential for a life-cycle extension for GlycoMimetics' uproleselan. The investigational drug has also been shown to represent a more highly-potent and subcutaneously bioavailable potential life-cycle extension for rivipansel.
About GlycoMimetics, Inc.
GlycoMimetics is a biotechnology company with two late-stage clinical development programs 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 a Company-sponsored Phase 3 trial in relapsed/refractory AML under Breakthrough Therapy designation. Rivipansel, a pan-selectin antagonist, is
being explored for use in treatment of acute VOC in sickle cell disease. GlycoMimetics has also completed a Phase 1 clinical trial with another wholly-owned drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist. 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, including expectations with regard to the enrollment of patients in its ongoing Phase 3 clinical trial of uproleselan and the Company's engagement with regulatory authorities, as well as the presentation of 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 February 28, 2020, 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 September 30, | Nine months ended September 30, | ||||||||||||
| 2020 | 2019 | 2020 | 2019 | ||||||||||
| (Unaudited) | (Unaudited) | ||||||||||||
| Revenue | $ | 1,000 | $ | - | $ | 10,000 | $ | - | |||||
| Costs and expenses: | |||||||||||||
| Research and development expense | 10,670 | 10,724 | 33,209 | 35,562 | |||||||||
| General and administrative expense | 4,058 | 3,381 | 12,732 | 10,492 | |||||||||
| Total costs and expenses | 14,728 | 14,105 | 45,941 | 46,054 | |||||||||
| Loss from operations | (13,728) | (14,105) | (35,941) | (46,054) | |||||||||
| Interest income | 5 | 853 | 477 | 2,888 | |||||||||
| Net loss and comprehensive loss | $ | (13,723) | $ | (13,252) | $ | (35,464) | $ | (43,166) | |||||
| Net loss per common share - basic and diluted | $ | (0.29) | $ | (0.31) | $ | (0.79) | $ | (1.00) | |||||
| Weighted-average common shares - basic and diluted | 47,511,818 | 43,295,397 | 44,962,886 | 43,215,125 |
| September 30, | December 31, | ||||||
| 2020 | 2019 | ||||||
| (unaudited) | |||||||
| Cash and cash equivalents | $ | 142,870 | $ | 158,201 | |||
| Working capital | 135,825 | 151,577 | |||||
| Total assets | 150,419 | 167,970 | |||||
| Total liabilities | 12,153 | 13,769 | |||||
| Total stockholders' equity | 138,266 | 154,201 |