- \n
- \nPivotal Phase 3 study of uproleselan combined with cytarabine-based chemotherapy in relapsed\/refractory (R\/R) acute myeloid leukemia (AML) continues to be projected to reach final survival event trigger within first half of 2024<\/p>\n<\/li>\n
- \nCash and cash equivalents expected to fund current operations into late 4th<\/sup> quarter of 2024<\/p>\n<\/li>\n
- \nConference call and webcast today at 8:30 a.m. ET<\/p>\n<\/li>\n<\/ul>\n
ROCKVILLE, Md.–(BUSINESS WIRE<\/a>)–
\nGlycoMimetics, 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 first quarter ended March 31, 2023. Cash and cash equivalents as of March 31, 2023 were $65.0 million.<\/p>\n\n\u201cThanks to the outstanding work of our team preparing the clinical trial database and evaluating the data from the recent interim utility analysis of our Phase 3 study of uproleselan in R\/R AML, GlycoMimetics is well positioned to expeditiously complete final trial analysis following the final survival events trigger, which is projected to occur within the first half of 2024,\u201d said Harout Semerjian, Chief Executive Officer of GlycoMimetics. \u201cWe are optimistic and excited about the potential of uproleselan to improve overall survival in R\/R AML and are fully focused on delivering on the potential of this important first-in-class therapy for patients in need of new, more effective treatment options.\u201d<\/p>\n
Operational Highlights<\/b><\/p>\n
Uproleselan<\/b><\/p>\n
- \n
- \nIn February 2023, GlycoMimetics announced that the independent Data Monitoring Committee for its ongoing Phase 3 trial of uproleselan in R\/R AML had conducted an interim utility analysis (IA) and subsequently recommended the study should continue to the originally planned final overall survival events trigger. A statistical plan to add an IA to the Phase 3 study was cleared with the FDA in the fourth quarter of 2022, which enabled the DMC to review efficacy data from that study at around 80% of planned survival events. The IA utilized a very conservative threshold to preserve the statistical integrity of the originally planned final overall survival analysis. The overall survival events trigger is projected to occur within the first half of 2024.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nThe NCI Alliance for Clinical Trials in Oncology will conduct a planned interim analysis of event-free survival in 267 patients randomized to its Phase 2\/3 clinical trial evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy. When available, the company will share these interim analysis results.<\/p>\n<\/li>\n<\/ul>\n
First Quarter 2023 Financial Results:<\/span><\/b><\/p>\n
- \n
- \nCash position: As of March 31, 2023, GlycoMimetics had cash and cash equivalents of $65.0 million as compared to $47.9 million as of December 31, 2022. During the quarter the Company raised $28.7 million dollars from sales of shares of common stock under its existing ATM facility.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nR&D Expenses: The Company\u2019s research and development expenses decreased to $5.4 million for the quarter ended March 31, 2023, as compared to $9.6 million for the same period in 2022. The decreased expenses were primarily due to lower clinical trial and development costs related to our global Phase 3 clinical trial of uproleselan in individuals with relapsed\/refractory AML, which completed enrollment in November 2021.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nG&A Expenses: The Company\u2019s general and administrative expenses increased to $5.5 million for the quarter ended March 31, 2023, as compared to $5.1 million for the same period in 2022, primarily due to commercial readiness expenses for uproleselan and additional patent fees.<\/p>\n<\/li>\n<\/ul>\n
- \n
- \nShares Outstanding: Shares of common stock outstanding as of March 31, 2023, were 64,245,224.<\/p>\n<\/li>\n<\/ul>\n
\nThe Company will host a conference call and webcast today at 8:30 a.m. ET. To access the call by phone, please go to this registration link<\/a> and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.<\/p>\n
\n
\n \n \n \n \nGlycoMimetics, Inc.<\/p>\n<\/td>\n
\n <\/tr>\n \n \n \n \n \nCondensed Statements of Operations<\/p>\n<\/td>\n
\n <\/tr>\n \n \n \n \n \n(In thousands, except share and per share data)<\/p>\n<\/td>\n
\n <\/tr>\n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \nThree months ended March 31,<\/p>\n<\/td>\n
\n <\/tr>\n \n \n \n \n \n2023<\/p>\n<\/td>\n
\n \n \n2022<\/p>\n<\/td>\n
\n <\/tr>\n \n \n \n \n \n(Unaudited)<\/p>\n<\/td>\n
\n <\/tr>\n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Revenue from collaboration and license agreements<\/td>\n \n \n \n$<\/p>\n<\/td>\n
\n \n–<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n–<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n <\/tr>\n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Cost and expenses:<\/td>\n \n \n \n \n \n <\/tr>\n \n Research and development expense<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n5,419<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n9,604<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n <\/tr>\n \n General and administrative expense<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n5,522<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n5,056<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n <\/tr>\n \n Total costs and expenses<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n10,941<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n14,660<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n <\/tr>\n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Loss from operations<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(10,941<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n(14,660<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n <\/tr>\n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Other income<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n582<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n7<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n <\/tr>\n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Net loss and comprehensive loss<\/td>\n \n \n \n$<\/p>\n<\/td>\n
\n \n(10,359<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(14,653<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n <\/tr>\n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Net loss per share – basic and diluted<\/td>\n \n \n \n$<\/p>\n<\/td>\n
\n \n(0.17<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n(0.28<\/p>\n<\/td>\n
\n \n)<\/p>\n<\/td>\n
\n <\/tr>\n \n Weighted-average common shares outstanding \u2013 basic and diluted<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n60,350,127<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n52,331,391<\/p>\n<\/td>\n
\n \n\u00a0<\/p>\n<\/td>\n
\n <\/tr>\n<\/table>\n \n
\n \n \n \n \nGlycoMimetics, Inc.<\/p>\n<\/td>\n
<\/tr>\n \n \n \n \n \nBalance Sheet Data<\/p>\n<\/td>\n
<\/tr>\n \n \n \n \n \n(In thousands)<\/p>\n<\/td>\n
<\/tr>\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n \n \n \n \nMarch 31,<\/p>\n<\/td>\n
\n \n \nDecember 31,<\/p>\n<\/td>\n
<\/tr>\n \n \n \n \n \n2023<\/p>\n<\/td>\n
\n \n \n2022<\/p>\n<\/td>\n
<\/tr>\n \n \n \n (unaudited)<\/td>\n \n \n <\/tr>\n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Cash and cash equivalents<\/td>\n \n \n \n$<\/p>\n<\/td>\n
\n \n65,002<\/p>\n<\/td>\n
\n \n \n$<\/p>\n<\/td>\n
\n \n47,871<\/p>\n<\/td>\n
<\/tr>\n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Working capital<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n61,346<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n41,834<\/p>\n<\/td>\n
<\/tr>\n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Total assets<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n68,922<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n51,811<\/p>\n<\/td>\n
<\/tr>\n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Total liabilities<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n6,740<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n8,881<\/p>\n<\/td>\n
<\/tr>\n \n \n \n \n \n \n \u00a0<\/td>\n<\/tr>\n \n Stockholders’ equity<\/td>\n \n \n \n\u00a0<\/p>\n<\/td>\n
\n \n62,181<\/p>\n<\/td>\n
\n \n \n\u00a0<\/p>\n<\/td>\n
\n \n42,930<\/p>\n<\/td>\n
<\/tr>\n<\/table>\n \n\u00a0<\/p>\n
<\/p>\n
View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20230503005074\/en\/<\/a><\/span><\/p>\n
Investor:
\n<\/span><\/b>
Argot Partners
\n
Leo Vartorella
\n
212-600-1902
\n
Glycomimetics@argotpartners.com
\n<\/a><\/p>\nPublic Relations:
\n<\/b>
Eliza Schleifstein
\n
G. Stone Connections, LLC
\n
917-763-8106<\/p>\nKEYWORDS:<\/b> Maryland United States North America<\/p>\n
INDUSTRY KEYWORDS:<\/b> Health Other Science Research Pharmaceutical Science Biotechnology<\/p>\n
- \nShares Outstanding: Shares of common stock outstanding as of March 31, 2023, were 64,245,224.<\/p>\n<\/li>\n<\/ul>\n
- \nG&A Expenses: The Company\u2019s general and administrative expenses increased to $5.5 million for the quarter ended March 31, 2023, as compared to $5.1 million for the same period in 2022, primarily due to commercial readiness expenses for uproleselan and additional patent fees.<\/p>\n<\/li>\n<\/ul>\n
- \nR&D Expenses: The Company\u2019s research and development expenses decreased to $5.4 million for the quarter ended March 31, 2023, as compared to $9.6 million for the same period in 2022. The decreased expenses were primarily due to lower clinical trial and development costs related to our global Phase 3 clinical trial of uproleselan in individuals with relapsed\/refractory AML, which completed enrollment in November 2021.<\/p>\n<\/li>\n<\/ul>\n
- \nCash position: As of March 31, 2023, GlycoMimetics had cash and cash equivalents of $65.0 million as compared to $47.9 million as of December 31, 2022. During the quarter the Company raised $28.7 million dollars from sales of shares of common stock under its existing ATM facility.<\/p>\n<\/li>\n<\/ul>\n
- \nThe NCI Alliance for Clinical Trials in Oncology will conduct a planned interim analysis of event-free survival in 267 patients randomized to its Phase 2\/3 clinical trial evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy. When available, the company will share these interim analysis results.<\/p>\n<\/li>\n<\/ul>\n
- \nConference call and webcast today at 8:30 a.m. ET<\/p>\n<\/li>\n<\/ul>\n
![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20230503005074\/en\/1780787\/3\/Logo-Glyco_%28002%29.jpg\"){kind=logo}
<\/td>\n<\/tr>\n