GlycoMimetics Reports Highlights and Financial Results for Third Quarter 2023
- Topline results from pivotal Phase 3 study of uproleselan in relapsed/refractory (R/R) Acute Myeloid Leukemia (AML) on track to be reported by end of Q2 2024
- NDA filing for uproleselan anticipated by end of 2024 pending outcome of R/R AML pivotal study
- Initial results for GMI-1687 Phase 1a study expected by end of Q1 2024 with initial focus to develop highly potent E-selectin antagonist as point-of-care treatment in sickle cell disease
-
Updated independent clinical data exploring potential of uproleselan in difficult to treat subtype of AML to be presented at the
American Society of Hematology (ASH) meeting in December -
Conference call and webcast today at
8:30 a.m. ET
“We look ahead to 2024 with anticipation and excitement. Topline results for our pivotal Phase 3 study of uproleselan in relapsed/refractory AML remain on track by the end of Q2 and together with our potential NDA filing before the end of 2024 represent a transformational opportunity for patients, clinicians, and our company,” said
Operational Highlights
Uproleselan
-
In Q2,
GlycoMimetics announcedU.S. Food and Drug Administration (FDA) clearance of a protocol amendment to the company’s pivotal Phase 3 study of uproleselan for R/R AML. This amendment provides for a time-based analysis of the primary endpoint of overall survival after a defined cutoff date, if the 295 survival events of the originally planned event-driven analysis have not been observed by that date. With the addition of the time-based analysis, the company expects topline results by the end of Q2 2024.
-
The National Cancer Institute (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 (NCI protocol A041701) evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy. Enrollment of the Phase 2 portion of the study was completed in December of 2021. The company reiterates that when available, it will share these results.
-
The company agreed with the
European Medicines Agency on a Pediatric Investigational Plan (PIP), which followed the prior agreement with the FDA in Q2 2023 on an initial Pediatric Study Plan (iPSP). The PIP and iPSP each include a deferral for study completion, and a waiver for children less than 28 days of age. As part of the pediatric plans, an NCI sponsored Phase 1/2 pediatric trial is currently being conducted by the Children’s Oncology Group Pediatric Early Phase Clinical Trials Network. The Phase 1/2 dose escalation study (NCI protocol PEPN2113) evaluates the safety and preliminary activity of uproleselan plus fludarabine and high dose cytarabine in pediatric AML patients after two or more prior therapies. The first patient in the Phase 1 portion of the study has been dosed with an expected enrollment of 18 patients.
-
Updated clinical data from an investigator-initiated trial studying the use of uproleselan in combination with chemotherapy for patients with treated secondary AML has been accepted for poster presentation at the ASH Annual Meeting in December. Investigators at
MD Anderson Cancer Center are conducting the Phase 1b/2 clinical trial to evaluate safety, tolerability, and preliminary efficacy of uproleselan added to cladribine and low dose cytarabine in patients with this difficult to treat subset of AML.
GMI-1687
-
In August,
GlycoMimetics initiated a Phase 1a double-blind, single-center, randomized, placebo-controlled, sequential, single ascending dose trial in healthy adult volunteers. It is expected to enroll approximately 40 subjects. Eligible subjects will receive a single dose of GMI-1687 or placebo (6:2 ratio) via subcutaneous injection. Safety, tolerability, and pharmacokinetics of up to five dose levels (3.3, 10, 20, 40, and 80 mg) will be evaluated. GMI-1687 is a highly potent E-selectin antagonist that has potential application in inflammatory diseases with initial focus on sickle cell disease. Initial results are expected by the end of Q1 2024.
Third Quarter 2023 Financial Results:
-
Cash position: As of
September 30, 2023 ,GlycoMimetics had cash and cash equivalents of$49.4 million as compared to$47.9 million as ofDecember 31, 2022 .
-
R&D Expenses: The company’s research and development expenses increased to
$5.3 million for the quarter endedSeptember 30, 2023 , as compared to$4.9 million for the same period in 2022. The increased expenses were primarily due to the clinical development costs related to the Phase 1a trial of GMI-1687 in healthy adult volunteers, which was initiated inAugust 2023 ; the increase was partially offset by decreased personnel-related and stock-based compensation costs due to a lower number of personnel than in the prior year.
-
G&A Expenses: The company’s general and administrative expenses increased to
$4.5 million for the quarter endedSeptember 30, 2023 , as compared to$3.8 million for the same period in 2022. The increased expenses were primarily due to higher personnel-related expenses and higher professional fees as the company advances uproleselan and prepares for potential regulatory filing and commercialization.
-
Shares Outstanding: Shares of common stock outstanding as of
September 30, 2023 were 64,368,843.
The company will host a conference call and webcast today at
A live webcast of the call will be available on the “Investors” tab on the
About Uproleselan
Discovered and developed by
About GMI-1687
Discovered and developed by
About
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 interactions or submissions, and pre-commercialization activities; 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
|
|||||||||||||||||||
Condensed Statements of Operations |
|||||||||||||||||||
(In thousands, except share and per share data) |
|||||||||||||||||||
Three months ended |
Nine months ended |
||||||||||||||||||
2023 |
2022 |
2023 |
2022 |
||||||||||||||||
(Unaudited) |
(Unaudited) |
||||||||||||||||||
Revenue from collaboration and license agreements |
$ |
- |
|
$ |
- |
|
$ |
- |
|
$ |
75 |
|
|||||||
Cost and expenses: | |||||||||||||||||||
Research and development expense |
|
5,292 |
|
|
4,923 |
|
|
14,783 |
|
|
22,500 |
|
|||||||
General and administrative expense |
|
4,522 |
|
|
3,845 |
|
|
14,901 |
|
|
14,356 |
|
|||||||
Total costs and expenses |
|
9,814 |
|
|
8,768 |
|
|
29,684 |
|
|
36,856 |
|
|||||||
Loss from operations |
|
(9,814 |
) |
|
(8,768 |
) |
|
(29,684 |
) |
|
(36,781 |
) |
|||||||
Other income |
|
611 |
|
|
244 |
|
|
1,864 |
|
|
336 |
|
|||||||
Net loss and comprehensive loss |
$ |
(9,203 |
) |
$ |
(8,524 |
) |
$ |
(27,820 |
) |
$ |
(36,445 |
) |
|||||||
Net loss per share - basic and diluted |
$ |
(0.14 |
) |
$ |
(0.16 |
) |
$ |
(0.44 |
) |
$ |
(0.70 |
) |
|||||||
Weighted-average common shares outstanding – basic and diluted |
|
64,349,709 |
|
|
52,423,944 |
|
|
62,992,006 |
|
|
52,387,561 |
|
|
|||||||||
Balance Sheet Data |
|||||||||
(In thousands) |
|||||||||
2023 |
2022 |
||||||||
(unaudited) | |||||||||
Cash and cash equivalents |
$ |
49,408 |
$ |
47,871 |
|||||
Working capital |
|
45,619 |
|
41,834 |
|||||
Total assets |
|
53,201 |
|
51,811 |
|||||
Total liabilities |
|
6,653 |
|
8,881 |
|||||
Stockholders' equity |
|
46,548 |
|
42,930 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20231103647179/en/
Investor Contact:
212-600-1902
Glycomimetics@argotpartners.com
Public Relations Contact:
973-652-7927
geoff@cookgm.co
Source: