GlycoMimetics reports Q2 2022 financial highlights and results

ROCKVILLE, Md.–(BUSINESS THREAD)–GlycoMimetics, Inc. (Nasdaq: GLYC) today reported its financial results and highlights for the second quarter ended June 30, 2022. Cash and cash equivalents at the end of the quarter were $60.2 million.

“During the second quarter, we advanced the transformation from a research company to a commercial-focused organization and are encouraged by the continued progress of our pivotal Phase 3 trial of uproleselan in relapsed/refractory AML,” he said Harout Semerjian, CEO. . “The FDA’s clearance of the IND for GMI-1687 demonstrates our ability to create and advance innovative drug candidates into clinical development. GMI-1687 is now ideal for collaboration and we are pursuing actively a license agreement for the continued development of this new molecule in sickle cell disease.”

Operational highlights

Additional sale

GlycoMimetics continued efforts to clean data received from the 70 sites in the US, Europe, Canada and Australia that enrolled a total of 388 patients in the company’s pivotal Phase 3 trial in relapsed/refractory AML. Progress to date allows the company to share a comparison of the demographics of these 388 patients with the demographics of patients in the company’s completed Phase 2 study in terms of age, severity of AML, the rate of prior stem cell transplantation and the distribution of relapse and refraction. patients (table 1). The company has previously disclosed and will continue to update its mid-2023 projection for the global survival event trigger, with the release of top-line data results shortly thereafter. The National Cancer Institute (NCI) continues to prepare for its planned interim analysis of event-free survival of the 267 patients in its Phase 2/3 clinical trial evaluating uproleselan in newly diagnosed older adults with AML who are eligible for chemotherapy. The company intends to publicly share the outcome of the NCI analysis of the Phase 2 data. Investigator-sponsored clinical trials to evaluate the expanded indications for uproleselan continue to progress at the University of California- Davis, at Washington University in St. Louis, MD Anderson Cancer Center and the University of Michigan.

BMI-1687

In June, GlycoMimetics received FDA clearance of an IND application for the clinical development of GMI-1687 in SCD. GMI-1687 is a highly potent E-selectin antagonist initially targeted for development to treat acute vaso-occlusive crises (AVC) in SCD with the potential to address an unmet medical need. E-selectin is thought to play an important role in the cascade of events leading to clots and blockages that cause VOC in patients. Administration of GMI-1687 by subcutaneous injection may have the potential to offer a treatment option at the onset of pain crisis. The Company is actively seeking a licensing partner to continue the clinical development of this drug candidate.

Financial results for the second quarter of 2022:

Cash Position: As of June 30, 2022, GlycoMimetics had cash and cash equivalents of $60.2 million compared to $90.3 million as of December 31, 2021.

Revenue: Minimal revenue was recognized for the three months ended June 30, 2022 and 2021.

R&D Expenses: The company’s research and development expenses decreased to $8.0 million in the quarter ended June 30, 2022, compared to $10.2 million in the same period period of 2021. The decrease in expenses was primarily due to lower clinical trial and development costs related to our ongoing global Phase 3 clinical trials of uproleselan in individuals with relapsed/refractory AML, as the Patient enrollment ended in November 2021.

Company General and Administrative Expenses: The Company’s general and administrative expenses increased to $5.5 million for the quarter ended June 30, 2022, compared to $4.2 million in the first quarter of 2021, primarily due to uproleselan’s start-up business expenses.

Shares outstanding: Common shares outstanding as of June 30, 2022 were 52,423,944.

The company will host a conference call and webcast today at 8:30 a.m. ET. To access the phone call, go to this registration link and you will be provided with a dial with details. Participants are encouraged to log in 15 minutes prior to the scheduled start time.

A live webcast of the call will be available at “investors” on the GlycoMimetics website. A replay of the webcast will be available for 30 days following the call.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is a first-in-class investigational E-selectin inhibitor. Uproleselan (yoo’ pro le’sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy Designation from the US FDA and the National Medical Products Administration of China for in the treatment of adult patients with relapsed or refractory AML. illness Uproleselan is designed to block e-selectin (an adhesion molecule on bone marrow cells) from binding to cancer cells in the blood as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a potent E-selectin antagonist that has been shown in animal models to be fully bioavailable after subcutaneous administration. It is a second-generation compound that may be developed to address certain challenges of IV therapies for SCD. E-selectin is thought to play an important role in the cascade of events that lead to clots and blockages that cause pain crises in people living with SCD. Administration of GMI-1687 by subcutaneous injection may have the potential to offer a treatment option at the onset of pain crisis.

About GlycoMimetics, Inc.

GlycoMimetics is a clinical-stage biotechnology company that discovers and develops glycobiology-based therapies for cancer, including acute myeloid leukemia (AML), and for inflammatory diseases with high unmet need. The company’s science is based on understanding the role carbohydrates play on the surface of every living cell and applying its specialized chemical platform to discover small molecule drugs, known as glycomimetics, that alter these carbohydrate-mediated pathways in various disease states. , including signaling in cancer and inflammation. As a leader in this space, GlycoMimetics is leveraging this unique approach to advance its portfolio 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. More information at www.glycomimetics.com.

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 and data of clinical trials, planned or potential clinical development, regulatory interactions and submissions, and the commercialization and potential benefits and impact of drug candidates. the company Actual results may differ materially from those described in these forward-looking statements. For a more detailed description of the risks associated with these statements, as well as other risks facing GlycoMimetics, see the risk factors described in the Company’s Annual Report on Form 10-K filed with the Commission of the US 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 such statements, except as required by law.

GlycoMimetics, Inc.

Condensed statements of operations

(In thousands, except for share and per share data)

Three months ended June 30

Six months ended June 30

2022

2021

2022

2021

(Not audited)

(Not audited)

Income from collaboration and license contracts

$

75

$

$

75

$

1,056

Cost and expenses:

Research and development expenses

7,973

10,167

17,577

21,315

General and administrative expenses

5,455

4,237

10,511

8,425

Total costs and expenses

13,428

14,404

28,088

29,740

Losses from operations

(13,353

)

(14,404

)

(28,013

)

(28,684

)

Another income

86

5

93

11

Net loss and overall loss

$

(13,267

)

$

(14,399

)

$

(27,920

)

$

(28,673

)

Net loss per share: basic and diluted

$

0.25

$

(0.28

)

$

(0.53

)

$

(0.56

)

Weighted average of ordinary shares outstanding: basic and diluted

52,407,347

51,539,010

52,369,369

51,118,096

GlycoMimetics, Inc.

Balance sheet data

(in thousands)

June 30,

December 31,

2022

2021

(not audited)

Cash and cash equivalents

$

60,244

$

90,255

working capital

52,326

78,964

Total assets

65,044

94,347

Total liabilities

9,317

12,743

net worth

55,727

81,604

Table 1
Demographic data: relapsed/refractory patients

301 Study 201 Study

N=388

N=66

Age, median (range)

58 (20-75)

59 (26-84)

Refractory, n (%)

130 (33.5%)

22 (33%)

Recidivism, n (%)

258 (66.5%)

44 (67%)

Duration of previous remission ≤6 months

49 (19%)

18 (41%)

Previous therapies

HSCT

70 (18%)

12 (18%)

≥2 Induction Regimes

63 (16%)

22 (33%)

ELN risk category

adverse

40%

50%

intermediate

21%

17%

favorable

22%

11%

unknown

17%

22%

Data as of August 2022



Source link

You May Also Like

About the Author: Chaz Cutler

My name is Chasity. I love to follow the stock market and financial news!