GLYC GlycoMimetics Inc.

2.26
+0.17  (+8%)
Previous Close 2.09
Open 2.11
52 Week Low 1.78
52 Week High 4.4
Market Cap $116,478,163
Shares 51,539,010
Float 41,569,401
Enterprise Value $-8,753,758
Volume 335,639
Av. Daily Volume 309,670
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Upcoming Catalysts

Drug Stage Catalyst Date
Uproleselan (GMI-1271) - NCI-sponsored
Acute myeloid leukemia (AML)
Phase 2/3
Phase 2/3
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Uproleselan with VENCLEXTA (Venetoclax) and VIDAZA (Azacitidine)
Acute myeloid leukemia (AML)
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
Uproleselan (GMI-1271)
Acute myeloid leukemia (AML) newly diagnosed and refractory - cancer
Phase 3
Phase 3
Phase 3 enrolment to be completed by end of 2021.
Uproleselan (GMI-1271)
Autologous Hematopoietic Cell Transplantation
Phase 2
Phase 2
Phase 2 initiation announced May 26, 2021.
GMI-1359
Hormone receptor positive metastatic breast cancer
Phase 1b
Phase 1b
Phase 1b data presented at AACR April 10, 2021.
GMI-1070 (rivipansel)
Vaso-occlusive crisis of sickle cell disease
Phase 3
Phase 3
Phase 3 data failed to meet endpoints - August 2, 2019.

Latest News

  1. GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that Chief Executive Officer Harout Semerjian will present at the upcoming H.C. Wainwright & Co 23rd Annual Global Investment Virtual Conference taking place September 13-15, 2021. The presentation will be available on the company's website at the "Investors" tab for 30 days, beginning Monday, September 13 at 7:00 a.m. EDT.

    To access the live webcast and subsequent archived recordings for the presentation, please visit the GlycoMimetics website at https://ir.glycomimetics.com/investor-relations

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia (AML), and for…

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that Chief Executive Officer Harout Semerjian will present at the upcoming H.C. Wainwright & Co 23rd Annual Global Investment Virtual Conference taking place September 13-15, 2021. The presentation will be available on the company's website at the "Investors" tab for 30 days, beginning Monday, September 13 at 7:00 a.m. EDT.

    To access the live webcast and subsequent archived recordings for the presentation, please visit the GlycoMimetics website at https://ir.glycomimetics.com/investor-relations

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia (AML), and for inflammatory diseases with high unmet need. The Company's science is based on an understanding of the role that carbohydrates play on the surface of every living cell and applying its specialized chemistry platform to discover small molecule drugs, known as glycomimetics, that alter these carbohydrate-mediated pathways in a variety of disease states, including signaling in cancer and inflammation. As a leader in this space, GlycoMimetics is leveraging this unique targeted approach to advance its pipeline of wholly owned drug candidates, with the goal of developing transformative therapies for serious diseases. The Company's lead drug candidate, uproleselan, has received Breakthrough Therapy Designation in the U.S. and China and is undergoing evaluation across a range of patient populations, including a Phase 3 trial in relapsed/refractory AML. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.

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    • Completion of enrollment is expected by year-end 2021 for the Company-sponsored Phase 3 pivotal trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML)
    • Completion of enrollment is expected by year-end 2021 for the Phase 2 portion of the NCI-sponsored Phase 2/3 registration trial evaluating uproleselan in newly diagnosed AML patients fit for chemotherapy
    • During the quarter and shortly after the quarter close, GlycoMimetics announced the initiation of three investigator-sponsored trials (ISTs) to expand the scope of its clinical research with uproleselan in AML and multiple myeloma
    • Yesterday, the Company announced that Harout Semerjian will become chief executive officer, effective August 6, to succeed
    • Completion of enrollment is expected by year-end 2021 for the Company-sponsored Phase 3 pivotal trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML)
    • Completion of enrollment is expected by year-end 2021 for the Phase 2 portion of the NCI-sponsored Phase 2/3 registration trial evaluating uproleselan in newly diagnosed AML patients fit for chemotherapy
    • During the quarter and shortly after the quarter close, GlycoMimetics announced the initiation of three investigator-sponsored trials (ISTs) to expand the scope of its clinical research with uproleselan in AML and multiple myeloma
    • Yesterday, the Company announced that Harout Semerjian will become chief executive officer, effective August 6, to succeed Rachel King, who is retiring
    • Hosting a conference call and webcast today at 8:30 a.m. ET

    GlycoMimetics, Inc. (NASDAQ:GLYC) today reported its financial results for the quarter ended June 30, 2021 and highlighted recent events. Cash and cash equivalents at June 30, 2021 were $118.9 million.

    "There are now six trials underway evaluating our lead clinical candidate, uproleselan, including three registration trials and three ISTs, which we anticipate will provide clinical data flow beginning in 2022. Importantly, recruitment rates in both our Company-sponsored Phase 3 trial and the National Cancer Institute's Phase 2 portion of the Phase 2/3 trial support our expectation that enrollment in both studies can be completed by the end of this year. The support of clinicians who are enrolling patients in our global studies, and now the new ISTs, has made it possible to broaden the scope of our uproleselan clinical research to address unmet needs in AML and beyond," commented Chief Executive Officer Rachel King.

    Operational Highlights

    Uproleselan

    • Enrollment of GlycoMimetics' pivotal Phase 3 trial in relapsed/refractory AML continued in the U.S., Canada, Australia and Europe at a steady pace throughout the second quarter of 2021. The Company continues to project that enrollment will be completed by year-end 2021.
    • The pace of enrollment in the National Cancer Institute (NCI)-sponsored Phase 2/3 registration trial, designed to evaluate the use of uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, continues to support the Company's expectation that the Phase 2 portion will complete in 2021, and allow for a subsequent interim Event-Free Survival analysis of 262 patients.
    • During the quarter and shortly after the quarter close, clinicians initiated three ISTs designed to evaluate uproleselan in AML and in bone marrow transplantation for multiple myeloma. These trials are expected to begin producing clinical data in 2022, which the Company believes will support the potential of uproleselan to be used as a foundational treatment in AML to overcome well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment and reduce adverse effects of chemotherapy.

    GMI-1359

    • In April 2021 at the American Association for Cancer Research (AACR) meeting, Duke University clinicians reported biologic activity, as demonstrated by cell mobilization, redistribution of immune subset profiles and changes in other pharmacodynamic markers, observed in the initial two patients treated in the ongoing Phase 1b study in patients with advanced breast cancer with bone metastases. The initial clinical data support the dual functionality of the compound and the potential of GMI-1359 to enhance responses to chemo and immune therapies.

    GMI-1687

    • The Company continued to advance GMI-1687 towards filing of an investigational new drug application (IND), anticipated in the first half of 2022.

    Management Transition

    • Yesterday, the Company announced that its Board of Directors has appointed Harout Semerjian as chief executive officer (CEO), effective August 6, 2021, to succeed Founding CEO Rachel King. Mrs. King, who has served as CEO since the Company's founding, has decided to retire for personal reasons and will continue her involvement with the Company through her role on the Board of Directors and serving as an advisor during a transition period. Mr. Semerjian, a seasoned executive with strong commercial oncology experience, will lead the Company as it advances its registration trials for uproleselan in AML, accelerates planning for potential commercialization, and continues to build out the Company's pipeline.

    Second Quarter 2021 Financial Results

    • Cash position: As of June 30, 2021, GlycoMimetics had cash and cash equivalents of $118.9 million as compared to $137.0 million as of December 31, 2020.
    • R&D Expenses: Research and development expenses increased to $10.2 million for the quarter ended June 30, 2021 as compared to $9.9 million for the quarter ended June 30, 2020. This increase was primarily due to an increase in clinical trial costs in our ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML.
    • G&A Expenses: General and administrative expenses were $4.2 million for the second quarter ended June 30, 2021 and 2020.
    • Shares Outstanding: Shares of common stock outstanding as of June 30, 2021 were 51,539,010.

    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 and (216) 562-0466 for international participants, with participant code 9977599. Participants are encouraged to connect 15 minutes in advance of the call to ensure they 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, with participant code 9977599.

    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 National Medical Products Administration 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-1359

    GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4, which are 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 completed a Phase 1 clinical trial in healthy volunteers, and a Phase 1b clinical study designed to enable investigators to study dose ranging and to generate initial biomarker data around the drug's activity in breast cancer patients is in progress. In the first two patients evaluated, the study showed evidence of on-target effects, immune-activation and cell mobilization. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma.

    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 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 GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia (AML), and for inflammatory diseases with high unmet need. The Company's science is based on an understanding of the role that carbohydrates play on the surface of every living cell and applying its specialized chemistry platform to discover small molecule drugs, known as glycomimetics, which alter these carbohydrate-mediated pathways in a variety of disease states, including signaling in cancer and inflammation. As a leader in this space, GlycoMimetics is leveraging this unique targeted approach to advance its pipeline 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. 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, 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 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 June 30,

    Six months ended June 30,

    2021

    2020

    2021

    2020

    (Unaudited)

    (Unaudited)

     
    Revenue

    $

    -

     

    $

    -

     

    $

    1,056

     

    $

    9,000

     

     
    Cost and expenses:
    Research and development expense

     

    10,167

     

     

    9,871

     

     

    21,315

     

     

    22,539

     

    General and administrative expense

     

    4,237

     

     

    4,235

     

     

    8,425

     

     

    8,675

     

    Total costs and expenses

     

    14,404

     

     

    14,106

     

     

    29,740

     

     

    31,214

     

     
    Loss from operations

     

    (14,404

    )

     

    (14,106

    )

     

    (28,684

    )

     

    (22,214

    )

     
    Other income

     

    5

     

     

    27

     

     

    11

     

     

    472

     

     
    Net loss and comprehensive loss

    $

    (14,399

    )

    $

    (14,079

    )

    $

    (28,673

    )

    $

    (21,742

    )

     
     
    Net loss per share - basic and diluted

    $

    (0.28

    )

    $

    (0.32

    )

    $

    (0.56

    )

    $

    (0.50

    )

    Weighted average shares - basic and diluted

     

    51,539,010

     

     

    43,801,251

     

     

    51,118,096

     

     

    43,688,420

     

     
     

    GlycoMimetics, Inc.

    Balance Sheet Data

    (In thousands)

     
     
     

    June 30,

    December 31,

    2021

    2020

    (unaudited)

     
    Cash and cash equivalents

    $

    118,854

     

    $

    137,035

     

     
    Working capital

     

    110,066

     

     

    125,845

     

     
    Total assets

     

    124,379

     

     

    142,832

     

     
    Total liabilities

     

    12,092

     

     

    14,613

     

     
    Stockholders' equity

     

    112,286

     

     

    128,219

     

     

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  2. Mrs. King, the company's founding CEO, will remain a Director and advisor to support transition

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that its Board of Directors has appointed Harout Semerjian as chief executive officer (CEO), effective August 6, 2021, to succeed retiring Founding CEO Rachel King. Mr. Semerjian, a seasoned executive with strong oncology commercialization experience, will lead the company as it advances its registrational trials on its lead clinical candidate, uproleselan, in acute myeloid leukemia (AML), accelerates planning for potential commercialization, and continues to build out the company's pipeline.

    Tim Pearson, Chairman of the Board of Directors of GlycoMimetics, said, "On behalf of the entire Board…

    Mrs. King, the company's founding CEO, will remain a Director and advisor to support transition

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that its Board of Directors has appointed Harout Semerjian as chief executive officer (CEO), effective August 6, 2021, to succeed retiring Founding CEO Rachel King. Mr. Semerjian, a seasoned executive with strong oncology commercialization experience, will lead the company as it advances its registrational trials on its lead clinical candidate, uproleselan, in acute myeloid leukemia (AML), accelerates planning for potential commercialization, and continues to build out the company's pipeline.

    Tim Pearson, Chairman of the Board of Directors of GlycoMimetics, said, "On behalf of the entire Board, I offer sincere thanks to Rachel for her leadership of GlycoMimetics and for her commitment to the company's employees and to patients who will hopefully benefit from GlycoMimetics' technology. We look forward to her continued contributions as a board member."

    Mr. Pearson continued, "Harout is ideally positioned to lead GlycoMimetics into the company's next phase of growth as we anticipate the completion of our Phase 3 trial and potential commercialization of uproleselan. He possesses the right leadership and operational skills as well as tremendous know-how from his many years at Novartis overseeing several oncology and hematology product launches and from subsequent C-level positions he has held within the industry. I am confident Harout will be an effective leader for GlycoMimetics into the future."

    Mrs. King, who has served as CEO for 18 years, has decided to retire for personal reasons and will continue her involvement with the company through her role on the Board of Directors and serving as an advisor during this transition. Mrs. King led GlycoMimetics' evolution from an early venture-backed company through its initial public offering, strategic partnerships and the advancement of two late-stage clinical candidates. She also shepherded the company's unique and productive glycochemistry platform to build a multi-faceted pipeline of drug candidates targeting key unmet needs in oncology, sickle cell disease and other indications.

    "It has been a privilege and a pleasure to lead GlycoMimetics and to work with such an extraordinary team of colleagues," said Mrs. King. "I am extremely proud of what we have collectively accomplished in the 18 years since the company was founded. When I approached the Board to let them know that I was considering retirement, I committed to do all I can to ensure a smooth transition. I look forward to working with Harout and the team as a board member to continue to advance our programs. My decision to focus on spending more time with my family seems appropriately timed as we near an opportunity to commercialize our first product candidate."

    Mr. Semerjian is a global biopharmaceutical veteran. Over the last 25 years, he acquired extensive US, European and international commercialization experience having led multiple successful hematology/oncology product launches, including preparation for the launch of midostaurin in AML. During his 16-year tenure at Novartis, Mr. Semerjian held both strategic and operational leadership roles including US Hematology franchise head. He then served as EVP, chief commercial officer at Ipsen where he was accountable for worldwide commercialization and portfolio strategy. Most recently, he briefly served as CEO of Immunomedics before its sale to Gilead Sciences, Inc.

    "I believe GlycoMimetics has exciting opportunities ahead. Uproleselan is a differentiated drug candidate already recognized by both FDA and the Chinese regulatory authority with Breakthrough Therapy Designations and the potential for significant impact across the spectrum of AML. The enthusiasm of independent investigators as well as the clinicians participating in our registration trials provides a foundation for a successful commercialization plan, should the readout and regulatory interactions prove positive. While there are just a few glycobiology-based therapeutics on the market today, the field of glycobiology is rapidly advancing and ripe with opportunity. The expertise resident in GlycoMimetics underlies my confidence in its platform's productivity. Across the pipeline, I'm seeing novel and potentially game-changing therapies," said Mr. Semerjian. "I look forward to working with the outstanding team at GlycoMimetics as we strive to make a difference in the lives of patients with cancer and other diseases."

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia (AML), and for inflammatory diseases with high unmet need. The Company's science is based on an understanding of the role that carbohydrates play on the surface of every living cell and applying its specialized chemistry platform to discover small molecule drugs, known as glycomimetics, that alter these carbohydrate-mediated pathways in a variety of disease states, including signaling in cancer and inflammation. As a leader in this space, GlycoMimetics is leveraging this unique targeted approach to advance its pipeline of wholly owned drug candidates, with the goal of developing transformative therapies for serious diseases. The Company's lead drug candidate, uproleselan, has received Breakthrough Therapy Designation in the U.S. and China and is undergoing evaluation across a range of patient populations, including a Phase 3 trial in relapsed/refractory AML. 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, and the potential benefits and impact, of the Company's product candidate, uproleselan, as well as the potential commercialization of uproleselan if it is approved. 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.

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  3. GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that it will host a conference call and webcast to report its second quarter financial results on Thursday, August 5, 2021, at 8:30 a.m. ET.

    The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 9977599. Participants are encouraged to connect 15 minutes in advance of the call to ensure they 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…

    GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that it will host a conference call and webcast to report its second quarter financial results on Thursday, August 5, 2021, at 8:30 a.m. ET.

    The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 9977599. Participants are encouraged to connect 15 minutes in advance of the call to ensure they 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, with participant code 9977599.

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia (AML), and for inflammatory diseases with high unmet need. The Company's science is based on an understanding of the role that carbohydrates play on the surface of every living cell and applying its specialized chemistry platform to discover small molecule drugs, known as glycomimetics, which alter these carbohydrate-mediated pathways in a variety of disease states, including signaling in cancer and inflammation. As a leader in this space, GlycoMimetics is leveraging this unique targeted approach to advance its pipeline of wholly owned drug candidates, with the goal of developing transformative therapies for serious diseases. The Company's lead drug candidate, uproleselan, has received Breakthrough Therapy Designation in the U.S. and China and is undergoing evaluation across a range of patient populations, including a Phase 3 trial in relapsed/refractory AML. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com.

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  4. Trial to study uproleselan combination in patients with high-risk treated secondary AML

    GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that clinicians have treated the first patient in a Phase 1b/2 study evaluating the company's lead drug candidate, uproleselan, added to cladribine plus low dose cytarabine (LDAC) in patients with treated secondary AML (ts-AML). The investigator-sponsored trial is being led by Tapan Kadia, M.D., associate professor of Leukemia at The University of Texas MD Anderson Cancer Center.

    According to Eric Feldman, M.D., GlycoMimetics' Chief Medical Officer, "Patients with treated secondary AML have an extremely poor prognosis. Despite new drug approvals in the field, subgroups of patients with limited options…

    Trial to study uproleselan combination in patients with high-risk treated secondary AML

    GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that clinicians have treated the first patient in a Phase 1b/2 study evaluating the company's lead drug candidate, uproleselan, added to cladribine plus low dose cytarabine (LDAC) in patients with treated secondary AML (ts-AML). The investigator-sponsored trial is being led by Tapan Kadia, M.D., associate professor of Leukemia at The University of Texas MD Anderson Cancer Center.

    According to Eric Feldman, M.D., GlycoMimetics' Chief Medical Officer, "Patients with treated secondary AML have an extremely poor prognosis. Despite new drug approvals in the field, subgroups of patients with limited options still exist, especially those whose disease has progressed following treatment with a hypomethylating agent. Our previous preclinical and clinical research supports the potential for these patients to benefit from the addition of uproleselan. If the new study demonstrates that targeting E-selectin with uproleselan could help to overcome resistance to other therapies, this would be a significant achievement that underscores the broad potential of our drug candidate."

    About the Phase 1b/2 Clinical Trial

    The Phase 1b/2 single-arm trial is enrolling patients 18 years or older, with a diagnosis of ts-AML who have not received therapy for their AML. Considered a distinct high-risk subset of AML with an adverse prognosis, ts-AML is defined as AML arising from a previously treated antecedent myeloid neoplasm (myelodysplastic syndrome or myeloproliferative neoplasm). Clinicians plan to enroll approximately 25 patients in the trial.

    GlycoMimetics is providing uproleselan for the investigator-sponsored trial. The study is designed to evaluate both the safety and tolerability of the combination therapy, as well as to identify a recommended Phase 2 dose of the uproleselan triple combination approach in patients with ts-AML. Among the trial's secondary objectives are efficacy assessments including overall response rate, complete response, complete response without blood count recovery, and other measures. The rate of minimal residual disease negativity will also be evaluated by flow cytometry at response. Exploratory endpoints include examination of biomarkers of response and resistance and the correlation of the expression of E-selectin ligand-forming glycosylation genes of leukemic blasts with clinical outcome.

    About Uproleselan

    Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted antagonist 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. Food and Drug Administration and the Chinese Health authority 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

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia (AML), and for inflammatory diseases with high unmet need. The Company's science is based on an understanding of the role that carbohydrates play on the surface of every living cell and applying its specialized chemistry platform to discover small molecule drugs, known as glycomimetics, that alter these carbohydrate-mediated pathways in a variety of disease states, including signaling in cancer and inflammation. As a leader in this space, GlycoMimetics is leveraging this unique targeted approach to advance its pipeline of wholly owned drug candidates, with the goal of developing transformative therapies for serious diseases. The Company's leading drug candidate, uproleselan, has received Breakthrough Therapy Designation in the U.S. and China and is undergoing evaluation across a range of patient populations, including a Phase 3 trial in relapsed/refractory AML. 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 and potential benefits and impact of the Company's drug candidate, uproleselan. 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, 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.

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