1. Manuscript highlights MRD negative rate of 69% in the relapsed/refractory patient population

    Efficacy and safety data from a Phase 1/2 clinical study of uproleselan, GlycoMimetics' lead investigational drug, were published online September 16, 2021 in the journal BLOOD. In the manuscript, scientists highlight an analysis of minimal residual disease (MRD) and report an MRD negative rate of 69 percent in trial participants with relapsed/refractory acute myeloid leukemia (AML), indicating an enhanced depth of response following addition of uproleselan to salvage therapy. The paper also confirms that uproleselan can be safely combined with an intensive salvage chemotherapy regimen without adding toxicity in both relapsed/refractory and in newly…

    Manuscript highlights MRD negative rate of 69% in the relapsed/refractory patient population

    Efficacy and safety data from a Phase 1/2 clinical study of uproleselan, GlycoMimetics' lead investigational drug, were published online September 16, 2021 in the journal BLOOD. In the manuscript, scientists highlight an analysis of minimal residual disease (MRD) and report an MRD negative rate of 69 percent in trial participants with relapsed/refractory acute myeloid leukemia (AML), indicating an enhanced depth of response following addition of uproleselan to salvage therapy. The paper also confirms that uproleselan can be safely combined with an intensive salvage chemotherapy regimen without adding toxicity in both relapsed/refractory and in newly diagnosed older AML patients and builds upon results first reported at the 2018 ASH Meeting. The paper's lead author, Daniel J. DeAngelo, M.D., Ph.D., of the Dana Farber Cancer Institute in Boston, noted that "the combination of uproleselan with a standard salvage regimen of mitoxantrone, etoposide and cytarabine (MEC) demonstrated a substantial improvement in both response rate and survival in relapsed/refractory AML patients compared to previously reported results with chemotherapy alone."

    "The results of this Phase 1/2 study demonstrate the safety and tolerability of uproleselan in combination with an intensive salvage chemotherapeutic regimen. The reported response rates and survival outcomes are superior to what has been seen with chemotherapy alone in similar relapsed/refractory AML patient populations," noted Eric J. Feldman, M.D., GlycoMimetics' Chief Medical Officer. "In particular, the MRD negative rate of 69 percent in the relapsed/refractory cohort is unprecedented in producing a high proportion of patients who underwent a successful transplant. We are confident that our ongoing Phase 3 randomized trial will confirm the efficacy seen in the Phase 1/2 study and will help to establish uproleselan in combination with intensive chemotherapy as the new standard of care in relapsed/refractory AML."

    According to Dr. DeAngelo, principal investigator of the company's ongoing Phase 3 registrational trial, "We believe that uproleselan is clearly a novel and potent inhibitor of E-selectin that has been shown in the clinic to overcome chemotherapy resistance. Should the ongoing registrational trial prove positive, we will have created a foundational paradigm shift that has the potential to significantly impact outcomes for AML patients worldwide."

    Key Data

    • MRD was assessed by multi-parametric flow cytometry in the relapsed/refractory cohort. Of the 16 evaluable patients, 11 patients (69%) were MRD negative at the end of induction. Following treatment with MEC plus the recommended Phase 2 dose (RP2D) of uproleselan, 31% of patients (17/54) underwent allogeneic hematopoietic stem cell transplant. Of the 22 patients achieving CR/CRi, 11 (50%) underwent transplant.
    • Median overall survival at the RP2D of 10 mg/kg in relapsed/refractory and newly diagnosed AML patients was 8.8 and 12.6 months, respectively.
    • The addition of uproleselan was associated with low rates of oral mucositis.
    • E-selectin-mediated drug resistance contributes to poor outcomes in patients with AML.
    • E‑selectin ligand expression on leukemic blasts was higher in patients with relapsed versus primary refractory AML, and with high-risk cytogenetics and secondary AML in newly diagnosed older patients. In the Relapsed/Refractory cohort, E‑selectin expression above 10% was associated with a higher response rate and improved survival.

    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/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 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 candidate, uproleselan, as well as the presentation of data from clinical trials and the potential benefits and impact of 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 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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  2. 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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  3. 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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  4. 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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  5. 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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  6. GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that clinicians at University of California (UC) Davis Comprehensive Cancer Center initiated dosing of the first patient in a clinical study of uproleselan combined with venetoclax and azacitidine for the treatment of older or unfit patients with treatment-naïve acute myeloid leukemia (AML). Brian A. Jonas, MD, PhD, FACP, UC Davis Division of Hematology/Oncology, is the clinical trial's principal investigator.

    According to Eric Feldman, MD, GlycoMimetics' Chief Medical Officer, "While the field has seen strong uptake on venetoclax paired with a hypomethylating agent (HMA) in the frontline unfit AML setting, the depth and durability of responses, particularly in patients with adverse risk biology…

    GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that clinicians at University of California (UC) Davis Comprehensive Cancer Center initiated dosing of the first patient in a clinical study of uproleselan combined with venetoclax and azacitidine for the treatment of older or unfit patients with treatment-naïve acute myeloid leukemia (AML). Brian A. Jonas, MD, PhD, FACP, UC Davis Division of Hematology/Oncology, is the clinical trial's principal investigator.

    According to Eric Feldman, MD, GlycoMimetics' Chief Medical Officer, "While the field has seen strong uptake on venetoclax paired with a hypomethylating agent (HMA) in the frontline unfit AML setting, the depth and durability of responses, particularly in patients with adverse risk biology, has been somewhat less than optimal. In this setting, there remains a significant unmet need, and we know that environment-mediated drug resistance (EMDR), driven by E-selectin, contributes to HMA/venetoclax resistance. If the study shows that E-selectin antagonism with uproleselan improves minimal residual disease (MRD) negative response rates, this would be an important step forward that underscores the foundational opportunities for uproleselan across the broad spectrum of patients treated for AML."

    The UC Davis Comprehensive Cancer Center study is an investigator-sponsored trial (IST) for which GlycoMimetics is providing uproleselan. Designed to evaluate the safety and efficacy of the triple combination, the study is non-randomized, open label and multi-center. The goal of the two-part trial is first to determine a recommended Phase 2 dose, and then to explore efficacy in a dose expansion cohort. Up to 31 patients will be enrolled, and a preliminary/interim readout is expected in 2022.

    At the 2020 annual meeting of the American Society of Hematology, a preclinical study of uproleselan in combination with venetoclax and the HMA azacitidine demonstrated the triple combination's potential in overcoming some of the limitations related to depth and durability of response with venetoclax/HMA alone. An oral presentation highlighted how antagonizing E-selectin with uproleselan can overcome microenvironment-mediated resistance to venetoclax/HMA therapy. In the study, the addition of uproleselan both prolonged survival of the murine model, and also promoted normal hematopeoic stem cell pro-survival signaling.

    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. FDA 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 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. 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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  7. GlycoMimetics, Inc. (NASDAQ:GLYC), today announces that Chief Executive Officer Rachel King will provide a company overview at the Jefferies 2021 Virtual Healthcare Conference. Ms. King's presentation will take place from 2:30 to 2:55 p.m. on June 3, 2021. More information is available in the Investors section of the GlycoMimetics website.

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia (AML) and breast cancer, and other inflammatory diseases with high unmet need. Our science is based on an understanding of the role that carbohydrates play on the surface of every living cell and applying our specialized chemistry…

    GlycoMimetics, Inc. (NASDAQ:GLYC), today announces that Chief Executive Officer Rachel King will provide a company overview at the Jefferies 2021 Virtual Healthcare Conference. Ms. King's presentation will take place from 2:30 to 2:55 p.m. on June 3, 2021. More information is available in the Investors section of the GlycoMimetics website.

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company discovering and developing glycobiology-based therapies for cancers, including acute myeloid leukemia (AML) and breast cancer, and other inflammatory diseases with high unmet need. Our science is based on an understanding of the role that carbohydrates play on the surface of every living cell and applying our 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, we are leveraging this unique targeted approach to advance our pipeline of wholly owned drug candidates, with the goal of developing transformative therapies for serious diseases. Our 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.

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  8. Clinicians at Washington University in St. Louis Enroll Trial's First Patient at Siteman Cancer Center

    GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that clinicians at Washington University School of Medicine in St. Louis have dosed the first patient in an investigator-sponsored trial (IST) evaluating uproleselan as a prophylactic agent to reduce gastrointestinal (GI) toxicities associated with high-dose melphalan in autologous hematopoietic cell transplantation (auto-HCT) for multiple myeloma (MM). Dr. Keith Stockerl-Goldstein, M.D., Professor of Medicine, Division of Oncology, Section of Bone Marrow Transplantation, Washington University School of Medicine, is the clinical trial's principal investigator.

    "GI side effects are the dose-limiting…

    Clinicians at Washington University in St. Louis Enroll Trial's First Patient at Siteman Cancer Center

    GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that clinicians at Washington University School of Medicine in St. Louis have dosed the first patient in an investigator-sponsored trial (IST) evaluating uproleselan as a prophylactic agent to reduce gastrointestinal (GI) toxicities associated with high-dose melphalan in autologous hematopoietic cell transplantation (auto-HCT) for multiple myeloma (MM). Dr. Keith Stockerl-Goldstein, M.D., Professor of Medicine, Division of Oncology, Section of Bone Marrow Transplantation, Washington University School of Medicine, is the clinical trial's principal investigator.

    "GI side effects are the dose-limiting toxicities of high-dose melphalan in autologous hematopoietic stem-cell transplantation. Preclinical data have demonstrated a protective effect of uproleselan against mucosal damage and, in the GlycoMimetics Phase 2 trial reported at the American Society of Hematology (ASH) meeting in 2018, uproleselan demonstrated the potential to mitigate severe mucositis in relapsed and refractory acute myeloid leukemia (AML) patients undergoing intensive chemotherapy," said Eric J. Feldman, M.D., GlycoMimetics' Chief Medical Officer. "With this background, Washington University clinicians at Siteman Cancer Center will be the first to look closely at the potential of uproleselan to attenuate GI toxicities in multiple myeloma patients undergoing transplant. If this placebo-controlled study demonstrates positive improvements, we believe it will underscore the unique properties of our compound and the potential safety benefits of adding uproleselan to a range of other standard blood cancer therapies where toxicity and durability of response are concerns."

    About the Phase 2 Study

    The study led by Washington University is a Phase 2, single-center, randomized, double-blind, and placebo-controlled IST designed to evaluate whether prophylactic uproleselan plus standard of care (SOC) compared to placebo plus SOC can reduce diarrhea severity in patients receiving high-dose melphalan conditioning in preparation for auto-HCT in MM. Clinicians will observe for oral mucositis severity and other GI toxicities as secondary endpoints. Exploratory endpoints will also assess minimal residual disease at 100 days post-HCT; soluble E-selectin levels at pre-dose and post-conditioning time points; progression free survival; and overall survival.

    Eligible patients undergoing first auto-HCT with melphalan conditioning (200mg/m2) for MM will be randomized in a 1:1 allocation to receive either prophylactic uproleselan plus SOC or placebo plus SOC. Randomization will be stratified by age ≥65 years and <65 years, due to increased frequency of GI toxicity in elderly populations. GlycoMimetics anticipates a data readout from the trial in mid-2022.

    Siteman Cancer Center, based at Barnes-Jewish Hospital and Washington University School of Medicine, is a top-ranked National Cancer Institute (NCI)-designated Comprehensive Cancer Center and recently received the NCI's highest possible rating of "Exceptional" for its research programs.

    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 breast cancer, and inflammatory diseases with high unmet need. Our science is based on an understanding of the role that carbohydrates play on the surface of every living cell and applying our 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, we are leveraging this unique targeted approach to advance our pipeline of wholly owned drug candidates, with the goal of developing transformative therapies for serious diseases. Our 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 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 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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    • GlycoMimetics continues to target year-end 2021 for completing enrollment of the Company-sponsored pivotal trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML)
    • Enrollment in the Phase 2 portion of the NCI-sponsored Phase 2/3 registration trial evaluating  uproleselan in newly diagnosed AML patients fit for chemotherapy is expected to complete by year-end 2021 and to support a subsequent interim analysis based on event-free survival
    • The Chinese heath agency granted a Breakthrough Therapy Designation for uproleselan as a treatment for relapsed or refractory AML; Apollomics, GlycoMimetics' exclusive collaborator for uproleselan in Greater China, announced dosing of the first patient in its registration
    • GlycoMimetics continues to target year-end 2021 for completing enrollment of the Company-sponsored pivotal trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML)
    • Enrollment in the Phase 2 portion of the NCI-sponsored Phase 2/3 registration trial evaluating  uproleselan in newly diagnosed AML patients fit for chemotherapy is expected to complete by year-end 2021 and to support a subsequent interim analysis based on event-free survival
    • The Chinese heath agency granted a Breakthrough Therapy Designation for uproleselan as a treatment for relapsed or refractory AML; Apollomics, GlycoMimetics' exclusive collaborator for uproleselan in Greater China, announced dosing of the first patient in its registration program
    • Company pipeline continued to advance with presentations of preclinical data at the 2021 annual meeting of the American Association for Cancer Research (AACR) as well progress in IND-enabling studies of GMI-1687
    • 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 March 31, 2021 and highlighted recent company events. Cash and cash equivalents at March 31, 2021 were $132.5 million.

    "Our recent achievements, both in our collaboration with Apollomics and in data presentations at AACR, underscore the productivity of our pipeline. Working closely with investigators, regulators and collaborators, we are seeing great enthusiasm for our lead program, uproleselan, globally. The Chinese health agency's granting of a Breakthrough Therapy Designation as well as Apollomics' announcement of dosing of the first patient in Greater China support our outlook for this drug candidate. Complementing that achievement is our work with uproleselan in the U.S., namely, continued progress on our own Phase 3 AML trial and that of the National Cancer Institute, or NCI. Finally, with a focus on the early results from our GMI-1359 proof-of-concept trial and our preclinical work in the galectin-3 space, the AACR meeting added visibility for our pipeline opportunities that have the potential to address key unmet needs in hematology and beyond," commented Rachel King, Chief Executive Officer.

    Operational Highlights

    Uproleselan

    • Enrollment of GlycoMimetics' pivotal Phase 3 trial in relapsed/refractory AML continued in the U.S., Australia and Europe at a steady pace throughout the first quarter of 2021. The Company continues to be confident that enrollment will be completed by year-end 2021.
    • The pace of enrollment in the NCI-sponsored Phase 2/3 registration trial, designed to evaluate uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, continues to support our expectation that the Phase 2 portion will complete in 2021, and allow for a subsequent interim Event-Free Survival analysis of 262 patients.
    • Apollomics, our exclusive collaborator for development and commercialization of uproleselan in Greater China, received Breakthrough Therapy Designation from the Center for Drug Evaluation of the China National Medical Products Administration in early January. In March, Apollomics reported the dosing of its first patient in a Phase 1 clinical trial that will bridge to a Phase 3 study in China.

    GMI-1359

    • In April 2021 at the AACR meeting, Duke University clinicians reported biologic activity, cell mobilization and immune activation in the first two patients treated in a proof-of-concept Phase 1b study to evaluate GMI-1359 in patients with advanced breast cancer with bone metastases. The ongoing study's data support the dual functionality of the compound.

    GMI-1687

    • The Company announced it would focus on advancing GMI-1687, designed for subcutaneous dosing, towards an Investigational New Drug Application and further development in sickle cell disease. Published preclinical data support the compound's profile as a fast-acting, subcutaneously-dosed, E-selectin inhibitor that could potentially be self-administered at the onset of a vaso-occlusive crisis to obviate the need for opioids, acute care visits and inpatient hospitalization.

    Executive Management Team

    • The Company announced the promotion of Eric Feldman, M.D., to Senior Vice President and Chief Medical Officer. Dr. Feldman, who joined the Company two years ago as Vice President, Global Clinical Development, is internationally recognized for his work in the development of new therapies for the treatment of leukemias and related bone marrow disorders.

    First Quarter 2021 Financial Results

    • Cash position: As of March 31, 2021, GlycoMimetics had cash and cash equivalents of $132.5 million as compared to $137.0 million as of December 31, 2020.
    • R&D Expenses: The Company's research and development expenses decreased to $11.2 million for the quarter ended March 31, 2021 as compared to $12.7 million for the same period in 2020 primarily due to lower clinical assay development and manufacturing expenses related to uproleselan.
    • G&A Expenses: The Company's general and administrative expenses decreased to $4.2 million for the quarter ended March 31, 2021 as compared to $4.4 million for the same period in 2020, primarily due to lower stock-based compensation expense.
    • Shares Outstanding: Shares of common stock outstanding as of March 31, 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 or (216) 562-0466 for international participants, with participant code 9891637. 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 9891637.

    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-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 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 GlycoMimetics, Inc.

    GlycoMimetics is a biotechnology company with a focus in hematology-oncology 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 in a Company-sponsored Phase 3 trial in relapsed/refractory AML. GlycoMimetics has an ongoing Phase 1b clinical trial evaluating its 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, 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 March 31,

     

     

    2021

     

    2020

     

     

    (Unaudited)

     

     

     

     

     

     

     

    Revenue

     

    $

    1,055

     

    $

    9,000

     

     

     

     

     

     

     

    Costs and expenses:

     

     

     

     

     

     

    Research and development expense

     

     

    11,147

     

     

    12,668

    General and administrative expense

     

     

    4,188

     

     

    4,440

    Total costs and expenses

     

     

    15,335

     

     

    17,108

     

     

     

     

     

     

     

    Loss from operations

     

     

    (14,280)

     

     

    (8,108)

     

     

     

     

     

     

     

    Interest income

     

     

    6

     

     

    445

     

     

     

     

     

     

     

    Net loss and comprehensive loss

     

    $

    (14,274)

     

    $

    (7,663)

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss per common share – basic and diluted

     

    $

    (0.28)

     

    $

    (0.18)

    Weighted-average common shares – basic and diluted

     

     

    50,697,183

     

     

    43,575,590

     

    GlycoMimetics, Inc.

    Balance Sheet Data

    (In thousands)

     

     

     

     

     

     

     

     

     

    March 31,

     

    December 31,

     

     

    2021

     

    2020

     

     

    (unaudited)

     

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    132,471

     

    $

    137,035

     

     

     

     

     

     

     

    Working capital

     

     

    122,867

     

     

    125,845

     

     

     

     

     

     

     

    Total assets

     

     

    138,020

     

     

    142,832

     

     

     

     

     

     

     

    Total liabilities

     

     

    12,896

     

     

    14,613

     

     

     

     

     

     

     

    Total stockholders' equity

     

     

    125,124

     

     

    128,219

     

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  9. GlycoMimetics, Inc. (NASDAQ:GLYC), today announces that it will host a conference call and webcast to report first quarter financial results on Monday, May 3, 2021, at 8:30 a.m. ET.

    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 9891637. 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…

    GlycoMimetics, Inc. (NASDAQ:GLYC), today announces that it will host a conference call and webcast to report first quarter financial results on Monday, May 3, 2021, at 8:30 a.m. ET.

    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 9891637. 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 9891637.

    About GlycoMimetics, Inc.

    GlycoMimetics is a biotechnology company with a focus in hematology-oncology 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 in 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.

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  10. - Preclinical research included in poster supports clinical findings and demonstrates enhanced immune response in metastatic breast carcinoma model

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announces that a Phase 1b trial of GMI-1359, being conducted at Duke University Cancer Center, showed evidence of on-target effects, immune-activation and cell mobilization in the initial two patients treated with the Company's dual antagonist of E-selectin and CXCR4. Dorothy Sipkins, MD, PhD, Associate Research Professor in Pharmacology and Cancer Biology at Duke University School of Medicine, will present results from the proof-of-concept clinical study as well as a separate preclinical study supporting the positive biologic findings of the Phase 1b study…

    - Preclinical research included in poster supports clinical findings and demonstrates enhanced immune response in metastatic breast carcinoma model

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announces that a Phase 1b trial of GMI-1359, being conducted at Duke University Cancer Center, showed evidence of on-target effects, immune-activation and cell mobilization in the initial two patients treated with the Company's dual antagonist of E-selectin and CXCR4. Dorothy Sipkins, MD, PhD, Associate Research Professor in Pharmacology and Cancer Biology at Duke University School of Medicine, will present results from the proof-of-concept clinical study as well as a separate preclinical study supporting the positive biologic findings of the Phase 1b study. The presentation will be made at the American Association of Cancer Research (AACR) 2021 Annual Meeting, which is being held virtually on April 10-15 and May 17-21. GMI-1359 is GlycoMimetics' novel small molecule drug candidate, a dual antagonist of E-selectin and CXCR4, designed to target tumor-microenvironment resistance to chemotherapy in cancers with bone metastases.

    The initial data from the study confirmed the dual CXCR4 and E-selectin antagonist's on-target effects. In the two patients who completed treatment, evaluations of peripheral blood showed a consistent mobilization of CD34+ hematopoietic stem and progenitor cells at doses beginning at 5 mg/kg and a reduction of plasma levels of soluble E-selectin. Furthermore, in one individual, following the administration of 7.0 mg/kg of GMI-1359, an immunophenotyping assessment of peripheral blood showed a redistribution of myeloid derived suppressor cells (MDSCs) as evidenced by increased percentages of both the monocytic and granulocytic MDSCs. In this same individual following administration of 7.0 mg/kg GMI-1359, the incidence of M1 proinflammatory macrophages increased while the M2 anti-inflammatory macrophages, often associated with tumor progression, decreased. The clinical poster concludes that GMI-1359 demonstrated an acceptable safety and tolerability profile in the patients treated to date. No dose limiting toxicities were observed following multiple dose administration up to 7 mg/kg.

    Dr. Sipkins noted, "Despite the fact that our patient numbers are very small due to COVID's impact on recruitment, we are seeing the on-target effects of antagonizing both CXCR4 and E-selectin with use of GMI-1359, and that the drug is well-tolerated at all dose levels. Our pilot immune profile analysis also suggests that the drug could have favorable effects on the tumor immune microenvironment, echoing results seen in our preclinical work."

    Dr. Sipkins will disclose preclinical evidence that it may be possible for GMI-1359 to augment immune recognition of the tumor. The data in the poster from a mouse metastatic breast carcinoma model demonstrated a reduction in the immune suppressive monocytic MDSCs at the primary tumor site and a significant increase in the CD8/Treg ratio in both the primary tumor and at the bone metastatic sites. These findings on immune cell redistributions strongly suggest the induction of a more favorable anti-tumor environment following GMI-1359 administration.

    According to Dr. Eric J. Feldman, GlycoMimetics Senior Vice President and Chief Medical Officer, "The information shared in this AACR poster provides us with important understandings upon which we expect to identify a potential indication for advancing GMI-1359 in the clinic. It suggests that this small molecule drug candidate could improve responses to therapies and potentially reduce the burden of metastatic breast cancer disease."

    In prior preclinical research supported by GlycoMimetics, Dr. Sipkins' laboratory demonstrated that E-selectin and CXCR4/SDF-1 interactions were critical for breast carcinoma cells (BCCs) invasion and retention, respectively, into bone. Moreover, they found that dormant and proliferating BCCs occupy distinct regions of the bone microenvironment, with dormant BCCs predominantly found in SDF-1 and E-selectin rich regions. These dormant BCCs are expected to be highly susceptible to GMI-1359 mobilization, suggesting a new intervention to break the foothold of dormant BC micrometastases in bone.

    Details on the GMI-1359 e-presentation at the AACR Meeting are as follows:

    Title: Development of GMI-1359, a novel agent targeting tumor-microenvironment cross-talk in bone metastatic cancer

    Presenter: Dorothy Sipkins, MD, PhD, Associate Research Professor in Pharmacology and Cancer Biology at Duke University School of Medicine

    Session: e-Presentation

    Date and Time: Saturday, April 10, 2021 (available online through Monday, June 21)

    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 is underway in breast cancer patients and is designed to enable investigators to identify study dose ranging and to generate initial biomarker data around the drug's activity. 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 GlycoMimetics, Inc.

    GlycoMimetics is a biotechnology company with a focus in hematology-oncology 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 in a Company-sponsored Phase 3 trial in relapsed/refractory AML. GlycoMimetics has an ongoing Phase 1b clinical trial evaluating its 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 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.

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  11. Study demonstrates GMI-1757's impact on immune cell infiltration and improvement of anti-PD-L1 therapeutic activity

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announces that an abstract presenting the results of a recent preclinical study on the therapeutic effects of GMI-1757, a new glycomimetic with dual antagonism to E-selectin and galectin-3, has been accepted for a poster presentation at the American Association of Cancer Research (AACR) 2021 Annual Meeting, to be held virtually on April 10-15 and May 17-21.

    The study demonstrates that GMI-1757 significantly improved anti-PD-L1 therapeutic activity in a pancreatic adenocarcinoma model. Results showed 50% partial regressions and an approximate 99% reduction of median tumor volume. Microscopic…

    Study demonstrates GMI-1757's impact on immune cell infiltration and improvement of anti-PD-L1 therapeutic activity

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announces that an abstract presenting the results of a recent preclinical study on the therapeutic effects of GMI-1757, a new glycomimetic with dual antagonism to E-selectin and galectin-3, has been accepted for a poster presentation at the American Association of Cancer Research (AACR) 2021 Annual Meeting, to be held virtually on April 10-15 and May 17-21.

    The study demonstrates that GMI-1757 significantly improved anti-PD-L1 therapeutic activity in a pancreatic adenocarcinoma model. Results showed 50% partial regressions and an approximate 99% reduction of median tumor volume. Microscopic evaluations also showed that in groups treated with GMI-1757 both the incidence and area of intratumoral fibrosis were markedly reduced. Additionally, GMI-1757 strongly increased the incidence of mononuclear cell tumor infiltration. These results suggest that the decreased intratumoral fibrotic development and increased mononuclear cell infiltration obtained with GMI-1757 created a favorable immune environment so that when combined with anti-PD-L1 it produced a more robust anti-tumor effect compared to anti-PD-L1 treatment alone. Investigations will continue on GMI-1757's impact when combined with immune modulators where fibrosis and restricted host cell infiltration negatively impact tumor response.

    GlycoMimetics Senior Vice President, Research and Chief Scientific Officer John Magnani commented, "We look forward to presenting the latest research on our novel glycomimetic compound at AACR's annual meeting. Our hope is that as this research progresses, we will move ever closer to achieving promising therapies for individuals living with forms of cancer where medical needs remain unmet."

    Details on GlycoMimetics e-presentation at the AACR Meeting are as follows:

    Title: A novel glycomimetic compound (GMI-1757) with dual functional antagonism to E-selectin and galectin-3 attenuates fibrosis, facilitates mononuclear cell infiltration and optimizes anti-PD-L1 therapeutic activity in a pancreatic adenocarcinoma model

    Presenter: William E. Fogler, Ph.D., GlycoMimetics

    Session: e-Presentation

    Date and Time: Saturday, April 10, 2021 (available online through Monday, June 21)

    About GMI-1757

    An innovative dual antagonist of E-selectin and galectin-3, GMI-1757 has shown anti-thrombotic and anti-fibrotic activity in preclinical models presented at major scientific meetings. Data suggest the compound may be able to play a role in the treatment of a variety of cancers and fibrotic conditions.

    About GlycoMimetics, Inc.

    GlycoMimetics is a biotechnology company with a focus in hematology-oncology 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 in a Company-sponsored Phase 3 trial in relapsed/refractory AML. GlycoMimetics has an ongoing Phase 1b clinical trial evaluating its 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 presentation of data from preclinical studies 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.

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  12. - Evidence of biologic activity of GMI-1359 observed in Phase 1b clinical trial interim analysis
    - Preclinical data highlight anti-tumor activity in pancreatic cancer model with GMI-1757, a novel galectin-3 antagonist

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announces that an abstract presenting the interim analysis of a Phase 1b proof-of-concept study of GMI-1359, the Company's dual antagonist of E-selectin and CXCR4, has been accepted for presentation at the American Association of Cancer Research (AACR) 2021 Annual Meeting, to be held virtually on April 10-15 and May 17-21. Preclinical studies indicate that targeting both E-selectin and CXCR4, a chemokine receptor, with a single compound could improve efficacy in the treatment of cancers…

    - Evidence of biologic activity of GMI-1359 observed in Phase 1b clinical trial interim analysis

    - Preclinical data highlight anti-tumor activity in pancreatic cancer model with GMI-1757, a novel galectin-3 antagonist

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announces that an abstract presenting the interim analysis of a Phase 1b proof-of-concept study of GMI-1359, the Company's dual antagonist of E-selectin and CXCR4, has been accepted for presentation at the American Association of Cancer Research (AACR) 2021 Annual Meeting, to be held virtually on April 10-15 and May 17-21. Preclinical studies indicate that targeting both E-selectin and CXCR4, a chemokine receptor, with a single compound could improve efficacy in the treatment of cancers that affect the bone and bone marrow, such as breast and prostate cancer. A second abstract also accepted for presentation highlights, for the first time, preclinical data in pancreatic cancer for the Company's novel dual antagonist of galectin-3 and E-selectin, GMI-1757. The latter is featured as a late-breaking abstract on the compound's impact on fibrosis, mononuclear cell infiltration, and anti-PD-L1 therapeutic activity in a pancreatic adenocarcinoma model.

    GlycoMimetics Chief Executive Officer Rachel King said, "We look forward to sharing results from two programs in our advancing portfolio at the upcoming AACR meeting, including the interim analysis of Phase 1b clinical data supporting further advancement of the GMI-1359 program. We are extremely proud to be collaborating with the Duke Cancer Institute on this important work, which we believe holds great promise in delivering a novel approach to treating cancers with bone involvement."

    Details on GlycoMimetics e-presentations at the AACR Meeting are as follows:

    Title: "Development of GMI-1359, a Novel Agent Targeting Tumor-microenvironment Cross-talk in Bone Metastatic Breast Cancer"

    Presenter: Dorothy Sipkins, M.D., Ph.D., Duke Cancer Institute

    Session: e-Presentation

    Date and Time: Saturday, April 10, 2021 (available online through Monday, June 21)

    Title: A novel glycomimetic compound (GMI-1757) with dual functional antagonism to E-selectin and galectin-3 attenuates fibrosis, facilitates mononuclear cell infiltration and optimizes anti-PD-L1 therapeutic activity in a pancreatic adenocarcinoma model

    Presenter: William E. Fogler, M.D., GlycoMimetics

    Session: e-Presentation

    Date and Time: Saturday, April 10, 2021 (available online through Monday, June 21)

    About GMI-1757

    An innovative dual antagonist of E-selectin and galectin-3, GMI-1757 was described in a poster presented at the 2018 annual meeting of the American Society of Hematology. The poster showcased the anti-thrombotic activity of the dual antagonist and suggested the compound may be able to play a role in the treatment of a variety of cancers and fibrotic conditions.

    About GMI-1359

    GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both 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 has completed a Phase 1 clinical trial in healthy volunteers. A Phase 1b clinical study is underway in breast cancer patients and is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug's activity. GMI-1359 has received Orphan Drug designation and Rare Pediatric Disease designation from the FDA for the treatment of osteosarcoma.

    About GlycoMimetics, Inc.

    GlycoMimetics is a biotechnology company with a focus in hematology-oncology 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 in a Company-sponsored Phase 3 trial in relapsed/refractory AML. GlycoMimetics has an ongoing Phase 1b clinical trial evaluating GMI-1359, a combined CXCR4 and E-selectin antagonist, also a wholly-owned drug candidate. 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.

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  13. GlycoMimetics (NASDAQ:GLYC) today announced that Apollomics has dosed the first patient in China in a Phase 1 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML). In February of this year, Apollomics initiated two Phase 1 study sites in Greater China.

    "Dosing of the first patient in Greater China is a significant accomplishment for Apollomics. Equally important is the fact that Apollomics support for uproleselan reflects a broad level of interest in our drug candidate's potential to make a real difference for AML patients. Clearly, for patients with relapsed/refractory disease, there is a huge unmet need," noted Rachel King, GlycoMimetics Chief Executive Officer…

    GlycoMimetics (NASDAQ:GLYC) today announced that Apollomics has dosed the first patient in China in a Phase 1 clinical trial of APL-106 (uproleselan injection) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML). In February of this year, Apollomics initiated two Phase 1 study sites in Greater China.

    "Dosing of the first patient in Greater China is a significant accomplishment for Apollomics. Equally important is the fact that Apollomics support for uproleselan reflects a broad level of interest in our drug candidate's potential to make a real difference for AML patients. Clearly, for patients with relapsed/refractory disease, there is a huge unmet need," noted Rachel King, GlycoMimetics Chief Executive Officer. "We believe that Apollomics' track record and leadership are particularly qualified to take this program through clinical development and on to commercialization."

    The Phase 1 clinical trial in China is a part of the Phase 1 and Phase 3 bridging clinical study of APL-106 in combination with chemotherapy in adults with relapsed or refractory AML. Its principal investigator is Professor Jianxiang Wang of the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. The primary objective of the Phase 1 trial is to study the pharmacokinetic (PK) characteristics of APL-106 in Chinese subjects with relapsed or refractory AML and to evaluate the safety and tolerability of APL-106 in combination with chemotherapy.

    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 the treatment of adult AML patients with relapsed or refractory disease. In January 2021, it was also granted Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) of the NMPA in China. 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 Apollomics, Inc.

    Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies to harness the immune system and target specific molecular pathways to eradicate cancer. The company's existing pipeline consists of several development-stage assets including novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. For more information, please visit www.apollomicsinc.com.

    About GlycoMimetics, Inc.

    GlycoMimetics is a biotechnology company with a focus in hematology-oncology 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 in a Company-sponsored Phase 3 trial in relapsed/refractory AML. GlycoMimetics has an ongoing Phase 1b clinical trial evaluating GMI-1359, a combined CXCR4 and E-selectin antagonist, also a wholly-owned drug candidate,. 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 benefit and impact of the Company's product 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 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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    • Second half of 2021 remains the target for completion of enrollment of the GlycoMimetics-sponsored pivotal Phase 3 trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML)
    • Enrollment in 2021 is expected to support a planned interim analysis based on event-free survival in the National Cancer Institute's (NCI) registration trial evaluating uproleselan in newly diagnosed AML patients over the age of 60 years and fit for chemotherapy
    • The Company announces plans to take GMI-1687 forward toward an investigational new drug (IND) filing, with acute treatment of acute vaso-occlusive crisis (VOC) in outpatient settings as one possible use. The Company discontinues development of rivipansel
    • Evidence of biologic
    • Second half of 2021 remains the target for completion of enrollment of the GlycoMimetics-sponsored pivotal Phase 3 trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML)
    • Enrollment in 2021 is expected to support a planned interim analysis based on event-free survival in the National Cancer Institute's (NCI) registration trial evaluating uproleselan in newly diagnosed AML patients over the age of 60 years and fit for chemotherapy
    • The Company announces plans to take GMI-1687 forward toward an investigational new drug (IND) filing, with acute treatment of acute vaso-occlusive crisis (VOC) in outpatient settings as one possible use. The Company discontinues development of rivipansel
    • Evidence of biologic activity in first patients treated in Phase 1b study of GMI-1359 in advanced breast cancer has been submitted to a scientific meeting for presentation
    • Hosting a conference call and webcast today at 8:30 a.m. ET

    GlycoMimetics, Inc. (NASDAQ:GLYC) today reported its financial results for the fourth quarter and year ended December 31, 2020, and highlighted recent Company events, including several accomplishments reported to date in 2021. Cash and cash equivalents at December 31, 2020 were $137.0 million.

    "During 2020, we remained on track to complete enrollment of our uproleselan pivotal trial in the second half of 2021. Uproleselan continues to have strong support from collaborators working with us in the clinical and preclinical arenas. We believe this broad-based support for uproleselan reflects confidence in our approach to establish this product candidate as a potential foundational therapy across the spectrum of AML. In addition, the Chinese regulatory authority granted Breakthrough Therapy designation for uproleselan for the treatment of relapsed/refractory AML, complementing a prior designation by the FDA. We will seek to demonstrate in both ongoing and new clinical trials that uproleselan in combination with standard treatments may both extend survival and ameliorate the severe side effects experienced by cancer patients," commented Rachel King, Chief Executive Officer.

    "December's ASH meeting gave us an opportunity to share an in-depth understanding of the rivipansel Phase 3 and subsequent Open Label Extension (OLE) data demonstrating the key role of E-selectin and importance of early treatment in VOC. Nevertheless, based on input from the FDA with respect to rivipansel as well as input from key opinion leaders in sickle cell disease, we intend to focus development in this setting on our GMI-1687 product candidate," she added. "We believe that development of GMI-1687 will be a better option than additional clinical work on rivipansel. This is particularly important since the care of individuals with sickle cell disease has continued to shift to the outpatient setting, a trend which has accelerated during the pandemic. As a potentially subcutaneously available compound, GMI-1687 may be ideally suited to this changing landscape, and we have, therefore, initiated IND-enabling work with the compound. Our current cash position provides a runway into the fourth quarter of 2022 and through several key milestones in the uproleselan program, based on our current plan."

    Operational Highlights

    Uproleselan

    • GlycoMimetics' pivotal Phase 3 trial in relapsed/refractory AML continued to enroll patients in the U.S., Australia and in Europe at a steady pace in the fourth quarter of 2020. With momentum carrying into 2021 and building further with newly added sites, the Company reiterates its projection that enrollment will be completed in the second half of 2021.
    • In parallel, the NCI-sponsored Phase 3 clinical trial, which is designed to evaluate uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, has continued to enroll patients. Based on the NCI's public disclosures, the Company anticipates the trial will achieve enrollment of the initial 262 patients necessary for the interim event-free survival assessment before the 2021 year-end.
    • Apollomics, our exclusive collaborator for development and commercialization of uproleselan in Greater China, received Breakthrough Therapy designation from the China National Medical Products Administration (NMPA) in early 2021.
    • Uproleselan was featured in December 2020 at the Annual Meeting of the American Society of Hematology (ASH), in a presentation by the MD Anderson Cancer Center Department of Leukemia. Specifically, new preclinical data were presented elucidating how inhibiting E-selectin with uproleselan overcomes microenvironment-mediated resistance to venetoclax/HMA therapy, resulting in prolonged survival. We are now working actively toward exploring this combination through an investigator-sponsored clinical trial.

    GMI-1687

    • At the Annual Scientific Conference on Sickle Cell and Thalassemia (ASCAT) meeting in October and at the ASH meeting in December, GlycoMimetics gave oral presentations on the effects of GMI-1687 in two separate preclinical models of VOC. These presentations highlighted the drug candidate's ability to prevent sickle red blood cell adherence to inflamed vasculature, inhibit vessel occlusion and restore normal blood flow within 90 minutes of administration. Suitable for subcutaneous dosing, the data support the development of GMI-1687 as a fast-acting, E-selectin inhibitor that could potentially be self-administered at the time of VOC onset to obviate the need for opioids, acute care visits and inpatient hospitalization.
    • In 2020, the Company initiated an IND-enabling program with sickle cell disease VOC as a potential lead indication.

    Rivipansel

    • GlycoMimetics completed and presented at the December ASH meeting a comprehensive review of the Phase 3 RESET data and for the first time, results of the OLE study. The analyses demonstrated that administration of rivipansel early during the cascade of VOC (within approximately 26-30 hours of the onset of VOC) resulted in statistically significant improvement on key clinical outcomes, particularly in the pediatric subgroup.
    • Today, GlycoMimetics announced that rather than continuing to focus on rivipansel, it plans to take GMI-1687 forward toward an IND, with treatment of acute VOC as one possible use.

    GMI-1359

    • The Company has observed evidence of biologic activity in the initial patients treated in a Phase 1b proof-of-concept trial. The analyses are based on pharmacodynamic biomarkers, and have been submitted for presentation at a major medical meeting.

    Executive Management Team

    • The Company announced the promotion of Eric Feldman, M.D., to Senior Vice President and Chief Medical Officer in February 2021.

    Fourth Quarter and Year-end 2020 Financial Results:

    • Cash position: As of December 31, 2020, GlycoMimetics had cash and cash equivalents of $137.0 million as compared to $158.2 million as of December 31, 2019.
    • Revenue: During the year ended December 31, 2020, the Company recognized revenue of $10.2 million, all of which was the result of payments received under our agreements with Apollomics for the development and commercialization of uproleselan and GMI-1687 in Greater China. There was no revenue recognized during the year ended December 31, 2019.
    • R&D Expenses: The Company's research and development expenses increased to $11.7 million for the quarter ended December 31, 2020 as compared to $11.5 million for the fourth quarter of 2019 due to higher clinical development expenses. Clinical expenses were higher as a result of increased number of sites and enrollment in the Company's ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML.



      Research and development expenses for the year ended December 31, 2020 decreased to $44.9 million as compared to $47.0 million in the prior year. The decrease in expenses was due to lower raw material purchases in the year ended December 31, 2020 offset by the higher clinical development expenses resulting from the increased number of sites and enrollment in the Company's ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML.
    • G&A Expenses: The Company's general and administrative expenses increased to $4.0 million for the quarter ended December 31, 2020 as compared to $3.9 million for the fourth quarter of 2019. General and administrative expenses for the year ended December 31, 2020 increased to $16.7 million as compared to $14.4 million in the prior year. These increases were due to a significant increase in the cost of directors and officers liability insurance in 2020 as compared to 2019. In addition, personnel-related and stock-based compensation expenses increased due to additional headcount, annual salary adjustments and retention bonuses. Other expenses decreased as compared to the prior year due to lower travel, meals and conference registration expenses as a result of travel restrictions due to the COVID-19 pandemic.
    • Shares Outstanding: Shares of common stock outstanding as of December 31, 2020 were 49,017,622.

    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 or (216) 562-0466 for international participants, with participant code 1034166. 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 1034166.

    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 NMPA 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-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 has also 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 Rivipansel

    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. Rivipansel has been granted a Rare Pediatric Disease designation for treatment of sickle cell disease in patients 18 years old and younger, and has also received Orphan Drug and Fast Track designations from the FDA. GlycoMimetics is discontinuing development of rivipansel as a treatment for VOC of sickle cell disease.

    About GMI-1359

    GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both 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 has completed a Phase 1 clinical trial in healthy volunteers. A Phase 1b clinical study is underway in breast cancer patients and is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug's activity. GMI-1359 has received Orphan Drug designation and Rare Pediatric Disease designation from the FDA for the treatment of osteosarcoma.

    About GlycoMimetics, Inc.

    GlycoMimetics is a biotechnology company with a focus in hematology-oncology 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 in a Company-sponsored Phase 3 trial in relapsed/refractory AML. GlycoMimetics has an ongoing Phase 1b clinical trial evaluating GMI-1359, a combined CXCR4 and E-selectin antagonist, also a wholly-owned drug candidate,. 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, the potential benefits and impact of the Company's drug candidates and the Company's expectations regarding its cash runway. 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 December 31,

     

    Year ended December 31,

     

    2020

    2019

     

    2020

    2019

     

    (Unaudited)

     
         
    Revenue  

    $

    163

     

    $

    -

     

     

    $

    10,163

     

    $

    -

     

         
    Costs and expenses:    
    Research and development expense  

     

    11,720

     

     

    11,467

     

     

     

    44,929

     

     

    47,029

     

    General and administrative expense  

     

    4,011

     

     

    3,868

     

     

     

    16,743

     

     

    14,360

     

    Total costs and expenses  

     

    15,731

     

     

    15,335

     

     

     

    61,672

     

     

    61,389

     

         
    Loss from operations  

     

    (15,568

    )

     

    (15,335

    )

     

     

    (51,509

    )

     

    (61,389

    )

         
    Interest income  

     

    5

     

     

    609

     

     

     

    482

     

     

    3,497

     

         
    Net loss and net comprehensive loss  

    $

    (15,563

    )

    $

    (14,726

    )

     

    $

    (51,027

    )

    $

    (57,892

    )

         
         
    Net loss per common share – basic and diluted  

    $

    (0.32

    )

    $

    (0.34

    )

     

    $

    (1.12

    )

    $

    (1.34

    )

    Weighted average common shares – basic and diluted  

     

    47,995,898

     

     

    43,373,753

     

     

     

    45,721,139

     

     

    43,254,782

     

         
         
      GlycoMimetics, Inc.

    Balance Sheet Data

    (In thousands)
     
         
      December 31,

    2020
    December 31,

    2019
     
         
         
    Cash and cash equivalents  

    $

    137,035

     

    $

    158,201

     

     
         
    Working capital  

     

    125,845

     

     

    151,577

     

     
         
    Total assets  

     

    142,832

     

     

    167,970

     

     
         
    Total liabilities  

     

    14,613

     

     

    13,769

     

     
         
    Total stockholders' equity  

     

    128,219

     

     

    154,201

     

     

     

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  14. GlycoMimetics, Inc. (NASDAQ:GLYC), today announces that executives from the Company plan to participate in three virtual healthcare conferences in March. More information about the presentations and panel discussions will be available on the Company's website, under the Investors tab. Details are as follows:

    Cowen 41st Annual Health Care Conference
    March 1 – March 4, 2021
    Eric Feldman, M.D., GlycoMimetics Vice President, Clinical Development, to participate in Leukemias Panel
    Wed, March 3, 2021, 11:40 a.m. – 12:40 p.m. (EST)
    Access to the panel discussion is for registered attendees only.

    H.C. Wainwright Global Life Sciences Conference
    March 9 – 10, 2021
    Rachel King, GlycoMimetics CEO, to present a corporate overview
    The presentation will…

    GlycoMimetics, Inc. (NASDAQ:GLYC), today announces that executives from the Company plan to participate in three virtual healthcare conferences in March. More information about the presentations and panel discussions will be available on the Company's website, under the Investors tab. Details are as follows:

    Cowen 41st Annual Health Care Conference

    March 1 – March 4, 2021

    Eric Feldman, M.D., GlycoMimetics Vice President, Clinical Development, to participate in Leukemias Panel

    Wed, March 3, 2021, 11:40 a.m. – 12:40 p.m. (EST)

    Access to the panel discussion is for registered attendees only.

    H.C. Wainwright Global Life Sciences Conference

    March 9 – 10, 2021

    Rachel King, GlycoMimetics CEO, to present a corporate overview

    The presentation will be available on-demand, beginning at 7 a.m. ET, March 9 through March 10. Access will be provided through the Company's website (Investors section) and archived for 90 days.

    33rd Annual Virtual Roth Conference

    March 15 – 17, 2021

    Rachel King, GlycoMimetics CEO, to present a corporate overview

    Mon, March 15, 10:00 a.m. – 12:00 p.m. (EST) in Virtual 2 (Panel: Navigating Clinical Development in Rare Hematology & Inflammatory Disease). A link to the panel session will be available in the Investors section of the GlycoMimetics website.

    About GlycoMimetics, Inc.

    GlycoMimetics is a biotechnology company with a focus in hematology-oncology 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 in 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.

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  15. GlycoMimetics, Inc. (NASDAQ:GLYC), today announces that it will host a conference call and webcast to report fourth quarter and year-end 2020 financial results on Tuesday, March 2, 2021, at 8:30 a.m. ET.

    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 1034166. 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…

    GlycoMimetics, Inc. (NASDAQ:GLYC), today announces that it will host a conference call and webcast to report fourth quarter and year-end 2020 financial results on Tuesday, March 2, 2021, at 8:30 a.m. ET.

    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 1034166. 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 1034166.

    About GlycoMimetics, Inc.

    GlycoMimetics is a biotechnology company with a focus in hematology-oncology 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 in 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.

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  16. GlycoMimetics, Inc. (NASDAQ:GLYC) today announced the promotion of Eric Feldman, M.D., to Senior Vice President and Chief Medical Officer. Dr. Feldman joined the Company in 2019 and was previously Vice President, Global Clinical Development.

    "Eric is internationally recognized for his work in the development of new therapies for the treatment of leukemias and related bone marrow disorders, and in the past two years, has established himself as a leader in our management group as well as in the trenches with our clinical operations team. Having spent his career dedicated to patients with hematologic malignancies, he is especially well positioned to lead our uproleselan program as it advances through Phase 3 clinical trials. In addition, his…

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced the promotion of Eric Feldman, M.D., to Senior Vice President and Chief Medical Officer. Dr. Feldman joined the Company in 2019 and was previously Vice President, Global Clinical Development.

    "Eric is internationally recognized for his work in the development of new therapies for the treatment of leukemias and related bone marrow disorders, and in the past two years, has established himself as a leader in our management group as well as in the trenches with our clinical operations team. Having spent his career dedicated to patients with hematologic malignancies, he is especially well positioned to lead our uproleselan program as it advances through Phase 3 clinical trials. In addition, his extensive clinical research background will serve us well as we drive forward other programs in our pipeline," said Rachel King, Chief Executive Officer.

    Before joining GlycoMimetics, Dr. Feldman served as Chief Medical Officer at Amphivena Therapeutics, Inc., focusing on breakthrough blood cancer treatments and T-cell engagement technologies, and prior to that, he oversaw the myeloid leukemia antibody-drug conjugate (ADC) program at Seattle Genetics, Inc. He has led or participated in the conduct of numerous clinical trials, several leading to U.S. Food and Drug Administration (FDA) approval. Dr. Feldman's extensive academic career includes a recent position as Professor of Medicine and Director of the Hematological Malignancies Service at Weill-Cornell/New York Presbyterian Hospital, as well as faculty positions at New York Medical College and the University of Texas, MD Anderson Cancer Center. Dr. Feldman has authored over 150 scientific articles and is a former Editor-in Chief of the journal Leukemia Research. He earned his medical degree at New York Medical College and holds a B.A. from Tulane University.

    Separately, Dr. Helen Thackray, M.D. F.A.A.P., has decided to leave the company to pursue another opportunity. She joined the company 15 years ago, and most recently served as Senior Vice President, Clinical Development and Chief Medical Officer.

    "Helen's contributions to the Company have been invaluable, leading two programs to late-stage development, and creating important relationships with clinicians all over the world. We are grateful for her years of service to GlycoMimetics and wish her well in her next endeavor," said Ms. King.

    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 and from the Chinese regulatory 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 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 GlycoMimetics, Inc.

    GlycoMimetics is a biotechnology company with a focus in hematology-oncology 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 in 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 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, its quarterly report on Form 10-Q filed with the SEC on November 6, 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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  17. FOSTER CITY, Calif. and HANGZHOU, China and GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and GlycoMimetics (NASDAQ:GLYC), today announced APL-106 (uproleselan) has been granted Breakthrough Therapy Designation (BTD) from the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for the treatment of relapsed/refractory acute myeloid leukemia (AML).

    "This Breakthrough Therapy Designation for APL-106 reinforces its potential and is an important regulatory milestone for Apollomics as we prepare to initiate our clinical development work in China for patients…

    FOSTER CITY, Calif. and HANGZHOU, China and GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, and GlycoMimetics (NASDAQ:GLYC), today announced APL-106 (uproleselan) has been granted Breakthrough Therapy Designation (BTD) from the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) for the treatment of relapsed/refractory acute myeloid leukemia (AML).

    "This Breakthrough Therapy Designation for APL-106 reinforces its potential and is an important regulatory milestone for Apollomics as we prepare to initiate our clinical development work in China for patients suffering from AML," said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. "AML is an aggressive disease and relapsed/refractory patients have an extremely poor prognosis. We look forward to initiating our Phase 3 bridging study this year and working with the CDE on a potentially accelerated clinical development program to address this important patient need."

    In September 2020, the NMPA CDE granted Investigational New Drug (IND) approval for APL-106 enabling the initiation of a Phase 1 pharmacokinetics (PK) and tolerability study and includes acceptance of a Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory AML.

    The BTD is part of the revised Drug Registration Regulation that became effective in July 2020 in China. The BTD is designed to expedite the development and review of therapies that are being developed for treatment of serious diseases for which there is no existing treatment or where preliminary evidence indicates significant advantages of the therapy over available treatment options.1

    About Uproleselan (APL-106)

    Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical-stage, potentially first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo' pro le' sel an) 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 2017, the U.S. Food and Drug Administration granted Breakthrough Therapy Designation to uproleselan for treatment of adults with relapsed or refractory AML. Apollomics licensed APL-106 from GlycoMimetics in January 2020 to develop and commercialize APL-106 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.  

    About Acute Myeloid Leukemia (AML)

    Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow. It is an aggressive disease that causes the bone marrow to produce immature cells that are unable to carry out their normal function and develop into leukemic white blood cells called myeloblasts. In the U.S., there are approximately 20,000 new cases of AML each year and a 5-year survival rate of 28.7%.2 The annual incidence of new cases of AML in China is 21,600, and relapsed/refractory AML has an extremely poor prognosis.3

    About Apollomics, Inc.

    Apollomics, Inc. is an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies to harness the immune system and target specific molecular pathways to eradicate cancer. The company's existing pipeline consists of several development-stage assets, including novel, humanized monoclonal antibodies that restore the body's immune system to recognize and kill cancer cells, and targeted therapies against uncontrolled growth signaling pathways. For more information, please visit www.apollomicsinc.com.

    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, including those relating to the planned or potential clinical development of uproleselan and engagement with regulatory authorities, as well as the potential benefits and impact of the product candidate. 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 they relate to GlycoMimetics, as well as other risks facing GlycoMimetics, please see the risk factors described in the GlycoMimetics 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.

    1China Drug Registration Regulation: http://www.gov.cn/gongbao/content/2020/content_5512563.htm

    2National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) Program

    3Yang Xiaofeng, Zhang Sufen, Zhang Qingyuan. Practical Therapeutics of Hematological Diseases[M]. Military Medical Science Press, 2008.

    Apollomics Contact Information:

      
    Investor Contact: 
    Wilson W. Cheung 
    Chief Financial Officer 
    (650) 209-4436 
    wcheung@apollomicsinc.com 
      
    China Media Contact: 
    Porda Havas International Finance Communications Group
    Kelly FungPhoenix Fung
    General ManagerAssistant Vice President
    (852) 3150 6763(852) 3150 6773
    kelly.fung@pordahavas.comphoenix.fung@pordahavas.com
      
    U.S. Media Contact: 
    Remy Bernarda 
    Corporate Communications 
    (415) 203-6386 
    remy.bernarda@apollomicsinc.com
      
    GlycoMimetics Contact Information:
      
    Investor Contact: 
    Shari Annes 
    650-888-0902 
    sannes@annesassociates.com 
      
    Media Contact: 
    Jamie Lacey-Moreira 
    410-299-3310 
    jamielacey@presscommpr.com 


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  18. Open label study demonstrated statistically significant effects of early treatment with rivipansel on time to discharge and time to discontinuation of intravenous opioids

    Benefit of early intervention with E-selectin antagonist in acute VOC now reproduced in independent, contemporaneous dataset that includes both the all-ages and pediatric populations

    Company expects to initiate Investigational New Drug-enabling work with GMI-1687 during 2021

    GlycoMimetics (NASDAQ:GLYC) today in an oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition disclosed new data reinforcing a now comprehensive set of findings that underscore the improvement of rivipansel when administered early during an acute vaso-occlusive…

    Open label study demonstrated statistically significant effects of early treatment with rivipansel on time to discharge and time to discontinuation of intravenous opioids

    Benefit of early intervention with E-selectin antagonist in acute VOC now reproduced in independent, contemporaneous dataset that includes both the all-ages and pediatric populations

    Company expects to initiate Investigational New Drug-enabling work with GMI-1687 during 2021

    GlycoMimetics (NASDAQ:GLYC) today in an oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition disclosed new data reinforcing a now comprehensive set of findings that underscore the improvement of rivipansel when administered early during an acute vaso-occlusive crisis (VOC) in individuals with sickle cell disease (SCD). The new data were part of an analysis of an Open Label Extension (OLE) trial of rivipansel, designed to evaluate real-world data on safety and efficacy in patients treated first in the RESET Phase 3 trial conducted by the company's former collaborator Pfizer. The OLE trial ran in parallel to the RESET trial and provides an independent, contemporaneous dataset for comparison of clinically meaningful efficacy outcomes with rivipansel. The data from the OLE efficacy analysis, together with more extensive data from the RESET trial post-hoc analysis previously reported, were presented at ASH by University of California Davis' Theodore Wun, M.D., Interim Vice Dean for Research, Associate Dean for Research, School of Medicine; Director, Clinical and Translational Science Center; and Chief, Division of Hematology and Oncology.

    In his oral presentation, Dr. Wun reviewed key findings from several post hoc analyses of the Phase 3 RESET trial and a subsequent pre-planned analysis of the OLE trial. Specifically, these included the achievement of statistically significant improvements in primary and key secondary endpoints, with early treatment in the pediatric subgroup as well as the all-ages treatment group and importantly, on several key secondary endpoints, including time to discharge (TTD) and time to discontinuation of IV opioids (TTDIVO).

    Dr. Wun's presentation highlighted data from the OLE trial reproducing the RESET efficacy outcomes for patients treated early with rivipansel. For the all-ages study population:

    • On duration of hospital stay, the median TTD with early rivipansel treatment in the OLE study was 80.89 hours compared to 103.97 hours with early placebo in the RESET study, a difference of nearly one day (23.08 hours). This difference achieved significance at the pre-specified 90% confidence level, with a P-value of 0.0617; and
    • On duration of IV opioid use, the median TTDIVO for early rivipansel treatment in the OLE study was 63.87 hours compared to 93.99 hours for the early placebo in the RESET study, a difference of more than one day (30.12 hours). This difference achieved significance at the pre-specified 90% confidence level, with a P-value of 0.0867.

    Dr. Wun also disclosed data for the pediatric population in the RESET trial, representing 41% of the total data set, including that:

    • Children treated with rivipansel within 30 hours of onset of VOC experienced a reduction in the primary endpoint median TTRFD by 29.3 hours (from 94.1 to 64.8 hours); and
    • Early treatment with rivipansel led to more children ready for discharge from the hospital by 24, 48, and 72 hours.

    Rachel King, GlycoMimetics' Chief Executive Officer, noted, "The OLE analysis of efficacy outcomes for early treatment with rivipansel confirms the observations made in post-hoc assessment of the RESET trial, and does so for two important, clinically meaningful endpoints. The consistency of these findings clearly supports the validity of E-selectin as a target, our product candidate's ability to hit the target, and the use of an E-selectin antagonist for treating patients early in VOC. While we fully expect that additional clinical data will be required to achieve registration for rivipansel, we plan to continue interactions with the FDA to determine the clinical and regulatory path forward prior to making any decision as to how or whether we will proceed in this acute setting. As Dr. Wun presented at ASH, there remains a need for therapy that will abrogate VOC and reduce the duration of hospitalization and opioid use. We are unaware of any late-stage clinical programs targeting the resolution of acute vaso-occlusive episodes. In sum, our data point to the potential for early administration of rivipansel to change the treatment paradigm from delayed palliation to early intervention to reduce length of hospitalization and IV opioid requirement."

    The OLE study results, presented for the first time at ASH, began in December of 2015 and treated 81 patients ages six years or older who had completed the double-blind Phase 3 RESET study. The study was designed to evaluate the safety of rivipansel as a treatment for one or more VOC events in hospitalized subjects with SCD. In this context, the OLE protocol originally included collection of data for TTD and TTDIVO analyses as part of the safety assessment. Upon completion of the post hoc analysis of the RESET trial dataset, GlycoMimetics recognized the opportunity to leverage the OLE as a contemporaneous clinical trial to confirm the RESET study early treatment efficacy findings for TTD and TTDIVO. GlycoMimetics developed and submitted a Statistical Analysis Addendum (SAA) to FDA to compare the single-arm OLE data to the RESET trial data to assess if the RESET observations were reproducible. The SAA was implemented prior to final reporting of the OLE study datasets and outcomes by Pfizer, allowing the OLE dataset to be evaluated for efficacy outcomes in a pre-planned analysis. In effect, a prospectively planned and executed OLE safety study was converted prior to final analysis by GlycoMimetics into a study including efficacy outcomes. This allowed independent confirmation of the improvements in TTD and TTDIVO observed with early rivipansel treatment in acute VOC, using a contemporaneous single-arm dataset.

    In addition to the rivipansel data, GlycoMimetics also presented preclinical data in another oral presentation at the ASH meeting showing that GMI-1687, the Company's highly potent E-selectin antagonist, was active in restoring blood flow in a mouse model of VOC when administered subcutaneously. "With data from the rivipansel program supporting targeting of E-selectin early in acute vaso-occlusive crisis, a subcutaneously administered E-selectin antagonist such as GMI-1687 could be ideally suited for self-administration by patients," Rachel King added.

    GlycoMimetics expects to initiate Investigational New Drug enabling work with GMI-1687 during 2021.

    The presentation will be available on the Company's website at www.glycomimetics.com under Scientific Publications, and Rivipansel. Details of the presentation are as follows:

    Title: Early Initiation of Treatment with Rivipansel for Acute Vaso-Occlusive Crisis in Sickle Cell Disease (SCD) Achieves Earlier Discontinuation of IV Opioids and Shorter Hospital Stay: Reset Clinical Trial Analysis (abstract #678)

    Presenter: Theodore Wun, M.D., University of California Davis, Interim Vice Dean for Research, Associate Dean for Research, School of Medicine; Director, Clinical and Translational Science Center; and Chief, Division of Hematology and Oncology.

    Session Name: 114 Hemoglobinopathies, Excluding Thalassemia—Clinical: Novel Treatments for Sickle Cell Disease

    Date and Time: Monday, December 7, 2020. 4:30 – 6:00 p.m. ET

    Presentation Time: 4:45 p.m. ET

    About Rivipansel

    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. Additional new efficacy data from an Open Label Extension trial of rivipansel were presented at the 62nd American Society of Hematology Annual Meeting and Exposition in December 2020. GlycoMimetics is engaging with the FDA to identify what, if any, next steps to take in connection with the development of rivipansel as a treatment for vaso-occlusive crisis of sickle cell disease.

    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 vaso-occlusive crisis of sickle cell disease. The investigational drug represents a potential life cycle extension opportunity for GlycoMimetics' drug candidates rivipansel and uproleselan.

    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 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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  19. GlycoMimetics exploring investigator-sponsored follow-up human studies

    Oral presentation at 62nd ASH Annual Meeting and Exposition points to potential role for uproleselan as foundational therapy in acute myeloid leukemia (AML)

    GlycoMimetics' (NASDAQ:GLYC) product candidate uproleselan — when added to a combination therapy of venetoclax and a hypomethylating agent (HMA) — was shown today in an oral presentation to break chemoresistance by dramatically and significantly reducing tumor burden as detected by circulating human AML cells after three weeks of treatment, and by significantly increasing survival (p = 0.0009) in an animal model engrafted with AML from a patient with acquired resistance to venetoclax/HMA combination therapy. The oral…

    GlycoMimetics exploring investigator-sponsored follow-up human studies

    Oral presentation at 62nd ASH Annual Meeting and Exposition points to potential role for uproleselan as foundational therapy in acute myeloid leukemia (AML)

    GlycoMimetics' (NASDAQ:GLYC) product candidate uproleselan — when added to a combination therapy of venetoclax and a hypomethylating agent (HMA) — was shown today in an oral presentation to break chemoresistance by dramatically and significantly reducing tumor burden as detected by circulating human AML cells after three weeks of treatment, and by significantly increasing survival (p = 0.0009) in an animal model engrafted with AML from a patient with acquired resistance to venetoclax/HMA combination therapy. The oral presentation made by Dr. Kyung Hee Chang, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, at the 62nd ASH Annual Meeting and Exposition supports the need for further clinical investigation to potentially extend the use of uproleselan, an investigational, first-in-class, targeted E-selectin antagonist, to other drug combinations and, in particular, to venetoclax/HMA.

    "As in previously reported models, uproleselan has shown benefit when added to multiple chemotherapy regimens. These data, showing the potential benefit of adding uproleselan to a combination therapy of venetoclax and HMA, are important given the rapid changes in the landscape of approved AML therapies as well as those in development. The data strongly support conducting a clinical trial with this combination therapy," said Rachel King, GlycoMimetics' Chief Executive Officer.

    "Given investigator interest in this data, we're actively exploring opportunities for investigator-sponsored clinical trials to study the implications in humans. If successful, these studies would further reinforce our goal of demonstrating the value of uproleselan across the spectrum of AML patients and with a variety of therapeutic combination regimens," she added.

    GlycoMimetics previously presented preclinical data showing that hypomethylating agents up-regulate the expression of E-selectin ligand on AML cells. The Company believes E-selectin upregulation increases the binding affinity of the blasts to the vascular endothelium, where E-selectin is expressed, and as a result, contributes to increased chemoresistance. By antagonizing E-selectin's role in this cascade, GlycoMimetics believes uproleselan may be able to play a key role in deepening patient responses to or enhancing the duration of efficacy of venetoclax/HMA combinations.

    Details on this presentation are as follows:

    Title: Targeting E-selectin with GMI-1271 Overcomes Microenvironment-mediated Resistance to Venetoclax/HMA Therapy.

    Presenters: Kyung Hee Chang, Muharrem Muftuoglu, Weiguo Zhang, Mahesh Basyal, Lauren Ostermann, William E. Fogler, John L. Magnani and Michael Andreeff.

    Session: 604 Molecular Pharmacology and Drug Resistance in Myeloid Diseases.

    Date and Time: Saturday, December 5, 2020. 5:00 - 8:30 p.m. ET

    Presentation Time: 6:15 p.m. ET

    About Uproleselan (GMI-1271)

    Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted E-selectin antagonist. 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.

    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 vaso-occlusive crisis 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 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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  20. GlycoMimetics, Inc. (NASDAQ:GLYC), today announces that CEO Rachel King plans to present an overview of the company at the upcoming Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17 and the Jefferies Virtual London Healthcare Conference on Thursday, November 19. Both presentations will be available on the Company's website, under the Investors tab. Details are as follows:

    Stifel 2020 Virtual Healthcare Conference
    November 16-18, 2020
    GlycoMimetics presentation: Tuesday, November 17, 8:00 a.m. (EST)

    Jefferies Virtual London Healthcare Conference
    November 17-19, 2020
    GlycoMimetics presentation: Thursday, November 19, 6:45 – 7:15 (BST)

    About GlycoMimetics, Inc.
    GlycoMimetics is a biotechnology company with two late-stage clinical…

    GlycoMimetics, Inc. (NASDAQ:GLYC), today announces that CEO Rachel King plans to present an overview of the company at the upcoming Stifel 2020 Virtual Healthcare Conference on Tuesday, November 17 and the Jefferies Virtual London Healthcare Conference on Thursday, November 19. Both presentations will be available on the Company's website, under the Investors tab. Details are as follows:

    Stifel 2020 Virtual Healthcare Conference

    November 16-18, 2020

    GlycoMimetics presentation: Tuesday, November 17, 8:00 a.m. (EST)

    Jefferies Virtual London Healthcare Conference

    November 17-19, 2020

    GlycoMimetics presentation: Thursday, November 19, 6:45 – 7:15 (BST)

    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 acute myeloid leukemia (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 SCD. 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.

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    • Enrollment in the Company-sponsored pivotal Phase 3 trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML) continues on track, and the Company reiterates its prior guidance that completion of enrollment for the Company-sponsored Phase 3 trial is expected in the second half of 2021
    • Enrollment also continues in the National Cancer Institute (NCI)-sponsored Phase 3 trial to evaluate uproleselan for newly-diagnosed AML patients fit for chemotherapy
    • Three oral presentations and two additional poster presentations at the upcoming American Society of Hematology (ASH) Annual Meeting will highlight the GlycoMimetics pipeline; multiple medical meetings in the second half of 2020 feature uproleselan and rivipansel
    • Enrollment in the Company-sponsored pivotal Phase 3 trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML) continues on track, and the Company reiterates its prior guidance that completion of enrollment for the Company-sponsored Phase 3 trial is expected in the second half of 2021
    • Enrollment also continues in the National Cancer Institute (NCI)-sponsored Phase 3 trial to evaluate uproleselan for newly-diagnosed AML patients fit for chemotherapy
    • Three oral presentations and two additional poster presentations at the upcoming American Society of Hematology (ASH) Annual Meeting will highlight the GlycoMimetics pipeline; multiple medical meetings in the second half of 2020 feature uproleselan and rivipansel
    • U.S. Food and Drug Administration (FDA) grants Company a Rare Pediatric Disease designation for rivipansel for treatment of sickle cell disease
    • Company hosting webcast and conference call this morning at 8:30 a.m. ET

    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

    Uproleselan

    • GlycoMimetics' ongoing pivotal Phase 3 trial in relapsed/refractory AML continued to activate clinical sites and enroll patients in North America, Australia and Europe. While individual sites were affected earlier in the year by the COVID-19 pandemic, in this quarter patient enrollment returned to forecasted rates.
    • GlycoMimetics reiterated its guidance that completion of enrollment for its trial was expected in the second half of 2021.
    • New preclinical studies support the use of uproleselan with venetoclax and a hypomethylating agent (HMA) in AML:
      • At the upcoming ASH meeting in December 2020, GlycoMimetics will make an oral presentation of preclinical data from a study in an AML mouse model that shows the potential benefit of a combination therapy of uproleselan with venetoclax and HMA.
      • At the virtual meeting of the Society of Hematologic Oncology (SOHO) in September 2020, GlycoMimetics presented preclinical data showing a statistically significant prolongation of survival in a patient-derived xenograft (PDX) model.

    Rivipansel

    • At the Foundation for Sickle Cell Disease Research (FSCDR) virtual meeting held in September 2020, GlycoMimetics presented for the first time new efficacy and biomarker data from the post hoc analysis of the Phase 3 RESET trial that showed statistically significant improvements for patients treated early in crisis (within 26.4 hours of onset of pain) in the primary efficacy endpoint of time to readiness for discharge compared to placebo. This primary endpoint analysis demonstrated p=0.03, and median improvement of 56.3 hours compared to placebo.
    • At the Annual Scientific Conference on Sickle Cell and Thalassaemia (ASCAT) in October 2020, a GlycoMimetics' poster highlighted new pediatric and other key secondary endpoint subset/subgroup efficacy and biomarker data from the Phase 3 RESET trial.
    • Accepted for oral presentation at the ASH meeting is an abstract also presenting pediatric and secondary endpoint data from the post hoc analysis of the Phase 3 RESET trial. These data as well as biomarker data show the potential benefits conferred when rivipansel is used to treat patients early in the VOC pain crisis.
    • FDA granted GlycoMimetics a Rare Pediatric Disease designation for rivipansel for treatment of sickle cell disease.
    • Based upon its review of the emerging Phase 3 rivipansel data set, 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 product candidate in sickle cell disease.

    GMI-1687

    • Building on clinical data for rivipansel disclosed at the FSCDR meeting in September and at ASCAT in October, GlycoMimetics also gave oral presentations at the FSCDR and ASCAT meetings reporting on preclinical data highlighting GMI-1687 in animal models of VOC. The data demonstrated its potential efficacy as a subcutaneously administered treatment for VOC to prevent sickle red blood cell adherence to inflamed vasculature, inhibit vessel occlusion and restore normal blood flow.
    • An abstract was accepted for oral presentation at the ASH meeting in December 2020 on the product candidate's potential for intravenous and subcutaneous administration to restore blood flow. A mouse model of VOC sickle cell disease will be highlighted.

    Third Quarter 2020 Financial Results:

    • Cash position: As of September 30, 2020, GlycoMimetics had cash and cash equivalents of $142.9 million as compared to $158.2 million as of December 31, 2019. During the quarter, the Company received a $1 million clinical development milestone from Apollomics pursuant to the Company's collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan.
    • R&D Expenses: The Company's research and development expenses were $10.7 million for each of the quarters ended September 30, 2020 and 2019. The Company's research and development expenses decreased to $33.2 million for the nine months ended September 30, 2020 as compared to $35.6 million for the same period in 2019. Manufacturing and formulation expenses decreased in the three and nine months ended September 30, 2020 as compared to the same periods in 2019 as a result of lower raw material costs purchased in 2020. These decreases were offset by higher clinical expenses due to the increased enrollment in the ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML and the Phase 2/3 clinical trial being conducted by the National Cancer Institute in 2020 as compared to 2019. Contract research services, consulting and other costs were lower in the three and nine months ended September 30, 2020 as research activities were affected at outside universities and travel by research and development personnel was largely eliminated due to the COVID-19 pandemic.
    • G&A Expenses: The Company's general and administrative expenses increased to $4.1 million for the third quarter ended September 30, 2020 as compared to $3.4 million for the third quarter of 2019. General and administrative expenses for the nine months ended September 30, 2020 increased to $12.7 million as compared to $10.5 million in the same period in 2019. Personnel-related expenses increased due to additional general and administrative headcount, annual salary adjustments awarded in the first quarter of 2020 and retention bonuses. Patent, legal fees, consulting and other professional expenses, including director and officer's insurance premiums, increased as compared to 2019. Other general and administrative expenses decreased for the three and nine months ended September 30, 2020, as compared to the same periods in 2019, due to lower travel, meals and conference registration expenses as a result of travel restrictions imposed during the COVID-19 pandemic.
    • Shares Outstanding: Shares of common stock outstanding as of September 30, 2020 were 47,828,831

    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.

    About Rivipansel

    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.

    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. 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.

    GlycoMimetics, Inc.

    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

     $                       -  

     
    Cost 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)

     
    Other income     

                                5

                           853

                           477

                        2,888

     
    Net loss and comprehensive loss      

     $            (13,723)

     $            (13,252)

     $            (35,464)

     $            (43,166)

     
     
    Net loss per share - basic and diluted        

     $                 (0.29)

     $                 (0.31)

     $                 (0.79)

     $                 (1.00)

    Weighted average shares - basic and diluted        

             47,511,818

             43,295,397

             44,962,886

             43,215,125

     

    GlycoMimetics, Inc.

    Balance Sheet Data

    (In thousands)

     
    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

     

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    • Data highlight the importance of early intervention with E-selectin inhibitors to disrupt inflammatory mechanisms driving acute vaso-occlusive crisis (VOC) in sickle cell disease (SCD)
    • Additional presentations highlight multiple E-selectin inhibition strategies and their potential to treat acute myeloid leukemia (AML)

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that three abstracts including data from the Company's clinical and research portfolio have been accepted for oral presentations and two abstracts have been accepted for poster presentations at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, to be held virtually December 5-8, 2020.

    Of particular note are primary and key secondary endpoint data…

    • Data highlight the importance of early intervention with E-selectin inhibitors to disrupt inflammatory mechanisms driving acute vaso-occlusive crisis (VOC) in sickle cell disease (SCD)
    • Additional presentations highlight multiple E-selectin inhibition strategies and their potential to treat acute myeloid leukemia (AML)

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that three abstracts including data from the Company's clinical and research portfolio have been accepted for oral presentations and two abstracts have been accepted for poster presentations at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, to be held virtually December 5-8, 2020.

    Of particular note are primary and key secondary endpoint data from additional analysis of the Phase 3 RESET study evaluating the efficacy of rivipansel in VOC. These findings point to the potential benefits, clinical improvements and improved outcomes associated with early treatment with GlycoMimetics' wholly-owned product candidate, which include shorter hospital stays for patients and reduced need for IV opioids to treat pain.

    A second presentation includes data from two different preclinical models of VOC using GlycoMimetics' highly potent and specific E-selectin antagonist, GMI-1687. This presentation will highlight the product candidate's potential for intravenous and subcutaneous administration to treat VOC by inhibiting occlusions and restoring blood flow.

    A third presentation discloses how targeting E-selectin with uproleselan may help patients with AML overcome resistance to venetoclax combined with hypomethylating agent (HMA) based therapy.

    Poster presentations convey how GMI-1359, a rationally-designed small molecule that inhibits E-selectin and CXCR4 (a chemokine receptor), enhances sorafenib's anti-leukemia effect in pre-clinical AML models; and how GMI-1359 can uniquely generate motility-enhancing signals in AML cells and deplete AML cells from protective vascular niches in the bone marrow.

    "GlycoMimetics is honored to have five abstracts from across our product candidate portfolio selected for presentations at this year's ASH meeting. The data convey new insights into the critical role of E-selectin in both malignant and inflammatory, adhesion-mediated conditions, suggesting novel treatment options for unmet need in sickle cell disease and AML," said Helen Thackray, MD, FAAP, GlycoMimetics' Chief Medical Officer.

    Details on GlycoMimetics presentations at the ASH Meeting are as follows:

    Title: Restoration of Normal Blood Flow in Mouse Models of Sickle Cell Vaso-occlusion Following Intravenous or Subcutaneous Administration of a Highly Potent E-Selectin Specific Inhibitor.

    Presenters: Madhan Thamilarasan, William E. Fogler, John L. Magnani and Rahima Zennadi.

    Session: 113 Hemoglobinopathies, Excluding Thalassemia—New Genetic Approaches to Sickle Cell Disease: New Insights Into Sickle Cell Disease Pathophysiology.

    Date and Time: December 5, 2020. 2:00 – 3:30 p.m. EST

    Presentation Time: 2:45 p.m.

    Title: Targeting E-selectin with GMI-1271 Overcomes Microenvironment-mediated Resistance to Venetoclax/HMA Therapy.

    Presenters: Kyung Hee Chang, Muharrem Muftuoglu, Weiguo Zhang, Mahesh Basyal, Lauren Ostermann, William E. Fogler, John L. Magnani and Michael Andreeff.

    Session: 604 Molecular Pharmacology and Drug Resistance in Myeloid Diseases.

    Date and Time: Saturday, December 5, 2020. 2:00 - 3:30 p.m.

    Presentation Time:
    3:15 p.m.

    Title: Dual CXCR4 and E-selectin Inhibition (GMI-1359) Rapidly Increases AML Cellular Motility Prior to Intravasation and Vascular Niche Depletion Observed by Intravital Bone Marrow 2-Photon Microscopy.

    Presenters: Tomasz Zal, M. Anna Zal, Mateusz Rytelewski, Kyung Hee Chang, Rodrigo Jacamo, William E. Fogler, John L. Magnani and Michael Andreeff.

    Session: 616 Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster II.

    Date: Sunday, December 6, 2020.

    Virtual Poster Hall: 7 a.m. – 3:30 p.m.

    Title: Combined Blockage of E-selectin and CXCR4 (GMI-1359) Enhances Anti-Leukemia Effect of FLT3 Inhibition (Sorafenib) and Protects Hematopoiesis in Pre-clinical AML Models.

    Presenters: Weiguo Zhang, Kyung Hee Chang, Mahesh Basyal, Yannan Jia, Lauren Ostermann, William E. Fogler, John L. Magnani, M. Anna Zal, Tomasz Zal and Michael Andreeff.

    Session: 616 Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Poster III.

    Date: Monday, December 7, 2020.

    Virtual Poster Hall: 7 a.m. – 3:30 p.m.

    Title: Early Initiation of Treatment with Rivipansel for Acute Vaso-Occlusive Crisis in Sickle Cell Disease (SCD) Achieves Earlier Discontinuation of IV Opioids and Shorter Hospital Stay: Reset Clinical Trial Analysis

    Presenter: Helen Thackray

    Session Name: 114 Hemoglobinopathies, Excluding Thalassemia—Clinical: Novel Treatments for Sickle Cell Disease

    Date and Time: Monday, December 7, 2020. 1:30 - 3:00 p.m.

    Presentation Time: 1:45 p.m.

    The accepted abstracts are available online through the ASH meeting website, https://ash.confex.com/ash/2020/webprogram/start.html

    About Rivipansel

    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 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 an additional 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.

    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. 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 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.

    About GMI-1359

    GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both 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. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The Duke University Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug's activity. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States.

    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 acute myeloid leukemia (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 SCD. 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 regarding preclinical data, clinical development and potential benefits and impact of the Company's drug candidates. These forward-looking statements include those relating to the planned or potential clinical development of the Company's product candidates, including the Company's engagement with regulatory authorities and the presentation of data from preclinical studies and clinical trials. 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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  21. GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that it will host a conference call and webcast to report its third quarter financial results on Friday, November 6, 2020, at 8:30 a.m. ET.

    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…

    GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that it will host a conference call and webcast to report its third quarter financial results on Friday, November 6, 2020, at 8:30 a.m. ET.

    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 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 SCD. 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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  22. - Data highlight the importance of early intervention with fast-acting E-selectin inhibitors to disrupt the underlying inflammatory mechanisms driving acute vaso-occlusive crisis (VOC)

    - Abstracts for two of GlycoMimetics' wholly-owned product candidates, rivipansel and GMI-1687, accepted for poster and oral presentations

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that new post hoc analyses of the Phase 3 RESET study evaluating the efficacy of rivipansel, its wholly-owned product candidate, in VOC show that pediatric patients treated with rivipansel within approximately 30 hours of the onset of acute crisis pain experienced statistically significant improvements in the primary efficacy endpoint of time to readiness for discharge (TTRFD…

    - Data highlight the importance of early intervention with fast-acting E-selectin inhibitors to disrupt the underlying inflammatory mechanisms driving acute vaso-occlusive crisis (VOC)

    - Abstracts for two of GlycoMimetics' wholly-owned product candidates, rivipansel and GMI-1687, accepted for poster and oral presentations

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that new post hoc analyses of the Phase 3 RESET study evaluating the efficacy of rivipansel, its wholly-owned product candidate, in VOC show that pediatric patients treated with rivipansel within approximately 30 hours of the onset of acute crisis pain experienced statistically significant improvements in the primary efficacy endpoint of time to readiness for discharge (TTRFD) compared to placebo as well as in two key secondary endpoints, namely time-to-discharge (TTD) and time-to-discontinuation-of-IV opioids (TTDIVO). The analyses also show that subjects treated within 26.4 hours of the onset of acute crisis pain achieved statistically significant improvements in the same endpoints. An abstract highlighting these analyses was selected for a poster presentation at the ASCAT meeting, which starts today. In addition to the rivipansel presentation, the meeting organizers also accepted for oral presentation an abstract containing data on GlycoMimetics' more selective and highly potent E-selectin antagonist, GMI-1687. The GMI-1687 abstract includes data from a preclinical model showing the drug candidate's potential as a subcutaneously, self-administered treatment for VOC. The British Society of Haematology (BSH) and the European Hematology Association co-sponsored virtual ASCAT meeting that runs through October 31, 2020.

    "The important data published today provide further support for the potential benefits of treatment with rivipansel early in the course of VOC, as observed in sickle cell patients in the RESET trial – both in the total patient population as well as in the pediatric subgroup. In addition to highlighting the importance of treating individuals early in the course of their acute painful crisis, these new findings confirm the critical role of E-selectin in acute vaso-occlusion and the opportunity to resolve that occlusion and pain with effective intervention," said Helen Thackray, MD, FAAP, GlycoMimetics' Chief Medical Officer.

    "The favorable safety profile of rivipansel observed in the Phase 3 RESET trial, as evaluated in a population with pediatric, adolescent, and adult patients, is highly encouraging to us. We are engaging in discussions with the FDA to determine what, if any, next steps could be taken to carry this program forward in acute VOC, either in pediatrics or in the overall population. This treatment setting remains an area of unmet medical need, as there are no drugs approved nor currently in late-stage development for acute intervention," she added.

    The rivipansel abstract includes data from a supportive analysis of the Phase 3 RESET trial of 345 patients (ranging in age from six years to adults, with a mean age of 22 years) who were experiencing acute VOC requiring hospitalization for treatment. The new data demonstrate that early rivipansel treatment conferred clinically meaningful improvements for two key secondary endpoints not previously reported: shortening IV opioid use and decreasing the hospital stay. Specifically, for the total treated patient population (n=320), rivipansel treatment within 26.4 hours of pain onset (earliest quartile of duration of VOC until treatment) reduced:

    • median TTD by 41.5 hours (from 112.8 to 71.3 hours; p=0.02), and
    • median TTDIVO by 50.5 hours (from 104.0 to 53.5 hours; p=0.03) vs. placebo.

    In addition, newly scheduled for presentation at this meeting are data for the pediatric subgroup, who make up a large proportion (41%) of patients treated in the RESET trial. Namely, data from children 6-17 years old in the study who were treated within 30 hours of VOC onset show:

    • a reduction in median TTRFD by 29.3 hours (p=0.02),
    • a reduction in median TTD by 23.2 hours (p=0.02),
    • a reduction in median TTDIVO by 15.4 hours (p=0.045), and
    • more children ready for discharge by 24, 48 and 72 hours, compared to placebo.

    The abstract also features key findings previously reported at the Foundation for Sickle Cell Research (FSCDR) meeting in September, 2020. Specifically, the analysis shows that patients treated with rivipansel early in their acute VOC pain episode experienced a statistically significant reduced median on the primary efficacy endpoint, TTRFD (p=0.03, median improvement was 56.3 hours). This endpoint reflects achievement of multiple clinical criteria assessing healthcare utilization and a patient's medical improvement prior to leaving the hospital. Specifically, rivipansel treatment within 26.4 hours of pain onset (earliest quartile of duration of VOC until treatment) reduced median TTRFD by 56.3 hours (from 122.0 to 65.7 hours), reduced median TTD by 41.5 hours (from 112.8 to 71.3 hours), and reduced median TTDIVO by 50.5 hours (from 104.0 to 53.5 hours), compared to placebo. Furthermore, patients treated with rivipansel showed a statistically significant reduction of 59% from baseline after a loading dose in soluble E-selectin, a biomarker indicating that the drug had the intended biological effect. The effect observed on soluble E-selectin in this trial provides valuable insight into the mechanism for the improvement in the clinical criteria for discharge from the hospital observed in those patients treated early in their acute VOC. Data from the RESET trial additionally demonstrate a safety profile for rivipansel that is comparable to the placebo.

    The second abstract, accepted for oral presentation, discloses data from two different preclinical models of VOC using GlycoMimetics' highly potent and specific E-selectin antagonist, GMI-1687. These data show the drug candidate's efficacy as a subcutaneously administered treatment for VOC. Using both a human sickle cell transplantation model and the Townes mouse model, GMI-1687 was shown to prevent sickle red blood cell adherence to inflamed vasculature, inhibit vessel occlusion and restore normal blood flow. Preliminary data showing the activity of GMI-1687 for the treatment of VOC were disclosed in an oral presentation late September at the FSCDR virtual meeting.

    Details on GlycoMimetics presentations at the ASCAT Meeting are as follows:

    Title: Early Initiation of Treatment with Rivipansel for Acute Vaso-Occlusive Crisis in Sickle Cell Disease (SCD) Achieves Earlier Discontinuation of IV Opioids and Shorter Hospital Stay: RESET Clinical Trial Analysis.

    Presenter: Jay Lozier, MD, PhD, FACP, Senior Medical Director, Clinical Development

    Date: October 26, 2020

    Title: Treatment of Acute Vaso-occlusion in Mouse Models of Sickle Cell Disease Following Intravenous or Subcutaneous Administration of a Highly Potent E-selectin Specific Inhibitor

    Presenter: John Magnani, PhD, GlycoMimetics Senior Vice President, Research & Chief Scientific Officer

    Session: Sickle Cell Disease – Basic Science: Emerging Therapies

    Date and Time: October 26, 2020. 1:10 – 3:30 p.m. BST

    About Sickle Cell Disease (SCD) and VOC

    SCD is the most common inherited blood disorder in the United States, impacting approximately 100,000 people. Worldwide, approximately 100 million people carry the SCD trait and an estimated five million live with the disease. While the majority of people with SCD are of African descent, the disease can affect all ethnic groups, especially those from areas where malaria is or was endemic, such as the Middle East, India and the Southern Mediterranean. Acute pain crises or VOCs are the most common clinical manifestation of SCD. A VOC occurs when hypoxia and inflammation lead to vascular occlusion, tissue ischemia and pain.

    About Rivipansel

    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 candidate to enter clinical development. After the Phase 3 RESET trial conducted by Pfizer, GlycoMimetics' former collaborator, produced disappointing results 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 in discussions to identify what, if any, next steps to take, with a focus on determining if there is a potential streamlined path forward for this product candidate in SCD.

    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. 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 been shown to represent a more highly-potent and subcutaneously bioavailable potential life-cycle extension for rivipansel, the company's wholly-owned drug candidate being explored for the treatment of acute VOC in SCD.

    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 acute myeloid leukemia (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 SCD. 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 regarding preclinical and clinical data, clinical development and potential benefits and impact of the Company's drug candidates. These forward-looking statements include those relating to the planned or potential clinical development of the Company's product candidates, including the Company's engagement with regulatory authorities and the presentation of data from preclinical studies and clinical trials. 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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  23. GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company a Rare Pediatric Disease designation for rivipansel for the treatment of sickle cell disease in patients 18 years old and younger. This designation recognizes the significant needs in pediatric patients.

    "The FDA's designation recognizes the morbidity and mortality burdens of sickle cell disease as well as its significant impact during childhood with life-long implications. With this designation, the agency acknowledges the urgent need for improved treatment of children living with sickle cell disease," stated Helen Thackray, Chief Medical Officer of GlycoMimetics.

    "With global rights for rivipansel in our hands, we are…

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company a Rare Pediatric Disease designation for rivipansel for the treatment of sickle cell disease in patients 18 years old and younger. This designation recognizes the significant needs in pediatric patients.

    "The FDA's designation recognizes the morbidity and mortality burdens of sickle cell disease as well as its significant impact during childhood with life-long implications. With this designation, the agency acknowledges the urgent need for improved treatment of children living with sickle cell disease," stated Helen Thackray, Chief Medical Officer of GlycoMimetics.

    "With global rights for rivipansel in our hands, we are exploring options to move forward in sickle cell disease, including discussions with the FDA as to whether there is a regulatory path to approval," added Rachel King, Chief Executive Officer. "We plan to roll out the full data set from the Phase 3 RESET program at upcoming medical meetings, based on the acceptance of abstract submissions."

    About Rare Pediatric Disease Designation

    The FDA defines a "rare pediatric disease" as a serious or life-threatening rare disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years. Under the FDA's Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an initial approval for a drug or biologic for a "rare pediatric disease" may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.

    About Sickle Cell Disease (SCD) and VOC

    SCD is the most common inherited blood disorder in the United States, impacting approximately 100,000 people. Worldwide, approximately 100 million people carry the SCD trait and an estimated five million live with the disease. While the majority of people with SCD are of African descent, the disease can affect all ethnic groups, especially those from areas where malaria is or was endemic, such as the Middle East, India and the Southern Mediterranean. Acute pain crises or VOCs are the most common clinical manifestation of SCD. A VOC occurs when hypoxia and inflammation lead to vascular occlusion, tissue ischemia and pain.

    About Rivipansel

    Rivipansel, a 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, produced disappointing results in 2019, new clinical outcome data from a post hoc analysis of early treatment with rivipansel were published in June 2020 in advance of a poster shown at the Foundation for Sickle Cell Disease Research Meeting on September 24, 2020.

    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 acute myeloid leukemia (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 SCD. 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 regarding the clinical development and potential benefits and impact of the Company's drug candidates. These forward-looking statements include those relating to the planned or potential clinical development of the Company's product candidates, including the presentation of data from clinical trials. 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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  24. GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that Chief Executive Officer Rachel King will present at the upcoming H.C. Wainwright & Co 22nd Annual Global Investment Virtual Conference taking place September 14-16, 2020. The presentation will be available on the company's website at the "Investors" tab for 30 days, beginning Monday, September 14 at 2:30 p.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 biotechnology company with two late-stage clinical development programs and a pipeline of novel glycomimetic drugs, all designed to address unmet medical…

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that Chief Executive Officer Rachel King will present at the upcoming H.C. Wainwright & Co 22nd Annual Global Investment Virtual Conference taking place September 14-16, 2020. The presentation will be available on the company's website at the "Investors" tab for 30 days, beginning Monday, September 14 at 2:30 p.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 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 as a potential treatment for acute vaso-occlusive crisis 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.

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    • Analysis of combination therapy demonstrated statistically significant prolongation of survival in a patient-derived xenograft (PDX) model
    • Abstract published online today in advance of virtual meeting of the Society of Hematologic Oncology (SOHO) taking place September 9-12, 2020

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced new preclinical data providing the first evidence that an E-selectin targeting strategy with uproleselan may help patients with acute myeloid leukemia (AML) to overcome resistance to venetoclax and hypomethylating agent (HMA)-based therapy. The poster (Abstract #AML-337) entitled "Targeting E-selectin with GMI-1271 Overcomes Microenvironment-mediated Resistance to Venetoclax/HMA Therapy," will be presented September…

    • Analysis of combination therapy demonstrated statistically significant prolongation of survival in a patient-derived xenograft (PDX) model
    • Abstract published online today in advance of virtual meeting of the Society of Hematologic Oncology (SOHO) taking place September 9-12, 2020

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced new preclinical data providing the first evidence that an E-selectin targeting strategy with uproleselan may help patients with acute myeloid leukemia (AML) to overcome resistance to venetoclax and hypomethylating agent (HMA)-based therapy. The poster (Abstract #AML-337) entitled "Targeting E-selectin with GMI-1271 Overcomes Microenvironment-mediated Resistance to Venetoclax/HMA Therapy," will be presented September 9 from 6:15-8:15 p.m. CDT on the virtual platform of the virtual meeting of the Society of Hematologic Oncology (SOHO).

    The data presented are from an animal model created using tissue derived from a patient who had developed resistance to venetoclax/HMA. In this model, the addition of uproleselan to the treatment regimen demonstrated robust anti-leukemic activity and a statistically significant prolongation of survival. The research strongly supports the opportunity for additional clinical evaluation of the triple combination of uproleselan, venetoclax and HMA in the frontline, unfit AML patient population.

    "We know that binding leukemic cells to E-selectin within the bone marrow niche up-regulates pro-survival mechanisms. This preclinical study shows that by blocking this activity with uproleselan, we can enhance the sensitivity to venetoclax/HMAs. This supports using this treatment regimen to potentially improve outcomes in patients whose duration of response is typically very short," said John Magnani, Ph.D., GlycoMimetics' Senior Vice-President of Research and Chief Scientific Officer. "We are excited to share this encouraging data and hope that additional clinical evaluation will provide more insight on the potential of this combination-therapy approach."

    Visit the meeting's website for more information: https://www.soho2020.com/., The virtual meeting will be held September 9-12, 2020.

    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.

    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 as a potential treatment for acute vaso-occlusive crisis 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 regarding the Company's strategy and the clinical development and potential utility, benefits and impact of its drug candidates. These forward-looking statements include those relating to the planned preclinical research and clinical development of the Company's product candidates. Actual results may differ materially from those expressed in or implied by 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, the updated risk factors described in the Company's quarterly report on Form 10-Q filed with the SEC on July 31, 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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    • Enrollment in the Company-sponsored pivotal Phase 3 trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML) continued, and the company affirmed second half of 2021 as target for completion of enrollment
    • A post hoc analysis of the Phase 3 RESET study evaluating the efficacy of rivipansel in acute vaso-occlusive crisis (VOC) in sickle cell disease (SCD) produced new efficacy data showing statistically significant improvements for patients treated early in crisis in the primary efficacy endpoint of time to readiness for discharge compared to placebo
    • Pfizer completed the transfer to GlycoMimetics of all commercial and development rights and the Investigational New Drug Application (IND) for rivipansel
    • Enrollment in the Company-sponsored pivotal Phase 3 trial evaluating uproleselan in patients with relapsed/refractory acute myeloid leukemia (AML) continued, and the company affirmed second half of 2021 as target for completion of enrollment
    • A post hoc analysis of the Phase 3 RESET study evaluating the efficacy of rivipansel in acute vaso-occlusive crisis (VOC) in sickle cell disease (SCD) produced new efficacy data showing statistically significant improvements for patients treated early in crisis in the primary efficacy endpoint of time to readiness for discharge compared to placebo
    • Pfizer completed the transfer to GlycoMimetics of all commercial and development rights and the Investigational New Drug Application (IND) for rivipansel

    GlycoMimetics, Inc. (NASDAQ:GLYC) today reported its financial results for the second quarter ended June 30, 2020, and highlighted recent company events. Cash and cash equivalents at June 30, 2020 were $149.8 million.

    "The second quarter was quite productive as we noted strong enrollment in our company-sponsored pivotal trial of uproleselan in relapsed/refractory AML. Though we did see a slow down early in the COVID crisis, we were pleased to see enrollment pick back up later in the quarter. This was an important achievement in the face of the COVID-19 pandemic, and we are able to maintain prior guidance that we expect to complete enrollment in the second half of 2021. Also important were new data from a post hoc analysis of the rivipansel Phase 3 study that showed that patients treated with rivipansel within approximately 26 hours of the onset of pain in their crisis experienced statistically significant improvements in the primary efficacy endpoint of time to readiness for discharge compared to placebo. These data provide a foundation, we believe, for us to discuss with the U.S. Food and Drug Administration (FDA) whether there may be a path forward for rivipansel in acute VOC," commented Rachel King, Chief Executive Officer.

    Operational Highlights

    Uproleselan

    • GlycoMimetics' ongoing pivotal Phase 3 trial in relapsed/refractory AML continued to activate clinical sites and enroll patients in North America, Australia and Europe. While individual sites were affected by COVID-19, overall clinicians continued to enroll patients well this quarter.
    • At the American Association for Cancer Research (AACR) Annual Meeting 2020, held June 22-24, preclinical research for both uproleselan and GMI-1359 was shared in a virtual format. Preclinical data supporting the potential use of uproleselan in the treatment of AML as well as in the setting of stem cell transplantation were presented. Additionally, new information demonstrated the ability of transcriptome profiling to identify those tumor types most likely to benefit from targeted E-selectin inhibition, a key mechanism of GlycoMimetics drug candidates.
    • Important new preclinical data on the mechanism of action for uproleselan were published in the April 27, 2020, issue of Nature Communications. The paper outlined how uproleselan, a first-in-class, targeted inhibitor of E-selectin, can reduce chemoresistance in AML through the key mechanism of targeted E-selectin inhibition.

    GMI-1687

    • An abstract that was accepted for oral presentation at the Foundation for Sickle Cell Disease (FSCDR) meeting and published online in June, disclosed data from a preclinical model of the Company's E-selectin antagonist, GMI-1687, which is more potent than rivipansel and is being formulated for subcutaneous dosing. The data support development of GMI-1687 as a possible follow-on to rivipansel, which has the potential for subcutaneous self-administration as would be used in an outpatient setting.

    Rivipansel

    • The FSCDR also published online an abstract including data from a post hoc analysis of the Phase 3 RESET trial of 345 patients (ranging in age from six years to adults, with a mean age of 22 years) who were experiencing acute VOC requiring hospitalization for treatment. The organization selected the abstract for poster presentation at its September meeting. The analysis showed that patients treated with rivipansel early in their acute episode experienced a statistically significant improvement on the primary efficacy endpoint, time to readiness for discharge (p=0.03, median improvement at 56.3 hours compared to placebo).
    • Based upon its review of the Phase 3 rivipansel data set, GlycoMimetics is committed to an assessment of what, if any, next steps to take, with a focus on determining if there is a potential path forward for this asset in sickle cell disease.
    • GlycoMimetics completed in April a transfer back from Pfizer of the commercial and development rights and licenses for rivipansel, the IND for the clinical development program, and the entire data set for the Phase 3 RESET trial.

    Executive Management Team

    • The Company announced that veteran regulatory expert Myra Rosario Herrle, PhD, RPh, RAC, joined the executive management team as Vice President, Regulatory Affairs.

    Second Quarter 2020 Financial Results:

    • Cash position: As of June 30, 2020, GlycoMimetics had cash and cash equivalents of $149.8 million as compared to $158.2 million as of December 31, 2019. During the quarter, the Company sold common stock under its at-the-market facility with Cowen for aggregate net proceeds of $9.6 million.
    • R&D Expenses: The Company's research and development expenses decreased to $9.9 million for the quarter ended June 30, 2020 as compared to $13.1 million for the second quarter of 2019. The Company's research and development expenses decreased to $22.5 million for the six months ended June 30, 2020 as compared to $24.8 million for the same period in 2019. These decreases were due primarily to a decrease in manufacturing and formulation expenses resulting from lower raw material costs as the validation manufacturing batches were purchased in the prior year. The decreases were offset in part by higher clinical expenses as a result of the increased enrollment in the ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML and the Phase 2/3 clinical trial being conducted by the National Cancer Institute. Contract research services, consulting and other costs were lower in 2020 as research activities were affected at outside universities and travel by research and development personnel was largely eliminated due to the COVID-19 pandemic.
    • G&A Expenses: The Company's general and administrative expenses increased to $4.2 million for the second quarter ended June 30, 2020 as compared to $3.8 million for the second quarter of 2019. General and administrative expenses for the six months ended June 30, 2020 increased to $8.7 million as compared to $7.1 million in the same period in 2019. Personnel-related expenses increased due to additional general and administrative headcount, annual salary adjustments awarded in the first quarter of 2020 and retention bonuses. Patent, legal fees, consulting and other professional expenses including director and officer's insurance premiums, increased as compared to 2019. Other general and administrative expenses decreased for both the three and six months ended June 30, 2020, as compared to the same periods in 2019, due to lower travel, meals and conference registration expenses as a result of the travel restrictions due to the COVID-19 pandemic.
    • Shares Outstanding: Shares of common stock outstanding as of June 30, 2020 were 46,714,698.

    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 or (216) 562-0466 for international participants, with participant code 1677593. 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 1677593.

    About Uproleselan (GMI-1271)

    Discovered and developed by GlycoMimetics, uproleselan and GMI-1687 are investigational, first-in-class, targeted inhibitors 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.

    About GMI-1687

    GMI-1687 is a rationally designed, innovative antagonist of E-selectin that is potentially suitable for subcutaneous (SC) administration. When given by SC injection in preclinical models, GMI-1687 has been observed to have equivalent activity to uproleselan, but at an approximately 1,000-fold lower dose. GlycoMimetics believes that GMI-1687 could be developed as a potential life-cycle expansion to broaden the clinical usefulness of an E-selectin antagonist to conditions, such as sickle cell disease crisis, where outpatient treatment may be preferred or required. GMI-1687 is currently undergoing IND-enabling studies.

    About Rivipansel

    Rivipansel, a 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 in advance of a presentation to occur at the Foundation for Sickle Cell Disease Research Meeting in September 2020. GlycoMimetics is committed to exploring a path forward for the use of rivipansel in treating acute VOC in SCD.

    About GMI-1359

    GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both 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. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The Duke University Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug's activity. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States.

    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 as a potential treatment for acute VOC in SCD. 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 regarding the Company's strategy and the clinical development and potential utility, benefits and impact of its drug candidates. These forward-looking statements include those relating to the planned preclinical research and 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 potential impact of the ongoing global COVID-19 pandemic on the Company's operations, and the Company's plans for discussing data from the Phase 3 clinical trial of rivipansel with the FDA. Actual results may differ materially from those expressed in or implied by 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, the updated risk factors described in the Company's quarterly report on Form 10-Q filed with the SEC on July 31, 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.

    GlycoMimetics, Inc.

    Condensed Statements of Operations

    (In thousands, except share and per share data)

     

    Three months ended June 30,

    Six months ended June 30,

    2020

    2019

    2020

    2019

    (Unaudited)

    (Unaudited)

     
    Revenue

    $

    -

     

    $

    -

     

    $

    9,000

     

    $

    -

     

     
    Cost and expenses:
    Research and development expense

     

    9,871

     

     

    13,065

     

     

    22,539

     

     

    24,838

     

    General and administrative expense

     

    4,235

     

     

    3,751

     

     

    8,675

     

     

    7,111

     

    Total costs and expenses

     

    14,106

     

     

    16,816

     

     

    31,214

     

     

    31,949

     

     
    Loss from operations

     

    (14,106

    )

     

    (16,816

    )

     

    (22,214

    )

     

    (31,949

    )

     
    Other income

     

    27

     

     

    986

     

     

    472

     

     

    2,035

     

     
    Net loss and comprehensive loss

    $

    (14,079

    )

    $

    (15,830

    )

    $

    (21,742

    )

    $

    (29,914

    )

     
     
    Net loss per share - basic and diluted

    $

    (0.32

    )

    $

    (0.37

    )

    $

    (0.50

    )

    $

    (0.69

    )

    Weighted average shares - basic and diluted

     

    43,801,251

     

     

    43,183,010

     

     

    43,688,420

     

     

    43,174,989

     

    GlycoMimetics, Inc.

    Balance Sheet Data

    (In thousands)

     

    June 30,

    December 31,

    2020

    2019

    (unaudited)

     
    Cash and cash equivalents

    $

    149,845

    $

    158,201

     
    Working capital

     

    143,657

     

    151,577

     
    Total assets

     

    158,353

     

    167,970

     
    Total liabilities

     

    12,600

     

    13,769

     
    Total stockholders' equity

     

    145,752

     

    154,201

     

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  25. GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that it will host a conference call and webcast to report its second quarter financial results on Friday, July 31, 2020, at 8:30 a.m. ET.

    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 1677593. 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…

    GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that it will host a conference call and webcast to report its second quarter financial results on Friday, July 31, 2020, at 8:30 a.m. ET.

    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 1677593. 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 1677593.

    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 SCD. 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 regarding the Company's strategy and the clinical development and potential benefits and impact of its drug candidates. These forward-looking statements include those relating to the planned clinical development of the Company's product candidates, including expectations with regard to the enrollment of patients in its ongoing Phase 3 clinical trial, and its other plans for its current cash resources. Actual results may differ materially from those 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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  26. GlycoMimetics, Inc. (the "Company") (NASDAQ:GLYC) today announced that the compensation committee of the Company's Board of Directors approved the grant on July 6, 2020 of a non-qualified stock option award to purchase an aggregate of 12,200 shares of its common stock to a new employee. The options were granted as an inducement equity award outside of the Company's 2013 Equity Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4), and were made as an inducement material to the acceptance of employment with the Company by the new employee. The options are subject to the terms and conditions of a stock option agreement covering the grant and the GlycoMimetics, Inc. Inducement Plan, which was adopted January 22, 2020 and provides for…

    GlycoMimetics, Inc. (the "Company") (NASDAQ:GLYC) today announced that the compensation committee of the Company's Board of Directors approved the grant on July 6, 2020 of a non-qualified stock option award to purchase an aggregate of 12,200 shares of its common stock to a new employee. The options were granted as an inducement equity award outside of the Company's 2013 Equity Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4), and were made as an inducement material to the acceptance of employment with the Company by the new employee. The options are subject to the terms and conditions of a stock option agreement covering the grant and the GlycoMimetics, Inc. Inducement Plan, which was adopted January 22, 2020 and provides for the granting of stock options to new employees.

    The stock option award has an exercise price equal to the closing price of the Company's common stock on July 06, 2020. The options have a ten-year term and vest over four years, with one-fourth of the shares vesting one year after the grant date, and the balance of the shares vesting in a series of thirty-six successive equal monthly installments measured from the first anniversary of the grant date, subject to the new employee's continued service with the Company through the applicable vesting dates.

    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 SCD. 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 regarding the clinical development and potential benefits and impact of the Company's drug candidates. These forward-looking statements include those relating to the planned clinical development of the Company's product candidates, including the presentation of data from preclinical studies and clinical trials. 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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  27. - Abstracts for two of GlycoMimetics' wholly-owned E-selectin inhibitors, rivipansel and GMI-1687, to be published at September meeting of the Foundation for Sickle Cell Disease Research

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that a post hoc analysis of the Phase 3 RESET study evaluating the efficacy of rivipansel , its wholly-owned development candidate, in acute vaso-occlusive crisis (VOC) shows that patients treated with rivipansel within approximately 26 hours of the onset of pain in their crisis experienced statistically significant improvements in the primary efficacy endpoint of time to readiness for discharge compared to placebo. This analysis and new biomarker data will be presented at the September meeting of the Foundation…

    - Abstracts for two of GlycoMimetics' wholly-owned E-selectin inhibitors, rivipansel and GMI-1687, to be published at September meeting of the Foundation for Sickle Cell Disease Research

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that a post hoc analysis of the Phase 3 RESET study evaluating the efficacy of rivipansel , its wholly-owned development candidate, in acute vaso-occlusive crisis (VOC) shows that patients treated with rivipansel within approximately 26 hours of the onset of pain in their crisis experienced statistically significant improvements in the primary efficacy endpoint of time to readiness for discharge compared to placebo. This analysis and new biomarker data will be presented at the September meeting of the Foundation for Sickle Cell Disease Research (FSCDR). In addition to the rivipansel poster, an abstract containing data on GlycoMimetics' more selective and highly potent E-selectin antagonist, GMI-1687, has been accepted for an oral presentation. The GMI-1687 abstract includes data from a preclinical model showing the drug candidate's potential as a subcutaneously administered treatment for VOC. FSCDR posted the abstracts online today for the meeting now scheduled for September 23-25, 2020, in Ft. Lauderdale, FL.

    The rivipansel abstract includes data from a supportive analysis of the Phase 3 RESET trial of 345 patients (ranging in age from six years to adults, with a mean age of 22 years) who were experiencing acute VOC requiring hospitalization for treatment. The analysis shows that patients treated with rivipansel early in their acute episode experienced a statistically significant improvement on the primary efficacy endpoint, time to readiness for discharge (p=0.03, median improvement was 58 hours). This endpoint reflects achievement of multiple clinical criteria assessing healthcare utilization and a patient's medical improvement prior to leaving the hospital. Furthermore, patients treated with rivipansel showed a statistically significant reduction in soluble E-selectin, a biomarker indicating that the drug had the intended biological effect. The effect observed on soluble E-selectin in this trial provides valuable insight into the mechanism for the improvement in the clinical criteria for discharge from the hospital observed in those patients treated early in their acute VOC. Data from the RESET trial additionally demonstrate a safety profile for rivipansel comparable to the placebo.

    "The important data disclosed today demonstrate that patients treated within approximately 26 hours of the start of a VOC benefited from receiving rivipansel. In addition, the biomarker data showing reductions in soluble E-selectin indicates that rivipansel is hitting its intended biological target. These two findings confirm the critical role of E-selectin in acute vaso-occlusion, as well as the importance of treating individuals early in the course of their acute painful crisis," said Helen Thackray, GlycoMimetics' Chief Medical Officer.

    "The favorable safety profile of rivipansel observed in this trial, as evaluated in a population with pediatric, adolescent, and adult patients, is highly encouraging to us. We are actively considering options for rivipansel in this acute treatment setting, for which there are no approved drugs and, to our knowledge, no drugs currently in late-stage development. Now that Pfizer's development and commercialization rights, including the investigational new drug (IND) application for rivipansel, have been transferred back to us, we intend to discuss these data with the U.S. Food and Drug Administration (FDA) to determine what, if any, next steps could be taken to carry this program forward in acute VOC, either in pediatrics or in the overall population," she added.

    The second abstract, accepted for oral presentation, discloses data from a preclinical model of GlycoMimetics E-selectin antagonist, GMI-1687, which is even more potent than rivipansel and is formulated for subcutaneous dosing.

    "The data disclosed in this second abstract support development of GMI-1687 as a possible follow-on to rivipansel, which has the potential for subcutaneous self-administration as would be used in an outpatient setting," continued Dr. Thackray. "Taken together, these abstracts support use of rivipansel in early treatment of acute VOC and the potential use of GlycoMimetics' drug candidates to address a very significant unmet medical need."

    About Sickle Cell Disease (SCD) and VOC

    SCD is the most common inherited blood disorder in the United States, impacting approximately 100,000 people. Worldwide, approximately 100 million people carry the SCD trait and an estimated five million live with the disease. While the majority of people with SCD are of African descent, the disease can affect all ethnic groups, especially those from areas where malaria is or was endemic, such as the Middle East, India and the Southern Mediterranean. Acute pain crises or VOCs are the most common clinical manifestation of SCD. A VOC occurs when hypoxia and inflammation lead to vascular occlusion, tissue ischemia and pain.

    About Rivipansel

    Rivipansel, a 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, produced disappointing results in 2019, new efficacy data from a post hoc analysis of rivipansel were published in June 2020 in advance of a presentation to occur at the Foundation for Sickle Cell Disease Research Meeting in September 2020. GlycoMimetics is committed to exploring a path forward for the use of rivipansel in treating acute VOC in SCD.

    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. 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 is also thought to represent a more highly-potent and subcutaneously bioavailable potential life-cycle extension for rivipansel, the company's drug candidate being explored for the treatment of acute VOC in SCD.

    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 SCD. 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 regarding the clinical development and potential benefits and impact of the Company's drug candidates. These forward-looking statements include those relating to the planned clinical development of the Company's product candidates, including the presentation of data from preclinical studies and clinical trials. 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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  28. GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that Chief Executive Officer Rachel King will provide a company overview at the upcoming Jefferies Virtual Healthcare Conference. The presentation will be available on the company's website at the "Investors" tab for 30 days, beginning Thursday, June 4 from 1:00 – 1:25 p.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 focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays…

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that Chief Executive Officer Rachel King will provide a company overview at the upcoming Jefferies Virtual Healthcare Conference. The presentation will be available on the company's website at the "Investors" tab for 30 days, beginning Thursday, June 4 from 1:00 – 1:25 p.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 focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics' wholly-owned drug candidate, uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial as a potential treatment for acute myeloid leukemia (AML) and is being evaluated across a range of patient populations including a Company-sponsored Phase 3 trial in relapsed/refractory AML. 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.

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  29. GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that preclinical research on two of its drug candidates, uproleselan and GMI-1359, will be shared at the American Association for Cancer Research (AACR) Annual Meeting 2020, which will now be held virtually from June 22-24.

    During the June session, GlycoMimetics will present preclinical data that further support the potential of the Company's compounds to be used in the treatment of acute myeloid leukemia (AML) as well as in the setting of stem cell transplantation. Additionally, new information will be presented on the ability of transcriptome profiling to identify those tumor types most likely to benefit from targeted E-selectin inhibition, a key mechanism of GlycoMimetics drug candidates…

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that preclinical research on two of its drug candidates, uproleselan and GMI-1359, will be shared at the American Association for Cancer Research (AACR) Annual Meeting 2020, which will now be held virtually from June 22-24.

    During the June session, GlycoMimetics will present preclinical data that further support the potential of the Company's compounds to be used in the treatment of acute myeloid leukemia (AML) as well as in the setting of stem cell transplantation. Additionally, new information will be presented on the ability of transcriptome profiling to identify those tumor types most likely to benefit from targeted E-selectin inhibition, a key mechanism of GlycoMimetics drug candidates, supporting their potential uses in a biomarker-driven approach.

    Important findings from the preclinical research include:

    - Co-targeting and inhibition of E-selectin/CXCR4/FLT3 with GMI-1359 in combination with sorafenib exerts protection of normal hematopoiesis (blood cell formation) and more efficiently reduces leukemic burden compared to sorafenib alone, resulting in extended overall survival, in a patient-derived FLT3 resistant AML model;

    - Inhibition of E-selectin with uproleselan during pre-transplant conditioning results in increased survival of mice in a hematopoietic stem cell transplantation and reconstitution model; and,

    - Further analysis of E-selectin glycosylation genes extends the prognostic importance of this unique gene signature in AML, highlighting the potential use of uproleselan in AML and other hematologic malignancies.

    "We look forward to presenting data at this year's AACR meeting that will support our approach to targeting E-selectin with both uproleselan and GMI-1359 as part of potential treatment regimens for patients with AML and other diseases," said John Magnani, Ph.D., GlycoMimetics Senior Vice President and Chief Scientific Officer. "Furthermore, the new data around glycosylation gene signatures highlights a potential biomarker-driven approach in targeting E-selectin."

    Of note, data will be presented demonstrating that lethality of the FLT-3 mutation is specifically dependent upon high levels of E-selectin ligand expressed on the surface of AML blasts. FLT-3 ITD AML patients are known to express higher levels of E-selectin on the vasculature endothelium. In the patient data to be reported at the AACR meeting, patients who had the FLT-3 ITD mutation, but presented low levels of E-selectin ligand on their AML cells, did not experience worse outcomes, whereas those who did have FLT-3 ITD with high levels of E-selectin ligand, experienced poor survival. This adds support to the key role of E-selectin ligand in contributing to poor outcomes in AML and to the potential of uproleselan to improve AML treatment.

    Details on GlycoMimetics' presentations at the upcoming virtual AACR meeting include:

    • Abstract Control #7924/ Permanent Abstract #5867:

    "Transcriptome profiling of ST3GAL4 and FUT7 in multiple tumor types and prognostic value in adult acute myeloid leukemia"

    Session Type: Poster Session

    Session Category: Molecular and Cellular Biology / Genetics

    Session Title: Functional Genomics and Other Topics

    • Abstract Control #3865/ Permanent Abstract #486:

    "Enhanced survival of lethally-irradiated mice with HSC reconstitution in combination with the E-selectin antagonist, GMI-1271 (uproleselan)"

    Session Type: Poster Session

    Session Category: Tumor Biology

    Session Title: Stem Cells, Cancer Stem Cell Therapeutic Targeting, and Regenerative Medicine

    • Abstract #5038:

    "Combined Targeting of E-selectin/CXCR4 and FLT3 by GMI-1359 and Sorafenib Effectively Reduces Leukemia Cell Burden and Protects Normal Hematopoiesis in a Patient-derived AML Xenograft Model"

    Session Type: Poster Session

    Session Category: Tumor Biology

    Session Title: Drug Targets in the Microenvironment

    Meeting abstracts are available at AACR's website.

    About Uproleselan

    Discovered and developed by GlycoMimetics, uproleselan and GMI-1687 are investigational, first-in-class, targeted inhibitors 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.

    About GMI-1359

    GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both 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. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The Duke University Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug's activity. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States.

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs 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. 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 regarding the clinical development and potential benefits and impact of the Company's drug candidates. These forward-looking statements include those relating to the planned clinical development of the Company's wholly-owned product candidates. Actual results may differ materially from those 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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  30. GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that its 2020 Annual Meeting of Shareholders (the "Annual Meeting") will be held virtually instead of in person. Due to the ongoing public health impact of the COVID-19 pandemic and to support the health and well-being of the Company's stockholders, employees and their families, the Company will hold the Annual Meeting via live audio webcast rather than as an in-person meeting. The virtual Annual Meeting is expected to provide stockholders with the same rights and opportunities to participate as they would have at an in-person meeting. As previously announced, the Annual Meeting will be held on Friday, May 22, 2020 at 9:00 a.m. EDT.

    As described in the Company's proxy materials previously…

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that its 2020 Annual Meeting of Shareholders (the "Annual Meeting") will be held virtually instead of in person. Due to the ongoing public health impact of the COVID-19 pandemic and to support the health and well-being of the Company's stockholders, employees and their families, the Company will hold the Annual Meeting via live audio webcast rather than as an in-person meeting. The virtual Annual Meeting is expected to provide stockholders with the same rights and opportunities to participate as they would have at an in-person meeting. As previously announced, the Annual Meeting will be held on Friday, May 22, 2020 at 9:00 a.m. EDT.

    As described in the Company's proxy materials previously distributed for the Annual Meeting, stockholders at the close of business on April 9, 2020, the record date, are entitled to participate in and vote at the Annual Meeting. Online access to the Annual Meeting will begin at 8:45 a.m. EDT. Stockholders will not be able to attend the Annual Meeting in person. To participate in and/or vote at the virtual Annual Meeting, stockholders should utilize the special website address at www.virtualshareholdermeeting.com/GLYC2020. Stockholders must enter the 16-digit control number found on their proxy card. Stockholders may still vote prior to the Annual Meeting by Internet, telephone or by mail per the instructions on their proxy card. The webcast of the Annual Meeting will be archived for one year after the date of the Annual Meeting at www.virtualshareholdermeeting/GLYC2020. Instructions on how to connect to the Annual Meeting and participate via the Internet, including how to demonstrate proof of stock ownership, are posted at www.virtualshareholdermeeting.com/GLYC2020.

    Asking Questions

    If you are attending the Annual Meeting as stockholder of record or beneficial owner, questions can be submitted by accessing the meeting center at www.virtualshareholdermeeting.com/GLYC2020, entering your 16-digit control number. Instructions on how to participate in the Annual Meeting are posted at www.virtualshareholdermeeting.com/GLYC2020.

    Voting Shares

    Stockholders of record and beneficial owners will be able to vote their shares electronically during the Annual Meeting by using the 16-digit control number. Instructions on how to vote while participating in the Annual Meeting live via the Internet are posted at www.virtualshareholdermeeting.com/GLYC2020.

    Whether or not stockholders plan to virtually attend the Annual Meeting, the Company urges them to vote and submit their proxy in advance of the Annual Meeting by one of the methods described in the proxy materials for the Annual Meeting.

    The proxy materials, including the proxy card and Notice of Internet Availability of Proxy Materials, previously distributed along with the definitive proxy statement will not be updated to reflect the change in location and may continue to be used to vote shares in connection with the Annual Meeting.

    Attending the Annual Meeting as a Guest

    Guests may enter the Annual Meeting in "listen-only" mode by entering the Annual Meeting at www.virtualshareholdermeeting.com/GLYC2020 and entering the information requested in the "Guest Login" section. Guests will not have the ability to vote or ask questions during the Annual Meeting.

    List of Stockholders

    A list of stockholders entitled to vote at the Annual Meeting will be available for examination for any purpose germane to the Annual Meeting during normal business hours for ten days prior to the Annual Meeting at our corporate headquarters. To the extent office access is impracticable due to the recent COVID-19 pandemic, you may email us at ir@glycomimetics.com for alternative arrangements. The stockholder list will also be available during the Annual Meeting at www.virtualshareholdermeeting.com/GLYC2020. Instructions on how stockholders of record can view the stockholder list during the Annual Meeting are posted at www.virtualshareholdermeeting.com/GLYC2020.

    Your vote is important to us. Whether or not you plan to participate in the live audio webcast of our annual meeting, we hope you will vote as soon as possible. Voting now at www.proxyvote.com will ensure your representation at the Annual Meeting.

    The proxy statement for the Annual Meeting and the Company's 2019 Annual Report are available at http://materials.proxyvote.com/38000Q. These materials also are available on the Company's website at www.glycomimetics.com under "Investors" and then "Financials and Filings."

    Our first priority is always the health and safety of our stockholders and employees. Our thoughts are with those already impacted by COVID-19 and our gratitude is with the many on the front lines of confronting this public health crisis. We look forward to your participation at our virtual Annual Meeting.

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics' wholly-owned drug candidate, uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial as a potential treatment for acute myeloid leukemia (AML) and is being evaluated across a range of patient populations including a Company-sponsored Phase 3 trial in relapsed/refractory AML. 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.

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    • Entered into an exclusive collaboration and license agreement with Apollomics for development and commercialization of uproleselan and GMI-1687 in the Greater China region
    • Announced first patient dosing in Phase 1b clinical trial of GMI-1359 in individuals with advanced breast cancer, led by co-principal investigators from the Duke Cancer Institute
    • Reiterated a commitment to determine what, if any, next steps to take with respect to the rivipansel program following transfer from Pfizer of the IND and the full Phase 3 RESET dataset
    • To host conference call and webcast today at 8:30 a.m. ET

    GlycoMimetics, Inc. (NASDAQ:GLYC) today reported its financial results for the first quarter ended March 31, 2020 and highlighted recent company…

    • Entered into an exclusive collaboration and license agreement with Apollomics for development and commercialization of uproleselan and GMI-1687 in the Greater China region
    • Announced first patient dosing in Phase 1b clinical trial of GMI-1359 in individuals with advanced breast cancer, led by co-principal investigators from the Duke Cancer Institute
    • Reiterated a commitment to determine what, if any, next steps to take with respect to the rivipansel program following transfer from Pfizer of the IND and the full Phase 3 RESET dataset
    • To host conference call and webcast today at 8:30 a.m. ET

    GlycoMimetics, Inc. (NASDAQ:GLYC) today reported its financial results for the first quarter ended March 31, 2020 and highlighted recent company events. Cash and cash equivalents at March 31, 2020 were $154.8 million.

    "During the quarter, patient enrollment continued on track in GlycoMimetics' Phase 3 registration program evaluating uproleselan in relapsed/refractory acute myeloid leukemia (AML) as well as in our collaboration with the National Cancer Institute (NCI) on a multi-center clinical trial evaluating the drug candidate in newly diagnosed patients fit for chemotherapy. Enrollment slowed in April as a result of the COVID-19 pandemic, and we continue to actively monitor the situation. At this time it is too early for us to comment on the potential impact of the pandemic on completion of enrollment in either trial, or the potential impact on cash burn. In addition, we are working closely with Apollomics in the Greater China region to initiate the Apollomics-funded third registration trial for uproleselan," commented Rachel King, Chief Executive Officer.

    "In early April, Pfizer transferred to us the rivipansel investigational new drug application (IND) as well as the study data set from its Phase 3 clinical trial evaluating the drug's clinical effect in sickle cell vaso-occlusive crisis," continued Ms. King. "We can now move forward to fully review the data to determine the next steps, if any, to take with respect to the rivipansel program now that we have worldwide development and commercialization rights."

    Operational Highlights

    Uproleselan

    • GlycoMimetics' pivotal Phase 3 trial in relapsed/refractory AML continued to activate clinical sites and enroll patients in the U.S., Australia and Europe through March 2020.
    • The COVID-19 pandemic has resulted in slowed clinical site initiation, patient recruitment and enrollment rates beginning in April 2020, which we continue to closely monitor for any potential material impact on our expected completion of enrollment. Investigators continued to enroll patients in the NCI-sponsored Phase 3 clinical trial designed to evaluate uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy, through March 2020.
    • GlycoMimetics and Apollomics announced an exclusive collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan (Greater China).

    GMI-1359

    • Duke University initiated a proof-of-concept Phase 1b study to evaluate GMI-1359 in patients with advanced breast cancer with bone metastases, and investigators dosed the first patient in January of this year. The trial is evaluating safety and pharmacodynamic biomarkers in individuals with hormone receptor positive metastatic breast cancer.
    • A new composition of matter and formulation patent was issued in the United States for GMI-1359, and the U.S. Food and Drug Administration (FDA) granted orphan drug and rare pediatric disease designations for the drug candidate for the treatment of osteosarcoma that may provide future development support and marketing protections.

    Rivipansel

    • GlycoMimetics and Pfizer worked closely to prepare for the transfer back to GlycoMimetics of the rivipansel program following Pfizer's April 2020 termination of the parties' 2011 license agreement for clinical development and commercialization of rivipansel in sickle cell disease (SCD). The transfer, now complete, includes the return of all rights and licenses previously granted, as well as the rivipansel IND and the Phase 3 RESET study data set.
    • GlycoMimetics is committed to a detailed assessment of what, if any, next steps to take with respect to the rivipansel program after reviewing the Phase 3 clinical data.

    First Quarter 2020 Financial Results

    • Cash position: As of March 31, 2020, GlycoMimetics had cash and cash equivalents of $ 154.8 million as compared to $158.2 million as of December 31, 2019. In January 2020, GlycoMimetics received an upfront cash payment of $9.0 million from Apollomics pursuant to the exclusive collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Greater China.
    • R&D Expenses: The Company's research and development expenses increased to $12.7 million for the quarter ended March 31, 2020 as compared to $ 11.8 million for the first quarter of 2019. Clinical development expenses increased by $2.4 million based on the higher clinical costs related to the Company's ongoing Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML and the Phase 3 clinical trial being conducted by the NCI. In addition, personnel-related and stock-based compensation expenses increased by $540,000 due to annual performance adjustments processed in the quarter ended March 31, 2020. These increases were offset in part by a $2.1 million decrease in manufacturing and formulation due to lower raw material expenses in the first quarter ended March 31, 2020 as compared to the first quarter ended March 31, 2019.
    • G&A Expenses: The Company's general and administrative expenses increased to $4.4 million for the quarter ended March 31, 2020 as compared to $3.4 million for the first quarter of 2019. Personnel-related expenses increased by $684,000 due to additional general and administrative headcount and annual salary adjustments awarded in the first quarter of 2020. Patent, legal fees, consulting and other professional expenses, including director and officer's insurance premiums, increased by $373,000 for the quarter ended March 31, 2020 as compared to March 31, 2019.
    • Shares Outstanding: Shares of common stock outstanding as of March 31, 2020 were 43,582,979.

    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 4567397. 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 4567397.

    About Uproleselan and GMI-1687

    Discovered and developed by GlycoMimetics, uproleselan and GMI-1687 are investigational, first-in-class, targeted inhibitors 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.

    GMI-1687 is a rationally designed, innovative antagonist of E-selectin that is potentially suitable for subcutaneous (SC) administration. When given by SC injection in preclinical models, GMI-1687 has been observed to have equivalent activity to uproleselan, but at an approximately 1,000-fold lower dose. GlycoMimetics believes that GMI-1687 could be developed as a potential life-cycle expansion to broaden the clinical usefulness of an E-selectin antagonist to conditions where outpatient treatment is preferred or required. GMI-1687 is currently undergoing IND-enabling studies.

    About GMI-1359

    GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both 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. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The Duke University Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug's activity. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States.

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs 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. 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 regarding the Company's strategy and the clinical development and potential benefits and impact of its drug candidates. These forward-looking statements include those relating to the planned clinical development of the Company's product candidates, including expectations with regard to the enrollment of patients in its ongoing Phase 3 clinical trial and the potential impact of the ongoing global COVID-19 pandemic on the Company's clinical programs, operations and cash burn, the expected timing for reviewing data from Pfizer's Phase 3 clinical trial of rivipansel, and its other plans for its current cash resources. Actual results may differ materially from those 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, the updated risk factors described in the Company's quarterly report on Form 10-Q filed with the SEC on May 1, 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.

    GlycoMimetics, Inc.

    Condensed Statements of Operations

    (In thousands, except share and per share data)

     

     

     

     

     

     

     

     

     

     

    Three months ended March 31,

     

     

     

    2020

     

    2019

     

     

     

    (Unaudited)

     

     

     

     

     

     

     

     

     

    Revenue

     

    $

    $ 9,000

     

    $

     

     

     

     

     

     

     

     

     

    Costs and expenses:

     

     

     

     

     

     

     

    Research and development expense

     

     

    12,668

     

     

    11,773

     

    General and administrative expense

     

     

    4,440

     

     

    3,360

     

    Total costs and expenses

     

     

    17,108

     

     

    15,133

     

     

     

     

     

     

     

     

     

    Loss from operations

     

     

    (8,108)

     

     

    (15,133)

     

     

     

     

     

     

     

     

     

    Interest income

     

     

    445

     

     

    1,049

     

     

     

     

     

     

     

     

     

    Net loss and comprehensive loss

     

    $

    (7,663)

     

    $

    (14,084)

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss per common share – basic and diluted

     

    $

    (0.18)

     

    $

    (0.33)

     

    Weighted-average common shares – basic and diluted

     

     

    43,575,590

     

     

    43,166,967

     

    GlycoMimetics, Inc.

    Balance Sheet Data

    (In thousands)

     

     

     

     

     

     

     

     

     

     

    March 31,

     

    December 31,

     

     

     

    2020

     

    2019

     

     

     

    (unaudited)

     

     

     

     

     

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    154,823

     

    $

    158,201

     

     

     

     

     

     

     

     

     

    Working capital

     

     

    146,269

     

     

    151,577

     

     

     

     

     

     

     

     

     

    Total assets

     

     

    162,099

     

     

    167,970

     

     

     

     

     

     

     

     

     

    Total liabilities

     

     

    13,609

     

     

    13,769

     

     

     

     

     

     

     

     

     

    Total stockholders' equity

     

     

    148,490

     

     

    154,201

     

     

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  31. Research shows that uproleselan is a potent antagonist of E-selectin, can break chemoresistance

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that important new preclinical data on the mechanism of action for its late-stage clinical candidate, uproleselan, are published in the April 27, 2020, issue of Nature Communications. The paper outlines how uproleselan, an investigational, first-in-class, targeted inhibitor of E-selectin, can reduce chemoresistance in acute myeloid leukemia (AML) through the key mechanism of targeted E-selectin inhibition.1

    "This paper offers compelling data on the mechanism of action of uproleselan," said John Magnani, Ph.D., GlycoMimetics Senior Vice President and Chief Scientific Officer. "AML cells that bind…

    Research shows that uproleselan is a potent antagonist of E-selectin, can break chemoresistance

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that important new preclinical data on the mechanism of action for its late-stage clinical candidate, uproleselan, are published in the April 27, 2020, issue of Nature Communications. The paper outlines how uproleselan, an investigational, first-in-class, targeted inhibitor of E-selectin, can reduce chemoresistance in acute myeloid leukemia (AML) through the key mechanism of targeted E-selectin inhibition.1

    "This paper offers compelling data on the mechanism of action of uproleselan," said John Magnani, Ph.D., GlycoMimetics Senior Vice President and Chief Scientific Officer. "AML cells that bind E-selectin become chemoresistant in protective niches in the bone marrow, eventually causing relapsed disease. This data demonstrates that, as a potent antagonist of E-selectin, uproleselan breaks this chemoresistance."

    Barbier et.al. explain in the manuscript how AML blasts release inflammatory cytokines that further enhance the expression of E-selectin. AML blasts that strongly express the E-selectin ligand (sialyl Lex), in particular, are 12 times more likely to survive chemotherapy, and this is a major cause of relapsed disease. By selectively inhibiting E-selectin, uproleselan disrupts this pro-survival pathway and prolongs survival when paired with chemotherapy in an animal model of AML.

    The journal article can be accessed here.

    1 Barbier et.al. Nature Communications (April 27) doi.org/10.1038/s41467-020-15817-5

    About Uproleselan

    Discovered and developed by GlycoMimetics, uproleselan and GMI-1687 are investigational, first-in-class, targeted inhibitors 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.

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics' wholly-owned 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. 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 regarding the clinical development and potential benefits and impact of the Company's drug candidates. Actual results may differ materially from those 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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  32. GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that it will host a conference call and webcast to report its first quarter financial results on Friday, May 1, 2020, 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 4567397. 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 4567397.

    We encourage speakers and participants to connect early to ensure…

    GlycoMimetics, Inc. (NASDAQ:GLYC) announced today that it will host a conference call and webcast to report its first quarter financial results on Friday, May 1, 2020, 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 4567397. 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 4567397.

    We encourage speakers and participants to connect early to ensure that all callers are able to connect. Perhaps, include language in earnings announcement and release to remind all speakers/participants to dial in 15 minutes prior to the call start time. Also, any callers who would like to ask questions, to queue early in the call.

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics' wholly-owned drug candidate, uproleselan, an E-selectin antagonist, was evaluated in a Phase 1/2 clinical trial as a potential treatment for Acute Myeloid Leukemia and is being evaluated across a range of patient populations including a Company-sponsored Phase 3 trial in relapsed/refractory AML. 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 regarding the Company's strategy and the clinical development and potential benefits and impact of its drug candidates. These forward-looking statements include those relating to the planned clinical development of the Company's product candidates, including expectations with regard to the enrollment of patients in its ongoing Phase 3 clinical trial, and its other plans for its current cash resources. Actual results may differ materially from those 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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  33. GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that veteran regulatory expert Myra Rosario Herrle, PhD, RPh, RAC, has joined the executive management team as Vice President, Regulatory Affairs.

    "We look forward to leveraging Myra's extensive regulatory expertise as we continue to progress our pipeline of novel, small-molecule glycomimetic therapeutics," said Chief Executive Officer Rachel King. "Her guidance will be particularly welcome as we continue our ongoing Phase 3 registration trial of uproleselan in relapsed or refractory acute myeloid leukemia (AML), and work in collaboration with the National Cancer Institute (NCI) on the institute's multi-center Phase 3 trial to evaluate the drug candidate in newly-diagnosed patients fit for…

    GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that veteran regulatory expert Myra Rosario Herrle, PhD, RPh, RAC, has joined the executive management team as Vice President, Regulatory Affairs.

    "We look forward to leveraging Myra's extensive regulatory expertise as we continue to progress our pipeline of novel, small-molecule glycomimetic therapeutics," said Chief Executive Officer Rachel King. "Her guidance will be particularly welcome as we continue our ongoing Phase 3 registration trial of uproleselan in relapsed or refractory acute myeloid leukemia (AML), and work in collaboration with the National Cancer Institute (NCI) on the institute's multi-center Phase 3 trial to evaluate the drug candidate in newly-diagnosed patients fit for chemotherapy."

    Dr. Herrle brings 25 years of pharmaceutical industry experience – with 15 years of regulatory experience and a deep background in oncology -- to her role at GlycoMimetics. Most recently, she served as Senior Director, Oncology Global Regulatory Strategy at AbbVie. Previously, she held positions of increasing responsibility at Novartis Pharmaceuticals Corporation, including Associate Director of Oncology Regulatory Affairs, Global Program Regulatory Director and Global Therapeutic Area Lead (Executive Director). Prior to Novartis, she was the Therapeutic Area Lead/Director of Oncology at Glaxo Wellcome/GlaxoSmithKline, focusing on oncology, musculoskeletal and inflammatory diseases.

    About Uproleselan (GMI-1271)

    Discovered and developed by GlycoMimetics, uproleselan is 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. Food and Drug Administration (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.

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics' wholly-owned 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. 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 regarding the clinical development and potential benefits and impact of the Company's drug candidates. These forward-looking statements include those relating to the planned clinical development of the Company's wholly-owned product candidates and the receipt of data from Pfizer's Phase 3 clinical trial of rivipansel. Actual results may differ materially from those 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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  34. GlycoMimetics, Inc. (the "Company") (NASDAQ:GLYC) today announced that the compensation committee of the Company's Board of Directors approved the grant on April 1, 2020 of non-qualified stock option awards to purchase an aggregate of 40,600 shares of its common stock to two new employees. The options were granted as inducement equity awards outside of the Company's 2013 Equity Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4), and were made as an inducement material to the acceptance of employment with the Company by each of the new employees. The options are subject to the terms and conditions of stock option agreements covering the respective grants and the GlycoMimetics, Inc. Inducement Plan, which was adopted January 22…

    GlycoMimetics, Inc. (the "Company") (NASDAQ:GLYC) today announced that the compensation committee of the Company's Board of Directors approved the grant on April 1, 2020 of non-qualified stock option awards to purchase an aggregate of 40,600 shares of its common stock to two new employees. The options were granted as inducement equity awards outside of the Company's 2013 Equity Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4), and were made as an inducement material to the acceptance of employment with the Company by each of the new employees. The options are subject to the terms and conditions of stock option agreements covering the respective grants and the GlycoMimetics, Inc. Inducement Plan, which was adopted January 22, 2020 and provides for the granting of stock options to new employees.

    The stock option awards have an exercise price equal to the closing price of the Company's common stock on April 1, 2020. The options have a ten-year term and vest over four years, with one-fourth of the shares vesting one year after the grant date, and the balance of the shares vesting in a series of thirty-six successive equal monthly installments measured from the first anniversary of the grant date, subject to the new employee's continued service with the Company through the applicable vesting dates.

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics' wholly-owned 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. 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 regarding the clinical development and potential benefits and impact of the Company's drug candidates. These forward-looking statements include those relating to the planned clinical development of the Company's wholly-owned product candidates. Actual results may differ materially from those 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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    • Continued patient enrollment in both the Company-sponsored and NCI-sponsored Phase 3 clinical trials of uproleselan in acute myeloid leukemia (AML)
    • Finalized an exclusive collaboration and license agreement with Apollomics for development and commercialization of uproleselan and GMI-1687 in the Greater China region
    • Announced in early 2020 first patient dosing in Phase 1b clinical trial of GMI-1359 in individuals with breast cancer, led by co-principal investigators from the Duke Cancer Institute
    • Upon receiving notice of Pfizer's termination of license agreement for rivipansel in early 2020, indicated we will work to determine what, if any, next steps to take after more completely reviewing Phase 3 clinical data in vaso-occlusive sickle
    • Continued patient enrollment in both the Company-sponsored and NCI-sponsored Phase 3 clinical trials of uproleselan in acute myeloid leukemia (AML)
    • Finalized an exclusive collaboration and license agreement with Apollomics for development and commercialization of uproleselan and GMI-1687 in the Greater China region
    • Announced in early 2020 first patient dosing in Phase 1b clinical trial of GMI-1359 in individuals with breast cancer, led by co-principal investigators from the Duke Cancer Institute
    • Upon receiving notice of Pfizer's termination of license agreement for rivipansel in early 2020, indicated we will work to determine what, if any, next steps to take after more completely reviewing Phase 3 clinical data in vaso-occlusive sickle cell crisis
    • To host conference call and webcast today at 8:30 a.m. ET

    GlycoMimetics, Inc. (NASDAQ:GLYC) today reported its financial results for the year and fourth quarter ended December 31, 2019 and highlighted recent company events including several accomplishments reported to date in 2020. Cash and cash equivalents at December 31, 2019 were $158.2 million.

    "GlycoMimetics ended 2019 with robust support from investigators for our uproleselan Phase 3 registration program in relapsed/refractory AML as well as our collaboration with the National Cancer Institute (NCI) on a multi-center clinical trial evaluating the drug candidate in newly diagnosed patients fit for chemotherapy. The two trials have raised awareness of our clinical data to date suggesting that uproleselan may be clearly differentiated from other drugs in development in AML. Endpoints from the two studies have potential to demonstrate that uproleselan could both extend survival and ameliorate the severe side effects experienced by patients following standard treatment," commented Rachel King, Chief Executive Officer.

    "Given our current cash position, we are confident that we can move through key milestones in the uproleselan program, advance our other pipeline programs, and continue to leverage our unique glycochemistry platform to deliver important and potentially game-changing treatments to patients and caregivers. With regard to Pfizer's recent decision to return rivipansel rights to us, we look forward to reviewing the full Phase 3 clinical data set and will work to determine what, if any, next steps to take," she added.

    Uproleselan

    • GlycoMimetics' pivotal Phase 3 trial of uproleselan in relapsed/refractory AML continued to initiate and activate clinical sites and to enroll patients in the U.S., Australia and in Europe, with completion of enrollment expected to occur in the second half of 2021.
    • Investigators continued to enroll patients in the NCI-sponsored Phase 3 clinical trial designed to evaluate uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy.
    • GlycoMimetics and Apollomics announced in January 2020 an exclusive collaboration and license agreement for the development and commercialization of uproleselan and GMI-1687 in Mainland China, Hong Kong, Macau and Taiwan.
    • Clinical data shared at the Annual ASH Meeting showed that uproleselan can potentially selectively break the underlying environment-mediated drug resistance of AML bone marrow tumors and prolong overall survival in high-risk patients with AML. Other presentations highlighted E-selectin as a major extrinsic contributor to chemoresistance in AML.

    Rivipansel

    • Pfizer announced in August 2019 that its Phase 3 clinical trial evaluating rivipansel in sickle cell disease (SCD) failed to meet the primary endpoint and key secondary endpoints.
    • In February 2020, GlycoMimetics received written notice from Pfizer of the termination of the parties' 2011 rivipansel license agreement, including the return of all rights and licenses previously granted to Pfizer. This termination becomes effective in April 2020, and GlycoMimetics will work to assess what, if any, next steps to take with respect to the rivipansel program after reviewing Pfizer's Phase 3 clinical data more completely.

    GMI-1359

    • Duke University initiated a proof-of-concept Phase 1b study to evaluate GMI-1359 in patients with advanced breast cancer with bone metastases, and investigators dosed the first patient in January of this year. The trial is evaluating safety and biomarkers of cancer cell mobilization in individuals with hormone receptor positive metastatic breast cancer.
    • Shortly after the 2019 year-end, a new composition of matter and formulation patent issued for GMI-1359, and the U.S. Food and Drug Administration (FDA) granted orphan drug and rare pediatric disease designations for the drug candidate for the treatment of osteosarcoma that may provide future development support and marketing protections.

    Fourth Quarter and Year-end 2019 Financial Results:

    • Cash position: As of December 31, 2019, GlycoMimetics had cash and cash equivalents of $158.2 million as compared to $209.9 million as of December 31, 2018.
    • R&D Expenses: The Company's research and development expenses decreased to $11.5 million for the quarter ended December 31, 2019 as compared to $12.0 million for the fourth quarter of 2018. This decrease was due to a reduction in manufacturing expenses in combination with an increase in clinical expenses in the fourth quarter of 2019 as compared to the same quarter in 2018. In the fourth quarter of 2018, the manufacturing expenses included raw materials for the upcoming manufacturing batches that were initiated in 2019. The clinical expenses increased in the fourth quarter of 2019 due to the start-up clinical costs related to our randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate uproleselan in individuals with relapsed/refractory AML.



      Research and development expenses increased by $6.9 million to $47.0 million for the year ended December 31, 2019, from $40.1 million in the year ended December 31, 2018. These increases were primarily the result of increased clinical costs related to our randomized, double-blind, placebo-controlled Phase 3 clinical trial to evaluate uproleselan in individuals with relapsed/refractory AML and costs associated with the Phase 2/3 randomized, controlled clinical trial to evaluate uproleselan in older adults with previously untreated AML who are suitable for intensive chemotherapy which is being conducted by the NCI. The NCI trial opened for enrollment in early 2019 and enrolled the first patient in April 2019. Personnel-related and stock-based compensation expenses increased due to an increase in clinical headcount and annual stock option awards granted in 2019.
    • G&A Expenses: The Company's general and administrative expenses increased to $3.9 million for the quarter ended December 31, 2019 as compared to $2.9 million for the fourth quarter of 2018. General and administrative expenses for the year ended December 31, 2019 increased to $14.4 million as compared to $11.4 million in the prior year. These increases were primarily due to higher legal and patent expenses as well as labor-related costs and stock-based compensation expense. Patent expenses were higher due to an increase in the number of patent applications filed in 2019 as compared to 2018. Personnel-related and stock-based compensation expenses increased due to additional headcount in 2019, annual salary adjustments and stock option and restricted stock unit awards granted in 2019.
    • Shares Outstanding: Shares of common stock outstanding as of December 31, 2019 were 43,466,933.

    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 4169765. 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 4169765.

    About Uproleselan (GMI-1271) and GMI-1687

    Discovered and developed by GlycoMimetics, uproleselan and GMI-1687 are investigational, first-in-class, targeted inhibitors 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 (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.

    GMI-1687 is a rationally designed, innovative antagonist of E-selectin that is potentially suitable for subcutaneous (SC) administration. When given by SC injection in preclinical models, GMI-1687 has been observed to have equivalent activity to uproleselan, but at an approximately 1,000-fold lower dose. GlycoMimetics believes that GMI-1687 could be developed as a potential life-cycle expansion to broaden the clinical usefulness of an E-selectin antagonist to conditions where outpatient treatment is preferred or required. GMI-1687 is currently undergoing investigational new drug (IND)-enabling studies.

    About GMI-1359

    GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both 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 acute myeloid leukemia (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. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. The newly initiated Phase 1b clinical study in breast cancer patients is designed to enable investigators to identify an effective dose of the drug candidate and to generate initial biomarker data around the drug's activity. GMI-1359 has received Orphan Drug Designation and Rare Pediatric Disease Designation from the FDA for the treatment of osteosarcoma, a rare cancer affecting about 900 adolescents a year in the United States.

    About GlycoMimetics, Inc.

    GlycoMimetics is a clinical-stage biotechnology company focused on the discovery and development of novel glycomimetic drugs to address unmet medical needs resulting from diseases in which carbohydrate biology plays a key role. GlycoMimetics' wholly-owned 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. 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 regarding the Company's strategy and the clinical development and potential benefits and impact of its drug candidates. These forward-looking statements include those relating to the planned clinical development of the Company's product candidates, including expectations with regard to the enrollment of patients in its ongoing Phase 3 clinical trial, and its other plans for its current cash resources. Actual results may differ materially from those 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.

     

    GlycoMimetics, Inc.

    Condensed Statements of Operations

    (In thousands, except share and per share data)

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Three months ended December 31,

     

    Year ended December 31,

     

     

    2019

     

    2018

     

    2019

     

    2018

     

     

    (Unaudited)

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Revenue

     

    $

     

    $

     

    $

     

    $

     

     

     

     

     

     

     

     

     

     

     

     

     

    Costs and expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development expense

     

     

    11,467

     

     

    12,039

     

     

    47,029

     

     

    40,092

    General and administrative expense

     

     

    3,868

     

     

    2,921

     

     

    14,360

     

     

    11,413

    Total costs and expenses

     

     

    15,335

     

     

    14,960

     

     

    61,389

     

     

    51,505

     

     

     

     

     

     

     

     

     

     

     

     

     

    Loss from operations

     

     

    (15,335)

     

     

    (14,960)

     

     

    (61,389)

     

     

    (51,505)

     

     

     

     

     

     

     

     

     

     

     

     

     

    Interest income

     

     

    609

     

     

    1,053

     

     

    3,497

     

     

    3,231

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss and comprehensive loss

     

    $

    (14,726)

     

    $

    (13,907)

     

    $

    (57,892)

     

    $

    (48,274)

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

    Net loss per common share – basic and diluted

     

    $

    (0.34)

     

    $

    (0.32)

     

    $

    (1.34)

     

    $

    (1.18)

    Weighted-average common shares – basic and diluted

     

     

    43,373,753

     

     

    43,143,272

     

     

    43,254,782

     

     

    41,044,621

    GlycoMimetics, Inc.

    Balance Sheet Data

    (In thousands)

     

     

    December 31,