GlycoMimetics Reports Fourth Quarter and Year-End 2018 Results
- Initiated first company-sponsored Phase 3 pivotal trial of uproleselan in relapsed/refractory acute myeloid leukemia (AML) at sites in U.S., Europe, Canada and Australia
- Provided oral presentation at the
American Societyof Hematology (ASH) Annual Meeting in December 2018on the final clinical outcomes data and subgroup analyses from the Phase 1/2 AML trial of uproleselan, which supports the potential benefit of treatment when added to chemotherapy
- Pfizer, the Company’s strategic collaborator, continued to enroll patients with sickle cell disease (SCD) in its Phase 3 clinical trial of rivipansel for the treatment of vaso-occlusive crisis (VOC) and reports that the trial remains on track to be completed in early 2019, with top-line data expected to be announced late in the second quarter of 2019
- Ended the year in a strong financial position with cash and cash equivalents of
- The Company will host a call and webcast today at
8:30 a.m. ET
2018 and Recent Highlights
GlycoMimetics-sponsored pivotal Phase 3 trial of uproleselan in relapsed/refractory AML enrolled its first patient; multiple investigative sites have now been initiated; work continues to expand to clinical sites across the US, Europe, Canada and Australia
- The National Cancer Institute (NCI) collaborative study of uproleselan in newly diagnosed patients fit for chemotherapy has opened and is recruiting patients at multiple sites
- Planning continues for the collaborative
Haemato Oncology Foundationfor Adults in the Netherlands (HOVON) European study of uproleselan in newly diagnosed patients unfit for chemotherapy with a goal of trial initiation in 2019
- At the ASH Annual Meeting in
December 2018, key new data on clinical outcomes from the Phase 1/2 relapsed/refractory AML trial of uproleselan underscored opportunities to position this drug candidate, if approved, as a potential foundational therapy across the spectrum of AML
- Our Japanese patent for uproleselan was granted in
August 2018, complementing patents already issued in the United Statesand Europe
- Preclinical data for several existing and new pipeline programs, including GMI-1687 and GMI-1757, were presented at key scientific meetings, including AACR in
March 2018and ASH in December 2018
- GlycoMimetics’ collaborator Pfizer advised that top-line results of the rivipansel Phase 3 clinical trial would be announced by late second quarter 2019
Scott Jackson, veteran biopharma executive, joined the Board of Directors
- Chairman of the Board,
M. James Barrett, Ph.D., GlycoMimetics’ founding venture investor and John Magnani, Ph.D., GlycoMimetics’ Co-founder and Chief Scientific Officer, notified the company that they will not run for reelection to the Board. At the Annual Meeting of Stockholders on May 17, 2019, the Board Chair position will be taken by Tim Pearson, a GlycoMimetics Director since 2014, and until recently, Chief Financial Officer and Executive Vice President for TESARO, Inc., a publicly held oncology-focused biopharmaceutical company recently acquired by GlaxoSmithKline
Fourth Quarter and Year-end 2018 Financial Results:
- Cash position: As of
December 31, 2018, GlycoMimeticshad cash and cash equivalents of $209.9 millionas compared to $123.9 millionas of December 31, 2017. In March 2018, the Company completed a public offering of 8,050,000 shares of common stock yielding net proceeds of $128.4 million.
- R&D Expenses: The Company’s research and development expenses increased to
$12.0 millionfor the quarter ended December 31, 2018as compared to $6.7 millionfor the fourth quarter of 2017. Research and development expenses increased by $16.0 million to $40.1 millionfor the year ended December 31, 2018, from $24.1 millionin the year ended December 31, 2017. These increases were primarily the result of higher manufacturing costs to scale up production of uproleselan clinical supplies for the Company’s Phase 3 clinical trial and for clinical trials conducted by or in collaboration with third parties. Personnel-related and stock-based compensation increased due to an increase in clinical headcount.
- G&A Expenses: The Company’s general and administrative expenses increased to
$2.9 millionfor the quarter ended December 31, 2018as compared to $2.8 millionfor the fourth quarter of 2017. General and administrative expenses for the year ended December 31, 2018increased to $11.4 millionas compared to $9.8 millionin the prior year. These increases were primarily due an increase in 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. Personnel-related and stock-based compensation expenses increased due to additional headcount in 2018, annual salary adjustments and annual stock option awards granted in the first quarter of 2018.
- Shares Outstanding: Shares of common stock outstanding as of
December 31, 2018were 43,160,751.
The company will host a conference call and webcast today at
About Uproleselan (GMI-1271)
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 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.
GMI-1359 is designed to simultaneously inhibit both E-selectin and CXCR4. E-selectin and CXCR4 are both adhesion molecules that keep cancer cells in the bone marrow. 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. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers.
rivipansel, the most advanced drug candidate in the
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.
This press release contains forward-looking statements regarding the clinical development and regulatory pathway of the Company’s drug candidates, including the expected enrollment in and conduct of clinical trials, expected timelines related to the announcement of top-line rivipansel data, the potential for rivipansel and the Company’s other drug candidates to be attractive therapies if approved and the expected safety and efficacy of the Company’s drug candidates based on data from completed clinical trials. 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
|Condensed Statements of Operations|
|(In thousands, except share and per share data)|
|Three months ended December 31,||Year ended December 31,|
|Costs and expenses:|
|Research and development expense||12,039||6,720||40,092||24,100|
|General and administrative expense||2,921||2,816||11,413||9,832|
|Total costs and expenses||14,960||9,536||51,505||33,932|
|Loss from operations||(14,960)||(9,536)||(51,505)||(33,932)|
|Net loss and net comprehensive loss||$||(13,907)||$||(9,258)||$||(48,274)||$||(33,281)|
|Net loss per common share – basic and diluted||$||(0.32)||$||(0.27)||$||(1.18)||$||(1.13)|
|Weighted average common shares – basic and diluted||43,143,272||34,138,681||41,044,621||29,395,756|
|Balance Sheet Data|
|December 31,||December 31,|
|Cash and cash equivalents||$||209,918||$||123,925|
|Total stockholders' equity||205,464||119,701|