GlycoMimetics Reports Operational Highlights and Financial Results for First Quarter 2020
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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
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To host conference call and webcast today at
8:30 a.m. ET
“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
“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
Operational Highlights
Uproleselan
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GlycoMimetics’ pivotal Phase 3 trial in relapsed/refractory AML continued to activate clinical sites and enroll patients in the
U.S. ,Australia andEurope throughMarch 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, throughMarch 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 andTaiwan (Greater China ).
GMI-1359
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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 theU.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
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GlycoMimetics and Pfizer worked closely to prepare for the transfer back toGlycoMimetics of the rivipansel program following Pfizer’sApril 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
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Cash position: As of
March 31, 2020 ,GlycoMimetics had cash and cash equivalents of$ 154.8 million as compared to$158.2 million as ofDecember 31, 2019 . InJanuary 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 inGreater China .
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R&D Expenses: The Company’s research and development expenses increased to
$12.7 million for the quarter endedMarch 31, 2020 as compared to$ 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 endedMarch 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 endedMarch 31, 2020 as compared to the first quarter endedMarch 31, 2019 .
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G&A Expenses: The Company’s general and administrative expenses increased to
$4.4 million for the quarter endedMarch 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 endedMarch 31, 2020 as compared toMarch 31, 2019 .
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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
About Uproleselan and GMI-1687
Discovered and developed by
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.
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
About
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
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Condensed Statements of Operations |
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(In thousands, except share and per share data) |
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Three months ended |
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2020 |
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2019 |
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(Unaudited) |
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Revenue |
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$ |
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$ |
— |
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Costs and expenses: |
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Research and development expense |
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12,668 |
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11,773 |
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General and administrative expense |
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4,440 |
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3,360 |
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Total costs and expenses |
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17,108 |
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15,133 |
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Loss from operations |
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(8,108) |
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(15,133) |
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Interest income |
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445 |
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1,049 |
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Net loss and comprehensive loss |
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$ |
(7,663) |
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$ |
(14,084) |
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Net loss per common share – basic and diluted |
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$ |
(0.18) |
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$ |
(0.33) |
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Weighted-average common shares – basic and diluted |
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43,575,590 |
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43,166,967 |
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Balance Sheet Data |
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(In thousands) |
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2020 |
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2019 |
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(unaudited) |
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Cash and cash equivalents |
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$ |
154,823 |
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$ |
158,201 |
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Working capital |
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146,269 |
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151,577 |
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Total assets |
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162,099 |
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167,970 |
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Total liabilities |
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13,609 |
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13,769 |
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Total stockholders' equity |
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148,490 |
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154,201 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20200501005068/en/
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