GlycoMimetics Reports First Quarter 2019 Results and Recent Operational Highlights
- Enrolled first patient in
National Cancer Institute(NCI)-sponsored Phase 3 trial of uproleselan in older adults with previously untreated acute myeloid leukemia (AML)
- Announced plans to initiate a trial of GMI-1359 in individuals with
breast cancer in collaboration with the
Duke Cancer Institute
- Established transition plan to new Chairman of Board of Directors
“The first quarter of 2019 was one of focused activity in the clinical
development arena. We continued to identify and initiate new sites and
enroll participants in our Company-sponsored Phase 3 trial in relapsed
or refractory AML patients. We also worked closely with our two
consortia partners to expand our late-stage uproleselan program,
culminating in our announcement that the NCI consortium dosed its first
patient in its trial in late April. During the same period, we worked
with clinical collaborators at
Key First-Quarter 2019 and Recent Operational Highlights:
GlycoMimetics-sponsored pivotal Phase 3 trial of uproleselan in relapsed/refractory AML continues to enroll patients in the US and Australia. Clinical sites across the US, Europe, Canadaand Australiacontinue to be identified and activated.
- The NCI-sponsored clinical trial evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy has initiated enrollment.
Study start-up activities continued for the collaborative
Haemato Oncology Foundation for Adultsin the Netherlands(HOVON) European study of uproleselan in newly diagnosed patients unfit for chemotherapy.
- The Company announced plans to initiate a proof-of-concept clinical trial of GMI-1359 in individuals with breast cancer whose tumors have spread to bone. The trial will evaluate safety and biomarkers of cancer cell mobilization in individuals with hormone receptor positive metastatic breast cancer.
- Data was published in Nature Cell Biology that strongly suggests that E-selectin is key to tumor growth and metastasis to bone and provides further support for the upcoming clinical trial of GMI-1359 in individuals with metastatic breast cancer.
Eric Feldmanhas joined the GlycoMimeticsexecutive team as Vice President, Clinical Development, and Christian Dinneen-Longhas joined as Vice President, Corporate Counsel.
A planned transition is taking place within the Company’s Board of
Directors. Current Board Chair
Jim Barrett, who has held the role since the Company’s inception, will not seek re-election as he retires from the Board of Directors and scales back participation in several organizations. Current GlycoMimetics Board Member Tim Pearson will become Board Chair as of the close of the Company’s annual meeting on May 17, 2019.
First Quarter 2019 Financial Results:
Cash position: As of
March 31, 2019, GlycoMimeticshad cash and cash equivalents of $195.6 millionas compared to $209.9 millionas of December 31, 2018.
R&D Expenses: The Company’s research and development expenses
$11.8 millionfor the quarter ended March 31, 2019as compared to $9.0 millionfor the first quarter of 2018. These increases were primarily the result of the Company’s Phase 3 clinical trial in relapsed or refractory AML patients.
G&A Expenses: The Company’s general and administrative expenses
$3.4 millionfor the quarter ended March 31, 2019as compared to $2.9 millionfor the quarter ended March 31, 2018. The increase was due to higher patent, legal and non-cash stock-based compensation expenses.
Shares Outstanding: Shares outstanding as of
March 31, 2019were 43,180,169.
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 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
Rivipansel, the most advanced drug candidate in the
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. GMI-1359 has completed a Phase 1 clinical trial in healthy volunteers. In the second half of 2019, the Company plans to initiate an exploratory clinical trial in individuals with breast cancer whose tumors have spread to bone.
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 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
|Condensed Statements of Operations|
(In thousands, except share and per share data)
|Three months ended March 31,|
|Cost and expenses:|
|Research and development expense||11,773||9,022|
|General and administrative expense||3,360||2,855|
|Total costs and expenses||15,133||11,877|
|Loss from operations||(15,133||)||(11,877||)|
|Net loss and comprehensive loss||$||(14,084||)||$||(11,513||)|
|Net loss per share - basic and diluted||$||(0.33||)||$||(0.33||)|
|Weighted average shares - basic and diluted||43,166,967||35,156,090|
|Balance Sheet Data|
|March 31,||December 31,|
|Cash and cash equivalents||$||195,561||$||209,918|