GlycoMimetics Reports Program Updates and Second Quarter 2017 Results
FDAgranted Breakthrough Therapy designation to the Company's drug candidate, GMI-1271, for treatment of adults with relapsed/refractory acute myeloid leukemia (AML)
- Company completed enrollment in the in Phase 2 portion of its Phase 1/2 trial of GMI-1271 for the treatment of AML
Clinicians presented interim clinical data from the Phase 1/2 trial of
GMI-1271 for the treatment of AML at the 2017 American Society of
Clinical Oncology (ASCO) and European Hematology Association(EHA) meetings
Company completed public offering raising gross proceeds of
"In the second quarter of 2017,
"The recent spotlight on our fast-progressing program in AML, however, should not obscure the potential of our platform and broad pipeline opportunities. In particular, GMI-1359, is a compound with potential in multiple cancer indications and is now in Phase 1 trials in healthy volunteers. During 2018, we plan to identify the initial patient population in which we will evaluate this compound. In addition, our most advanced clinical development program to evaluate GlycoMimetics' drug candidate rivipansel for the treatment of vaso-occlusive crisis of sickle cell diseases, is on track to complete enrollment of the Phase 3 pivotal trial in the second half of 2018, according to our collaborator Pfizer," she added.
Key Operational Highlights for the Second Quarter of 2017:
The company presented new data from its Phase 1/2 AML trial of
GMI-1271 at the
June 2017annual meetings of ASCO and EHA. In the relapsed or refractory disease arm of the trial, 66 patients had been enrolled. Of the 54 relapsed/refractory AML patients for whom data was available, the CR/CRi rate was 41%. The mortality rate among this group at 60 days was 7%. We believe these results compare favorably to what would be expected in this population, based on published historical controls in similar patients. Researchers also observed a median E-selectin ligand expression of 35% at baseline, with higher rates among those patients in this cohort who achieved remission. In the newly-diagnosed, treatment-naïve elderly arm of the trial, 25 patients had been enrolled. Among these 25 patients, the CR/CRi rate was 68%, with a 73% rate for patients with de novo disease and 64% for patients with secondary AML.
May 2017, the company completed enrollment of 91 patients in the Phase 1/2 trial of GMI-1271. The Phase 2 portion of the trial included one cohort of 25 patients over 60 years of age with newly diagnosed AML and a second cohort of 44 patients with relapsed or refractory AML. Unlike in the Phase 1 portion, some of the patients in the Phase 2 portion may be treated with multiple cycles of GMI-1271. We plan to provide additional updates from this clinical trial in the second half of 2017 and in 2018. We also intend to discuss with the FDAthe design of a potential Phase 3 pivotal trial that could support an application for marketing approval for GMI-1271 for the treatment of AML.
May 2017, GMI-1271 received Breakthrough Therapy designation from the FDAfor the treatment of adults with relapsed/refractory AML. The FDAgrants Breakthrough Therapy designation to companies to help accelerate development and review of drug candidates when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. The designation is designed to expedite the development and review of designated therapies, without changing FDAstandards for new drug approval. In addition, in May 2017, the European Commission, based on a favorable recommendation from the European Medicines Agency Committee for Orphan Medicinal Products, granted orphan designation for GMI-1271 for the treatment of AML.
Second Quarter 2017 Financial Results:
Cash position: As of
June 30, 2017, GlycoMimeticshad cash and cash equivalents of $119.1 millionas compared to $40.0 millionas of December 31, 2016. The Company raised $86.8 millionin net proceeds from the public offering of common stock completed in May 2017and an additional $7.4 millionin net proceeds under an at-the-market equity facility that was terminated in May 2017in connection with the public offering.
R&D Expenses: The company's research and development expenses
$5.7 millionfor the quarter ended June 30, 2017as compared to $5.8 millionfor the second quarter of 2016. The decrease was primarily caused by a decrease in expenses related to non-clinical toxicology studies and manufacturing and process development for its earlier-state drug candidate, GMI-1359, partially offset caused by the on-going costs associated with the ongoing clinical trials of GMI-1271 for the treatment of AML and multiple myeloma (MM).
G&A Expenses: The company's general and administrative expenses
$2.5 millionfor the quarter ended June 30, 2017as compared to $2.3 millionfor the second quarter of 2016. These increases were primarily attributable to annual salary adjustments and additional stock-based compensation expense caused by 2017 equity awards to employees and directors.
Shares Outstanding: Shares of common stock outstanding as of
June 30, 2017were 32,716,357.
GMI-1271 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 2 clinical trial which has now completed enrollment, GMI-1271 is being evaluated in both elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations, patients treated with GMI-1271 together with standard chemotherapy have continued to achieve higher than expected remission rates based on historical controls, as well as lower than expected induction-related mortality rates. Importantly, treatment in this patient population has been well tolerated with minimal 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 MM or in solid tumors that metastasize to the bone, such as prostate cancer and breast cancer. GMI-1359 is currently in Phase 1 testing in healthy volunteers.
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.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding the
clinical development of the company's drug candidates, including the
expected timing of completion of clinical trials and the presentation of
clinical data. 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
Six months ended
|Cost and expenses:|
|Research and development expense||5,722||5,781||11,601||11,300|
|General and administrative expense||2,522||2,312||4,614||4,369|
|Total costs and expenses||8,244||8,093||16,215||15,669|
|Loss from operations||(8,244||)||(8,093||)||(16,215||)||(15,669||)|
|Net loss and comprehensive loss||$||(8,142||)||$||(8,071||)||$||(16,073||)||$||(15,627||)|
|Net loss per share - basic and diluted||$||(0.30||)||$||(0.41||)||$||(0.63||)||$||(0.80||)|
|Weighted average shares - basic and diluted||27,239,902||19,793,202||25,360,167||19,432,520|
|Balance Sheet Data|
|Cash and cash equivalents||$||119,148||$||40,042|
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