GlycoMimetics (NASDAQ: GLYC) has soared 172% since a company conference call on Wednesday announcing results from its ongoing Phase 2 clinical trials of its product candidate GMI-1271.
GLYC has seen huge volume the past few days and it has moved from $5.38 to a high of $14.64.
Driving this move was GLYC’s announcement on its ongoing Phase 2 clinical trials of GMI-1271 which included the following results:
In the ongoing Phase 2 trial, AML patients treated with GMI-1271, combined with chemotherapy, continue to experience higher-than-expected remission rates and lower-than-expected induction-related mortality rates in both arms of the trial. In addition, researchers have observed that baseline expression of the E-selectin ligand biomarker on leukemia cells was predictive of clinical response and tied to greater likelihood of achieving remission in the cohort of AML patients with relapsed/refractory disease, which supports the mechanism of action of GMI-1271. Treatment with GMI-1271 continues to be well tolerated, with no obvious incremental toxicity observed when GMI-1271 is added to chemotherapy.
In addition, GLYC’s product candidate, GMI-1271, has also received a Breakthrough Therapy designation from the FDA for treatment of adult relapsed/refractory acute myeloid leukemia (AML.
According to GLYC’s press release:
The FDA grants 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 FDA standards for new drug approval.
GLYC’s stock has seen some pullback since the end of March when it was announced that Scott Koenig would be joining the board and two other board directors would be stepping down.
On May 8th, GLYC announced Q117 earnings results and here are the highlights:
- The first of two patient cohorts in the Phase 2 portion of the AML trial of GMI-1271 has completed enrollment.
- Pre-clinical research supporting the potential of two of its drug candidates, GMI-1271 and GMI-1359, against multiple myeloma was shared via an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2017.
- GLYC announced that it will provide an update on clinical data from its Phase 1/2 study of GMI-1271 in AML at the 2017 American Society for Clinical Oncology in Chicago.
- Cash position: As of March 31, 2017, GLYC had cash and cash equivalents of $34.6 million as compared to $40.0 million as of December 31, 2016. Subsequent to March 31, 2017, GLYC has raised an additional $3.8 million in net proceeds under the at-the-market facility.
- R&D Expenses: GLYC’s research and development expenses increased to $5.9 million for the quarter ended March 31, 2017 as compared to $5.5 million for the first quarter of 2016. The increase was due to on-going costs associated with the clinical trials for GMI-1271 in AML and MM, partially offset by a decrease in expenses related to manufacturing and process development for GMI-1271.
- G&A Expenses: GLYC’s general and administrative expenses remained at $2.1 million for both the quarters ended March 31, 2017 and 2016.
- Shares Outstanding: Shares outstanding as of March 31, 2017 were 23,855,934.
GLYC is a clinical-stage biotechnology company that uses novel and proprietary glycobiology technology to develop treatments for diseases, particularly where there is high unmet need.
Rivipansel, the lead candidate within GLYC’s clinical portfolio is in a Phase 3 clinical trial being conducted by Pfizer Inc.
It has been shown in a Phase 2 clinical study to have the potential to provide a treatment for vaso-occlusive crisis of sickle cell disease, one of the most common genetic diseases in the United States.
GLYC began clinical trials of its second drug candidate, GMI-1271, in 2014.
This drug candidate is currently being studied in a Phase 1/2 clinical trial as a potential treatment for AML in combination with chemotherapy and in a Phase 1 clinical trial, combined with bortezomib-based chemotherapy, as a potential treatment for multiple myeloma.
Recent Company Milestones
GLYC has primarily been focused on advancing the clinical trials of its products and presenting data as it moves these products through the approval process:
- May 2017 – Announces high overall response rates, low induction mortality, and promising survival outcomes for its GMI-1271 Phase 2 trial (see news release)
- May 2017 – Receives FDA Breakthrough Therapy designation for adult relapsed/refractory acute myeloid leukemia (see news release)
- March 2017 – Appoints Scott Koenig to board of directors (see news release)
- March 2017 – Completes enrollment of newly diagnosed AML patient cohort in Phase 2 clinical trial of GMI-1271 (see news release)
GLYC is led by a seasoned management team with experience growing early-stage biotech companies and bringing products through clinical trials.
Rachel H. King
Chief Executive Officer
Mrs. King is co-founder and CEO of GLYC Before founding GLYC, she was an Executive in Residence at New Enterprise Associates (NEA), one of the nation’s leading venture capital firms. Mrs. King came to NEA after serving as a Senior Vice President of Novartis Corporation. Before joining Novartis, Mrs. King spent ten years with Genetic Therapy, Inc. through the company’s early stage, initial public offering, and eventual sale to Novartis. After the sale to Novartis, she was named CEO and ran the company as a wholly owned subsidiary of Novartis.
John Magnini, Ph.D.
Senior Vice-President, Research and Chief Scientific Officer
Dr. Magnani is co-founder and CSO of GLYC. Prior to co-founding GLYC, Dr. Magnani founded and led the predecessor company, GlycoTech Corporation as its President and CEO. Previously, he helped co-found the U.S. subsidiary of BioCarb and became its international Vice President of Research.
Helen Thackray, M.D., FAAP
Senior Vice-President, Clinical Development and Chief Medical Officer
Dr. Thackray joined GLYC in 2006. She has extensive experience in design and execution of clinical trials, including early-stage development of novel biologics and small molecules through to successful clinical proof of concept. In addition, she has a particular interest in Orphan Drug and Fast Track products.
Chief Financial Officer
Mr. Hahn has over 15 years of senior financial and operations experience in emerging organizations. He joined GLYC in 2010. Previously, Mr. Hahn served as Executive Director of Finance at MiddleBrook Pharmaceuticals (formerly Advancis Pharmaceutical), a publicly traded specialty pharmaceutical company.
Vice President, Corporate Development
Mr. Girard has extensive partnering experience having completed collaborations, licenses, acquisitions and spinouts by and between leading pharmaceutical and biotech companies. As GLYC’s Vice President of Corporate Development, he is responsible for corporate strategy, for pursuing partnering and licensing opportunities in support of the GLYC pipeline, and for managing the company’s corporate and institutional alliances.
Vice President, Technical Operations
Mr. Flanner has over 20 years of experience in the development of biopharmaceutical products in emerging pharmaceutical companies. He joined GLYC in 2007 bringing knowledge and experience in chemistry, manufacturing and controls (CMC) as well as biopharmaceutics.
GLYC is delivering solid results in its Phase 2 clinical trials of GM-1271 and appears to have a handle on its business with managing expenses and financings.
As GLYC moves its products through the approval process, continue to keep watching the company as it positions itself to strategically align with a more established player in the biopharma market.
Disclosure: We have no position in GLYC and have not been compensated for this article.