ROCKVILLE, Md. - GlycoMimetics, Inc. (NASDAQ:GLYC), a biotechnology firm engaged in the development of therapies for cancer and inflammatory diseases, disclosed today that its Phase 3 trial of uproleselan, in combination with chemotherapy, did not meet the primary endpoint of overall survival in patients with relapsed/refractory acute myeloid leukemia (R/R AML).
The study aimed to determine the efficacy of uproleselan in improving survival rates when used alongside standard chemotherapy treatments.
The international study, which included 388 R/R AML patients, found a median overall survival of 13 months for those treated with uproleselan, marginally higher than the 12.3 months observed in the placebo group. The adverse events reported were in line with the known side effects of the chemotherapy regimens employed in the trial.
Harout Semerjian, CEO of GlycoMimetics, expressed gratitude to the participants and acknowledged the unmet expectations of the trial. The company has initiated a comprehensive data review with expert collaboration and plans to present the findings at a future medical conference.
In parallel, the National Cancer Institute (NCI) continues its Phase 2/3 study of uproleselan in newly diagnosed AML patients, assessing the drug's impact when added to a standard chemotherapy protocol.
Moreover, GlycoMimetics provided a glimpse into its financial health, reporting a cash position of $31.3 million as of March 31, 2024, a decrease from the $41.8 million at the end of the previous year. Research and development expenses rose to $6.0 million for the quarter, while general and administrative costs saw a slight decrease.
The company will conduct a conference call and webcast later today to discuss the trial results and financial updates, replacing the previously scheduled financial results call for May 9, 2024.
Acute myeloid leukemia is a challenging disease with a low survival rate, particularly for those with relapsed or refractory conditions, emphasizing the need for new treatment options.
Uproleselan, an investigational E-selectin antagonist, has previously garnered Breakthrough Therapy and Fast Track designations from the U.S. Food and Drug Administration (FDA) for its potential use in adult AML patients with relapsed or refractory disease.
This report is based on a press release statement from GlycoMimetics, Inc.
InvestingPro Insights
GlycoMimetics, Inc. (NASDAQ:GLYC), a biotech company specializing in novel therapies, recently faced a setback with its uproleselan treatment in a Phase 3 trial. Despite this, the company's financial health and stock performance offer a mixed picture, as reflected in the latest data and analysis from InvestingPro.
InvestingPro Data shows that GlycoMimetics holds a market capitalization of $117.94 million, with a significantly negative P/E ratio of -3.2 for the last twelve months as of Q4 2023, indicating that the company is not currently profitable.
The company has seen a drastic revenue decline of 86.67% during the same period. The stock price has experienced significant volatility, with an 18.06% return over the last week, contrasting with a -33.45% return over the last month and a -42.81% return over the last three months. However, there has been a 37.59% price uptick over the last six months.
InvestingPro Tips for GlycoMimetics highlight that the company holds more cash than debt on its balance sheet, which could provide some financial stability in the short term. Yet, analysts are concerned as the company is quickly burning through cash, and they do not anticipate the company will be profitable this year. Moreover, the stock has been identified as a niche player in its industry, which could impact its market position and growth prospects.
For investors seeking a deeper analysis, InvestingPro offers additional InvestingPro Tips for GlycoMimetics, which can provide further guidance on the company's financial health and stock performance. Interested readers can access these tips and more detailed metrics by visiting https://www.investing.com/pro/GLYC. Users can take advantage of a special offer using coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
The insights from InvestingPro, coupled with the recent clinical trial results, can help investors make informed decisions regarding GlycoMimetics. With a complex landscape in the biotechnology sector, particularly for companies like GlycoMimetics that are working on treatments for serious diseases such as AML, these financial metrics and expert tips are crucial for understanding the potential risks and opportunities.
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