HOUSTON - Moleculin Biotech, Inc. (NASDAQ:MBRX), a clinical stage pharmaceutical company, announced today that it has received an Issue Notification from the United States Patent and Trademark Office for a patent related to its drug candidate Annamycin. The patent, which will be officially issued on April 9, 2024, extends composition of matter protection until June 2040, with the possibility for further extension.
The patent, numbered 11,951,118, covers the preparation of a preliposomal formulation of Annamycin, a novel treatment for acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets). This development is particularly significant for the estimated 58% of AML patients who currently have no approved therapy available.
Walter Klemp, CEO and Chairman of Moleculin, expressed that the patent issuance is timely, coinciding with potential partnering discussions and follows recent clinical results where Annamycin demonstrated a 60% complete response composite rate in second-line AML subjects. This rate surpasses that of other drugs approved for the same condition.
Annamycin is designed to avoid multidrug resistance and minimize cardiotoxicity, common issues with current treatments. Moleculin's pipeline also includes other drug candidates targeting difficult-to-treat tumors and viruses, such as WP1066 and WP1220 for various cancers and antimetabolites like WP1122 for potential treatment of viruses and cancers.
The company's growing portfolio and recent clinical advancements suggest a positive outlook for addressing unmet needs in cancer therapy. Moleculin's relationship with MD Anderson is managed in accordance with an institutional conflict of interest plan due to a disclosed institutional conflict of interest.
This news is based on a press release statement and the patent's expected issuance is subject to change. Moleculin's forward-looking statements involve risks and uncertainties, and actual results may differ materially from those projected. The company does not undertake any obligation to update forward-looking statements.
InvestingPro Insights
As Moleculin Biotech, Inc. (NASDAQ:MBRX) prepares for the official issuance of a patent that could provide long-term protection for its drug candidate Annamycin, the company's financial metrics provide additional context for investors. With a market cap of approximately $10.42 million, MBRX is a small-cap company that could offer growth opportunities, particularly as it advances its clinical pipeline. However, the company is not without its challenges. According to recent data, Moleculin has reported an operating loss of $29.63 million over the last twelve months, highlighting the high costs associated with drug development and the importance of successful commercialization of its products.
Annamycin's potential in treating AML and STS lung mets is a key focus for the company, but InvestingPro Tips suggest that MBRX is currently burning through cash quickly and analysts do not anticipate the company will be profitable this year. This underscores the importance of the company's ability to manage its financial resources effectively while pursuing its clinical objectives.
Moreover, the stock's performance has been notably volatile, with a 1-month price total return of -49.35%, indicating significant investor sensitivity to news and market conditions. For those considering an investment in Moleculin, it may be valuable to explore the full range of InvestingPro Tips, which include 13 additional insights on the company's financial health and stock performance. These tips can be found by visiting the dedicated page at https://www.investing.com/pro/MBRX.
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