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Moleculin Biotech, Inc. (NASDAQ: MBRX) is a clinical stage pharmaceutical company focused on developing therapies for hard-to-treat tumors and viruses. Known for its innovative drug candidates, Moleculin's pipeline aims to address significant unmet medical needs. The company's flagship product, Annamycin, is a next-generation anthracycline designed to overcome multidrug resistance mechanisms and minimize cardiotoxicity. Annamycin is currently in Phase II clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.
Moleculin's research is rooted in discoveries from the acclaimed M.D. Anderson Cancer Center. In addition to Annamycin, the company is developing WP1066, an Immune/Transcription Modulator targeting brain tumors, pancreatic cancer, and other malignancies. WP1066 aims to inhibit oncogenic transcription factors such as p-STAT3 while stimulating the patient's immune response.
Another promising candidate, WP1220, an analog of WP1066, is being developed for the topical treatment of cutaneous T-cell lymphoma. The company also has a robust antimetabolite portfolio, including WP1122, which is being investigated for its potential in treating both viral infections and various cancers.
Recent achievements highlight Moleculin's significant progress. Positive preclinical data for Annamycin were presented at the American Association for Cancer Research (AACR) Annual Meeting, demonstrating its non-cardiotoxic properties and potent inhibition of topoisomerase II-beta. Annamycin has also received Orphan Drug Designation from both the FDA and the European Medicines Agency (EMA) for AML, providing Moleculin with extended market exclusivity and reduced regulatory fees.
Financially, Moleculin maintains a solid footing with sufficient capital to support its ongoing clinical trials and future projects. The company's recent financial report indicates a strategic focus on advancing its clinical and regulatory strategies. With multiple patents issued and pending, Moleculin continues to strengthen its intellectual property portfolio, positioning itself favorably for potential partnerships and market expansion.
Collaborations with leading institutions such as Northwestern University and funding from entities like the National Institutes of Health (NIH) underscore the robust support for Moleculin's initiatives. The company's innovative approach and commitment to addressing challenging medical conditions make it a noteworthy entity in the biopharmaceutical landscape.
For more details, please visit Moleculin's website and connect on Twitter, LinkedIn, and Facebook.
Moleculin Biotech, Inc. (Nasdaq: MBRX) has announced that underwriters of its public offering, dated February 3, 2021, fully exercised their option to purchase an additional 2,141,052 shares at $4.75 each. This brings the total shares sold in the offering to 16,414,736, with gross proceeds of approximately $78.0 million before expenses. The offering was made under a shelf registration statement filed with the SEC. Oppenheimer & Co. acted as the sole book-running manager for this transaction.
Moleculin Biotech announced a grant of $1.5 million from the Polish Medical Research Agency to fund a Phase 1B/2 clinical trial of Annamycin for treating soft tissue sarcoma lung metastases. The trial, led by Prof. Piotr Rutkowski in Warsaw, aims to address the unmet need for better treatments in this area. Annamycin, a next-generation anthracycline, has shown promising results in animal models and lacks the cardiotoxicity seen in traditional treatments like doxorubicin. The study is part of a broader collaboration between US and Polish teams.
Moleculin Biotech, Inc. announced a public offering of 14,273,684 shares of common stock priced at $4.75 per share, expected to close on February 5, 2021. The offering could raise approximately $67.8 million before expenses. The funds will support clinical trials, preclinical programs, and general corporate purposes. The underwriters have an option to purchase an additional 2,141,052 shares. Oppenheimer & Co. Inc. is the sole book-running manager, with Roth Capital Partners and Maxim Group serving as co-managers.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced its intention to conduct an underwritten public offering of common stock or pre-funded warrants. The offering will be managed by Oppenheimer & Co. Inc., which will also have a 30-day option to purchase an additional 15% of the shares. Proceeds will be allocated to clinical trials, preclinical programs, and general corporate purposes. The offering is subject to market conditions and completion timelines are uncertain, as detailed in their effective Form S-3 registration statement.
Moleculin Biotech (Nasdaq: MBRX) announced promising results from a preclinical study demonstrating that Annamycin significantly suppresses tumor growth in metastatic osteosarcoma. Treated animals exhibited a 100% survival rate over 130 days, contrasting with only 10% survival in untreated subjects. Annamycin shows superior lung accumulation compared to doxorubicin, a standard treatment with limited efficacy and cardiotoxicity. The FDA has granted IND status and Orphan Drug Designation for Annamycin in treating soft tissue sarcomas.
Moleculin Biotech (Nasdaq: MBRX) announced an agreement with Catalyst Clinical Research to manage a US clinical trial studying Annamycin's efficacy against soft tissue sarcoma (STS) metastasized to the lungs. STS accounts for approximately 130,000 cases annually, with a significant unmet need for effective therapies, especially post-surgical intervention. Annamycin, a next-generation anthracycline, is expected to avoid the cardiotoxicity seen in standard treatments like doxorubicin. The trial aims to address this critical healthcare gap.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a 1-for-6 reverse stock split, effective January 29, 2021, at 5:00 pm Eastern Time. This move will reduce its outstanding shares from approximately 72 million to 12 million, with no change in the par value per share of $0.001. The adjusted stock will start trading on February 1, 2021, under the symbol 'MBRX.' Fractional shares will be rounded up, and adjustments will be made to stock options and compensation plans. This action is intended to enhance the stock's marketability and comply with Nasdaq listing requirements.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced its participation in the virtual H.C. Wainwright BioConnect 2021 Conference, scheduled for January 11-14, 2021. Management will present on January 11 at 6:00 AM ET. The webcast will be available on demand after the presentation and viewable for 90 days. Moleculin focuses on developing drugs for highly resistant tumors, including Annamycin for acute myeloid leukemia and WP1066 for various cancers. For further details, visit Moleculin's website.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that the FDA has granted Orphan Drug Designation to Annamycin for the treatment of soft tissue sarcomas. This designation can facilitate drug development and provides benefits like tax credits and market exclusivity. The FDA also allowed the company to begin a Phase 1B/2 clinical trial targeting patients with STS that has spread to the lungs. Annamycin shows a significant increase in lung accumulation compared to doxorubicin and lacks cardiotoxicity. This marks the second Orphan Drug designation for Annamycin.
Moleculin Biotech, Inc. announced the FDA's approval of its IND application to commence a Phase 1B/2 clinical trial for Annamycin, targeting soft tissue sarcoma lung metastases. This approval allows the company to address a significant unmet need, as approximately 36,000 new cases of soft tissue sarcoma occur annually in key markets, with a potential market size exceeding $177 million. Annamycin shows promising in vivo antitumor activity and high uptake in lung tissues, potentially outperforming existing treatments. The trial is expected to begin by mid-2021.