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Moleculin Biotech, Inc. reports developments as a clinical-stage pharmaceutical company advancing drug candidates for hard-to-treat tumors and viruses. Its lead program is Annamycin, also known as naxtarubicin, a next-generation anthracycline designed to avoid cardiotoxicity and multidrug resistance, with development focused on relapsed or refractory acute myeloid leukemia and soft tissue sarcoma lung metastases.
Recurring news covers Annamycin clinical and preclinical data, the MIRACLE study of Annamycin in combination with cytarabine, oncology conference presentations, intellectual-property protection for liposomal Annamycin, and corporate financial updates. Additional pipeline coverage includes WP1066, an immune/transcription modulator targeting p-STAT3 and other oncogenic transcription factors, and WP1122, an antimetabolite program for pathogenic viruses and cancer indications.
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.
Moleculin Biotech (Nasdaq: MBRX) announced the presentation of animal data on December 3, 2020, at the American Society for Hematology's annual meeting. The data demonstrates improved efficacy of its drug, Liposomal Annamycin (L-ANN), in combination with cytarabine (Ara-C) against acute myeloid leukemia (AML). In a mouse model, the combination resulted in median survival extending from 13 to 56-76 days, with some animals completely cured. CEO Walter Klemp expressed optimism about further clinical trials for this promising combination.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that the FDA has granted its drug candidate WP1066 a "Rare Pediatric Disease" designation. This approval allows the company to receive a transferrable Priority Review Voucher (PRV) upon New Drug Approval for three indications: diffuse intrinsic pontine glioma, medulloblastoma, and atypical teratoid rhabdoid tumor. PRVs have been valued at over $100 million, highlighting a significant future revenue opportunity for Moleculin.