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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. (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.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced new animal study results showing significant improvements in survival rates for acute myeloid leukemia (AML) when Liposomal Annamycin (L-ANN) is combined with Ara-C (cytarabine). The combination therapy led to median survival times ranging from 56 to 76 days, representing a 585% increase compared to single-agent treatments. Moleculin plans to initiate clinical trials for the combination therapy, termed 'AnnAraC,' following these promising results. The findings were presented at the 62nd Annual Meeting of the American Society for Hematology.
Moleculin Biotech, Inc. (Nasdaq: MBRX) reported a net loss of $3.4 million for Q3 2020, improving from $4.1 million in Q3 2019. R&D expenses rose to $4.4 million, mainly due to increased clinical trials. The company advances its lead drug, Annamycin, in multiple indications with promising preclinical results, especially targeting lung tumors. The ongoing WP1066 trials for brain tumors show positive preliminary data. The company holds $12.8 million in cash, expected to fund operations into Q3 2021. A new collaboration aims to enhance antiviral drug WP1122's development.
Moleculin Biotech, Inc. (Nasdaq: MBRX) has partnered with the University of Campinas, Brazil, to advance research on WP1122, a drug candidate targeting COVID-19. Recent studies indicate that WP1122, a pro-drug of 2-deoxy-D-glucose (2-DG), may inhibit SARS-CoV-2 replication by targeting glycolysis. The collaboration aims to enhance resources for WP1122's development, with potential in vivo testing slated for early 2021. The company continues to evaluate its strategy and plans for an Investigational New Drug request to the FDA.
Moleculin Biotech, a clinical stage pharmaceutical company, announced its participation in ROTH Capital's healthcare event titled "COVID-19 Therapeutics in Development" on October 28, 2020. The session, titled "Indirect Antivirals Against SARS-CoV2 Virus," will take place from 12:00 to 1:20 PM ET. The company focuses on developing drug candidates for treatment-resistant tumors and viruses, including Annamycin for AML and WP1066 for brain tumors and pancreatic cancer. For details, visit their website.