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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. (MBRX) announced positive preliminary findings from its collaboration with the Rega Institute, indicating that drug candidates WP1096 and WP1097 exhibit significant in vitro activity against various infectious diseases, including COVID-19, HIV, Zika, and Dengue Fever. The company is expanding its infectious disease program while continuing clinical development of Annamycin for acute myeloid leukemia and WP1066 for brain tumors and pancreatic cancer. CEO Walter Klemp emphasized the potential for these drug candidates to address critical unmet medical needs and attract governmental support.
Moleculin Biotech, Inc. (Nasdaq: MBRX) appointed Elizabeth (Liz) Cermak to its Board of Directors on October 5, 2020. With nearly four decades in the healthcare sector, Cermak is expected to leverage her extensive experience in drug commercialization and licensing to advance Moleculin's oncology and infectious disease drug pipelines. Previously, she held significant roles at POZEN and Johnson & Johnson, overseeing large product portfolios. Chairman and CEO Walter Klemp emphasized her potential to provide valuable guidance for the company's future endeavors.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced positive preliminary results from its phase 1 clinical trial at Emory University for WP1066, targeting pediatric brain tumors. The first cohort of three patients received a 4 mg/kg dose without adverse effects, leading to progression to the 6 mg/kg dose level. Notably, one patient with diffuse intrinsic pontine glioma (DIPG) exhibited clinical improvement and tumor size reduction. CEO Walter Klemp highlighted the promising results amid a challenging landscape for DIPG treatments and emphasized the company's commitment to its diverse drug candidate pipeline.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a significant discovery regarding its new drug candidate, WP1096, which exhibited substantial in vitro antiviral activity against SARS-CoV-2. Laboratory tests revealed a therapeutic index exceeding 10, suggesting strong commercial potential for antiviral drugs. Chairman and CEO Walter Klemp indicated that this unexpected result could lead to expanded therapeutic applications, including other viruses. The company will continue preclinical development for WP1122 while pursuing further studies for WP1096 and WP1097, anticipating a twelve-month timeline for clinical assessment.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a contract with an independent laboratory to test its antiviral drug candidate WP1122 in a COVID-19 animal model using hamsters. Initial data may be available in December 2020, and this study aims to support an Investigational New Drug (IND) application to the FDA in 2021. Moleculin is also conducting additional in vitro studies of its WP1122 portfolio against SARS-CoV-2. The company remains focused on developing treatments for highly resistant tumors and viruses.
Moleculin Biotech, Inc. (Nasdaq: MBRX) will present virtually at two upcoming conferences: H.C. Wainwright's 22nd Annual Global Investment Conference on September 14, 2020, at 5:00 PM ET, and the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22, 2020, at 10:00 AM ET. Management will engage in 1-on-1 meetings with investors, with replays of the presentations available on the Company's website for 90 days post-event. Moleculin focuses on developing cancer therapies targeting resistant tumors and viruses.
BRK, Inc. (OTC: BRKK) announces the appointment of Archil Kublashvili to drive business expansion in Europe and CIS. With strong C-suite connections in industrial and cryptocurrency sectors, Kublashvili aims to unlock growth in cash flow-positive market verticals, particularly in zero-emissions transport and the Gen2 sports franchise. BRK specializes in innovative live-action broadcasting technology, supporting both traditional and e-sports. However, the company notes potential risks, including competition and capital raising needs, affecting future performance.
Moleculin Biotech (Nasdaq: MBRX) successfully completed a pre-IND meeting with the FDA regarding Annamycin, focusing on treating soft tissue sarcomas with lung metastases. The FDA did not object to the proposed clinical trial design and provided guidance on next steps, including the need for a repeat dose toxicology study and an end-of-phase 1 meeting after defining the recommended Phase 2 dose. The Company plans to file the IND by the end of 2020 and initiate a Phase 1b/2 trial. CEO Wally Klemp expressed optimism about advancing Annamycin’s development.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced its participation in the LD Micro 500 Virtual Investor Conference on September 1, 2020. CEO Walter Klemp will present at 4:40 pm ET. The company focuses on oncology drug candidates for resistant tumors, including Annamycin for AML, WP1066 for brain tumors, and WP1220 for cutaneous T-cell lymphoma. Investors can schedule one-on-one meetings with company management during the event. For more details, visit Moleculin's website.
Moleculin Biotech (MBRX) reported its Q2 2020 financial results, highlighting progress across its drug development platforms amidst COVID-19 challenges. The company emphasized advancements in its antiviral candidate, WP1122, showing significant efficacy against SARS-CoV-2 in preclinical studies. Additionally, Annamycin for acute myeloid leukemia met its Phase 1 trial endpoints with a favorable safety profile. However, the company faced a net loss of $10.1 million, up from $1.2 million in Q2 2019, mainly due to increased R&D expenses. As of June 30, 2020, cash reserves stood at $16.7 million.
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