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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) announced that President and CEO Walter Klemp will present at the virtual H.C. Wainwright BioConnect Conference from January 10-13, 2022. The presentation will be available on-demand starting January 10, 2022, at 7:00 AM ET for registered participants and accessible on the Company's website for 90 days thereafter. Moleculin is focused on developing a portfolio of drug candidates targeting resistant tumors and viruses, including Annamycin for acute myeloid leukemia and WP1066 for various cancers.
Moleculin Biotech, Inc. (Nasdaq: MBRX) reported preliminary results from its ongoing Phase 1b/2 clinical trial of Annamycin for soft tissue sarcoma (STS) lung metastases. The trial, focusing on dose escalation, recently concluded its third cohort safety review and proceeded to the fourth cohort. Initial data indicate encouraging activity, with three of six patients in earlier cohorts showing stable disease for over four months. Notably, Annamycin has demonstrated no cardiotoxicity, positioning it as a safer alternative to current anthracyclines. The trial continues to enroll subjects at an accelerated pace.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that the FDA has approved its IND application to study WP1122 for the treatment of Glioblastoma Multiforme (GBM). This allows the company to initiate a Phase 1 study assessing the safety and efficacy of oral WP1122 in adult GBM patients. Moleculin plans to conduct an additional trial in the UK to evaluate WP1122 as a potential COVID-19 therapy. Their strategy aims to address highly glycolytic cancers and leverage external funding for future clinical trials, particularly in 2022.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced participation in a Virtual Investor Roundtable Event on November 18, 2021, at 11:00 AM ET. CEO Walter V. Kemp and Senior CMO Dr. John Paul Waymack will present, joined by Dr. Sant P. Chawla. The event will include a presentation, moderated discussion, and live Q&A. Participants can submit questions via the conference website. A live video webcast will be available, with a replay accessible afterward. Moleculin focuses on developing drugs for resistant tumors and viruses, including Annamycin for acute myeloid leukemia and soft tissue sarcoma.
Moleculin Biotech, Inc. (Nasdaq: MBRX) reported its financial results for Q3 2021, revealing a decrease in R&D expenses to $4.1 million, down from $4.4 million in 2020. General and administrative expenses rose to $2.0 million. The Company recorded a net loss of $13.1 million for the nine-month period. Moleculin is advancing its oncology drug pipeline, with six clinical trials underway or expected for clearance by year-end 2021. A significant milestone includes the authorization for a Phase 1a trial of WP1122 for COVID-19 in the UK.
Moleculin Biotech (Nasdaq: MBRX) announced on Oct. 19, 2021, the authorization from the MHRA to start a Phase 1a clinical trial for WP1122 in the UK. WP1122, a prodrug of 2-deoxy-D-glucose, aims to inhibit viral replication in COVID-19 patients. The trial will involve about 80 healthy volunteers to assess the drug's safety and pharmacokinetics. Preclinical data show WP1122's potential as a more potent antiviral compared to 2-DG. Moleculin is also exploring additional countries for Phase 2 studies and developing other antimetabolites.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced interim results from its Phase 1b/2 clinical trial for Annamycin, targeting soft tissue sarcoma (STS) lung metastases. Preliminary data shows encouraging responses, with four out of five patients demonstrating clinical activity, including one with over 30% tumor size reduction. The trial is progressing well, having quickly completed two cohorts within four months. Annamycin, designed to be non-cardiotoxic, has received Fast Track Status and Orphan Drug Designation from the FDA. Patient enrollment for additional cohorts is currently underway.
Moleculin Biotech, Inc. (Nasdaq: MBRX), a clinical stage pharmaceutical company, announced that its CEO, Walter Klemp, will present at the 2021 Cantor Virtual Global Healthcare Conference on September 27, 2021, at 8:40 AM ET. Moleculin will also offer virtual one-on-one meetings for qualified investors. The live webcast will be accessible on the Investors section of their website, with a replay available for 90 days.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that CEO Walter Klemp will present at the virtual Oppenheimer Fall Healthcare Life Sciences and MedTech Summit on September 20, 2021, at 4:35 PM ET. The management team will also hold virtual one-on-one meetings with registered investors. A live webcast of the presentation will be available on the Company's website, with a replay accessible for 90 days post-event. Moleculin focuses on developing drug candidates for highly resistant tumors and viruses, including Annamycin for acute myeloid leukemia and WP1066 for brain tumors.
On September 8, 2021, Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that CEO Walter Klemp will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The company specializes in developing drug candidates for resistant tumors and viruses.
Management will also hold virtual one-on-one meetings with registered investors. A video webcast of the presentation will be available on-demand on September 13, 2021, at 7:00 AM ET and archived for 90 days.
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