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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) 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.
Moleculin Biotech, Inc. (Nasdaq: MBRX) reported its financial results for Q2 2021, showing R&D expenses of $3.0 million, down from $3.3 million in Q2 2020, primarily due to previous cost timings. General and administrative expenses rose to $2.4 million, up from $1.7 million, driven by increased consulting fees. The company reported a net loss of $8.7 million for the first half of 2021, an improvement from $11.3 million in 2020. Moleculin ended the quarter with $79.5 million in cash, sufficient for projected operating needs through 2024. Upcoming milestones include progress in multiple clinical trials.
Moleculin Biotech, Inc. (Nasdaq: MBRX) has received approval from the Bioethics Committee of the Medical University of Poznań and the Polish Department of Registration of Medicinal Products for a protocol amendment in its Phase 1/2 trial of Annamycin, aimed at treating acute myeloid leukemia (AML). This amendment permits continued dose escalation based on new dose-limiting toxicity (DLT) criteria, allowing the study to evaluate Annamycin's safety further. Preliminary data shows promising clinical benefits and a clean safety profile. Annamycin has also received Fast Track Status and Orphan Drug Designation from the FDA.
Moleculin Biotech (Nasdaq: MBRX) has initiated enrollment and has dosed its first patient in a Phase 1b/2 clinical trial of Annamycin, aimed at treating soft tissue sarcoma (STS) lung metastases. This trial addresses serious limitations in existing chemotherapy options, particularly the cardiotoxicity associated with doxorubicin. Annamycin has shown promising results in animal models, demonstrating superior lung accumulation and reduced cardiotoxicity. With Fast Track Status and Orphan Drug Designation from the FDA, this study may fill a significant therapeutic gap in treating resistant tumors.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced its inclusion in the Russell 2000® Index, effective after market close on June 25, 2021. This milestone reflects the company's ongoing efforts to gain market exposure for its drug development programs targeting resistant tumors and viruses. The Russell 2000® Index represents about 10% of the total market capitalization of the Russell 3000® Index, which utilizes approximately $9 trillion in assets for investment benchmarks. Moleculin is focused on developing oncology drug candidates, including Annamycin for acute myeloid leukemia, and WP1066 for various cancers.