Welcome to our dedicated page for Moleculin Biotec news (Ticker: MBRX), a resource for investors and traders seeking the latest updates and insights on Moleculin Biotec stock.
Moleculin Biotech, Inc. (Nasdaq: MBRX) is a Phase 3 clinical stage pharmaceutical company whose news flow is driven by developments in its oncology and virology pipeline. The company regularly issues updates on its lead anthracycline program Annamycin (naxtarubicin), its Immune/Transcription Modulator WP1066, and its antimetabolite portfolio, including WP1122.
News about Moleculin often focuses on clinical trial milestones, particularly for the pivotal, adaptive design Phase 2B/3 MIRACLE trial in relapsed or refractory acute myeloid leukemia (AML). Investors can follow announcements on enrollment progress, interim unblinding plans, trial expansion across multiple countries, and independent assessments of Annamycin’s cardiotoxicity profile. The company has highlighted an independent expert review of 90 Annamycin-treated subjects across five trials with no evidence of cardiotoxicity based on ECG, echocardiography and cardiac biomarkers.
Another key news theme is pipeline expansion. Moleculin reports investigator-initiated and grant-funded research that extends Annamycin into pancreatic cancer and glioblastoma multiforme (GBM), including collaborations with UNC-Chapel Hill and CIC biomaGUNE. Updates also cover externally funded clinical activity for WP1066 in adult GBM at Northwestern University and pediatric brain tumors at Emory University, along with published Phase 1 data showing STAT3 suppression and anti-tumor immune responses in children.
Moleculin’s news stream also includes corporate and regulatory updates such as reverse stock split actions, Nasdaq listing compliance developments, warrant exercises and patent grants, including an Australian patent for preliposomal Annamycin lyophilizate. For investors tracking MBRX, this news page provides a centralized view of scientific, clinical, regulatory and capital markets announcements related to the company’s efforts in hard-to-treat cancers and certain viral infections.
Moleculin Biotech (MBRX) reported preliminary results from the second cohort of its Phase 1a clinical trial for WP1122. The cohort, consisting of 8 subjects receiving 16 mg/kg or placebo, demonstrated safety and tolerability, allowing the company to escalate to a 32 mg/kg dose in the third cohort. The trial aims to establish the maximum tolerated dose (MTD) and evaluate WP1122 for COVID-19. The study is expected to enroll approximately 80 subjects, with multiple ascending doses commencing after the successful completion of three single ascending dose cohorts.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced positive preliminary results from its first cohort in the Phase 1a study of WP1122, a drug targeting resistant tumors and viruses. The first cohort, consisting of 9 subjects who received 8 mg/kg or placebo, was deemed safe and well-tolerated, allowing the Company to escalate the dosage to 16 mg/kg in the next cohort. This study is pivotal in establishing the maximum tolerated dose for WP1122, which is also being investigated for potential COVID-19 treatment, with future cohorts to assess further safety and efficacy.
Moleculin Biotech (Nasdaq: MBRX) has initiated dosing in its first-in-human Phase 1a study of WP1122, a prodrug developed to treat COVID-19. This study aims to assess safety and pharmacokinetics in healthy volunteers, marking a critical step in development. The trial will include single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, with enrollment anticipated for about 80 subjects. The maximum dose in SAD could reach 64 mg/kg. Results from preclinical models indicate potential antiviral efficacy. The company also received FDA IND clearance for a Phase 1 study of WP1122 in glioblastoma.
Moleculin Biotech, Inc. (Nasdaq: MBRX), a clinical stage pharmaceutical company, announced its participation in the H.C. Wainwright Global Investment Conference from May 23-26, 2022, in Miami, FL. CEO Walter Klemp will present at the event. Following the presentation, management will hold virtual one-on-one meetings with registered investors. A video webcast of the presentation will be available on-demand starting May 24, 2022, at 7:00 AM ET. Moleculin is focused on developing drugs targeting resistant tumors and viruses, including its lead candidate, Annamycin, for acute myeloid leukemia.
Moleculin Biotech reported its financial results for Q1 2022, showing a net loss of $6.9 million, compared to $4.4 million in Q1 2021. R&D expenses rose to $4.6 million due to increased clinical trial activity. The company's cash balance stands at $66.1 million, sufficient to fund operations into 2024. Notable advancements include authorizations for clinical trials of WP1122 (COVID-19) in the UK and Annamycin (AML treatment) in Poland. The company anticipates multiple key clinical milestones throughout 2022, aiming to address unmet medical needs in resistant tumors and viruses.
Moleculin Biotech (MBRX) has received approval from the UK's MHRA to initiate a first-in-human Phase 1a study of WP1122, targeting COVID-19. The study focuses on safety and pharmacokinetics with dosing expected to start soon. WP1122, a prodrug of 2-deoxy-D-glucose, exhibits enhanced antiviral and anticancer properties. The trial will assess single and multiple ascending doses in approximately 80 healthy volunteers in the UK. Successful preclinical results position WP1122 as a promising candidate for treating resistant tumors and viral infections.
Moleculin Biotech has received approval for its Phase 1/2 clinical trial of Annamycin combined with Cytarabine for treating acute myeloid leukemia (AML) in Poland. This follows promising preclinical data showing a 68% increase in overall survival (OS) with the combination treatment compared to Annamycin alone, and a 241% increase compared to Cytarabine alone. The trial is expected to start this quarter, with plans to expand to other European countries. Annamycin has demonstrated no cardiotoxicity and aims to overcome multidrug resistance seen in current treatments.
Moleculin Biotech, Inc. (Nasdaq: MBRX) has appointed Dr. Wolfram C. M. Dempke as its EU Chief Medical Officer to lead upcoming clinical trials in Europe. Dr. Dempke brings over 30 years of experience in oncology and hematology, having contributed to significant drug developments in various companies. He will oversee the Company's initiatives targeting highly resistant tumors. Moleculin's lead program, Annamycin, aims to address acute myeloid leukemia and soft tissue sarcoma with minimal cardiotoxicity. The Company continues to advance its clinical pipeline, focusing on unmet oncological needs.
Moleculin Biotech (Nasdaq: MBRX) announced the FDA's clearance of its Investigational New Drug (IND) application for WP1066, aimed at treating recurrent malignant glioma. The company plans to conduct a Phase 1 trial to assess the safety and efficacy of this treatment in adult patients. WP1066 has shown significant anti-tumor activity in preclinical studies and is currently being evaluated in pediatric brain tumor trials at Emory University, where preliminary results have demonstrated clinical improvement in a treated subject.
Moleculin Biotech, Inc. (Nasdaq: MBRX) announced a corporate rebranding and the launch of a new website, aiming to align its branding with its vision to combat resistant cancers and viruses. The company emphasizes its commitment to overcoming medical challenges through innovative treatments, particularly highlighting Annamycin, a next-generation anthracycline that shows promise in treating relapsed acute myeloid leukemia and soft tissue sarcoma lung metastases without cardiotoxicity. The refreshed branding and website reflect Moleculin's dedication to advancing its clinical programs and development pipeline.