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 clinical-stage pharmaceutical company advancing novel therapies for resistant cancers and viral diseases. This news hub provides investors and researchers with essential updates on clinical developments, regulatory milestones, and scientific breakthroughs.
Access timely announcements about Annamycin's progress through late-stage trials for acute myeloid leukemia (AML), WP1066's immune-modulating potential, and strategic partnerships advancing oncology research. Our curated collection includes press releases on FDA designations, trial protocol updates, and peer-reviewed study publications.
Key coverage areas include non-cardiotoxic anthracycline developments, orphan drug status achievements, and preclinical data on metabolic pathway inhibitors. Bookmark this page for verified updates on Moleculin's innovative approaches to overcoming multidrug resistance in cancer treatment.
Moleculin Biotech presented new pre-clinical data for their cancer drug Annamycin at the AACR Annual Meeting 2025 in Chicago. The research shows Annamycin's potential to treat multiple cancer types, including pancreatic cancer.
Key findings demonstrate that Annamycin can work synergistically with various FDA-approved anticancer drugs both in laboratory tests (in vitro) and in living organisms (in vivo). The drug showed promising results against resistant cell lines, including those resistant to cytarabine and venetoclax.
The study explored Annamycin's effectiveness in combination with approved cancer treatments, focusing on leukemia, sarcoma, and pancreatic cancer models. CEO Walter Klemp highlighted this as a significant market expansion opportunity, particularly valuable for combination therapy approaches in cancer treatment.
The research was presented by Dr. Waldemar Priebe from MD Anderson Cancer Center, focusing on Annamycin's combination potential with drugs like azacitidine, cytarabine, gemcitabine, ifosfamide, trabectedin, and vincristine.
Moleculin Biotech (NASDAQ: MBRX) has announced that its research on Annamycin, their next-generation anthracycline drug candidate, will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. The presentation, scheduled for April 28, 2025, will focus on combining Annamycin with various other drugs to enhance anticancer effects.
The poster presentation, titled 'Combining Annamycin, a Non-cardiotoxic Potent Topo II Poison, with Azacitidine, Cytarabine, Gemcitabine, Ifosfamide, Trabectedin, or Vincristine to Synergize Anticancer Effects and Identify Potential Clinical Applications' will be delivered by Dr. Rafal Zielinski from MD Anderson Cancer Center. The presentation is part of the Drug Combination Strategies for Cancer Treatment session.
Moleculin Biotech (MBRX) has initiated patient dosing in its pivotal Phase 3 MIRACLE trial, evaluating Annamycin combined with Cytarabine (AnnAraC) for treating AML patients who are refractory to or relapsed after induction therapy.
The global approval trial, conducted across the US, Europe, and Middle East, features an adaptive design with two parts. Part A will randomize 75-90 subjects (1:1:1) to receive high dose cytarabine with either placebo, 190 mg/m2, or 230 mg/m2 of Annamycin. Part B will enroll approximately 220 additional subjects.
The company expects preliminary data unblinding from the first 45 subjects in H2 2025, with a second unblinding anticipated in H1 2026. Annamycin holds Fast Track Status and Orphan Drug Designation from FDA for R/R AML treatment, plus Orphan Drug Designation for soft tissue sarcoma and from EMA.
Moleculin Biotech (NASDAQ: MBRX) has reported its financial results for fiscal year 2024 and provided updates on its MIRACLE trial progress. The company is advancing its pivotal Phase 3 clinical trial for Annamycin in combination with Cytarabine for treating relapsed or refractory Acute Myeloid Leukemia (R/R AML).
Key developments include:
- First subject treatment expected in Q1 2025
- Initial data readout from 45 subjects anticipated in H2 2025
- Multiple subjects currently being screened at first MIRACLE site
- Received positive FDA guidance leading to smaller trial size
- Secured first European country approval for trial enrollment
Financial highlights for 2024:
- R&D expenses decreased to $17.7M from $19.5M in 2023
- G&A expenses reduced to $8.8M from $10.0M in 2023
- Cash position of $4.3M as of December 31, 2024
- Additional $9.3M raised in February 2025
Moleculin Biotech (Nasdaq: MBRX), a late-stage pharmaceutical company focused on developing treatments for hard-to-treat tumors and viruses, has scheduled its full year 2024 financial results announcement for March 21, 2025.
The company will host a conference call and live audio webcast to discuss operational and financial results on March 24, 2025, at 8:30 AM ET. Investors can join via phone by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international). The webcast will be available on the Events page of Moleculin's website and archived for 90 days.
Moleculin Biotech (Nasdaq: MBRX), a late-stage pharmaceutical company focused on developing treatments for hard-to-treat tumors and viruses, has participated in the Virtual Investor 'Top 5 for '25' On-Demand Conference.
During the event, Chairman and CEO Walter Klemp presented the top five reasons why investors and industry colleagues should focus on Moleculin in 2025. The presentation is now available for viewing on the company's website and through the conference platform.
Moleculin Biotech (Nasdaq: MBRX), a late-stage pharmaceutical company focused on developing treatments for hard-to-treat tumors and viruses, has announced its participation in the 37th Annual ROTH Conference in Dana Point, CA.
Chairman and CEO Walter Klemp will engage in a fireside chat on Tuesday, March 18, 2025, at 11:00 AM PT. The presentation will be accessible via live webcast through the Events page in the Investors section of Moleculin's website. Management will also be available for one-on-one meetings with qualified registered conference attendees.
Moleculin Biotech (MBRX) has received a Notice of Intent to Grant for a European patent application for its Annamycin drug candidate, extending patent protection until June 2040. The patent covers methods of making liposomal Annamycin suspension and its use in cancer treatment.
Annamycin is positioned to become the first non-cardiotoxic anthracycline for approval, currently being developed for acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases. The company is initiating the MIRACLE Phase 3 trial, evaluating Annamycin in combination with cytarabine (AnnAraC) for relapsed or refractory AML, with initial data readout expected in second half of 2025.
The drug uses a unique lipid-based delivery technology and has shown potential for treating various cancers in preclinical studies. Moleculin has additional patent applications pending worldwide to enhance global exclusivity.
Moleculin Biotech (NASDAQ: MBRX) announced that its abstract has been accepted for poster presentation at the Acute Leukemias XIX (ISALXIX) International Symposium taking place March 16-19, 2025, in Munich, Germany.
The poster presentation (Abstract P002) will focus on 'Liposomal Annamycin in Combination with Cytarabine for Treatment of Acute Myeloid Leukemia (AML)' and will be presented by Dr. Cristina Papayannidis from the University of Bologna's Department of Medical and Surgical Sciences.
Moleculin Biotech (MBRX) has announced a $3.5 million registered direct offering and concurrent private placement priced at $1.07 per share. The deal includes the sale of 3,271,029 shares of common stock (or pre-funded warrants) and warrants to purchase up to 6,542,058 additional shares.
The warrants will have an exercise price of $1.07 per share, becoming exercisable upon shareholder approval, and will expire 5 years from the initial exercise date. Roth Capital Partners is serving as the exclusive placement agent.
The offering is expected to close around February 26, 2025. The company plans to use the net proceeds for working capital and general corporate purposes. The common stock offering is being conducted under an effective shelf registration statement, while the warrants are being issued through a private placement.
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