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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 (Nasdaq: MBRX) has reached a significant milestone in its Phase 2B/3 MIRACLE trial by dosing the first EU patient for its AnnAraC treatment targeting relapsed/refractory acute myeloid leukemia (R/R AML). The trial has active recruitment sites in the US, Spain, Ukraine, Georgia, and Romania.
The adaptive design study will evaluate AnnAraC (Annamycin combined with cytarabine) across 75-90 subjects in Part A, with an initial data unblinding planned for the first 45 subjects in 2H 2025. Part B will involve approximately 220 additional subjects. The company expects to complete the second unblinding in 1H 2026.
Annamycin holds Fast Track Status and Orphan Drug Designation from both FDA and EMA for various indications, highlighting its potential significance in treating hard-to-treat cancers.
Moleculin Biotech (Nasdaq: MBRX), a late-stage pharmaceutical company focused on developing treatments for tumors and viruses, has secured $6.0 million in gross proceeds through warrant exercises. The company entered into agreements with existing warrant holders for the immediate exercise of warrants to purchase 16,216,216 shares at $0.37 per share.
In exchange for the immediate cash exercise, Moleculin will issue new unregistered warrants for up to 64,864,864 shares at an exercise price of $0.55 per share, exercisable for five years upon shareholder approval. The transaction is expected to close on August 28, 2025. The company plans to use the proceeds for working capital and general corporate purposes.
Moleculin Biotech (Nasdaq: MBRX) has announced significant positive survival data from its Phase 1B/2 (MB-106) clinical trial of Annamycin combined with Cytarabine (AnnAraC) for acute myeloid leukemia (AML) treatment. The trial demonstrated remarkable median overall survival rates: 15 months for complete remission subjects (n=8), 12 months for 2nd line patients (n=9), and 9 months for the intent-to-treat population (n=22).
Key achievements include a 36% complete remission rate in the total population and a 50% CR rate in second-line patients. Notably, 50% of CR patients proceeded to bone marrow transplant. The treatment showed no cardiotoxicity, with median CR durability of 10 months. The company expects database lock by September 2025 and final clinical study report in Q1 2026.
Moleculin continues to advance Part A of its pivotal Phase 3 MIRACLE trial, targeting recruitment of 45 patients by year-end 2025.
Moleculin Biotech (Nasdaq: MBRX), a late-stage pharmaceutical company focused on developing treatments for hard-to-treat tumors and viruses, will participate in the upcoming Webull Financial Corporate Connect Webinar Series: Biotech/MedTech. The virtual presentation will be delivered by Walter Klemp, the company's Founder, President, CEO and Chairman, on Wednesday, August 20, 2025 at 2:00 PM ET.
Moleculin Biotech (Nasdaq: MBRX) reported Q2 2025 financial results and significant progress in its clinical trials. The company's flagship Phase 2B/3 MIRACLE trial for Annamycin in treating relapsed/refractory AML is expanding, with 4 active sites and 20+ additional sites expected in Q3 2025. The trial's first data readout is anticipated by end of 2025.
Key developments include positive topline results from the Phase 1B/2 trial for soft tissue sarcoma lung metastases, showing 13.5-month median overall survival. The company reported $7.6 million in cash, sufficient to fund operations into Q4 2025. R&D expenses decreased to $3.6 million from $4.1 million year-over-year, while G&A expenses remained stable at $2.1 million.
[ "Expansion of MIRACLE trial with 4 active sites and 20+ additional sites expected by Q3 2025", "Positive FDA feedback received on pediatric AML study plan", "Encouraging preclinical data for Annamycin against liver cancers", "Strong Phase 1B/2 results showing 13.5-month median overall survival in STS lung mets trial", "New European patent strengthening intellectual property portfolio" ]Moleculin Biotech (NASDAQ:MBRX) has presented promising preclinical data for its lead drug candidate Annamycin in treating various liver cancers. The drug demonstrated significant efficacy against hepatocellular carcinoma (HCC), colorectal liver metastases, and pancreatic ductal adenocarcinoma (PDAC) liver metastases.
Key findings show that Annamycin achieves higher concentrations in the liver, spleen, lungs, and pancreas compared to doxorubicin. The drug exhibited strong anti-tumor activity in multiple cancer models while maintaining a favorable safety profile with low or no cardiotoxicity. Notably, 32 out of 42 subjects previously received above FDA's lifetime maximum allowable anthracycline level without cardiotoxicity evidence.
Annamycin is currently in late-stage clinical development for AML treatment, with preliminary data expected in 2H 2025.
Moleculin Biotech (Nasdaq: MBRX) has received a Notice of Intent to Grant for a European patent application for its drug candidate Annamycin (naxtarubicin). The patent, extending until 2040, covers methods of making preliposomal Annamycin lyophilizate with improved stability and high purity.
Annamycin is positioned to become the first non-cardiotoxic anthracycline for treating acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases. The drug has received Fast Track Status and Orphan Drug Designation from both FDA and EMA, utilizing a unique lipid-based delivery technology with potential applications across various cancer types.
Moleculin Biotech (Nasdaq: MBRX), a late-stage pharmaceutical company focused on developing treatments for hard-to-treat tumors and viruses, announced its participation in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference.
During the conference, Walter Klemp, the company's Founder, President, CEO and Chairman, shared insights about his journey with Moleculin and his passion for the company's development programs. The presentation is now available for viewing on virtualinvestorco.com and Moleculin's investor relations website.
Moleculin Biotech (Nasdaq: MBRX) has appointed Adriano Treve as Strategic Advisor for partnerships. Treve brings over 40 years of experience from Roche, with extensive expertise in global healthcare markets and senior executive roles across multiple regions.
The appointment comes at a crucial time as Moleculin approaches key milestones in its Phase 2B/3 MIRACLE trial of Annamycin (naxtarubicin) in combination with cytarabine for acute myeloid leukemia (AML). The company expects the first unblinding of data for 45 patients in H2 2025, followed by a second unblinding in H1 2026.
Annamycin currently holds Fast Track Status and Orphan Drug Designation from both FDA and EMA for various indications, including relapsed or refractory AML and soft tissue sarcoma treatment.
Moleculin Biotech (Nasdaq: MBRX) has received approval from Georgia's RAMPA to conduct its Phase 2B/3 MIRACLE clinical trial for Annamycin in combination with cytarabine (AnnAraC) for treating relapsed/refractory acute myeloid leukemia (R/R AML).
The trial has shown early progress with 7 subjects treated and 1 in screening. The company plans to expand to 16 additional clinical sites by August end, building to over 30 sites for Part A. Initial data from the first 45 subjects is expected in 2H 2025.
The MIRACLE study features an adaptive design with Part A randomizing 75-90 subjects across three arms, followed by Part B with approximately 220 additional subjects. Annamycin currently holds Fast Track Status and Orphan Drug Designation from both FDA and EMA.