Moleculin Biotec Stock Price, News & Analysis

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.

Moleculin Biotech (MBRX) has announced a public offering to raise $5.9 million through the sale of 16,080,000 shares of common stock and Series E warrants. The combined offering is priced at $0.37 per share, with warrants to purchase up to 48,240,000 additional shares at the same exercise price. The warrants will be exercisable upon stockholder approval and will expire after five years. The offering is expected to close around June 23, 2025. The company plans to use the proceeds to advance its drug portfolio, including Annamycin, through clinical development, conduct preclinical studies, sponsor research, and provide working capital. Roth Capital Partners is serving as the exclusive placement agent, with Maxim Group LLC acting as financial advisor.

Moleculin Biotech (MBRX) participated in a Virtual Investor segment to discuss recent FDA feedback on their Pediatric Study Plan for Annamycin. The segment focused on the drug's potential application in treating children with relapsed/refractory acute myeloid leukemia (R/R AML). CEO Walter Klemp led the discussion, highlighting the company's progress in developing treatments for challenging tumors and viruses. The segment is available for viewing online.

Moleculin Biotech (NASDAQ: MBRX) has received positive FDA feedback on its Initial Pediatric Study Plan (iPSP) for Annamycin in treating children with relapsed/refractory acute myeloid leukemia (R/R AML). The FDA agreed to a single pediatric approval study of AnnAraC (Annamycin + Cytarabine combination) and recommended including patients as young as 6 months old. Notably, Annamycin has shown no cardiotoxicity in 84 adult patients treated to date, addressing a significant concern as about 60% of children with cancer are treated with potentially cardiotoxic anthracyclines. The company plans to initiate the pediatric trial in H2 2027. Meanwhile, Moleculin's pivotal Phase 3 MIRACLE trial for adult R/R AML patients is ongoing with initial data expected in H2 2025. Annamycin has received Fast Track Status and Orphan Drug Designations from both FDA and EMA.

Moleculin Biotech (NASDAQ: MBRX) participated in a Virtual Investor segment featuring Dr. Brian Andrew Van Tine, who discussed positive topline results from their completed U.S. Phase 1B/2 clinical trial of Annamycin for Soft Tissue Sarcoma Lung Metastases (MB-107). The trial was a multi-center, open-label, single-arm study that determined the Maximum Tolerable Dose and Recommended Phase 2 Dose in Phase 1B, while Phase 2 evaluated Annamycin's efficacy as a monotherapy for STS lung metastases patients eligible for chemotherapy.

Moleculin Biotech (MBRX) has released an on-demand KOL webcast discussing final data from its U.S. Phase 1B/2 clinical trial of Annamycin for treating soft tissue sarcoma lung metastases. The webcast features presentations from company executives Walter Klemp (CEO) and Dr. Paul Waymack (Senior CMO), alongside expert KOLs including Dr. Mohamad Cherry from Atlantic Health System, Prof. Bernd Kasper from Mannheim Cancer Center, and Dr. Sant P. Chawla from Sarcoma Oncology Center. The webcast is available on Moleculin's website investor section for 90 days.

Moleculin Biotech (MBRX) announced positive topline efficacy results from its completed U.S. Phase 1B/2 clinical trial of Annamycin for treating soft tissue sarcoma lung metastases. The trial achieved a Clinical Benefit Rate of 59.4% (n=32), with 18 subjects showing stable disease and 1 achieving partial response. The study demonstrated median Overall Survival of 411 days and Progression-Free Survival of 63 days. In Phase 2 at 330 mg/m2, patients showed median PFS of 105 days and OS of 13.5 months, exceeding typical second-line monotherapy results. Notably, patients with fewer prior therapies (≤2) showed improved OS/PFS of 19.9 months/127 days. The drug showed no cardiotoxicity and has potential to address 13,500 new STS cases annually, with a market opportunity expected to reach $2.6B by 2030.