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, 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.

Moleculin Biotech (MBRX) has secured agreements for the immediate exercise of existing warrants to purchase 5,828,570 shares of common stock at a reduced price of $1.00 per share, expecting to generate gross proceeds of approximately $5.8 million.

In exchange for the immediate cash exercise, the company will issue new unregistered warrants to purchase up to 11,657,140 shares of common stock at $0.75 per share, exercisable immediately upon issuance for a five-year term. The transaction is expected to close around February 14, 2025.

The proceeds will be used for working capital and general corporate purposes. The new warrants are being offered through private placement, and Moleculin has agreed to file a registration statement with the SEC for the resale of shares issuable upon exercise of these new warrants.

Moleculin Biotech (NASDAQ: MBRX) has received positive FDA guidance for its Phase 3 MIRACLE trial, evaluating Annamycin in combination with Cytarabine (AnnAraC) for treating refractory or relapsed AML patients. The FDA's feedback allows for a 10% reduction in Part B trial size while maintaining major aspects unchanged.

The MIRACLE trial will be conducted globally across the US, Europe, and Middle East. The adaptive design includes Part A with 75-90 subjects randomized 1:1:1, and Part B with approximately 220 subjects randomized 1:1. The company expects to reach first unblinding (45 subjects) in H2 2025 and second unblinding in H1 2026.

Annamycin, positioned as the first-ever non-cardiotoxic anthracycline, holds Fast Track Status and Orphan Drug Designation from both FDA and EMA. The company remains on track for first subject treatment in Q1 2025.

Moleculin Biotech (NASDAQ: MBRX) has received its first country regulatory approval in Europe (Ukraine) to begin recruiting for the MIRACLE Phase 3 pivotal trial, evaluating Annamycin in combination with Cytarabine (AnnAraC) for treating refractory or relapsed AML patients. The global trial will include sites across the US, Europe, and the Middle East.

The study features an adaptive design with two parts: Part A will randomize 75-90 subjects (1:1:1) to receive high-dose cytarabine combined with either placebo, 190 mg/m2, or 230 mg/m2 of Annamycin. The amended protocol allows for preliminary data unblinding at 45 subjects in H2 2025. Part B will enroll approximately 244 additional subjects randomized between HiDAC plus placebo or HiDAC plus optimum Annamycin dose.

The company remains on track for first subject treatment in Q1 2025, with initial site approvals expected throughout Q1-Q3 2025.

Moleculin Biotech (NASDAQ: MBRX) announced CEO Walter Klemp's participation in a Virtual Investor 'What This Means' segment, focusing on updates regarding the company's Phase 3 MIRACLE trial. The pivotal trial evaluates Annamycin in combination with Cytarabine (AnnAraC) for treating acute myeloid leukemia (AML) patients who are refractory to or relapsed after induction therapy.

The global MIRACLE trial (Moleculin R/R AML AnnAraC Clinical Evaluation) will include sites across the US, Europe, and the Middle East. During the segment, Klemp discussed recent developments in the AML space and their implications for Moleculin's Annamycin development program.