Moleculin Biotec Stock Price, News & Analysis

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.

Moleculin Biotech (MBRX) has received IRB approval for its pivotal Phase 3 'MIRACLE' trial of Annamycin in combination with cytarabine for R/R AML treatment. The trial's preliminary readouts are expected in H2 2025 (n=45) and 1H 2026 (n=~75-90), with potential NDA process starting in 2027.

Recent preliminary clinical results show Annamycin plus Ara-C achieved 60% CR/CRi in subjects relapsed/refractory to Venetoclax regimens, exceeding historical rates by more than 4 times. The Phase 1B/2 trial demonstrated a 50% Complete Remission rate and 60% CRc rate for 2nd line subjects, with median survival of 11.6 months for 2nd line subjects.

The MIRACLE trial will be conducted globally, utilizing an adaptive design with two parts. Part A will randomize 75-90 subjects, while Part B will include approximately 244 additional subjects. The company has engaged Catalyst Clinical Research as CRO for the trial.

Moleculin Biotech announced the publication of preclinical data demonstrating the significant activity of Annamycin in treating venetoclax-resistant acute myeloid leukemia (AML) cell lines. The study, presented at the American Society of Hematology Annual Meeting, revealed that Annamycin effectively targets both Cytarabine (Ara-C) and Venetoclax resistant AML cell lines from heavily pretreated relapsed/refractory primary AML patients in vitro.

The data showed Annamycin's synergy with Ara-C and Venetoclax in reducing cell viability, a lack of cardiotoxicity, improved organotropism, and potential immune-memory reinforcing properties. These findings correlate with preliminary clinical data showing a 60% composite complete remission (CRc) rate in subjects using Annamycin and Ara-C (AnnAraC) as a second-line treatment.

Annamycin's favorable toxicity profile, as compared to DOX, and its ability to extend survival in combination with Ara-C, underscore its potential as a breakthrough treatment. Moleculin is advancing Annamycin in a Phase 3 trial, 'MIRACLE,' set to begin patient treatment in Q1 2025. Annamycin has Fast Track Status and Orphan Drug Designation from the FDA and EMA.

Moleculin Biotech (MBRX) announced new findings showing Annamycin's effectiveness in treating Venetoclax-resistant acute myeloid leukemia (AML). Preliminary clinical results demonstrate that Annamycin plus Ara-C achieved a 60% CR/CRi rate in subjects previously treated with Venetoclax regimens, which is more than 4 times higher than historical rates. The MB-106 trial showed median overall survival of 11.6 months in subjects receiving AnnAraC as second-line therapy. The company is advancing to a Phase 3 'MIRACLE' trial, with patient treatment expected to begin in Q1 2025. Annamycin has received Fast Track Status and Orphan Drug Designation from both FDA and EMA.

Moleculin Biotech (MBRX) has amended its Phase 3 MIRACLE trial protocol for Annamycin in combination with Cytarabine (AnnAraC) for treating relapsed/refractory AML. The amended protocol allows for earlier unblinding of preliminary efficacy data at 45 subjects in H2 2025, accelerating from the previous 2026 timeline. The trial will use an adaptive design with two parts: Part A will randomize 75-90 subjects across three arms, while Part B will include 244 additional subjects. The study maintains its planned first subject treatment start in Q1 2025. Annamycin holds Fast Track Status and Orphan Drug Designation from both FDA and EMA for various indications.