Moleculin Biotec Stock Price, News & Analysis

Moleculin Biotech (NASDAQ: MBRX) has announced the pricing of a public offering to raise up to $16.5 million. The offering includes 2,466,368 shares of common stock (or equivalents) and two series of warrants at a combined price of $2.23 per share. The initial gross proceeds are expected to be $5.5 million, with potential for an additional $11 million if all warrants are exercised. The company plans to use the funds for advancing its drug portfolios, including Annamycin, through clinical development and preclinical studies. The offering is expected to close around August 19, 2024, subject to customary conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for this transaction.

Moleculin Biotech (Nasdaq: MBRX) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:

1. Positive outcome from End of Phase 1B/2 Meeting with FDA
2. Proceeding with pivotal, adaptive Phase 3 MIRACLE trial for possible accelerated approval of Annamycin in combination with cytarabine for R/R AML treatment
3. Q2 2024 R&D expense: $4.1 million (up $0.2 million YoY)
4. Q2 2024 G&A expense: $2.1 million (down $0.4 million YoY)
5. Cash and cash equivalents: $10.8 million as of June 30, 2024
6. Filed S-1 to raise additional $12 million through equity issuance

The company expects to begin contracting MIRACLE trial sites in 2H 2024 and treat the first subject in Q1 2025.

Moleculin Biotech (Nasdaq: MBRX) has announced a webcast presentation on August 6, 2024, at 8:30 AM ET to discuss plans for its MIRACLE Phase 3 pivotal trial. The trial will evaluate Annamycin in combination with Cytarabine (AnnAraC) for treating AML patients who are refractory to or relapsed after induction therapy. This global trial, including US sites, marks a significant step in Moleculin's clinical development program.

The presentation will feature Walter Klemp, CEO, Dr. Paul Waymack, Senior Chief Medical Officer, and Dr. Michael Andreeff from MD Anderson Cancer Center. Investors can access the webcast via conference call or the company's website.

Moleculin Biotech (Nasdaq: MBRX) has announced plans for its MIRACLE Phase 3 pivotal trial following a positive End of Phase 1B/2 meeting with the FDA. The trial will evaluate Annamycin in combination with cytarabine (AnnAraC) for treating relapsed or refractory acute myeloid leukemia (R/R AML). Key points include:

1) The trial will be global, including US sites.
2) It will use an adaptive design with CR (complete remission) at day 30 as the primary endpoint.
3) The study will allow dosing above the lifetime maximum allowable anthracycline dose.
4) The trial design offers potential for accelerated approval.
5) Initial focus on 2nd line R/R AML treatment, followed by 3rd line R/R AML.

Moleculin aims to begin contracting trial sites in 2H 2024, with the first subject treated in Q1 2025. The company expects to submit an NDA for accelerated approval in 2H 2028.

Moleculin Biotech has completed its End of Phase 2 (EOP2) meeting with the FDA for its Phase 1B/2 clinical trial of Annamycin combined with Cytarabine for treating AML (MB-106). The meeting focused on reviewing clinical data and planning the next steps, with official outcomes expected by Q3 2024. Interim results show that out of 22 enrolled subjects, 45% achieved a composite complete remission (CRc) and 40% had a complete remission (CR). For second-line treatments, 50% achieved CR and 60% achieved CRc. Annamycin holds Fast Track Status and Orphan Drug Designations for relapsed or refractory AML in the U.S. and EMA.

Moleculin Biotech reported additional positive interim data from its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (AnnAraC) for acute myeloid leukemia (AML). The trial enrolled 22 subjects, with 20 completing efficacy evaluations. The results showed a composite complete remission (CRc) in 45% of subjects, a median durability of response (mDOR) of 6 months and increasing, and no cardiotoxicity. In a 2nd line setting, AnnAraC achieved a median overall survival (mOS) of 6 months and 50% complete remissions (CR). The data was presented at the European Hematology Association (EHA) 2024 Hybrid Congress and showcased promising efficacy outcomes, especially for poor prognosis patients.

Moleculin Biotech (Nasdaq: MBRX) announced its participation in the Virtual Investor Pitch Conference on June 18, 2024, at 3:00 PM ET. Walter Klemp, Chairman and CEO, will present an elevator pitch and discuss the company's upcoming milestones. Investors can submit questions during the live video webcast, available on Moleculin's website. A replay will be accessible for 90 days post-event.

Moleculin Biotech (Nasdaq: MBRX) announced its participation in the Virtual Investor Lunch Break: The Moleculin Opportunity event scheduled for June 12, 2024, at 12:00 PM ET. Walter Klemp, Chairman and CEO, will provide a corporate overview and business outlook. The event includes a live Q&A session where attendees can submit questions. A live webcast will be available on Moleculin's website, with a replay accessible for 90 days.

Moleculin Biotech (Nasdaq: MBRX) announced that its abstract has been accepted for a poster presentation at the European Hematology Association (EHA) 2024 Hybrid Congress. The event will take place from June 13-16, 2024, in Madrid, Spain, and virtually.

The presentation will focus on the study titled 'Liposomal Annamycin (L-ANN) in Combination with Cytarabine for Treatment of Patients with Acute Myeloid Leukemia (AML) Refractory to or Relapsed After Induction Therapy (MB-106 Study).'

The presenting author will be Dr. Wolfram C. M. Dempke, European Chief Medical Officer of Moleculin.