Moleculin Biotec Stock Price, News & Analysis

Moleculin Biotech (MBRX), a Phase 3 clinical stage pharmaceutical company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event will take place from September 9-11, 2024 in New York, NY.

Key points:

• Walter Klemp, Chairman and CEO, will present at the conference
• Management will be available for in-person one-on-one meetings with qualified investors
• A video webcast of the presentation will be accessible on-demand from September 9, 2024, at 7:00 AM ET
• The webcast will be available on the Events page in the Investors section of Moleculin's website
• The webcast replay will be archived for 90 days following the event

Moleculin Biotech (Nasdaq: MBRX), a Phase 3 clinical stage pharmaceutical company, has announced its participation in the LIVE! with Webull Corporate Connect: Healthcare Investment Webinar. Walter Klemp, Chairman and CEO of Moleculin, will present on Wednesday, August 28, 2024, at 3:40 PM ET.

Moleculin specializes in developing drug candidates for hard-to-treat tumors and viruses. This presentation offers an opportunity for investors and interested parties to gain insights into Moleculin's progress and future plans. The virtual event format allows for wide accessibility, potentially increasing investor engagement and visibility for the company.

Moleculin Biotech, Inc. (Nasdaq: MBRX) has closed a public offering of up to $16.5 million, including $5.5 million upfront and potential additional $11.0 million from warrant exercises. The offering comprises 2,466,368 shares of common stock (or equivalents) and two series of warrants at $2.23 per share. Series A warrants expire in 2 years or 60 days after positive MIRACLE trial interim data, while Series B warrants expire in 5 years or 6 months after final MIRACLE trial data. Both warrant series require shareholder approval for exercise. H.C. Wainwright & Co. acted as the exclusive placement agent. Moleculin plans to use the proceeds for advancing its drug portfolios, including Annamycin, through clinical development and preclinical studies.

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.