Welcome to our dedicated page for Moleculin Biotech news (Ticker: MBRX), a resource for investors and traders seeking the latest updates and insights on Moleculin Biotech stock.
Moleculin Biotech, Inc. (NASDAQ: MBRX) is a clinical stage pharmaceutical company focused on developing therapies for hard-to-treat tumors and viruses. Known for its innovative drug candidates, Moleculin's pipeline aims to address significant unmet medical needs. The company's flagship product, Annamycin, is a next-generation anthracycline designed to overcome multidrug resistance mechanisms and minimize cardiotoxicity. Annamycin is currently in Phase II clinical trials for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases.
Moleculin's research is rooted in discoveries from the acclaimed M.D. Anderson Cancer Center. In addition to Annamycin, the company is developing WP1066, an Immune/Transcription Modulator targeting brain tumors, pancreatic cancer, and other malignancies. WP1066 aims to inhibit oncogenic transcription factors such as p-STAT3 while stimulating the patient's immune response.
Another promising candidate, WP1220, an analog of WP1066, is being developed for the topical treatment of cutaneous T-cell lymphoma. The company also has a robust antimetabolite portfolio, including WP1122, which is being investigated for its potential in treating both viral infections and various cancers.
Recent achievements highlight Moleculin's significant progress. Positive preclinical data for Annamycin were presented at the American Association for Cancer Research (AACR) Annual Meeting, demonstrating its non-cardiotoxic properties and potent inhibition of topoisomerase II-beta. Annamycin has also received Orphan Drug Designation from both the FDA and the European Medicines Agency (EMA) for AML, providing Moleculin with extended market exclusivity and reduced regulatory fees.
Financially, Moleculin maintains a solid footing with sufficient capital to support its ongoing clinical trials and future projects. The company's recent financial report indicates a strategic focus on advancing its clinical and regulatory strategies. With multiple patents issued and pending, Moleculin continues to strengthen its intellectual property portfolio, positioning itself favorably for potential partnerships and market expansion.
Collaborations with leading institutions such as Northwestern University and funding from entities like the National Institutes of Health (NIH) underscore the robust support for Moleculin's initiatives. The company's innovative approach and commitment to addressing challenging medical conditions make it a noteworthy entity in the biopharmaceutical landscape.
For more details, please visit Moleculin's website and connect on Twitter, LinkedIn, and Facebook.
Moleculin Biotech (Nasdaq: MBRX) has announced the start of an investigator-initiated Phase 2 clinical trial evaluating WP1066 in combination with radiation therapy for the treatment of glioblastoma. The study, conducted at Northwestern University, is funded by the NIH and BrainUp®. WP1066 is Moleculin's Immune/Transcription Modulator designed to stimulate immune response to tumors by inhibiting regulatory T cells and oncogenic transcription factors.
The trial aims to address the unmet need in glioblastoma treatment, with four subjects already active and expectations to fill the safety lead-in group of six subjects soon. Glioblastoma is an aggressive brain tumor with a median survival of only 15 months. Moleculin has received Orphan Drug Designation for WP1066 for brain tumors and Rare Pediatric Disease designation for three other pediatric indications.
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.
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