Moleculin Biotec Stock Price, News & Analysis

Moleculin Biotech, Inc. (MBRX) announced the approval from Italy's AIFA and ISS for its Phase 1/2 trial of Annamycin in combination with Cytarabine (Ara-C) for treating refractory or relapsed Acute Myeloid Leukemia (AML). This adds to the ongoing approval in Poland, where three sites are already recruiting. The company expects to treat its first subject in Italy in Q1 2023. Annamycin has shown significant potential in preclinical studies, enhancing overall survival rates. The company is expanding its clinical trial efforts across Europe to improve recruitment rates.

Moleculin Biotech announced an impressive 80% overall response rate (ORR) in the final cohort of its Phase 1 clinical trial for Annamycin in treating relapsed/refractory acute myeloid leukemia (AML). The drug has shown significant safety results, with an independent report confirming no cardiotoxicity in 42 subjects across three trials. Additionally, Annamycin has received FDA Fast Track and Orphan Drug Designation for AML and STS lung metastases. The company is expanding its clinical trials into Europe to improve recruitment.

Moleculin Biotech, Inc. (Nasdaq: MBRX) announced on December 7, 2022, that the FDA granted Fast Track designation for its drug WP1122 to treat Glioblastoma Multiforme (GBM). This designation aims to expedite the development of therapies for serious conditions with unmet needs, allowing more frequent regulatory communication. Walter Klemp, CEO, emphasized the significance of this designation and the promising preclinical data for WP1122. With GBM having a median survival of only 15 months, WP1122 shows potential as a treatment option, especially after receiving Orphan Drug Designation and IND clearance for a Phase 1 study.

Moleculin Biotech reported its Q3 2022 financial results, highlighting significant progress in clinical trials. The company is conducting three Phase 1/2 studies for Annamycin, with no evidence of cardiotoxicity in treated patients. Moleculin has sufficient capital of $50.4 million to fund operations through mid-2024. Their R&D expenses rose to $14.8 million, reflecting increased clinical activities. Additionally, the FDA granted Orphan Drug Designation for WP1122 aimed at treating Glioblastoma Multiforme. A conference call to discuss these results was held on November 10, 2022.

Moleculin Biotech, Inc. (Nasdaq: MBRX) will release its financial results for Q3 2022 on November 10, 2022. An inaugural quarterly conference call will follow at 5:00 PM ET to discuss both operational and financial outcomes. Moleculin specializes in developing drug candidates for resistant tumors and viral infections, with lead program Annamycin aimed at treating relapsed acute myeloid leukemia and soft tissue sarcoma. The company also has ongoing projects targeting brain tumors and COVID-19.

Moleculin Biotech, Inc. (Nasdaq: MBRX) has provided an update on its Phase 1a clinical trial for WP1122, designed to treat resistant tumors and viruses. The second multiple ascending dose (MAD) cohort was halted due to adverse events in 2 subjects, leading to the initiation of MAD cohort 2a at 48 mg/kg. The trial includes around 70 subjects and aims to establish a maximum tolerated dose. While initial doses were well tolerated, the company aims to explore WP1122's potential against COVID-19 and other severe infections. Future studies may occur in additional countries.

Moleculin Biotech announced that its compound WP1096, part of the WP1122 portfolio, will undergo animal studies funded by NIAID. This investigation aims to assess WP1096's potential as a therapy for hemorrhagic fever viruses, which currently lack FDA-approved treatments. Preliminary studies show WP1096 exhibits a broader antiviral spectrum compared to 2-DG. Moleculin is also advancing other projects, including a Phase 1 trial for another compound, WP1122, in COVID-19 patients. The company aims to further develop WP1096 if animal studies demonstrate significant efficacy.

Moleculin Biotech announced a live moderated video webcast for its Phase 1/2 study of Annamycin, targeting Acute Myeloid Leukemia (AML). The event is scheduled for September 28, 2022, at 11:00 AM ET. Management, including CEO Walter V. Kemp, will discuss Annamycin's clinical development and its combination with Cytarabine (AnnAraC). This open-label trial (MB-106) builds on prior safety data from earlier Phase 1 trials. Investors can submit questions and access a live webcast.

Moleculin Biotech, Inc. (Nasdaq: MBRX), a clinical-stage pharmaceutical firm, announced its participation in the 2nd Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care from September 8-10, 2022, at the Roswell Park Comprehensive Cancer Center, Buffalo, NY. Presentations will include The Value of Collaboration in Clinical Development by CEO Walter Klemp and Translating Preclinical Research Into Clinical Trials by Dr. Robert Shepard. The company focuses on drug candidates for resistant tumors, including Annamycin for leukemia and WP1066 for brain tumors.