Moleculin Biotec Stock Price, News & Analysis

Moleculin Biotech, Inc. (Nasdaq: MBRX) announced that the FDA granted Orphan Drug Designation for WP1122, aimed at treating Glioblastoma Multiforme (GBM), an aggressive brain tumor. This milestone follows the progress in WP1122's Phase 1 clinical trial and supports its potential in addressing a significant medical need. GBM accounts for 16% of primary brain tumors, with a dire median survival of only 15 months. Orphan Drug Designation offers benefits like financial incentives and up to seven years of market exclusivity upon approval, enhancing Moleculin's strategic position in oncology.

Moleculin Biotech announced promising preliminary results from the third cohort of its Phase 1a study for WP1122, a drug under investigation for COVID-19 treatment. The Safety Review Committee deemed the 32 mg/kg dosage safe, allowing escalation to 64 mg/kg for the next cohort. The multiple ascending dose (MAD) phase will also begin with a daily dose of 32 mg/kg. Following the completion of three single ascending dose (SAD) cohorts, the study aims to investigate WP1122's safety and pharmacokinetics, with a target of enrolling approximately 80 subjects.

Moleculin Biotech, Inc. (Nasdaq: MBRX) reported its Q2 2022 financial results, highlighting continued progress in clinical programs targeting resistant tumors and viruses. The company successfully completed the Phase 1b portion of its Annamycin trial for soft tissue sarcoma lung metastases and commenced a Phase 2 trial. Moleculin holds sufficient capital, ending the quarter with $58 million, to sustain operations beyond mid-2024. The net loss increased to $13.6 million for the first half of 2022, compared to $8.7 million in the prior year.

Moleculin Biotech, Inc. (Nasdaq: MBRX) has completed the Phase 1b trial of Annamycin for soft tissue sarcoma (STS) lung metastases, demonstrating clinical activity with stable disease in several subjects. The Recommended Phase 2 Dose (RP2D) is set at 360 mg/m² for the next phase, with enrollment for Phase 2 commencing soon. Annamycin holds Fast Track Status and Orphan Drug Designation from the FDA, indicating potential as a novel treatment with reduced cardiotoxicity compared to traditional anthracyclines. Preliminary data indicate two subjects remain on treatment, while eight show no disease progression for over two months.

Moleculin Biotech (MBRX) reported preliminary results from the second cohort of its Phase 1a clinical trial for WP1122. The cohort, consisting of 8 subjects receiving 16 mg/kg or placebo, demonstrated safety and tolerability, allowing the company to escalate to a 32 mg/kg dose in the third cohort. The trial aims to establish the maximum tolerated dose (MTD) and evaluate WP1122 for COVID-19. The study is expected to enroll approximately 80 subjects, with multiple ascending doses commencing after the successful completion of three single ascending dose cohorts.

Moleculin Biotech, Inc. (Nasdaq: MBRX) announced positive preliminary results from its first cohort in the Phase 1a study of WP1122, a drug targeting resistant tumors and viruses. The first cohort, consisting of 9 subjects who received 8 mg/kg or placebo, was deemed safe and well-tolerated, allowing the Company to escalate the dosage to 16 mg/kg in the next cohort. This study is pivotal in establishing the maximum tolerated dose for WP1122, which is also being investigated for potential COVID-19 treatment, with future cohorts to assess further safety and efficacy.

Moleculin Biotech (Nasdaq: MBRX) has initiated dosing in its first-in-human Phase 1a study of WP1122, a prodrug developed to treat COVID-19. This study aims to assess safety and pharmacokinetics in healthy volunteers, marking a critical step in development. The trial will include single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, with enrollment anticipated for about 80 subjects. The maximum dose in SAD could reach 64 mg/kg. Results from preclinical models indicate potential antiviral efficacy. The company also received FDA IND clearance for a Phase 1 study of WP1122 in glioblastoma.

Moleculin Biotech, Inc. (Nasdaq: MBRX), a clinical stage pharmaceutical company, announced its participation in the H.C. Wainwright Global Investment Conference from May 23-26, 2022, in Miami, FL. CEO Walter Klemp will present at the event. Following the presentation, management will hold virtual one-on-one meetings with registered investors. A video webcast of the presentation will be available on-demand starting May 24, 2022, at 7:00 AM ET. Moleculin is focused on developing drugs targeting resistant tumors and viruses, including its lead candidate, Annamycin, for acute myeloid leukemia.

Moleculin Biotech reported its financial results for Q1 2022, showing a net loss of $6.9 million, compared to $4.4 million in Q1 2021. R&D expenses rose to $4.6 million due to increased clinical trial activity. The company's cash balance stands at $66.1 million, sufficient to fund operations into 2024. Notable advancements include authorizations for clinical trials of WP1122 (COVID-19) in the UK and Annamycin (AML treatment) in Poland. The company anticipates multiple key clinical milestones throughout 2022, aiming to address unmet medical needs in resistant tumors and viruses.