Moleculin Biotec Stock Price, News & Analysis

Moleculin Biotech (MBRX) has received IRB approval for its pivotal Phase 3 'MIRACLE' trial of Annamycin in combination with cytarabine for R/R AML treatment. The trial's preliminary readouts are expected in H2 2025 (n=45) and 1H 2026 (n=~75-90), with potential NDA process starting in 2027.

Recent preliminary clinical results show Annamycin plus Ara-C achieved 60% CR/CRi in subjects relapsed/refractory to Venetoclax regimens, exceeding historical rates by more than 4 times. The Phase 1B/2 trial demonstrated a 50% Complete Remission rate and 60% CRc rate for 2nd line subjects, with median survival of 11.6 months for 2nd line subjects.

The MIRACLE trial will be conducted globally, utilizing an adaptive design with two parts. Part A will randomize 75-90 subjects, while Part B will include approximately 244 additional subjects. The company has engaged Catalyst Clinical Research as CRO for the trial.

Moleculin Biotech announced the publication of preclinical data demonstrating the significant activity of Annamycin in treating venetoclax-resistant acute myeloid leukemia (AML) cell lines. The study, presented at the American Society of Hematology Annual Meeting, revealed that Annamycin effectively targets both Cytarabine (Ara-C) and Venetoclax resistant AML cell lines from heavily pretreated relapsed/refractory primary AML patients in vitro.

The data showed Annamycin's synergy with Ara-C and Venetoclax in reducing cell viability, a lack of cardiotoxicity, improved organotropism, and potential immune-memory reinforcing properties. These findings correlate with preliminary clinical data showing a 60% composite complete remission (CRc) rate in subjects using Annamycin and Ara-C (AnnAraC) as a second-line treatment.

Annamycin's favorable toxicity profile, as compared to DOX, and its ability to extend survival in combination with Ara-C, underscore its potential as a breakthrough treatment. Moleculin is advancing Annamycin in a Phase 3 trial, 'MIRACLE,' set to begin patient treatment in Q1 2025. Annamycin has Fast Track Status and Orphan Drug Designation from the FDA and EMA.

Moleculin Biotech (MBRX) announced new findings showing Annamycin's effectiveness in treating Venetoclax-resistant acute myeloid leukemia (AML). Preliminary clinical results demonstrate that Annamycin plus Ara-C achieved a 60% CR/CRi rate in subjects previously treated with Venetoclax regimens, which is more than 4 times higher than historical rates. The MB-106 trial showed median overall survival of 11.6 months in subjects receiving AnnAraC as second-line therapy. The company is advancing to a Phase 3 'MIRACLE' trial, with patient treatment expected to begin in Q1 2025. Annamycin has received Fast Track Status and Orphan Drug Designation from both FDA and EMA.

Moleculin Biotech (MBRX) has amended its Phase 3 MIRACLE trial protocol for Annamycin in combination with Cytarabine (AnnAraC) for treating relapsed/refractory AML. The amended protocol allows for earlier unblinding of preliminary efficacy data at 45 subjects in H2 2025, accelerating from the previous 2026 timeline. The trial will use an adaptive design with two parts: Part A will randomize 75-90 subjects across three arms, while Part B will include 244 additional subjects. The study maintains its planned first subject treatment start in Q1 2025. Annamycin holds Fast Track Status and Orphan Drug Designation from both FDA and EMA for various indications.

Moleculin Biotech (NASDAQ: MBRX) has received Institutional Review Board (IRB) approval for its MIRACLE Phase 3 pivotal trial evaluating Annamycin in combination with Cytarabine for treating relapsed or refractory AML. The global trial is designed for possible accelerated approval and is expected to begin enrollment in Q1 2025. The study will use an adaptive design with initial enrollment of 75-90 subjects in Part A, followed by approximately 240 additional subjects in Part B. Annamycin holds Fast Track Status and Orphan Drug Designation from both FDA and EMA for various indications.

Moleculin Biotech reported its Q3 2024 financial results and provided a corporate update. Key highlights include the initiation of dosing in the Phase 3 MIRACLE trial for Annamycin in Q1 2025. The median durability of CRc in the MB-106 trial has exceeded 8 months. Moleculin hosted a virtual AML KOL event and appointed Dr. Daniel D. Von Hoff to its Scientific Advisory Board.

Financially, R&D expenses rose to $4.9 million from $3.3 million year-over-year, while G&A expenses decreased to $2.2 million from $2.6 million. The company closed a $5.5 million financing and has $9.4 million in cash reserves, expected to fund operations into Q1 2025.

Upcoming milestones include the first subject treated in the MIRACLE trial in Q1 2025 and final data readout for the STS lung metastases trial in 2025. Moleculin will host a conference call on November 11, 2024, at 8:30 AM ET to discuss these updates.

Moleculin Biotech (MBRX) has scheduled its third quarter 2024 financial results announcement for November 8, 2024. The company will host a conference call and webcast to discuss operational and financial results on November 11, 2024, at 8:30 AM ET. Participants can join via phone using the numbers (877) 407-0832 (domestic) or (201) 689-8433 (international). The webcast will be available on the company's website and archived for 90 days.

Moleculin Biotech (NASDAQ: MBRX) has appointed Dr. Daniel D. Von Hoff to its Annamycin Scientific Advisory Board. Dr. Von Hoff, a Distinguished Professor at the Translational Genomics Research Institute and expert in pancreatic cancer, joins following promising preclinical evidence of Annamycin's potential in treating pancreatic cancer presented at AACR. Annamycin is currently in clinical trials for treating relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases. The drug holds Fast Track Status and Orphan Drug Designation from FDA for AML treatment, plus Orphan Drug Designation for soft tissue sarcoma and from EMA for AML.

Moleculin Biotech, Inc. (Nasdaq: MBRX) has announced that the transcript from its recent Virtual Acute Myeloid Leukemia (AML) Key Opinion Leader (KOL) event is now available. The event featured Moleculin's executives and renowned AML experts discussing the potential of Annamycin in changing the AML treatment landscape. The transcript can be accessed on the company's website and SEC Filings page.

The event included an overview of Annamycin, the use of anthracyclines, and Moleculin's recently announced global Phase 3 pivotal trial (MIRACLE) for treating AML patients who are refractory to or relapsed after induction therapy. Walter Klemp, CEO of Moleculin, expressed gratitude to the KOLs for their insights and support, highlighting the growing body of positive preliminary data for Annamycin in addressing the unmet need for safe and effective therapies for R/R AML.