Core Viewpoint - Moleculin Biotech, Inc. has received approval from the European Medicines Agency (EMA) for its pivotal Phase 2B/3 clinical trial of Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia (R/R AML) [1][2] Group 1: Clinical Trial Details - The "MIRACLE" trial is a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating Annamycin for R/R AML patients, particularly those who have failed venetoclax regimens [1][2] - The trial has been approved in all nine EU countries submitted, including Belgium, Czechia, France, Germany, Italy, Lithuania, Poland, Romania, and Spain [2] - Patient enrollment and dosing have commenced, with initial data readout expected in the second half of 2025 [1][5] Group 2: Trial Design and Protocol - The trial utilizes an adaptive design, with the first 75 to 90 subjects randomized to receive high dose cytarabine combined with either placebo or two different doses of Annamycin (190 mg/m and 230 mg/m) [2][3] - The protocol allows for unblinding of preliminary primary efficacy data at 45 subjects, with the first unblinding expected in the second half of 2025 [3] - Part B of the trial will randomize approximately 220 additional subjects to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin [4] Group 3: Regulatory Status and Designation - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for R/R AML and soft tissue sarcoma [6] - The EMA has also granted Orphan Drug Designation for Annamycin for the treatment of R/R AML [6] Group 4: Company Overview - Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company focused on developing therapeutic candidates for hard-to-treat tumors and viral infections [7] - The lead program, Annamycin, is designed to avoid multidrug resistance mechanisms and lacks the cardiotoxicity associated with current anthracyclines [7][8]

Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viruses [3] - The company's lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance and cardiotoxicity, currently in development for relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases [3] Recent Developments - The company initiated patient recruitment for its pivotal Phase 3 MIRACLE trial (MB-108) evaluating Annamycin in combination with cytarabine for treating relapsed or refractory AML [4] - Following a successful Phase 1B/2 study (MB-106) and FDA input, the company believes it has de-risked the development pathway for Annamycin's potential approval for AML [4] Additional Pipeline - Moleculin is also developing WP1066, an Immune/Transcription Modulator targeting brain tumors and pancreatic cancers, and a portfolio of antimetabolites including WP1122 for treating pathogenic viruses and certain cancer indications [5] Upcoming Events - The company will report its financial results for Q1 2025 on May 13, 2025, followed by a conference call on May 14, 2025, at 8:30 AM ET [1][2]

Core Viewpoint - Annamycin, a next-generation anthracycline, is being developed by Moleculin Biotech, Inc. for the treatment of serious cancers, particularly relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases, with the potential to be safer and more effective than current treatments [1][4] Group 1: Drug Development and Trials - The ongoing pivotal Phase 3 clinical trial, named the "MIRACLE" trial, is evaluating Annamycin in combination with cytarabine (referred to as AnnAraC) for treating relapsed or refractory AML, with initial data expected in the second half of 2025 [1][3] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for AML treatment, as well as Orphan Drug Designation from the European Medicines Agency (EMA) [3] - The recruitment of patients for the MIRACLE trial commenced in March 2025, following a successful Phase 1B/2 study, which has de-risked the development pathway towards potential approval [5] Group 2: Regulatory Approvals and Naming - The World Health Organization's International Nonproprietary Names (INN) Expert Committee has approved "naxtarubicin" as the non-proprietary name for Annamycin, marking a significant step in its development and future commercialization [2] - The INN naming process ensures that drug names adhere to guidelines and are conflict-free, facilitating safe prescription and dispensing [2] Group 3: Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing therapeutic candidates for hard-to-treat tumors and viral infections, with Annamycin as its lead program [4] - The company is also developing other candidates, including WP1066, an immune/transcription modulator targeting various cancers, and WP1122, aimed at treating pathogenic viruses [6]

Core Viewpoint - Moleculin Biotech, Inc. has received two additional U.S. patents for Annamycin, enhancing its intellectual property portfolio and exclusivity for this novel drug candidate targeting hard-to-treat cancers and viruses [1][3]. Patent and Intellectual Property - The U.S. Patent and Trademark Office granted U.S. patent number 12,257,261 for the preparation of preliposomal Annamycin lyophilizate and U.S. patent 12,257,262 for the method of reconstituting liposomal Annamycin, both extending the patent term until June 2040 [1]. - With these new patents, the total number of U.S. patents related to Annamycin has increased to four, in addition to European patents granted [3]. Drug Development and Clinical Trials - Annamycin is being developed as a treatment for acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets), with potential applications for other cancer types based on preclinical studies [2][4]. - The company is conducting the pivotal, adaptive Phase 3 MIRACLE trial evaluating Annamycin in combination with cytarabine for relapsed or refractory AML, with initial data expected in the second half of 2025 [3][5]. Regulatory Status - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML and STS lung mets, as well as Orphan Drug Designation from the European Medicines Agency [3]. Company Overview - Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company focused on developing therapeutic candidates for hard-to-treat tumors and viruses, with Annamycin as its lead program designed to avoid cardiotoxicity associated with current anthracyclines [4].

Core Viewpoint - Annamycin is a next-generation anthracycline that shows potential for synergistic effects with various FDA-approved anticancer therapies, indicating opportunities for expanded clinical applications in treating both hematological malignancies and solid tumors [1][2][4] Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viral infections, with Annamycin as its lead program [6][7] - The company is advancing its pipeline through pivotal clinical trials, including the MIRACLE trial for relapsed or refractory acute myeloid leukemia (AML) [8] Research Findings - Recent studies presented at the AACR Annual Meeting 2025 demonstrate that Annamycin can work effectively in combination with various FDA-approved drugs, both in vitro and in vivo [1][4] - The research aims to identify new clinical applications for Annamycin, particularly in combination therapies for treatment-resistant cancers [4][5] Clinical Trials - The company is initiating the MIRACLE trial, which evaluates Annamycin in combination with cytarabine for AML treatment, following a successful Phase 1B/2 study [8] - Annamycin has shown high activity against drug-resistant cell lines in previous experiments, suggesting its potential effectiveness in challenging cancer cases [3][4] Future Development - The company is exploring additional indications for Annamycin, including pancreatic cancer and soft tissue sarcomas, as part of its strategy to expand the drug's market potential [2][4]

Core Insights - Moleculin Biotech, Inc. announced that an abstract regarding its next-generation anthracycline, Annamycin, has been selected for poster presentation at the AACR Annual Meeting 2025 [1][2] Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viruses [3] - The lead program, Annamycin, is designed to avoid multidrug resistance and eliminate cardiotoxicity associated with current anthracyclines, targeting relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases [3] Clinical Trials - The company is initiating the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory AML [4] - Following a successful Phase 1B/2 study, the company believes it has de-risked the development pathway towards potential approval for Annamycin [4] Additional Developments - Moleculin is also developing WP1066, an immune/transcription modulator targeting brain tumors and other cancers, and a portfolio of antimetabolites including WP1122 for treating pathogenic viruses and certain cancer indications [5]

While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts about the future earnings of this company is a solid fundamental factor that enhances the prospects of a trend reversal for the stock. Understanding Hammer Chart and the Technique to Trade It A downtrend has been apparent in Moleculin Biotech, Inc. (MBRX) lately. While the stock has lost 8.2% over the past week, it could witness a tre ...

– Initial data readout on track for second half of 2025 HOUSTON, April 01, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viruses, today announced the first patient has been dosed in its Phase 3 pivotal trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred ...

Core Viewpoint - Moleculin Biotech, Inc. (MBRX) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system emphasizes the importance of changing earnings estimates in determining stock price movements, with empirical research showing a strong correlation between earnings estimate revisions and near-term stock performance [4][6]. - For Moleculin Biotech, the rising earnings estimates indicate an improvement in the company's underlying business, which is expected to drive the stock price higher [5][10]. Earnings Estimate Revisions - For the fiscal year ending December 2025, Moleculin Biotech is projected to earn -$2.67 per share, reflecting a 57.8% change from the previous year's reported figure [8]. - Over the past three months, the Zacks Consensus Estimate for Moleculin Biotech has increased by 46.9%, indicating a positive trend in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% of stocks receiving a 'Strong Buy' or 'Buy' rating, highlighting their superior earnings estimate revision features [9][10]. - The upgrade of Moleculin Biotech to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Financial Data and Key Metrics Changes - The company reported a cash balance of approximately $13 million at the end of the year, which includes $9 million raised in February 2025, providing a runway into the third quarter of 2025 [27] - Operating expenses were reduced by about $3 million in 2024 compared to 2023 [28] - The current market capitalization is $16.2 million with 14 million shares outstanding, reflecting an increase from year-end due to equity issuance [28] Business Line Data and Key Metrics Changes - The MIRACLE Phase 3 trial for Annamycin is a pivotal study aimed at treating relapsed and refractory AML patients, with 25 sites selected and patient screening already begun [7][8] - Annamycin's Phase 2 data showed a 50% complete remission rate in second-line patients, significantly outperforming existing therapies [17][18] - The median progression-free survival has increased to nine months, with overall survival at 11 months for second-line therapy patients [18] Market Data and Key Metrics Changes - The company is focusing on the development of Annamycin while relying on externally funded programs for WP1066 and WP1122 [28] - The company anticipates that the first patient in the MIRACLE trial will be treated before the end of the current quarter [23] Company Strategy and Development Direction - The company aims to position Annamycin as the first non-cardiotoxic anthracycline, addressing a significant unmet need in AML and potentially other cancers [35] - The strategy includes moving towards first-line therapy after demonstrating efficacy in second-line therapy [65] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Annamycin, highlighting its unique structure and lack of cross-resistance with traditional therapies [35] - The company expects to be busy in 2025 with multiple milestones, including data readouts and potential pivotal trials [33] Other Important Information - The MIRACLE trial will have multiple unblindings of data, providing stakeholders with visibility on progress [10] - The primary endpoint of the MIRACLE trial is the rate of complete remission at approximately day 35 [23] Q&A Session Summary Question: What efficacy is required to pick one Annamycin dose at 45 patients rather than waiting until 90? - Management indicated that if Annamycin performs as well as in Phase 2 and HiDAC underperforms, it may reach statistical significance to shorten the trial [40][41] Question: What was the thinking behind cutting off about 10% of patients from Part D? - The reduction was based on FDA recommendations for a different biostatistical scheme [45] Question: What is the STS lung met efficacy needed to proceed to a pivotal trial? - Management stated that they have already achieved strong results in challenging STS patients, garnering interest for a pivotal trial [49] Question: What are the overall costs of the trial? - The estimated cost for the full patient load of the Phase 3 trial is upwards of $60 million to $70 million, with a cash burn of $5 million per quarter for the remainder of 2025 [58] Question: Thoughts on moving to frontline therapy after showing activity in relapse refractory settings? - Management agreed that first-line therapy is the ultimate objective, especially since Annamycin is not cardiotoxic and can be used in unfit patients [65] Question: Rationale for choosing the 190 dose for the MIRACLE trial? - The 190 dose was chosen based on FDA guidance and previous efficacy observed in studies [71]