Moleculin(MBRX)
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Moleculin(MBRX) - 2025 Q1 - Quarterly Results
2025-05-14 11:30
Exhibit 99.1 Moleculin Reports First Quarter 2025 Financial Results and Provides Corporate Update Enrollment and dosing underway in Phase 3 clinical trial (the "MIRACLE" trial) evaluating Annamycin (naxtarubicin) for the treatment of R/R AML Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) The Company is currently evaluating Annamycin (naxtarubicin) in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") in a Phase 3 pi ...
Moleculin Reports First Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-05-14 11:30
Core Insights - The company is advancing its Phase 3 clinical trial, known as the "MIRACLE" trial, evaluating Annamycin (naxtarubicin) for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML) with interim data readout expected in the second half of 2025 [1][11] - The European Medicines Agency (EMA) has granted approval for the trial in nine additional countries, enhancing the company's operational scope [1][6] - The company reported a decrease in research and development expenses for Q1 2025 compared to the same period in 2024, indicating a focus on clinical trial activities [18] Clinical Development Update - The MIRACLE trial is a pivotal, adaptive Phase 3 study evaluating Annamycin in combination with Cytarabine for R/R AML patients, with 38 sites selected globally, including 5 in the US as of April 2025 [4][23] - The trial design allows for unblinding of preliminary efficacy data at 45 subjects, with the first unblinding expected in the second half of 2025 [8][11] - The company is also seeing advancements in its pipeline, including the MB-107 trial for soft tissue sarcoma lung metastases, with final data readouts expected by the end of June 2025 [3][13] Financial Results - For Q1 2025, the company reported research and development expenses of $3.4 million, down from $4.3 million in Q1 2024, reflecting reduced clinical trial activity levels [18] - General and administrative expenses increased slightly to $2.5 million in Q1 2025 from $2.4 million in Q1 2024, primarily due to higher regulatory and legal fees [19] - As of March 31, 2025, the company had cash and cash equivalents of $7.7 million, which is expected to fund operations into Q3 2025 [19] Regulatory and Intellectual Property Developments - The company received EMA approval for its Clinical Trial Application to conduct the MIRACLE trial in all nine EU countries submitted [6] - Two new U.S. patents were granted, enhancing the intellectual property portfolio for Annamycin [6] - Annamycin has received Fast Track Status and Orphan Drug Designation from both the FDA and EMA for the treatment of R/R AML and soft tissue sarcoma [14]
Moleculin(MBRX) - 2025 Q1 - Quarterly Report
2025-05-13 20:15
Clinical Trials and Development - The company is conducting a pivotal Phase 3 trial for Annamycin in combination with Cytarabine for relapsed/refractory acute myeloid leukemia (AML), with interim unblinding expected by the end of 2025[74]. - Annamycin has shown no evidence of cardiotoxicity in 84 subjects treated across five clinical trials, with some subjects receiving doses significantly above the FDA's lifetime maximum anthracycline limit of 550 mg/m²[81]. - The MIRACLE trial has received approval from the European Medicines Agency (EMA) to expand into nine EU countries, contingent on presenting results of appropriate nonclinical GLP studies before initiating Part B[91]. - The FDA has allowed a reduction in the size of Part B of the Phase 3 trial protocol to 222 subjects, which is approximately a 10% decrease from the initial proposal[89]. - The company has completed a Phase 1B/2 clinical trial for Annamycin treating Acute Myeloid Leukemia (AML) and is currently in follow-up[85]. - The company has selected 38 sites for the MIRACLE trial across the US, Europe, and the Middle East/Africa, with one site in Ukraine actively treating subjects[88]. - Annamycin is designed to avoid multidrug resistance and has shown no cardiotoxicity in clinical trials, which could disrupt the competitive landscape for AML and Advanced STS treatments[76]. - The company has multiple active INDs/CTAs, comprising a total of fourteen clinical trials, both internally and externally funded[85]. - The company plans to host a Key Opinion Leader (KOL) call to announce and review final top-line data from the MB-107 trial in May or early June[92]. - The company is focusing on the development of Annamycin due to its potential to benefit a majority of patients with AML and Advanced STS[76]. Financial Performance - Revenues for the three months ended March 31, 2025, were $0, consistent with the same period in 2024[105]. - Research and development expenses decreased to $3.4 million in Q1 2025 from $4.3 million in Q1 2024, a reduction of approximately 21%[106]. - General and administrative expenses increased slightly to $2.5 million in Q1 2025 from $2.4 million in Q1 2024, reflecting a 4% increase[107]. - The net loss for the three months ended March 31, 2025, was $6.4 million, compared to a net loss of $5.0 million in the same period of 2024, representing a 29% increase in losses[105]. - The company recorded a net gain of $9.1 million from the change in fair value of warrant liability in Q1 2025, compared to a gain of $1.5 million in Q1 2024[108]. - Cash used in operating activities decreased to $4.6 million in Q1 2025 from $6.7 million in Q1 2024, a decrease of approximately 31%[112]. - The company raised gross proceeds of $9.3 million in February 2025 through various securities offerings[114]. - As of March 31, 2025, the company had $0.6 million in cash on hand and projected sufficient funds to support operations into Q3 2025[116]. - The company anticipates needing approximately $15 million in additional funding to support operations into Q1 2026[116]. Regulatory and Naming Approvals - The World Health Organization approved "naxtarubicin" as the International Non-Proprietary Name for Annamycin, facilitating its recognition in clinical and public documents[99].
Moleculin Receives European Medicines Agency Approval to Expand Phase 3 MIRACLE Clinical Trial
Globenewswire· 2025-05-12 12:40
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]
Moleculin to Report First Quarter 2025 Financial Results on May 13, 2025 and Host Conference Call and Webcast
Globenewswire· 2025-05-07 13:00
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]
Moleculin Announces World Health Organization Approval of “naxtarubicin” as International Non-Proprietary Name for Annamycin
Globenewswire· 2025-05-06 13:00
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]
Moleculin Bolsters Annamycin Intellectual Property Portfolio with Granting of Two New U.S. Patents
Globenewswire· 2025-05-05 12:45
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].
Moleculin Announces New Pre-Clinical Data for Annamycin Demonstrating Market Expansion Potential Including Treatment for Pancreatic Cancer
Globenewswire· 2025-04-29 12:35
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]
Moleculin Announces Acceptance of Abstract to be Presented at the American Association for Cancer Research (AACR) Annual Meeting 2025
Newsfilter· 2025-04-17 12:30
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]
Here's Why Moleculin Biotech (MBRX) Is a Great 'Buy the Bottom' Stock Now
ZACKS· 2025-04-01 15:01
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 ...