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]

Moleculin Biotech (MBRX) Q4 2024 Earnings Call March 24, 2025 06:53 PM ET Company Participants Walter Klemp - Founder, Chairman, President & CEOJohn Paul Waymack - Senior CMOJonathan Foster - EVP & CFOJason Mccarthy - Senior Managing DirectorVernon Bernardino - Managing Director Conference Call Participants Jonathan Aschoff - Managing Director, Senior Research Analyst Operator Hello, and welcome to the Molecular Biotech Fourth Quarter and Full Year twenty twenty four Update Conference Call and Webcast. A qu ...

Financial Performance - The company reported a net loss of $21.8 million for the year ended December 31, 2024, compared to a net loss of $29.8 million in 2023[26]. - The weighted average common shares outstanding increased to 3,442,997 in 2024 from 1,975,610 in 2023[26]. Expenses - Research and development (R&D) expenses for the year ended December 31, 2024, were $17.7 million, a decrease of $1.8 million from $19.5 million in 2023[14]. - General and administrative (G&A) expenses decreased to $8.8 million in 2024 from $10.0 million in 2023, primarily due to reduced regulatory and legal services[15]. Cash Position - As of December 31, 2024, the company had cash and cash equivalents of $4.3 million, which, along with $9.3 million from February 2025 financing, is expected to fund operations into Q3 2025[16]. Clinical Trials - The company expects to unblind preliminary data from the first 45 subjects in the MIRACLE trial in the second half of 2025[2]. - The MIRACLE trial will randomize 75 to 90 subjects to receive either high dose cytarabine combined with placebo or Annamycin, with the first unblinding expected in the second half of 2025[5]. - The company completed enrollment in the Phase 2 portion of its U.S. Phase 1B/2 clinical trial for Annamycin as monotherapy for soft tissue sarcoma lung metastases, with a clinical study report expected by the end of April 2025[10]. Regulatory Status - The company received positive FDA guidance for the MIRACLE trial, allowing for a smaller number of subjects in the study[6]. - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia[11].

Core Insights - Moleculin Biotech, Inc. is making significant progress in its pivotal Phase 3 clinical trial, the "MIRACLE" trial, with the first subject expected to be treated in Q1 2025 and initial data readout anticipated in the second half of 2025 [1][2] Clinical Development Update - The company is evaluating Annamycin in combination with Cytarabine for the treatment of relapsed or refractory Acute Myeloid Leukemia (AML) in a global Phase 3 trial [4] - The MIRACLE trial will utilize an adaptive design, with the first 75 to 90 subjects randomized to receive different doses of Annamycin combined with HiDAC [5] - The first unblinding of preliminary efficacy data is expected in the second half of 2025, with a second unblinding anticipated in the first half of 2026 [5][6] Recent Highlights - The company received positive FDA guidance for the MIRACLE trial, leading to a smaller number of subjects required for the study [6] - Regulatory approvals have been obtained in Europe and the US for the trial, with multiple sites being activated for patient recruitment [7][8] Financial Results Summary - For the fiscal year ended December 31, 2024, research and development expenses were $17.7 million, a decrease from $19.5 million in 2023, primarily due to a sublicense termination [12] - General and administrative expenses also decreased to $8.8 million from $10.0 million, attributed to reduced regulatory and legal services [13] - The company reported a net loss of $21.8 million for 2024, compared to a net loss of $29.8 million in 2023, with a net loss per share of $6.32 [12][13][25] Expected Milestones - Key upcoming milestones include the first subject enrollment in the MIRACLE trial in Q1 2025, data readout in the second half of 2025, and interim efficacy data in the first half of 2026 [14][15]

Clinical Trials and Drug 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 data expected by the end of 2025[22]. - The company has completed or is currently conducting fourteen clinical trials for its drug candidates, with three candidates showing human activity in clinical trials[23]. - The Phase 2B/3 trial for Annamycin is expected to be pivotal, with the first site initiated for the global trial[34]. - The FDA's EOP2 meeting in July 2024 resulted in a positive discussion and the design of a Phase 2B/3 pivotal trial (MIRACLE) for R/R AML patients, which will be a global trial including sites in the US, Europe, Western Asia, and the Middle East[39]. - The MIRACLE trial will utilize a double-blind, placebo-controlled design, comparing Annamycin to high-dose cytarabine (HiDAC) with complete remission (CR) as the primary endpoint[39]. - The company completed recruitment and treatment in the MB-107 Phase 1B/2 clinical trial using Annamycin for STS lung mets in 2023, with follow-up for progression-free survival (PFS) and overall survival (OS) during 2024[38]. - The company plans to initiate a follow-on MIRACLE2 trial for third-line patients once the optimum dose is established in the MIRACLE trial[39]. - The company completed recruitment of 22 subjects for the MB-106 clinical trial, focusing on Annamycin in combination with Cytarabine for AML treatment[84]. - The Phase 1 clinical trial of Annamycin (MB-104) successfully demonstrated safety at the lifetime maximum allowable dose of anthracycline, with no signs of cardiotoxicity observed[67]. - The Phase 1B/2 clinical trial for Annamycin in STS lung metastases has completed enrollment with 36 subjects, and results are anticipated by the end of April 2025[100]. Drug Efficacy and Safety - Annamycin has shown a complete response (CR) rate of 50% and a composite complete response (CRc) rate of 60% in combination with Cytarabine for the treatment of R/R AML, which is higher than other approved second-line therapies[25]. - Annamycin has demonstrated non-cardiotoxicity in clinical trials, with some patients safely dosed at five times the typical lifetime maximum allowed anthracycline dose[25]. - Annamycin's overall survival (OS) rate is approximately 11 months, which is climbing, in combination with Cytarabine for the treatment of R/R AML[25]. - Annamycin has shown no signs of cardiotoxicity in clinical trials, allowing for higher dosing and potential treatment of traditionally "Unfit" patients[64]. - In the MB-106 trial, 41% of subjects achieved a complete response (CR) or CR with incomplete recovery (CRi) when treated with Annamycin and Cytarabine[76]. - The combination of Annamycin and Cytarabine (AnnAraC) demonstrated a 68% improvement in median overall survival (OS) compared to Annamycin alone and a 241% increase compared to Cytarabine alone in animal models[72]. - The company has received independent assessments covering 84 subjects treated with Annamycin, showing no evidence of cardiotoxicity, even with doses exceeding the FDA's lifetime maximum anthracycline limit[56]. Regulatory Designations and Market Potential - The company has received orphan drug and fast track status for Annamycin, with patent protection extending through 2040[25]. - The FDA and EMA have granted Orphan Drug Designation (ODD) to Annamycin for AML and soft tissue sarcoma, indicating a medically plausible basis for its use[48]. - The company has obtained orphan drug designations (ODD) from the FDA for Annamycin, WP1066, and WP1122 for various cancer treatments[147]. - The FDA granted orphan drug designation (ODD) for WP1066 for glioblastoma treatment, indicating a medically plausible basis for its use[105]. - The FDA granted "Rare Pediatric Disease" designation for WP1066, which may lead to a Priority Review Voucher valued at up to $100 million[170]. - The US market for anthracyclines, including Annamycin, was estimated at approximately $1.3 billion in 2023 and is expected to grow to $2 billion by 2032[158][159]. - The global market size for soft tissue sarcoma (STS) is projected to grow from $1.58 billion in 2024 to $2.57 billion by 2030[164]. - The American Cancer Society projects 2.0 million new cancer cases and 618,120 cancer deaths in the US in 2025, highlighting the significant market potential for oncology drugs[156]. Competitive Landscape and Challenges - The company faces significant competition in the oncology market from larger pharmaceutical and biotechnology firms, as well as academic institutions[185]. - FDA approved targeted therapies for AML patients with specific gene mutations, but they only serve subsets of the population[189]. - Only 20% of patients with soft-tissue sarcomas (STS) lung metastases respond to current treatments, indicating a significant unmet need[190]. - There are currently 551 ongoing clinical trials for pancreatic cancer, leading to intense competition for patient enrollment[191]. Financial and Operational Aspects - The company has a workforce of 17 full and part-time employees as of year-end 2024, operating primarily in a virtual environment[139]. - The company does not have manufacturing facilities and contracts all manufacturing activities to third parties[139]. - Total expenses under license agreements for the years ended December 31, 2024, and 2023 were $0.2 million and $0.3 million, respectively[175]. - The company has a sponsored research agreement with MD Anderson, with expenses of $2.0 million and $0.8 million for the years ended December 31, 2024, and 2023, respectively[176]. - The reverse stock split on March 22, 2024, reduced the number of authorized shares from approximately 33 million to 2 million[182]. Drug Mechanism and Research - Annamycin is designed to avoid multidrug resistance and has shown no cardiotoxicity in subjects treated in five clinical trials to date[28]. - WP1066 has shown significant anti-tumor activity in various animal models, with the ability to inhibit key transcription factors such as c-Myc and HIF-1α, and boost immune response by reducing TRegs[107]. - WP1066 has demonstrated potential for combination use with checkpoint inhibitors, with preclinical evidence suggesting it may reverse immune tolerance in brain tumor patients[109]. - The company believes WP1122 has the potential to enhance the effectiveness of checkpoint inhibitors and impact hard-to-treat viruses reliant on glycolysis[131].

Core Viewpoint - Moleculin Biotech, Inc. is set to report its financial results for the year ended December 31, 2024, on March 21, 2025, with a conference call scheduled for March 24, 2025, to discuss these results [1][2] Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses [1][3] - The company's lead program, Annamycin, is a next-generation anthracycline aimed at overcoming multidrug resistance and reducing cardiotoxicity associated with current treatments [3] Clinical Trials and Development - The company is initiating the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML) [4] - Following a successful Phase 1B/2 study, the company believes it has de-risked the development pathway for Annamycin's potential approval for AML treatment [4] - Additionally, the company is developing WP1066, an immune/transcription modulator targeting various cancers, and a portfolio of antimetabolites, including WP1122 for treating pathogenic viruses and certain cancer indications [5]

Core Insights - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focusing on drug candidates for hard-to-treat tumors and viruses [1][3] - The company participated in the Virtual Investor "Top 5 for '25" On-Demand Conference, where CEO Walter Klemp highlighted five reasons for investment interest in Moleculin [2] Company Overview - Moleculin is advancing a pipeline of therapeutic candidates, with its lead program Annamycin targeting relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases [3] - Annamycin is designed to avoid multidrug resistance and eliminate cardiotoxicity associated with current anthracyclines [3] Clinical Trials - The company is initiating the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for AML treatment [4] - Following a successful Phase 1B/2 study, the company believes it has de-risked the development pathway for Annamycin's potential approval [4] Additional Developments - Moleculin is also developing WP1066, an Immune/Transcription Modulator targeting brain tumors and pancreatic cancers [5] - The company is working on a portfolio of antimetabolites, including WP1122 for treating pathogenic viruses and certain cancer indications [5]