Moleculin Biotech (MBRX) AI Stock Analysis

• Market Cap: $12.27M
• Dividend Yield: N/A
• Average Volume (3M): 2.71M
• Price to Earnings (P/E): ―
• Beta (1Y): 2.59
• Revenue Growth: N/A
• EPS Growth: 52.82%
• Country: US
• Employees: 17
• Sector: Healthcare
• Sector Strength: 78
• Industry: Biotechnology
• EPS (TTM): -7.12
• Shares Outstanding: 14,127,494
• 10 Day Avg. Volume: 660,691
• 30 Day Avg. Volume: 2,711,308
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): 136.34
• Price to Cash Flow (P/CF): -0.10
• P/FCF Ratio: 0.00
• Enterprise Value/Market Cap: N/A
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: N/A
• Enterprise Value/Ebitda: N/A
• 1Y Price Target: $13.33
• Price Target Upside: 1432.18% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 3

Moleculin Biotech faces significant financial challenges typical of early-stage biotech firms, with no revenue and increasing losses. The stock is under bearish technical indicators, reflecting low investor confidence. However, positive developments in clinical trials and a solid financial runway offer potential upside if milestones are met. The overall risk remains high due to financial instability and the high costs associated with ongoing trials.

Positive Factors

Clinical Trial Progress

The planned Phase 3 'MIRACLE' trial is based on positive Phase 1b/2 results, which showed promising complete remission rates in patients with previous treatment lines, bolstering confidence in Annamycin's potential.

Drug Characteristics

Annamycin is differentiated from other anthracyclines for not showing cumulative cardiotoxicity, which limits long-term use of other anthracyclines.

Regulatory Approval

Annamycin currently has Fast Track and Orphan Drug Designation from the FDA for the treatment of R/R AML, increasing potential to accelerate its timeline for approval.

Negative Factors

Commercial Timelines

The commercial timelines for Annamycin in acute myeloid leukemia have been pushed out to 2029 due to extended trial timelines.

Financial Challenges

The company's cash reserves are low with high quarterly cash burn, necessitating immediate capital raising efforts.

Stock Dilution

The company is seeking to raise capital through the sale of common stock and warrants, which could lead to significant share dilution and affect the company's ability to operate.

Moleculin Biotech Business Overview & Revenue Model

Company Description

Moleculin Biotech, Inc., a clinical-stage pharmaceutical company, focuses on the development of drug candidates for the treatment of highly resistant tumors and viruses. Its lead drug candidate is Annamycin that is in Phase 1/2 studies for the treatment of relapsed or refractory acute myeloid leukemia (AML) and cancers metastasized to the lungs. The company's flagship immune/transcription modulator is WP1066, which is in Phase I clinical trial for the treatment of brain tumors and pediatric brain tumors, as well as pancreatic cancer and other malignancies. It also develops WP1220, an analog of WP1066 for the topical treatment of cutaneous T-cell lymphoma; and WP1122 to treat glioblastoma multiforme and COVID-19. The company has partnership and collaboration agreements with MD Anderson; Animal Life Sciences, LLC; and WPD Pharmaceuticals Sp z.o.o. Moleculin Biotech, Inc. was incorporated in 2015 and is headquartered in Houston, Texas.

How the Company Makes Money

Moleculin Biotech primarily makes money through the development and potential commercialization of its oncology drug candidates. The company seeks to generate revenue by advancing its drug candidates through clinical trials and securing regulatory approvals. Revenue streams may include licensing agreements, collaborations with larger pharmaceutical companies, and potential sales of approved drugs. Additionally, Moleculin may receive milestone payments and royalties from partners involved in the commercialization of its drug candidates. The company's financial success heavily relies on its ability to successfully demonstrate the efficacy and safety of its drug candidates in clinical trials and to navigate the regulatory landscape for drug approvals.

Moleculin Biotech Financial Statement Overview

Summary

Moleculin Biotech is in a challenging financial position typical for early-stage biotech firms. The absence of revenue and increasing losses highlight the high-risk nature of its operations. Despite low debt levels, the declining equity and assets raise concerns about long-term sustainability, with continuous reliance on external funding.

Income Statement

Moleculin Biotech has consistently reported zero revenue over the years, reflecting its pre-commercial stage typical in the biotech industry. The net income has been negative, with increasing losses each year, indicating growing expenses without revenue generation. This suggests a high-risk profile in terms of profitability and revenue generation.

Balance Sheet

The company's debt-to-equity ratio remains low due to minimal debt levels, which is positive for financial stability. However, the equity has been declining over the years, reflecting continuous operational losses. The equity ratio suggests a relatively moderate reliance on equity financing, but the declining trend in total assets highlights potential liquidity concerns.

Cash Flow

Moleculin Biotech has been consistently generating negative free cash flow, with no signs of improvement, reflecting its high cash burn rate common in biotech firms. The operating cash flow to net income ratio is high due to substantial operating losses. Financing cash flows have been positive, indicating reliance on external funding for operations.

Breakdown
Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement		Total Revenue
0.00	0.00	0.00	0.00	0.00
	Gross Profit
0.00	-127.00K	-222.00K	-260.00K	-285.00K
	EBIT
-26.64M	-29.63M	-30.64M	-22.97M	-19.74M
	EBITDA
-26.52M	-29.50M	-30.51M	-22.80M	-19.54M
	Net Income Common Stockholders
-21.76M	-29.77M	-27.41M	-8.86M	-15.00M
Balance Sheet		Cash, Cash Equivalents and Short-Term Investments
4.28M	23.55M	43.15M	70.90M	15.17M
	Total Assets
16.93M	38.22M	57.42M	84.09M	29.03M
	Total Debt
478.00K	574.00K	451.00K	159.00K	277.00K
	Net Debt
-3.80M	-22.98M	-42.69M	-70.74M	-14.90M
	Total Liabilities
10.95M	12.14M	5.23M	5.10M	11.27M
	Stockholders Equity
5.98M	26.07M	52.19M	78.99M	17.76M
Cash Flow		Free Cash Flow
-23.88M	-24.23M	-27.71M	-18.97M	-18.15M
	Operating Cash Flow
-23.86M	-24.10M	-27.64M	-18.95M	-17.77M
	Investing Cash Flow
-13.00K	-124.00K	-67.00K	-19.00K	-374.00K
	Financing Cash Flow
4.63M	4.65M	-23.00K	74.72M	22.55M

Moleculin Biotech Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 0.87
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Positive
• RSI: Neutral
• STOCH: Positive

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For MBRX, the sentiment is Negative. The current price of 0.87 is below the 20-day moving average (MA) of 1.08, below the 50-day MA of 1.21, and below the 200-day MA of 2.28, indicating a bearish trend. The MACD of -0.07 indicates Positive momentum. The RSI at 40.08 is Neutral, neither overbought nor oversold. The STOCH value of 12.79 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for MBRX.

Moleculin Biotech Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
Sector *	48 Neutral	$6.86B	1.11	-50.22%	2.47%	16.71%	1.53%
AVIR	46 Neutral	$248.02M	―	-33.88%	―	―	-22.66%
CTXR	42 Neutral	$9.64M	―	-52.85%	―	―	8.99%
CYCC	36 Underperform	$47.69M	―	-807.39%	―	-80.98%	62.27%
IMUX	36 Underperform	$96.01M	―	-424.44%	―	―	51.02%
MBRX	32 Underperform	$12.27M	―	-135.80%	―	―	52.82%

Moleculin Biotech Corporate Events

Moleculin Biotech Begins Phase 3 MIRACLE Trial Dosing

On April 1, 2025, Moleculin Biotech announced the commencement of dosing for the first patient in its Phase 3 MIRACLE trial, which evaluates Annamycin combined with Cytarabine for treating relapsed or refractory acute myeloid leukemia (R/R AML). This trial marks a significant milestone for the company and the AML community, with initial data expected in the second half of 2025. The trial’s adaptive design and global scope aim to accelerate Annamycin’s development towards approval, potentially impacting Moleculin’s market positioning and providing valuable insights for stakeholders.

Moleculin Biotech Shares Corporate Presentation Update

On March 24, 2025, Moleculin Biotech, Inc. utilized a corporate presentation for its website, which was detailed in a Current Report on Form 8-K. The presentation, noted as Exhibit 99.1, was shared for informational purposes and not intended for filing under the Securities Exchange Act of 1934 or the Securities Act of 1933.

Moleculin Biotech Gets FDA Nod for Phase 3 Trial

On February 13, 2025, Moleculin Biotech announced receiving FDA feedback that allows a reduced size for its Phase 3 trial protocol evaluating Annamycin combined with Cytarabine for treating relapsed or refractory AML. This trial, named MIRACLE, will be conducted globally, including in the US, Europe, and the Middle East, and aims to accelerate the approval timeline for this potentially groundbreaking non-cardiotoxic anthracycline. The feedback enables quicker site openings and recruitment, with implications for significantly impacting AML treatment and eliminating cardiotoxic risks in cancer therapies.

Moleculin Biotech Gains European Approval for Phase 3 Trial

On February 11, 2025, Moleculin Biotech announced receiving regulatory approval in Europe to start recruiting for its Phase 3 MIRACLE trial, evaluating Annamycin combined with Cytarabine for treating relapsed or refractory acute myeloid leukemia. The trial will include sites in the US, Europe, and the Middle East. The announcement signifies a crucial step in advancing their pivotal clinical trial, aiming for unblinded preliminary data from the first 45 subjects in the second half of 2025, potentially enhancing their market position in cancer therapeutics.

Moleculin Biotech Launches MIRACLE Study for AML

On January 27, 2025, Moleculin Biotech announced the launch of its MIRACLE pivotal study for second line relapsed/refractory acute myeloid leukemia (AML), marking a significant milestone in its drug development efforts. The company has made substantial progress in preparing for this global registration trial, including selecting over 25 clinical sites and expecting to activate over 70, with the first patient anticipated to be treated within the first quarter. The trial aims to complete the 90-patient Part A by early 2026. Moleculin’s drug Annamycin shows promising preliminary results, outpacing competitors, and is generating increased interest from potential partners, reflecting its potential impact on the AML treatment landscape.

Moleculin Biotech Shares Updates on MIRACLE Trial

On January 27, 2025, Moleculin Biotech announced that its CEO, Walter Klemp, participated in a Virtual Investor ‘What This Means’ segment. During the event, Klemp shared updates on the MIRACLE trial, a Phase 3 study evaluating Annamycin for treating relapsed or refractory acute myeloid leukemia. This trial is a significant step for Moleculin as it expands globally, with sites in the US, Europe, and the Middle East, and reflects advancements in AML treatment. Moleculin’s progress in developing Annamycin and other drug candidates could enhance its position in the pharmaceutical industry, with potential implications for regulatory approval and stakeholder investment.

Moleculin Biotech Shares Corporate Presentation Update

Moleculin Biotech, Inc. announced the use of a corporate presentation as part of its communication strategy, which is now available on their website. This presentation is being shared for informational purposes and will not be filed under the Securities Exchange Act, which may impact how stakeholders and investors perceive the company’s communications.

Moleculin Biotech Advances Annamycin to Phase 3 Trial

Moleculin Biotech announced significant progress in the development of its drug Annamycin, particularly for relapsed or refractory acute myeloid leukemia (AML). The company has received approval for a pivotal Phase 3 trial, with initial data indicating Annamycin’s potential superiority over existing therapies. The accelerated trial timelines and promising preliminary results could enhance Moleculin’s market position and provide substantial value to stakeholders.