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Moleculin Biotech (MBRX)
NASDAQ:MBRX
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Moleculin Biotech (MBRX) AI Stock Analysis

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MBRX

Moleculin Biotech

(NASDAQ:MBRX)

Rating:44Neutral
Price Target:
Moleculin Biotech's stock score reflects a high-risk financial position with no revenue and growing losses typical of early-stage biotech firms. Positive developments in clinical trials and a solid financial runway provide potential upside, but significant risks remain due to financial instability, high trial costs, and future funding needs. Technical indicators suggest bearish momentum, and the valuation is unattractive due to the absence of earnings.
Positive Factors
Clinical Trials
The first interim readout for the MIRACLE study could be a substantial de-risking event for the P3 study if the complete remissions are comparable to those seen in the MB-106 study.
Regulatory Progress
Positive FDA feedback brings annamycin one step closer to clinical evaluation in pediatric cancer patients.
Therapeutic Potential
Annamycin could emerge as an important therapy for AML management and like Venetoclax when it emerged, could be a high-value opportunity.
Negative Factors
Financial Outlook
Management believes the cash runway to be sufficient to fund operations into 4Q25.
Financial Performance
Moleculin Biotech announced 2Q25 financial results, posting EPS of ($0.49), compared to the estimate of ($0.41).
Stock Impact
MBRX shares traded down following announcement of a warrant inducement transaction that brought in $6M in gross proceeds.

Moleculin Biotech (MBRX) vs. SPDR S&P 500 ETF (SPY)

Moleculin Biotech Business Overview & Revenue Model

Company DescriptionMoleculin 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 MoneyMoleculin 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 Earnings Call Summary

Earnings Call Date:Aug 13, 2025
(Q1-2025)
|
% Change Since: |
Next Earnings Date:Nov 17, 2025
Earnings Call Sentiment Positive
The earnings call reflects significant progress in clinical trials and regulatory approvals, particularly for Annamycin. New patents and drug names bolster future market positioning. However, financial constraints and potential EU approval delays pose challenges.
Q1-2025 Updates
Positive Updates
Phase 3 MIRACLE Trial Progress
The Phase 3 MIRACLE trial for Annamycin has officially started with the first patient treated, and 38 sites selected worldwide. The European Medicines Agency has approved the trial in all nine countries requested.
New Drug Name and Patent Protection
The World Health Organization has recognized a new generic drug name for Annamycin as naxtarubicin, and additional patents have been secured, extending protection into at least 2040.
MB-106 Phase 2 Trial Results
The MB-106 trial shows promising results with the first patient achieving a nearly two-year complete remission, and additional subjects maintaining complete remission.
WP1066 Progress
WP1066 is in an investigator-sponsored clinical trial showing activity in the treatment of brain tumors, with rapid patient recruitment at Northwestern University.
Financial Health and Market Activity
Market cap is over $14 million, with healthy trading volume, and plans to raise $15 million to support ongoing trials.
Negative Updates
Financial Runway and Need for Additional Funding
The company ended the quarter with $8 million in cash, which will only run operations into the third quarter of this year, necessitating a $15 million raise.
Potential Delays in EU Approval
Approval timelines in the EU could be impacted by the need for additional GLP preclinical data as requested by the EMA.
Challenges with Drug Delivery
Current WP1066 delivery is not optimal, with ongoing efforts to develop an IV formulation.
Company Guidance
During the Moleculin Biotech First Quarter 2025 Update Conference Call, several key metrics and guidance were discussed. The company announced the initiation of the Phase 3 MIRACLE trial for Annamycin, with 38 sites selected globally and the first patient already treated. The European Medicines Agency provided approval for the trial across nine EU countries, marking a significant milestone. Moleculin also revealed additional patent protections for Annamycin, extending its composition of matter protection into at least 2040. They highlighted the progress of their MB-107 clinical trial for advanced soft tissue sarcoma and the investigator-sponsored trial of WP1066, which has recruited seven patients at Northwestern University. Financially, Moleculin ended the quarter with $8 million in cash and anticipates needing to raise approximately $15 million to fund operations into the first quarter of 2026. They aim to unblind data from the first 45 patients in the MIRACLE trial by the end of 2025, which they believe will be pivotal for potential new drug approval. Their market cap stands at over $14 million, with 14.1 million shares outstanding and a three-month average trading volume of nearly 6 million shares per day.

Moleculin Biotech Financial Statement Overview

Summary
Moleculin Biotech is in a high-risk financial position typical for early-stage biotech firms. The absence of revenue and increasing losses emphasize the risky nature of its operations. Despite low leverage, the declining equity and assets raise concerns about sustainability. Continuous reliance on external funding underscores the need for successful product development to generate future revenues.
Income Statement
10
Very Negative
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
25
Negative
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
15
Very Negative
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.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue126.00K0.000.000.000.000.00
Gross Profit-28.00K-126.00K-127.00K-222.00K-260.00K-285.00K
EBITDA-27.24M-21.64M-29.50M-30.51M-22.80M-19.54M
Net Income-26.55M-21.76M-29.77M-29.02M-15.89M-17.36M
Balance Sheet
Total Assets21.59M16.93M38.22M57.42M84.09M29.03M
Cash, Cash Equivalents and Short-Term Investments7.56M4.28M23.55M43.15M70.90M15.17M
Total Debt292.00K478.00K574.00K451.00K159.00K277.00K
Total Liabilities28.76M10.95M12.14M5.23M5.10M11.27M
Stockholders Equity-7.17M5.98M26.07M52.19M78.99M17.76M
Cash Flow
Free Cash Flow-21.34M-23.88M-24.23M-27.71M-18.97M-18.15M
Operating Cash Flow-21.34M-23.86M-24.10M-27.64M-18.95M-17.77M
Investing Cash Flow0.00-13.00K-124.00K-67.00K-19.00K-374.00K
Financing Cash Flow18.08M4.63M4.65M-23.00K74.72M22.55M

Moleculin Biotech Technical Analysis

Technical Analysis Sentiment
Negative
Last Price0.38
Price Trends
50DMA
0.57
Negative
100DMA
0.71
Negative
200DMA
1.15
Negative
Market Momentum
MACD
-0.07
Positive
RSI
33.06
Neutral
STOCH
9.52
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 0.38 is below the 20-day moving average (MA) of 0.55, below the 50-day MA of 0.57, and below the 200-day MA of 1.15, indicating a bearish trend. The MACD of -0.07 indicates Positive momentum. The RSI at 33.06 is Neutral, neither overbought nor oversold. The STOCH value of 9.52 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for MBRX.

Moleculin Biotech Risk Analysis

Moleculin Biotech disclosed 58 risk factors in its most recent earnings report. Moleculin Biotech reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 1 New Risks
1.
New tax laws or regulations that are enacted or existing tax laws and regulations that are interpreted, modified or applied adversely to us or our customers may have a material adverse effect on our business and financial condition. Q3, 2022

Moleculin Biotech Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
51
Neutral
$7.95B-0.40-42.50%2.21%22.29%-1.85%
45
Neutral
$17.08M11.60-7.30%-100.00%98.69%
44
Neutral
$11.36M-503.80%60.64%
44
Neutral
$11.60M-144.68%44.55%-17.92%
42
Neutral
$11.68M-102.18%85.26%
41
Neutral
$14.51M-491.97%45.96%
34
Underperform
$9.83M-165.56%58.67%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
MBRX
Moleculin Biotech
0.38
-1.98
-83.90%
IMNN
Imunon
5.76
-8.20
-58.74%
PHIO
Phio Pharmaceuticals
2.04
-0.73
-26.35%
SYBX
Synlogic
1.46
-0.01
-0.68%
MRKR
Marker Therapeutics
0.90
-2.18
-70.78%
INAB
IN8bio
2.16
-6.99
-76.39%

Moleculin Biotech Corporate Events

Product-Related AnnouncementsBusiness Operations and Strategy
Moleculin Biotech Unveils Promising Annamycin Data at AACR
Positive
Apr 29, 2025

On April 28, 2025, Moleculin Biotech presented new pre-clinical data for their drug Annamycin at the AACR Annual Meeting, highlighting its potential to expand into markets such as pancreatic cancer. The research suggests Annamycin can work synergistically with various FDA-approved anticancer drugs, potentially enhancing its clinical applications and attractiveness to future partners, which could significantly impact the company’s market positioning and stakeholder interest.

Spark’s Take on MBRX Stock

According to Spark, TipRanks’ AI Analyst, MBRX is a Underperform.

Moleculin Biotech’s stock score reflects the company’s high-risk financial position, characterized by no revenue and growing losses typical of early-stage biotech firms. The technical analysis signals bearish momentum, while the valuation highlights financial instability. Positive clinical trial developments and a solid cash position provide potential upside, but significant risks remain, especially regarding high trial costs and future funding needs.

To see Spark’s full report on MBRX stock, click here.

Regulatory Filings and Compliance
Moleculin Biotech Releases Corporate Presentation Online
Neutral
Apr 21, 2025

On April 21, 2025, Moleculin Biotech, Inc. made a corporate presentation available on its website. The presentation is part of a Current Report on Form 8-K but is not filed under the Securities Exchange Act of 1934 or the Securities Act of 1933.

Spark’s Take on MBRX Stock

According to Spark, TipRanks’ AI Analyst, MBRX is a Underperform.

Moleculin Biotech faces significant financial challenges with no revenue and high cash burn, typical of early-stage biotech firms. Bearish technical indicators and negative valuation metrics reflect 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.

To see Spark’s full report on MBRX stock, click here.

Product-Related AnnouncementsBusiness Operations and Strategy
Moleculin Biotech’s Annamycin Highlighted at AACR 2025
Positive
Apr 17, 2025

On April 17, 2025, Moleculin Biotech announced that their abstract on Annamycin, a next-generation anthracycline, was selected for a poster presentation at the AACR Annual Meeting 2025. This recognition highlights the potential of Annamycin in cancer treatment and strengthens Moleculin’s position in the pharmaceutical industry, particularly in developing innovative cancer therapies.

Spark’s Take on MBRX Stock

According to Spark, TipRanks’ AI Analyst, MBRX is a Underperform.

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.

To see Spark’s full report on MBRX stock, click here.

Product-Related AnnouncementsBusiness Operations and Strategy
Moleculin Biotech Begins Phase 3 MIRACLE Trial Dosing
Positive
Apr 1, 2025

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.

Regulatory Filings and Compliance
Moleculin Biotech Shares Corporate Presentation Update
Neutral
Mar 24, 2025

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.

Product-Related AnnouncementsBusiness Operations and StrategyRegulatory Filings and Compliance
Moleculin Biotech Gets FDA Nod for Phase 3 Trial
Positive
Feb 13, 2025

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.

Product-Related AnnouncementsBusiness Operations and Strategy
Moleculin Biotech Gains European Approval for Phase 3 Trial
Positive
Feb 11, 2025

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.

Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.

Disclaimer

This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.Date of analysis: Apr 30, 2025