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Moleculin Biotech (MBRX)
NASDAQ:MBRX

Moleculin Biotech (MBRX) AI Stock Analysis

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Moleculin Biotech

(NASDAQ:MBRX)

44Neutral
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
With MIRACLE now enrolling and dosing patients in the US, clearance for EU sites to start up and positioned for unblinded interim data, Moleculin should be positioned to unlock value on the data readout.
Financial Performance
The company was able to successfully complete two transactions under more favorable terms, including a warrant inducement transaction and a registered direct offering, which combined raised $9.3M.
Regulatory Approvals
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
Capital Raising
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.
Financial Stability
The company's cash reserves are low with high quarterly cash burn, necessitating immediate capital raising efforts.
Stock Rating
The downgrade to Hold from Buy is influenced by potential significant dilution from ongoing capital-raising efforts.

Moleculin Biotech (MBRX) vs. S&P 500 (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 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.
Breakdown
TTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
63.00K0.000.000.000.000.00
Gross Profit
32.00K0.00-127.00K-222.00K-260.00K-285.00K
EBIT
-25.91M-26.64M-29.63M-30.64M-22.97M-19.74M
EBITDA
-25.78M-21.64M-29.50M-30.51M-22.80M-19.54M
Net Income Common Stockholders
-23.23M-21.76M-29.77M-27.41M-8.86M-15.00M
Balance SheetCash, Cash Equivalents and Short-Term Investments
23.55M4.28M23.55M43.15M70.90M15.17M
Total Assets
38.22M16.93M38.22M57.42M84.09M29.03M
Total Debt
574.00K478.00K574.00K451.00K159.00K277.00K
Net Debt
-22.98M-3.80M-22.98M-42.69M-70.74M-14.90M
Total Liabilities
12.14M10.95M12.14M5.23M5.10M11.27M
Stockholders Equity
26.07M5.98M26.07M52.19M78.99M17.76M
Cash FlowFree Cash Flow
-21.72M-23.88M-24.23M-27.71M-18.97M-18.15M
Operating Cash Flow
-21.71M-23.86M-24.10M-27.64M-18.95M-17.77M
Investing Cash Flow
-13.00K-13.00K-124.00K-67.00K-19.00K-374.00K
Financing Cash Flow
12.63M4.63M4.65M-23.00K74.72M22.55M

Moleculin Biotech Technical Analysis

Technical Analysis Sentiment
Negative
Last Price0.94
Price Trends
50DMA
1.00
Negative
100DMA
1.24
Negative
200DMA
1.86
Negative
Market Momentum
MACD
>-0.01
Positive
RSI
44.68
Neutral
STOCH
18.25
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 0.94 is below the 20-day moving average (MA) of 1.02, below the 50-day MA of 1.00, and below the 200-day MA of 1.86, indicating a bearish trend. The MACD of >-0.01 indicates Positive momentum. The RSI at 44.68 is Neutral, neither overbought nor oversold. The STOCH value of 18.25 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 0 New Risks

Moleculin Biotech Peers Comparison

Overall Rating
UnderperformOutperform
Sector (52)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
52
Neutral
$5.15B3.02-44.64%2.83%16.44%-0.47%
45
Neutral
$12.63M9.2211.34%-99.76%76.96%
44
Neutral
$13.28M-214.79%52.82%
44
Neutral
$12.56M-97.30%-3.23%38.05%
42
Neutral
$8.83M-76.12%81.71%
41
Neutral
$7.07M-397.54%24.16%
34
Underperform
$11.68M-174.66%38.53%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
MBRX
Moleculin Biotech
0.94
-4.01
-81.01%
IMNN
Imunon
0.48
-0.89
-64.96%
PHIO
Phio Pharmaceuticals
1.84
-5.22
-73.94%
SYBX
Synlogic
1.08
-0.54
-33.33%
MRKR
Marker Therapeutics
1.11
-3.09
-73.57%
INAB
IN8bio
0.13
-0.89
-87.25%

Moleculin Biotech Earnings Call Summary

Earnings Call Date:May 14, 2025
(Q1-2025)
|
% Change Since: -12.15%|
Next Earnings Date:Aug 13, 2025
Earnings Call Sentiment Positive
The earnings call presented several positive developments, including the start of a pivotal Phase 3 trial, regulatory approvals, and promising preliminary data. However, financial constraints and potential regulatory hurdles in the EU were noted as significant challenges.
Q1-2025 Updates
Positive Updates
Start of Phase 3 MIRACLE Trial
The Phase 3 MIRACLE trial for Annamycin in treating relapsed and refractory acute myeloid leukemia has officially started with 38 sites selected worldwide.
European Medicines Agency Approval
The company received complete sign-off from the European Medicines Agency to open the trial in nine countries in the EU, marking a major milestone in regulatory approval.
New Generic Drug Name for Annamycin
The World Health Organization has recognized a new generic drug name for Annamycin, 'naxtarubicin,' facilitating future drug launch efforts.
Patent Protection Extended
Additional patents for Annamycin have been announced, extending protection beyond the existing composition of matter protection until at least 2040.
Promising Preliminary Data for MB-107
Preliminary numbers from the MB-107 clinical trial using Annamycin to treat advanced soft tissue sarcoma are impressive, with final data expected to draw significant attention.
WP1066 Clinical Trial Progress
WP1066, the lead STAT3 inhibitor, is in a new clinical trial at Northwestern University, showing rapid recruitment with nearly one patient per month.
Strong Market Cap and Trading Volume
Market cap has increased to over $14 million with a healthy trading volume, indicating positive investor interest.
Negative Updates
Financial Runway Concerns
Current cash on hand is $8 million, projected to last only into the third quarter of 2025, necessitating a $15 million raise to fund operations into 2026.
Regulatory Hurdles in EU
Additional GLP preclinical data required by the EMA could impact the timeline for EU approval, although it's not expected to delay the trial.
Potential Increase in R&D Expenses
R&D expenses are expected to rise, especially in 2026, due to additional GLP studies and drug manufacturing costs.
Disappointment Over Relapse
A patient in the MB-106 Phase 2 trial relapsed after over 600 days, although it was noted as a remarkable duration for complete remission in their condition.
Company Guidance
During the Moleculin Biotech First Quarter 2025 Update Conference Call, guidance was provided on several key metrics and milestones. The Phase 3 MIRACLE trial for Annamycin, aimed at treating relapsed and refractory acute myeloid leukemia (AML), has officially commenced with the first patient treated and 38 sites selected worldwide. The European Medicines Agency approved the trial in nine EU countries, marking significant progress. Moleculin also received a new generic drug name, naxtarubicin, for Annamycin. The company plans to release final data from the MB-107 trial on advanced soft tissue sarcoma soon. Financially, Moleculin ended the quarter with $8 million in cash, projecting the need to raise $15 million to extend operations into the first quarter of 2026. This funding is expected to support the initial 45-subject data readout, moving towards a second data readout in the first half of 2026. The company is focused on increasing its market cap, with Annamycin positioned as a potentially groundbreaking non-cardiotoxic anthracycline.

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
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.

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.