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Humacyte (HUMA)
NASDAQ:HUMA
US Market

Humacyte (HUMA) AI Stock Analysis

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HU

Humacyte

(NASDAQ:HUMA)

Rating:42Neutral
Price Target:
Humacyte's overall stock score reflects significant financial and technical challenges. The lack of revenue, persistent losses, and negative equity weigh heavily on the financial performance. Technical analysis indicates bearish momentum. The valuation metrics suggest the stock may be overpriced given the negative P/E ratio and absence of dividends. The earnings call offered some optimism regarding future growth due to FDA approvals and product launches, but these are long-term prospects amid current financial difficulties. Recent corporate events provide mixed signals with potential legal risks and a successful capital raise.
Positive Factors
Clinical Trials and Approvals
Humacyte is on track to file an IND application with the FDA for clinical testing of the small-diameter acellular tissue engineered vessel in coronary artery bypass grafting.
Market Potential and Financial Performance
Humacyte's valuation reflects a discount to peer regenerative medical technology companies, making it an attractive investment opportunity.
Product Launch and Adoption
Symvess achieved approximately $0.5M in the first two months of launch, indicating a promising start to commercialization.
Negative Factors
Operational Challenges
Humacyte reduced its workforce by approximately 31 employees, deferred additional planned new hires, and reduced other operating expenses to extend the cash runway.
Revenue and Sales Expectations
FY26 will require accelerated utilization as Street estimates grow significantly compared to FY25.

Humacyte (HUMA) vs. SPDR S&P 500 ETF (SPY)

Humacyte Business Overview & Revenue Model

Company DescriptionHumacyte, Inc. (HUMA) is a biotechnology company focused on developing bioengineered human tissues and organs for use in regenerative medicine and vascular surgery. The company's core product revolves around its proprietary platform technology to create universally implantable, bioengineered human tissues that have the potential to improve treatment outcomes for patients with vascular and organ diseases. Humacyte operates primarily within the healthcare and biotechnology sectors, leveraging its innovative technology to address significant unmet medical needs.
How the Company Makes MoneyHumacyte makes money primarily through the development and commercialization of its bioengineered human tissues, particularly its Human Acellular Vessel (HAV), which is designed for vascular surgeries. The company generates revenue through partnerships and collaborations with healthcare providers and research institutions that utilize its products in clinical trials and therapeutic applications. Additionally, Humacyte may earn income from licensing agreements, grants, and other funding sources that support the advancement of its technology and product pipeline. The successful commercialization and adoption of its bioengineered tissues in the healthcare market are key factors contributing to its earnings.

Humacyte Financial Statement Overview

Summary
Humacyte faces significant financial challenges with no current revenue stream and persistent operating losses, reflecting weak profitability metrics. The balance sheet indicates financial instability, with negative equity and high liabilities. Cash flows are negative, and the company is reliant on external financing for liquidity. These factors suggest a risky financial position with potential sustainability concerns unless revenue generation and profitability improve.
Income Statement
35
Negative
Humacyte's income statement shows significant challenges with no revenue reported in the latest year, leading to an inability to calculate profit margins. Historical revenue has been minimal and inconsistent, with no clear growth trajectory. The company has consistently reported operating losses, with EBIT and EBITDA margins being negative. This reflects ongoing difficulties in achieving profitability and scalability in its operations.
Balance Sheet
40
Negative
The balance sheet shows a negative stockholders' equity of $52.7 million, indicating financial instability. Total liabilities exceed total assets, which is concerning for leverage and solvency. With a debt-to-equity ratio being inapplicable due to negative equity, the company faces significant risk. However, the company has managed to reduce net debt, primarily through financing activities, which provides some liquidity buffer.
Cash Flow
45
Neutral
Cash flow analysis reveals negative free cash flow, indicating the company is not generating sufficient cash from its operations to cover capital expenditures. However, the operating cash flow to net income ratio is not calculable due to zero or negative net income, highlighting cash flow issues. The company has relied heavily on financing activities to support its cash position, which may not be sustainable long-term.
Breakdown
Dec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income StatementTotal Revenue
0.000.001.56M1.26M1.49M
Gross Profit
0.00-76.55M-6.69M1.21M-6.94M
EBIT
-114.40M-100.05M-84.58M-81.21M-64.60M
EBITDA
-114.40M-96.46M2.49M-72.97M-56.25M
Net Income Common Stockholders
0.00-110.78M64.22M37.54M-68.73M
Balance SheetCash, Cash Equivalents and Short-Term Investments
44.94M80.45M151.88M225.50M39.93M
Total Assets
137.87M128.22M204.30M286.53M106.69M
Total Debt
16.54M57.51M47.76M48.47M28.86M
Net Debt
-28.40M-22.94M-102.01M-169.03M-11.07M
Total Liabilities
190.54M114.68M87.37M164.36M457.00M
Stockholders Equity
-52.67M13.55M116.93M122.17M-350.32M
Cash FlowFree Cash Flow
-99.69M-75.58M-72.18M-81.41M-55.89M
Operating Cash Flow
-98.12M-73.31M-71.13M-81.19M-55.57M
Investing Cash Flow
-1.57M-173.00K4.84M-8.22M-268.00K
Financing Cash Flow
114.18M4.51M-1.45M266.98M2.05M

Humacyte Technical Analysis

Technical Analysis Sentiment
Neutral
Last Price2.34
Price Trends
50DMA
1.88
Positive
100DMA
3.02
Negative
200DMA
4.22
Negative
Market Momentum
MACD
0.13
Negative
RSI
67.55
Neutral
STOCH
90.92
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For HUMA, the sentiment is Neutral. The current price of 2.34 is above the 20-day moving average (MA) of 1.61, above the 50-day MA of 1.88, and below the 200-day MA of 4.22, indicating a neutral trend. The MACD of 0.13 indicates Negative momentum. The RSI at 67.55 is Neutral, neither overbought nor oversold. The STOCH value of 90.92 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for HUMA.

Humacyte Risk Analysis

Humacyte disclosed 69 risk factors in its most recent earnings report. Humacyte 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.
We have concluded that a substantial doubt is deemed to exist concerning our ability to continue as a going concern. Q3, 2024

Humacyte Peers Comparison

Overall Rating
UnderperformOutperform
Sector (53)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
60
Neutral
$290.39M-41.31%-7.93%
53
Neutral
$5.24B3.07-43.58%2.80%16.87%-0.11%
52
Neutral
$256.82M-68.21%-97.15%54.85%
48
Neutral
$261.67M-8.38%3.18%-835.29%
47
Neutral
$248.18M-30.47%-22.66%
42
Neutral
$386.25M-257.38%-17.92%
33
Underperform
$296.11M-98.14%-33.79%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
HUMA
Humacyte
2.34
-4.87
-67.55%
VNDA
Vanda
4.24
-0.67
-13.65%
PVLA
Palvella Therapeutics
22.11
11.62
110.77%
AVIR
Atea Pharmaceuticals
2.81
-0.88
-23.85%
CMPX
Compass Therapeutics
2.10
0.60
40.00%
CADL
Candel Therapeutics
5.47
-5.22
-48.83%

Humacyte Earnings Call Summary

Earnings Call Date:May 13, 2025
(Q1-2025)
|
% Change Since: 77.27%|
Next Earnings Date:Aug 19, 2025
Earnings Call Sentiment Positive
The earnings call highlighted significant progress with the commercial launch of Symvess and promising developments in the pipeline, supported by strong financial performance. However, challenges such as workforce reductions and negative press were notable concerns. Despite these challenges, the positive developments and financial improvements outweigh the lowlights.
Q1-2025 Updates
Positive Updates
Successful Commercial Launch of Symvess
Humacyte commenced its commercial launch of Symvess in late February 2025, with the first commercial shipments made during the first quarter to three Level 1 trauma centers.
Strong Hospital Engagement
45 hospitals have commenced evaluation of Symvess as part of their value analysis committee (VAC) approval process, and five hospitals have already approved the purchase.
FDA IND Filing for ATEV
Plans to file an IND with the FDA for first-in-human clinical testing of the small-diameter ATEV in coronary artery bypass grafting later this year.
Financial Improvement
Net income was $39.1 million for Q1 2025, compared to a net loss of $31.9 million for Q1 2024, primarily due to an increase in the non-cash remeasurement of the contingent earn-out liability.
Extended Cash Runway
Steps taken to extend Humacyte's cash runway, including a public offering providing $46.7 million in net proceeds and cost reductions.
Negative Updates
Workforce Reduction
A plan was implemented to reduce the workforce by approximately 31 employees due to current market conditions.
Negative Press Impact
Some headwinds from unfounded negative press, impacting VAC processes particularly in April.
Increased General and Administrative Expenses
General and administrative expenses increased to $8.1 million in Q1 2025, from $5.3 million in Q1 2024, primarily due to the U.S. commercial launch of Symvess.
Company Guidance
During Humacyte's Q1 2025 earnings call, the company detailed its strategic priorities and financial outlook. Following the FDA approval of Symvess for extremity vascular trauma, Humacyte's commercial launch has been successful, with first shipments made to three Level 1 trauma centers and 45 hospitals evaluating Symvess for VAC approval. The company reported $517,000 in revenue for Q1 2025, including $147,000 from Symvess sales, and a net income of $39.1 million, driven by a $62.3 million non-cash remeasurement of contingent earn-out liabilities. Humacyte enhanced its cash runway with $46.7 million from a public offering and expects to save over $50 million in costs through workforce reductions and other measures. Future milestones include the publication of clinical results, filing an IND for coronary artery bypass grafting, and progressing the V012 Phase 3 trial for dialysis access, aiming for a supplemental BLA filing in 2026.

Humacyte Corporate Events

Legal ProceedingsRegulatory Filings and Compliance
Humacyte Challenges FDA Petition Amidst Controversy
Negative
Apr 18, 2025

On April 17, 2025, Humacyte, Inc. addressed a ‘citizen petition’ filed with the FDA by individuals who have not used its products, aiming to halt the company’s operations. Dr. Laura Niklason, CEO of Humacyte, criticized the petitioners, highlighting potential conflicts of interest, particularly with Robert E. Lee, a former FDA employee now consulting for a competitor. Humacyte remains committed to challenging these claims and defending its reputation.

Spark’s Take on HUMA Stock

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

Humacyte’s overall stock score reflects significant financial and technical challenges. The lack of revenue, persistent losses, and negative equity weigh heavily on the financial performance. Technical analysis indicates bearish momentum. The valuation metrics suggest the stock may be overpriced given the negative P/E ratio and absence of dividends. The earnings call offered some optimism regarding future growth due to FDA approvals and product launches, but these are long-term prospects amid current financial difficulties.

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

Product-Related AnnouncementsRegulatory Filings and Compliance
Humacyte Defends Symvess Approval Amid FDA Scrutiny
Neutral
Mar 27, 2025

On March 27, 2025, Humacyte, Inc. responded to a New York Times article questioning the FDA’s approval process for their product, Symvess. The company clarified that the FDA conducted a thorough review, including consultations with external experts, before approving Symvess for treating vascular trauma. Humacyte emphasized their commitment to safety and effectiveness, citing successful outcomes in trials and ongoing post-approval studies. The company also addressed inaccuracies in the article, defending the product’s use in battlefield injuries and highlighting their humanitarian efforts in Ukraine.

Private Placements and FinancingBusiness Operations and Strategy
Humacyte Announces Public Offering to Raise $46.6 Million
Positive
Mar 26, 2025

On March 25, 2025, Humacyte, Inc. announced an underwritten public offering of 25,000,000 shares of its common stock at $2.00 per share, with an option for underwriters to purchase an additional 3,750,000 shares. The offering is expected to raise approximately $46.6 million, or $53.7 million if the option is fully exercised, and is set to close on March 27, 2025. The proceeds will be used to commercialize SYMVESS™ for vascular trauma, develop other pipeline products, and for general corporate purposes. This move is part of Humacyte’s strategy to advance its biotechnology platform and expand its market presence in bioengineered human tissues.

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.