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Humacyte (HUMA)
NASDAQ:HUMA
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Humacyte (HUMA) AI Stock Analysis

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HUMA

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
Market Expansion
HUMA's clearance on the Electronic Catalog (ECAT) opens up Symvess to ~190 military facilities where Symvess will have increased utility in vascular trauma.
Pricing Strategy
The recent lowering of Symvess price to $24,250 from prior $29,500 could potentially improve commercial momentum.
Revenue Growth
The monthly Symvess revenue run rate has increased with July product sales already exceeding the total product sales in the first half of the year.
Negative Factors
Financial Performance
Operating expenses totaled $30.0M, driving a net income loss of $37.7M.
Revenue Forecast
Considering the weak 1H25 sales, the 2025 total revenues have been conservatively lowered to $2.5M from prior $10.4M.
Revenue Performance
Humacyte reported 2Q revenue of $0.3 million, below our estimate of $1.0 million and the broader consensus estimate of $0.8 million.

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

Humacyte Business Overview & Revenue Model

Company DescriptionHumacyte, Inc. engages in the development and manufacture of off-the-shelf, implantable, and bioengineered human tissues for the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. The company using its proprietary and scientific technology platform to engineer and manufacture human acellular vessels (HAVs). Its investigational HAVs are designed to be easily implanted into any patient without inducing a foreign body response or leading to immune rejection. The company is developing a portfolio of HAVs, which would target the vascular repair, reconstruction, and replacement market, including vascular trauma; arteriovenous access for hemodialysis; peripheral arterial disease; and coronary artery bypass grafting, as well as developing its HAVs for pediatric heart surgery and cellular therapy delivery, including pancreatic islet cell transplantation to treat Type 1 diabetes. The company was founded in 2004 and is headquartered in Durham, North Carolina.
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 Earnings Call Summary

Earnings Call Date:Aug 11, 2025
(Q2-2025)
|
% Change Since: |
Next Earnings Date:Nov 07, 2025
Earnings Call Sentiment Positive
The call highlighted significant progress in expanding Symvess approvals and sales, including entering military markets, and successful clinical trial results. However, challenges included a denial of CMS NTAP application and delays caused by public attacks.
Q2-2025 Updates
Positive Updates
Expansion of Symvess Approvals
The number of civilian hospitals eligible to purchase Symvess increased from 5 to 82, and an additional 40 VAC sites are currently reviewing the product.
First Military Sale and ECAT Listing
Recorded the first sale to a U.S. military facility and received ECAT listing approval, making Symvess available to 35 military treatment facilities and 160 VA hospitals.
V007 Phase III Trial Success
Presented successful results from the V007 Phase III trial at the Society of Vascular Surgery Annual Meeting, showing significant improvements in patency and usability.
Sales Surge in July
July product sales of approximately $0.3 million exceeded total sales for the first half of the year.
Significant Cost Reductions
Implemented a plan to reduce workforce and costs, estimating savings up to $38 million in 2026.
Negative Updates
CMS NTAP Application Denied
Application for new technology add-on payment for Symvess was declined due to lack of unique mechanism of action.
Headwinds from Public Attacks
Experienced delays in VAC approval processes due to unsubstantiated public attacks by detractors.
Workforce Reductions
Reduced workforce by 30 employees to extend cash runway, incurring charges of approximately $0.7 million.
Company Guidance
During the Humacyte Second Quarter 2025 Results Conference Call, significant progress in the commercial launch of Symvess was highlighted, with VAC approvals expanding eligibility to 82 civilian hospitals, up from just 5 previously, and an additional 40 VAC sites under review. The company recorded a notable increase in sales, with July product sales reaching $0.3 million, surpassing total sales for the first half of the year. The U.S. Defense Logistics Agency granted ECAT listing approval, facilitating Symvess availability at approximately 35 military treatment facilities and 160 U.S. Department of Veterans Affairs hospitals. The call also addressed financial results, noting a second-quarter revenue of $0.3 million, with cost-reduction measures expected to yield over $50 million in savings through 2026. Research and development expenses decreased to $22.0 million for the quarter, with a net loss of $37.7 million, a substantial improvement from the previous year's $56.7 million loss. Cash reserves stood at $88.4 million as of June 30, 2025. Despite CMS declining the NTAP application for Symvess, the company remains optimistic about private payer reimbursement discussions, driven by promising clinical data. The call also provided updates on the ATEV program, with the V012 Phase III trial targeting completion of patient enrollment by year-end and a supplemental BLA filing anticipated in the second half of 2026.

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.
BreakdownTTMDec 2024Dec 2023Dec 2022Dec 2021Dec 2020
Income Statement
Total Revenue8.05M0.000.001.56M1.26M1.49M
Gross Profit428.00K-7.19M-76.55M-6.69M-60.08M-6.94M
EBITDA-37.33M-132.23M-96.46M-76.37M-72.97M-56.25M
Net Income-58.66M-148.70M-110.78M-11.96M-26.48M-66.52M
Balance Sheet
Total Assets138.79M137.87M128.22M204.30M286.53M106.69M
Cash, Cash Equivalents and Short-Term Investments38.03M44.94M80.45M151.88M225.50M39.93M
Total Debt15.12M16.54M57.45M50.07M51.18M28.86M
Total Liabilities134.74M190.54M114.68M87.37M164.36M36.02M
Stockholders Equity4.05M-52.67M13.55M116.93M122.17M70.67M
Cash Flow
Free Cash Flow-106.29M-99.69M-75.58M-72.18M-81.41M-55.89M
Operating Cash Flow-104.50M-98.12M-73.31M-71.13M-81.19M-55.57M
Investing Cash Flow-1.79M-1.57M-173.00K4.84M-8.22M-268.00K
Financing Cash Flow100.76M114.18M4.51M-1.45M266.98M2.05M

Humacyte Technical Analysis

Technical Analysis Sentiment
Negative
Last Price1.43
Price Trends
50DMA
2.08
Negative
100DMA
2.04
Negative
200DMA
2.90
Negative
Market Momentum
MACD
-0.20
Negative
RSI
32.49
Neutral
STOCH
17.49
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For HUMA, the sentiment is Negative. The current price of 1.43 is below the 20-day moving average (MA) of 1.66, below the 50-day MA of 2.08, and below the 200-day MA of 2.90, indicating a bearish trend. The MACD of -0.20 indicates Negative momentum. The RSI at 32.49 is Neutral, neither overbought nor oversold. The STOCH value of 17.49 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative 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 0 New Risks

Humacyte Peers Comparison

Overall Rating
UnderperformOutperform
Sector (51)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
60
Neutral
$578.20M-51.84%-100.00%-25.75%
52
Neutral
$615.80M-68.21%-97.15%54.85%
51
Neutral
$7.95B-0.40-41.67%2.21%22.29%-1.85%
48
Neutral
$274.17M-13.01%11.78%-504.50%
47
Neutral
$267.43M-32.38%23.24%
42
Neutral
$231.22M-257.38%63.92%
33
Underperform
$274.48M-55.18%60.29%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
HUMA
Humacyte
1.43
-3.96
-73.47%
VNDA
Vanda
4.61
-0.41
-8.17%
PVLA
Palvella Therapeutics
55.68
38.25
219.45%
AVIR
Atea Pharmaceuticals
3.37
-0.30
-8.17%
CMPX
Compass Therapeutics
3.44
1.85
116.35%
CADL
Candel Therapeutics
5.00
-1.44
-22.36%

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
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: May 03, 2025