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Humacyte (HUMA)
NASDAQ:HUMA
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Humacyte
(NASDAQ:HUMA)
41Neutral
Positive Factors
Economic Value
The Budget Impact Model published in the Journal of Medical Economics demonstrates the economic value of Symvess by projecting cost savings due to reductions in amputations and conduit infections.
Financial Health
HUMA reported a pro-forma cash balance of $141.9M following an equity offering, providing the company with capital to support expansion.
Product Launch
Humacyte is poised to gain significant share for surgical procedures requiring vascular grafts, including trauma reconstruction and vascular access for dialysis patients.
Negative Factors
Market Valuation
PT moves to $5 from $7.50, reflecting the recent contraction in small-cap valuations and the new share count.
Humacyte (HUMA) vs. S&P 500 (SPY)
Market Cap
$301.19M
Dividend YieldN/A
Average Volume (3M)3.47M
Price to Earnings (P/E)―
Beta (1Y)1.15
Revenue GrowthN/A
EPS Growth-17.92%
CountryUS
Employees183
SectorHealthcare
Sector Strength72
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.26
Shares Outstanding153,668,490
10 Day Avg. Volume6,010,909
30 Day Avg. Volume3,470,419
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)N/A
Price to Cash Flow (P/CF)-4.60
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$14.00Price Target Upside723.53% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering5
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 substantial financial challenges across all statements. The income statement shows persistent losses, the balance sheet reveals financial instability with negative equity, and cash flow indicates reliance on external financing. The company must address its operational inefficiencies and restructure its financials to move towards profitability and sustainability.Income Statement
Humacyte's income statement reflects significant challenges, with consistent net losses and negative EBIT and EBITDA margins over the years. The TTM data shows some revenue growth, but profitability remains elusive. Gross Profit Margin is negative, indicating cost issues. Despite some revenue growth, the company struggles with high operational expenses, leading to ongoing net losses.30
Negative
Balance Sheet
The balance sheet reveals a weak equity position with negative stockholders' equity in the TTM period, indicating financial instability. The debt-to-equity ratio is not calculable due to negative equity, posing a risk. Total liabilities exceed total assets, indicating financial distress. The company needs to improve its capital structure and reduce liabilities to stabilize financially.25
Negative
Cash Flow
Humacyte's cash flow statements show consistent negative free cash flow, indicating operational cash consumption. The TTM period reflects large negative operating cash flow compared to net income. Financing activities have been a crucial source of cash, highlighting reliance on external funding. The company needs to focus on improving operational efficiency to achieve positive cash flow.35
Negative
| Breakdown | |||||
| TTM | Dec 2023 | Dec 2022 | Dec 2021 | Dec 2020 | Dec 2019 |
|---|---|---|---|---|---|
| Income Statement | Total Revenue | ||||
| 10.79M | 0.00 | 1.56M | 1.26M | 1.49M | 6.19M |
| Gross Profit | |||||
| 3.80M | -76.55M | -6.69M | 1.21M | -6.94M | -69.42M |
| EBIT | |||||
| -112.49M | -100.05M | -84.58M | -81.21M | -64.60M | -85.69M |
| EBITDA | |||||
| -130.85M | -96.46M | 2.49M | -72.97M | -56.25M | -78.94M |
| Net Income Common Stockholders | |||||
| -152.87M | -110.78M | 64.22M | 37.54M | -68.73M | -85.42M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | ||||
| 93.71M | 80.45M | 151.88M | 225.50M | 39.93M | 93.71M |
| Total Assets | |||||
| 0.00 | 128.22M | 204.30M | 286.53M | 106.69M | 168.69M |
| Total Debt | |||||
| 0.00 | 57.51M | 47.76M | 48.47M | 28.86M | 25.65M |
| Net Debt | |||||
| 0.00 | -22.94M | -102.01M | -169.03M | -11.07M | -68.06M |
| Total Liabilities | |||||
| -132.20M | 114.68M | 87.37M | 164.36M | 457.00M | 36.49M |
| Stockholders Equity | |||||
| 132.20M | 13.55M | 116.93M | 122.17M | -350.32M | 132.20M |
| Cash Flow | Free Cash Flow | ||||
| -92.26M | -75.58M | -72.18M | -81.41M | -55.89M | -79.91M |
| Operating Cash Flow | |||||
| -90.60M | -73.31M | -71.13M | -81.19M | -55.57M | -71.79M |
| Investing Cash Flow | |||||
| -1.66M | -173.00K | 4.84M | -8.22M | -268.00K | -8.13M |
| Financing Cash Flow | |||||
| 62.84M | 4.51M | -1.45M | 266.98M | 2.05M | -74.00K |
Humacyte Technical Analysis
Negative
1.70
Price Trends
3.57
Negative
4.11
Negative
5.16
Negative
Market Momentum
-0.40
Positive
24.25
Positive
5.36
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 1.7 is below the 20-day moving average (MA) of 2.85, below the 50-day MA of 3.57, and below the 200-day MA of 5.16, indicating a bearish trend. The MACD of -0.40 indicates Positive momentum. The RSI at 24.25 is Positive, neither overbought nor oversold. The STOCH value of 5.36 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 (48)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
67 Neutral | $1.12B | 26.71 | 25.01% | ― | 8.52% | -32.91% | |
49 Neutral | $96.01M | ― | -114.71% | ― | 288.94% | 39.45% | |
48 Neutral | $6.84B | 1.02 | -53.11% | 2.50% | 16.84% | 0.92% | |
47 Neutral | $318.70M | ― | -526.33% | ― | ― | 14.39% | |
46 Neutral | $74.38M | ― | -80.11% | ― | -7.43% | 69.03% | |
41 Neutral | $301.19M | ― | 239.90% | ― | ― | -17.92% | |
38 Underperform | $34.97M | ― | -88.91% | ― | ― | 30.37% |
* Healthcare Sector Average
Performance Comparison
HUMA
Humacyte
1.70
-1.27
-42.76%
VERU
Veru
0.49
-0.28
-36.36%
VSTM
Verastem
6.03
-5.49
-47.66%
MDXG
MiMedx Group
7.60
0.72
10.47%
VXRT
Vaxart
0.41
-0.83
-66.94%
ALXO
ALX Oncology Holdings
0.62
-10.10
-94.22%
Humacyte Earnings Call Summary
Earnings Call Date: Mar 28, 2025 | % Change Since: -15.42% | Next Earnings Date: May 9, 2025
Earnings Call Sentiment Neutral
The call highlighted significant achievements such as the FDA approval and successful launch of Symvess, as well as progress in the ATEV program. However, financial challenges remain with no revenue reported for 2024 and increased net losses. The sentiment reflects a balanced view of optimism for future growth and ongoing financial hurdles.Highlights
FDA Approval of Symvess
Symvess received full FDA approval for the treatment of extremity vascular trauma, marking an important milestone in vascular surgery. The product went through over 20 years of research and development.
Successful Commercial Launch of Symvess
The commercial launch of Symvess is proceeding well, with 34 hospitals initiating their VAC approval process. The first commercial shipments have already been made to several Level 1 trauma centers.
New Patent Issued
A new U.S. patent covering key aspects of the manufacturing system for Symvess and other bioengineered human tissues has been issued, providing protection into 2040.
Progress in ATEV Program
The V007 Phase 3 clinical trial for ATEV in dialysis access met its co-primary endpoints, showing superior function and patency at 6 and 12 months compared to AV fistula.
Financial Position
Completion of an underwritten public offering of common stock provided approximately $46.6 million in additional net proceeds.
Lowlights
No Revenue Recorded for 2024
There was no revenue reported for the fourth quarter or the entire year of 2024, continuing the trend from 2023.
Increased Net Loss
Net loss increased to $148.7 million for the year ended December 31, 2024, compared to $110.8 million for 2023, primarily due to noncash remeasurement of the contingent earn-out liability.
R&D and Administrative Expenses
Research and development expenses increased to $88.6 million in 2024 from $76.6 million in 2023, and general and administrative expenses also rose, reflecting preparation for the commercial launch.
Delayed AV Graft Program
Plans for the AV graft program in dialysis have been delayed, with a supplemental BLA now expected to be submitted in the second half of 2026.
Company Guidance
During the Humacyte Fourth Quarter Results Conference Call, the company provided detailed guidance on its recent achievements and future plans, with a strong focus on the commercial launch and anticipated expansion of its product, Symvess. Having received FDA approval for Symvess for extremity vascular trauma, the company highlighted significant engagement with hospitals, with 34 initiating the Value Analysis Committee (VAC) approval process and three already completing it. The company is optimistic about its NTAP application with CMS, which could commence reimbursement by October 1, 2025. Humacyte also discussed its ongoing Phase 3 trials for the ATEV program in dialysis access, planning to submit a supplemental BLA in the second half of 2026, as well as its preclinical progress on a small diameter ATEV for coronary artery bypass grafting. Financially, Humacyte reported a net loss of $148.7 million for 2024, with research and development expenses increasing to $88.6 million, reflecting their expanded clinical activities and manufacturing efforts. The company completed a public offering, raising approximately $46.6 million, which bolsters its cash position for continued development and commercialization efforts.Humacyte Corporate Events
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.