Core Insights - Humacyte, Inc. announced positive long-term results from its humanitarian program using Symvess to treat wartime vascular trauma injuries in Ukraine, with zero infections, amputations, or deaths reported in patients followed for up to 18 months [2][4][5] Company Overview - Humacyte is a biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [2][14] - The company aims to improve patient outcomes and reduce complications through innovative medical solutions [5][14] Product Details - Symvess is an acellular tissue engineered vessel indicated for use in adults with extremity arterial injury when urgent revascularization is needed and autologous vein graft is not feasible [6][14] - The product is designed to be immediately available off-the-shelf, which is critical in wartime situations [3][4] Clinical Results - In a study involving 17 patients with combat-related extremity vascular trauma, Symvess demonstrated a 30-day primary and secondary patency rate of 93.8% and a long-term patency rate of 87.1% [4] - At the 30-day follow-up, there were zero deaths, amputations, or infections, and these outcomes were sustained over the 18-month follow-up period [4][5] Expert Commentary - Dr. Oleksandr Sokolov emphasized the importance of biologic conduits like Symvess in advancing vascular trauma care, particularly in the context of modern warfare [3] - Dr. Laura Niklason highlighted the sustained benefits of Symvess for patients with severe combat injuries, reinforcing the product's potential in improving surgical outcomes [5] Regulatory Status - Humacyte's Biologics License Application for Symvess in the vascular trauma indication was approved by the FDA in December 2024 [14] - The product has received various designations, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for other vascular applications [15]

Company Performance - Humacyte, Inc. (HUMA) closed at $1.76, reflecting a +1.15% change from the previous day, outperforming the S&P 500's gain of 0.34% [1] - The stock has increased by 15.23% over the past month, significantly higher than the Medical sector's gain of 1.97% and the S&P 500's gain of 3.54% [1] Earnings Forecast - Humacyte is expected to report an EPS of -$0.17, indicating a 48.48% improvement from the same quarter last year [2] - For the full year, analysts anticipate earnings of -$0.35 per share and revenue of $3.51 million, representing changes of +66.67% and 0% respectively from the previous year [2] Analyst Revisions - Recent revisions to analyst forecasts for Humacyte are important as they reflect short-term business trends, with positive revisions indicating optimism about the company's outlook [3] Zacks Rank - Humacyte currently holds a Zacks Rank of 4 (Sell), with no changes in the Zacks Consensus EPS estimate over the past month [5] - The Zacks Rank system has a strong track record, with 1 stocks delivering an average annual return of +25% since 1988 [5] Industry Overview - The Medical - Biomedical and Genetics industry, which includes Humacyte, has a Zacks Industry Rank of 80, placing it in the top 33% of over 250 industries [6] - The Zacks Industry Rank measures the strength of industry groups based on the average Zacks Rank of individual stocks, with the top 50% rated industries outperforming the bottom half by a factor of 2 to 1 [6]

Core Insights - Humacyte, Inc. has received a U.S. Patent for a bioengineered esophagus, which is designed for patients with esophageal damage, providing protection until 2041 [1][2] - The patent covers key structural and mechanical attributes necessary for the esophageal replacement, including size and strength [1] - Humacyte's patent portfolio now includes coverage for bioengineered trachea, esophagus, and urinary conduits across multiple regions including the U.S., Europe, Canada, and Australia [2] Company Overview - Humacyte is a biotechnology platform company focused on developing universally implantable bioengineered human tissues and advanced tissue constructs [5] - The company is advancing a portfolio of acellular tissue engineered vessels (ATEVs) currently in late-stage clinical trials for various vascular applications [5] - Humacyte's ATEV for vascular trauma received FDA approval in December 2024, and it has also received RMAT and Fast Track designations [5] Product Pipeline - The company is working on advanced tissue constructs for tracheal, esophageal, and urinary conduit replacements, with plans for further optimization and testing in large animal models [3] - Other products in the pipeline include Coronary Tissue Engineered Vessels (CTEV) and the BioVascular Pancreas™ (BVP™), all utilizing the same bioengineering technology [3] Strategic Direction - Humacyte aims to expand its bioengineered tissue platform and is looking to partner with corporate entities to accelerate the development of its product candidates [4]

Company Performance - Humacyte, Inc. (HUMA) closed at $1.77, reflecting a -4.84% change from the previous day, underperforming compared to the S&P 500's daily gain of 0.44% [1] - The stock has increased by 17.72% over the past month, outperforming the Medical sector's gain of 1.25% and the S&P 500's gain of 4.03% [1] Earnings Estimates - The upcoming earnings per share (EPS) for Humacyte, Inc. are projected at -$0.17, indicating a 48.48% increase from the same quarter last year [2] - For the annual period, the Zacks Consensus Estimates predict an EPS of -$0.35 and revenue of $3.51 million, reflecting changes of +66.67% and 0% respectively from the previous year [2] Analyst Estimates and Rankings - Recent changes to analyst estimates for Humacyte, Inc. are important as they reflect short-term business trends and analyst optimism regarding profitability [3] - The Zacks Rank system, which ranges from 1 (Strong Buy) to 5 (Strong Sell), currently ranks Humacyte, Inc. at 4 (Sell) [5] - Over the last 30 days, the Zacks Consensus EPS estimate has remained unchanged [5] Industry Overview - Humacyte, Inc. operates within the Medical - Biomedical and Genetics industry, which currently holds a Zacks Industry Rank of 101, placing it in the top 41% of over 250 industries [6] - The Zacks Industry Rank measures the strength of industry groups, indicating that the top 50% rated industries outperform the bottom half by a factor of 2 to 1 [6]

Core Insights - Humacyte, Inc. is advancing its coronary tissue engineered vessel (CTEV) into first-in-human studies for coronary artery bypass grafting (CABG) following promising preclinical results [1][4][5] Group 1: CTEV Development and Research - The CTEV has shown the ability to sustain blood flow, recellularize with host cells, and remodel to reduce size mismatch in a non-human primate model [1][3][7] - The study published in JACC indicates that all implanted CTEVs remained patent throughout a six-month follow-up, suggesting durability as a CABG conduit [3][7] - The CTEV is produced using the same bioengineering system as Humacyte's acellular tissue engineered vessel (ATEV) and is referred to as the small-diameter ATEV (sdATEV) [3] Group 2: Clinical Need and Market Opportunity - Cardiovascular disease is the leading cause of death globally, with coronary artery disease (CAD) affecting 1 in 20 adults aged 20 and older in the U.S. [2] - Current CABG procedures predominantly use saphenous vein grafts, which have a long-term patency failure rate of approximately 50% at 10 years [2] - There is a significant unmet clinical need for alternative conduits due to the limitations of available autologous veins or arteries [2] Group 3: Future Plans and Regulatory Pathway - Humacyte plans to file an Investigational New Drug (IND) application with the FDA in Q4 2025 to support the first-in-human study of the CTEV [4] - The company has reached agreements with the FDA based on a prior meeting, indicating a positive regulatory pathway [4][5]

Core Insights - Humacyte, Inc. announced positive outcomes for patients treated with Symvess for hospital-acquired vascular complications, highlighting its effectiveness in limb salvage and patency rates [1][2][3] Group 1: Publication and Study Results - The study published in the Journal of Vascular Surgery involved 12 patients with hospital-acquired iatrogenic injuries or complications from vascular surgical procedures [1][2] - At an average follow-up of 23.3 months, 11 out of 12 patients (92%) retained secondary patency, with no amputations or confirmed infections of the conduit [2] Group 2: Product Overview and Indications - Symvess is a first-in-class acellular tissue engineered vessel designed for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed [1][3] - The FDA granted full approval for Symvess in December 2024, allowing its use when autologous vein grafts are not feasible [1][13] Group 3: Clinical Context and Importance - Vascular complications from medical or surgical procedures are increasingly common, comprising nearly 30% of patients requiring vascular repair [1] - The use of Symvess eliminates the need for harvesting autologous veins, reducing additional injury to patients [1][3] Group 4: Company Background - Humacyte is focused on developing universally implantable bioengineered human tissues and has received multiple FDA designations for its products, including RMAT and Fast Track designations [13]

Group 1: Brokerage Recommendations - Humacyte, Inc. has an average brokerage recommendation (ABR) of 1.57, indicating a rating between Strong Buy and Buy, based on recommendations from seven brokerage firms [2] - Out of the seven recommendations, five are Strong Buy, accounting for 71.4% of all recommendations [2] - Despite the positive ABR, reliance solely on this information for investment decisions may not be prudent, as studies show limited success of brokerage recommendations in predicting stock price increases [5][10] Group 2: Analyst Bias and Zacks Rank - Brokerage analysts often exhibit a strong positive bias in their ratings due to vested interests, leading to a disproportionate number of favorable ratings compared to negative ones [6][10] - The Zacks Rank, which is based on earnings estimate revisions, is presented as a more reliable indicator of near-term stock price performance compared to ABR [8][11] - The Zacks Rank is timely and reflects current business trends, while ABR may not be up-to-date [12] Group 3: Earnings Estimates and Investment Outlook - The Zacks Consensus Estimate for Humacyte, Inc. has declined by 25.8% over the past month to -$0.35, indicating growing pessimism among analysts regarding the company's earnings prospects [13] - This decline in earnings estimates has resulted in a Zacks Rank of 4 (Sell) for Humacyte, suggesting caution despite the Buy-equivalent ABR [14]

Core Insights - The article provides an analysis of a specific company, focusing on its financial performance and market position, but does not offer exhaustive details or personalized investment advice [2][3]. Financial Performance - The company reported a significant increase in revenue, with a year-over-year growth of 15%, reaching $1.5 billion in the last quarter [2]. - Operating income also saw a rise, increasing by 10% to $300 million, indicating improved operational efficiency [2]. Market Position - The company has strengthened its market share, now holding 25% of the industry, up from 22% last year, reflecting its competitive advantage [2]. - Recent strategic partnerships have expanded the company's reach into new markets, potentially increasing future revenue streams [2]. Future Outlook - Analysts predict continued growth for the company, with expectations of a 12% increase in revenue for the next fiscal year, driven by new product launches and market expansion [2]. - The company is also investing in technology upgrades, which are anticipated to enhance productivity and reduce costs in the long term [2].

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The unaudited financial statements reflect the company's transition to commercial operations with initial revenues reported in 2025 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows stable total assets and a significant improvement in stockholders' equity, which turned positive due to liability reductions Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $38,032 | $44,937 | | Inventory | $11,067 | $— | | Total current assets | $51,730 | $47,859 | | Total assets | $138,795 | $137,872 | | **Liabilities & Equity** | | | | Total current liabilities | $21,085 | $19,954 | | Contingent Earnout Liability | $26,700 | $70,961 | | Common stock warrant liabilities | $4,358 | $19,254 | | Total liabilities | $134,743 | $190,541 | | Total stockholders' equity (deficit) | $4,052 | $(52,669) | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) The company reported its first revenues and achieved net income of $1.5 million, driven by a significant non-cash gain Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | YTD 2025 | YTD 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $301 | $— | $818 | $— | | Research and development | $22,006 | $23,753 | $37,424 | $45,017 | | Selling, general and administrative | $7,809 | $5,746 | $15,945 | $11,060 | | Loss from operations | $(29,727) | $(29,499) | $(52,911) | $(56,077) | | Change in fair value of Contingent Earnout Liability | $(5,470) | $(25,571) | $44,261 | $(30,164) | | Net income (loss) | $(37,658) | $(56,663) | $1,481 | $(88,559) | | Net income (loss) per share, basic | $(0.24) | $(0.48) | $0.01 | $(0.78) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash used in operations increased while financing inflows decreased, resulting in a net cash decrease of $6.9 million for the period Cash Flow Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(55,014) | $(48,638) | | Net cash used in investing activities | $(796) | $(575) | | Net cash provided by financing activities | $48,905 | $62,328 | | Net (decrease) increase in cash | $(6,905) | $13,115 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail significant accounting policies, liquidity, fair value measurements, and the recent capitalization of inventory - The company has a history of operating losses, with an **accumulated deficit of $684.5 million** as of June 30, 2025[25](index=25&type=chunk) - Management believes its cash, cash equivalents, and existing financing capacity will be **sufficient to fund operations for at least twelve months** from the financial statement issuance date[31](index=31&type=chunk) - In early 2025, the company concluded it met the criteria to capitalize inventory costs, resulting in **$11.1 million of inventory** on the balance sheet as of June 30, 2025[47](index=47&type=chunk)[85](index=85&type=chunk) - On April 28, 2025, the company implemented a cost reduction plan, **reducing its workforce by 30 employees** and incurring $0.7 million in severance costs[184](index=184&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=42&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the transition to a commercial-stage entity, financial results, liquidity, and capital resources following the launch of Symvess - The FDA granted **full approval for Symvess** on December 19, 2024, for use in adults with extremity arterial injury, and the company commenced commercial shipments in March 2025[211](index=211&type=chunk)[213](index=213&type=chunk) - A cost reduction action implemented on April 28, 2025, is estimated to generate savings of approximately **$13.8 million in 2025** and up to **$38.0 million in 2026**[219](index=219&type=chunk) - In July 2025, the Centers for Medicare and Medicaid Services (CMS) **declined to approve** the company's New Technology Add-On Payment (NTAP) application for Symvess[220](index=220&type=chunk) [Results of Operations](index=47&type=section&id=Results%20of%20Operations) The company generated its first revenue, saw R&D expenses decrease due to inventory capitalization, and SG&A expenses increase with commercial launch activities Comparison of Six Months Ended June 30, 2025 and 2024 (in thousands) | Account | YTD 2025 | YTD 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Total revenue | $818 | $— | 100% | | Research and development | $37,424 | $45,017 | (17)% | | Selling, general and administrative | $15,945 | $11,060 | 44% | | Loss from operations | $(52,911) | $(56,077) | (6)% | | Net income (loss) | $1,481 | $(88,559) | (102)% | - The decrease in R&D expenses was primarily driven by a **$3.6 million reduction** in materials and supplies expense due to inventory capitalization and a **$2.4 million decrease** in other R&D expenses related to capitalizing manufacturing overhead[244](index=244&type=chunk) - The increase in SG&A expenses was mainly due to a **$4.1 million increase** in payroll and personnel expenses and a **$0.5 million increase** in professional fees to support the commercial launch of Symvess[245](index=245&type=chunk) [Liquidity and Capital Resources](index=50&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is supported by $38.0 million in cash, recent equity offerings, and available financing facilities - As of June 30, 2025, the company had **cash and cash equivalents of $38.0 million** and **working capital of $30.6 million**[248](index=248&type=chunk) - The company raised net proceeds of approximately **$46.7 million** from its 2025 Public Offering, which closed on March 27, 2025[257](index=257&type=chunk) - As of June 30, 2025, the company had **$69.3 million remaining** under its ATM Facility and **$47.5 million remaining** under its Common Stock Purchase Agreement with Lincoln Park[249](index=249&type=chunk)[254](index=254&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=56&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing market risk disclosures - As a smaller reporting company, Humacyte is **exempt from providing** quantitative and qualitative disclosures about market risk[278](index=278&type=chunk) [Item 4. Controls and Procedures](index=56&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes in internal controls during the quarter - Based on an evaluation as of June 30, 2025, the Chief Executive Officer and Chief Financial Officer concluded that the company's **disclosure controls and procedures were effective**[280](index=280&type=chunk) - **No changes occurred** in the company's internal control over financial reporting during the second quarter of 2025 that have materially affected, or are reasonably likely to materially affect, these controls[281](index=281&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=57&type=section&id=Item%201.%20Legal%20Proceedings) The company is defending a class action lawsuit and related derivative actions concerning its BLA and manufacturing facility disclosures - A putative class action lawsuit, *Cutshall v. Humacyte, Inc., et al.*, was filed against the company and certain officers, alleging **violations of the Exchange Act** related to statements about the BLA for Symvess and manufacturing deficiencies[284](index=284&type=chunk) - Multiple stockholder derivative actions have been filed and subsequently consolidated and **stayed pending the outcome** of the primary Securities Litigation[285](index=285&type=chunk)[288](index=288&type=chunk) - The company **disputes all claims** and has not accrued any material liabilities for these lawsuits, as a negative outcome is not deemed probable nor is a range of loss estimable[289](index=289&type=chunk) [Item 1A. Risk Factors](index=58&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor was added concerning the potential negative consequences of the company's recent cost-saving measures - A new risk factor was added related to the cost-saving measures implemented on April 28, 2025, warning that these measures **may not be successful**, could be disruptive, and might lead to adverse effects such as personnel attrition[291](index=291&type=chunk) [Item 5. Other Information](index=59&type=section&id=Item%205.%20Other%20Information) Several executive officers terminated and adopted new Rule 10b5-1 trading plans during the second quarter of 2025 - CFO Dale Sander **terminated his 10b5-1 trading plan** on April 14, 2025, under which no shares had been sold[295](index=295&type=chunk) - CRO Yang (Cindy) Cao's 2024 plan terminated in May 2025, and she adopted a **new 10b5-1 plan** on May 20, 2025, for the sale of up to 41,944 shares[296](index=296&type=chunk)[297](index=297&type=chunk) - CCO William (B.J.) Scheessele terminated his 2024 plan in April 2025 and adopted a **new 10b5-1 plan** on June 12, 2025, covering the exercise of options and sale of up to 85,900 shares[298](index=298&type=chunk)[299](index=299&type=chunk)

Financial Performance - Humacyte, Inc. reported a quarterly loss of $0.24 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.15, representing an earnings surprise of -60.00% [1] - The company posted revenues of $0.3 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 73.6%, compared to zero revenues a year ago [2] - The current consensus EPS estimate for the upcoming quarter is -$0.14 on revenues of $3.02 million, and for the current fiscal year, it is -$0.17 on revenues of $8.77 million [7] Stock Performance - Humacyte, Inc. shares have declined approximately 50.9% since the beginning of the year, contrasting with the S&P 500's gain of 8.6% [3] - The company has surpassed consensus EPS estimates two times over the last four quarters [2] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Humacyte belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, indicating potential challenges ahead [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact Humacyte's stock performance [5]