Financial Data and Key Metrics Changes - The company reported $300,000 in revenue for Q2 2025, with $100,000 from U.S. sales of CIMVEST and $200,000 from a research collaboration [19] - Revenue for the six months ended June 30, 2025, was $800,000, compared to no revenue for the same period in 2024 [20] - Net loss decreased to $37.7 million for 2025 from $56.7 million in 2024, while net income for the first half of 2025 was $1.5 million compared to a net loss of $88.6 million in the same period of 2024 [25][26] Business Line Data and Key Metrics Changes - The commercial launch of CIMVEST has seen significant traction, with 13 organizations completing the Value Analysis Committee (VAC) process, allowing 82 civilian hospitals to purchase CIMVEST, up from just 5 hospitals previously [8][10] - July sales of CIMVEST reached approximately $300,000, exceeding total sales for the first half of the year [10] Market Data and Key Metrics Changes - The U.S. Defense Logistics Agency granted ECAT listing approval for CIMVEST, making it available to approximately 35 military treatment facilities and 160 U.S. Department of Veterans Affairs hospitals [11] - The company recorded its first sale to a U.S. military facility following ECAT approval, indicating strong interest in CIMVEST among military healthcare providers [12] Company Strategy and Development Direction - The company aims to expand its market presence through continued VAC approvals and is actively engaging with private payers for supplemental reimbursement discussions [14][58] - The focus remains on the commercial launch of CIMVEST, completion of the V012 Phase III pivotal study, and filing a supplemental BLA for dialysis access [21] Management's Comments on Operating Environment and Future Outlook - Management acknowledged headwinds from public attacks but noted an acceleration in VAC approval activity and commercial sales in June and July [6][38] - The company is optimistic about its growth trajectory in 2025 and beyond, driven by the successful launch of CIMVEST and advancements in its pipeline programs [6][17] Other Important Information - The Centers for Medicare and Medicaid Services (CMS) declined to approve the NTAP application for CIMVEST, but management believes the impact on commercial success will be limited due to the low percentage of vascular trauma patients covered under Medicare [13] - The company has implemented a workforce reduction plan to extend its cash runway, estimating net savings of approximately $38 million in 2026 [21][22] Q&A Session Summary Question: Changes in commercial dynamics from Q2 to July - Management indicated that the increase in hospital approvals was partly due to the passage of time and the recent price reduction of CIMVEST from $29,500 to $24,250, which facilitated easier VAC committee reviews [30][31] Question: Pricing strategy for CIMVEST - The new price point of $24,250 is expected to be standard moving forward, with annual price increases considered thereafter [32][33] Question: Impact of public attacks on approval processes - Management noted that public attacks slowed the approval process, but they are optimistic about overcoming these challenges and have a full sales funnel [36][38] Question: Military treatment facilities and VA hospital channel strategy - The company is targeting both individual hospitals and larger bulk purchases, with plans to penetrate military treatment facilities and VA hospitals more aggressively [40][42] Question: Enrollment completion for AV access indication trial - Management aims to complete enrollment of 150 patients by the end of 2025, with interim analysis expected in April 2026 [43][45] Question: Impact of CMS decision on private payers - Management believes that the financial case for supplemental payments from private payers will be strong, focusing on long-term cost savings associated with their product [55][58] Question: Update on coronary artery bypass graft program - The company is preparing to submit an IND filing with the FDA later in 2025 and anticipates starting clinical trials in 2026 [62]

[CEO Statement & Q2 Execution Summary](index=1&type=section&id=CEO%20Statement%20%26%20Q2%20Execution%20Summary) The CEO reported significant progress in Symvess™ commercial launch, expanding hospital access and accelerating sales, alongside positive V007 trial data - The number of civilian hospitals eligible to purchase Symvess™ increased from 5 to **82** due to individual and healthcare system Value Analysis Committee (VAC) approvals[3](index=3&type=chunk) - Inclusion on the Electronic Catalog (ECAT) makes Symvess™ available to approximately **190** Military Treatment Facilities and U.S. Department of Veterans Affairs (VA) hospitals[3](index=3&type=chunk) - July 2025 product sales exceeded the total sales recorded during the first half of the year, and the first commercial sale to a U.S. military treatment facility was achieved[3](index=3&type=chunk) - The V007 trial data, highlighted by the Society of Vascular Surgery, showed superior functional patency for the ATEV™ over autologous fistula in key subgroups like women, and men with diabetes and obesity[3](index=3&type=chunk) [Corporate Highlights](index=1&type=section&id=Corporate%20Highlights) This section details Symvess™ market expansion through hospital and military approvals and updates on ATEV™ Phase 3 clinical trials [Symvess™ Market Launch](index=1&type=section&id=Symvess%E2%84%A2%20Market%20Launch) Symvess™ market access expanded significantly through VAC and ECAT approvals, driving a sharp increase in July sales and initial military facility orders - A total of **13** Value Analysis Committees (VACs) have approved Symvess, making it available to **82** civilian hospitals, with an additional **40** VACs currently in the review process[4](index=4&type=chunk) - July 2025 product sales reached **$0.3 million**, exceeding the total sales recorded during the first half of the year. To date, **12** hospitals have ordered Symvess[4](index=4&type=chunk)[5](index=5&type=chunk) - ECAT listing was granted in July 2025, making Symvess available to approximately **35** Military Treatment Facilities and **160** VA hospitals[8](index=8&type=chunk) [ATEV™ in Dialysis Clinical Trials](index=2&type=section&id=ATEV%E2%84%A2%20in%20Dialysis%20Clinical%20Trials) Positive V007 Phase 3 results showed superior ATEV™ patency, while the V012 study reached 100 patients, enabling interim analysis and a potential BLA submission - Results from the V007 Pivotal Phase 3 trial, presented at VAM25, showed significantly higher functional and secondary patency for ATEV recipients in a high-risk cohort compared to the AV fistula control group[8](index=8&type=chunk) - The V012 Phase 3 clinical trial has enrolled **100 patients**, achieving the threshold for a planned interim analysis when the first 80 patients reach one-year follow-up[8](index=8&type=chunk) - Humacyte plans to submit a supplemental Biologics License Application (BLA) in H2 2026 to expand the Symvess label for AV access in hemodialysis, subject to interim results from the V012 study[8](index=8&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) This section provides an overview of Humacyte's financial results, including revenue, net loss, operating expenses, and cash position [Second Quarter 2025 Financial Highlights](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Highlights) Humacyte reported $0.3 million in Q2 2025 revenue, a narrowed net loss of $37.7 million, and maintained $88.4 million in cash Financial Highlights Table | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | **Total Revenue** | **$0.3M** | **$0** | | *Product Revenue* | *$0.1M* | *$0* | | *Contract Revenue* | *$0.2M* | *$0* | | **Net Loss** | **($37.7M)** | **($56.7M)** | - Selling, general and administrative (SG&A) expenses increased to **$7.8 million** from **$5.7 million** YoY, primarily due to the U.S. commercial launch of Symvess[9](index=9&type=chunk) - Research and development (R&D) expenses decreased to **$22.0 million** from **$23.8 million** YoY, mainly due to the capitalization of overhead costs for commercial manufacturing[9](index=9&type=chunk) - The company held **$88.4 million** in cash, cash equivalents, and restricted cash as of June 30, 2025[10](index=10&type=chunk) [Cost Reduction Plan](index=3&type=section&id=Cost%20Reduction%20Plan) Humacyte implemented a cost reduction plan, including a 30-employee workforce reduction, projected to save over $50 million through 2026 - The company implemented a plan to reduce its workforce by **30 employees**, defer new hires, and reduce other operating expenses[9](index=9&type=chunk) - A one-time cash expenditure of approximately **$0.7 million** for severance and termination benefits was incurred, with the majority recorded in Q2 2025[9](index=9&type=chunk) Estimated Net Savings from Cost Reduction Plan | Period | Estimated Net Savings | | :--- | :--- | | 2025 | ~$13.8 million | | 2026 | ~$38.0 million | | **Total (2025-2026)** | **> $50 million** | [Consolidated Financial Statements](index=7&type=section&id=Consolidated%20Financial%20Statements) This section presents detailed unaudited Condensed Consolidated Statements of Operations and Balance Sheets for the periods ended June 30, 2025 and 2024 [Statements of Operations](index=7&type=section&id=Statements%20of%20Operations) Humacyte reported $301,000 in Q2 2025 revenue with a $37.7 million net loss, while the six-month period showed $818,000 revenue and $1.5 million net income Three Months Ended June 30 (in thousands, except per share) | (in thousands, except per share) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total revenue | $301 | $0 | | Loss from operations | ($29,727) | ($29,499) | | Net income (loss) | ($37,658) | ($56,663) | | Net income (loss) per share, basic | ($0.24) | ($0.48) | Six Months Ended June 30 (in thousands, except per share) | (in thousands, except per share) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total revenue | $818 | $0 | | Loss from operations | ($52,911) | ($56,077) | | Net income (loss) | $1,481 | ($88,559) | | Net income (loss) per share, basic | $0.01 | ($0.78) | [Balance Sheets](index=8&type=section&id=Balance%20Sheets) As of June 30, 2025, total assets were $138.8 million, liabilities $134.7 million, and stockholders' equity improved to $4.1 million Balance Sheet Data (in thousands) | (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $38,032 | $44,937 | | Total current assets | $51,730 | $47,859 | | **Total assets** | **$138,795** | **$137,872** | | **Liabilities & Equity** | | | | Total current liabilities | $21,085 | $19,954 | | **Total liabilities** | **$134,743** | **$190,541** | | **Total stockholders' equity (deficit)** | **$4,052** | **($52,669)** | [Product Information & Disclosures](index=4&type=section&id=Product%20Information%20%26%20Disclosures) This section provides essential information regarding Symvess™ indications, safety warnings, and standard forward-looking statement disclaimers [Symvess™ Indication and Safety Information](index=4&type=section&id=Symvess%E2%84%A2%20Indication%20and%20Safety%20Information) Symvess™ is indicated for urgent extremity revascularization, carrying a boxed warning for graft failure and risks like rupture, thrombosis, and anastomotic failure - Symvess is indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed and autologous vein graft is not feasible[12](index=12&type=chunk) - The product has a BOXED WARNING for graft failure, noting that loss of integrity can result in life-threatening hemorrhage[13](index=13&type=chunk) - Key warnings and precautions include graft rupture, anastomotic failure, and thrombosis. Anti-platelet therapy is recommended following treatment[15](index=15&type=chunk)[16](index=16&type=chunk)[17](index=17&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section includes standard forward-looking statements, subject to significant risks and uncertainties that may cause actual results to differ materially - The press release contains forward-looking statements concerning the commercialization of Symvess, market acceptance, manufacturing capabilities, clinical trial execution, and the timing of regulatory filings[22](index=22&type=chunk)[23](index=23&type=chunk) - These statements are subject to numerous risks and uncertainties, and the company cautions that actual results may differ materially from those projected[23](index=23&type=chunk)

Core Insights - Humacyte, Inc. reported total revenues of $301,000 for the second quarter of 2025 and $818,000 for the first half of 2025, primarily from sales and collaborative research agreements [1] - The company has achieved significant progress in the commercial launch of its product Symvess, with 82 civilian hospitals now approved to purchase it, a substantial increase from five hospitals in the previous quarter [2][3] - The Electronic Catalog (ECAT) approval allows Symvess to be available to approximately 190 Military Treatment Facilities and U.S. Department of Veterans Affairs hospitals [2][3] - The company experienced a notable increase in product sales in July 2025, exceeding total sales from the first half of the year [2][3] Financial Performance - For the second quarter of 2025, Humacyte reported revenues of $0.3 million, with $0.1 million from U.S. sales of Symvess and $0.2 million from a research collaboration [6][10] - The total revenue for the first six months of 2025 was $0.8 million, with $0.2 million from U.S. sales of Symvess and $0.6 million from research collaboration [10] - The company reported a net loss of $37.7 million for the second quarter of 2025, an improvement from a net loss of $56.7 million in the same period of 2024 [10][26] - Research and development expenses decreased to $22.0 million for the second quarter of 2025 from $23.8 million in the same quarter of 2024 [10][26] Product Development and Clinical Trials - The V007 Phase 3 clinical trial results for the acellular tissue engineered vessel (ATEV) were highlighted at a major vascular surgery conference, showing superior functional patency compared to the autologous fistula control group [7][10] - The V012 Phase 3 clinical trial has enrolled 100 patients to assess the efficacy and safety of ATEV for dialysis in female patients, with plans for an interim analysis [10] - The company aims to submit a supplemental Biologics License Application (BLA) in the second half of 2026, pending interim results from the V012 trial [10] Operational Updates - Humacyte has implemented a workforce reduction plan, resulting in a net savings of approximately $13.8 million in 2025 and an estimated $38.0 million in 2026 [10] - The company has retained key personnel and resources to meet its corporate goals, including the commercial launch of Symvess and completion of clinical trials [10] - As of June 30, 2025, Humacyte reported cash, cash equivalents, and restricted cash totaling $88.4 million [10][28]

Core Viewpoint - Humacyte, Inc. is set to release its financial results for Q2 2025 on August 11, 2025, and will provide a corporate and financial update during a conference call [1] Group 1: Company Overview - Humacyte, Inc. is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [2] - The company has received FDA approval for its acellular tissue engineered vessel (ATEV) for vascular trauma in December 2024 and is conducting late-stage clinical trials for other vascular applications [2] - Humacyte's ATEV has received multiple designations, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA [2] Group 2: Financial and Conference Call Details - The financial results for the quarter ended June 30, 2025, will be released on August 11, 2025, with a conference call scheduled for 8:00 a.m. ET [1] - Investors can access the conference call via specific dial-in numbers and a conference ID, with a webcast available 15 minutes prior to the call [1]

Group 1 - Humacyte, Inc. closed at $2.53, down 5.24% from the previous day, underperforming the S&P 500's gain of 0.4% [1] - The stock has increased by 20.27% over the past month, outperforming the Medical sector's gain of 1.19% and the S&P 500's gain of 4.61% [1] Group 2 - Humacyte, Inc. is expected to report an EPS of -$0.15, reflecting a 44.44% improvement from the same quarter last year [2] - For the fiscal year, earnings are projected at -$0.17 per share and revenue at $8.77 million, indicating an 83.81% increase in earnings but no change in revenue from the previous year [2] Group 3 - Recent revisions to analyst forecasts for Humacyte, Inc. are important as they reflect short-term business trends, with positive revisions indicating a favorable business outlook [3] - The Zacks Rank system, which incorporates estimate changes, has a strong track record of outperforming, with stocks rated 1 yielding an average annual return of +25% since 1988 [4][5] Group 4 - The Medical - Biomedical and Genetics industry, part of the Medical sector, holds a Zacks Industry Rank of 95, placing it in the top 39% of over 250 industries [6] - Research indicates that the top 50% rated industries outperform the bottom half by a factor of 2 to 1 [6]

Company Performance - Humacyte, Inc. closed at $2.67, reflecting a decrease of 2.2% from the previous trading session, underperforming the S&P 500's gain of 0.07% [1] - Over the past month, Humacyte's shares increased by 24.66%, significantly outperforming the Medical sector's gain of 2.39% and the S&P 500's gain of 5.71% [1] Earnings Expectations - Analysts anticipate Humacyte to report earnings of -$0.15 per share in the upcoming earnings disclosure, indicating a year-over-year growth of 44.44% [2] - For the entire year, Zacks Consensus Estimates project earnings of -$0.17 per share and revenue of $8.77 million, reflecting changes of +83.81% in earnings and no change in revenue compared to the previous year [2] Analyst Estimates and Market Trends - Recent changes to analyst estimates for Humacyte are crucial as they often indicate shifts in near-term business trends, with upward revisions suggesting positive sentiment towards the company's operations [3] - The Zacks Rank system, which incorporates estimate changes, has shown a correlation between these revisions and near-term share price momentum [4] Zacks Rank and Industry Position - Humacyte currently holds a Zacks Rank of 3 (Hold), with the consensus EPS estimate remaining unchanged over the last 30 days [5] - The Medical - Biomedical and Genetics industry, which includes Humacyte, ranks 94 in the Zacks Industry Rank, placing it in the top 39% of over 250 industries [6]

Core Insights - Humacyte, Inc. has announced the first sale of its product Symvess to a U.S. Military Treatment Facility, marking a significant milestone for the company in the defense healthcare sector [1][4] - The sale follows the recent approval of Symvess for listing on the Electronic Catalog (ECAT) by the U.S. Defense Logistics Agency, which allows access to military healthcare professionals [2][4] - Symvess is an acellular tissue engineered vessel that received FDA approval for use in extremity vascular trauma in December 2024, and is currently being developed for various other vascular applications [3][5] Company Overview - Humacyte, Inc. is focused on developing universally implantable bioengineered human tissues and advanced tissue constructs aimed at improving patient outcomes and transforming medical practices [5] - The company’s acellular tissue engineered vessel (ATEV) has received multiple designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations, highlighting its potential in treating vascular trauma and other conditions [5] - Humacyte is also engaged in late-stage clinical trials for additional vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease, as well as preclinical development for coronary artery bypass grafts and pediatric heart surgery [5]

Company Performance - Humacyte, Inc. (HUMA) experienced a decline of 7.69% in its stock price, closing at $2.28, underperforming the S&P 500 which fell by 0.4% [1] - Over the past month, Humacyte's shares increased by 2.49%, outperforming the Medical sector's decline of 1.56% but lagging behind the S&P 500's gain of 4.97% [1] Earnings Expectations - The upcoming earnings report for Humacyte is anticipated to show an EPS of -$0.15, representing a 44.44% improvement from the same quarter last year [2] - For the full year, analysts expect an EPS of -$0.17 and revenue of $8.77 million, indicating changes of +83.81% for EPS and no change for revenue compared to the previous year [2] Analyst Estimates and Rankings - Recent changes to analyst estimates for Humacyte reflect shifting business dynamics, with positive revisions indicating optimism about the company's profitability [3] - The Zacks Rank system, which assesses estimate changes, currently ranks Humacyte at 3 (Hold), with no changes in the consensus EPS estimate over the past month [5] Industry Context - Humacyte operates within the Medical - Biomedical and Genetics industry, which holds a Zacks Industry Rank of 77, placing it in the top 32% of over 250 industries [6] - The Zacks Industry Rank indicates that the top 50% rated industries outperform the bottom half by a factor of 2 to 1 [6]

Core Insights - Humacyte, Inc. has received Electronic Catalog (ECAT) listing approval for its product Symvess, making it accessible to healthcare professionals in U.S. Department of Defense and Department of Veterans Affairs facilities [1] - Symvess is an acellular tissue engineered vessel that was approved by the FDA for extremity vascular trauma in December 2024 [2] - The company aims to expand the availability of Symvess to more patients, having received positive feedback from DOD hospitals [3] Company Overview - Humacyte, Inc. is focused on developing bioengineered human tissues and advanced tissue constructs to improve patient care and transform medical practices [4] - The company’s acellular tissue engineered vessel (ATEV) has received FDA approval for vascular trauma and is in late-stage clinical trials for other vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease [4] - Humacyte's 6mm ATEV has received both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA, indicating its potential for urgent arterial repair and advanced PAD treatment [4]

Company Performance - Humacyte, Inc. (HUMA) closed at $2.09, reflecting a -1.42% change from the previous day, underperforming compared to the S&P 500's gain of 0.52% [1] - Prior to the latest trading session, Humacyte's shares had decreased by 20.6%, while the Medical sector gained 1.88% and the S&P 500 increased by 4.27% [1] Earnings Expectations - Analysts expect Humacyte to report earnings of -$0.15 per share, indicating a year-over-year growth of 44.44% [2] - For the full year, Zacks Consensus Estimates project earnings of -$0.18 per share and revenue of $8.77 million, representing changes of +82.86% and 0% respectively from the prior year [2] Analyst Estimates and Market Sentiment - Recent changes to analyst estimates for Humacyte reflect short-term business trends, with positive revisions indicating analyst optimism regarding the company's profitability [3] - The Zacks Rank system, which assesses estimate changes, currently ranks Humacyte at 2 (Buy), suggesting a favorable outlook [5] Industry Context - Humacyte operates within the Medical - Biomedical and Genetics industry, which holds a Zacks Industry Rank of 88, placing it in the top 36% of over 250 industries [6] - Research indicates that the top 50% rated industries outperform the bottom half by a factor of 2 to 1, highlighting the potential for growth within this sector [6]