Financial Performance - Total revenues for Q1 2025 were $517,000, with $147,000 from the initial U.S. commercial launch of Symvess and $370,000 from a research collaboration[11]. - Net income for Q1 2025 was $39.1 million, compared to a net loss of $31.9 million in Q1 2024, largely due to a non-cash remeasurement of the contingent earnout liability[11]. - Total revenue for Q1 2025 was $517,000, compared to $0 in Q1 2024, indicating a significant growth[27]. - Product revenue was $147,000, while contract revenue was $370,000, both contributing to the total revenue[27]. - Operating expenses decreased to $23,701,000 in Q1 2025 from $26,578,000 in Q1 2024, reflecting a reduction of approximately 11%[27]. - The net income for Q1 2025 was $39,139,000, a turnaround from a net loss of $31,896,000 in Q1 2024[27]. - Net income per share, basic, was $0.28 in Q1 2025, compared to a loss of $0.29 per share in Q1 2024[27]. Cash and Assets - As of March 31, 2025, Humacyte reported cash, cash equivalents, and restricted cash of $113.2 million[11]. - Cash and cash equivalents increased to $62,847,000 as of March 31, 2025, up from $44,937,000 at the end of 2023[29]. - Total assets rose to $162,553,000 as of March 31, 2025, compared to $137,872,000 at the end of 2023, marking an increase of approximately 18%[29]. - Total liabilities decreased significantly to $126,510,000 from $190,541,000, indicating a reduction of about 34%[29]. - Stockholders' equity improved to $36,043,000 as of March 31, 2025, compared to a deficit of $52,669,000 at the end of 2023[29]. Cost Management - The company implemented cost reduction measures, including a workforce reduction of approximately 31 employees, expected to save about $13.8 million in 2025 and up to $38.0 million in 2026[7]. - Research and development expenses for Q1 2025 were $15.4 million, down from $21.3 million in Q1 2024, primarily due to decreased materials costs[11]. Product Development and Market Approval - 45 hospitals have initiated the Value Analysis Committee (VAC) approval process for Symvess, with five hospitals already approving its purchase[4]. - A total of 84 patients have been enrolled in the V012 Phase 3 clinical trial for dialysis, with an interim analysis planned upon reaching the one-year follow-up for the first 80 patients[8]. - Humacyte plans to file an Investigational New Drug (IND) application with the FDA for first-in-human clinical testing of the small-diameter ATEV in coronary artery bypass grafting (CABG) later this year[8]. Economic Value - The economic value of Symvess is projected to be lower than that of synthetic grafts, with significant cost savings attributed to reduced amputation and infection rates[8]. - The company reported a change in fair value of contingent earnout liability of $49,731,000 in Q1 2025, compared to a loss of $4,593,000 in Q1 2024[27].

Core Insights - Humacyte, Inc. has successfully launched its product Symvess™ for treating extremity vascular trauma, marking a significant milestone for the company [2][3] - The company reported total revenues of $517,000 for the first quarter of 2025, with $147,000 from the initial commercial sales of Symvess and $370,000 from a research collaboration [9][27] - Humacyte completed a public offering that raised $46.7 million in net proceeds, which will help extend its cash runway [6][9] Market Launch and Sales - The commercial launch of Symvess began in late February 2025, with initial shipments to three Level 1 trauma centers [3] - 45 hospitals have initiated the Value Analysis Committee (VAC) approval process for Symvess, with five hospitals already approving its purchase [2][3] - The company anticipates further approvals and sales growth in the upcoming quarters [3] Financial Performance - The first quarter of 2025 saw a revenue increase to $517,000 compared to no revenue in the same period of 2024 [9][27] - Research and development expenses decreased to $15.4 million from $21.3 million year-over-year, attributed to reduced material costs and clinical study expenses [9][27] - General and administrative expenses rose to $8.1 million from $5.3 million, primarily due to the costs associated with the commercial launch of Symvess [9][27] Cost Management and Future Plans - The company implemented cost reduction measures, including workforce reductions and deferring new hires, aiming for estimated savings of approximately $13.8 million in 2025 and up to $38 million in 2026 [6][9] - Humacyte plans to file an Investigational New Drug (IND) application with the FDA for the small-diameter ATEV™ in coronary artery bypass grafting (CABG) later this year [2][8] - The company is on track to submit a supplemental Biologics License Application (BLA) for ATEV in dialysis in 2026, following a major enrollment milestone in its Phase 3 trial [2][8] Corporate Developments - Humacyte was issued a new U.S. patent in January 2025, providing protection for its biomanufacturing platform until 2040 [4] - The company reported a net income of $39.1 million for the first quarter of 2025, a significant improvement from a net loss of $31.9 million in the same period of 2024 [17][27] - As of March 31, 2025, Humacyte had cash, cash equivalents, and restricted cash totaling $113.2 million [17][28]

Core Viewpoint - Humacyte, Inc. is set to release its financial results for Q1 2025 on May 13, 2025, and will provide a corporate and financial update during a webcast and conference call [1][2]. Company Overview - Humacyte, Inc. is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][3]. - The company manufactures acellular tissues aimed at treating various diseases, injuries, and chronic conditions [3]. - The FDA approved the Biologics License Application for Humacyte's acellular tissue engineered vessel (ATEV) for vascular trauma in December 2024 [3]. - ATEVs are currently in late-stage clinical trials for additional vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease [3]. - Preclinical development is ongoing for coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes treatment, and other novel cell and tissue applications [3]. - Humacyte's 6mm ATEV for AV access in hemodialysis is notable for being the first product to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received Fast Track designation [3]. - The ATEV has received priority designation for vascular trauma treatment from the U.S. Secretary of Defense [3]. Financial Results Announcement - The financial results for the quarter ended March 31, 2025, will be announced on May 13, 2025, at 8:30 AM ET [2]. - A conference call will be available for U.S. and international investors, with specific dial-in numbers provided [2]. - The webcast will be accessible 15 minutes prior to the call and will be available for replay for at least 30 days [2].

Company Performance - Humacyte, Inc. (HUMA) ended the latest trading session at $1.45, reflecting a +1.4% adjustment from the previous day's close, outperforming the S&P 500 which gained 0.15% [1] - The stock has decreased by 4.03% over the past month, which is worse than the Medical sector's loss of 4.39% and the S&P 500's loss of 0.21% [1] Earnings Forecast - Humacyte, Inc. is projected to report earnings of -$0.19 per share in the upcoming release, indicating a year-over-year growth of 34.48% [2] Analyst Revisions - Recent revisions to analyst forecasts for Humacyte, Inc. are important as they reflect changes in short-term business dynamics, with positive revisions indicating analysts' confidence in the company's performance [3] Zacks Rank System - The Zacks Rank system, which ranges from 1 (Strong Buy) to 5 (Strong Sell), has a strong track record, with 1 stocks averaging an annual return of +25% since 1988 [5] - Over the last 30 days, the Zacks Consensus EPS estimate for Humacyte, Inc. has increased by 14.6%, and the company currently holds a Zacks Rank of 2 (Buy) [5] Industry Context - Humacyte, Inc. operates within the Medical - Biomedical and Genetics industry, which has a Zacks Industry Rank of 78, placing it in the top 32% 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]

Core Viewpoint - Humacyte, Inc. (HUMA) has received an upgrade to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, indicating a positive outlook for the company's stock price [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors often rely on earnings estimates to determine the fair value of a company's shares, leading to significant stock price movements when estimates are revised [4]. Recent Performance and Projections - For the fiscal year ending December 2025, Humacyte, Inc. is expected to earn -$0.69 per share, reflecting a 34.3% change from the previous year's reported number [8]. - Over the past three months, the Zacks Consensus Estimate for Humacyte has increased by 16.9%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - Humacyte's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Company Performance - Humacyte, Inc. closed at $1.48, with a daily increase of +0.68%, underperforming the S&P 500's gain of 2.03% [1] - Over the past month, Humacyte's shares have decreased by 26.5%, compared to the Medical sector's loss of 8.57% and the S&P 500's loss of 5.07% [1] Earnings Expectations - The upcoming earnings report for Humacyte is anticipated to show an EPS of -$0.19, which represents a 34.48% increase from the same quarter last year [2] Analyst Estimates - Recent changes in analyst estimates for Humacyte indicate a positive outlook, reflecting analysts' confidence in the company's business performance and profit potential [3] - The Zacks Consensus EPS estimate has increased by 10.48% over the last 30 days, suggesting a favorable trend in analyst sentiment [5] Industry Context - Humacyte operates within the Medical - Biomedical and Genetics industry, which currently holds a Zacks Industry Rank of 79, placing it in the top 32% of over 250 industries [6] - The Zacks Industry Rank measures the strength of industry groups, indicating that the top 50% rated industries tend to outperform the bottom half by a factor of 2 to 1 [6]

Company Overview - Humacyte, Inc. (HUMA) closed at $1.55, reflecting a +0.65% change from the previous session, outperforming the S&P 500's loss of 2.24% on the same day [1] - Over the past month, shares of Humacyte have depreciated by 50.8%, significantly underperforming the Medical sector's loss of 7.47% and the S&P 500's loss of 4.17% [1] Financial Performance Expectations - Analysts expect Humacyte to report earnings of -$0.19 per share in the upcoming financial results, indicating a year-over-year growth of 34.48% [2] - The Zacks Consensus EPS estimate for Humacyte has increased by 10.48% over the past month [5] Analyst Sentiment and Estimates - Recent changes to analyst estimates for Humacyte reflect short-term business trends, with positive revisions indicating analysts' confidence in the company's performance and profit potential [3] - Humacyte currently holds a Zacks Rank of 3 (Hold), which is part of a ranking system that has historically delivered an average annual return of +25% for stocks rated 1 [5] Industry Context - Humacyte operates within the Medical - Biomedical and Genetics industry, which holds a Zacks Industry Rank of 75, placing it in the top 31% 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]

Product Launch and Approvals - Humacyte commenced the U.S. commercial launch of its first FDA-approved product, Symvess™, in Q1 2025, targeting the vascular repair market[17]. - The FDA granted full approval for Symvess™ on December 19, 2024, for use in adults as a vascular conduit for extremity arterial injury[20]. - The FDA granted full approval for ATEV on December 19, 2024, for use in adults with extremity vascular trauma when autologous vein grafts are not feasible[98]. - A New Technology Add-On Payment (NTAP) application for Symvess was submitted to CMS in October 2024, with potential reimbursement starting on October 1, 2025[213]. Clinical Trials and Results - As of December 31, 2024, approximately 601 patients have received ATEVs, with ongoing Phase 3 and Phase 2 trials for AV access in hemodialysis and PAD[19]. - The V007 Phase 3 trial for dialysis access met co-primary endpoints, with topline results expected in August 2024[56]. - The ATEV has shown a 30-day primary patency rate of 95% in the V001 trial for dialysis access, with a 0% infection rate per year[56]. - The V005 Phase 2/3 trial demonstrated a primary patency rate of 84.3% for ATEVs compared to 78.9% for synthetic grafts, and a secondary patency rate of 90.2% versus 78.9%[77]. - The V011 clinical trial for dialysis access completed with a 30-day primary patency rate of 97% and a 12-month secondary patency rate of 83%[23]. - The V006 trial achieved a 30-day primary patency of 93% and a 12-month secondary patency of 82%, with an infection rate of 0.93% per year[115]. - The V002 trial reported a secondary patency rate of 60% at 72 months, with no infections or amputations reported[168]. - The V004 trial showed a secondary patency of 86% at 6 months and 64% at 12 months, with no reported infections or amputations[173]. Manufacturing and Production - Humacyte's manufacturing facility spans 83,000 square feet and can accommodate over 40 LUNA200 systems, currently operating eight systems[33]. - The LUNA200 system can produce up to 200 ATEVs (42cm in length) per batch, with the ability to generate 400 ATEVs (13cm in length) per batch[35]. - The ATEV manufacturing process utilizes primary human aortic vascular cells, with each qualified isolation capable of producing approximately 500,000 to 1 million ATEVs[205]. - The LUNA200 system can produce up to 200 ATEVs per batch, with an annual gross capacity of approximately 7,200 ATEVs from eight installed systems[204]. Patient Population and Market Potential - The estimated annual eligible patient population for ATEVs in the U.S. is approximately 26,000, based on trauma injury analysis[41]. - In 2024, over 555,000 patients received hemodialysis in the U.S., with at least 160,000 requiring new AV access annually[43]. - Over 230,000 peripheral artery disease-related procedures are reported annually in the U.S., with significant potential for ATEVs as bypass conduits[46]. - Approximately 1,800 babies are born with Tetralogy of Fallot in the U.S. each year, and the company plans to submit an orphan drug application for ATEV use as a BT shunt[53]. Safety and Efficacy - The ATEV has shown a low infection rate of approximately 1.0% or less per patient-year in AV access trials, with rates in trauma and PAD trials ranging from 0% to approximately 2%[60]. - The ATEV has demonstrated maximal pressure withstand capabilities of approximately 3,200 mmHg, comparable to native human blood vessels[36]. - The ATEV has shown strong patency rates and no reported infections in clinical studies for PAD, supporting its development as a bypass conduit[161]. - The ATEV demonstrated a statistically significant lower rate of conduit infections compared to ePTFE, highlighting its safety advantage[126]. Financial and Strategic Considerations - The ATEVs are projected to be cost-saving for trauma centers and third-party payors, primarily due to reductions in costs related to amputations and conduit infections[42]. - A Budget Impact Model indicates that the per-patient cost of treating with Symvess is expected to be lower than current treatments, with significant cost savings attributed to reduced amputation and infection rates[212]. - The company received approximately $6.8 million in grants from the Department of Defense for the development of ATEVs for vascular reconstruction and repair[70]. - The ATEV technology has been designated as a priority by the DoD, expediting its development and review process[70]. Partnerships and Collaborations - A distribution agreement with Fresenius Medical Care grants exclusive rights to develop and commercialize the 6mm x 42cm ATEV outside the U.S. and EU, with collaboration for U.S. commercialization[215]. - The agreement with Fresenius Medical Care includes responsibilities for regulatory approval in the U.S. and efforts to meet market entry criteria in other countries[216]. - The company anticipates exploring strategic partnerships for earlier-stage applications of its technology platform, such as CABG and BVP for diabetes, as clinical results are generated[214].

Financial Data and Key Metrics Changes - No revenue was reported for the fourth quarter of 2024 or 2023, and no revenue was recorded for the years ended December 31, 2024, and 2023. However, commercial revenues have started to be booked for the first time in the company's history within the last several weeks [23] - Research and development expenses for the fourth quarter of 2024 were $20.7 million, a decrease from $22.9 million in the third quarter of 2024, but a slight increase from $20.2 million in the fourth quarter of 2023. For the year ended December 31, 2024, R&D expenses were $88.6 million, compared to $76.6 million in 2023 [24] - General and administrative expenses for the fourth quarter of 2024 were $7.4 million, consistent with the third quarter of 2024, and increased from $6 million in the fourth quarter of 2023. Total G&A expenses for the year ended December 31, 2024, were $25.8 million, compared to $23.5 million in 2023 [25] - Net loss for the fourth quarter of 2024 was $20.9 million, down from $39.2 million in the third quarter of 2024 and $25.1 million in the fourth quarter of 2023. The net loss for the year ended December 31, 2024, was $148.7 million, compared to $110.8 million in 2023 [28] - Cash, cash equivalents, and restricted cash totaled $95.3 million as of December 31, 2024, with an additional $46.6 million raised from a public offering completed shortly after [29] Business Line Data and Key Metrics Changes - The commercial launch of Symvess is proceeding at full speed, with 34 hospitals initiating their Value Analysis Committee (VAC) approval process. Three hospitals have already approved the purchase of Symvess [9][10] - The ATEV program for dialysis access has shown superior function and patency compared to AV fistula in clinical trials, with plans to submit a supplemental BLA in the second half of 2026 [18][20] Company Strategy and Development Direction - The company aims to drive adoption of Symvess through a highly experienced sales team, focusing on both civilian and military healthcare providers [16][17] - The company is committed to expanding its pipeline, including the ATEV program and small diameter ATEV for coronary artery bypass grafting, with plans for IND application filing [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the transformative potential of Symvess and its impact on patient outcomes, emphasizing the importance of commercial execution and pipeline programs [31] - The management acknowledged the challenges of the VAC approval process but remains optimistic about the adoption of Symvess in trauma centers [41][42] Other Important Information - A new U.S. patent covering key aspects of the manufacturing system for Symvess was issued, providing protection until 2040 [14] - The company has published a Budget Impact Model indicating cost reductions associated with the use of Symvess in traumatic injury [12] Q&A Session Summary Question: Characteristics of hospitals that approved Symvess - Management noted that approvals were driven by hospitals committed to improving patient care and having surgeon champions advocating for the product [35][36] Question: Goals for the launch in 2025 - Management refrained from providing specific guidance but indicated a strong start with ongoing VAC processes and expected sales growth in the second half of the year [40][44] Question: Feedback from surgeons regarding a controversial article - Surgeons involved in clinical trials expressed strong discontent with the article, drafting a rebuttal that was not published by the New York Times [49][50] Question: Interim analysis for the V012 trial - The interim analysis will focus on catheter-free days during the first year, with expectations for positive results based on previous data [60] Question: Supplemental BLA review timeline - Management hopes for a shorter review time for the supplemental BLA compared to the initial application, but acknowledges the unpredictability of FDA timelines [90] Question: Cost of manufacturing small diameter ATEV - The cost of producing smaller diameter ATEV is expected to be less than that of larger sizes, with no need for new equipment [95]

Financial Data and Key Metrics Changes - No revenue was reported for the fourth quarter of 2024 or 2023, and no revenue for the years ended December 31, 2024, and 2023. However, commercial revenues have started to be booked for the first time in the company's history within the last several weeks [23] - Research and development expenses were $20.7 million for the fourth quarter of 2024, a decrease from $22.9 million in the third quarter of 2024, but a slight increase from $20.2 million in the fourth quarter of 2023. For the year ended December 31, 2024, R&D expenses were $88.6 million compared to $76.6 million in 2023 [24] - General and administrative expenses were $7.4 million for the fourth quarter of 2024, consistent with the previous quarter, but an increase from $6 million in the fourth quarter of 2023. Total G&A expenses for the year were $25.8 million compared to $23.5 million in 2023 [25] - Net loss was $20.9 million for the fourth quarter of 2024, down from $39.2 million in the third quarter of 2024 and $25.1 million in the fourth quarter of 2023. The net loss for the year was $148.7 million compared to $110.8 million in 2023 [28] Business Line Data and Key Metrics Changes - The commercial launch of Symvess is proceeding at full speed, with 34 hospitals initiating their Value Analysis Committee (VAC) approval process. Three hospitals have already approved the purchase of Symvess [9][10] - The ATEV program for dialysis access has shown superior function and patency compared to AV fistula in clinical trials, with plans for a supplemental BLA submission in the second half of 2026 [18][20] Market Data and Key Metrics Changes - The market response to Symvess has been positive, with hospitals engaged in the VAC process and early commercial shipments made to Level 1 trauma centers [9][10] - A Budget Impact Model published in the Journal of Medical Economics indicates that the use of Symvess can lead to cost reductions associated with avoiding vascular infections and amputations [12] Company Strategy and Development Direction - The company aims to drive adoption of Symvess through a highly experienced sales team and is focused on expanding its pipeline, including the ATEV program and small diameter ATEV for coronary artery bypass grafting [16][20] - The company is committed to delivering transformative regenerative medicine solutions and improving patient outcomes, with a strong emphasis on commercial execution and pipeline development [31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial strategy and the potential impact of Symvess on vascular patient care, anticipating a significant year ahead [31] - The company is evaluating its cash position and prioritizing investments for future trials, particularly for the PAD program [75] Other Important Information - The company completed a public offering of common stock that provided approximately $46.6 million in additional net proceeds [29] - A new U.S. patent covering key aspects of the manufacturing system for Symvess was issued, providing protection until 2040 [14] Q&A Session Summary Question: Characteristics of hospitals that approved Symvess - Management noted that the speed of VAC approvals is influenced by hospitals committed to improving patient care and having surgeon champions advocating for the product [35][36] Question: Goals for the U.S. launch in 2025 - Management provided estimates that many Level 1 trauma centers would initiate the VAC process by the end of the year, with projected sales between $7 million and $13 million, primarily in the second half of the year [40][43] Question: Feedback from surgeons regarding a controversial article - Surgeons involved in clinical trials expressed strong discontent with the article, drafting a rebuttal that was not published by the New York Times [49][50] Question: Interim analysis for the V012 trial - The interim analysis will focus on catheter-free days during the first year, with expectations for positive results based on previous data [60] Question: Supplemental BLA submission timeline - Management hopes for a shorter review time for the supplemental BLA compared to the initial application, aiming for priority review [90] Question: Cost of manufacturing small diameter ATEV - The cost of producing smaller diameter ATEV is expected to be less than that of larger sizes, with no need for new equipment [95] Question: Update on the biovascular pancreas project - The company is continuing primate studies, showing long-term insulin production and survival of islets, with ongoing adjustments to maximize therapeutic effects [100][102]