Financial Data and Key Metrics Changes - Humacyte reported revenue of $517,000 for Q1 2025, with $147,000 from the U.S. commercial launch of CymVest and $370,000 from a research collaboration, compared to no revenue in Q1 2024 [21] - Cost of goods sold was $147,000 for Q1 2025, reflecting overhead related to unused production capacity, while there was no cost of goods sold in Q1 2024 [21] - Research and development expenses decreased to $15.4 million in Q1 2025 from $21.3 million in Q1 2024, primarily due to reduced material costs and clinical study costs [22] - General and administrative expenses increased to $8.1 million in Q1 2025 from $5.3 million in Q1 2024, mainly due to increased personnel expenses related to the sales effort [23] - Net income for Q1 2025 was $39.1 million, a significant increase from a net loss of $31.9 million in Q1 2024, primarily due to a non-cash remeasurement of the contingent earn-out liability [23][24] Business Line Data and Key Metrics Changes - The commercial launch of CymVest commenced in late February 2025, with initial shipments to three level one trauma centers [9] - 45 hospitals are currently evaluating CymVest as part of their value analysis committee (VAC) approval process, representing approximately 25% of all level one trauma centers nationwide [9][10] - Five hospitals have already approved the purchase of CymVest, with expectations for further approvals in the second quarter [10] Market Data and Key Metrics Changes - The company is actively addressing both civilian and military markets for CymVest, with multiple military treatment facilities expressing interest in purchasing the product [10][11] - The publication of a budget impact model in March 2025 supports the economic value of CymVest, indicating potential cost reductions compared to synthetic conduits and xenografts [10] Company Strategy and Development Direction - Humacyte's primary focus is on the commercial launch of CymVest and expanding its bioengineering pipeline, with plans to file an IND with the FDA for small diameter ATAV in coronary artery bypass grafting later in 2025 [5][6] - The company aims to submit a supplemental BLA for ATEF in dialysis in 2026, leveraging positive results from ongoing clinical trials [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial launch of CymVest despite a volatile economic environment, highlighting strong support from surgeons and positive clinical outcomes [5][8] - The company anticipates that the majority of first-year sales will occur in the second half of 2025, aligning with the VAC approval process [11] Other Important Information - Humacyte completed a public offering in March 2025, generating $46.7 million in net proceeds, which will help extend the company's cash runway [19] - The company implemented workforce reductions to align its organizational structure with business objectives, estimating net savings of approximately $13.8 million in 2025 [19][20] Q&A Session Summary Question: Can you provide insights on the experience of the three sites that purchased CymVest? - Management confirmed that the first implant was performed with a sales representative present, but noted that many surgeons are already familiar with the product from clinical trials [32][33] Question: How is the uptake of CymVest expected to progress this year? - Management indicated a good conversion rate of VAC approvals, with expectations for increased sales in the second half of the year [36][37] Question: What is the process for military hospitals to order CymVest once on ECAT? - Management explained that while military hospitals can order through ECAT, surgeon champions are essential for successful adoption [39][41] Question: Are current revenue estimates for 2025 still reasonable? - Management affirmed that they remain comfortable with their revenue guidance based on current traction and VAC processes [46][47] Question: What learnings from previous Phase III studies are being applied to the VO12 trial? - Management highlighted the importance of post-surgical care and adherence to clinical protocols in dialysis centers as critical factors for trial success [50][51] Question: How is the partnership with Fresenius progressing? - Management reported a strong partnership with Fresenius, focusing on the economic case for CIMVEST in dialysis access [54] Question: What are the surgeon adoption patterns at accounts using the products? - Management noted that adoption typically starts with one or two surgeons, who then influence their peers [64]

Financial Data and Key Metrics Changes - The company reported revenue of $517,000 for Q1 2025, with $147,000 from the U.S. commercial launch of CymVest and $370,000 from a research collaboration, compared to no revenue in Q1 2024 [18] - Net income for Q1 2025 was $39.1 million, a significant increase from a net loss of $31.9 million in Q1 2024, primarily due to a non-cash remeasurement of a contingent earn-out liability [20] - Cash, cash equivalents, and restricted cash totaled $113.2 million as of March 31, 2025, with net cash provided of $17.9 million for the first three months of 2025, down from $35.1 million in the same period of 2024 [21] Business Line Data and Key Metrics Changes - The commercial launch of CymVest began in late February 2025, with initial shipments to three level one trauma centers and 45 hospitals evaluating the product [7][9] - Five hospitals have approved the purchase of CymVest, with expectations for further approvals in the second quarter [8] - Research and development expenses decreased to $15.4 million in Q1 2025 from $21.3 million in Q1 2024, attributed to reduced material costs and clinical study costs [19] Market Data and Key Metrics Changes - The company is focusing on both civilian and military markets for CymVest, with interest expressed by multiple military treatment facilities [9] - The VAC process has shown a good conversion rate for approvals, although some delays were noted due to external factors such as media coverage [30][34] Company Strategy and Development Direction - The primary focus is on the commercial launch of CymVest and expanding the bioengineering pipeline, with plans to file an IND for a small diameter ATEF for coronary artery bypass grafting later in 2025 [4][5] - The company aims to submit a supplemental BLA for the ATEF in dialysis access in 2026, leveraging positive results from ongoing clinical trials [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial execution and the potential of the pipeline programs, despite a volatile economic environment [4][23] - The company is addressing unfounded criticisms regarding CymVest with scientific data and is optimistic about the long-term outcomes of clinical trials [6] Other Important Information - The company implemented workforce reductions to extend cash runway and align organizational structure with business objectives, estimating net savings of approximately $13.8 million in 2025 [16][17] - The publication of a budget impact model in March 2025 supports the economic value of CymVest, which is expected to aid in gaining traction in the market [8] Q&A Session Summary Question: Can you provide insights on the experience of the three sites that purchased CymVest? - The company has performed its first implant at one site with a sales representative present, but many surgeons are experienced enough to proceed without direct support [29][30] Question: How is the uptake of CymVest expected to progress this year? - The company anticipates a strong conversion rate from VAC approvals, with most sales expected in the second half of the year [34][44] Question: What is the process for military hospitals to order CymVest once on ECAT? - Military hospitals can order CymVest through ECAT, but surgeon champions are essential for successful procurement [35][36] Question: Are current revenue estimates for 2025 still reasonable? - Management remains comfortable with the revenue guidance provided earlier, expecting most revenues to come in the second half of the year [44] Question: What learnings from previous Phase III studies are being applied to the VO12 trial? - The company is focusing on the handling of the conduit in dialysis centers and adherence to clinical trial protocols to ensure positive outcomes [48] Question: What is the status of the partnership with Fresenius? - The partnership remains strong, with ongoing efforts to quantify the costs associated with ineffective access in patients, aligning with Fresenius's business objectives [51]

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]