Humacyte (NasdaqGS:HUMA) Q4 2025 Earnings call March 27, 2026 08:00 AM ET Company Participants Dale Sander - CFO and Chief Development Officer Jason Kolbert - Head of Research Laura Niklason - President and CEO Swayampakula Ramakanth - Managing Director of Equity Research Thomas Johnson - Director of Corporate Communications Conference Call Participants Operator Good morning, ladies and gentlemen, and welcome to Humacyte's fourth quarter and full year 2025 earnings conference call. Currently, all participan ...

Humacyte (NasdaqGS:HUMA) Q4 2025 Earnings call March 27, 2026 08:00 AM ET Company ParticipantsDale Sander - CFO and Chief Development OfficerJason Kolbert - Head of ResearchLaura Niklason - President and CEOSwayampakula Ramakanth - Managing Director of Equity ResearchThomas Johnson - Director of Corporate CommunicationsConference Call ParticipantsMatt Miksic - Equity Research AnalystPeter Spanogiannopoulos - Biotech Equity Research AnalystRyan Zimmerman - Managing Director and Medical Technology AnalystNone ...

Humacyte (NasdaqGS:HUMA) Q4 2025 Earnings call March 27, 2026 08:00 AM ET Speaker4Good morning, ladies and gentlemen, and welcome to Humacyte's fourth quarter and full year 2025 earnings conference call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Instructions will follow at that time. As a reminder, this conference call is being recorded. I will now turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead.Speaker9Thank you, op ...

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $0.8 million, with $0.7 million from U.S. sales of Symvess, a significant increase from $0.1 million in Q3 2024 [20][21] - Net loss for Q3 2025 was $17.5 million, down from a net loss of $39.2 million in the prior year [23] - Cash, cash equivalents, and restricted cash totaled $19.8 million as of September 30, 2025, with an additional $56.5 million raised post-quarter [24] Business Line Data and Key Metrics Changes - Product sales of Symvess improved to $703,000 in Q3 2025, up from $100,000 in the previous quarter [6] - Research and development expenses decreased to $17.3 million in Q3 2025 from $22.9 million in the prior year [21] - General and administrative expenses increased slightly to $7.6 million in Q3 2025 from $7.3 million in the prior year [22] Market Data and Key Metrics Changes - 25 hospitals have completed the Value Analysis Committee (VAC) process, representing 92 civilian hospitals eligible to purchase Symvess [5][6] - An additional 45 VAC committees are currently reviewing Symvess [6] Company Strategy and Development Direction - The company is focused on the commercial launch of Symvess and advancing other bioengineered vessel programs, including dialysis access and coronary tissue engineered vessels [5][18] - The company plans to file a supplemental Biologics License Application (BLA) for dialysis access in the second half of 2026 [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong results from the V007 phase III trial for dialysis access, indicating a significant market opportunity [15][31] - The company is optimistic about the ongoing commercial rollout of Symvess and the potential for further validation through research publications [19][26] Other Important Information - The company has expanded its intellectual property estate with a new U.S. patent covering a bioengineered esophagus, providing protection until 2041 [19] - The company has seen a positive response from surgeons regarding the usability and function of Symvess in clinical settings [35] Q&A Session Summary Question: How many hospitals that have started ordering have begun the reorder process? - Management indicated that the majority of hospitals that have ordered Symvess have also reordered, although specific data was not disclosed [30] Question: How does the new data from the V007 trial change the view for Symvess in dialysis? - Management believes the strong results in duration of usability in high unmet need subgroups will support the supplemental BLA application for dialysis access [31] Question: What is the status of the interim analysis for the V012 trial? - The interim analysis is planned when the first 80 patients reach one year of follow-up, expected around April 2026 [17] Question: How is the sales force transitioning towards hemodialysis? - The company is strategically adding a small number of sales representatives to target the same surgeons who perform both trauma and dialysis access operations [52] Question: What is the strategy regarding the NTAP submission? - The company has opted not to resubmit for the NTAP in trauma, focusing instead on driving market activity through price reductions [59][61]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $0.8 million, with $0.7 million from U.S. sales of Symvess, a significant increase from $0.1 million in Q2 2025 [19][20] - Research and development expenses decreased to $17.3 million in Q3 2025 from $22.9 million in the prior year, reflecting cost reductions and capitalization of manufacturing costs [20] - Core net loss for Q3 2025 was $17.5 million, down from $39.2 million in the prior year, indicating improved financial performance [22] Business Line Data and Key Metrics Changes - Product sales of Symvess improved to $703,000 in Q3 2025 from $100,000 in Q2 2025, showing strong market traction [5][19] - 25 hospitals have completed the Value Analysis Committee (VAC) process, with approvals representing 92 civilian hospitals eligible to purchase Symvess [4][5] Market Data and Key Metrics Changes - The company has recorded its first commercial sale of Symvess to U.S. military facilities following ECAT approval, indicating expansion into military healthcare [7][18] - The ATEV for dialysis patients demonstrated superior duration of use over 24 months compared to autogenous fistula, targeting a historically underserved market [14][15] Company Strategy and Development Direction - The company is focused on expanding its commercial launch of Symvess and advancing its bioengineered vessel programs, including dialysis access and coronary tissue engineered vessels [4][18] - The strategy includes targeting high-risk patient populations, particularly women and men with diabetes and obesity, for dialysis access solutions [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential and value generation for the remainder of 2025 and beyond, supported by strong clinical data and market adoption [25] - The company plans to submit a supplemental BLA for dialysis access in the second half of 2026, contingent on positive interim results from ongoing trials [16][22] Other Important Information - The company has expanded its intellectual property estate with a new U.S. patent covering a bioengineered esophagus, enhancing its product portfolio [18] - Cash position as of September 30, 2025, was $19.8 million, with additional net proceeds of approximately $56.5 million from a recent stock sale, providing a cash runway exceeding 12 months [23] Q&A Session Summary Question: How many hospitals that have started ordering have begun the reorder process? - Management indicated that the majority of hospitals that have ordered Symvess have also reordered, although specific data was not disclosed [29] Question: How does the new data from the trial for V007 change the view for Symvess in dialysis? - Management believes the strong results in duration of usability in high unmet need subgroups will support the supplemental BLA application for dialysis access [30] Question: What is the status of the cost savings initiatives? - Management confirmed that cost savings initiatives are on track, with significant reductions already realized in R&D and operating expenses [40] Question: How will the sales force transition to target hemodialysis? - The company plans to strategically add a small number of sales representatives to target the same surgeons who perform both trauma and dialysis access operations [52] Question: What is the strategy regarding the NTAP submission? - Management decided not to resubmit for NTAP in trauma, focusing instead on driving market activity through price reductions [58][61]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $0.8 million, with $0.7 million from U.S. sales of Symvess, a significant increase from $0.1 million in Q3 2024 [18] - Core net loss decreased to $17.5 million for Q3 2025 from $39.2 million in Q3 2024, and net loss for the nine months ended September 30, 2025 was $16.0 million compared to $127.8 million for the same period in 2024 [22] - Cash, cash equivalents, and restricted cash totaled $19.8 million as of September 30, 2025, with an additional $56.5 million raised post-quarter, providing a cash runway exceeding 12 months [23] Business Line Data and Key Metrics Changes - Product sales of Symvess improved to $703,000 in Q3 2025 from $100,000 in Q2 2025, indicating strong market traction [5] - 25 hospitals have completed the Value Analysis Committee (VAC) process and approved the purchase of Symvess, representing 92 civilian hospitals eligible to purchase [4][5] Market Data and Key Metrics Changes - The commercial rollout of Symvess has been supported by recent publications demonstrating its effectiveness in vascular trauma, enhancing its market acceptance [6][8] - The company is targeting underserved populations in dialysis access, particularly women and high-risk men, who represent over half of the dialysis access market [12][14] Company Strategy and Development Direction - The company is focused on expanding its commercial launch of Symvess and advancing its bioengineered vessel programs, including dialysis access and coronary tissue engineered vessels [4][16] - A new U.S. patent covering a bioengineered esophagus was granted, extending protection into 2041, indicating a commitment to expanding its intellectual property portfolio [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential and value generation for the remainder of 2025 and beyond, citing strong commercial execution and a promising pipeline [25] - The company is optimistic about the upcoming interim analysis of the VO12 trial and its implications for filing a supplemental BLA for dialysis access [14][77] Other Important Information - Research and development expenses decreased to $17.3 million for Q3 2025 from $22.9 million in the prior year, reflecting cost reductions and the capitalization of manufacturing costs [19] - The company has seen a positive response from surgeons regarding the usability and functionality of Symvess in surgical settings [33] Q&A Session Summary Question: How many hospitals that have started ordering have begun the reorder process? - Management indicated that the majority of hospitals that have ordered Symvess have also reordered, although specific data was not disclosed [29] Question: How does the new data from the trial for V007 change the view for Symvess in dialysis? - Management believes the strong results in duration of usability in high unmet need subgroups will support the supplemental BLA application for dialysis access [30] Question: What is the status of the launch and how many units have been used versus initial stocking orders? - Initial stocking orders range from one to three units, with hospitals reordering as they reach their par levels, and positive feedback from surgeons has been received [32][33] Question: How has the price reduction for Symvess impacted adoption? - The price reduction has accelerated the VAC process and opened doors to hospitals that previously did not consider the product [36] Question: What are the expectations for cost savings initiatives? - Management confirmed that they are on track to achieve the targeted $50 million in cost savings, with reductions already observed in operating expenses [40] Question: What is the strategy regarding the NTAP submission? - The company has opted not to resubmit for NTAP in trauma, focusing instead on driving market activity through price reductions [60] Question: How are real-world outcomes being tracked post-approval? - A post-approval registry study is planned to follow at least 100 trauma patients for a year, with data expected to emerge in 2027 [45] Question: How does the company plan to transition its sales force for dialysis? - The company plans to strategically add sales representatives targeting the same surgeons who perform both trauma and dialysis access operations [51]

Core Insights - Humacyte, Inc. reported total revenues of $753,000 for Q3 2025 and $1,571,000 for the first nine months of 2025, primarily from sales and collaborative research agreements [1][8] - The company is advancing its pipeline with plans for a Biologics License Application (BLA) filing for its acellular tissue engineered vessel (ATEV) in dialysis and initiating first-in-human studies for coronary artery bypass grafting (CABG) [1][3] - Significant sales growth of the Symvess product was noted, with Q3 sales reaching $703,000, a substantial increase from $100,000 in Q2 2025 [3][4] Financial Performance - Revenue for Q3 2025 was $753,000, with $703,000 from U.S. sales of Symvess and $50,000 from a research collaboration [8][19] - The net loss for Q3 2025 was $17.5 million, a decrease from a net loss of $39.2 million in Q3 2024 [13][19] - Research and development expenses decreased to $17.3 million in Q3 2025 from $22.9 million in Q3 2024, attributed to capitalizing costs related to Symvess manufacturing [13][19] Product Development and Pipeline - The company has received 25 Value Analysis Committee (VAC) approvals for Symvess, up from 13 in August 2025, allowing 92 civilian hospitals to purchase the product [4][5] - Positive results from the V007 Phase 3 trial for ATEV in dialysis were presented at Kidney Week 2025, indicating superior duration of use compared to autogenous fistulas [9] - Humacyte plans to submit a supplemental BLA for ATEV in dialysis in the second half of 2026, based on data from ongoing clinical trials [9][19] Intellectual Property and Research - Humacyte expanded its intellectual property portfolio with a new U.S. patent for a bioengineered esophagus, enhancing its existing claims for engineered trachea and urinary conduits [9][19] - The company published multiple studies highlighting the efficacy of Symvess in treating vascular complications, demonstrating high patency rates and limb salvage [4][5]