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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]

Humacyte (NasdaqGS:HUMA) Q3 2025 Earnings Call November 12, 2025 08:00 AM ET Speaker2Good morning ladies and gentlemen and welcome to the Humacyte third quarter results conference call. Currently all participants are in a listen only mode. Later we will conduct a question and answer session and instructions will follow at that time. As a reminder, this conference call is being recorded. I'll now turn the call over to Tom Johnson with LifeSci Advisors. Please go ahead.Speaker4Thank you, operator. Before we p ...

- Total revenues of $753,000 for third quarter, and $1,571,000 for first nine months of 2025, from sales and collaborative research agreement -  - Major advances in pipeline as Humacyte moves closer to planned BLA filing in dialysis and first-in-human studies in cardiac bypass graft surgery – – IND submitted to the FDA for the CABG indication – - Symvess™ and pipeline programs highlighted in multiple scientific publications and presentations - - Conference call today at 8:00 am ET - DURHAM, N.C., Nov. 12, ...

Core Insights - Humacyte, Inc. announced the publication of a study comparing the clinical outcomes of its product Symvess to autologous vein in treating extremity arterial trauma, showing similar short-term outcomes [1][2][4] Company Overview - Humacyte, Inc. is a biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][13] - The company has received FDA approval for its acellular tissue engineered vessel (ATEV) for vascular trauma indications [13][14] Study Findings - The study published in the AAST's Trauma Surgery & Acute Care Open Journal indicated that Symvess achieved comparable outcomes to autologous vein in terms of primary patency (86.6% for Symvess vs. 91.8% for autologous vein), secondary patency (91.0% vs. 97.7%), amputation rates (7.5% vs. 8.2%), conduit infection (1.5% vs. 0%), and mortality (4.5% for both) [2][3] - The analysis utilized data from Humacyte's Phase 2/3 V005 study and the Humanitarian V017 study, matched against the PROOVIT registry [2][3] Product Indication - 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 [5][13] Market Context - Autologous vein has been the gold standard for treating extremity arterial trauma due to its resistance to infection and maintenance of patency, but may not always be available [2][3] - Symvess offers an off-the-shelf solution that can save critical surgical time in traumatic situations [3][4] Leadership Perspective - Humacyte's CEO emphasized the need for innovative alternatives to autologous vein grafts, highlighting Symvess as a safe and effective option for complex trauma cases [4][13]

Core Insights - Humacyte's shares experienced an 18% increase following the announcement of positive data from a humanitarian initiative utilizing their bio-engineered human tissue product, Symvess, for treating vascular trauma injuries [5] Company Summary - The initiative involved a total of 17 patients, indicating a focused application of Humacyte's technology in a real-world medical scenario [5]

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]

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]

- Results were published in the Journal of Vascular Surgery - - Publication described treatment of patients with Symvess who had hospital-acquired iatrogenic injuries or complications of vascular surgical procedures - - Patients treated with Symvess were observed to have high levels of patency, 100% limb salvage, and zero cases of conduit infection - DURHAM, N.C., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implan ...