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Humacyte, Inc.

Humacyte, Inc.HUMA财报

Nasdaq · 医疗保健 · 生物制品（不含诊断物质）

Humacyte, Inc. is a clinical-stage biotechnology firm focused on developing and commercializing universally implantable off-the-shelf bioengineered human tissues and therapeutic products. Its core offerings target unmet needs in vascular care, trauma treatment and regenerative medicine, serving patients and healthcare partners worldwide.

What changed in Humacyte, Inc.'s 10-K — 2024 vs 2025

Top changes in Humacyte, Inc.'s 2025 10-K

575 paragraphs added · 483 removed · 403 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

170 edited+23 added−20 removed415 unchanged
In military populations, as the rate of battlefield fatalities has been declining due to faster evacuations and more robust protection from body armor, the rate of survivable vascular injuries has been increasing.
In military populations, as the rate of battlefield fatalities has been declining due to faster evacuations and more robust protection from body armor, the rate of survivable vascular injuries has been increasing.
The FDA inspected our manufacturing facility in April 2024 as part of its review and approval of our BLA in extremity vascular trauma, and we are using this facility to provide product for the United States commercial launch in that indication which commenced in the first quarter of 2025.
The FDA inspected our manufacturing facility in April 2024 as part of its review and approval of our BLA in extremity vascular trauma, and we are using this facility to provide product for the United States commercial launch in that indication which commenced in the first quarter of 2025.
Issued patents and additional patents issuing from this licensed portfolio will expire no earlier than 2032, and the term of each patent may be extended by patent term adjustment, patent term extension, or foreign equivalents thereof. Issued U.S. patent No. 10,172,707 will expire no earlier than 2035.
Issued patents and additional patents issuing from this licensed portfolio will expire no earlier than 2032, and the term of each patent may be extended by patent term adjustment, patent term extension, or foreign equivalents thereof. Issued U.S. patent No. 10,172,707 will expire no earlier than 2035.
Yale may also terminate for our non-payment, uncured material breach, failure to obtain adequate insurance, bringing or assisting in bringing of a patent challenge against Yale, abandonment of the research and development of our product or insolvency.
Yale may also terminate for our non-payment, uncured material breach, failure to obtain adequate insurance, bringing or assisting in bringing of a patent challenge against Yale, abandonment of the research and development of our product or insolvency.
Under certain circumstances, Yale may, at its option, convert the exclusive license to a non-exclusive license if we decline to initiate certain infringement or interference proceedings with respect to the licensed patents. We have agreed to indemnify Yale against certain third-party claims.
Under certain circumstances, Yale may, at its option, convert the exclusive license to a non-exclusive license if we decline to initiate certain infringement or interference proceedings with respect to the licensed patents. We have agreed to indemnify Yale against certain third-party claims.
SAEs Reported in V006 Phase 3 Clinical Study in AV Access Description of SAE Number of SAEs (% of total subjects) ATEV ePTFE Number of subjects in V006 study 177 178 General disorders and administration conditions: Implant site extravasation 0(0.0)% 1(0.6)% Infections and infestations: Vascular access site infection 0(0.0)% 5(2.8)% Injury, poisoning and procedural complications: Anastomotic stenosis 1(0.6)% (0.0)% Vascular access site hematomas 1(0.6)% (0.0)% Vascular access site hemorrhage 0(0.0)% 3(1.7)% Vascular access site pain 1(0.6)% 0(0.0)% Vascular access site pseudoaneurysm 10(5.6)% 0(0.0)% Vascular access site rupture 2(1.1)% 0(0.0)% Vascular access site thrombosis 41(23.2)% 28(15.7)% Skin and subcutaneous tissue disorders: Skin necrosis 0(0.0)% 1(0.6)% Vascular disorders: Steal syndrome 2(1.1)% 2(1.1)% Subclavian vein occlusion 0(0.0)% 1(0.6)% Vascular stenosis 34(19.2)% 27(15.2)% Venous stenosis 3(1.7)% 9(5.1)% Overall, although the primary efficacy endpoint concerning secondary patency was not met, the ATEV performed in the V006 trial as was expected, based upon ATEV performance in previous Phase 2 trials in hemodialysis and in other clinical applications.
SAEs Reported in V006 Phase 3 Clinical Study in AV Access Description of SAE Number of SAEs (% of total subjects) ATEV ePTFE Number of subjects in V006 study 177 178 General disorders and administration conditions: Implant site extravasation 0(0.0)% 1(0.6)% Infections and infestations: Vascular access site infection 0(0.0)% 5(2.8)% Injury, poisoning and procedural complications: Anastomotic stenosis 1(0.6)% (0.0 )% Vascular access site hematomas 1(0.6)% (0.0 )% Vascular access site hemorrhage 0(0.0)% 3(1.7)% Vascular access site pain 1(0.6)% 0(0.0)% Vascular access site pseudoaneurysm 10(5.6)% 0(0.0)% Vascular access site rupture 2(1.1)% 0(0.0)% Vascular access site thrombosis 41(23.2)% 28(15.7)% Skin and subcutaneous tissue disorders: Skin necrosis 0(0.0)% 1(0.6)% Vascular disorders: Steal syndrome 2(1.1)% 2(1.1)% Subclavian vein occlusion 0(0.0)% 1(0.6)% Vascular stenosis 34(19.2)% 27(15.2)% Venous stenosis 3(1.7)% 9(5.1)% Overall, although the primary efficacy endpoint concerning secondary patency was not met, the ATEV otherwise performed in the V006 trial as was expected, based upon ATEV performance in previous Phase 2 trials in hemodialysis and in other clinical applications.
The laws that may affect our ability to operate include but are not limited to: • the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs; 54 Table of Contents • federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent; • federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; • the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”), which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information; • the federal Physician Payments Sunshine Act, which requires drug and device companies to annually report to CMS all payments and transfers of value provided to physicians and teaching hospitals for posting on a public website; and • state law equivalents of many of the above federal laws, including anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers.
The laws that may affect our ability to operate include but are not limited to: • the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs; • federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent; • federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; • the federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”), which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information; • the federal Physician Payments Sunshine Act, which requires drug and device companies to annually report to CMS all payments and transfers of value provided to physicians and teaching hospitals for posting on a public website; and • state law equivalents of many of the above federal laws, including anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers.
Phase 3 V006 HUMANITY trial secondary patency results Secondary Patency 6 months 12 months 18 months 24 months ATEV HUMANITY [Mean (95% CI)] 92% (87 – 95%) 82% (75 – 87%) 73% (65 – 79%) 67% (59 – 74%) ePTFE HUMANITY [Mean (95% CI)] 87% (81 – 85%) 80% (73 – 85%) 77% (70 – 83%) 74% (67 – 81%) Cox Proportional Hazards Model for Time to Loss of Secondary Patency Treatment Group (ATEV vs ePTFE) Hazard Ratio Non-inferiority Margin Hazard Non-inferiority Demonstrated (Yes/No) Estimate 95% CI 12 months 0.869 (0.528, 1.431) 1.491 Yes 24 months 1.284 (0.867, 1.903) 1.488 No Phase 3 V006 HUMANITY trial rates of infection 25 Table of Contents The reported SAEs related to the ATEV and ePTFE in the V006 trial, in this patient population, which typically has a high prevalence of existing medical conditions, are detailed in the table below.
Phase 3 V006 HUMANITY trial secondary patency results Secondary Patency 6 months 12 months 18 months 24 months ATEV HUMANITY [Mean (95% CI)] 92% (87 – 95%) 82% (75 – 87%) 73% (65 – 79%) 67% (59 – 74%) ePTFE HUMANITY [Mean (95% CI)] 87% (81 – 85%) 80% (73 – 85%) 77% (70 – 83%) 74% (67 – 81%) Cox Proportional Hazards Model for Time to Loss of Secondary Patency Treatment Group (ATEV vs ePTFE) Hazard Ratio Non- inferiority Margin Hazard Non- inferiority Demonstrated (Yes/No) Estimate 95% CI 12 months 0.869 (0.528, 1.431) 1.491 Yes 24 months 1.284 (0.867, 1.903) 1.488 No 26 Table of Contents Phase 3 V006 HUMANITY trial rates of infection The reported SAEs related to the ATEV and ePTFE in the V006 trial, in this patient population, which typically has a high prevalence of existing medical conditions, are detailed in the table below.
We are leveraging our novel, scalable technology platform to develop proprietary, bioengineered, acellular human tissues for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. We are initially using our proprietary, scientific technology platform to engineer and manufacture acellular tissue engineered vessels, or ATEVs TM .
We are leveraging our novel, scalable technology platform to develop proprietary, bioengineered, acellular human tissues for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. We are initially using our proprietary, scientific technology platform to engineer and manufacture acellular tissue engineered vessels, or ATEVs.
Phase 3 V006 HUMANITY trial subject demographics V006 Demographics (N=355) ePTFE (n=178) ATEV (n=177) p-value Age(years) 59.9 62.6 0.06 Male (%) 49.4% 49.7% NS Caucasian (%) 65.2% 69.5% NS Black (%) 27.5% 24.9% NS Hispanic (%) 11.2% 14.7% NS Asian / Other (%) 3.4% 2.3% NS Body Mass Index (BMI) 29.2 28.9 NS Hypertension (%) 79.8% 79.7% NS Cardiac Disease (%) 50.6% 57.1% NS Diabetes (%) 29.2% 32.8% NS Prior Stroke (%) 5.6% 12.4% 0.02 24 Table of Contents The secondary patency of the ATEV was greater than that of ePTFE at six and 12 months but lower at 18 and 24 months, an outcome that had not been modelled in the V006 trial design.
Phase 3 V006 HUMANITY trial subject demographics V006 Demographics (N=355) ePTFE (n=178) ATEV (n=177) p-value Age(years) 59.9 62.6 0.06 Male (%) 49.4% 49.7% NS Caucasian (%) 65.2% 69.5% NS Black (%) 27.5% 24.9% NS Hispanic (%) 11.2% 14.7% NS Asian / Other (%) 3.4% 2.3% NS Body Mass Index (BMI) 29.2 28.9 NS Hypertension (%) 79.8% 79.7% NS Cardiac Disease (%) 50.6% 57.1% NS Diabetes (%) 29.2% 32.8% NS Prior Stroke (%) 5.6% 12.4% 0.02 The secondary patency of the ATEV was greater than that of ePTFE at six and 12 months but lower at 18 and 24 months, an outcome that had not been modelled in the V006 trial design.
Based on the results of the results of this research, we have commenced a clinical study designed to demonstrate the clinical and health economic benefits of the ATEV in women dialysis patients, a high-unmet-need population. We have commenced a Phase 3 trial, which we refer to as the V012 trial, in up to 150 patients with ESRD.
Based on the results of this research, we designed a clinical study designed to demonstrate the clinical and health economic benefits of the ATEV in women dialysis patients, a high-unmet-need population. We commenced the Phase 3 trial, which we refer to as the V012 trial, in up to 150 patients with ESRD.
This interest has resulted in significant proposed and enacted reform measures affecting healthcare reimbursement and drug pricing, including the enactment in August 2022 of significant changes to potential Medicare drug product reimbursement through government negotiation of certain drug prices, as well as manufacturer discount and inflation rebate obligations under the Inflation Reduction Act (the “IRA”). 41 Table of Contents Intellectual Property We strive to protect and enhance the proprietary technology, inventions and improvements that are commercially important to the development of our business, including seeking, maintaining, and defending patent rights, whether developed internally or licensed from third parties.
This interest has resulted in significant proposed and enacted reform measures affecting healthcare reimbursement and drug pricing, including the enactment in August 2022 of significant changes to potential Medicare drug product reimbursement through government negotiation of certain drug prices, as well as manufacturer discount and inflation rebate obligations under the Inflation Reduction Act (the “IRA”). 43 Table of Contents Intellectual Property We strive to protect and enhance the proprietary technology, inventions and improvements that are commercially important to the development of our business, including seeking, maintaining, and defending patent rights, whether developed internally or licensed from third parties.
The steps for obtaining FDA approval of a BLA to market a biologic product in the United States generally include: • Completion of extensive preclinical laboratory tests and preclinical animal studies performed in accordance with the FDA’s current good laboratory practice (“GLP”) regulations; • Submission to the FDA of an IND, which must become effective before human clinical trials in the United States may begin; • Approval of the protocol and related documentation by an Institutional Review Board (“IRB”) or ethics committee representing each clinical site before each clinical trial may be initiated; • Performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as GCPs and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the product candidate for each proposed indication; • Submission to the FDA of a BLA; • Satisfactory completion of an FDA inspection of the manufacturing facility or facilities and distribution site at which the product is produced: to assess compliance with cGMP regulations; to assure that the facilities, production methods, testing and controls are adequate; and, if applicable, to assure compliance with current good tissue practice (“cGTP”) requirements for human cellular and tissue-derived products; • Potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA; • Review of the product candidate by an FDA advisory committee, if applicable; • Payment of user fees for FDA review of the BLA (unless a fee waiver applies); and • FDA review and approval, or licensure, of the BLA prior to any commercial marketing, sale or shipment of the product. 48 Table of Contents U.S.
The steps for obtaining FDA approval of a BLA to market a biologic product in the United States generally include: • Completion of extensive preclinical laboratory tests and preclinical animal studies performed in accordance with the FDA’s current good laboratory practice (“GLP”) regulations; • Submission to the FDA of an IND, which must become effective before human clinical trials in the United States may begin; • Approval of the protocol and related documentation by an Institutional Review Board (“IRB”) or ethics committee representing each clinical site before each clinical trial may be initiated; • Performance of adequate and well-controlled human clinical trials according to the FDA’s regulations commonly referred to as GCPs and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the product candidate for each proposed indication; • Submission to the FDA of a BLA; • Satisfactory completion of an FDA inspection of the manufacturing facility or facilities and distribution site at which the product is produced: to assess compliance with cGMP regulations; to assure that the facilities, production methods, 50 Table of Contents testing and controls are adequate; and, if applicable, to assure compliance with current good tissue practice (“cGTP”) requirements for human cellular and tissue-derived products; • Potential FDA audit of the nonclinical study and clinical trial sites that generated the data in support of the BLA; • Review of the product candidate by an FDA advisory committee, if applicable; • Payment of user fees for FDA review of the BLA (unless a fee waiver applies); and • FDA review and approval, or licensure, of the BLA prior to any commercial marketing, sale or shipment of the product.
Hence, the subjects enrolled in the V004 trial had severe and debilitating limb ischemia due to PAD and had no autologous vein that was suitable for lesion bypass and revascularization. 31 Table of Contents 12-month results from V004 Phase 2 study in PAD Result from V004 Trial (as of April 2021) Pre-Op 6 mos 12 mos Secondary Patency — 86% 64% Ankle-Brachial Index (median) 0.51 0.85 0.90 Rate of Amputation — 0% 0% VascuQol Quality of Life Assessment 3.1 5.6 5.9 In the V004 trial, ATEV secondary patency was 86% at 6 months, and 64% at 12 months.
Hence, the subjects enrolled in the V004 trial had severe and debilitating limb ischemia due to PAD and had no autologous vein that was suitable for lesion bypass and revascularization. 33 Table of Contents 12-month results from V004 Phase 2 study in PAD Result from V004 Trial (as of April 2021) Pre-Op 6 mos 12 mos Secondary Patency — 86% 64% Ankle-Brachial Index (median) 0.51 0.85 0.90 Rate of Amputation — 0% 0% VascuQol Quality of Life Assessment 3.1 5.6 5.9 In the V004 trial, ATEV secondary patency was 86% at 6 months, and 64% at 12 months.
Phase 3 V007 trial 12-month results – target population (female patients and males with obesity and diabetes ) Co-Primary Endpoints ATEV (n=56) AVF (n=54) p-value Functional Patency at Month 6 85.7% 51.9% Secondary Patency at Month 12 76.8% 46.3% Difference p-value Duration of Use Over First 12 Months 8.0 months 4.5 months 3.5 months 0.0002 28 Table of Contents The ATEV showed no increased in overall safety events per year of usability in the expected target population (all females and males with obesity and diabetes) as summarized in the following table.
Phase 3 V007 trial 12-month results – target population (female patients and males with obesity and diabetes ) Co-Primary Endpoints ATEV (n=56) AVF (n=54) p-value Functional Patency at Month 6 85.7% 51.9% Secondary Patency at Month 12 76.8% 46.3% Difference p-value Duration of Use Over First 12 Months 8.0 months 4.5 months 3.5 months 0.0002 The ATEV showed no increased in overall safety events per year of usability in the expected target population (all females and males with obesity and diabetes) as summarized in the following table.
Ownership of all other know-how, patents, materials and other intellectual property created, conceived or developed during the performance of activities under the distribution agreement will be determined in accordance with U.S. patent laws for determining inventorship. 40 Table of Contents We are obligated to make payments to Fresenius Medical Care based on a share of aggregate net sales by or on behalf of us of the distribution product in the United States in the field.
Ownership of all other know-how, patents, materials and other intellectual property created, conceived or developed during the performance of activities under the distribution agreement will be determined in accordance with U.S. patent laws for determining inventorship. 42 Table of Contents We are obligated to make payments to Fresenius Medical Care based on a share of aggregate net sales by or on behalf of us of the distribution product in the United States in the field.
Under the Duke License Agreement, we have also agreed to pay Duke: a low single-digit percentage royalty on eligible sales of licensed products and licensed services, plus a low double-digit percentage of any sublicensing revenue; an annual minimum royalty beginning in 2012, which increases in the calendar year immediately following the first commercial sale of licensed products or licensed services (whichever occurs first); and an additional amount in license fees, as certain scientific milestones are met.
Under the Duke License Agreement, we have also agreed to pay Duke: a low single-digit percentage royalty on eligible sales of licensed products and licensed services, plus a low double-digit percentage of any sublicensing revenue; an annual minimum royalty beginning in 2012, which increased in the calendar year immediately following the first commercial sale of licensed products or licensed services (whichever occurs first); and an additional amount in license fees, as certain scientific milestones are met.
We agree to indemnify Duke against certain third-party claims. 43 Table of Contents License Agreements with Yale University Large Diameter ATEV In August 2019, we entered into a license agreement with Yale University (“Yale”) that granted us a worldwide license to the patents jointly owned with us related to tubular prostheses which are large diameter versions of our ATEVs, which may or may not contain a stent (the “Tubular Prothesis License Agreement”).
We agree to indemnify Duke against certain third-party claims. 45 Table of Contents License Agreements with Yale University Large Diameter ATEV In August 2019, we entered into a license agreement with Yale University (“Yale”) that granted us a worldwide license to the patents jointly owned with us related to tubular prostheses which are large diameter versions of our ATEVs, which may or may not contain a stent (the “Tubular Prothesis License Agreement”).
Biological Products Development Process The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any further approvals for Symvess and/or our product candidates will be granted on a timely basis, if at all. Once a product candidate is identified for development, that biologic candidate enters the preclinical testing stage.
U.S. Biological Products Development Process The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any further approvals for Symvess and/or our product candidates will be granted on a timely basis, if at all. Once a product candidate is identified for development, that biologic candidate enters the preclinical testing stage.
Distribution of Hemodialysis Access Modes in Use in the United States Access Type Fistulae Catheters Synthetic Grafts Incident Patients: At Initiation of Hemodialysis 16.7 % 80.3 % 3.0 % Prevalent Patients: For Ongoing Hemodialysis 64.5 % 18.9 % 16.6 % 21 Table of Contents Overview of ATEV Experience in Hemodialysis Access: A table listing our clinical trials of the ATEV in hemodialysis access is included below.
Distribution of Hemodialysis Access Modes in Use in the United States Access Type Fistulae Catheters Synthetic Grafts Incident Patients: At Initiation of Hemodialysis 16.7 % 80.3 % 3.0 % Prevalent Patients: For Ongoing Hemodialysis 64.5 % 18.9 % 16.6 % Overview of ATEV Experience in Hemodialysis Access: A table listing our clinical trials of the ATEV in hemodialysis access is included below.
We provide notifications of news or announcements regarding our financial performance, including SEC filings, investor events, and press releases, as part of our investor relations website. The contents of these websites are not intended to be incorporated by reference into this report or in any other report or document we file. 58 Table of Contents
We provide notifications of news or announcements regarding our financial performance, including SEC filings, investor events, and press releases, as part of our investor relations website. The contents of these websites are not intended to be incorporated by reference into this report or in any other report or document we file. 61 Table of Contents
Overall, we also determined through the histological assessment of explanted specimens that there were normal vascular cells within the ATEV and there was no infection or signs of immunological reaction to the graft. There have been no ATEV-related infections reported during the V002 trial as of December 31, 2024, and no amputations of the treated extremity.
Overall, we also determined through the histological assessment of explanted specimens that there were normal vascular cells within the ATEV and there was no infection or signs of immunological reaction to the graft. There have been no ATEV-related infections reported during the V002 trial as of December 31, 2025, and no amputations of the treated extremity.
The image presents two views of the same subject, and shows uniform ATEV diameter along the length of the implant. 30 Table of Contents A CT Angiogram from a V002 Subject at 51 months after ATEV implantation Patients in the V002 trial are currently in long-term follow-up out to ten years.
The image presents two views of the same subject, and shows uniform ATEV diameter along the length of the implant. 32 Table of Contents A CT Angiogram from a V002 Subject at 51 months after ATEV implantation Patients in the V002 trial are currently in long-term follow-up out to ten years.
We believe that the ATEVs multiple key characteristics will drive rapid clinical adoption amongst surgeons and the broader healthcare community: • Off-the-Shelf : Our “cabinet” of ATEVs of varying diameters and lengths is designed to be stored on-site at facilities such as hospitals, trauma centers and outpatient surgical centers. 46 Table of Contents • Immediately Available : When needed, our ATEVs are available for immediate use by opening and removing the ATEV from its original flexible bioreactor bag.
We believe that the ATEVs multiple key characteristics will drive rapid clinical adoption amongst surgeons and the broader healthcare community: • Off-the-Shelf : Our “cabinet” of ATEVs of varying diameters and lengths is designed to be stored on-site at facilities such as hospitals, trauma centers and outpatient surgical centers. • Immediately Available : When needed, our ATEVs are available for immediate use by opening and removing the ATEV from its original flexible bioreactor bag.
He underwent a successful bypass with the ATEV. Imaging at one year demonstrated a patent graft as illustrated below. 32 Table of Contents 42-year-old with Infected Dacron Graft An ATEV was used in a 42-year-old female to replace an 8 mm Dacron iliac artery bypass graft that had become infected.
He underwent a successful bypass with the ATEV. Imaging at one year demonstrated a patent graft as illustrated below. 34 Table of Contents 42-year-old with Infected Dacron Graft An ATEV was used in a 42-year-old female to replace an 8 mm Dacron iliac artery bypass graft that had become infected.
Item 1. Business Business Overview Executive Summary Humacyte, Inc. is a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, and in the first quarter of 2025 commenced the United States commercial launch of our first FDA-approved product.
Item 1. B usiness Business Overview Executive Summary Humacyte, Inc. is a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, and in the first quarter of 2025 commenced the United States commercial launch of our first FDA-approved product.
V005 Phase 2/3 ATEV Adverse Events Adverse Event V005 Trial - ATEV Extremity Group (n=51) Number of Patients (%) Total Adverse Events 50 (98.0%) Non-Fatal Serious Adverse Events 28 (54.9%) Deaths: At Day 30 Over Duration of Study 3 (5.9%) 4 (7.8%) ATEV Infections 2 (3.9%) ATEV Rupture 1 (2.0%) ATEV Occlusion/Thrombosis 15 (29.4%) Pseudoaneurysm 1 (2.0%) Aneurysm 1 (2.0%) Other 2 (3.9%) 16 Table of Contents There were no unexpected safety signals for the ATEV in the V005 trial.
V005 Phase 2/3 ATEV Adverse Events Adverse Event V005 Trial - ATEV Extremity Group (n=51) Number of Patients (%) Total Adverse Events 50 (98.0%) Non-Fatal Serious Adverse Events 28 (54.9%) Deaths: At Day 30 Over Duration of Study 3 (5.9%) 4 (7.8%) ATEV Infections 2 (3.9%) ATEV Rupture 1 (2.0%) ATEV Occlusion/Thrombosis 15 (29.4%) Pseudoaneurysm 1 (2.0%) Aneurysm 1 (2.0%) Other 2 (3.9%) There were no unexpected safety signals for the ATEV in the V005 trial.
Type I Diabetes : Type 1 diabetes, caused by auto-immune destruction of insulin-producing cells in the islets of the pancreas, is a devastating disease affecting more than 1.7 million people in the United States, and costing at least $10 billion to $14 billion annually.
Type I Diabetes : Type 1 diabetes, caused by auto-immune destruction of insulin-producing cells in the islets of the pancreas, is a devastating disease affecting more than 1.5 million people in the United States, and costing at least $10 billion to $14 billion annually.
Each of these vascular access methods has substantial limitations, as outlined below: 20 Table of Contents Three Traditional Methods for Obtaining Vascular Access for Hemodialysis Fistula . An AV fistula is created by surgically connecting a vein to an artery, typically in the patient’s arm.
Each of these vascular access methods has substantial limitations, as outlined below: Three Traditional Methods for Obtaining Vascular Access for Hemodialysis 22 Table of Contents Fistula . An AV fistula is created by surgically connecting a vein to an artery, typically in the patient’s arm.
BT Shunt Implant Schematic In October 2023, results of the preclinical study were published in the open-access Journal of Thoracic and Cardiovascular Surgery (JTCVS Open) . In the study, researchers implanted 3.5mm diameter ATEVs into a juvenile large-animal model of pediatric heart disease.
BT Shunt Implant Schematic In October 2023, results of the preclinical study were published in the open-access Journal of Thoracic and Cardiovascular Surgery (JTCVS Open) . In the study, researchers implanted 3.5mm diameter CTEVs into a juvenile large-animal model of pediatric heart disease.
To support a potential future IND filing with the FDA, we have evaluated the use of our ATEV as an mBTT shunt for up to six months in juvenile primates at the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio.
To support a potential future IND filing with the FDA, we have evaluated the use of our CTEV as an mBTT shunt for up to six months in juvenile primates at the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio.
Efforts to scale-up the technology to human-sized organs are ongoing. 36 Table of Contents Structure of Lung, Scaffold for Lung Engineering, and Implanted Engineered Lung Manufacturing We have developed a novel paradigm for manufacturing human tissues that mimics key aspects of human physiology.
Efforts to scale-up the technology to human-sized organs are ongoing. 38 Table of Contents Structure of Lung, Scaffold for Lung Engineering, and Implanted Engineered Lung Manufacturing We have developed a novel paradigm for manufacturing human tissues that mimics key aspects of human physiology.
The baboon study provided an effective model for demonstrating the feasibility, mechanical durability and capacity for host-cell remodeling of the sdATEV for CABG. After implantation, the sdATEV was observed to recellularize with host cells and remodel to effectively reduce the initial size mismatch with the RCA.
The baboon study provided an effective model for demonstrating the feasibility, mechanical durability and capacity for host-cell remodeling of the CTEV for CABG. After implantation, the CTEV was observed to recellularize with host cells and remodel to effectively reduce the initial size mismatch with the RCA.
Safety Set = Treatment group assignment based on actual treatment. Topline results were reported in August 2024 and expanded results, including subgroup analyses, were presented at the American Society of Nephrology’s (ASN) Kidney Week 2024, the premier nephrology meeting, in October 2024.
Safety Set = Treatment group assignment based on actual treatment. Topline results were reported in August 2024 and expanded results, including subgroup analyses, were presented at the American Society of Nephrology’s (“ASN”) Kidney Week 2024, the premier nephrology meeting, in October 2024.
(“AHAC”), a Delaware corporation, consummated a merger pursuant to that certain Business Combination Agreement, dated as of February 17, 2021 (the “Merger Agreement”), by and among Legacy Humacyte, AHAC and Hunter Merger Sub (“Merger Sub”), a Delaware corporation and wholly owned subsidiary of AHAC.
(“AHAC”), consummated a merger pursuant to that certain Business Combination Agreement, dated as of February 17, 2021 (the “Merger Agreement”), by and among Legacy Humacyte, AHAC and Hunter Merger Sub (“Merger Sub”), a wholly owned subsidiary of AHAC.
Other surgical alternatives include minimally invasive approaches such as stenting and angioplasties that are suitable for smaller atherosclerotic lesions and can delay — but oftentimes not prevent — the ultimate need for surgical revascularization. 29 Table of Contents We have observed strong patency rates and no reported cases of infection for the ATEV in PAD in clinical studies to date.
Other surgical alternatives include minimally invasive approaches such as stenting and angioplasties that are suitable for smaller atherosclerotic lesions and can delay — but oftentimes not prevent — the ultimate need for surgical revascularization. We have observed strong patency rates and no reported cases of infection for the ATEV in PAD in clinical studies to date.
We have termed this new paradigm for pancreatic islet cell delivery the BioVascular Pancreas or “BVP TM .” We believe that a reliable, low-risk, and easily implantable islet cell delivery method that could ensure the survival and functionality of a therapeutic number of islet cells in a human adult would be transformational for the treatment of Type 1 diabetes.
We have termed this new paradigm for pancreatic islet cell delivery the BioVascular Pancreas or “BVP TM .” 10 Table of Contents We believe that a reliable, low-risk, and easily implantable islet cell delivery method that could ensure the survival and functionality of a therapeutic number of islet cells in a human adult would be transformational for the treatment of Type 1 diabetes.
The centralized procedure is compulsory for medicinal products that (1) are derived from biotechnology processes, (2) contain a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative disorders, viral diseases or autoimmune diseases and other immune dysfunctions, (3) are orphan medicinal products or (4) are advanced therapy medicinal products.
The centralized procedure is compulsory for medicinal products that (1) are derived from 58 Table of Contents biotechnology processes, (2) contain a new active substance indicated for the treatment of certain diseases, such as HIV/AIDS, cancer, diabetes, neurodegenerative disorders, viral diseases or autoimmune diseases and other immune dysfunctions, (3) are orphan medicinal products or (4) are advanced therapy medicinal products.
There were a total of 37 sites that participated in the study, enrolling a combined total of 355 subjects. 24-Month Results: The V006 study enrolled 355 subjects who were roughly equally matched in terms of demographics and co-morbidities. ATEV subjects trended older (p=0.06) and had more prior strokes (p=0.02) than did ePTFE subjects.
There were a total of 37 sites that participated in the study, enrolling a combined total of 355 subjects. 25 Table of Contents 24-Month Results: The V006 study enrolled 355 subjects who were roughly equally matched in terms of demographics and co-morbidities. ATEV subjects trended older (p=0.06) and had more prior strokes (p=0.02) than did ePTFE subjects.
For a human cellular or tissue product the FDA also may refuse to approve the product if the manufacturer is not in compliance with GTP requirements, in addition to cGMPs. 50 Table of Contents The FDA also has authority to require a Risk Evaluation and Mitigation Strategy (“REMS”) from manufacturers to ensure that the benefits of a biological product outweigh its risks.
For a human cellular or tissue product the FDA also may refuse to approve the product if the manufacturer is not in compliance with GTP requirements, in addition to cGMPs. The FDA also has authority to require a Risk Evaluation and Mitigation Strategy (“REMS”) from manufacturers to ensure that the benefits of a biological product outweigh its risks.
In addition to regulations in Europe and the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial distribution of our future products. Facilities Our corporate headquarters, manufacturing, and research and development facilities are located in Durham, North Carolina where we lease approximately 83,000 square feet of space.
In addition to regulations in Europe and the United States, we will be subject to a variety of foreign regulations governing clinical trials and commercial distribution of our future products. 60 Table of Contents Facilities Our corporate headquarters, manufacturing, and research and development facilities are located in Durham, North Carolina where we lease approximately 83,000 square feet of space.
In addition, in 2018 our ATEV product candidate was assigned a priority designation by the Secretary of Defense under Public Law 115-92, enacted to expedite the FDA’s review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel.
In addition, in 2018 our ATEV product candidate was assigned a priority designation by the Secretary of Defense under Public Law 115-92, enacted to expedite the FDA’s review 5 Table of Contents of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel.
Rates of traumatic limb loss are strongly tied to ischemia time, and therefore rapid revascularization using an off-the-shelf ATEV conduit may decrease ischemia time and lead to better outcomes. 45 Table of Contents The use of autologous vein for creating an AV fistula for use in hemodialysis is often limited by vein size and location.
Rates of traumatic limb loss are strongly tied to ischemia time, and therefore rapid revascularization using an off-the-shelf ATEV conduit may decrease ischemia time and lead to better outcomes. The use of autologous vein for creating an AV fistula for use in hemodialysis is often limited by vein size and location.
The initiation and pace of the expansion of vessel capacity will be determined based on our assessment of market opportunity. We initiate ATEV production using primary human aortic vascular cells from a working cell stock (“WCS”) that is isolated from FDA-compliant donor tissues and cryopreserved.
The initiation and pace of the expansion of vessel capacity will be determined based on our assessment of market opportunity. 39 Table of Contents We initiate ATEV production using primary human aortic vascular cells from a working cell stock (“WCS”) that is isolated from FDA-compliant donor tissues and cryopreserved.
These procedures must involve, among other things, testing donors for certain communicable diseases and the use of quarantines for HCT/Ps that have not yet been shown to meet the eligibility requirements. Manufacturers must keep detailed records regarding donor eligibility determinations. Current Good Tissue Practices.
These procedures must involve, among other things, testing donors for certain communicable diseases and the use of quarantines for HCT/Ps that have not yet been shown to meet the eligibility requirements. Manufacturers must keep detailed records regarding donor eligibility determinations. 55 Table of Contents Current Good Tissue Practices.
We performed a preclinical study at Duke University to evaluate the use of our small diameter ATEV for CABG in adult primates (baboons), and we have also performed studies of the sdATEV in sheep and pig models of CABG surgery, with follow-up times ranging from 1-3 months.
We performed a preclinical study at Duke University to evaluate the use of our small diameter CTEV for CABG in adult primates (baboons), and we have also performed studies of the CTEV in sheep and pig models of CABG surgery, with follow-up times ranging from 1-3 months.
EU Requirements Applicable to Medical Devices Under the previous medical devices directive, Directive 93/42/EEC, our ATEVs were not classified as medical devices in the EU because, with limited exceptions, products incorporating or derived from tissues or cells of human origin are expressly excluded from the scope of the EU medical devices rules under Directive 93/42.
EU Requirements Applicable to Medical Devices Under the previous medical devices directive, Directive 93/42/EEC, our ATEVs were not classified as medical devices in the EU because, with limited exceptions, products incorporating or derived from tissues or cells of human origin are expressly 59 Table of Contents excluded from the scope of the EU medical devices rules under Directive 93/42.
Of these families, 12 are solely owned by Humacyte, one is jointly owned by Humacyte and Global Life Sciences Solutions USA LLC, one is jointly owned by Humacyte and Yale University, one is exclusively licensed to Humacyte from Duke University and one is exclusively licensed to Humacyte from Yale University.
Of these families, 11 are solely owned by Humacyte, one is jointly owned by Humacyte and Global Life Sciences Solutions USA LLC, one is jointly owned by Humacyte and Yale University, one is exclusively licensed to Humacyte from Duke University and one is exclusively licensed to Humacyte from Yale University.
After the BLA submission is accepted for filing, the FDA reviews the BLA to determine, among other things, whether the proposed product is safe and potent, or effective, for its intended use, and has an acceptable purity profile, and whether the product is being manufactured in accordance with cGMPs (and, where applicable, GTPs) to assure and preserve the product’s identity, safety, strength, quality, potency, and purity, and biological product standards.
After the BLA submission is accepted for filing, the FDA reviews the BLA to determine, among other things, whether the proposed product is safe and potent, or effective, for its intended use, and has an 52 Table of Contents acceptable purity profile, and whether the product is being manufactured in accordance with cGMPs (and, where applicable, GTPs) to assure and preserve the product’s identity, safety, strength, quality, potency, and purity, and biological product standards.
Consequently, we believe there is an increasingly urgent unmet need for novel materials that are immediately available for permanent vascular repair for both civilian and military vascular trauma. Options in Surgical Treatment of Vascular Trauma Autologous vein is the preferred conduit for vascular repair.
Consequently, we believe there is an increasingly urgent unmet need for novel materials that are immediately available for permanent vascular repair for both civilian and military vascular trauma. 14 Table of Contents Options in Surgical Treatment of Vascular Trauma Autologous vein is the preferred conduit for vascular repair.
Our current Chair of the Board is Kathleen Sebelius, the former Secretary of the Department of Health and Human Services (“HHS”), and the former Governor of Kansas. Merger On August 26, 2021 (the “Closing Date”), Humacyte, Inc. (“Legacy Humacyte”), a Delaware corporation, and Alpha Healthcare Acquisition Corp.
Our current Chair of the Board is Kathleen Sebelius, the former Secretary of the Department of Health and Human Services (“HHS”), and the former Governor of Kansas. Merger On August 26, 2021 (the “Closing Date”), Humacyte, Inc. (“Legacy Humacyte”) and Alpha Healthcare Acquisition Corp.
We believe these and other attributes have the potential to address unmet clinical needs in a range of disease states, including atherosclerosis, end-stage kidney disease, coronary artery disease, vascular trauma, pediatric congenital heart disease, airway disease, and others.
We believe these and other attributes have the potential to address unmet clinical needs in a range of disease 48 Table of Contents states, including atherosclerosis, end-stage kidney disease, coronary artery disease, vascular trauma, pediatric congenital heart disease, airway disease, and others.
Images and long-term results from Phase 2 V001 trial of ATEV in AV Access 23 Table of Contents Phase 3 V006 AV Access Study Trial Design: Our V006 HUMANITY study was a prospective, multi-center, multinational, open-label, randomized, two-arm, comparative study.
Images and long-term results from Phase 2 V001 trial of ATEV in AV Access Phase 3 V006 AV Access Study Trial Design: Our V006 HUMANITY study was a prospective, multi-center, multinational, open-label, randomized, two-arm, comparative study.
None of our employees are represented by a collective bargaining agreement, and we have never experienced any work stoppage. We believe we have good relations with our employees.
None of our employees are represented by a collective bargaining agreement, and we have never experienced any work stoppages. We believe we have good relations with our employees.
Even if a product candidate qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.
Even if a product candidate 54 Table of Contents qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.
These include registrations for Symvess™ in the United States, Europe, United Kingdom and Ukraine, HUMACYL™ in the United States, Europe, Australia, Canada, China, and Israel; HUMAGRAFT™ in Australia, China, Europe, and Israel; HUMAPASS™ in Europe, Australia, and Israel; and HUMACYTE, in the United States, Europe, Australia, Canada, and Israel.
These include registrations for Symvess® in the United States and pending registrations for Symvess in Europe, United Kingdom and Ukraine, HUMACYL™ in the United States, Europe, Australia, Canada, China, and Israel; HUMAGRAFT™ in Australia, China, Europe, and Israel; HUMAPASS™ in Europe, Australia, and Israel; HUMACYTE in the United States, Europe, Australia, Canada, and Israel; and, BVP™ in the United States.
In acute trauma, the time to restore blood flow to injured limbs is delayed when a vein must be harvested from the patient, which puts the limbs at greater risk of reduced function or amputation.
In acute trauma, the time to restore blood flow to injured limbs is delayed when a vein must 47 Table of Contents be harvested from the patient, which puts the limbs at greater risk of reduced function or amputation.
The onus of ensuring a device is safe enough to be placed on the market is ultimately the responsibility of the manufacturer and the notified body. 57 Table of Contents As part of the conformity assessment procedure, the manufacture will need to conduct a clinical evaluation of the device.
The onus of ensuring a device is safe enough to be placed on the market is ultimately the responsibility of the manufacturer and the notified body. As part of the conformity assessment procedure, the manufacture will need to conduct a clinical evaluation of the device.
A total of 29 expanded access/compassionate use cases have been granted by the FDA, and another 28 patients with severe PAD have been treated with the ATEV under an investigator IND at the Mayo Clinic. Lastly, 19 patients suffering vascular injuries during the conflict in Ukraine have been treated with the ATEV under a humanitarian program.
A total of 30 expanded access/compassionate use cases have been granted by the FDA, and another 35 patients with severe PAD have been treated with the ATEV under an investigator IND at the Mayo Clinic. Lastly, 19 patients suffering vascular injuries during the conflict in Ukraine have been treated with the ATEV under a humanitarian program.
Failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as 53 Table of Contents warning letters, suspension of manufacturing, seizure of product, injunctive action or possible civil penalties.
Failure to comply with the statutory and regulatory requirements can subject a manufacturer to possible legal or regulatory action, such as warning letters, suspension of manufacturing, seizure of product, injunctive action or possible civil penalties.
Over the longer term, we are developing our ATEV for the delivery of cellular therapies, including pancreatic islet cell transplantation to treat Type 1 diabetes (our BioVascular Pancreas TM or “BVP”).
Over the longer term, we are developing our ATEV for the delivery of cellular therapies, including pancreatic islet cell transplantation to treat Type 1 diabetes (our BioVascular Pancreas or “BVP TM ”).
We believe that the production of the functional 3.5mm ATEV is indicative of the potentially broad application of our proprietary bioengineered tissue platform and manufacturing processes. 35 Table of Contents Engineered Trachea for Treatment of Severe Airway Injuries Each year in the United States, approximately 4,000 operations are performed to repair or reconstruct the trachea or mainstem bronchi.
We believe that the production of the functional 3.5mm CTEV is indicative of the potentially broad application of our proprietary bioengineered tissue platform and manufacturing processes. Engineered Trachea for Treatment of Severe Airway Injuries Each year in the United States, approximately 4,000 operations are performed to repair or reconstruct the trachea or mainstem bronchi.
However, our owned and licensed pending patent applications, and any patent applications that we may in the future file or license from third parties, may not result in the issuance of patents.
However, our owned and licensed pending patent applications, and any patent applications that 44 Table of Contents we may in the future file or license from third parties, may not result in the issuance of patents.
These initial trials to evaluate the potential toxicity and pharmacological activity of the investigational product (including pharmacokinetics, if applicable), and, if possible, gain early evidence on effectiveness. • Phase 2 .
These initial trials to evaluate the potential toxicity and pharmacological activity of the investigational product (including pharmacokinetics, if applicable), and, if possible, gain early evidence on effectiveness. 51 Table of Contents • Phase 2 .
The most common reasons reported by clinicians for using the ATEV in the V005 trial instead of the standard of care, saphenous vein, was the need to avoid the time required to harvest saphenous vein (32.3%), the quality of the patient’s vein (25.8%), and concomitant injuries to the vein (16.1%), suggesting that the ready, off-the-shelf feature of the ATEV has the potential to save valuable time for surgeons in the restoration of blood flow. 15 Table of Contents The V005 trial met its objectives.
The most common reasons reported by clinicians for using the ATEV in the V005 trial instead of the standard of care, saphenous vein, was the need to avoid the time required to harvest saphenous vein (32.3%), the quality of the patient’s vein (25.8%), and concomitant injuries to the vein (16.1%), suggesting that the ready, off-the-shelf feature of the ATEV has the potential to save valuable time for surgeons in the restoration of blood flow.
We continue to explore the development redundant vendors for all critical materials and we manage all vendor changes through a robust change control process. 38 Table of Contents Supply Agreement with SeraCare In January 2014, we entered into a supply agreement with SeraCare for the supply of human plasma, which was amended in October 2018 (as amended, the “SeraCare Agreement”).
We continue to explore the development redundant vendors for all critical materials and we manage all vendor changes through a robust change control process. Supply Agreement with SeraCare In January 2014, we entered into a supply agreement with SeraCare for the supply of human plasma, which was amended in October 2018 and March 2021 (as amended, the “SeraCare Agreement”).
In the preclinical study, the sdATEV was implanted between the aorta and right coronary artery (“RCA”) in five baboons to simulate a CABG procedure. Animals were followed for six months after sdATEV implantation and all sdATEVs maintained patency throughout the study.
In the preclinical study, the CTEV was implanted between the aorta and right coronary artery (“RCA”) in five baboons to simulate a CABG procedure. Animals were followed for six months after CTEV implantation and all CTEVs maintained patency throughout the study.
In December 2017, portions of the ACA dealing with the individual mandate insurance requirement were effectively repealed by the Tax Cuts and Jobs Act of 2017. U.S.
In December 2017, portions of the ACA dealing with the individual mandate insurance requirement were effectively repealed by the Tax Cuts and Jobs Act of 2017. 56 Table of Contents U.S.
The BT shunt is a surgical procedure that is used to increase pulmonary blood flow for the treatment of babies born with a complex congenital heart defect called Tetralogy of Fallot, a common type of “blue baby syndrome”. In 2024, there were approximately 1,800 babies born in the United States with Tetralogy of Fallot.
The BT shunt is a surgical procedure that is used to increase pulmonary blood flow for the treatment of babies born with a complex congenital heart defect called Tetralogy of Fallot, a common type of “blue baby syndrome”. There are approximately 1,800 babies born in the United States with Tetralogy of Fallot each year.
The ATEV has been implanted in approximately 601 patients, across more than 85 clinical sites in seven countries, over more than ten years as of December 31, 2024. We have observed zero instances of clinical rejection of the ATEV in any clinical trial over the past ten years, suggesting that the ATEV was not immunologically rejected after implantation.
As of December 31, 2025, the ATEV has been implanted in patients in clinical trials across more than 85 clinical sites in seven countries, over more than ten years. We have observed zero instances of clinical rejection of the ATEV in any clinical trial over the past ten years, suggesting that the ATEV was not immunologically rejected after implantation.
The goal of the primate and other large animal studies is to assess patency and function of the small diameter ATEV, as well as host responses and cellular remodeling. ATEVs are followed by ultrasound imaging of the heart, and angiographic imaging of the conduits.
The goal of the primate and other large animal studies is to assess patency and function of the small diameter CTEV, as well as host responses and cellular remodeling. CTEVs are followed by ultrasound imaging of the heart, and angiographic imaging of the conduits.
Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are more effective, safer, have fewer or less severe side effects, are more convenient or are less expensive than the products that we develop.
Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are more effective, safer, have fewer or less severe side effects, are more convenient or are less expensive than the products that we 49 Table of Contents develop.
The sponsor of a biological product candidate may request the FDA to designate the biologic as a Fast Track product at any time during the clinical development of the product.
The sponsor of a biological product 53 Table of Contents candidate may request the FDA to designate the biologic as a Fast Track product at any time during the clinical development of the product.
In addition to vascular trauma, we and our collaborators are currently conducting Phase 3 and Phase 2 trials of our 6 millimeter ATEV in AV access for hemodialysis and PAD. We were granted Fast Track designation by the FDA for our 6 millimeter ATEV for use in AV access for hemodialysis in 2014.
In addition to vascular trauma, we are currently conducting a Phase 3 trial of our 6 millimeter ATEV in AV access for hemodialysis, and previously completed Phase 2 trials in PAD. We were granted Fast Track designation by the FDA for our 6 millimeter ATEV for use in AV access for hemodialysis in 2014.
Mayo Clinic Study in Severe PAD The Mayo Clinic, Rochester, MN, is conducting a study in patients with CLTI under an investigator-initiated IND filed with the FDA.
Mayo Clinic Study in Severe PAD The Mayo Clinic, Rochester, MN, conducted a study in patients with CLTI under an investigator-initiated IND filed with the FDA.
V005 results included in the BLA submission to the FDA and published in JAMA Surgery , an American Medical Association peer-reviewed journal, in November 2024, are summarized in the following table.
The V005 trial met its objectives. V005 results included in the BLA submission to the FDA and published in JAMA Surgery , an American Medical Association peer-reviewed journal, in November 2024, are summarized in the following table.
We have agreed to use reasonable commercial efforts to develop and commercialize the licensed patents and any licensed products and methods, and to use reasonable efforts to make the licensed products available to patients in low and low-middle income countries.
We have agreed to use reasonable commercial efforts to develop and commercialize the licensed patents and any licensed products and methods, and to use reasonable efforts to make the licensed products available to patients in low 46 Table of Contents and low-middle income countries.
For more information regarding these license agreements, see “— License Agreement with Duke University” and “— License Agreements with Yale University.” Our 15 families of patents are comprised of: (i) Twelve issued U.S. patents, 73 foreign patents in Austria, Australia, Belgium, Canada, China, Cyprus, Denmark, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Netherlands, Portugal, Spain, Sweden, Switzerland, Turkey, and the UK, seven pending U.S. non-provisional patent applications, and 12 pending foreign applications in Australia, Canada, China, Europe, Japan and Hong Kong, which are solely owned by us, (ii) three issued U.S. patents, 18 issued foreign patents in Australia, Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, Turkey, and the UK, one pending U.S. non-provisional patent application, and four pending foreign patent applications in Europe and Canada, which we co-own, and (iii) one issued U.S. patent, one issued foreign patent in Japan, one pending U.S. non-provisional patent application, and five pending foreign patent applications in Australia, Canada, Europe, Japan, and Hong Kong, which we exclusively license.
For more information regarding these license agreements, see “— License Agreement with Duke University” and “— License Agreements with Yale University.” Our 15 families of patents are comprised of: (i) Eleven issued U.S. patents, 76 foreign patents in Austria, Australia, Belgium, Canada, China, Cyprus, Denmark, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Netherlands, Portugal, Spain, Sweden, Switzerland, Turkey, and the UK, eight pending U.S. non-provisional patent applications, and 15 pending foreign applications in Australia, Canada, China, Europe, Japan and Hong Kong, which are solely owned by us, (ii) four issued U.S. patents, 25 issued foreign patents in Australia, Austria, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Portugal, Netherlands, Spain, Sweden, Switzerland, Turkey, and the UK, no pending U.S. non-provisional patent applications, and three pending foreign patent applications in Europe and Canada, which we co-own, and (iii) two issued U.S. patent, two issued foreign patents in Australia and Japan, one pending U.S. non-provisional patent application, and three pending foreign patent applications in Canada, Europe, and Hong Kong, which we exclusively license.
We expect to file a BLA with the FDA in the second half of 2026 seeking approval for the use of ATEV in AV access for hemodialysis, and to target our commercialization efforts particularly toward those patients who are at high risk of fistula failure or non-maturation, such as women and male patients with two risk factors, such as obesity and diabetes.
Subject to the outcome of the interim data analysis of the V012 clinical trial, we expect to file a BLA with the FDA in the second half of 2026 seeking approval for the use of ATEV in AV access for hemodialysis, and to target our commercialization efforts particularly toward those patients who are at high risk of fistula failure or non-maturation, such as women and male patients with two risk factors, such as obesity and diabetes.
As of December 31, 2024, our patent estate is comprised of 15 families of patents.
As of December 31, 2025, our patent estate is comprised of 15 families of patents.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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If a natural disaster, power outage or other unforeseen event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as our in-house manufacturing facility, or that otherwise significantly disrupted our operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time.
If a natural disaster, power outage or other unforeseen event occurred that prevented us from using all or a significant portion of our headquarters, that damaged our critical infrastructure, such as our in-house manufacturing facility, or that otherwise significantly disrupted our operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time.
Government; • federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; • the anti-inducement law, which prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of items or services reimbursable by a federal or state governmental program; • the federal transparency requirements under the ACA, including the provision commonly referred to as the Physician Payments Sunshine Act and its implementing regulations, which require applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the State Children’s Health Insurance Program to report annually to CMS information related to payments or other transfers of value made to certain health care professionals and teaching hospitals; • federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs; • federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; 78 Table of Contents • HIPAA, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information; and • state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.
Government; • federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; • the anti-inducement law, which prohibits, among other things, the offering or giving of remuneration, which includes, without limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of items or services reimbursable by a federal or state governmental program; • the federal transparency requirements under the ACA, including the provision commonly referred to as the Physician Payments Sunshine Act and its implementing regulations, which require applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the State Children’s Health Insurance Program to report annually to CMS information related to payments or other transfers of value made to certain health care professionals and teaching hospitals; • federal government price reporting laws, which require us to calculate and report complex pricing metrics in an accurate and timely manner to government programs; • federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; • HIPAA, which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information; and 84 Table of Contents • state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.
Accordingly, disputes may arise between us and our licensor, our licensor and its licensors, regarding intellectual property subject to a license agreement, including those relating to: • the scope of rights, if any, granted under the license agreement and other interpretation-related issues; • whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the license agreement; • whether our licensor or its licensor had the right to grant the license agreement; • whether third parties are entitled to compensation or equitable relief, such as an injunction, for our use of the intellectual property without their authorization; • our right to sublicense patent and other rights to third parties under collaborative development relationships; • whether we are complying with our obligations with respect to the use of the licensed technology in relation to our development and commercialization of Symvess and our product candidates; 85 Table of Contents • our involvement in the prosecution of the licensed patents and our licensors’ overall patent enforcement strategy; • the allocation of ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and by us and our partners; and • the amounts of royalties, milestones or other payments due under the license agreement.
Accordingly, disputes may arise between us and our licensor, our licensor and its licensors, regarding intellectual property subject to a license agreement, including those relating to: • the scope of rights, if any, granted under the license agreement and other interpretation-related issues; • whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the license agreement; • whether our licensor or its licensor had the right to grant the license agreement; • whether third parties are entitled to compensation or equitable relief, such as an injunction, for our use of the intellectual property without their authorization; • our right to sublicense patent and other rights to third parties under collaborative development relationships; • whether we are complying with our obligations with respect to the use of the licensed technology in relation to our development and commercialization of Symvess and our product candidates; • our involvement in the prosecution of the licensed patents and our licensors’ overall patent enforcement strategy; 92 Table of Contents • the allocation of ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our licensors and by us and our partners; and • the amounts of royalties, milestones or other payments due under the license agreement.
If these market opportunities are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the relevant patient population, our revenue and ability to achieve profitability might be materially and adversely affected. • Our distribution agreement with Fresenius Medical Care imposes obligations on us that may restrict our ability to operate our business in ways we believe to be in our long-term best interest. • If we receive approval for a product candidate that is not subject to our distribution agreement with Fresenius Medical Care, and we are unable to establish our own marketing, sales and distribution capabilities or are unable to enter into agreements with third parties to do so, we may not be able to generate product revenue and will have to alter our development and commercialization plans. 59 Table of Contents • The manufacture of Symvess and our product candidates is complex, we have limited experience manufacturing commercial product, and we have in the past and may in the future encounter difficulties in production.
If these market opportunities are smaller than we estimate or if any approval that we obtain is based on a narrower definition of the relevant patient population, our revenue and ability to achieve profitability might be materially and adversely affected. • Our distribution agreement with Fresenius Medical Care imposes obligations on us that may restrict our ability to operate our business in ways we believe to be in our long-term best interest. 62 Table of Contents • If we receive approval for a product candidate that is not subject to our distribution agreement with Fresenius Medical Care, and we are unable to establish our own marketing, sales and distribution capabilities or are unable to enter into agreements with third parties to do so, we may not be able to generate product revenue and will have to alter our development and commercialization plans. • The manufacture of Symvess and our product candidates is complex, we have limited experience manufacturing commercial product, and we have in the past and may in the future encounter difficulties in production.
Specifically, the IRA’s Price Negotiation Program applies to high-expenditure single-source drugs and biologics that have been approved for at least 7 or 11 years, respectively, among other negotiation selection criteria, beginning with ten high-cost Part D drugs starting in 2026, followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and beyond.
Specifically, the IRA’s Price Negotiation Program applies to high-expenditure single-source drugs and biologics that have been approved for at least 7 or 11 years, respectively, among other negotiation selection criteria, beginning with ten high-cost Part D drugs starting in 2026, to be followed by 15 Part D drugs in 2027, 15 Part B or Part D drugs in 2028, and 20 Part B or Part D drugs in 2029 and beyond.
Symvess and any other product that we commercialize may not gain acceptance by physicians, patients, health care payors and others in the medical community due to ethical, social, medical, cost and legal concerns. If these products do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not become profitable.
Symvess and any other product that we commercialize may not gain acceptance by physicians, patients, health care payors and others in the medical community due to ethical, social, medical, cost, reputational and legal concerns. If these products do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not become profitable.
Each of these risks is more fully described in the individual risk factors immediately following this summary. • We have never generated product revenue and have incurred significant losses to date. We expect to continue to incur losses for the foreseeable future and may never generate product revenue or be profitable.
Each of these risks is more fully described in the individual risk factors immediately following this summary. • We have incurred significant losses to date. We expect to continue to incur losses for the foreseeable future and may never generate significant product revenue or be profitable.
If we or any third-party manufacturer encounter such difficulties, our ability to supply Symvess for commercial sale or Symvess and our product candidates for clinical trials could be delayed or halted entirely. • The terms of the Purchase Agreement (defined below) may limit our ability to incur future debt. • We rely on third parties to conduct and support our clinical trials, and those third parties may not perform satisfactorily, including by failing to adhere to regulatory requirements or our stated protocols or to meet deadlines for the completion of such trials. • We rely on third-party suppliers, including sole source suppliers, to provide certain components for our product candidates.
If we or any third-party manufacturer encounter such difficulties, our ability to supply Symvess for commercial sale or Symvess and our product candidates for clinical trials could be delayed or halted entirely. • The terms of the Loan Agreement (defined below) may limit our ability to incur future debt. • We rely on third parties to conduct and support our clinical trials, and those third parties may not perform satisfactorily, including by failing to adhere to regulatory requirements or our stated protocols or to meet deadlines for the completion of such trials. • We rely on third-party suppliers, including sole source suppliers, to provide certain components for our product candidates.
If we fail to comply with regulatory requirements of the FDA and, if relevant, other non-U.S. regulatory authorities, we could be subject to administrative or judicially imposed sanctions, including the following: • issuance of warning letters or untitled letters by regulatory authorities asserting that we are in violation of the law; • imposition of injunctions or significant civil monetary penalties or pursuit by regulatory authorities of civil or criminal prosecutions and fines or other civil and/or criminal penalties against us or our responsible officers; • suspension or withdrawal of marketing approval; • suspension of any ongoing clinical trials or refusal by regulatory authorities to approve pending marketing applications or supplements to approved applications; • seizure of products or refusal to allow us to enter into supply contracts, including government contracts, or to import or export products; • voluntary or mandatory product recalls and publicity requirements; and • restrictions on operations, including marketing efforts, or restrictions that mandate costly new manufacturing requirements.
If we fail to comply with regulatory requirements of the FDA and, if relevant, other non-U.S. regulatory authorities, we could be subject to administrative or judicially imposed sanctions, including the following: • issuance of warning letters or untitled letters by regulatory authorities asserting that we are in violation of the law; • imposition of injunctions or significant civil monetary penalties or pursuit by regulatory authorities of civil or criminal prosecutions and fines or other civil and/or criminal penalties against us or our responsible officers; • suspension or withdrawal of marketing approval; • suspension of any ongoing clinical trials or refusal by regulatory authorities to approve pending marketing applications or supplements to approved applications; 78 Table of Contents • seizure of products or refusal to allow us to enter into supply contracts, including government contracts, or to import or export products; • voluntary or mandatory product recalls and publicity requirements; and • restrictions on operations, including marketing efforts, or restrictions that mandate costly new manufacturing requirements.
On December 12, 2023, we submitted our BLA for the ATEV in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated and autologous vein use is not feasible.
For example, on December 12, 2023, we submitted our BLA for the ATEV in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated and autologous vein use is not feasible.
Additionally, even though we received FDA approval for Symvess in trauma, we may face a number of difficulties if the results of our clinical trials for additional Symvess indications or for our product candidates are unfavorable, inconclusive, or only modestly favorable or if there are safety concerns, such as AEs or SAEs, which could include clotting, mechanical failure, immunological rejection or infection, that could outweigh potential benefits associated with such product candidates.
Additionally, even though we received FDA approval for Symvess in certain types of trauma, we may face a number of difficulties if the results of our clinical trials for additional Symvess indications or for our product candidates are unfavorable, inconclusive, or only modestly favorable or if there are safety concerns, such as AEs or SAEs, which could include clotting, mechanical failure, immunological rejection or infection, that could outweigh potential benefits associated with such product candidates.
Patient enrollment and trial completion is affected by many factors including the: • size of the patient population and process for identifying subjects; • design of the trial protocol; • inclusion and exclusion criteria; • safety profile to date of the product candidate under study; • perceived risks and benefits of the product candidate under study; • availability of competing therapies and clinical trials; • severity of the disease under investigation; • degree of progression of the subject’s disease at the time of enrollment; • proximity and availability of clinical trial sites for prospective subjects; • the impact of pandemics or similar events on patients’ willingness and ability to participate in clinical trials or on study site policies; • ability to obtain and maintain subject consent; • risk that enrolled subjects will drop out before completion of the trial; • patient referral practices of physicians; and • ability to monitor subjects adequately during and after treatment.
Patient enrollment and trial completion is affected by many factors including the: • size of the patient population and process for identifying subjects; 67 Table of Contents • design of the trial protocol; • inclusion and exclusion criteria; • safety profile to date of the product candidate under study; • perceived risks and benefits of the product candidate under study; • availability of competing therapies and clinical trials; • severity of the disease under investigation; • degree of progression of the subject’s disease at the time of enrollment; • proximity and availability of clinical trial sites for prospective subjects; • the impact of pandemics or similar events on patients’ willingness and ability to participate in clinical trials or on study site policies; • ability to obtain and maintain subject consent; • risk that enrolled subjects will drop out before completion of the trial; • patient referral practices of physicians; and • ability to monitor subjects adequately during and after treatment.
At the federal level, the Inflation Reduction Act of 2022, or IRA: • Requires manufacturers to pay rebates for a Medicare Part B or Part D drug if the price increases for the drug exceed the rate of inflation. • Eliminates the “donut hole” under Medicare Part D beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and requiring manufacturers to subsidize 10% of Part D enrollees’ prescription costs for brand drugs below the out-of-pocket maximum and 20% once the out-of-pocket maximum has been reached. • Delays the rebate rule that would require pass through of pharmacy benefit manager rebates to beneficiaries. • Directs the Centers for Medicare & Medicaid Services, or CMS, to engage in price-capped negotiation for certain Medicare Part B and Part D drugs and biologics.
At the federal level, the Inflation Reduction Act of 2022, or IRA: • Requires manufacturers to pay rebates for a Medicare Part B or Part D drug if the price increases for the drug exceed the rate of inflation. • Eliminates the “donut hole” under Medicare Part D beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and requiring manufacturers to subsidize 10% of Part D enrollees’ prescription costs for brand drugs below the out-of-pocket maximum and 20% once the out-of-pocket maximum has been reached. • Delays the rebate rule that would require pass through of pharmacy benefit manager rebates to beneficiaries. 82 Table of Contents • Directs the Centers for Medicare & Medicaid Services, or CMS, to engage in price-capped negotiation for certain Medicare Part B and Part D drugs and biologics.
At this time, Symvess has been approved in the United States in an initial indication, and none of our product candidates have been approved in the United States, Europe or in any other jurisdiction.
At this time, Symvess has been approved in the United States in an initial indication, and none of our other product candidates have been approved in the United States, Europe, Israel, or in any other jurisdiction.
The degree of market acceptance of Symvess or any of our product candidates that receives marketing approval will depend on a number of factors, including: • the efficacy and potential advantages of Symvess or our product candidates compared with alternative products or methods, including convenience and ease of administration; • the prices we charge for Symvess or our other products, if approved; • the availability of third-party coverage and adequate reimbursement; • the willingness of the target patient population to try new products and methods and of physicians to use these products and methods; • the strength of marketing and distribution support; • the availability of the product and our ability to meet market demand; • the prevalence and severity of any side effects, or the emergence of new, previously unknown side effects; and • any restrictions on the use of Symvess and our other products, if approved.
The degree of market acceptance of Symvess or any of our product candidates that receives marketing approval will depend on a number of factors, including: • the efficacy and potential advantages of Symvess or our product candidates compared with alternative products or methods, including convenience and ease of administration; • the prices we charge for Symvess or our other products, if approved; • the availability of third-party coverage and adequate reimbursement; • the willingness of the target patient population to try new products and methods and of physicians to use these products and methods; • the strength of marketing and distribution support; • the availability of the product and our ability to meet market demand; 64 Table of Contents • the prevalence and severity of any side effects, or the emergence of new, previously unknown side effects; and • any restrictions on the use of Symvess and our other products, if approved.
The FDA could delay, limit or deny approval of our product candidates for many reasons, including because it: • may not deem the product candidate to be adequately safe or effective; • may not find the data from preclinical studies, clinical trials or CMC data sufficient to support approval; • may not approve the manufacturing processes or facilities associated with the product candidate; • may conclude that the long-term integrity of the product candidate for which approval is being sought has not been sufficiently demonstrated; • may change approval policies or adopt new regulations; or • may not accept a submission due to, among other reasons, the content or formatting of the submission.
The FDA could delay, limit or deny approval of our product candidates for many reasons, including because it: • may not deem the product candidate to be adequately safe or effective; • may not find the data from preclinical studies, clinical trials or CMC data sufficient to support approval; • may not approve the manufacturing processes or facilities associated with the product candidate; • may conclude that the long-term integrity of the product candidate for which approval is being sought has not been sufficiently demonstrated; 79 Table of Contents • may change approval policies or adopt new regulations; or • may not accept a submission due to, among other reasons, the content or formatting of the submission.
The misuse or off-label use of our product may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory authorities if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
The misuse or off-label use of our product may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in costly investigations, fines or civil or criminal sanctions by regulatory authorities if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.
Item 1A. Risk Factors Our operations and financial results are subject to a high degree of risk. These risks include, but are not limited to, those described below, each of which may have a material and adverse effect on our business, prospects, operating results, financial condition and the trading price of our securities.
Item 1A. R isk Factors Our operations and financial results are subject to a high degree of risk. These risks include, but are not limited to, those described below, each of which may have a material and adverse effect on our business, prospects, operating results, financial condition and the trading price of our securities.
If our trade secrets are disclosed to or misappropriated or independently developed by a third party, it would harm our ability to protect our rights and could materially harm our business and competitive position. 86 Table of Contents Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
If our trade 93 Table of Contents secrets are disclosed to or misappropriated or independently developed by a third party, it would harm our ability to protect our rights and could materially harm our business and competitive position. Third parties may assert that our employees or consultants have wrongfully used or disclosed confidential information or misappropriated trade secrets.
Our industry is highly regulated, and changes in or revisions to laws and regulations that make gaining coverage of and adequate reimbursement for Symvess or our product candidates more difficult or subject to different criteria and standards may adversely impact our business, prospects, operating results and financial condition.
Our industry is highly regulated, and changes in or revisions to laws, regulations, or other policies that make gaining coverage of and adequate reimbursement for Symvess or our product candidates more difficult or subject to different criteria and standards may adversely impact our business, prospects, operating results and financial condition.
We have devoted substantially all of our financial resources and efforts to research and development, including preclinical studies and clinical trials and development of manufacturing technology, and we anticipate that our expenses will continue to increase over the next several years as we continue these activities.
We have devoted substantially all of our financial resources and efforts to sales, marketing, research and development, including preclinical studies and clinical trials and development of manufacturing technology, and we anticipate that our expenses will continue to increase over the next several years as we continue these activities.
Uncertainties resulting from our participation in patent litigation or other proceedings could have a material adverse effect on our business. 84 Table of Contents Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could harm our business, prospects, operating results and financial condition.
Uncertainties resulting from our participation in patent litigation or other proceedings could have a material adverse effect on our business. Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could harm our business, prospects, operating results and financial condition.
Certain of these jurisdictions pose a risk of potential FCPA violations, and we have relationships with third parties, including government-affiliated hospitals and universities, whose actions could potentially subject us to liability under the FCPA or local anti-corruption laws. 81 Table of Contents We are also subject to other laws and regulations governing our international operations, including regulations administered by the U.S.
Certain of these jurisdictions pose a risk of potential FCPA violations, and we have relationships with third parties, including government-affiliated hospitals and universities, whose actions could potentially subject us to liability under the FCPA or local anti-corruption laws. We are also subject to other laws and regulations governing our international operations, including regulations administered by the U.S.
An adverse determination in any such challenges may result in loss of the patent or in patent or patent application claims being narrowed, invalidated or held unenforceable, in whole or in part, or in denial of the patent application or loss or reduction in the scope of one or more claims of the patent or patent application, any of which could limit our ability to 83 Table of Contents stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products.
An adverse determination in any such challenges may result in loss of the patent or in patent or patent application claims being narrowed, invalidated or held unenforceable, in whole or in part, or in denial of the patent application or loss or reduction in the scope of one or more claims of the patent or patent application, any of which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our technology and products.
Further, whether we commercialize any such product candidate on our own or rely on a third party to do so, our ability to generate revenue will be dependent on the effectiveness of the organization performing these functions. 66 Table of Contents There is uncertainty with respect to third-party coverage and reimbursement of Symvess and our product candidates, if approved.
Further, whether we commercialize any such product candidate on our own or rely on a third party to do so, our ability to generate revenue will be dependent on the effectiveness of the organization performing these functions. There is uncertainty with respect to third-party coverage and reimbursement of Symvess and our product candidates, if approved.
We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous materials. In addition, we may be required to incur substantial costs to comply with future environmental, health and safety laws and regulations.
We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous materials. 86 Table of Contents In addition, we may be required to incur substantial costs to comply with future environmental, health and safety laws and regulations.
The scientific discoveries that form the basis for our efforts to develop our product candidates are relatively new, and the scientific evidence to support the feasibility of developing product candidates based on these discoveries is both preliminary and limited.
The scientific discoveries that form the basis for our efforts to develop our product candidates are relatively new, and the scientific evidence to support the feasibility of developing product candidates based on these discoveries is limited.
For example, the FDA approved package insert for Symvess contains a boxed warning relating to mid-graft rupture or anastomotic failure. We may not be successful in our efforts to use our proprietary scientific technology platform to build a pipeline of additional product candidates.
For example, the FDA approved package insert for Symvess contains a boxed warning relating to mid-graft rupture or anastomotic failure. 68 Table of Contents We may not be successful in our efforts to use our proprietary scientific technology platform to build a pipeline of additional product candidates.
We may not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names, which we need for name recognition by potential partners or customers in our markets of interest. During trademark registration proceedings, we may receive rejections.
We may not be able to protect our rights to these trademarks and trade names or may be forced to stop using these names, which we need for name recognition by potential partners or customers in our markets of interest. During 95 Table of Contents trademark registration proceedings, we may receive rejections.
Should any of these events occur, they could harm our business, financial condition, results of operations, and prospects. Risks Related to Business Matters and Our Ability to Manage Growth Our future success depends on our ability to retain our key employees, consultants and advisors and to attract, retain and motivate qualified personnel.
Should any of these events occur, they could harm our business, financial condition, results of operations, and prospects. 96 Table of Contents Risks Related to Business Matters and Our Ability to Manage Growth Our future success depends on our ability to retain our key employees, consultants and advisors and to attract, retain and motivate qualified personnel.
This exclusive forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits with respect to such claims.
This exclusive forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, other employees or stockholders, which may discourage lawsuits with 102 Table of Contents respect to such claims.
We will need to raise additional capital to finance our operations, which we may not be able to do on acceptable terms or at all. • Our near-term prospects are dependent on the success of Symvess, our sole FDA-approved product, and if we are unable to successfully commercialize it in the vascular trauma indication and obtain regulatory approval for Symvess in additional indications, our business, operating results and financial condition will be materially harmed. • Symvess and our product candidates, if approved, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success. • We face and will continue to face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do, which may adversely affect our ability to successfully market or commercialize Symvess or our product candidates. • If our clinical trials fail to demonstrate safety and efficacy to the satisfaction of the FDA or similar regulatory authorities outside the United States or do not otherwise produce favorable results, we may incur significant additional costs or experience significant delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates. • We may experience delays or difficulties in the enrollment of patients in our clinical trials, which may delay or prevent additional clinical trials and our receipt of necessary marketing approvals. • Lack of experience by investigators and surgeons with our ATEVs can lead to incorrect implantation or follow-up procedures which could harm the results of our clinical trials and market acceptance of Symvess and our product candidates, if approved. • We may not be successful in our efforts to use our proprietary scientific technology platform to build a pipeline of additional product candidates. • The sizes of the market opportunities for Symvess and our product candidates have not been established with precision and are estimates that management believes to be reasonable.
We will need to raise additional capital to finance our operations, which we may not be able to do on acceptable terms or at all. • Our near-term prospects are dependent on the success of Symvess, our sole FDA-approved product, and if we are unable to increase sales in the vascular trauma indication and obtain regulatory approval for Symvess in additional indications, our business, operating results and financial condition will be materially harmed. • Symvess and our product candidates, if approved, may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success. • If we are found or alleged to have improperly promoted off-label uses, we may become subject to significant liability. • We face and will continue to face substantial competition, which may result in others discovering, developing or commercializing competing products before or more successfully than we do, which may adversely affect our ability to successfully market or commercialize Symvess or our product candidates. • If our clinical trials fail to demonstrate safety and efficacy to the satisfaction of the FDA or similar regulatory authorities outside the United States or do not otherwise produce favorable results, we may incur significant additional costs or experience significant delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates. • We may experience delays or difficulties in the enrollment of patients in our clinical trials, which may delay or prevent additional clinical trials and our receipt of necessary marketing approvals. • Lack of experience by investigators and surgeons with our ATEVs can lead to incorrect implantation or follow-up procedures which could harm the results of our clinical trials and market acceptance of Symvess and our product candidates, if approved. • We may not be successful in our efforts to use our proprietary scientific technology platform to build a pipeline of additional product candidates. • The sizes of the market opportunities for Symvess and our product candidates have not been established with precision and are estimates that management believes to be reasonable.
In the event we are unable to develop our own marketing, sales and distribution functions or collaborate with a third-party organization for this purpose, we may not be able to successfully commercialize a product candidate that is not subject to the distribution agreement with Fresenius Medical Care, which would adversely affect our ability to generate revenue.
In the event we 70 Table of Contents are unable to develop our own marketing, sales and distribution functions or collaborate with a third-party organization for this purpose, we may not be able to successfully commercialize a product candidate that is not subject to the distribution agreement with Fresenius Medical Care, which would adversely affect our ability to generate revenue.
Regulatory authorities may also seek to impose 64 Table of Contents restrictive labeling or proactive communication obligations on any marketing approval granted for use of our ATEVs as a result, which could reduce market acceptance of any of our ATEVs that receive marketing approval.
Regulatory authorities may also seek to impose restrictive labeling or proactive communication obligations on any marketing approval granted for use of our ATEVs as a result, which could reduce market acceptance of any of our ATEVs that receive marketing approval.
The ultimate content, timing, or effect of any healthcare reform legislation or executive order or the impact that the resulting changes may have on us is uncertain, but we expect there will continue to be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health care.
The ultimate content, timing, or effect of any healthcare regulation, legislation, executive order, or other policy or the impact that the resulting changes may have on us is uncertain, but we expect there will continue to be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health care.
In particular, it is unclear to what extent the UK regime will begin diverging from the GDPR and how data transfers to and from the UK will be regulated.
In particular, it is unclear when and to what extent the UK regime will begin diverging from the GDPR and how data transfers to and from the UK will be regulated in the future.
We may also issue additional shares of 90 Table of Contents common stock or other equity securities of equal or senior rank in the future in connection with, among other things, future acquisitions or repayment of outstanding indebtedness, without stockholder approval, in a number of circumstances.
We may also issue additional shares of common stock or other equity securities of equal or senior rank in the future in connection with, among other things, future acquisitions or repayment of outstanding indebtedness, without stockholder approval, in a number of circumstances.
We are an “emerging growth company” and a “smaller reporting company” within the meaning of the rules adopted by the SEC, and if we take advantage of certain exemptions from disclosure requirements available to emerging growth companies and smaller reporting companies, this could make our securities less attractive to investors and may make it more difficult to compare our performance with other public companies.
We are a “smaller reporting company” within the meaning of the rules adopted by the SEC, and if we take advantage of certain exemptions from disclosure requirements available to smaller reporting companies, this could make our securities less attractive to investors and may make it more difficult to compare our performance with other public companies.
In addition, individual states have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
This came as individual states have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
These healthcare reforms and the implementation of any future cost containment measures or other reforms may prevent us from being able to generate sufficient revenue, attain and/or maintain profitability or commercialize our drug candidates.
These healthcare reforms and the 71 Table of Contents implementation of any future cost containment measures or other reforms may prevent us from being able to generate sufficient revenue, attain and/or maintain profitability or commercialize our drug candidates.
As cyber threats continue to evolve, we 79 Table of Contents may be required to incur additional expenses in order to enhance our protective measures or to remediate any information security vulnerability. There can be no assurance that we or our third-party providers will be successful in preventing cyber-attacks or successfully mitigating their effects.
As cyber threats continue to evolve, we may be required to incur additional expenses in order to enhance our protective measures or to remediate any information security vulnerability. There can be no assurance that we or our third-party providers will be successful in preventing cyber-attacks or successfully mitigating their effects.
In addition, the use of pixels and other website technologies increasingly are attracting attention from privacy regulators and private litigants, including under theories involving state wiretap laws. These privacy laws may impact our business activities and exemplify the vulnerability of our business to the evolving regulatory environment related to personal data.
In addition, the use of pixels and other website technologies increasingly are attracting attention from privacy regulators and private litigants, including under theories involving federal and state wiretap laws. These privacy laws may impact our business activities and exemplify the vulnerability of our business to the evolving regulatory environment related to personal data. Further, the U.S.
If we fail to adequately monitor our third party service providers’ and partners’ performance, including for compliance with our agreements and regulatory and legal requirements, we may have to incur additional costs to correct errors, our reputation could be harmed or we could be subject to litigation, claims, legal or regulatory proceedings, inquiries or investigations.
If we fail to adequately monitor our third party service providers’ and partners’ 85 Table of Contents performance, including for compliance with our agreements and regulatory and legal requirements, we may have to incur additional costs to correct errors, our reputation could be harmed or we could be subject to litigation, claims, legal or regulatory proceedings, inquiries or investigations.
If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in any future patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology.
If we are unable to obtain an exclusive license to any such third-party co-owners’ 89 Table of Contents interest in any future patents or patent applications, such co-owners may be able to license their rights to other third parties, including our competitors, and our competitors could market competing products and technology.
For more information, see the section of this Annual Report on Form 10-K titled “Business." 63 Table of Contents We may experience delays or difficulties in the enrollment of patients in our clinical trials, which may delay or prevent additional clinical trials and our receipt of necessary marketing approvals.
For more information, see the section of this Annual Report on Form 10-K titled “Business.” We may experience delays or difficulties in the enrollment of patients in our clinical trials, which may delay or prevent additional clinical trials and our receipt of necessary marketing approvals.
Pending and future patent applications may not result in patents being issued that protect our business, in whole or in part, or which effectively prevent others from commercializing competitive products. Competitors may also be able to design around our owned or licensed patents.
Pending and future patent applications may not result in patents being issued that protect our business, in whole or in part, or which effectively prevent others from commercializing competitive products. 90 Table of Contents Competitors may also be able to design around our owned or licensed patents.
In addition, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act or the rules and regulations promulgated thereunder.
In addition, unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act or the rules and regulations promulgated thereunder. 103 Table of Contents Item 1B.
Risks Related to the Development of Symvess and Commercialization of Our Product Candidates Our near-term prospects are dependent on the success of Symvess, our sole FDA-approved product, and if we are unable to successfully commercialize it in the vascular trauma indication and obtain regulatory approval for Symvess in additional indications, our business, operating results and financial condition will be materially harmed.
Risks Related to the Development of Symvess and Commercialization of Our Product Candidates Our near-term prospects are dependent on the success of Symvess, our sole FDA-approved product, and if we are unable to increase sales in the vascular trauma indication and obtain regulatory approval for Symvess in additional indications, our business, operating results and financial condition will be materially harmed.
Clinical testing is expensive and time-consuming, and its outcomes are uncertain. 61 Table of Contents A number of factors may impact the timing of our preclinical and clinical programs and the development and commercialization of our product candidates.
Clinical testing is expensive and time-consuming, and its outcomes are uncertain. A number of factors may impact the timing of our preclinical and clinical programs and the development and commercialization of our product candidates.
We have historically financed our operations primarily through the sale of equity securities and convertible debt, proceeds from our going public transaction, borrowings under loan facilities, the Purchase Agreement and, to a lesser extent, through grants from governmental agencies.
We have historically financed our operations primarily through the sale of equity securities and convertible debt, proceeds from our going public transaction, borrowings under loan facilities, including the Loan Agreement (as defined below), the Purchase Agreement (as defined below) and, to a lesser extent, through grants from governmental agencies.
Failure to comply with U.S. and international data protection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation and adverse publicity and could negatively affect our operating results and business.
Failure to comply with U.S. and international data protection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation and adverse publicity and 87 Table of Contents could negatively affect our operating results and business.
Furthermore, because patent applications are published sometime after filing, and because applications can take several years to issue, there may be additional currently pending third-party patent applications that are unknown to us, which may later result in issued patents.
Furthermore, because patent applications are published sometime after filing, and because applications can take several years to issue, there may be 91 Table of Contents additional currently pending third-party patent applications that are unknown to us, which may later result in issued patents.
These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical 69 Table of Contents trials, as well as in acquiring technologies complementary to, or necessary for, our programs.
Pursuant to the terms of the Purchase Agreement, we may be limited in our ability to incur future debt.
Pursuant to the terms of the Loan Agreement, we may be limited in our ability to incur future debt.
As a result, in the near term we are dependent on the success of Symvess, and if we are unable to successfully commercialize it in the vascular trauma indication and obtain regulatory approval for Symvess in additional indications, our business, along with our operating results and financial condition, will be materially harmed.
As a result, in the near term we are dependent on the success of Symvess, and if we are unable to increase sales in the vascular trauma indication and obtain regulatory approval for Symvess in additional indications, our business, along with our operating results and financial condition, will be materially harmed.
The price of our common stock may fluctuate due to a variety of factors, including: • actual or anticipated fluctuations in our quarterly and annual results and those of other public companies in our industry; • mergers and strategic alliances in the industry in which we operate; • market prices and conditions in the industry in which we operate; • publication of negative news articles or other media releases which could affect public opinion about our products or result in increased regulatory scrutiny of our product and product candidates; • changes in government regulation; • potential or actual military conflicts or acts of terrorism; • announcements concerning the Company or our competitors; and • the general state of the securities markets.
The price of our common stock may fluctuate due to a variety of factors, including: • actual or anticipated fluctuations in our quarterly and annual results and those of other public companies in our industry; • mergers and strategic alliances in the industry in which we operate; • market prices and conditions in the industry in which we operate; • publication of negative news articles or other media releases which could affect public opinion about our products or result in increased regulatory scrutiny of our product and product candidates; • changes in government regulation; • potential or actual military conflicts or acts of terrorism; • announcements concerning the Company or our competitors; and • the general state of the securities markets. 97 Table of Contents These market and industry factors may materially reduce the market price of our common stock, regardless of our operating performance.
Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive 65 Table of Contents than the products that we develop.
Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than the products that we develop.
Our efforts to scale out our manufacturing operations may not succeed. Scaling out a biologic manufacturing process is a difficult task, as there are risks including, among others, cost overruns, process reproducibility, stability issues, lot consistency and timely availability of raw materials.
As our commercial and clinical needs grow, our efforts to further scale out our manufacturing operations may not succeed. Scaling out a biologic manufacturing process is a difficult task, as there are risks including, among others, cost overruns, process reproducibility, stability issues, lot consistency and timely availability of raw materials.
We have in the past and may in the future need to terminate trial sites due to 69 Table of Contents failure to conduct a trial in accordance with its protocol, applicable regulations, GCPs, and generally accepted research standards.
We have in the past and may in the future need to terminate trial sites due to failure to conduct a trial in accordance with its protocol, applicable regulations, GCPs, and generally accepted research standards.
As long as we are an emerging growth company under the JOBS Act or a non-accelerated filer and a “smaller reporting company” as defined in Rule 12b-2 of the Exchange Act, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act.
As long as we are a non-accelerated filer and a “smaller reporting company” as defined in Rule 12b-2 of the Exchange Act, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act.
Even our ability to generate product revenue and become profitable from Symvess depends on our assumptions regarding the relevant market opportunity and the degree of market acceptance for Symvess, and if approved, our other products, for which our estimates may prove inaccurate, and market acceptance in any approved indication, which may never occur.
Our ability to increase sales and become profitable from Symvess depends on our assumptions regarding the relevant market opportunity and the degree of market acceptance for Symvess, and if approved, our other products, for which our estimates may prove inaccurate, and market acceptance in any approved indication, which may never occur.
The GDPR will increase our responsibility and liability in relation to personal data that we process, and we may be required to put in place additional mechanisms to ensure compliance with the new EU (which also includes the European Economic Area, or “EEA”) data protection rules.
The GDPR increased our responsibility and liability in relation to personal data that we process, and we may be required to put in place additional mechanisms to ensure compliance with the EU data protection rules (which also apply in the European Economic Area, or “EEA”) data protection rules.
We may never be able to successfully commercialize Symvess or our product candidates or meet our expectations with respect to revenues for a number of reasons, including: • a lack of acceptance of Symvess by physicians, patients, third-party payors and other members of the medical community; • our limited experience in marketing, selling and distributing Symvess or any other product; • our limited experience in the commercial manufacturing of Symvess or any other product; • reimbursement and coverage policies of government and private payors such as Medicare, Medicaid, group purchasing organizations, insurance companies, health maintenance organizations and other plan administrators; • our ability to expand the current FDA-approved indications for Symvess into treatment of pediatric patients, treatment of a broader set of traumas, or indications outside of trauma; • emergence of new AEs associated with Symvess once the product is in commercial use or data suggesting that known AEs are more frequent or severe than originally thought; • changed or increased regulatory restrictions in the United States, EU and other foreign territories; and • a lack of adequate financial or other resources to commercialize Symvess successfully. 60 Table of Contents For example, during its review of the Symvess BLA, the FDA identified concerns relating to mid-graft rupture or anastomotic failure of Symvess post-implantation.
We may never be able to increase sales of Symvess or our product candidates or meet our expectations with respect to revenues for a number of reasons, including: • a lack of acceptance of Symvess by physicians, patients, third-party payors and other members of the medical community; • our limited experience in marketing, selling and distributing Symvess or any other product; 63 Table of Contents • our limited experience in the commercial manufacturing of Symvess or any other product; • reimbursement and coverage policies of government and private payors such as Medicare, Medicaid, group purchasing organizations, insurance companies, health maintenance organizations and other plan administrators; • our ability to expand the current FDA-approved indications for Symvess into treatment of pediatric patients, treatment of a broader set of traumas, or indications outside of trauma; • emergence of new AEs associated with Symvess once the product is in commercial use or data suggesting that known AEs are more frequent or severe than originally thought; • changed or increased regulatory restrictions in the United States, EU, Israel and other foreign territories; and • a lack of adequate financial or other resources to commercialize Symvess successfully.
Accounting Standards Codification 815, Derivatives and Hedging (“ASC 815”), provides for the remeasurement of the fair value of such derivatives at each balance sheet date, with a resulting non-cash gain or loss related to the change in the fair value being recognized in earnings in the statement of operations.
Accounting Standards 99 Table of Contents Codification 815, Derivatives and Hedging (“ASC 815”), provides for the remeasurement of the fair value of such derivatives at each balance sheet date, with a resulting non-cash gain or loss related to the change in the fair value being recognized in earnings in the consolidated statements of operations and comprehensive loss.
Under certain circumstances, we could also be held liable for the activities of our employees, contractors, and partners that violate anti-corruption laws, even if we do not explicitly authorize or have actual knowledge of such activities. Even allegations of such violations could potentially damage our reputation and harm our business.
Under certain circumstances, we could also be held liable for the activities of our employees, contractors, and partners that violate anti-corruption laws, even if we do not explicitly authorize or have actual knowledge of such activities.
In addition, many countries limit the enforceability of patents against government agencies or government contractors. In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of those patents. This could limit our potential revenue opportunities.
In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of those patents. This could limit our potential revenue opportunities.
In addition, we had tax credit carryforwards for federal and state tax purposes of approximately $27.3 million as of December 31, 2024, which begin to expire in 2025 and will expire completely in 2044. The future utilization of net operating loss and tax credit carryforwards may be limited due to changes in ownership.
In addition, we had tax credit carryforwards for federal and state tax purposes of approximately $32.6 million as of December 31, 2025, which will begin to expire in 2026 and will expire completely in 2045. The future utilization of net operating loss and tax credit carryforwards may be limited due to changes in ownership.
Recent policy actions by the Trump administration, including the imposition of new tariffs on imported materials and goods from certain foreign countries, including Canada, Mexico and China, and the temporary freeze on federal grants and loans, may have an adverse impact on our business.
Ongoing policy actions by the Trump administration, including the imposition of new tariffs on imported materials and goods from many foreign countries, and the temporary freeze on federal grants and loans, may have an adverse impact on our business.
Our business currently depends heavily on our ability to successfully commercialize Symvess in the United States and in other jurisdictions where we may obtain marketing approval.
Our business currently depends heavily on our ability to increase sales of Symvess in the United States and in other jurisdictions where we may obtain marketing approval.
As of December 31, 2024, we had cash and cash equivalents of $44.9 million and restricted cash of $50.4 million , and as of December 31, 2023, we had cash and cash equivalents of $80.4 million and restricted cash of $0.4 million.
As of December 31, 2025, we had cash and cash equivalents of $50.5 million and restricted cash of $0.4 million , and as of December 31, 2024, we had cash and cash equivalents of $44.9 million and restricted cash of $50.4 million.
The FDA could also decide to consult an advisory committee as part of our BLA review process, which often leads to a longer review time.
The FDA could require us to submit major amendments to the BLA, which could lead to a longer review time. The FDA could also decide to consult an advisory committee as part of our BLA review process, which often leads to a longer review time.
Use of open label study designs further complicates the clinical development process. Because of these and other factors, we may experience substantial difficulties in agreeing with FDA and other regulatory authorities on clinical trial design. If our studies are not successful, we be delayed in obtaining marketing approval or may not receive marketing approval at all.
Because of these and other factors, we may experience substantial difficulties in agreeing with FDA and other regulatory authorities on clinical trial design. If our studies are not successful, we be delayed in obtaining marketing approval or may not receive marketing approval at all.
Furthermore, the FDA can waive orphan exclusivity if we are unable to manufacture sufficient supply of our product. 75 Table of Contents Inadequate funding for the FDA and other government agencies, including from government shut downs, global health concerns or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Inadequate funding for the FDA and other government agencies, including from government shut downs, global health concerns or other disruptions to these agencies’ operations, could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
The IRA is anticipated to have significant effects on the pharmaceutical industry and may reduce the prices pharmaceutical manufacturers can charge and the reimbursement pharmaceutical manufacturers can receive for approved products, among other effects. Lowering prescription drug prices was a stated priority of the Biden administration.
The IRA is having significant effects on the pharmaceutical industry and may reduce the prices pharmaceutical manufacturers can charge and the reimbursement pharmaceutical manufacturers can receive for approved products, among other effects. Lowering prescription drug prices was a stated priority of the Biden administration and resulted in additional drug pricing policies.
This could result in: • obtaining approval for indications or patient populations that are not as broad as intended or desired; • obtaining approval with, or later becoming subject to, labelling that includes significant use or distribution restrictions or significant safety warnings; • being subject to a REMS or equivalent requirement from a comparable foreign regulatory agency, to ensure that the benefits of a biological product outweigh its risks or to change the way the product is used; • being required to perform additional clinical trials to support approval or comparability or being subject to additional post-marketing testing requirements; • having regulatory authorities withdraw their approval of the product; • being sued; or • suffering damage to our reputation. 62 Table of Contents Any of these events could cause us to incur significant additional costs, significant delays and prevent us from achieving or maintaining market acceptance of or commercializing one or more of our product candidates.
This could result in: • obtaining approval for indications or patient populations that are not as broad as intended or desired; • obtaining approval with, or later becoming subject to, labelling that includes significant use or distribution restrictions or significant safety warnings; • being subject to a REMS or equivalent requirement from a comparable foreign regulatory agency, to ensure that the benefits of a biological product outweigh its risks or to change the way the product is used; • being required to perform additional clinical trials to support approval or comparability or being subject to additional post-marketing testing requirements; • having regulatory authorities withdraw their approval of the product; • being sued; or • suffering damage to our reputation.
Even minor deviations from normal manufacturing processes has resulted, and could in the future result, in reduced production yields, batch failures, product defects and other supply disruptions. For example, from time to time we have had multiple batch failures in succession. We believe we have identified the root cause of those failures and have implemented appropriate corrective actions.
Even minor deviations from normal manufacturing processes has resulted, and could in the future result, in reduced production yields, batch failures, product defects and other supply disruptions. For example, from time to time we have had multiple batch failures in succession.
Our ability to use our net operating loss and tax credit carryforwards to offset future taxable income may be subject to certain limitations. As of December 31, 2024, we had net operating loss carryforwards for federal and state tax purposes of approximately $465.0 million and $471.7 million, respectively, which begin to expire in 2025.
Our ability to use our net operating loss and tax credit carryforwards to offset future taxable income may be subject to certain limitations. As of December 31, 2025, we had net operating loss carryforwards for federal and state tax purposes of approximately $599.4 million and $614.8 million, respectively, which began to expire in 2025.
We are currently enrolling patients in several clinical trials, including in our V012 trial, which is a Phase 3 clinical trial comparing the safety and efficacy of our 6 millimeter ATEV to AV fistula for hemodialysis access in women. Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success.
We are currently enrolling patients in several clinical trials, including in our V012 trial, which is a Phase 3 clinical trial comparing the safety and efficacy of our 6 millimeter ATEV to AV fistula for hemodialysis access in women, and may in the future enroll patients in other clinical trials.
If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively and our business may be adversely affected. 88 Table of Contents Intellectual property rights do not necessarily address all potential threats.
Opposition or cancellation proceedings may be filed against our trademarks, and our trademarks may not survive such proceedings. If we are unable to establish name recognition based on our trademarks and trade names, we may not be able to compete effectively and our business may be adversely affected. Intellectual property rights do not necessarily address all potential threats.
Even though we received FDA approval to market Symvess in the United States, we must comply with the numerous and varying regulatory and compliance related requirements of other countries, including the submission of extensive preclinical and clinical data, manufacturing and quality information regarding the process and facility, scientific data characterizing the relevant product candidate and other supporting data in order to establish safety and effectiveness. 74 Table of Contents Approval procedures vary among countries and can involve additional product testing and additional administrative review periods, including obtaining reimbursement and pricing approval in select markets.
Even though we received FDA approval to market Symvess in the United States, we must comply with the numerous and varying regulatory and compliance related requirements of other countries, including the submission of extensive preclinical and clinical data, manufacturing and quality information regarding the process and facility, scientific data characterizing the relevant product candidate and other supporting data in order to establish safety and effectiveness.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Item 1C. Cybersecurity. Cybersecurity Risk Management and Strategy We have certain processes for assessing, identifying, and managing material risks from cybersecurity threats, which are integrated into our enterprise risk management processes. Specifically, we have processes for: • Identifying and Managing Cybersecurity Risks — We have implemented a cross-functional approach to assessing, identifying and managing material cybersecurity threats and incidents.
Item 1C. C ybersecurity. Cybersecurity Risk Management and Strategy We have certain processes for assessing, identifying, and managing material risks from cybersecurity threats, which are integrated into our enterprise risk management processes. Specifically, we have processes for: • Identifying and Managing Cybersecurity Risks — We have implemented a cross-functional approach to assessing, identifying and managing material cybersecurity threats and incidents.
Any material cybersecurity incidents are promptly reported by management to our Audit Committee. 96 Table of Contents We use an internal management committee to run our information and technology function, comprised of information technology, finance, and legal employees, and led by our Vice President – Information Technology and Automation, and Chief Financial Officer, each of whom have experience managing the information and technology functions, and cybersecurity safeguards, at multiple prior companies.
We use an internal management committee to run our information and technology function, comprised of information technology, finance, and legal employees, and led by our Vice President – Information Technology and Automation, and Chief Financial Officer, each of whom have experience managing the information and technology functions, and cybersecurity safeguards, at multiple prior companies.
The Audit Committee of our Board of Directors meets not less than annually to discuss our approach to overseeing cybersecurity threats with management, including with members of our internal cybersecurity team.
The Audit Committee of our Board of Directors meets not less than annually 104 Table of Contents to discuss our approach to overseeing cybersecurity threats with management, including with members of our internal cybersecurity team. Any material cybersecurity incidents are promptly reported by management to our Audit Committee.

Item 2. Properties

Properties — owned and leased real estate

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Item 2. Properties. Our corporate headquarters, manufacturing, and research and development facilities are located in Durham, North Carolina where we lease approximately 83,000 square feet of space. This space includes approximately 55,000 square feet for production and distribution operations including manufacturing, bioprocessing, quality control, mechanical space and inventory. The remainder of the facility consists of offices, laboratories, and common spaces.
Item 2. Pr operties. Our corporate headquarters, manufacturing, and research and development facilities are located in Durham, North Carolina where we lease approximately 83,000 square feet of space. This space includes approximately 55,000 square feet for production and distribution operations including manufacturing, bioprocessing, quality control, mechanical space and inventory.
Added
The remainder of the facility consists of offices, laboratories, and common spaces.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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The complaints in each action assert claims for violations of Section 14(a) of the Exchange Act, breach of fiduciary duty, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets, based on a variety of allegations including claims that the defendants are responsible for any damages sustained by the Company as a result of the Securities Litigation.
The complaints in each action assert claims for violations of Section 14(a) of the Exchange Act, breach of fiduciary duty, unjust enrichment, abuse of control, gross mismanagement, and waste of corporate assets, based on a variety of allegations including 105 Table of Contents claims that the defendants are responsible for any damages sustained by the Company as a result of the Securities Litigation.
Item 3. Legal Proceedings On November 18, 2024, James A. Cutshall filed a putative class action lawsuit, captioned Cutshall v. Humacyte, Inc., et al ., No. 1:24-cv-00954 (the “Securities Litigation”), against the Company and certain of the Company’s officers in the United States District Court for the Middle District of North Carolina.
Item 3. Le gal Proceedings On November 18, 2024, James A. Cutshall filed a putative class action lawsuit, captioned Cutshall v. Humacyte, Inc., et al ., No. 1:24-cv-00954 (the “Securities Litigation”), against the Company and certain of the Company’s officers in the United States District Court for the Middle District of North Carolina.
On March 11, 2025, the parties entered a joint motion to stay the Consolidated Derivative Action pending final resolution of the Securities Litigation.
On March 11, 2025, the parties entered a joint motion to stay the Consolidated Derivative Action pending final resolution of the Securities Litigation, which the court granted.
On January 7 and 10, 2025, putative stockholders of the Company filed two verified stockholder derivative actions in the United States District Court for the Middle District of North Carolina, captioned Silva v. Sebelius, et al ., No. 1:25-cv-00005 (the “ Silva Action”) and Misko v. Niklason, et al ., No. 1:25-cv-00028 (the “ Misko Action”).
The court has yet to rule on the motion, which remains pending. On January 7 and 10, 2025, putative stockholders of the Company filed two verified stockholder derivative actions in the United States District Court for the Middle District of North Carolina, captioned Silva v. Sebelius, et al ., No. 1:25-cv-00005 (the “ Silva Action”) and Misko v.
On March 24, 2025, the court granted the parties’ joint motion to stay the Consolidated Derivative Action. 97 Table of Contents On December 19, 2024, the Company received a demand letter (the “Demand Letter”) from a purported stockholder of the Company, demanding that the Board assert claims against certain of the Company’s current or former officers and directors for breach of fiduciary duty, gross mismanagement, corporate waste, unjust enrichment, aiding and abetting, violations of Section 14(a) of the Exchange Act, and insider trading, based on a variety of allegations including claims that the Company’s current and former officers and directors are responsible for any damages sustained by the Company as a result of the Securities Litigation.
On December 19, 2024, the Company received a demand letter (the “Demand Letter”) from a purported stockholder of the Company, demanding that the Board assert claims against certain of the Company’s current or former officers and directors for breach of fiduciary duty, gross mismanagement, corporate waste, unjust enrichment, aiding and abetting, violations of Section 14(a) of the Exchange Act, and insider trading, based on a variety of allegations including claims that the Company’s current and former officers and directors are responsible for any damages sustained by the Company as a result of the Securities Litigation.
The Complaint seeks a variety of relief, including unspecified compensatory damages, attorneys fees and costs. On January 31, 2025, the court appointed co-lead plaintiffs.
The Complaint seeks a variety of relief, including unspecified compensatory damages, attorneys fees and costs. On January 31, 2025, the court appointed co-lead plaintiffs. On May 22, 2025, the co-lead plaintiffs filed the amended complaint in the Securities Litigation.
See the section “Legal Matters” contained in Note 13 — Commitments and Contingencies in the notes to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K for additional information. Item 4. Mine Safety Disclosures. None. 98 Table of Contents Part II
See the sec tion “Legal Matters” contained in Note 14, Commitments and Contingencies in the notes to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K for additional information. Item 4. Mi ne Safety Disclosures. None. 106 Table of Contents Par t II
Each of these derivative actions was brought on behalf of the Company against certain of its current or former directors and officers, as well as Ayabudge LLC.
Niklason, et al ., No. 1:25-cv-00028 (the “ Misko Action”). Each of these derivative actions was brought on behalf of the Company against certain of its current or former directors and officers, as well as Ayabudge LLC.
The Company disputes all claims asserted against it in the Securities Litigation and disputes that the plaintiffs in the Consolidated Derivative Action and Olson Action have standing to assert claims derivatively on its behalf. The Company is currently unable to estimate the potential loss or range of loss, if any, associated with these lawsuits, which could be material.
The Company disputes all claims asserted against it in the Securities Litigation and disputes that the plaintiffs in the Consolidated Derivative Action, the Dusci Action and Olson Action have standing to assert claims derivatively on its behalf.
Removed
On February 19, 2025, the court entered a scheduling order directing the co-lead plaintiffs to file a consolidated amended complaint by April 24, 2025 and the defendants to answer or otherwise respond to the amended complaint by June 27, 2025.
Added
The amended complaint expands the putative class to include persons and entities that purchased or otherwise acquired securities of the Company between August 14, 2023 and March 25, 2025.
Added
It alleges that the defendants made or were responsible for false or misleading statements and omissions related to the safety of Symvess, alleged deficiencies at the Company’s Durham, North Carolina manufacturing facility, and the Company’s financial condition and liquidity. On July 25, 2025, defendants moved to dismiss the amended complaint in its entirety and with prejudice.
Added
On April 22, 2025, the parties filed a joint motion to stay the Olson Action pending final resolution of the Securities Litigation, which the court granted.
Added
On May 19, 2025, the Company received a demand letter (the “2025 Demand Letter”) from a purported stockholder of the Company, making demands and stating allegations substantially similar to those in the 2024 Demand Letter.
Added
The letter was referred to the demand evaluation committee for evaluation, and the demand evaluation committee recommended that the board of directors of the Company defer action on the demand until after the resolution of the pending motion to dismiss in the securities class action.
Added
The board of directors accepted the demand evaluation committee’s recommendation, and counsel for the demand evaluation committee informed the shareholder of the board of director’s determination to defer action on the demand by letter dated September 24, 2025.
Added
On June 9, 2025, a putative stockholder of the Company filed a verified stockholder derivative action in the United States District Court for the District of Delaware, captioned Dusci v. Bamforth, et al ., No. 1:25-cv-00722 (the “Dusci Action”).
Added
The complaint in the Dusci Action asserts substantive claims and allegations that are substantively similar to those asserted in the Consolidated Derivative Action and Olson Action. On September 8, 2025, the parties field a joint stipulation to stay the Dusci Action, pending final resolution of the Securities Litigation, which the court granted.
Added
The Company is currently unable to estimate the potential loss or range of loss, if any, associated with these lawsuits, which could be material.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Any decision to declare and pay dividends in the future will be made at the sole discretion of our Board will depend on, among other things, our results of operations, cash requirements, financial condition, contractual restrictions and other factors that our board of directors may deem relevant. Item 6. [Reserved]
Any decision to declare and pay dividends in the future will be made at the sole discretion of our Board will depend on, among other things, our results of operations, cash requirements, financial condition, contractual restrictions and other factors that our board of directors may deem relevant.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is currently listed on The Nasdaq Global Select Market under the symbol “HUMA.” As of March 27, 2025, there were 181 holders of record of our common stock.
Item 5. Ma rket for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is currently listed on The Nasdaq Global Select Market under the symbol “HUMA.” As of March 24, 2026, there were 180 holders of record of our common stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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The determination of the grant date fair value of options using an option pricing model is affected principally by our estimated fair value of shares of our common stock and requires management to make a number of other assumptions, including the expected term of the option, the volatility of the underlying shares, the risk-free interest rate and expected dividends.
The determination of the grant date fair value of stock options using an option pricing model is affected principally by our estimated fair value of shares of our common stock and requires management to make a number of other assumptions, including the expected term of the option, the volatility of the underlying shares, the risk-free interest rate and expected dividends.
On December 19, 2024, the FDA granted full approval for the ATEV under the brand name Symvess TM for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible.
On December 19, 2024, the FDA granted full approval for the ATEV under the brand name Symvess ® for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible.
See Note 8 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K for further information regarding our leases.
See Note 9 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K for further information regarding our leases.
We have existing license agreements with Duke University and Yale University, a distribution agreement with Fresenius Medical Care and our JDRF Agreement. The amount and timing of any potential milestone payments, license fee payments, royalties and other payments that we may be required to make under these agreements are unknown or uncertain at December 31, 2024.
We have existing license agreements with Duke University and Yale University, a distribution agreement with Fresenius Medical Care and our JDRF Agreement. The amount and timing of any potential milestone payments, license fee payments, royalties and other payments that we may be required to make under these agreements are unknown or uncertain at December 31, 2025.
At December 31, 2024, the revenue interest liability is calculated using our current estimate of forecasted global net sales of our products, and impacted by a debt discount comprising the estimated fair value of a bifurcated derivative liability related to the Purchasers’ put option under the Purchase Agreement, the estimated fair value of a freestanding option agreement related to the Purchase Agreement, and issuance and transaction costs incurred.
At December 31, 2024, the revenue interest liability was calculated using our current estimate of forecasted global net sales of our products, and impacted by a debt discount comprising the estimated fair value of a bifurcated derivative liability related to the Purchasers’ put option under the Purchase Agreement, the estimated fair value of a freestanding option agreement related to the Purchase Agreement, and issuance and transaction costs incurred.
Our future funding requirements, both short-term and long-term, will depend on many factors, including: • the cost and timing of our future commercialization activities, including product manufacturing, marketing and distribution for Symvess in the United States, and any other product candidate for which we receive marketing approval in the future; • the amount and timing of revenues, if any, that we receive from commercial sales of Symvess and any product candidates for which we receive marketing approval; • the progress and results of our clinical trials and interpretation of those results by the FDA and other regulatory authorities; • the cost, timing and outcome of regulatory review of our product candidates, particularly for marketing approval of Symvess outside of the United States and of our product candidates in the United States; 108 Table of Contents • the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our additional product candidates; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and • the costs of operating as a public company, including hiring additional personnel as well as increased director and officer insurance premiums, audit and legal fees, and expenses for compliance with public company reporting requirements under the Exchange Act and rules implemented by the SEC and Nasdaq.
Our future funding requirements, both short-term and long-term, will depend on many factors, including: • the cost and timing of our ongoing sales and future commercialization activities, including product manufacturing, marketing and distribution for Symvess in the United States, and any other product candidate for which we receive marketing approval in the future; • the amount and timing of revenues, which we receive from commercial sales of Symvess and any product candidates for which we receive marketing approval; 119 Table of Contents • the progress and results of our clinical trials and interpretation of those results by the FDA and other regulatory authorities; • the cost, timing and outcome of regulatory review of our product candidates, particularly for marketing approval of Symvess outside of the United States and of our product candidates in the United States; • the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for our additional product candidates; • the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims; and • the costs of operating as a public company, including hiring additional personnel as well as increased director and officer insurance premiums, audit and legal fees, and expenses for compliance with public company reporting requirements under the Exchange Act and rules implemented by the SEC and Nasdaq.
Cash Flow from Financing Activities Net cash provided by financing activities for the year ended December 31, 2024 consisted primarily of $43.1 million of net proceeds from our Registered Direct Offerings we completed in October and November 2024, $43.0 million of net proceeds from our Offering we completed in March 2024 and $19.5 million of net proceeds from our Purchase Agreement.
Net cash provided by financing activities for the year ended December 31, 2024 consisted primarily of $43.1 million of net proceeds from our Registered Direct Offerings we completed in October and November 2024, $43.0 million of net proceeds from our Public Offering we completed in March 2024 and $19.5 million of net proceeds from our Purchase Agreement.
We recorded a revenue interest liability related to the Purchase Agreement on our consolidated balance sheet on the date we entered into the Purchase Agreement, which is presented net of issuance costs and a debt discount. We impute interest expense associated with this liability using the interest method.
We recorded a revenue interest liability related to the Purchase Agreement on our consolidated balance sheet on the date we entered into the Purchase Agreement, which is presented net of issuance costs and a debt discount. We imputed interest expense associated with this liability using the interest method.
The estimated probability and timing of underlying events triggering the exercisability of the contingent derivative liability bifurcated from within the Purchase Agreement, forecasted cash flows and the discount rate are significant unobservable inputs used to determine the estimated fair value of the entire instrument with the embedded derivative.
The estimated probability and timing of underlying events triggering the exercisability of the contingent derivative liability bifurcated from within the Purchase Agreement, forecasted cash flows and the discount rate were significant unobservable inputs used to determine the estimated fair value of the entire instrument with the embedded derivative.
We control the timing and amount of any sales to Lincoln Park. As of December 31, 2024 , we had completed sales of shares under the Common Stock Purchase Agreement that provided $2.5 million in gross proceeds.
We control the timing and amount of any sales to Lincoln Park. As of December 31, 2025, we had completed sales of shares under the Common Stock Purchase Agreement that provided $2.5 million in gross proceeds.
For additional information regarding our agreements with Duke University, Yale University, and Fresenius Medical Care, and the nature of payments that could become due thereunder, see the sections in this Annual Report on Form 10-K titled “Business — Distribution” and “Business — Intellectual Property.” For additional information about our JDRF Agreement, see Note 13 — Commitments and Contingencies to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K .
For additional information regarding our agreements with Duke University, Yale University, and Fresenius Medical Care, and the nature of payments that could become due thereunder, see the sections in this Annual Report on Form 10-K titled “Business — Distribution” and “Business — Intellectual Property.” For additional information about our JDRF Agreement, see Note 14 to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K.
We are leveraging our novel, scalable technology platform to develop proprietary bioengineered, acellular human tissues for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. 99 Table of Contents We are initially using our proprietary, scientific technology platform to engineer and manufacture ATEVs.
We are leveraging our novel, scalable technology platform to develop proprietary bioengineered, acellular human tissues for use in the treatment of diseases and conditions across a range of anatomic locations in multiple therapeutic areas. We are initially using our proprietary, scientific technology platform to engineer and manufacture ATEVs.
The mid-point between the vesting date and the maximum contractual expiration date is used as 111 Table of Contents the expected term under this method. For awards with multiple vesting-tranches, the times from grant until the mid-points for each of the tranches may be averaged to provide an overall expected term. • Expected Volatility .
The mid-point between the vesting date and the maximum contractual expiration date is used as the expected term under this method. For awards with multiple vesting-tranches, the times from grant until the mid-points for each of the tranches may be averaged to provide an overall expected term. • Expected Volatility .
(formerly known as Alpha Healthcare Acquisition Corp.) and its consolidated subsidiaries (including Humacyte Global, Inc.) following the Merger (defined below); references to “Legacy Humacyte” refer to Humacyte, Inc. prior to the Merger; and references to “AHAC” refer to Alpha Healthcare Acquisition Corp. prior to the Merger.
(formerly known as Alpha Healthcare Acquisition Corp.) and its consolidated subsidiaries following the Merger (defined below); references to “Legacy Humacyte” refer to Humacyte, Inc. prior to the Merger; and references to “AHAC” refer to Alpha Healthcare Acquisition Corp. prior to the Merger.
On October 4, 2024, we entered into a securities purchase agreement with an institutional investor pursuant to which the investor purchased approximately $30.0 million worth of Common Stock and warrants in the October 2024 Registered Direct Offering (as defined below).
On October 4, 2024, we entered into a securities purchase agreement with an institutional investor pursuant to which the investor purchased approximately $30.0 million worth of Common Stock and warrants in the October 2024 Registered Direct Offering (as defined in Note 10).
On November 13, 2024, we entered into a securities purchase agreement with an institutional investor pursuant to which the investor purchased approximately $15.0 million worth of Common Stock and warrants in the November 2024 Registered Direct Offering (as defined below).
On November 13, 2024, we entered into a securities purchase agreement with an institutional investor pursuant to which the investor purchased approximately $15.0 million worth of Common Stock and warrants in the November 2024 Registered Direct Offering (as defined in Note 10).
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our accompanying consolidated financial statements and related notes contained in Part II, Item 8 of this Annual Report on Form 10-K.
Item 7. Ma nagement’s Discussion and Analysis of Financial Condition and Results of Operations The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our accompanying consolidated financial statements and related notes contained in Part II, Item 8 of this Annual Report on Form 10-K.
As of March 31, 2025 , we had $47.5 million in remaining availability for sales of our Common Stock under our Common Stock Purchase Agreement with Lincoln Park.
As of December 31, 2025, we had $47.5 million in remaining availability for sales of our Common Stock under our Common Stock Purchase Agreement with Lincoln Park.
Costs related to development activities which broadly support multiple programs using our technology platform, including personnel, materials and supplies, external services costs, and other internal expenses, such as facilities and overhead costs, are not allocated to 102 Table of Contents individual research and development programs.
Costs related to development activities which broadly support multiple programs using our technology platform, including personnel, materials and supplies, external services costs, and other internal expenses, such as facilities and overhead costs, are not allocated to individual research and development programs.
An accounting estimate or assumption is considered critical if both (a) the nature of the estimate or assumption involves a significant level of estimation uncertainty, and (b) the impact within a reasonable range of outcomes of the estimate and assumption is material to our financial condition. Our critical accounting policies are summarized below.
An accounting estimate or assumption is considered critical if both (a) the nature of the estimate or assumption involves a significant level of estimation uncertainty, and (b) the impact within a reasonable range of outcomes of the estimate and assumption is material to our financial condition.
Pursuant to the Purchase Agreement, and subject to customary closing conditions, the Purchasers purchased certain revenue interests (the “Revenue Interests”) from us in exchange for an aggregate investment amount of up to $150.0 million (the “Investment Amount”).
Pursuant to the Purchase Agreement, and subject to customary closing conditions, the Purchasers purchased certain revenue interests from us in exchange for an aggregate investment amount of up to $150.0 million.
In addition to extremity vascular trauma, we and our collaborators are currently conducting Phase 3 and Phase 2 trials of our 6 millimeter ATEV in AV access for hemodialysis and PAD. We were granted Fast Track designation by the FDA for our 6 millimeter ATEV for use in AV access for hemodialysis in 2014.
In addition to extremity vascular trauma, we are currently conducting a Phase 3 trial of our 6 millimeter ATEV in AV access for hemodialysis, and previously completed Phase 2 trials in PAD. We were granted Fast Track designation by the FDA for our 6 millimeter ATEV for use in AV access for hemodialysis in 2014.
Contingent Earnout Liability In connection with the Reverse Recapitalization, Legacy Humacyte equity holders are entitled to receive as additional merger consideration of up to 15,000,000 shares of our common stock in the aggregate, in two equal tranches of 7,500,000 shares of common stock per tranche, for no consideration upon the occurrence of certain triggering events, including a change of control event that is not solely indexed to the common stock.
Our critical accounting policies are summarized below. 121 Table of Contents Contingent Earnout Liability In connection with the Reverse Recapitalization, Legacy Humacyte equity holders are entitled to receive as additional merger consideration of up to 15,000,000 shares of our common stock in the aggregate, in two equal tranches of 7,500,000 shares of common stock per tranche, for no consideration upon the occurrence of certain triggering events, including a change of control event, that is not solely indexed to the common stock.
Net cash flows used in operating activities were $98.1 million and $73.3 million during the years ended December 31, 2024 and 2023, respectively. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations.
Net cash flows used in operating activities were $105.0 million and $98.1 million during the years ended December 31, 2025 and 2024, respectively. Substantially all of our operating losses resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations.
Dependent upon interim results from our ongoing V012 Phase 3 trial in women, we plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026. 100 Table of Contents We have generated no product revenue and incurred operating losses and negative cash flows from operations in each year since our inception in 2004.
Dependent upon interim results from our ongoing V012 Phase 3 trial in women, we plan to submit a supplemental BLA for the ATEV to the FDA for an indication in AV access for hemodialysis in the second half of 2026. Since its inception in 2004, we have incurred operating losses and negative cash flows from operations in each year.
We are also developing the ATEV for CABG and pediatric heart surgery. Over the longer term, we are developing our ATEV for the delivery of cellular therapies, including pancreatic islet cell transplantation to treat Type 1 diabetes (our BVP).
We are also developing a smaller diameter blood vessel, the CTEV for CABG and pediatric heart surgery. Over the longer term, we are developing our ATEV for the delivery of cellular therapies, including pancreatic islet cell transplantation to treat Type 1 diabetes (our BVP).
See Note 6 for further information. 106 Table of Contents On February 29, 2024, we entered into an underwriting agreement with Cowen and Company, LLC and Cantor & Fitzgerald & Co., as representatives of the several underwriters named therein, relating to the issuance and sale in an underwritten offering (the “Offering”) of 15,410,000 shares of our Common Stock at a price to the public of $3.00 per share.
On February 29, 2024, we entered into an underwriting agreement with TD Cowen and Company, LLC and Cantor & Fitzgerald & Co., as representatives of the several underwriters named therein, relating to the issuance and sale in an underwritten offering (the “Offering”) of 15,410,000 shares of our Common Stock at a price to the public of $3.00 per share.
From inception through December 31, 2024, we have been awarded grants, including grants from the California Institute of Regenerative Medicine (“CIRM”), NIH, and the DoD, to support our development, production scaling and clinical trials of our product candidates.
The remainder of our revenue has been derived from contracts. From inception through December 31, 2025, we have been awarded grants, including grants from the California Institute of Regenerative Medicine (“CIRM”), NIH, and the DoD, to support our development, production scaling and clinical trials of our product candidates.
Total Other Income (Expense), net Total other expense, net was $34.3 million for the year ended December 31, 2024, compared to net expense of $10.7 million for the year ended December 31, 2023.
Total Other Income (Expense), net Total other income, net was $67.3 million for the year ended December 31, 2025, compared to net expense of $34.3 million for the year ended December 31, 2024.
Under the terms of the Purchase Agreement, $40.0 million of the Investment Amount , less certain transaction expenses, was funded o n May 12, 2023, which was used to repay in full all and retire our indebtedness under our loan agreement with SVB, with the remaining proceeds funded to the Company .
Under the terms of the Purchase Agreement, $40.0 million of the investment amount, less certain transaction expenses, was funded on May 12, 2023, and was used to repay in full and retire our indebtedness under our loan agreement with Silicon Valley Bank, with the remaining proceeds funded to the Company.
Our future contractual obligations under our lease agreements as of December 31, 2024 are as follows: ($ in thousands) Total Less than 1 year 1 – 3 years 3 – 5 years More than 5 years Finance leases $ 21,431 $ 4,212 $ 7,000 $ 4,447 $ 5,772 Operating lease 784 105 210 210 259 Future Funding Requirements We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) commercialize Symvess and seek marketing approval for Symvess in additional indications and for our product candidates in the United States and to obtain marketing approval for our 6 millimeter ATEV outside of the United States, (ii) continue clinical development of our 6 millimeter ATEV for use in hemodialysis AV access and submit a BLA for FDA approval of an indication in hemodialysis AV access, (iii) advance our pipeline in major markets, including PAD Phase 3 trials and continue preclinical development and advance to planned clinical studies in CABG and BVP for diabetes, and (iv) scale out our manufacturing facility as required to satisfy market demand.
Our future contractual obligations under our lease agreement as of December 31, 2025 are as follows: ($ in thousands) Total Less than 1 year 1 – 3 years 3 – 5 years More than 5 years Finance leases $ 61,165 $ 2,428 $ 2,199 $ 7,180 $ 49,358 Future Funding Requirements We expect to incur significant expenses in connection with our ongoing activities as we seek to (i) continue to sell Symvess for the vascular trauma indication and seek marketing approval for Symvess in additional indications and for our product candidates in the United States and to obtain marketing approval for our 6 millimeter ATEV outside of the United States, (ii) continue clinical development of our 6 millimeter ATEV for use in hemodialysis AV access and submit a BLA for FDA approval of an indication in hemodialysis AV access, (iii) advance our pipeline in major markets, including PAD Phase 3 trials and continue preclinical development and advance to planned clinical studies in CABG and BVP for diabetes, and (iv) scale out our manufacturing facility as required to satisfy market demand.
If we are unable to raise capital, we could be forced to delay, reduce, suspend or cease our research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. See “Risk Factors” for additional information.
If we are unable to raise capital, we plan to implement a program to delay, reduce, suspend or cease our planned capital expenditures, research and development programs or 109 Table of Contents any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition. See “Risk Factors” for additional information.
Our ability to generate product revenue will depend on the successful development and commercialization of Symvess and our product candidates.
Our ability to generate sufficient product revenue to finance our operations will depend on the successful commercialization of Symvess and the advancement of our product candidates.
The assumptions utilized in the calculation were based on the achievement of certain stock price milestones, including our current common stock price, expected volatility, risk-free rate, expected term and expected dividend yield.
The assumptions utilized in the calculation were based on the achievement of certain stock price milestones, including the expected volatility and expected term, as well as certain data inputs, including the Company’s common stock price, risk-free interest rate, and expected dividend yield.
As of December 31, 2024 and 2023, we had an accumulated deficit of $686.0 million and $537.3 million, respectively, and working capital of $27.9 million and $64.8 million, respectively. Our operating losses were approximately $114.4 million and $100.0 million for the years ended December 31, 2024 and 2023, respectively.
As of December 31, 2025 and 2024, we had an accumulated deficit of $726.8 million and $686.0 million, respectively, and working capital of $49.4 million and $27.9 million, respectively. Our operating losses were approximately $108.1 million and $114.4 million for the years ended December 31, 2025 and 2024, respectively.
Material Cash Requirements Our known material cash requirements include: (1) the purchase of supplies and services that are primarily for research and development; (2) repayments pursuant to the Purchase Agreement (for additional information see below and Note 6 to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K); (3) employee wages, benefits, and incentives; (4) financing and operating lease payments (for additional information see below and Note 8 to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K), and (5) payments under our JDRF Agreement (for additional information see Note 13 to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K).
Material Cash Requirements Our known material cash requirements include: (1) the purchase of supplies and services that are primarily for research and development; (2) manufacturing and commercialization expenditures; (3) employee wages, benefits, and incentives; (4) financing and operating lease payments (for additional information see below and Note 9, Leases to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K); (5) debt service obligations under our senior secured Term Loan Facility (for additional information see below and Note 8, Debt to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K); and (6) payments under our JDRF Agreement (for additional information see Note 14, Commitments and Contingencies to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K).
We have not paid dividends on our Common Stock nor do we expect to pay dividends in the foreseeable future. Accordingly, we have estimated the dividend yield to be zero.
We have not paid dividends on our Common Stock nor do we expect to pay dividends in the foreseeable future.
Common Stock Warrants Public and Private Placement Warrants Under the Merger, we assumed 5,000,000 publicly-traded warrants (“Public Warrants”) and 177,500 private placement warrants issued to AHAC in connection with AHAC’s initial public offering (“Private Placement Warrants” and, together with the Public Warrants, the “Common Stock Warrants”).
Accordingly, we have estimated the dividend yield to be zero. 123 Table of Contents Common Stock Warrants Public and Private Placement Warrants Under the Merger, we assumed 5,000,000 publicly-traded warrants (“Public Warrants”) and 177,500 private placement warrants issued to AHAC in connection with AHAC’s initial public offering (“Private Placement Warrants” and, together with the Public Warrants, the “Common Stock Warrants”).
ATM Facility On September 1, 2022, we entered into an agreement with Jefferies LLC for the sale from time to time of up to $80.0 million of shares of Common Stock pursuant to a sales agreement (the “ATM Facility”).
ATM Facilities On September 1, 2022, we entered into a sales agreement with Jefferies LLC, acting as sales agent (the “Jefferies ATM Sales Agreement”) for the sale from time to time of up to $80.0 million of shares of Common Stock (the “Jefferies ATM Facility”).
We account for the Common Stock Warrants in accordance with the guidance contained in ASC Topic 480, Distinguishing Liabilities from Equity ( “ASC 480”) and ASC Topic 815, Derivatives and Hedging ( “ASC 815”) .
We account for the Common Stock Warrants in accordance with the guidance contained in ASC Topic 480, “Distinguishing Liabilities from Equity” (“ASC 480”) and ASC Topic 815, “Derivatives and Hedging” (“ASC 815”).
Our research and development expenses consist primarily of: • salaries and related overhead expenses for personnel in research and development functions, including stock-based compensation and benefits; • fees paid to CROs and consultants, including in connection with our clinical trials, and other related clinical trial fees, such as for clinical site fees and investigator grants related to patient screening and treatment, conduct of clinical trials, laboratory work and statistical compilation and analysis; • allocation of facility lease and maintenance costs; • depreciation of leasehold improvements, laboratory equipment and computers; • costs related to purchasing raw materials and producing our product candidates for clinical trials; • costs related to compliance with regulatory requirements; • costs related to our manufacturing development and expanded-capabilities initiatives; and • license fees related to in-licensed technologies.
Our research and development expenses consist primarily of: • salaries and related overhead expenses for personnel in research and development functions, including stock-based compensation and benefits; • fees paid to CROs and consultants, including in connection with our clinical trials, and other related clinical trial fees, such as for clinical site fees and investigator grants related to patient screening and treatment, conduct of clinical trials, laboratory work and statistical compilation and analysis; • allocation of facility lease and maintenance costs; • depreciation of leasehold improvements, laboratory equipment and computers; • costs related to purchasing raw materials and producing our product candidates for clinical trials; • costs related to compliance with regulatory requirements; • costs related to our manufacturing development and expanded-capabilities initiatives; and • license fees related to in-licensed technologies. 111 Table of Contents The majority of our research and development resources are currently focused on our Phase 2 and 3 clinical trials for our 6 millimeter ATEV and other work needed to obtain marketing approval for our 6 millimeter ATEV for use for in AV access in hemodialysis in the United States.
We also granted the underwriters a 30-day option to purchase up to an additional 3,750,000 shares of Common Stock at the same price as the Firm Shares. The net proceeds to us from the Public Offering were approximately $46.6 million after deducting underwriting discounts and commissions and estimated Public Offering expenses. The Public Offering closed on March 27, 2025.
We also granted the underwriters a 30-day option to purchase up to an additional 3,750,000 shares of Common Stock at the same price per share, which was not exercised by the underwriters. The net proceeds to us from the public offering were approximately $46.7 million after deducting underwriting discounts and commissions and estimated public offering expenses.
Major changes in expenses included a $2.6 million increase in salaries and benefits due to the recruitment and hiring of a sales force for Symvess and other expansion of the commercial team, and a $1.3 million increase in professional fees, partially offset by a $1.8 million decrease in non-cash stock compensation expense.
Major changes in expenses included a $5.3 million increase in salaries and benefits due to the recruitment and hiring of a sales force for Symvess and other expansion of the commercial team, and a $0.8 million increase in professional fees, partially offset by a $1.4 million decrease in external services and consulting expenses.
The “with-and-without” methodology involves valuing the whole instrument on an as-is basis and then valuing the instrument without the individual embedded derivative. The difference between the entire instrument with the embedded derivative compared to the instrument without the embedded derivative was the fair value of the contingent derivative liability.
The fair value of the contingent derivative liability was valued using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis and then valuing the instrument without the individual embedded derivative.
See Note 9 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K for further information regarding the assumptions used in the valuations at December 31, 2024 and 2023. 110 Table of Contents The Contingent Earnout Shares are categorized as a Level 3 fair value measurement (see “Fair Value of Financial Instruments” accounting policy described in Note 2 to our financial statements contained elsewhere in this Annual Report on Form 10-K) because we estimated projections over a ten-year period utilizing unobservable inputs.
The Contingent Earnout Shares are categorized as a Level 3 fair value measurement (see “Fair Value of Financial Instruments” accounting policy described in Note 2, Summary of Significant Accounting Policies to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K) because we estimated projections over a ten-year period utilizing unobservable inputs.
In December 2024, we sold an aggregate of 1,333,596 shares of Common Stock under the ATM Facility at an average price of $5.26 per share for net proceeds of approximately $6.8 million after deducting sales commissions of approximately $0.2 million .
In December 2024, we sold an aggregate of 1,333,596 shares of Common Stock under the Jefferies ATM Facility at an average price of $5.26 per share for net proceeds of approximately $6.8 million. In the year ended December 31, 2025, the Company completed sales of shares under the Jefferies ATM Facility that provided net proceeds of approximately $10.0 million.
We anticipate that our expenses will increase substantially as we seek to: • commercialize Symvess via U.S. market launch for indications in vascular trauma and, if approved, in AV access for hemodialysis; • obtain marketing approval for our 6 millimeter ATEV in additional indications involving vascular repair, reconstruction and replacement, including in AV access for hemodialysis; • scale out our manufacturing facility to the extent required to satisfy potential market demand for Symvess in the United States and our product candidates, following receipt of any regulatory approval; • continue our preclinical and clinical development efforts; • maintain, expand and protect our intellectual property portfolio; • add operational, financial and management information systems and personnel to support, among other things, our product development and commercialization efforts and operations; and • continue operating as a public company, which includes higher costs associated with hiring additional personnel, director and officer insurance premiums, audit and legal fees and expenses for compliance with public company reporting requirements under the Exchange Act and rules implemented by the SEC and The Nasdaq Stock Market LLC (“Nasdaq”). 101 Table of Contents Recent Developments On March 25, 2025, we entered into an underwriting agreement with TD Securities (USA) LLC, Barclays Capital Inc. and BTIG, LLC, as representatives of the several underwriters named therein, relating to the issuance and sale in an underwritten offering (the “Public Offering”) of 25,000,000 shares of Common Stock, at a price to the public of $2.00 per share (the “Firm Shares”).
We anticipate that our expenses will increase substantially as we seek to: • continue to generate revenue from sales of Symvess in the United States for the indication in vascular trauma and, if approved, via U.S. market launch for the indication in AV access for hemodialysis; • obtain marketing approval for our 6 millimeter ATEV in additional indications involving vascular repair, reconstruction and replacement, including in AV access for hemodialysis; • scale out our manufacturing facility to the extent required to satisfy potential market demand for Symvess in the United States and our product candidates, following receipt of any regulatory approval; • continue our preclinical and clinical development efforts; • maintain, expand and protect our intellectual property portfolio; • add operational, financial and management information systems and personnel to support, among other things, our product development and commercialization efforts and operations; and • continue operating as a public company, which includes higher costs associated with hiring additional personnel, director and officer insurance premiums, audit and legal fees and expenses for compliance with public company reporting requirements under the Exchange Act and rules implemented by the SEC and The Nasdaq Stock Market LLC (“Nasdaq”).
We expect to incur substantial operating losses and negative cash flows from operations for the foreseeable future as we begin to commercialize Symvess and advance our product candidates. As of December 31, 2024, we had cash and cash equivalents of $44.9 million and restricted cash of $50.4 million.
We expect to continue incurring substantial operating losses and to experience negative cash flows from operations for the foreseeable future as we scale the commercialization of Symvess and advance our product candidates. As of December 31, 2025, we had cash and cash equivalents of $50.5 million and restricted cash of $0.4 million.
In July 2024, we announced positive topline results from our V007 Phase 3 trial, where the ATEV met the primary endpoints in the study.
In April 2023, we announced completion of enrollment of our V007 Phase 3 trial of the ATEV for use in AV access for hemodialysis. In July 2024, we announced positive topline results from our V007 Phase 3 trial, where the ATEV met the primary endpoints in the study.
Given the competitive advantages our ATEVs are designed to have over existing vascular substitutes, we believe that ATEVs have the potential to become the standard of care and lead to improved patient outcomes and lower healthcare costs. As of December 31, 2024 , our ATEV s have been implanted in approximately 601 patients.
Given the competitive advantages 108 Table of Contents our ATEVs are designed to have over existing vascular substitutes, we believe that ATEVs have the potential to become the standard of care and lead to improved patient outcomes and lower healthcare costs.
For additional information regarding repayment, see Note 6 — Revenue Interest Purchase Agreement to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K.
See Note 1, Organization and Description of Business to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K for additional information regarding our assessment.
For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate being required to conduct in order to complete the clinical development of any of our product candidates, or if we experience significant delays in the enrollment or the conduct of any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.
For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate being required to conduct in order to complete the clinical development of any of our product candidates, or if we experience significant delays in the enrollment or the conduct of any of our clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development. 112 Table of Contents General and Administrative Expenses General and administrative expenses consist primarily of salaries and related costs for employees in executive, finance, human resources, commercialization, and administrative support functions, which also include stock-based compensation expenses and benefits for such employees.
Until such time, if ever, we expect to finance our operations through the use of existing cash and cash equivalents, the sale of equity or debt, borrowings under credit facilities, or through potential collaborations, other strategic transactions or government and other grants. Adequate capital may not be available to us when needed or on acceptable terms.
Until such time, if ever, we expect to finance our operations primarily through the use of existing cash and cash equivalents, private or public equity financings, debt financings, debt refinancings or restructurings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements. Adequate capital may not be available to us when needed or on acceptable terms.
On March 11, 2024, $20.0 million of the Investment Amount was funded to the Company. On December 19, 2024, the FDA granted full approval for our BLA for the vascular trauma indication, and we did not elect to draw the additional $40.0 million that became available under the Purchase Agreement.
On December 19, 2024, the FDA granted full approval of our BLA for the vascular trauma indication, and we elected not to draw the additional $40.0 million that became available under the Purchase Agreement. As of and subsequent to December 31, 2024, we were not entitled to draw any further installments under the Purchase Agreement.
The increase in general and administrative expenses during the year ended December 31, 2024 of $2.3 million, or 10%, compared to the year ended December 31, 2023 was primarily driven by preparation for our planned commercial launch of the ATEV in vascular trauma.
The increase in general and administrative expenses during the year ended December 31, 2025 of $5.4 million, or 21%, compared to the year ended December 31, 2024 was primarily driven by the commercial launch of Symvess.
Moreover, we may be subject to additional material cash requirements that are contingent upon the occurrence of certain events, for example, legal contingencies, uncertain tax positions, and other matters. 107 Table of Contents As of December 31, 2024, we had non-cancellable purchase com mitments of $31.3 million for supplies and services that are primarily for research and development.
Moreover, we may be subject to additional material cash requirements that are contingent upon the occurrence of certain events, for example, legal contingencies, uncertain tax positions, and other matters.
Cash Flows The following table shows a summary of our cash flows for each of the periods shown below: Year Ended December 31, ($ in thousands) 2024 2023 Net loss $ (148,701) $ (110,776) Non-cash adjustments to reconcile net loss to net cash used in operating activities (1) : 50,268 30,900 Changes in operating assets and liabilities: 311 6,571 Net cash used in operating activities (98,122) (73,305) Net cash used in investing activities (1,572) (173) Net cash provided by financing activities 114,183 4,507 Net increase (decrease) in cash, cash equivalents and restricted cash $ 14,489 $ (68,971) Cash, cash equivalents and restricted cash at the beginning of the period $ 80,801 $ 149,772 Cash, cash equivalents and restricted cash at the end of the period $ 95,290 $ 80,801 ___________________________ (1) Primarily includes depreciation, amortization related to our leases, stock-based compensation expense, non-cash interest expense related to our revenue interest liability and our JDRF Award liability (defined below) the changes in fair value of our Contingent Earnout Liability and our derivative liabilities and asset, and an immaterial amount of loss on disposal of property and equipment, and in 2023 includes a loss on extinguishment of debt, amortization of our debt discount. 109 Table of Contents Cash Flow from Operating Activities The increase in net cash used in operating activities from 2023 to 2024 was primarily due to increased spending on preclinical, clinical and pre-commercial activities as well as payroll and personnel expenses, expansion of clinical development of the ATEV for use in AV access, and preparation for the planned commercial launch of the ATEV for an indication in vascular trauma.
Cash Flows The following table shows a summary of our cash flows for each of the periods shown below: Year Ended December 31, ($ in thousands) 2025 2024 Net loss $ (40,833 ) $ (148,701 ) Non-cash adjustments to reconcile net loss to net cash used in operating activities (a) : (40,814 ) 50,268 Changes in operating assets and liabilities: (23,395 ) 311 Net cash used in operating activities (105,042 ) (98,122 ) Net cash used in investing activities (884 ) (1,572 ) Net cash provided by financing activities 61,486 114,183 Net increase (decrease) in cash, cash equivalents and restricted cash $ (44,440 ) $ 14,489 Cash, cash equivalents and restricted cash at the beginning of the period $ 95,290 $ 80,801 Cash, cash equivalents and restricted cash at the end of the period $ 50,850 $ 95,290 120 Table of Contents (a) Primarily includes depreciation; amortization related to our leases; stock-based compensation expense; non-cash interest expense related to our revenue interest liability, our JDRF Award liability (defined below), and our Term Loan Facility; the changes in fair value of our Contingent Earnout Liability and our derivative liabilities and asset; and an immaterial amount of loss on disposal of property and equipment.
Our liquidity plans are subject to a number of risks and uncertainties, including those described in the sections of this Annual Report on Form 10-K titled “Forward-Looking Statements” and “Risk Factors.” If we are unable to raise sufficient capital, we plan to implement a program that delays, reduces, suspends or ceases certain of our planned capital expenditures, research and development programs or any future commercialization efforts, which would have a negative impact on our business, prospects, operating results and financial condition.
If the Company is unable to raise capital, the Company plans to implement a program that delays, reduces, suspends or ceases certain of its planned capital expenditures, research and development programs or any future commercialization efforts, which would have a negative impact on its business, prospects, operating results and financial condition.
From December 31, 2024 through March 31, 2025, we sold an aggregate of 75,793 shares of Common Stock under the ATM Facility at an average price of $5.04 per share for net proceeds of approximately $0.4 million .
As of December 31, 2025, no shares had been sold under the TD Cowen ATM Facility. From January 1, 2026 until March 17, 2026, we sold an aggregate of 4,018,497 shares of Common Stock under the TD Cowen ATM Facility at an average price of $1.16 per share for net proceeds of approximately $4.6 million.
Cash Flow from Investing Activities Net cash used in investing activities for the year ended December 31, 2024 consisted of purchases of property and equipment. Net cash used in investing activities for the year ended December 31, 2023 consisted primarily of purchases of property and equipment, which fully offset proceeds from the maturity of our short-term investments (certificates of deposit).
Cash Flow from Investing Activities Net cash used in investing activities for the years ended December 31, 2025 and 2024 consisted of purchases of property and equipment.
Our need for additional capital will depend in part on the scope and costs of our development and commercial manufacturing activities, and the results of our commercial sales efforts. We recently received FDA approval to commercialize Symvess, but we have not generated any revenue from the sale of commercialized products to date.
Our need for additional capital will depend in part on the scope and costs of our development and commercial manufacturing activities and on the results of our ongoing commercial sales efforts. Since receiving FDA approval to commercialize Symvess in the vascular trauma indication, we have generated $1.4 million in product revenue for the year ended December 31, 2025.
As of December 31, 2024 and 2023, we had cash and cash equivalents of $44.9 million and $80.4 million, respectively, and restricted cash of $50.4 million and $0.4 million, respectively. We funded the restricted cash account on August 14, 2024, in accordance with our amended Purchase Agreement (defined below), of which $50.0 million is not subject to our unilateral control.
We funded the restricted cash account on August 14, 2024, in accordance with the second amendment to the Purchase Agreement (the “Purchase Agreement Amendment”), of which $50.0 million was not subject to our unilateral control.
In exchange for the removal of this requirement, on August 14, 2024 we funded an account in the amount of $54.0 million, over which the Agent has certain consent and other rights to $50.0 million of the funds.
On May 8, 2024, we agreed with the Purchasers to amend the Purchase Agreement to remove requirements related to the leasehold mortgage, and, in connection therewith, on August 14, 2024, we funded an account in the amount of $54.0 million, over which the Agent had certain consent and other rights to $50.0 million of the funds.
Research and Development Expenses Since our inception, we have focused our resources on our research and development activities, including conducting preclinical studies and clinical trials, developing and refining our manufacturing process and activities related to regulatory filings for our product candidates. We recognize research and development expenses as they are incurred.
Research and Development Expenses Prior to our recent shift in focus to the sale of Symvess for the vascular trauma indication, we have historically focused, and continue to focus a substantial portion of our resources on our research and development activities, including conducting preclinical studies and clinical trials, developing and refining our manufacturing process and activities related to regulatory filings for our product candidates.
In February 2025, the FDA completed its required review of commercial batch information for Symvess and has authorized us to commence commercial shipments. In April 2023, we announced completion of enrollment of our V007 Phase 3 trial of the ATEV for use in AV access for hemodialysis.
In February 2025, the FDA completed its required review of commercial batch information for Symvess and has authorized us to commence commercial shipments. We commenced commercial sales of Symvess in the vascular trauma indication in the first quarter of 2025.
As of December 31, 2024, we are not entitled to draw on any further installments under the Purchase Agreement. See Note 6 to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K for additional details about this financing transaction.
See Note 10 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K for further information regarding the assumptions used in the valuations at December 31, 2025 and 2024.
Since our inception, we have incurred significant operating losses and negative cash flows. As of December 31, 2024 and 2023, we had an accumulated deficit of $686.0 million and $537.3 million, respectively. 105 Table of Contents As of December 31, 2024 and 2023, we had working capital of $27.9 million and $64.8 million, respectively.
As of December 31, 2025 and 2024, we had an accumulated deficit of $726.8 million and $686.0 million, respectively. As of December 31, 2025 and 2024, we had working capital of $49.4 million and $27.9 million, respectively.
Leases Our finance leases relate to our headquarters facility containing our manufacturing, research and development and general and administrative functions, which was substantially completed in June 2018 and is being leased through May 2033, and our operating lease relates to the land lease associated with our headquarters.
Leases Our finance lease relates to our headquarters facility containing our manufacturing, research and development and general and administrative functions, which was substantially completed in June 2018. On September 29, 2025, we executed a Sixth Amendment to our lease agreements that extended the lease term and modified key financial terms.
The future viability of the Company beyond that point is dependent on our ability to generate cash flows from the sale of Symvess and raise additional capital to finance our operations. See Note 1 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K for additional information regarding our assessment.
The cash payment was funded with proceeds from the Term Loan Facility (see Note 8 to our accompanying consolidated financial statements in Part II, Item 8 of this Annual Report on Form 10-K).
Stock-Based Compensation We measure and recognize compensation expense for all options based on the estimated fair value of the award on the grant date. We use the Black-Scholes option-pricing model to estimate the fair value of option awards. The fair value is recognized as expense on a straight-line basis over the requisite service period.
Stock-Based Compensation Stock-based compensation expense represents a significant non-cash expense and is based on the grant-date fair value of equity awards. The Company grants stock options and restricted stock units under its equity incentive plans. The grant-date fair value of stock options is estimated using the Black-Scholes option-pricing model.
These increases are expected to include increased employee-related expenses, increased sales and marketing expenses, and increased director and officer insurance premiums, audit and legal fees, and expenses for compliance with public company reporting requirements under the Exchange Act and rules implemented by the SEC, as well as Nasdaq rules. 103 Table of Contents Other Income (Expense), Net Total other income (expense), net consists of (i) the change in fair value of the Contingent Earnout Liability that was accounted for as a liability as of the date of the Merger, and is remeasured to fair value at each reporting period, resulting in a non-cash gain or loss, (ii) interest income earned on our cash and cash equivalents and short-term investments, (iii) interest expense incurred on the Purchase Agreement (defined below), finance leases, and our former loan agreement with SVB during the periods each were outstanding, (iv) the change in fair value of our derivative liabilities and asset including the private placement Common Stock warrant liabilities related to the Private Placement Warrants, which we assumed in connection with the Merger; Common Stock warrant liabilities related to our Registered Direct Offerings; the contingent derivative liability related to the Purchase Agreement; a liability related to a freestanding option agreement related to the Purchase Agreement; a derivative liability related to our agreement with JDRF (defined below); and a derivative asset related to our Common Stock Purchase Agreement (defined below), all of which are subject to remeasurement to fair value at each balance sheet date resulting in a non-cash gain or loss, (v) a loss on debt extinguishment related to the prepayment of our loan agreement with Silicon Valley Bank in May 2023, and (vi) an employee retention credit we recognized in June 2023.
Other Income (Expense), Net Total other income (expense), net consists of (i) the change in fair value of the Contingent Earnout Liability that was accounted for as a liability as of the date of the Merger and is remeasured to fair value at each reporting period, resulting in a non-cash gain or loss, (ii) interest income earned on our cash and cash equivalents and short-term investments, (iii) interest expense incurred on our Term Loan Facility, finance leases, and our former Purchase Agreement during the periods each were outstanding, (iv) the change in fair value of our derivative liabilities and assets, including the private placement Common Stock warrant liabilities related to the Private Placement Warrants, which we assumed in connection with the Merger; Common Stock warrant liabilities related to our Registered Direct Offerings; the warrant liability related to the Loan Agreement; the former contingent derivative liability related to the terminated Purchase Agreement; a former liability related to a freestanding option agreement related to the terminated Purchase Agreement; a derivative liability related to our agreement with JDRF; a derivative liability related to the Loan Agreement; and a derivative asset related to our Common Stock Purchase Agreement, all of which are subject to remeasurement to fair value at each balance sheet date each liability is outstanding, resulting in a non-cash gain or loss, and (v) a loss on debt extinguishment related to the termination of the Purchase Agreement in December 2025. 113 Table of Contents Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 Year Ended December 31, Change ($ in thousands) 2025 2024 $ % Revenue Product revenue, net $ 1,389 $ — $ 1,389 100 % Contract revenue 649 — 649 100 % Total revenue 2,038 — 2,038 100 % Operating expenses: Cost of goods sold 9,702 — 9,702 100 % Research and development 69,302 88,599 (19,297 ) (22 )% General and administrative 31,171 25,799 5,372 21 % Total operating expenses 110,175 114,398 (4,223 ) (4 )% Loss from operations (108,137 ) (114,398 ) 6,261 (5 )% Other income (expense), net Interest income 2,587 4,104 (1,517 ) (37 )% Change in fair value of Contingent Earnout Liability 59,469 (33,045 ) 92,514 (280 )% Interest expense (11,250 ) (9,277 ) (1,973 ) 21 % Change in fair value of derivatives 38,765 3,915 34,850 890 % Loss on extinguishment of debt (22,267 ) — (22,267 ) N/A Total other expense, net 67,304 (34,303 ) 101,607 (296 )% Net loss $ (40,833 ) $ (148,701 ) $ 107,868 (73 )% Costs of Goods Sold Cost of goods sold was $9.7 million for the year ended December 31, 2025, compared to $0 for the year ended December 31, 2024.
Liquidity and Capital Resources Sources of Liquidity We have historically financed our operations primarily through the sale of equity securities and convertible debt, including pursuant to the Offering (as defined below) and Registered Direct Offerings we completed in October and November 2024, proceeds from the Merger and related PIPE Financing (as defined in Note 14 to our accompanying consolidated financial statements contained in Part II, Item 8 of this Annual Report on Form 10-K), borrowings under loan facilities, the Purchase Agreement (defined below), and, to a lesser extent, through grants from governmental and other agencies.
We have historically financed 115 Table of Contents our operations primarily through the sale of equity securities and convertible debt, borrowings under loan facilities, including the Term Loan Facility, the Purchase Agreement, and, to a lesser extent, through grants from governmental and other agencies. Since our inception, we have incurred significant operating losses and negative cash flows.
Net cash provided by financing activities for the year ended December 31, 2023 consisted primarily of $37.9 million of net proceeds from our Purchase Agreement, partially offset by $31.8 million of cash payments related to the repayment of our loan agreement with SVB.
Cash Flow from Financing Activities Net cash provided by financing activities for the year ended December 31, 2025 consisted primarily of $56.5 million of net proceeds from our Registered Direct Offering we completed in October 2025, $46.7 million of net proceeds from our Public Offering we completed in March 2025, $39.0 million of net proceeds from the Term Loan Facility we entered into in December 2025, and $10.0 million of net proceeds from issuance of shares of Common Stock under the Jefferies ATM Facility, which was partially offset by a $88.0 million repayment of the Purchase Agreement.
Determining the fair value of the Registered Direct Offering Warrants involves certain assumptions requiring significant judgment and actual results can differ from assumed and estimated amounts. 112 Table of Contents Emerging Growth Company and Smaller Reporting Company Status We are an “emerging growth company” as defined in the Jumpstart our Business Startups Act of 2012 (the “JOBS Act”), and may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies until it is no longer an emerging growth company.
Determining the fair value of the Loan Agreement conversion derivative liability involves certain assumptions requiring significant judgment and actual results can differ from assumed and estimated amounts. Smaller Reporting Company Status We are a “smaller reporting company” as defined in Item 10(f)(1) of Regulation S-K under the Exchange Act (“Regulation S-K”).
General and Administrative Expenses General and administrative expenses were $25.8 million and $23.5 million for the years ended December 31, 2024 and 2023, respectively.
In addition, our direct expenses related to clinical studies decreased by $2.1 million, primarily due to reduced spending on vascular trauma trials as this clinical program was completed. General and Administrative Expenses General and administrative expenses were $31.2 million and $25.8 million for the years ended December 31, 2025 and 2024, respectively.
Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 Year Ended December 31, Change ($ in thousands) 2024 2023 $ % Operating expenses: Research and development $ 88,599 $ 76,550 $ 12,049 16 % General and administrative 25,799 23,497 2,302 10 % Total operating expenses 114,398 100,047 14,351 14 % Loss from operations (114,398) (100,047) (14,351) 14 % Other income (expense), net Interest income 4,104 5,467 (1,363) (25) % Change in fair value of Contingent Earnout Liability (33,045) (10,023) (23,022) 230 % Interest expense (9,277) (6,599) (2,678) 41 % Change in fair value of derivatives 3,915 (260) 4,175 (1606) % Employee retention credit — 3,107 (3,107) (100) % Loss on extinguishment of debt — (2,421) 2,421 (100) % Total other expense, net (34,303) (10,729) (23,574) 220 % Net loss $ (148,701) $ (110,776) $ (37,925) 34 % 104 Table of Contents Research and Development Expenses The following table discloses the breakdown of research and development expenses for the periods indicated: Year Ended December 31, Change ($ in thousands) 2024 2023 $ % Direct Expenses Vascular Trauma $ 2,181 $ 3,976 $ (1,795) (45) % AV Access 6,620 8,748 (2,128) (24) % PAD 143 306 (163) (53) % Total 8,944 13,030 (4,086) (31) % Unallocated Expenses External services 7,071 6,106 965 16 % Materials and supplies 21,765 13,705 8,060 59 % Payroll and personnel expenses 36,537 30,118 6,419 21 % Other research and development expenses 14,282 13,591 691 5 % Total 79,655 63,520 16,135 25 % Total research and development expenses $ 88,599 $ 76,550 $ 12,049 16 % Research and development expenses were $88.6 million for the year ended December 31, 2024, representing an increase of $12.0 million, or 16%, from $76.6 million for the year ended December 31, 2023.
There was no cost of goods sold recognized during 2024, as Symvess had not yet been commercialized and manufacturing costs incurred prior to approval were expensed as research and development. 114 Table of Contents Research and Development Expenses The following table discloses the breakdown of research and development expenses for the periods indicated: Year Ended December 31, Change ($ in thousands) 2025 2024 $ % Direct Expenses Vascular Trauma $ 892 $ 2,181 $ (1,289 ) (59 )% AV Access 5,944 6,620 (676 ) (10 )% PAD 0 143 (143 ) (100 )% Total 6,836 8,944 (2,108 ) (24 )% Unallocated Expenses External services 5,241 7,071 (1,830 ) (26 )% Materials and supplies 16,173 21,765 (5,592 ) (26 )% Payroll and personnel expenses 33,380 36,537 (3,157 ) (9 )% Other research and development expenses 7,672 14,282 (6,610 ) (46 )% Total 62,466 79,655 (17,189 ) (22 )% Total research and development expenses $ 69,302 $ 88,599 $ (19,297 ) (22 )% Research and development expenses were $69.3 million for the year ended December 31, 2025, representing a decrease of $19.3 million, or 22%, from $88.6 million for the year ended December 31, 2024.
Removed
In September 2023, we announced positive topline results from our V005 Phase 2/3 trial in vascular trauma, and in December 2023, we filed a BLA for urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and autologous vein use is not feasible.
Added
As of December 31, 2025, our ATEVs have been implanted in approximately 636 patients in clinical studies as well as additional patients following the U.S. commercial launch of Symvess in the vascular trauma indication.
Removed
In February 2024, the FDA accepted the BLA filing and granted priority review and set a PDUFA date of August 10, 2024. On August 9, 2024, the FDA informed us that it required additional time to complete its review of the BLA for the vascular trauma indication.
Added
The Company will not have sufficient liquidity to fund its operations beyond one year from the date of this Annual Report on Form 10-K if the Company is unable to generate sufficient cash flows from commercial sales on a timely basis and/or obtain additional capital.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk We qualify as a smaller reporting company, as defined by Item 10 of Regulation S-K and, thus, are not required to provide the information required by this Item. 113 Table of Contents
Item 7A. Q uantitative and Qualitative Disclosures About Market Risk We qualify as a smaller reporting company, as defined by Item 10 of Regulation S-K and, thus, are not required to provide the information required by this Item. 125 Table of Contents