INTRODUCTION

RESULTS

OBJECTIVES

CONCLUSIONS

CONTACT & ACKNOWLEDGEMENTS

REFERENCES

Scientific and medical understanding are essential for bringingregenerative medicine products to the clinic. Furthermore,translation of regenerative medicine products requires cutting-edgetechnology, scaled manufacturing, and clinical trial and regulatoryexpertise. Since its founding in 2005, Humacyte has worked tosequentially solve the translational hurdles related to the productionof Human Acellular Vessels, or HAVs.

Humacyte’s platform involves the use of differentiated humanvascular cells that are cryopreserved and are leveraged to generateengineered vascular tissues of a shape and size dictated by thebioreactor and polymer scaffolding of our manufacturing process. Todate, HAVs have been implanted into more than 450 patients havingdiseases ranging from kidney failure, to peripheral arterial disease,to vascular trauma.

MATERIALS & METHODS

At Month 3, primary patency and primary assisted patency weremaintained in 29 of 30 subjects, and all subjects showed secondarygraft patency. HAV infections and indications of mechanical failureor weakness of the HAV were not observed. The percentage ofsubjects who exhibited elevation from Baseline in Class I PRA levelsat Month 2 (7%) is consistent with previous clinical studies of Aura-or Terra-produced HAVs in patients requiring hemodialysis (6%).

At Month 12 (Day 365), primary patency was observed in 17subjects (57%), primary assisted patency in 19 subjects (63%), andsecondary graft patency in 23 subjects (77%). The Kaplan-Meierprobabilities to retain patency at Month 12 were 60% for primary,67% for primary assisted, and 83% for secondary patency.

The proportion of subjects who exhibited elevation from Baseline inPRA levels at Month 12 (33%) is higher than in previous clinicalstudies of Aura- or Terra-produced HAVs in patients requiringhemodialysis (6%). However, PRA levels subsequently decreasedback to baseline over time in the majority of patients and theincrease in PRA levels across all subjects were found not to beattributed to the HAV.

This was a Phase 2, prospective, multicenter, open-label, single-armstudy in subjects with end-stage renal disease (ESRD) who requiredhemodialysis and were targeted for implantation of an arteriovenous(AV) graft for dialysis access.

A total of 30 eligible subjects were enrolled, received a humanacellular vessel (HAV) on Day 0, and were followed up for 12months post-implantation regardless of the HAV’s patency status atroutine study visits scheduled at Day 7, Day 28, Month 2, Month 3,Month 6 and Month 12. After 12 months, only subjects with a patentHAV will be followed up (while the HAV remains patent) at studyvisits every 6 months for up to 3 years (36 months).

The primary analysis was performed after the last subject completed3 months of follow-up. A second analysis was performed after allsubjects had completed 12 months of follow-up.

The final analysis will be performed after the last subject hascompleted 36 months of follow-up.

The HAVs for this Phase 2 study were produced in the Luna200system. The Luna200 equipment consists of 4 cage fluidic modules(CFM), housed in an incubator, which controls the temperature ofthe system to support the HAV growth and decellularization stages.Each CFM consists of five (5) drawers, and each drawer containsten (10) bioreactor bags. The materials management module(MMM) supplies each CFM with culture media from a mediareservoir to maintain cell growth. The MMM also delivers processgases, decellularization buffers, and removes waste from the CFMs.A network of tubing sets, control valves, flow controllers, pressuresensors, and fluid pumps are used to supply culture media, processgases, and decellularization buffers to the bioreactor bags for HAVproduction. A control panel is used to run automated batch recipesthat control and monitor the Luna200 system.

The primary objective of this study is to evaluate the safety, efficacyand immunogenicity over 3 months after implantation of HAVsmanufactured using the commercial manufacturing system LUNA.

The secondary objective of this study is to evaluate the long-termsafety and efficacy of the HAV (manufactured with the LUNAsystem) over a period of up to 36 months after implantation.

Funding was provided by Humacyte, Inc. We thank our ClinicalOperations team. Please reach out to clinical@humacyte.com withfurther questions or inquiries.

§ At Month 12, primary patency and primary assisted patency weremaintained in 17 and 19 subjects, respectively, and 23 subjectsstill showed secondary graft patency.

§ HAV infections and indications of mechanical failure or weaknessof the HAV were not observed.

§ Overall, the results of the LUNA-produced HAV to date do notindicate any particular safety or immunogenicity issues.

§ These data show that HAVs, produced in the commercial-scalemanufacturing system, function as expected when used asdialysis access grafts.

SAFETY, EFFICACY, AND IMMUNOGENICITY ASSESSMENT OF HUMACYTE’S HUMAN ACELLULAR VESSEL FOR DIALYSIS

VASCULAR ACCESS: LUNA SYSTEM Jeffrey Lawson1, Jakub Turek2, Wojciech Witkiewicz3, Maciej Zielinski4

1Humacyte, Inc., Durham NC, 2The Regional Specialist Hospital of Wroclaw, Poland, 3Poznan University of Medical Sciences

1. Bylsma LC et al, Eur J Vasc Endovasc Surg (2017) 54, 513e5222. Chang WG & Niklason LE, NPJ Regen Med. 2017 ; 2: . doi:10.1038/s41536-017-0011-6.3. Dahl SL, et al., Cell Transplant. 2003;12(6):659-66.4. Lawson J, et al. Lancet 2016; 387: 2026–34