Form 8-K

8-K — Humacyte, Inc.

Accession: 0001104659-26-072382

Filed: 2026-06-10

Period: 2026-06-10

CIK: 0001818382

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2617224d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2617224d1_ex99-1.htm)

EX-99.2 — EXHIBIT 99.2 (tm2617224d1_ex99-2.htm)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange

Act of 1934

Date of Report (Date of earliest event reported):

June 10, 2026

Humacyte, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-39532

85-1763759

(State or other jurisdiction of

incorporation or organization)

(Commission File Number)

(I.R.S. Employer

Identification Number)

2525 East North Carolina Highway 54

Durham, NC

27713

(Address of principal executive offices)

(Zip code)

(919) 313-9633

(Registrant’s telephone number, including

area code)

Not Applicable

(Former name or former address, if changed since

last report)

Check the appropriate box below if the Form 8-K

filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which

registered

Common

Stock, par value $0.0001 per share

HUMA

The Nasdaq Stock Market LLC

Redeemable

Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50

HUMAW

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant

is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the

Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period

for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01. Other Events.

Clinical Update

On June 10, 2026, Humacyte, Inc. (the “Company”) issued

a press release announcing the presentation of results from its Phase 3 clinical trial (V012) of the acellular tissue engineered vessel

(ATEV) in arteriovenous access for female patients with end-stage renal disease requiring hemodialysis. A copy of this press release is

filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

Investor Presentation

On June 10, 2026, the Company made available an investor presentation

(the “Investor Presentation”), which the Company expects to use in connection with investor calls and/or conferences. A copy

of the Investor Presentation is attached hereto as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

Number

Description

99.1

Press release, dated June 10, 2026.

99.2

Humacyte, Inc. Investor

Presentation June 2026.

104

Cover Page Interactive Data File (embedded within the

Inline XBRL document).

SIGNATURE

Pursuant to the requirements of the Securities

Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

HUMACYTE,

INC.

Date: June 10,

2026

By:

/s/

Dale A. Sander

Name:

Dale A. Sander

Title:

Chief Financial Officer,

Chief Corporate Development Officer and Treasurer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2617224d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Humacyte ATEV

Met Superiority Primary Endpoint Compared to Standard of Care AV Fistula in Interim Analysis of V012 Phase 3 Study in

Female Dialysis Access Patients

- Humacyte plans to file a supplemental Biologic

License Application (BLA) with the Food and Drug Administration (FDA) during the second half of 2026 -

- The ATEV met V012’s primary

endpoint and was observed to have superior catheter-free days (p=0.00070) compared to autologous arteriovenous (AV) fistula, the

current standard of care -

- The ATEV’s ability to reduce time on

catheter has the potential to improve patient outcomes and lower the burden of dialysis costs on the healthcare system. -

DURHAM, N.C., June 10,

2026 – Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable,

bioengineered human tissues at commercial scale, today announced positive top-line interim results for the V012 Phase 3 study of

the acellular tissue engineered vessel (ATEV) in female patients for dialysis access. In a prespecified interim analysis conducted in

the first 80 patients enrolled in the study, the V012 trial’s primary endpoint was met with the ATEV observed to have an average

of 91 more catheter-free days compared to autologous arteriovenous (AV) fistula, the current standard of care.

In accordance with the study protocol, as a result of meeting the

primary endpoint, study enrollment will terminate and existing patients will continue to be followed as per protocol. Humacyte plans to file a supplemental BLA with the FDA during the second half of

2026. The currently planned target indication is focused on adult patients with end-stage kidney disease who are at increased risk

of AV fistula maturation failure.

“We are excited to announce positive clinical results for

the Phase 3 V012 study, particularly as these results represent a real advancement in the dialysis care for female patients, a

population that currently has suboptimal access options,” said Shamik Parikh, MD, Humacyte’s Chief Medical Officer.

“Patients receiving an ATEV had an average of three months additional catheter-free time as compared to AV fistula, a highly

significant outcome. Reducing patients’ reliance on catheters is critical given the high risk of infection and complications

seen with indwelling catheters. These results reinforce the potential of our bioengineered human blood vessel to improve outcomes while

addressing longstanding challenges in dialysis access.”

The V012 clinical study is designed to demonstrate the efficacy

and safety of the ATEV as a dialysis access method compared to autologous AV fistula in female dialysis patients, a high-unmet-need

population. V012 is a Phase 3, prospective, multi-center, open label, randomized, two-arm comparative study conducted in the United

States in up to 150 patients, with 120 patients are currently enrolled. The primary measure of efficacy is total days free from

in-dwelling catheter (“catheter-free days”) until 365 days after access placement, or until access abandonment, whichever occurs first. A

prespecified interim analysis was conducted after the first 80 patients enrolled had completed 12 months of follow-up. In this analysis, patients implanted with the ATEV achieved an

average of 220 catheter-free days compared to 129 catheter-free days for patients who received an AV fistula. The result was

statistically significant (p=0.00070), meeting the primary endpoint of the study.

The primary safety measure in the V012 study is the

number and severity of infections related to all accesses (including catheters) from the date of access creation until 365 days thereafter.

Patients receiving the ATEV incurred infections at a rate of six per 100 patient years, as compared to 23 per 100 patient years for

patients receiving an AV fistula procedure. There were no study access-associated infections reported in the ATEV patients, while

there were three among the AV fistula patients. There were no spontaneous ruptures reported in either of the treatment groups. The

overall benefit risk profile of the ATEV was observed to be favorable, with no new or unexpected safety signals identified.

Over 800,000 Americans are currently living with end stage kidney

disease, and nearly 500,000 Americans depend on hemodialysis for survival. Dialysis treatments require establishing a durable point

of access to a patient’s circulatory system in order to transfer large volumes of blood to the dialysis machine, and then back

into the patient. However, the current standard of care for establishing access for hemodialysis has significant risks and

shortcomings. Catheters, which are tunneled underneath the skin, have high rates of bloodstream infections and other complications.

Autogenous AV fistulas often fail to function after surgery, particularly for women, forcing patients to rely on infection-prone catheters. In

addition, many patients are not suitable candidates for AV fistula placement due to gender, small vessel anatomy, advanced age,

obesity, or other comorbidities.

Humacyte’s ATEV is a bioengineered human tissue derived

from cultured human cells that is designed to be a universally implantable vascular conduit for use in vascular replacement and

repair. The ATEV has been observed to have a low rate of infection in multiple clinical trials. The ATEV

is designed to be available off-the-shelf, and ready whenever surgeons need it, potentially saving valuable operating room time and

improving patient outcomes.

Results from the V012 Phase 3 study will be presented the evening of June 11, 2026 at the Society for Vascular Surgery's (SVS's) Vascular

Annual Meeting (VAM) in Boston in the Women's Health seminar.

For uses other than the FDA approval in the extremity vascular

injury indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory

agency.

About Humacyte

Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology

platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve

the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide

range of diseases, injuries, and chronic conditions. Humacyte’s Biologics License Application for the acellular tissue engineered

vessel (ATEV) in the vascular injury indication was approved by the FDA in December 2024. ATEVs are also currently in late-stage

clinical trials targeting other vascular applications, including arteriovenous (AV) access for hemodialysis and peripheral artery disease

(PAD). Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes,

and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate

to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation.

Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular injury and for advanced PAD also have received RMAT

designations. The ATEV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more

information, visit www.Humacyte.com.

Forward-Looking Statements

This press release contains forward-looking statements that are based

on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following

words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,”

“plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,”

“potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology,

although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that

may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or

implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained

in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and

our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not

limited to, our plans and ability to commercialize Symvess and, if approved by regulatory authorities, our product candidates, successfully

and on our anticipated timelines; the degree of market acceptance of and the availability of third-party coverage and reimbursement for

Symvess and, if approved by regulatory authorities, our product candidates; our ability to manufacture Symvess and, if approved by regulatory

authorities, our product candidates in sufficient quantities to satisfy our clinical trial and commercial needs; the anticipated benefits

of our ATEVs relative to existing alternatives; our plans and ability to execute product development, process development and preclinical

development efforts successfully and on our anticipated timelines; our plans, anticipated timeline and ability to file applications for,

and obtain marketing approvals from, the FDA and other regulatory authorities, including the European Medicines Agency, for our ATEVs

and product candidates; our plans and expectations regarding the results of our clinical trials, including our V012 Phase 3 clinical trial,

and regarding our ongoing or planned clinical trials; our ability to design, initiate and successfully complete clinical trials and other

studies for our product candidates; the anticipated characteristics and performance of our ATEVs and the public perception thereof; the

implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances

and approvals. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking

statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected

results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by

other economic, business, competitive and/or reputational factors, and other risks and uncertainties, including those described under

the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and Form 10-Q

for the quarter ended March 31, 2026, each filed by Humacyte with the SEC, and in future SEC filings. Most of these factors are outside

of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy

may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements

as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or

at all. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release.

You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of

this press release.

Humacyte Investor Contact:

Joyce Allaire

LifeSci Advisors LLC

+1-617-435-6602

jallaire@lifesciadvisors.com

investors@humacyte.com

Humacyte Media Contact:

Rich Luchette

Precision Strategies

+1-202-845-3924

rich@precisionstrategies.com

media@humacyte.com

EX-99.2 — EXHIBIT 99.2

EX-99.2

Filename: tm2617224d1_ex99-2.htm · Sequence: 3

Exhibit 99.2

Universally Implantable

Regenerative Human Tissue

Disclaimer

These slides and the accompanying oral presentation contain forward-looking statements. All statements, other than statements of historical fact, included in these slides

and the accompanying oral presentation are forward-looking statements reflecting management’s current beliefs and expectations. In some cases, you can identify forward-looking statements by terminology such as “will,” “anticipate,” “expect,” “believe,” “intend” and “should” or the negative of these terms or other comparable terminology.

Forward-looking statements in these slides and the accompanying oral presentation include, but are not limited to, statements about our plans and ability to commercialize

our bioengineered acellular tissue engineered vessels (“ATEV s”) in the United States under the brand name Symvess in vascular trauma repair; the anticipated

commercialization of our ATEVs and our ability to manufacture ATEVs and other product candidates in sufficient quantities to satisfy our clinical trial and commercial needs;

our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines; our plans,

anticipated timelines and ability to obtain marketing approval from the U.S. Food and Drug Administration (“FDA”) and other regulatory authorities, including the European

Medicines Agency and Israel, for our ATEVs in other indications and other product candidates; our plans and expectations regarding the results of our clinical trials. Including

our V012 Phase 3 clinical trial, and regarding our ongoing or planned clinical trials; our ability to design, initiate and successfully complete clinical trials and other studies for

our product candidates; the outcome of our ongoing discussions with the FDA concerning the design of our clinical trials; our anticipated growth rate and market

opportunities; the potential liquidity and trading of our securities; our ability to raise additional capital in the future; our ability to use our proprietary scientific technology

platform to build a pipeline of additional product candidates; the anticipated characteristics and performance of our ATEVs; the expected size of the target populations and

addressable markets for our product candidates; the anticipated benefits of our ATEVs relative to existing alternatives; our assessment of the competitive landscape; the

degree of market acceptance of ATEVs and the availability of third-party coverage and reimbursement; the implementation of our business model and strategic plans for our

business; our expectations regarding our strategic partnership with Fresenius Medical Care Holdings, Inc.; the performance of other third parties on which we rely, including

our third-party manufacturers, our licensors, our suppliers and the organizations conducting our clinical trials; our ability to obtain and maintain intellectual property

protection for our product candidates as well as our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property

rights of others; our ability to maintain the confidentiality of our trade secrets, particularly with respect to our manufacturing process; our compliance with applicable laws

and regulatory requirements, including FDA regulations, healthcare laws and regulations, and anti-corruption laws; our ability to attract, retain and motivate qualified

personnel and to manage our growth effectively; our future financial performance and capital requirements; our ability to implement and maintain effective internal

controls; and the impact of the overall global economy and increasing interest rates and inflation on our business. These statements relate to future events or to our future

financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be

materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. The potential risks and uncertainties

that could cause actual results to differ from the results predicted include, among others, those risks and uncertainties included under the captions “Risk Factors” and

“Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-K for the year ended December 31, 2025, our quarterly report on

Form 10-Q for the quarter ended March 31, 2026, each filed by Humacyte with the Securities and Exchange Commission, and in future filings made with the Securities and

Exchange Commission from time to time. Any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of the date

hereof. Except as required by law, we assume no obligation to update these forward-looking statements, even if new information becomes available in the future. This

presentation shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of our securities, in any state or other jurisdiction in which

such offer, solicitation or sale would be unlawful prior to the reregistration or qualification under the securities laws of any such state or other jurisdiction. This presentation

shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which

such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

V012 Interim Results – Study Met Primary Endpoint

• The ATEV met V012’s primary endpoint by

demonstrating superior catheter-free days compared to

arteriovenous fistula (AVF), the standard of care

• 91 more catheter-free days for ATEV versus AVF

• ATEV patients incurred 17 fewer dialysis access

infections than AVF per 100 patient-years, the primary

safety measure for the study

• The ATEV was observed to have consistent

advantages over AVF in multiple secondary endpoints

• Overall benefit-risk safety profile of ATEV was

favorable with no new or unexpected safety concerns

identified

RMAT

Statistically Significant

p=0.0007

Pre-specified superiority threshold met

Interim analysis: ATEV (N=40) vs AVF (N=40)

Humacyte plans to file a supplemental BLA with the FDA during the second half of 2026

(target indication is in adult patients with end-stage kidney disease (ESKD) who are at

increased risk of AV fistula maturation failure)

Humacyte is a Leader the Field of Regenerative Medicine:

Bioengineered Tissues & Organs

Off-the-shelf, no special

preparation required

Universally implantable

with no immuno-suppression

Regenerate as the

patient’s own tissue

Category-Defining Innovation that Creates New Tissues

Humacyte Leadership & Board

Leadership Team Board of Directors

Kathleen Sebelius

Chair of the Board

John P. Bamforth, PhD

Emery N. Brown, MD, PhD

Michael T. Constantino

Brady W. Dougan

Charles Bruce Green, MD

Keith Anthony Jones, M.D.,

Laura E. Niklason, MD, PhD

Diane Seimetz, PhD

Max Wallace, JD

Susan Windham-Bannister, PhD

Laura E. Niklason, MD,

PhD

Founder, President,

Chief Executive Officer

Dale Sander

Chief Financial Officer,

Chief Corporate

Development Officer

Shamik Parikh, MD

Chief Medical Officer

Sabrina Osborne

Chief People Officer

Heather Connelly

Chief Quality &

Regulatory Officer

Prior Experience

Tood Rasmussen, MD

Chief Surgical Officer

Lisa Molyneux

EVP, Enterprise

Planning & Analysis

Jim Mercandante

Chief Commercial

Officer

Platform & Manufacturing:

Enable Broad Pipeline of Regenerative Medicine Products

Vascular tissue

constructs (ATEV)

Advanced tissue

constructs

Advanced organ

systems

Bioengineering Platform

Cell

seeding

Tissue

formation

Cell removal

and packaging

Working cell stock

Cells transferred

onto polymer

mesh

Cells proliferate &

build extracellular matrix

Polymer mesh degrades, leaving

vascular cells and extracellular

matrix

Decellularization solutions clean and

remove vascular cells from vessel

Commercial-Scale Manufacturing

Strategically designed with modular capabilities

to manufacture products at scale

Enables creation of universally implantable tissues and organs

Our platform technology enables development of a broad range of product candidates

Symvess Demonstrates Mechanical Strength

and Remodeling with Patient’s Own Cells

Pipeline with Multiple Potential Commercial Launches

Preclinical Phase 1/2 Phase 3 Approved

Vascular Tissue Constructs

Trauma

Dialysis (AV Access)

PAD

CABG

Pediatric Heart Disease

Complex Tissue Constructs

Urinary Conduit

Tracheal Replacement

Esophageal Replacement

Complex Organ Systems

BioVascular Pancreas (T1D)

Lung

Approved by FDA

V007 Phase 3 Trial Met Co-Primary Endpoints

Phase 3 Study Under Design

V012 Phase 3 Trial in Women – Met Primary Interim Endpoint

Dialysis (AV Access)

ATEV CTEV

Phase 2a Planned Q326

Vascular Trauma

FDA Approved in

Extremity Vascular Trauma

Symvess

acellular tissue

engineered vessel-tyod

Symvess is FDA Approved in Extremity Vascular Trauma

Repopulates with

the patient’s cells1-2,3

Low susceptibility

to infection4

No immune response

observed1-3,5

Off-the-shelf,

ready to use1,3

Low amputation

results1

INDICATION

SYMVESS is an acellular tissue engineered vessel indicated for use in adults as a

vascular conduit for extremity arterial injury when urgent revascularization is needed to

avoid imminent limb loss, and autologous vein graft is not feasible.

PLEASE SEE ACCOMPANYING FULL PRESCRIBING INFORMATION AT SYMVESS.COM, INCLUDING BOXED WARNING.

REFERENCES: 1. Symvess U.S. Prescribing Information. Durham, NC. Humacyte Global, Inc. 2. Kirkton RD, et al. Bioengineered human acellular vessels recellularize and evolve into

living blood vessels after human implantation. Sci Transl Med. 2019;11(485):eaau6934. 3. Dahl S, et al. Readily available tissue-engineered vascular grafts. Sci Transl Med. 2011 Feb

2;3(68):68ra9. 4. Wang J, et al. Biological mechanisms of infection resistance in tissue engineered blood vessels compared to synthetic expanded polytetrafluoroethylene grafts. JVS Vasc

Sci. 2023;4:100120. 5. Moore EE, et al. Bioengineered Human Arteries for the Repair of Vascular Injuries. JAMA Surg. 2024 Nov 20:e244893.

• Common causes of vascular injuries include workplace injuries, car accidents, gunshots and

stabbings, and sports injuries

• Symvess addresses major drawbacks of current treatment options:

Vascular Trauma Injuries – Symvess Value Proposition

Vein is the standard of

care, but takes valuable

time, delaying

revascularization

Prosthetic grafts are

quick, but have

infection risk and

high rates of amputation

Amputation

Symvess is

immediately

available,

off-the-shelf,

and does

not require

further

injuring

the patient

Two Studies Were Used to Support FDA Approval

Gunshot Wound Industrial Accident Knee Dislocation

First Study: CLN-PRO-V005 Phase 2/3 Pivotal Trial In U.S. and Israel

• Single-arm, open label study

• Conducted at Level 1 trauma centers

• Arteria injury repair

• Extremity injuries at high risk of contamination / infection

Statistical Analysis Plan

• Historical Benchmark Comparator

> Systematic literature review of

synthetic grafts in vascular trauma

• Primary Comparison

> 30-day endpoint of patency

• Secondary Comparisons

> 30-day infection rate

> 30-day amputation rate

• 69 patients enrolled as of data cut off

• As agreed upon with FDA, focus for BLA filing was 51

patients with extremity injuries

Examples of Symvess Implants in V005 Study

• At request of Ukraine surgeons Humacyte supported humanitarian program for patients injured in conflict

• 19 patients received Symvess

• At suggestion of FDA, patients from humanitarian program were included in BLA filing

• 17 consented for data collection and study participation

• 16 patients had extremity trauma repair (one patient required Symvess for Iatrogenic trauma repair)

Ukraine Real World Experience in Vascular Repair

Pre-op CT Scan Symvess repair of

Femoral artery

Ukraine Patient Blast Injury Walking once again

(Day 113) 13

Second Study: V017 Humanitarian Program in Ukraine

Case Study of Patient Treated in Ukraine Program

Clinical Improvement with Symvess over Synthetics

Improved outcomes of Symvess compared to synthetic graft benchmark

observed in two studies

Symvess represents a new definitive and durable repair option in patients with extremity arterial injury

when a vascular graft is needed and no vein is available.

Symvess was observed to have higher secondary patency and lower amputation and infection rates

compared to the synthetic graft benchmark used in the BLA filing.

Outcome

Day 30

Combined Symvess

V005 and V017 Studies

(N=67) Synthetic Graft Benchmark

Primary Patency 87.1% 78.9%

Secondary Patency 91.5% 78.9%

Conduit Infection rate 0.9% 8.4%

Amputation rate 4.5% 24.3%

Death rate (all cause) 3. 5% 3.4%

Moore EE, et al. JAMA Surg. 2024 Nov 20:e244893. ; Humacyte BLA filed December 11, 2023.

Clinical Data

After up to 36 months of follow-up, patients

demonstrated:

• High rates of limb salvage

• Low rates of infection

• No unprovoked structural failures

Durability of Symvess in Injury Repair

Long-Term V005 Results1 Long-Term V017 Results2

• Trauma patients with battlefield

injuries in Ukraine were

followed for up to 18 months.

• Wartime patients treated with

Symvess were observed to

have:

• High rate of patency (87.1%)

• 100% limb salvage

• Zero cases of conduit

infection

• Zero deaths

Publications

1Curi MA, et al. J Vasc Surg Cases Innov Tech. 2025 Nov

2Parikh S, et al.. Mil Med. 2025 Sep

U.S. Vascular Trauma Market – Total Addressable Market for

Symvess

Total Vascular Trauma Patients

(All Injuries)1

79,000

Emergent Vascular Trauma – 56,000

Iatrogenic Vascular Trauma – 23,000

Target U.S. TAM for Symvess

Based on Hospital Claims Data2

26,000

Emergent Vascular Trauma – 18,667

Iatrogenic Vascular Trauma – 7,333

1Third-partymarket research based on procedural volumes (2019) and secondary literature search

2Based on analysis of Definitive Healthcare (DHC) Claims Database 2022, claims as of November 2023. Adjusted to reflect estimate the database captures approximately 60% of

procedures:

Diagnosis (Dx) Codes: Identify Injury type, location

Procedure Codes: ICD-10 PCS or CPT

3Based on analysis of Prospective Observational Vascular Injury Trial (PROOVIT) registry

Symvess-Eligible Patients Exclusions

• Type of repair: Bypass,repair, replacement,

supplement, destruction or restriction

• Location: Extremity arteries of interest

• Iatrogenic: Arterial injuries co-occurring with other

surgeries

• Vein injury / repair

• Injuries to torso, head, neck, wrist, hand, ankle, foot

• Primary repair: Ligation or endovascular repair

Drivers of U.S . C ommercial L aunch in Vas cular Trauma

The Right Team

Sales team of 12 executives who are

experienced in vascular and/or trauma

surgery and regenerative therapies

Sales team is complemented by Medical Affairs, market

access, and marketing teams

Health Economics

Budget Impact Model projects that the

per-patient cost of treating patients with

Symvess is estimated to be less than the cost of treating

with synthetic grafts and other conduits

Concentrated Market

Approximately 200 Level 1

trauma centers in U.S.

Approximately 3,000 vascular

surgeons across civilian and military

market opportunities

Strong Clinical Results

In the civilian and military clinical

studies, Symvess was observed

to have high rates of patency

and low rates of amputation

and infection

Symvess

acellulartissue

engineered vessel-tyod

Symvess in Extremity Injury: Savings in Hospital Charges

Healthcare Economics

Symvess is associated with meaningful reductions in hospital charges when used in patients lacking

feasible saphenous vein

Additional hospital

charges associated

with each vascular

graft infection:

$589,921

Additional hospital

charges associated

with each

amputation:

$492,986

1. Velez, F. F., Rajani, R. R., Malone, D. C., et al. Journal of Medical Economics, 28(1), 323–334. 2. Brouwer E, Velez FF, Tan J. Submitted manuscript undergoing peer review.

Symvess Budget Impact Model (BIM) in Extremity Arterial Injury

Healthcare Economics

At its current price point of $17,000, Symvess was shown to be the second-most economical arterial

graft, after saphenous vein1

Published in J Med Econ, showed use of

Symvess in patients without feasible

saphenous vein resulted in a net cost

reduction1

1. Velez, F. F., Rajani, R. R., Malone, D. C., et al. Journal of Medical Economics, 28(1), 323–334. 2. Brouwer E, Velez FF, Tan J. Submitted manuscript undergoing peer review.

Department of Defense Support

DEPARTMENT OF DEFENSE SUPPORT

Symvess (ATEV) for Vascular Trauma designated as a “Priority Product” by DoD • designation created by Public Law 115-92 to expedite the development and FDA review of DoD priority technologies

V005 Phase 3 clinical trial was partially funded by the DoD

Symvess successfully treated Ukrainian warfighters, resulting in 100% limb salvage

FY 2026 DoD Appropriations Act includes funding for the evaluation and incorporation of

biologic vascular repair technologies for warfighters

The Department of Defense (DoD) invested in Symvess in recognition of its benefit

in battlefield injuries for warfighters

In civilian mass-casualty situations, having Symvess on the shelf can also help with response

to terrorism/other threats, since surgeons can operate more quickly

and treat more patients, not having to take time to harvest vein

Pipeline:

AV Access

for Dialysis

AV Access for Hemodialysis Has Limitations

Estimate of Permanent Access

Procedures Performed in U.S.

~20% Grafts

~20% Catheters

~60% AV fistulas

Venous / Temporary Catheter

Primary/AV Fistula (Autogenous)

Secondary / Graft

Market targeted by V007 and V012

Phase 3 Trials

• ~40% of fistulas fail to mature

• Even the fistulas that do mature take 3-6 months to

become usable for dialysis

• Catheter infection rates are up to 200% per

patient-year

Limitations of AV Fistulas

(Current Standard of Care)

Access During the First Year: Too Many Catheters!

More than 80% of patients begin dialysis with a catheter.

After 12 Months, many patients are still on a catheter –

Fistulas and Synthetic Grafts Are Not Working for These Patients.

USRDS 2025: Figure 4.8a, Chapter 4

Hospitalizations From Access Infections Each Year Annual Hospitalized Percentage for Each Access Type

USRDS 2025: Figures 4.5a and 4.6, Chapter 4

Prevalent patients from Figure 1.12, Chapter 1

Assumes no more than 1 hospitalization per month per patient.

11,335

Patients

hospitalized

per year

22,671

Patients

hospitalized

per year

73,680

Patients

hospitalized

per year

Though less than

half of accesses

one year after

starting dialysis,

Catheters and

Synthetic Grafts

together account

for ≈90%

of infections.

> 100,000 Hospitalizations Per Year for Hemodialysis Access Infections:

A Multi-Billion Dollar Problem for Insurers

1: Farrington, C.A. et al, Am J Nephrol 2019; 50: 126-132.

2: Cheng, T.W. et al, J Vasc Surg 2019; 70: 193-198.

3: Mohapatra, A., et al, J Vasc Surg 2021; 73: 581-587

Hemodialysis Catheter Infections 1.3

Hospitalization rate ~ 60%/patient-year

> 70,000 hospitalizations per year

Average hospitalization 4-5 days

Metastatic infections to heart,

bones, joints, lungs, etc.

Can be debilitating and/or fatal.

COST PER Hospitalization: $29,175

COST TOTAL: $2.15 billion/yr

Synthetic Graft Infections 2,3

Hospitalization rate ~ 27%/patient-year

> 20,000 hospitalizations per year

Average hospitalization 8 ± 6 days

Half of patients still on catheter

after 1 year, for fear of

surgical access re-infection.

COST PER Hospitalization: $29,175

COST TOTAL: $0.62 billion/yr

Women are Burdened with Infection-Prone Accesses

49.9% of women use an infection-prone access – half of all women on dialysis.

Catheters cause more bloodstream infections; episodes of sepsis; metastatic infections;

and hospitalizations. Catheters and infections substantially increase costs.

USRDS 2025: Table 1.6, Chapter 1

USRDS 2025: Figure 4.7, Chapter 4

ATEV is Designed to Address Failures in AV Access

• ATEV usable for dialysis after only four weeks

• ATEV reduces catheter contact time, thereby reducing risk

of catheter infection

• > 80% of ATEVs functional for dialysis at 6 months

• ATEV infection rate is comparable to AVF

• Opportunity to reduce cost of access failures and other

complications:

• Access failures and complications

• Dialysis complications

• Infections

RMAT RMAT designation

granted by FDA

ATEV provides potential for improved patient outcomes

Strategic collaboration with

FMC, the largest provider of

renal care services

V007 Phase 3 Results

in Dialysis Access

• More adverse events were reported in patients on the ATEV treatment arm than those on the AV

fistula treatment arm:

• More thromboses in the ATEV group, but virtually all were resolved

• A number of serious events occurred more frequently in the AVF arm:

• Two ruptures of AVF (a potentially fatal event), none for ATEV

• Substantially more “steal” (ischemia of the hand), surgical revisions, and balloon-assisted maturation in the AVF group compared to

the ATEV group

V007 Top-Line Results – ATEV Met Co-Primary Endpoints

ATEV was observed to have superior function and patency at six and 12 months (co-primary

endpoints) compared to autogenous fistula, the current standard of care for hemodialysis

Co-Primary Endpoints ATEV (N=123) AVF (N=119) p-value

Functional Patency at Month 6 81.3% 66.4%

0.0071

Secondary Patency at Month 12 68.3% 62.2%

• Subjects with end-stage renal disease in need ATEV

of dialysis

• Enrollment completed April 2023, 242 total

subjects

Single-stage AV

Fistula

V007 Superior Subgroup Results

Females ATEV (N=37) AVF (N=33) p-value

Functional Patency at Month 6 89.2% 54.5%

<0.0001

Secondary Patency at Month 12 81.1% 48.5%

Difference p-value

Duration of Use Over First 12 Months 8.3 months 5.0 months 3.3 months 0.0011

ATEV showed superior function and patency in subgroups with historically poor outcomes

Females, and males with

BMI ≥ 30 and diabetes ATEV (N=56) AVF (N=54) p-value

Functional Patency at Month 6 85.7% 51.9%

<0.0001

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

V007 Safety Results in Key Subgroup

ATEV has shown no increased safety events per year of usability in all females and males

with BMI ≥ 30 kg/m2 and diabetes

12-Month Safety Summary

ATEV AVF

Subjects

(%) n=54

Events

per

Patient

Year

Subjects

(%) n=56

Events per

Patient

Year

Treatment Emergent Adverse Events 96.3% 14.8 98.2% 21.8

Serious Adverse Events 77.8% 4.2 67.9% 6.1

Adverse Events of Special Interest:

CEC SA-related infections

Thrombosis

Stenosis

Clinically significant Steal Syndrome

Rupture of SA

Leading to SA revision or ligation

Leading to SA excision

7.4%

51.9%

64.8%

1.9%

0.0%

11.1%

5.6%

0.1

1.2

3.0

0.0

0.2

5.5%

12.5%

51.8%

3.6%

28.6%

3.6%

0.1

0.3

2.9

0.1

1.2

0.1

V007 Two-Year Results in Female Patients

ATEV has shown superior long-term patency at 24 months in females, and in all females and

males with BMI ≥ 30 kg/m2 and diabetes

V012 Top-Line Interim

Results

ATEV for Dialysis Access in

Women

CLN-PRO-V012:

Phase 3 Study Designed to Address the Unmet Need in Women

STUDY DESIGN

Prospective · Multicenter · Open-Label · Randomized

NCT05908084 | ClinicalTrials.gov | CLN-PRO-V012

PRE-SPECIFIED INTERIM ANALYSIS

Follow-up Period

0 24

Months

6 12 18

n=80 patients enrolled

Interim Analysis Trigger

Superiority Analysis

PRIMARY ENDPOINT

AVF Catheter-free days at 12 months

ATEV

24-month follow-up · All patients with study access

1:1

150 patient

enrollment target

Female ESKD

patients on HD

OTHER ENDPOINTS AT 12 MONTHS

Dialysis Access Infection Rate & Severity · Catheter-free

Days at 6 months · Functional Patency at 12 months ·

Secondary Patency at 6 & 12 months · Study Access

Survival (from maturation to abandonment) · AESIs

V012 - Two Arms are Balanced in Baseline Characteristics

Characteristic ATEV

(N=40)

AVF

(N=40)

Age (Y), Mean (SD) 53.9 (16.6) 52.6 (16.9)

Age > 65 years, N (%) 10 (25.0%) 11 (27.5%)

Obese (BMI ≥ 30), N (%) 20 (50.0%) 19 (47.5%)

Diabetes, N (%) 21 (52.5%) 20 (50.0%)

Subject counts (N) are intent-to-treat population

Stratification: By location of the vascular access (forearm versus upper arm) and by type of AVF

creation procedure planned by the surgeon at randomization (1-stage AVF versus 2-stage AVF).

Inclusion criteria- Women on Hemodialysis needing AV access with suitable anatomy for creation of

a forearm or upper arm AVF and for implantation of straight, curved, or looped ATEV in either the

forearm or upper arm.

V012 Met Primary Endpoint: 12-Month Catheter-Free Days

PRE - SPECIFIED PRIMARY ENDPOINT • 12 - MONTH CATHETER - FREE DAYS

Statistically Significant

p=0.00070

Pre-specified superiority threshold met

Interim analysis: ATEV (N=40) vs AVF (N=40)

TREATMENT DIFFERENCE

91 More catheter-Free Days in Year 1

95% CI: 39.8 – 142.4

ATEV 220.4

AVF 129.3

WHAT IT MEANS

ATEV patients spent ~3 additional months off a

catheter vs. AVF in the first year.

CLN-PRO-V012 · Pre-specified interim analysis · ITT population · NCT05908084

V012 Primary Safety – Fewer Access Infections

ATEV Observed to Have Reduced Dialysis Infection Rates

17 Less Dialysis Access Infections per 100 Patient-Years

No hypothesis was pre-specified

ATEV 2 events [6 / 100 patient years]

AVF 9 events [23 / 100 patient years]

ATEV: 2 subjects (5.1%)

AVF: 6 subjects (15.0%)

V012 Secondary Efficacy Analyses

Secondary Analyses ATEV (N=40) AVF (N=40) p-value

1. Six-Month Catheter-Free Days 88.4 days 32.3 days 0.00009

2. 12-Month Functional Patency 250.1 days 151.7 days 0.00057

3. Six-Month Secondary Patency 87.5% 65.0% 0.0013

4. 12-Month Secondary Patency 77.5% 62.5% 0.16

ATEV was observed to have consistent advantages over AVF

V012 Interim Safety Results

Overall benefit-risk safety profile of ATEV is favorable with no new or unexpected safety concerns identified

12-Month Safety Summary

ATEV (n=39) AVF (n=40)

% of

Subjects Events

Events

per

Patient

Year of

Use

% 0f

Subjects Events

Events per

Patient

Year of

Use

Treatment Emergent Adverse Events 94.9% 235 8.84 92.5% 287 18.26

Serious Adverse Events 51.3% 46 1.73 60.0% 75 4.77

Adverse Events of Special Interest:

Study access infections

Thrombosis1

Stenosis

Clinically significant Steal Syndrome

Rupture of SA

Iatrogenic injury of SA

AE leading to Abandonment

0.0%

35.9%

66.7%

7.7%

0.0%

2.6%

7.7%

0.00

0.75

1.62

0.11

0.00

0.04

0.11

7.5%

17.5%

40.0%

7.5%

0.0%

20.0%

0.19

0.51

2.29

0.19

0.00

0.57

175% of the ATEV thrombosis cases were successfully resolved compared to 37.5% of AVF cases

V012 Interim Results Summary

• The ATEV met V012’s primary endpoint by demonstrating superior catheter-free days

compared to AVF, the current standard of care

• 91 more catheter-free days than AVF (p=0.0007)

• ATEV patients incurred 17 fewer dialysis access infections than AVF per 100 patient years,

the primary safety measure for the study

• The ATEV was observed to demonstrate consistent advantages over AVF in multiple

secondary endpoints

• Overall benefit-risk safety profile of ATEV is favorable with no new or unexpected safety

concerns identified

In accordance with the study protocol, as a result of meeting the primary endpoint,

study enrollment will terminate. Humacyte plans to file a supplemental BLA with the

FDA during the second half of 2026 (target indication is in adult patients with ESKD

who are at increased risk of AV fistula maturation failure).

Pipeline:

Peripheral Arterial

Disease (PAD)

• Tissue does not receive enough

blood flow to survive

• If untreated, leads to tissue loss,

gangrene, and ultimately

amputation

Critical Limb Threatening

Ischemia

• Non-surgical, catheter-based

intervention

• Surgical bypass

Treatment Requires

Restoration of Blood Flow

Can progress to multiple leg

arteries, further reducing

circulation

For the 40% of PAD patients who do not have an ipsilateral saphenous vein for arterial bypass,

ATEV may represent a promising means of revascularization and limb salvage

Peripheral Artery Disease (PAD)

Current Clinical Experience with ATEV

in Peripheral Arterial Disease

1Piotr Gutowski, et al, 6-Year Outcomes of a Phase 2 Study of Human-Tissue Engineered Blood Vessels for

Peripheral Arterial Bypass, JVS: Vascular Science (2023)

2Lauria A, Kersey A, Propper B, et al. Annals of Vascular Surgery. 2022 Apr 6:S0890-5096(22)00180-7

• V002 – 20 patients (EU)

• V004 – 15 patients (US)

Phase

Trials

Over 20 U.S. patients with critical limb

ischemia treated under FDA Expanded

Access program

Investigator-sponsored IND

• 29 patients with severe PAD at risk of

limb loss

• Patients did no have saphenous vein

available

Mayo

IND

• Six-year results from V002 published

in Journal of Vascular Surgery –

Vascular Science1

• Publication of First Eight Expanded

Access Cases in Annals of Vascular

Surgery2

• Outcomes published in Midwestern

Vascular Surgical Society showing 86%

limb salvage rate

Pipeline:

CTEV for Coronary

Bypass Graft Surgery

Coronary Artery Bypass Grafting (CABG)

Introduction

• The most commonly performed cardiac surgical procedure in the U.S. (approx.

300,000 per year)

• In the United States, 79 people per 100,000 have triple bypass surgery each

year.

• CABG is generally recommended when there are high-grade blockages in any

of the major coronary arteries and/or percutaneous coronary intervention

(PCI) has failed to clear the blockages

Most commonly used autologous grafts

• Left internal mammary artery (LIMA)

• Most often used to bypass Left Anterior Descending (LAD) Artery

• >90% patency at 10 years

• Saphenous vein graft (SVG)

• Often used to bypass Right Coronary Artery (RCA) or Left Circumflex

Artery

• SVGs used in 80-90% of CABG procedures

• 10%-25% failure rate at 1 year, 40%-50% failure rate at 10 years

• Radial artery and other arm veins

Concerns with Saphenous Vein Grafts

Vein Quality Issues

• Varicosities (20-30% of patients)

• Previous vein stripping or ablation

• Small diameter (<3mm)

• Sclerotic or diseased veins

• Peripheral vascular disease effects

Medical Co-morbidities

• Bilateral leg amputations

• Need to preserve vein for future peripheral bypass

• Prior vein harvest for CABG or peripheral surgery

• Obesity (difficult harvest)

• Patients with diabetes (higher failure rates)

Harvest-Related Morbidity

• Wound complications (5-10%)

• Leg edema and pain

• Infection risk

• Nerve injury (saphenous nerve)

• Prolonged recovery time

Long-Term Clinical Impact

• Need for repeat revascularization

• Recurrent angina (20-30% at 5 years)

• Risk of graft atherosclerosis

• Reduced event-free survival

• Higher healthcare costs

• Zenati MA et al. N Engl J Med. 2019;380:2069-77

• Hess CN et al. Circulation. 2014;130:815-27

• Lopes RD et al. JAMA. 2012;307:265-74

Coronary Tissue Engineered Vessel (CTEV):

Addressing an Unmet Need in Multivessel CABG • The CTEV is designed to be a

first-of-its-kind, sterile, off-the- shelf human-derived vessel

that requires no preparation, is

non-immunogenic, and resist

infection.

• The CTEV has an inner

diameter of 3.5 mm and is

approximately 23 cm in length.

• Designed to address unmet

conduit needs in CABG

patients lacking autologous

options, potentially offering

patency and durability

comparable to or better than

saphenous vein without the

need for harvesting.

• First human study of CTEV

planned for 2nd Half 2026.

Non-Human Primate CABG Out To 6 Months

Remodeling of CABG Conduit in Non-Human Primates

Pipeline:

BioVascular Pancreas

The BioVascular Pancreas (BVP) Acellular Tissue Engineered Vessel

(ATEV) is implanted in the arm

BioVascular Pancreas

(BVP)

The BVP is an innovative implantable device designed to deliver

pancreatic islets, for treating Type 1 Diabetes (T1D)

•Core Components: Combines Humacyte's FDA-approved Acellular

Tissue-Engineered Vessel (ATEV) with a fibrin-based hydrogel "sleeve"

populated with islets.

•Mechanism: The ATEV hydrogel coating allows islets access to oxygen

from arterial blood through the vessel wall without direct blood contact,

reducing hypoxia and inflammation.

•Implantation: Deployed as a vascular graft – i.e. as an arteriovenous

graft in the arm. After implantation BVP promotes neovascularization

and long-term islet survival and function.

•Development Status: Non-human primate dose range finding studies

planned 2026. First in human study planned 2027.

Developed in collaboration with

Milestones

Commercial Manufacturing Scale – LUNA200 System

Commercial 83,000 sq ft Bioprocessing Facility

• Currently operating 8 LUNA200 systems

• Annual capacity expected to exceed 40,000 ATEVs

• Functionally closed system with state-of-the-art process automation

Bioreactor bag

Each bioreactor

bag contains a

single polymer

mesh scaffold,

seeded with

banked human

cells

10 bioreactor bags

per growth drawer;

tubing connects to

shared nutritive

media

Each LUNA200 can

produce 200 ATEVs

per batch (or

~1,000 ATEVs

annually)

Growth drawer LUNA200 System

Anticipated 2026 Milestones

Vascular Trauma (Symvess):

• U.S. commercial launch growth

• Expansion into international

markets

Dialysis (ATEV):

• Publication of V007 Phase 3

results

• Interim results from V012 Phase

3 trial in female patients

• Supplemental BLA filing with FDA

All milestone dates are only management estimates

Vascular Trauma - Symvess:

• U.S. commercial launch

• Long-term results showing

durability of Symvess

V007 dialysis positive Phase 3

ATEV two-year results

Cardiac Bypass Graft Surgery

(CABG) CTEV preclinical results

from large-animal studies

Preclinical BVP results showing

survival and function of islets in

large animals

Completed in 2025 Planned for 2026

CABG (CTEV):

• Commencement of first-in-human

study

• First patient results

BioVascular Pancreas (BVP) for type-1

diabetes:

• Preparation for first human study

Publications & Presentations

(Multiple other clinical and preclinical publications and presentations expected for 2026)

Universally Implantable

Regenerative Human Tissue

Thank You

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