Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that senior leadership will present at five scientific and medical events in September 2021.

“We’re pioneering the first engineered off-the-shelf human acellular vessel (HAV) and are wholly committed to realizing the full potential of our HAV across a wide range of applications,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “Our presentations at multiple scientific conferences this month highlight the robust body of data we’ve amassed on our HAV and the breadth of its potential.”

The details of the events are as follows:

Vascular Access Society of Britain and Ireland (VASBI) Annual Scientific Meeting 2021 Virtual
Session: Updates and Developments in Dialysis Access
Title: The Humacyte Graft – Longer term patency with a bioengineered human tissue graft
The presentation provided an overview of Humacyte’s HAV and discussed long-term follow-up data from a Phase 2 vascular access trial in which we observed the long-term durability of the HAV for hemodialysis.
Location: Virtual webcast
Date / time: Thursday, Sept. 16, 2021, 6:15-7:15 p.m. BST
Presenter: Jeffrey Lawson, M.D., Ph.D., Chief Surgical Officer, Humacyte

Life/2021 Nephrology Conference
Session: Interdisciplinary approaches to unlock new therapy solutions to kidney disease
Title: Novel Approaches in Vascular Tissue Engineering
The presentation will summarize Humacyte’s ongoing HAV development program in vascular repair, reconstruction and replacement and potential future applications.
Location: Virtual webcast
Date / time: Friday, Sept. 17, 2021, 12-7 p.m. CEST
Presenter: Juliana Blum, Ph.D., Co-founder and Executive Vice President of Corporate Development, Humacyte

Next Generation Tissue Engineering Symposium 2021
Session: Translation
Title: Navigating Translation of Engineered Tissues
The presentation will describe key steps in translating cell therapies and engineered tissues from the benchtop into early and late-stage clinical trials.
Location: Virtual webcast
Date / time: Thursday, Sept. 23, 2021, 1:15-3:15 EDT
Presenter: Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer, Humacyte

Joint Congress of the International Xenotransplantation Association (IXA) and the Cell Transplant and Regenerative Medicine Society (CTRMS)
Session: Islet Transplantation: Allo & Xeno
Title: A Pancreatic Islet Transplantation Approach using an Acellular Vessel
The presentation will highlight data on laboratory and preclinical models demonstrating the potential to engineer a biovascular pancreas to deliver islet cells to produce insulin in Type 1 diabetic patients.
Location: Virtual webcast
Date / time: Thursday, Sept. 23, 2021, 3-4:15 p.m. GMT
Presenter: Jeffrey Lawson, M.D., Ph.D., Chief Surgical Officer, Humacyte

American Association of Kidney Patients 46th National Patient Meeting
Session: Global Kidney Voices™: Leading the Charge – Kidney Patients Driving Global Innovation and Independence
Title: Innovations in Vascular Tissue Engineering – A Promising New Potential for Patients
The presentation will summarize Humacyte’s ongoing HAV clinical program in dialysis access care, including current clinical trials, the potential for the HAV to improve dialysis patient treatment, and the role patient communities play in furthering innovation and expanding access to advancements in dialysis care.
Location: Virtual webcast
Date / time: Friday, Sept. 24, 2021, 10 a.m. EDT
Presenter: Juliana Blum, Ph.D., Co-founder and Executive Vice President of Corporate Development, Humacyte

About HAV

Human Acellular Vessels (HAV) are engineered off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction and replacement. HAV is intended to overcome long-standing limitations in vessel tissue repair and replacement – it can be manufactured at commercial scale, it eliminates the need for harvesting a vessel from a patient, and clinical evidence suggests that it is non-immunogenic, infection-resistant, and can become durable living tissue. HAV is currently being evaluated in two Phase 3 trials in AV access and a Phase 2/3 trial for vascular trauma, and has been used in more than 460 patient implantations. It is the first product to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration, and has also received FDA Fast Track designation.

About Humacyte

Humacyte, Inc., (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and organs 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 initial opportunity, a portfolio of human acellular vessels (HAVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. Pre-clinical 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 HAVs were the first product to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) expedited review designation and 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, statements regarding the initiation, timing, progress and results of our clinical trials; the anticipated characteristics and performance of our HAVs, our ability to successfully complete, clinical trials for our HAVs; the anticipated benefits of our HAVs relative to existing alternatives; the commercialization of our HAVs and our ability to manufacture at commercial scale; the implementation of our business model, strategic plans for our business; the scope of protection we are able to establish and maintain for intellectual property rights covering our HAVs and related technology; the timing or likelihood of regulatory filings and approvals; timing, scope and rate of reimbursement for our HAVs; and our estimated available market opportunity. 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, the impact of COVID-19 on Humacyte’s business, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, 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 8-K filed with the Securities and Exchange Commission on August 30, 2021 and subsequent annual reports, quarterly reports and other filings made with the Securities and Exchange Commission from time to time. 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. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. 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.

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