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8-KAccepted Jun 10, 4:34 PM ET

Humacyte, Inc. Presents Phase 3 ATEV Results for Female Hemodialysis Patients

HUMAHumacyte, Inc.

Accepted (ET)

4:34 PM

Jun 10, 2026

Filed

Jun 10, 2026

Documents

70

Size

12.4 MB

Summary

Humacyte, Inc. Presents Phase 3 ATEV Results for Female Hemodialysis Patients

Updated

What Happened

  • On June 10, 2026, Humacyte, Inc. announced the presentation of results from its Phase 3 clinical trial (V012) of the acellular tissue engineered vessel (ATEV) for arteriovenous access in female patients with end‑stage renal disease requiring hemodialysis. The company filed a press release (Exhibit 99.1) and made an investor presentation available (Exhibit 99.2) in the Form 8‑K.

Key Details

  • Date of announcement: June 10, 2026.
  • Trial: Phase 3 V012, evaluating ATEV in arteriovenous access for female ESRD patients on hemodialysis.
  • Materials filed with the 8‑K: press release (Exhibit 99.1) and investor presentation (Exhibit 99.2).
  • The filing does not include financial statements or other operational disclosures beyond these materials.

Why It Matters

  • Phase 3 data are major clinical milestones; publishing and presenting V012 results provides investors with new information about Humacyte’s lead product candidate and its performance in a defined patient subgroup.
  • The investor presentation and press release give the market a chance to assess clinical progress, which can influence investor sentiment, potential regulatory discussions, and commercial outlook depending on the data content.
  • Investors should review the attached press release and presentation for details on outcomes, safety, and next steps the company outlines.

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