Humacyte (HUMA) pipeline and stated timing

Name in SEC filings: Humacyte, Inc.

Pipeline at a glance

Program	Event	Stage	Stated timing	Filing
acellular tissue engineered vessel / ATEV	submission	—	second half of 2026	10-Q · Aug 12, 2026

Source: ORION, orionbiotechai.com/company/HUMA, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/HUMA

Nearest upcoming stated timing: acellular tissue engineered vessel / ATEV · NDA/BLA submission · second half of 2026

SEC sources last checked Oct 18, 2026.

Programs and stated timing

○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.

acellular tissue engineered vessel / ATEV

Matched

NDA/BLA submissionsecond half of 2026

Stage: —

Public float: $280,300,000 · as of Jun 30, 2025 · SEC filing

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.

10-Q · Filed Aug 12, 2026 · Last checked Oct 18, 2026

Source details

Accession 0001193125-26-347022

Alert me · Calendar: same stage and window-end month (2026-12)

How this date was described over time

Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of Oct 19, 2026.

Program / event	Stated period and SEC wording	Disclosure in stated period
acellular tissue engineered vessel / ATEVSubmission	second half of 2026 “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.” Filed Aug 12, 2026 · 10-Q	Still within period As of Oct 19, 2026
acellular tissue engineered vessel / ATEVSubmission	second half of 2026 “Humacyte plans to file a supplemental BLA with the FDA during the second half of 2026.” Filed Jun 10, 2026 · EX-99.1	Still within period As of Oct 19, 2026
acellular tissue engineered vessel / ATEVSubmission	second half of 2026 “If the interim results from our ongoing V012 Phase 3 trial in women are positive, 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.” Filed May 13, 2026 · 10-Q	Still within period As of Oct 19, 2026
acellular tissue engineered vessel / ATEVSubmission	second half of 2026 “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.” Filed May 13, 2026 · 10-Q	Still within period As of Oct 19, 2026
acellular tissue engineered vessel / ATEVSubmission	second half of 2026 “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.” Filed Mar 27, 2026 · 10-K	Still within period As of Oct 19, 2026
acellular tissue engineered vessel / ATEVSubmission	second half of 2026 “If the interim results from our ongoing V012 Phase 3 trial in women are positive, 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.” Filed Nov 12, 2025 · 10-Q	Still within period As of Oct 19, 2026
acellular tissue engineered vessel / ATEVSubmission	second half of 2026 “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.” Filed Nov 12, 2025 · 10-Q	Still within period As of Oct 19, 2026
acellular tissue engineered vessel / ATEVSubmission	second half of 2026 “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.” Filed Aug 11, 2025 · 10-Q	Still within period As of Oct 19, 2026
acellular tissue engineered vessel / ATEVSubmission	second half of 2026 “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.” Filed May 13, 2025 · 10-Q	Still within period As of Oct 19, 2026
acellular tissue engineered vessel / ATEVSubmission	second half of 2026 “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.” Filed Mar 31, 2025 · 10-K	Still within period As of Oct 19, 2026

“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.

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Reading these records

First stated window: The timing wording in the earliest company statement located within the sources checked, quoted as written (for example “2H 2026”). An earlier statement may exist outside those sources.
Disclosure date: The date of the filing or company release that disclosed the readout. “None found” means no such disclosure was located in the sources checked. SEC filings were searched through the “SEC filings searched through” date shown.
1H, 2H, 1Q–4Q: First or second half, or first to fourth quarter, of the year named, as the company wrote it. Equivalent notations are compared together; the original wording stays visible.
SEC original: The filing as published on the SEC EDGAR system. “Company original” is the release on the company's own investor site.
Status: One of seven labels set by founder review of the original filings. Definitions: Methodology.

See HUMA in the calendar · Review labels and methodology