Humacyte, Inc. (HUMA) Earnings Call Transcripts

Humacyte, Inc.'s Latest Earnings Call - June 15, 2026

In the second quarter of fiscal year 2026, Humacyte, Inc. reported significant advancements in its clinical trials, particularly the V012 study, which demonstrated that its engineered blood vessel, ATEV, provided 91 additional catheter-free days compared to traditional AV fistulas. This interim analysis met its primary efficacy endpoint with a p-value of 0.007, indicating strong statistical significance. Management plans to file a supplemental BLA application with the FDA later this year, which could catalyze future growth and stock movement.

Reported metrics

Guidance from management

Management plans to file a supplemental BLA application with the FDA in the second half of 2026, aiming for approval based on the V012 trial results and existing data from previous studies.

What management said

No, we didn't use A1c criteria because you could have patients who are very well controlled on diabetes whose A1s would be perfectly normal. So these are patients who have a history of type 2 diabetes documented, just like you would have a history of hypertension. And yes, a minimal A1c was not needed to participate. They had to have history of diabetes. I think there was an exclusion for severely uncontrolled diabet...

I'll answer it, but I would also like for Dr. Hussain to add his perspective on how commonly it is known about patients at risk of maturation failure. So one, this is a very well-published area in the literature of patients of risk factors for maturation failure. And as I sort of indicated, women, obesity, diabetes and in some cases, elderly have been identified as strong predictors of maturation failure. In this stu...

What analysts pressed on

Analysts expressed concerns regarding the generalizability of the V012 trial results, which focused exclusively on women. Questions were raised about how these findings would translate to a broader patient population and the implications for future clinical practice.

Main topics on the call

• V012 Trial Results — The V012 trial met its primary efficacy endpoint, showing that patients with ATEV had 221 catheter-free days compared to 130 days for AVF, a significant difference. Management stated, 'ATEV met its primary endpoint by de...
• Safety Profile — The ATEV demonstrated a favorable safety profile with significantly fewer infections, reporting only 2 infection events compared to 9 in the AVF group. Management noted, 'ATEV patients incurred 17 fewer dialysis access i...
• Regulatory Path Forward — Management confirmed plans to file a supplemental BLA with the FDA based on the V012 results, indicating confidence in their regulatory strategy. They stated, 'We will be engaging in a discussion with them on how the BLA...
• Market Opportunity — Humacyte highlighted the significant unmet need in dialysis access, particularly for women and high-risk patients, which could expand the market for ATEV. Dr. Hussain emphasized that 'this could very well be in the algor...

Read the full Humacyte, Inc. transcript (June 15, 2026) → Summary generated from the call transcript; every figure above is stated by management on the record.

Earnings Call History

EarningsCalls.dev has 26 Humacyte, Inc. earnings call transcripts on record, spanning March 29, 2022 to June 15, 2026. Based on this history, Humacyte, Inc. reports quarterly. The most recent call on file is dated June 15, 2026. The full list is below — each row opens the complete, free-to-read transcript.

Ticker

HUMA

Exchange

NasdaqGS

Country

US

Sector

Health Care

Industry

Biotechnology

Calls on record

26

First call

March 29, 2022

Most recent

June 15, 2026

Reporting cadence

quarterly