Humacyte Confirms Plans for ATEV Supplemental BLA Filing for Dialysis Access Following FDA Discussions
– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 –

Humacyte, Inc. focuses on developing and manufacturing readily available, implantable human tissues engineered in a laboratory setting. These bioengineered tissues are designed ...
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Est. EPS $-0.09 · Revenue $769380.00 · 2 analysts
Est. EPS $-0.09 · Revenue $1.84M · 3 analysts
Est. EPS $-0.40 · Revenue $3.51M · 4 analysts
Est. EPS $-0.08 · Revenue $1.93M · 1 analysts
EPS $0.28 · Revenue $517000.00
| Metric | Latest | YoYYoY means Year-over-Year. It compares the latest annual value with the previous annual value to show long-term trend strength. | QoQQoQ means Quarter-over-Quarter. It compares the latest quarter with the immediately previous quarter to show short-term momentum changes. |
|---|---|---|---|
| RevenueThe total money that came through the front door from selling things, before paying a single bill. Think of it as the grand total of every credit card swipe from customers. (YoY compares this year to last year's performance, while QoQ compares the current three months to the previous three). | $2.0M | — | -18.0% |
| Net IncomeThe absolute bottom line. If the company paid every single supplier, employee, banker, and tax collector, this is the actual money left in their pocket at the end of the day. | $-40.8M | +72.5% | -108.9% |
| Gross MarginThe basic markup. If they sell a $100 pair of sneakers, this percentage tells you how much of that price tag is profit right after paying for the rubber and shoelaces, but before paying for things like store rent or TV commercials. | -736.5% | — | +34.8% |
| Operating MarginThe 'day job' efficiency score. Out of every dollar a customer spends, this shows how many cents the company keeps after making the product AND paying for all the everyday corporate overhead (like salaries, marketing, and keeping the lights on). | -5271.7% | — | -13.8% |
| Net MarginThe final take-home percentage. When you strip away every conceivable cost, tax, and interest payment, this is the exact number of cents the company truly gets to keep from every dollar in sales. | -2003.6% | — | -154.7% |
| Free Cash FlowThe holy grail of corporate cash. It's the spendable, physical money left over after the business pays for its daily operations AND buys the big, expensive upgrades (like new factories or servers) it needs to survive. This is the 'free' money they can use to pay dividends or buy back stock. | $-105.9M | -6.3% | +12.3% |
| FCF MarginThe ultimate cash conversion rate. It shows how good the company is at turning regular sales directly into cold, hard, spendable cash. A high percentage means the business is an absolute cash-printing machine. | -5197.5% | — | -6.9% |
| Debt / EquityThe financial risk gauge. It compares how much of the company's empire was built using borrowed money (loans) versus the owners' own money (shareholders). A high number means they are heavily leveraged and playing a riskier game; a low number means they are playing it safe. | 2085.8% | +6742.9% | -62.7% |
| Current RatioThe 12-month survival check. It simply compares the cash they have right now (plus things they can quickly turn into cash) against the immediate bills they absolutely must pay this year. A score above 1 means they have enough in the wallet to cover the upcoming bills without panicking. | 3.69x | +53.9% | +58.0% |
| Total AssetsThe absolute size of the company's empire. It bundles together absolutely everything of value they own—from the cash in the register and the inventory in the warehouse, to the software patents in the vault and the factories on the ground. | $116.4M | -15.6% | +24.9% |
| Metric | Annual (A vs E) | Annual Surprise | Quarter (A vs E) | Quarter Surprise |
|---|---|---|---|---|
| EPS Surprise | -0.26 vs -0.29 | +11.3% | -0.16 vs -0.09 | -75.3% |
| Revenue Surprise | $2.0M vs $2.7M | -25.4% | $406000 vs $769380 | -47.2% |
| Date | Executive | Title | Security | Side | Shares | Price |
|---|---|---|---|---|---|---|
| Aug 20, 2026 | Jones Keith Anthony | director | Common Stock | A | 10,000 | $0.69 |
| Aug 17, 2026 | Jones Keith Anthony | director | Common Stock | A | 30,000 | $0.59 |
| Jun 11, 2026 | Windham-Bannister Susan Richards | director | Stock Options (right to buy) | A | 80,000 | $1.08 |
| Jun 11, 2026 | Constantino Michael T. | director | Stock Options (right to buy) | A | 80,000 | $1.08 |
| Jun 11, 2026 | Wallace Max N. | director | Stock Options (right to buy) | A | 80,000 | $1.08 |
Operator: Good morning, ladies and gentlemen, and welcome to Humacyte's second quarter 2026 earnings conference call. [Operator Instructions] As a reminder, this conference call is being recorded. I will now turn the call over to Tom Johnson with LifeSci Advisors. Thomas Johnson: Thank you, operator. Before we begin with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. Forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements except as required by law. Information presented on this call is contained in the press release we issued this morning and in our Form 10-Q, which after filing may be accessed from the investor page of the Humacyte website. Joining me on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer; Jim Mercadante, Chief Commercial Officer; and Dale Sander, Chief Financial Officer and Chief Corporate Development Officer. Dr. Niklason will provide a summary of the company's progress for the second quarter and recent weeks. Jim Mercadante will provide an update on commercial transformation and the progress with the Symvess commercial launch. And Dale Sander will review the company's financial results for the quarter ended June 30, 2026. With that, I'll now turn the call over to Dr. Niklason. Laura? Laura Niklason: Thank you, Tom. Good morning, everyone, and thank you all for joining us for our second quarter financial results and business update call. During today's call, I'll review progress across our development programs for the quarter and recent weeks, and then I'll turn the call over to Jim Mercadante for a review of our commercial progress for our Symvess launch in the vascular injury indication. As you know, Jim was appointed as our Chief Commercial Officer in April and is a seasoned commercial executive with a track record of successful leadership across medical devices, diagnostics, and healthcare technology. We're pleased to have him with us on today's call. After Jim's update, Dale will review our financial results for the quarter and six months ending June 30. As a reminder, our goals for 2026 include the advancing of the U.S. and global commercial launch of Symvess, completion of our V012 Phase III pivotal trial of our ATEV in dialysis access, and filing of a supplemental BLA with the FDA in the dialysis indication, and the commencement of a human study of our Coronary Tissue Engineered Vessel, or CTEV, in coronary artery bypass …
| Name | Title | Compensation | Gender | Year Born | Status |
|---|---|---|---|---|---|
Laura E. Niklason | Founder, President, Chief Executive Officer & Director | USD 902,183 | — | 1963 | Active |
Dale A. Sander | Chief Financial Officer, Chief Corporate Development Officer & Treasurer | USD 735,503 | Male | 1960 | Active |
Shamik J. Parikh | Chief Medical Officer | USD 700,401 | — | 1973 | Active |
Heather Connelly | Chief Quality & Regulatory Officer | — | — | — | Active |
Lisa Molyneux | Chief Strategy Officer | — | Female | — | Active |
Jim Mercadante | Chief Commercial Officer | — | Male | — | Active |
Sabrina Osborne | Chief People Officer | — | Female | — | Active |
Rick McElheny | Senior Vice President of Business Development | — | Male | — | Active |
Todd E. Rasmussen | Chief Surgical Officer | — | — | — | Active |
– Supplemental Biologics License Application (BLA) expected to be filed with the Food and Drug Administration (FDA) in November 2026 –

NEW YORK and NEW ORLEANS, Aug. 21, 2026 /PRNewswire/ -- Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq.

– Phase 3 results highlight benefits of ATEV for patients at higher risk of fistula failure, including all women and men with obesity and diabetes –

Denali Therapeutics (NASDAQ: DNLI - Get Free Report) and Humacyte (NASDAQ: HUMA - Get Free Report) are both healthcare companies, but which is the superior stock? We will compare the two businesses based on the strength of their analyst recommendations, dividends, valuation, institutional ownership, earnings, profitability and risk. Analyst Recommendations This is a summary of recent recommendations

– Jeromy Brink, MD, Mayo Clinic–trained vascular surgeon in Phoenix, is the first surgeon in Arizona to implant Symvess, the first and only FDA-approved bioengineered human blood vessel –
