AVR — Q2 2026 Financial Report Analysis

Anteris spent more as its heart-valve trial expanded, and the cash raised in January covers it for now

Anteris Technologies is a development-stage medical device company. Its product, the DurAVR transcatheter heart valve, is a replacement aortic valve implanted through a catheter rather than by open-heart surgery. It treats aortic stenosis, a narrowing of the valve that can be life-threatening. DurAVR is not yet approved for sale anywhere, so the company's results are mainly a record of how fast it spends money and what that spending pays for. In the second quarter of 2026 (April to June) it spent more on all fronts. R&D rose 43% to $23.4 million and the operating loss widened 48% to $31.0 million. At the same time the PARADIGM pivotal trial began enrolling patients in the United States. A pivotal trial is the large study whose results regulators use to decide on approval. The $320 million raised in January (including $90 million from Medtronic) left $260.9 million of cash at June 30, and management says that covers at least the next 12 months.

At a glance

• $260.9 million cash, up from $12.6 million at December 31, 2025. The January stock sale took the company from almost out of money to about two and a half years of spending at the first half's pace, by our estimate.
• Net loss of $29.1 million, up 40% from $20.8 million. Spending is rising because Anteris is scaling up manufacturing and running a global trial. This is planned growth, not a sign the business is getting worse.
• Loss per share fell to $0.30 from $0.58, but only because the share count roughly tripled. Each existing shareholder now owns a much smaller slice of the company.

The numbers

Figures are in US dollars. The cash comparison uses June 30, 2025. Source: Form 10-Q for the quarter ended June 30, 2026, and the Q2 earnings release.

Where the money went

R&D ($23.4 million, +$7.0 million). The 10-Q breaks down the increase:

• +$3.6 million for scaling up manufacturing and quality systems, including process development and validation work and more staff. Anteris is moving production of the valve, the ComASUR delivery system, the crimper and the access sheath into new or expanded clean rooms so it can supply the trial reliably.
• +$3.1 million for PARADIGM trial activity, including a larger field-based clinical team.
• +$1.4 million in higher stock-based pay, because the share price and headcount both rose.
• Partly offset by $0.7 million less in early-stage DurAVR product research and $0.6 million less spent on v2vmedtech. That is a mitral and tricuspid valve-repair venture the company stopped funding in April 2026, after paying a $0.4 million break fee.

Most of the R&D increase is therefore spending on the trial and on manufacturing, not on research into new products. That is normal for a company moving from development toward a regulatory filing.

SG&A ($8.4 million, +68%). Management attributes the rise to higher employee costs from hiring, more stock-based pay, and more consulting and IT spending. SG&A, the cost of running the company outside the lab, grew faster than R&D this quarter. That is worth watching, because general overhead does not move the valve closer to approval.

Revenue is not a DurAVR signal. The $1.0 million of sales came from regenerative tissue products sold to 4C Medical Technologies, a business left over from before DurAVR. Anteris chose not to renew the 4C supply agreement, and it expired on June 1, 2026. The company expects to keep filling purchase orders placed before then and says the expiry is not material. Expect this line to shrink over time. The jump to $1.0 million most likely reflects final orders before the expiry. The 10-Q says only "increased sales of tissue products to 4C", so that reading is ours.

The trial: where DurAVR stands

PARADIGM is a randomized trial. Patients are randomly assigned to receive either DurAVR or a valve that is already approved and sold. The main measure is a combination of death from any cause, stroke and hospitalization for heart problems, one year after the procedure. The test is non-inferiority: DurAVR needs to be shown no worse than existing valves on that measure, not better. Patients whose earlier surgically implanted valve is failing go into a separate registry, a parallel study that is not randomized.

Progress to date, according to the 10-Q and the earnings release:

• October 2025: enrollment began in Europe.
• November 2025: the FDA approved an Investigational Device Exemption (IDE), which allows an unapproved device to be used in a US clinical study.
• April 2026: Medicare agreed to cover eligible procedures performed in the trial under its existing TAVR (transcatheter aortic valve replacement) coverage policy. Without that, US hospitals would have had little reason to enroll patients.
• May 2026: the first US patients were enrolled and treated.
• June 2026: France gave regulatory clearance, and Canada also gave clearance during the quarter. Patients are being enrolled in the US, Denmark and the Netherlands, and Australian sites are still in start-up.

More than 130 patients have received DurAVR in earlier studies. The company has not disclosed how many patients PARADIGM has enrolled or when it expects enrollment to finish. Because the main measure is taken one year after each procedure, approval is at least a year after the last patient is treated, plus the time the FDA takes to review a Premarket Approval (PMA) application. PMA is the FDA's strictest approval route for high-risk devices. Anteris expects European CE Mark approval to progress alongside the PMA.

What the headline numbers hide

• Cash burn ran ahead of the loss in Q1, then fell in Q2. Operating cash outflow was $49.5 million for the six months against a $51.7 million loss, so cash and loss tracked each other closely. Within that, Q2 used only $20.8 million (per the earnings release), which means Q1 used about $28.7 million. The 10-Q gives the reason. Supplier bills had built up at year-end while the company waited for the January raise, and paying them pushed cash out in Q1. Accounts payable fell from $11.1 million to $5.1 million. The Q2 figure is a better guide to underlying burn than Q1, but expenses are still rising.
• Interest income is making the loss look smaller. Other non-operating income was $2.4 million in Q2, against $0.1 million a year earlier. It is interest on money-market funds and Treasuries bought with the January proceeds. It helps, but it will fall as the cash is spent. The operating loss of $31.0 million is the better measure of what the business costs to run.
• Loss per share fell because of dilution, not better results. The loss grew 40%, yet loss per share almost halved, because the average share count rose from 36.1 million to 97.3 million. January added 55.7 million shares at $5.75: 40.0 million in the public offering and 15.7 million to Medtronic. In May, Anteris also set up an at-the-market program, which lets it sell up to $250 million more stock into the market whenever it chooses. Any sales under it would dilute existing holders further.
• Small one-offs, all disclosed. A $0.5 million Swiss withholding-tax charge from a prior-period audit hit Q1. The $0.4 million v2vmedtech break fee was paid in Q2. Neither changes the picture.
• A cost that rises with the share price. Some employee awards will be paid in cash at the share price rather than in shares. The liability for them grew from $0.3 million to $2.2 million in six months as the stock rose. If the share price keeps rising, these costs rise too, even with no extra work done.
• A large lease not yet on the balance sheet. Anteris has signed a long-term property lease that has not started yet, with $23.2 million of future payments. That is not yet in the lease liabilities shown. The 10-Q lists Minnesota sites in Brooklyn Park (lease to 2037) and Maple Grove.
• Medtronic now owns about 16% of the company. Its 15.65 million shares out of 97.4 million outstanding come to roughly 16%. Medtronic is one of the two biggest sellers of TAVR valves. The filing describes the deal only as a stock purchase, with no commercial agreement disclosed. Even so, a major competitor holding a stake is unusual and worth knowing about.

Takeaway: The question for Anteris is whether PARADIGM enrolls fast enough to finish before the money runs out. The $260.9 million covers roughly two and a half years at the first half's pace, by our estimate. A one-year follow-up after enrollment plus FDA review probably needs most of that time, possibly more. Until the company says how many patients PARADIGM has enrolled, investors can't check this.

Outlook

Management gives no financial guidance. Its only formal statement about funding is that current cash will cover "at least the next 12 months," and it expects to need more capital before DurAVR can be sold. Our own estimate is about two and a half years of runway at the first half's $49.5 million burn, falling as US sites activate and spending on trial and manufacturing keeps rising. Interest income and any sales under the $250 million ATM program would extend it.

What to watch in the next reports:

• Enrollment numbers. A patient count, or a target date for finishing PARADIGM enrollment, would be the most useful disclosure Anteris could make. Without one, the timeline can't be modeled.
• How fast US sites come on. Medicare coverage arrived only in April and the first US patients in May, so Q3 is the first full quarter of US enrollment.
• Quarterly cash burn. Watch whether it stays near Q2's $20.8 million or moves back toward $25–30 million as the trial scales.
• ATM activity. Any shares sold under the $250 million program will show up in the share count.
• Leadership. After the quarter ended, Brent Moen became CFO, effective September 11, 2026 (8-K filed September 8). He was previously CFO at Tactile Systems Technology and Entellus Medical.