Abeona Therapeutics (ABEO) Q2 FY26 earnings call: guidance and Q&A

When do leading QTCs like Lurie and Stanford expect to reach 1 patient per month? How should we think about the long-term manufacturing success rate given recent low-yield/out-of-spec batches?

Madhav stated that 1 patient per month per QTC is expected once centers reach a steady state, but it's too early to say when. Vish explained that the low-yield batch was a rare event (first time encountered), and the out-of-spec batch was due to a Pan-CK marker identity test specification set during BLA review that the company is working with the FDA to revise.

“But if you look at overall numbers to date, for any autologous therapy that has been launched in the past, you will see such examples. And we'll continue to keep refining numbers and probabilities as we gain more experience there.”

asked by Maury Raycroft (Jefferies) · answered by Vishwas Seshadri

What are the current manufacturing yields (sheets per patient) compared to clinical trials, and what is the low-yield threshold for revenue recognition?

Vish stated current average yield is 9 sheets per lot, better than the 5 sheets in clinical trials. The low-yield threshold for not recognizing revenue is anything less than 4 sheets in a batch.

“Anything that is lesser than 4 sheets in a batch is a low-yield batch. So, that's really our threshold. So 3, 2 or 1 as per NDC is still on label, but it's -- for billing purposes, we will not recognize revenue for those batches.”

asked by Stephen Willey (Stifel) · answered by Vishwas Seshadri

How often do last-minute patient cancellations occur, and how large would the QTC network need to be to cover 80% of the addressable patient population?

Madhav clarified that only 2 last-minute cancellations due to health deterioration have occurred, and patients typically reschedule rather than withdraw permanently. He stated that 40% of the addressable market has in-state QTC access, and patients already travel out-of-state, implying 80% coverage doesn't require QTCs in all states.

“So, far in the patients we have treated, as we mentioned on our prior quarterly call, we've actually had quite a few patients traveling from out of state already. So, that mechanism already exists for people to travel and get treated.”

asked by Ram Selvaraju (H.C. Wainwright) · answered by Madhav Vasanthavada

When will NTAP status be reflected in revenue cadence and margins?

Madhav explained NTAP primarily benefits Medicare beneficiaries (10% of payer mix) by providing vital reimbursement for centers, which previously had limited access. Vish added that NTAP provides a "halo effect" for other payers, aiding negotiations, and is more about making QTCs whole (preventing P&L loss) than directly impacting Abeona's margins.

“For us, it's not so much of a margin place more for the QTCs on are they going to be whole -- made whole. And that's where the NTAP plays a big role because currently for Medicare patients, as you know from the CAR-T world, without NTAP, it's a big P&L loss for a treating institution.”

asked by Ram Selvaraju (H.C. Wainwright) · answered by Vishwas Seshadri

Which issues could having more patients at the top of the funnel mitigate, and which disruptions would still continue?

Madhav stated that a larger funnel helps mitigate issues outside their control, like biopsy date movements, by providing more "shots at filling those manufacturing slots." Vish added that last-minute cancellations (e.g., day of biopsy) are hard to adjust for, but more patients provide flexibility for earlier adjustments.

“If you only have 1 or 2, those idiosyncratic examples will just take over, we don't have reaction time to make amend.”

asked by Kristen Kluska (Cantor Fitzgerald) · answered by Vishwas Seshadri