Three of the ZEVASKYN treatments reported to date took place in Q1 2026 and translated into net revenue of $8.7 million for that quarter. Second, we're sharing meaningful updates to our R&D pipeline, featuring a potentially game-changing, radically novel engineered T-cell technology for advanced prostate cancer. As our initial ZEVASKYN commercial patients share their experiences over time, we expect these stories to become one of the most powerful demand drivers available to us in this rare disease setting. Now I'll share some important pipeline updates that highlight our focus on assets that align with our core competencies and what we believe would deliver the greatest long-term value.
We reported total net product revenue of $8.7 million for the first quarter of 2026. This reflects a strong quarter-over-quarter increase of $6.3 million compared to $2.4 million in the fourth quarter of 2025. The growth was driven by early commercial traction following the launch of ZEVASKYN. The increase was primarily driven by the scaling of commercial ZEVASKYN, with three patient treatments in Q1 versus one treatment in Q4.
Selling general and administrative expenses were $19.5 million, representing an increase of $9.7 million year-over-year first quarter. This increase was expected and reflects our continued investment in commercial infrastructure post-approval. Our balance sheet remains strong and positions us well to support continued commercial execution and pipeline advancement. Overall, we are encouraged by the early commercial progress of ZEVASKYN and remain disciplined in our capital allocation as we scale the business.
| Metric | Period | Current guidance |
|---|---|---|
| Monthly profitability | June 2026 | Maintained; monthly profitability could begin as soon as June 2026 depending on how scheduled biopsies convert |
| Active QTCs | End of 2026 | Six activated; on track for at least seven this year, working toward nine or ten EB centers with the needed infrastructure over time |
| Manufacturing capacity | End of 2026 | Six runs/month now, ramping to about 10 per month by year-end; additional-suite design work done, construction not yet started |
| Payer mix | 2026 | Expected ~60% commercial and ~30-33% Medicaid; gross-to-net expected in the mid-to-upper teens at scale (Medicaid rebate 23.1%) |
| Operating expense run-rate | Rest of 2026 | Excluding the one-time $7M PSMA upfront, R&D and SG&A run-rate roughly steady, with costs shifting from SG&A to COGS as volume grows |
| PSMA CAR-T (ABO-701) | 2H 2027 | Pre-IND FDA meeting on June 3, 2026; IND filing and first-in-human studies to begin in 2H 2027; near-term spend low single-digit millions |
| Metric | YoY | Note |
|---|---|---|
| Net product revenue | $8.7M vs $2.4M (Q4 2025) | Three commercially insured treatments in the quarter; favorable commercial gross-to-net versus the Q4 Medicaid patient. |
| Net loss | -$17.1M vs -$12.0M | Increased commercial investment plus the $7M PSMA CAR-T licensing upfront. |
| EPS | -$0.30 vs -$0.24 | Wider net loss. |
| R&D expense | $9.6M vs $9.9M | Includes a $7M PSMA upfront; excluding it, R&D declined as manufacturing costs shifted to inventory/COGS post-approval. |
| SG&A expense | $19.5M vs $9.8M | Continued commercial infrastructure investment: $5.4M personnel/stock-based comp, $1.9M engineering runs, plus other commercialization costs. |
| Cost of sales | $2.7M vs $1.0M (Q4 2025) | Three treatments in Q1 versus one in Q4. |
| Cash and investments | $168.3M vs $191.4M (YE2025) | Funding commercial execution and the PSMA licensing transaction. |
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| Commercial inflection | 1 treatment | Net product revenue jumped to $8.7M on three commercial treatments; five patients treated since launch, six QTCs live, momentum building. | — |
| QTC expansion | 4 centers | Six activated (added Columbia and CHOP) with national coverage; targeting seven this year and up to nine-to-ten EB centers over time as capacity grows. | — |
| Market access | >80% commercial | 95% of commercial lives now covered by published policies; no attrition, no final denials; out-of-state Medicaid remains the main friction. | — |
| Pipeline pivot to oncology | Ophthalmology preclinical | In-licensed PSMA-directed engineered T-cell therapy ABO-701 for advanced prostate cancer ($7M upfront); deprioritized in-house ophthalmology; pre-IND June 3, 2026; first-in-human 2H 2027; CDMO-run to protect ZEVASKYN focus. | — |
| Path to profitability | 1H 2026 | Monthly profitability possible as early as June 2026; steady-state ~one patient/month per QTC; gross-to-net expected mid-to-upper teens at scale. | — |
| Manufacturing | 6/month | Six runs/month now, ramping to ~10 by year-end; 23-26 day turnaround; every valid biopsy has produced a sheet, usually double-digit sheets. | — |