Abeona Therapeutics Inc. (ABEO) Earnings
Abeona Therapeutics Inc. is expected to report next earnings on August 13, 2026 (in NaN days), with a consensus EPS estimate of $-0.23. ABEO has beaten EPS estimates in 10 of its last 12 reported quarters (average surprise +153.5% over the last four).
| Report date | EPS est | EPS actual | Surprise | Revenue | Rev. surprise |
|---|---|---|---|---|---|
| May 13, 2026 | $-0.33 | $-0.30 | +9.1% | $9M | +90.7% |
| Mar 17, 2026 | $-0.35 | $-0.34 | +3.4% | $5M | -33.9% |
| Nov 12, 2025 | $-0.27 | $-0.10 | +63.0% | — | — |
| Aug 14, 2025 | $-0.39 | $1.71 | +538.5% | $400000 | -93.9% |
| May 15, 2025 | $-0.35 | $-0.24 | +31.4% | — | — |
| Mar 20, 2025 | $-0.43 | $-0.24 | +44.2% | — | — |
| Nov 14, 2024 | $-0.38 | $-0.31 | +18.4% | — | — |
| May 15, 2024 | $-0.47 | $-0.53 | -12.8% | — | — |
| Mar 18, 2024 | $-0.51 | $-0.64 | -25.5% | $3M | — |
| Nov 13, 2023 | $-0.53 | $-0.48 | +9.4% | — | — |
| May 11, 2023 | $-0.58 | $-0.54 | +6.9% | — | — |
| Nov 14, 2022 | $-1.78 | $-1.48 | +16.9% | — | — |
Source: company filings + earnings calendar. For informational purposes only — not investment advice.
Earnings call summary
Q1 FY2026 · May 13, 2026
AI summary of management’s prepared remarks and analyst Q&A. For informational purposes only — not investment advice.
Management highlights
- ZivaSkin Commercial Launch Progress * As of the call, 5 patients have been treated with ZivaSkin total since commercial launch: 1 in Q4 2025, 3 in Q1 2026, and 1 in Q2 2026 to date. One additional patient has been biopsied with manufacturing underway, and 6 more patients are scheduled for biopsy in Q2 2026. * 6 Qualified Treatment Centers (QTCs) have been activated across geographically diverse U.S. regions, on track to reach 7 activated QTCs by the end of 2026. More than 100 patients have been identified as candidates across activated QTCs and referring physicians, and the company is actively engaging with 45 referring physicians for patient referrals. * Payer coverage for ZivaSkin has reached 95% of commercially covered lives with published coverage policies, with no patient attrition or final payer denials to date. Coverage spans commercial and Medicaid insurers, and patient adoption includes both adult and pediatric patients as young as 5 years old. * New 5-year Phase 3 trial data and 12-year Phase 1/2A follow-up data confirming durable wound healing and a favorable safety profile will be presented at the upcoming Society for Investigative Dermatology conference. - R&D Pipeline Updates * The company has deprioritized its in-house preclinical ophthalmology programs to focus on high-value core pipeline assets aligned with its cell therapy expertise. * Abiona has in-licensed SIRT-T, a novel engineered T-cell technology targeting PSMA for the treatment of advanced prostate cancer. The lead asset PSMA-13 (AB0701) is an autologous T-cell therapy designed to overcome historical limitations of CAR-T and TCR therapies for solid tumors, with promising deep, durable anti-tumor responses in preclinical mouse models. * A pre-IND meeting with the FDA is scheduled for June 3, 2026, with IND filing and first-in-human trials planned to begin in the second half of 2027. All near-term development for PSMA-13 will be conducted via an external CDMO, with no disruption to internal ZivaSkin commercialization efforts. - Financial Performance * Q1 2026 net loss totaled $17.1 million, or $0.30 per basic/diluted share, compared to a $12 million net loss ($0.24 per share) in Q1 2025. The year-over-year increase reflects higher commercial infrastructure investment and the $7 million upfront payment for the PSMA SIRT licensing deal. * The company ended Q1 2026 with $168.3 million in cash, cash equivalents, and short-term investments, maintaining a strong balance sheet to support commercial execution and pipeline advancement.
Guidance
- The company remains on track to activate 7 QTCs for ZivaSkin by the end of 2026, with long-term plans to activate 9-10 total QTCs, aligned with incremental increases to internal manufacturing capacity that will be ramped up to match patient demand. - Management expects a majority of the 8 patients currently in the ZivaSkin treatment pipeline (1 treated, 1 in manufacturing, 6 scheduled for biopsy) to be treated and recognized as revenue in Q2 2026, with some late June biopsies potentially spilling over to Q3 2026 treatment. - Excluding the one-time $7 million PSMA licensing upfront payment, the current operating expense run rate will remain largely consistent for the remainder of 2026. Only low single-digit millions in additional R&D spending is expected for the PSMA program in 2026. - When the patient treatment mix normalizes, management expects gross-to-net discounts to land in the mid-to-upper teens percentage range, with a long-term expected patient mix of ~60% commercial patients and ~30-33% Medicaid patients. - Management maintained prior guidance that monthly profitability could potentially begin as early as June 2026, depending on ZivaSkin biopsy and treatment timelines.
Segment performance
Abiona Therapeutics only has one commercial product segment, ZivaSkin, for the treatment of recessive dystrophic epidermolysis bullosa (RDEV). In Q1 2026, ZivaSkin generated total net product revenue of $8.7 million, which is 100% of the company's total net revenue. This represents a $6.3 million quarter-over-quarter increase from the $2.4 million net revenue recorded in Q4 2025. Cost of sales for ZivaSkin in Q1 2026 was $2.7 million, up from $1 million in Q4 2025, driven by scaling commercial operations to treat 3 patients in Q1 2026 compared to 1 patient in the prior quarter. The company's R&D and SG&A segments are corporate-level functions supporting ZivaSkin commercialization and pipeline development: R&D expenses were $9.6 million in Q1 2026, and selling, general and administrative expenses were $19.5 million in the quarter.
Risks & headwinds
- Lengthy insurance approval processes are a near-term headwind for ZivaSkin, particularly for out-of-state Medicaid patients, due to the one-time paperwork and enrollment requirements for new high-cost gene therapies at commercial launch. While the process will improve over time as precedents are set, it currently creates delays in treatment timelines. - QTC activation requires a multi-month, multi-step process including multidisciplinary team formation, institutional business case approval, clinical/quality training, and legal contracting, which can extend the timeline from initial engagement to first patient treatment to more than a year. Only a limited number of U.S. EB treatment centers have the required multidisciplinary infrastructure in place to treat patients. - PSMA-13 is an early-stage preclinical asset, and its ability to outperform historical CAR-T and TCR therapies in human solid tumors is unproven. Clinical development success depends on future trial results that cannot be guaranteed. - Actual results may differ materially from forward-looking projections due to regulatory, clinical, payer, and manufacturing factors, consistent with the risks disclosed in the company's SEC filings.
Analyst Q&A
Q: What is the typical profile of patients treated so far, and is there clinical need for repeat ZivaSkin treatments? /
A: All treated patients have severe RDEV, as expected, and many require more than 12 ZivaSkin sheets, creating clear clinical need for potential future retreatment. It is too early to know when or how many former clinical trial or initial commercial patients will return for retreatment, and consultations are ongoing with interested patients. Management will provide updates as more data becomes available.
Q: What are the key challenges to QTC activation, and what is the biopsy manufacturing success rate for commercial patients? /
A: QTC activation is a multi-month process requiring multidisciplinary team assembly, institutional business case approval, clinical training, and legal contracting, often taking multiple months or even more than a year from initial outreach. Only around 5-10 of the 23 current U.S. EB care centers have the required infrastructure to treat patients, so the company is focused on these high-potential centers. To date, every valid commercial biopsy has successfully produced usable ZivaSkin sheets, with turnaround time ranging between 23 and 26 days.
Q: What are the deal economics for the PSMA SIRT licensing, and will clinical development disrupt ZivaSkin commercialization? /
A: The $7 million upfront payment is the primary near-term cost, with only ~$1 million in additional milestone payments due through the end of Phase 1. After Phase 1 data readout, the company can either enter a 50-50 co-development agreement with Angelus or exercise an option for full ownership with biobucks and royalties to Angelus. All early development will be handled via an external CDMO with only a small internal team assigned, so there will be no disruption to internal teams focused on ZivaSkin commercialization. Significant costs will not be incurred until first-in-human trials begin in H2 2027.
Q: Why is Abiona confident PSMA-13 can succeed where past solid tumor CAR-T programs failed? /
A: PSMA-13 uses SIRT-T technology that is structurally distinct from traditional CAR-T, combining the direct target binding of CAR-T with the native physiologic signaling of natural T-cell receptors to enable more controlled, durable anti-tumor activity. Preclinical head-to-head studies against equivalent PSMA CAR-T controls showed deeper, more persistent anti-tumor responses in mouse models with lower cytokine release. This fundamental structural and functional novelty addresses key limitations that have constrained prior solid tumor engineered T-cell therapies.