What Abeona Therapeutics (ABEO) Said on Its Q3 Earnings Call

Key Points

• ZEVASKYN revenue increased 18% quarter over quarter to $13.5 million, with five of six patients treated in Q3 generating recognized revenue. Abeona has expanded to eight qualified treatment centers, but manufacturing capacity and a planned shutdown may push some treatments into early 2027.
• Abeona acquired ABO-801, an oral candidate for eosinophilic esophagitis, after two Phase III trials missed their co-primary symptom endpoint individually. The company plans another roughly 400-patient Phase III study, targeting results around the end of 2028, and estimates development costs of $50 million to $60 million.
• The ABO-801 deal included $20 million in Abeona stock upfront, with potential approval and commercial milestones and tiered royalties. Abeona reported a Q3 net loss of $4.8 million and $134.9 million in cash and short-term investments at quarter-end, excluding proceeds from a separate $30 million private placement.

Abeona Therapeutics NASDAQ: ABEO reported higher ZEVASKYN revenue for the third quarter of 2026 and announced the acquisition of a late-stage drug candidate for eosinophilic esophagitis, as it seeks to expand beyond its first commercial product.

Net revenue from ZEVASKYN, the company’s treatment for recessive dystrophic epidermolysis bullosa, or RDEB, rose 18% from the previous quarter to $13.5 million. Six patients received treatment during the quarter, although Abeona recognized revenue for only five.

Chief Executive Officer Vish Seshadri said the ZEVASKYN launch remains the company’s immediate priority. Abeona also acquired APT-1011, now called ABO-801, from Ellodi Pharmaceuticals and plans to begin another Phase III study of the candidate in mid-2027.

ZEVASKYN launch progresses, but treatment timing remains uneven

Chief Commercial Officer Madhav Vasanthavada said 15 patients have received ZEVASKYN since its launch. The company did not recognize revenue for one third-quarter treatment because the batch was outside specifications for an identity assay.

Abeona expanded its network to eight qualified treatment centers during the quarter, adding Cincinnati Children’s and University of Florida Health. Four centers have treated patients, including Children’s Hospital of Philadelphia and University of Texas Medical Branch, which treated their first patients during the quarter.

Vasanthavada said patients at all eight centers are moving through the treatment process, but the company declined to provide a count of patients awaiting biopsies or treatment. He said scheduling can depend on clinical readiness, insurance authorizations, payment agreements, travel and surgery availability.

A planned annual manufacturing shutdown will also affect timing. Abeona expects to stop collecting biopsies around mid-November and resume in mid-January. Vasanthavada said some patients could move into early 2027 for biopsies and that the first quarter would also be shortened, with approximately six weeks in which collected biopsies could potentially be converted into treatments during the quarter.

Seshadri said Abeona’s current manufacturing capacity is six patients per month. The company is working with the Food and Drug Administration on changes that could increase capacity to 10 manufacturing slots per month within its existing clean-room space, with the expansion targeted for around mid-2027.

New drug candidate faces another Phase III test

ABO-801 is a once-daily, orally disintegrating tablet containing fluticasone propionate for eosinophilic esophagitis, or EoE, a chronic inflammatory disease of the esophagus. Seshadri said the candidate has FDA Orphan Drug and Fast Track designations and that Abeona sees potential for more than $750 million in peak annual revenue.

The candidate has already been evaluated in two Phase III studies involving more than 350 patients combined. Seshadri said the studies showed improvements in measures of inflammation and esophageal structure, but neither individually met its co-primary patient-reported symptom endpoint.

A pooled, post-hoc exploratory analysis of 12-week data from both trials found a significant improvement in complete symptom response compared with placebo, Seshadri said. He attributed the individual studies’ symptom-endpoint misses in part to variability associated with the questionnaire used by Ellodi.

Abeona plans to use the Dysphagia Symptom Questionnaire, an assessment tool used in studies of approved EoE therapies, in its next trial. The proposed study would enroll approximately 400 patients and compare ABO-801 with placebo, with co-primary endpoints measuring symptoms and histologic response at week 12. The company anticipates top-line results around the end of 2028, depending on initiation and enrollment.

Seshadri said Abeona plans to discuss the design with the FDA at a Type C meeting. He said the company believes one additional Phase III trial could support a new drug application, based on the existing data and prior discussions, but it does not have written confirmation that one trial will be sufficient.

Deal terms and financial results

At closing, Abeona issued Ellodi $20 million in common stock for ABO-801, with no upfront cash payment, Chief Financial Officer Joe Vazzano said. Ellodi is eligible for $30 million upon FDA approval, up to another $30 million in commercial milestone payments, and tiered royalties ranging from the low to mid-teens on net sales.

Abeona also announced a $30 million private placement to support its pipeline and ZEVASKYN commercialization. Vazzano estimated that clinical development costs to get ABO-801 to FDA approval would total $50 million to $60 million. He said the company’s cash, financing proceeds, future ZEVASKYN sales and royalties would provide sufficient capital for that goal.

For the third quarter, Abeona reported a net loss of $4.8 million, or $0.08 per share, compared with a loss of $20.2 million, or $0.35 per share, in the second quarter. It ended September with $134.9 million in cash, cash equivalents and short-term investments, excluding the private-placement proceeds.

Seshadri also noted that Ultragenyx received FDA approval in September for FAYUVI, a treatment for Sanfilippo syndrome type A that Abeona advanced before out-licensing it in 2022. Abeona is eligible for commercial milestone payments and tiered royalties under that agreement.

About Abeona Therapeutics (NASDAQ:ABEO)

Abeona Therapeutics Inc NASDAQ: ABEO is a biopharmaceutical company focused on developing and commercializing cell and gene therapies for serious and rare genetic diseases. The company's programs are designed to address conditions with limited treatment options, including diseases caused by genetic defects affecting the skin and other tissues.

Abeona's lead product, prademagene zamikeracel, is an autologous cell therapy for recessive dystrophic epidermolysis bullosa (RDEB), a rare inherited disorder that causes fragile skin and chronic wounds.

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