Earnings summaries and quarterly performance for ABEONA THERAPEUTICS.
Executive leadership at ABEONA THERAPEUTICS.
Board of directors at ABEONA THERAPEUTICS.
Research analysts who have asked questions during ABEONA THERAPEUTICS earnings calls.
James Molloy
Alliance Global Partners
4 questions for ABEO
Also covers: ACXP, AIM, AQST +11 more
David Bautz
Zacks Small-Cap Research
3 questions for ABEO
Also covers: QLGN
Jeff Jones
Oppenheimer & Co. Inc.
3 questions for ABEO
Also covers: CLRB, CMMB, CRVS +8 more
Raghuram Selvaraju
H.C. Wainwright & Co.
3 questions for ABEO
Also covers: ACOG, AQST, ASRT +20 more
Dae Gon Ha
Stifel
2 questions for ABEO
Also covers: BEAM, CRBP, EDIT +10 more
Josh
Barclays
2 questions for ABEO
Also covers: DAN
Kristen Kluska
Cantor Fitzgerald
2 questions for ABEO
Also covers: ADMA, AQST, CAPR +24 more
Ram Selvaraju
H.C. Wainwright
2 questions for ABEO
Also covers: ADXN, BCPC, BTAI +8 more
Rick Miller
Cantor Fitzgerald
2 questions for ABEO
Also covers: ADMA, SELB
Stephen Willey
Stifel
2 questions for ABEO
Also covers: ABCL, CGEN, CMPX +7 more
Amin Makarem
Jefferies
1 question for ABEO
Also covers: CELC, CMPX, RIGL
Amin (on for Maury Raycroft)
Jefferies
1 question for ABEO
Also covers: AFMD
Farzin Haque
Jefferies
1 question for ABEO
Also covers: ARWR, AUPH, NTLA +3 more
Matt
Western Standard
1 question for ABEO
Also covers: CWCO, FCEL, IOT +1 more
Matthew Venezia
Alliance Global Partners
1 question for ABEO
Also covers: CAPR, CBUS
Maurice Raycroft
Jefferies Financial Group
1 question for ABEO
Also covers: AFMD, ALNY, ARWR +14 more
Maury Raycroft
Jefferies
1 question for ABEO
Also covers: ALNY, ARWR, BCRX +11 more
Rick
Cantor Fitzgerald
1 question for ABEO
Rick Miller
C.L. King & Associates
1 question for ABEO
Also covers: ADMA, CDXS, FULC
Recent press releases and 8-K filings for ABEO.
Abeona Therapeutics Provides ZivaSkin Commercialization Update and Financial Outlook
ABEO
Product Launch
Guidance Update
New Projects/Investments
- Abeona Therapeutics is a commercial-stage cell and gene therapy company following the Q2 approval of ZivaSkin for recessive dystrophic epidermolysis bullosa (RDEB). The company anticipates becoming profitable in 2026 with the launch of ZivaSkin.
- A temporary pause on patient biopsies for ZivaSkin was implemented in late August 2025 due to a false positive on a rapid sterility assay during the first manufacturing run, caused by human cells. This issue has been resolved, reducing the risk of false positives from 35% to less than 1%, and patient biopsy collection resumed in November 2025.
- Patient demand for ZivaSkin is strong, with 12 ZivaSkin Product Order Forms (ZPOFs) secured from the first two activated Centers of Excellence (QTCs), and the total number of identified patients (intent to treat) has grown to nearly 30. The company aims to activate 5 to 7 QTCs in 2026, with a long-term goal of up to 10.
- Manufacturing capacity is set to increase from 6 slots per month in January 2026 to 10 slots per month by mid-2026. The company also has the ability to expand to 20 slots per month by late 2027.
- Abeona reported a balance of $207.5 million, providing two years of operating runway without accounting for future revenues. The company has also secured a permanent J Code for ZivaSkin, effective January 1, 2026, and achieved baseline Medicaid coverage in all 50 states as of October 1, 2025.
Nov 13, 2025, 6:20 PM
Abeona Therapeutics Provides Q3 2025 Update on ZEVASKYN Launch and Financials
ABEO
Earnings
Product Launch
Guidance Update
- Abeona Therapeutics announced that the first patient treatment for ZEVASKYN has been shifted to Q4 2025 due to optimization of a product release assay, though the company remains confident in achieving its 2026 launch goals.
- The company has secured broad market access for ZEVASKYN, with policies from major commercial payers covering over 80% of commercially insured lives and baseline coverage across all 51 state Medicaid programs and Puerto Rico effective October 1, 2025.
- Patient demand for ZEVASKYN is increasing, with identified eligible patients at Qualified Treatment Centers (QTCs) more than doubling to approximately 30, and 12 ZEVASKYN Product Order Forms received.
- As of September 30, 2025, Abeona reported $207.5 million in cash, cash equivalents, restricted cash, and short-term investments, expected to fund operations for over two years. The net loss for Q3 2025 was $5.2 million, or negative $0.10 per basic and diluted common share.
- Despite the temporary delay in first patient treatment, Abeona still projects to be a profitable business in the first half of 2026.
Nov 12, 2025, 1:30 PM
Abeona Therapeutics Reports Q3 2025 Financials and ZEVASKYN Commercial Progress
ABEO
Earnings
Product Launch
Guidance Update
- Abeona Therapeutics reported a net loss of $5.2 million or -$0.10 per share for Q3 2025, an improvement from the $30.3 million or -$0.63 per share net loss in Q3 2024, with $207.5 million in cash and equivalents as of September 30, 2025, which is expected to fund operations for over two years.
- The first patient treatment for ZEVASKYN has been delayed to Q4 2025 due to the optimization of a rapid sterility assay that previously yielded false positive results. Despite this, the company reaffirms its 2026 launch goals and expects to achieve profitability in the first half of 2026.
- Commercial momentum for ZEVASKYN is building, with 12 Product Order Forms received and identified eligible patients at Qualified Treatment Centers (QTCs) more than doubling to approximately 30. The QTC network has expanded to three activated centers, and market access is broad, covering over 80% of commercially insured lives and all 51 state Medicaid programs and Puerto Rico as of October 1, 2025. A permanent product J-code for ZEVASKYN will be effective January 1, 2026.
Nov 12, 2025, 1:30 PM
Abeona Therapeutics Provides Q3 2025 Financial and ZEVASKYN Launch Update
ABEO
Earnings
Product Launch
Guidance Update
- Abeona Therapeutics reported a cash position of $207.5 million as of September 30, 2025, which is expected to fund current and planned operations for over two years without anticipated ZEVASKYN revenue. The net loss for Q3 2025 was $5.2 million, or negative $0.10 per basic and diluted common share, compared to a net loss of $30.3 million in Q3 2024.
- The first patient treatment for ZEVASKYN has been shifted to Q4 2025 due to optimization of a product release assay, with biopsy collection resuming in November 2025. Despite this temporary delay, the company remains confident in achieving its 2026 launch goals and still projects profitability in the first half of 2026.
- Commercial launch momentum for ZEVASKYN continues, with identified eligible patients at qualified treatment centers more than doubling to approximately 30, the network expanding to three activated centers, and broad market access established across commercial payers (covering over 80% of commercially insured lives) and all 51 state Medicaid programs. A permanent product J-code for ZEVASKYN will be effective January 1, 2026.
Nov 12, 2025, 1:30 PM
Abeona Therapeutics Reports Q3 2025 Financial Results and ZEVASKYN Launch Update
ABEO
Earnings
Product Launch
New Projects/Investments
- Abeona Therapeutics reported a net loss of $(5.2) million, or $(0.10) per basic and diluted common share, for the third quarter of 2025.
- As of September 30, 2025, the company held $207.5 million in cash, cash equivalents, restricted cash, and short-term investments, which is expected to fund operations for over two years.
- The first anticipated ZEVASKYN patient treatment has been shifted to the fourth quarter of 2025 due to the implementation of an optimized release assay, despite strong and growing patient demand with approximately 30 eligible patients identified.
- Research and development (R&D) spending for Q3 2025 was $4.2 million, while selling, general, and administrative (SG&A) expenses increased to $19.3 million, primarily due to reclassified costs and commercial launch activities for ZEVASKYN.
Nov 12, 2025, 12:30 PM
Abeona Therapeutics Reports Q3 2025 Financials and ZEVASKYN Launch Update
ABEO
Earnings
Product Launch
Guidance Update
- Abeona Therapeutics reported a net loss of $(5.2) million for the third quarter of 2025, an improvement from $(30.3) million in the same period of 2024.
- The company's cash, cash equivalents, restricted cash, and short-term investments totaled $207.5 million as of September 30, 2025, which is expected to fund operations for over two years.
- The first anticipated ZEVASKYN patient treatment has been shifted to 4Q 2025 following the implementation of an optimized release assay, though the company remains steadfast in its 2026 launch goals.
- ZEVASKYN is experiencing strong and growing patient demand, with 12 product order forms received and approximately 30 eligible patients identified across three activated Qualified Treatment Centers.
- Broad market access for ZEVASKYN is established, with commercial health plans covering approximately 60% of RDEB patients and a permanent HCPCS J-code effective January 1, 2026.
Nov 12, 2025, 12:30 PM
Abeona Therapeutics Announces Permanent J-Code for ZEVASKYN
ABEO
Product Launch
- Abeona Therapeutics Inc. announced that the Centers for Medicare and Medicaid Services (CMS) has established a permanent Healthcare Common Procedure Coding System (HCPCS) J-code for ZEVASKYN (prademagene zamikeracel).
- ZEVASKYN is the company's autologous gene therapy indicated for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
- The new J-code, J3389 (Topical administration, prademagene zamikeracel, per treatment), will become effective on January 1, 2026, and is expected to simplify claims and reimbursement processing, supporting hospital adoption and patient access.
Oct 30, 2025, 2:45 PM
Abeona Therapeutics and Children's Hospital Colorado Announce Newest ZEVASKYN Treatment Center
ABEO
Product Launch
New Projects/Investments
- Abeona Therapeutics Inc. and Children's Hospital Colorado announced the activation of Children's Colorado as the newest Qualified Treatment Center (QTC) for ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets.
- ZEVASKYN is an FDA-approved, first-of-its-kind autologous cell sheet-based gene therapy indicated for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
- This activation, involving a pioneering institution in epidermolysis bullosa (EB) care, represents a major milestone in broadening access to ZEVASKYN across a growing network of established EB centers.
Oct 8, 2025, 11:30 AM
Abeona Therapeutics Highlights ZEVASKYN™ Commercialization Partnership
ABEO
Product Launch
New Projects/Investments
- Abeona Therapeutics Inc. highlighted its HUB partnership with AscellaHealth for the successful pre-and-post launch commercialization of ZEVASKYN™, an FDA-approved cell-based gene therapy.
- AscellaHealth provided patient-centric, end-to-end solutions, including the AbeonaAssist™ patient support program, to support ZEVASKYN™.
- ZEVASKYN™ (prademagene zamikeracel) is the first and only autologous cell sheet-based gene therapy for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).
- Commercial production of ZEVASKYN™ is handled at Abeona's fully integrated cGMP manufacturing facility in Cleveland, Ohio.
Jul 29, 2025, 2:00 PM
Abeona Therapeutics Amends Loan Agreement and Issues Warrants
ABEO
Debt Issuance
- On July 18, 2025, Abeona Therapeutics Inc. and its subsidiaries amended their Loan and Security Agreement with Avenue Venture Opportunities Fund, L.P. and Avenue Venture Opportunities Fund II, L.P..
- The amendment reduces the interest rate for the senior secured term loan from 13.5% to a fixed rate of 11.75% per annum.
- In connection with the amendment, the company issued warrants to the lenders to purchase an aggregate of 16,474 shares of common stock, with an exercise price of $6.07 per share and an expiration date of July 18, 2030.
Jul 18, 2025, 12:00 AM
Quarterly earnings call transcripts for ABEONA THERAPEUTICS.
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