Form 8-K

8-K — ABEONA THERAPEUTICS INC.

Accession: 0001493152-26-022610

Filed: 2026-05-13

Period: 2026-05-13

CIK: 0000318306

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

EX-99.1 (ex99-1.htm)

EX-99.2 (ex99-2.htm)

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

DC 20549

FORM

8-K

CURRENT

REPORT

PURSUANT

TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date

of report (Date of earliest event reported): May 13, 2026

ABEONA

THERAPEUTICS INC.

(Exact

name of registrant as specified in its charter)

Delaware

001-15771

83-0221517

(State

or other jurisdiction

(Commission

(I.R.S.

Employer

incorporation)

File

Number)

Identification

No.)

6555

Carnegie Ave, 4th Floor

Cleveland,

OH 44103

(Address

of principal executive offices) (Zip Code)

(646)

813-4701

(Registrant’s

telephone number, including area code)

N/A

(Former

name or former address, if changed since last report)

Check

the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under

any of the following provisions (see General Instruction A.2. below):

☐

Written

communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d 2(b))

☐

Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities

registered pursuant to Section 12(b) of the Act:

Title

of Each Class

Trading

Symbol

Name

of each exchange on which registered

Common

Stock, $0.01 par value

ABEO

The

Nasdaq Capital Market

Indicate

by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405

of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging

growth company ☐

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item

2.02. Results of Operations and Financial Condition.

May 13, 2026, Abeona Therapeutics Inc. (the “Company”) issued a press release regarding its financial results for the quarter

ended March 31, 2026. On the same date, the Company posted on its investor relations website, located at investors.abeonatherapeutics.com,

a presentation that will be used by management during the Company’s earnings conference call (the “Earnings Presentation”).

A copy of the press release and the Earnings Presentation are furnished herewith as Exhibits 99.1 and 99.2, respectively, and are incorporated

into this Item 2.02 by reference.

The

information in Item 2.02 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2 attached hereto and incorporated

herein, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act

of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed

incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly

set forth by specific reference in such a filing.

Item

9.01 Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit

No.

Description

99.1

Press release dated May 13, 2026

99.2

Abeona Therapeutics Inc. Presentation, dated May 13, 2026, entitled “Q1 2026 Results and Pipeline Update”

104

Cover

Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned hereunto duly authorized.

Abeona

Therapeutics Inc.

(Registrant)

By:

/s/

Joseph Vazzano

Name:

Joseph

Vazzano

Title:

Chief

Financial Officer

Date:

May 13, 2026

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

Abeona

Therapeutics® Reports First Quarter 2026 Results

and

Provides Pipeline Update

Three patients treated with ZEVASKYN® in Q1 2026 -

-QTC

network expands to six sites, with two new additions on the East Coast -

In-licensed radically novel engineered T-cell technology with game changing potential in the field of solid tumors; ophthalmology programs

deprioritized -

$168.3M in cash, cash equivalents and short-term investments as of March 31, 2026 –

Webcast today at 8:30am ET -

CLEVELAND,

May 13, 2026 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the first quarter of 2026, highlighting

commercial momentum for ZEVASKYN.

● Steady

increase in ZEVASKYN adoption with three patients completing treatment in the first quarter

of 2026, one treatment to date in the second quarter, one biopsy currently in manufacturing

process, and six additional patients expected to be biopsied in the second quarter, three

of whom have biopsies scheduled.

● Qualified

treatment center (QTC) network expands to six sites with the activation of New York-Presbyterian

/ Columbia University Irving Medical Center in New York, NY and Children’s Hospital

of Philadelphia (CHOP).

● Patient

access to ZEVASKYN continues to grow with published coverage policies now in place for

95% of commercially insured U.S. lives.

● Data

presentation at SID2026 on sustained wound healing and long-term safety after one-time pz-cel

application: 12-year case report and 5-year Phase 3 data

“We

are excited that an increasing number of patients at our QTCs are getting scheduled for ZEVASKYN slots this quarter,” said Vish

Seshadri, PhD, President and CEO of Abeona Therapeutics. “We’re encouraged by the recent acceleration of onboarding efforts

of QTCs to activate, so they can begin to treat patients with ZEVASKYN.”

Pipeline

Update

Building

on its proven end-to-end competency in engineered cell therapy, Abeona will focus its development efforts on ABO-701, a recently licensed

radically novel engineered T-cell therapy targeting Prostate-Specific Membrane Antigen (PSMA). PSMA is a validated target for advanced

prostate cancer, which is a leading cause of cancer mortality, with more than 30,000 deaths annually in the U.S. despite multiple approved

therapies and recent advances in the field.

ABO-701

is an autologous engineered T-cell therapy that carries a Synthetic Immune Receptor (SIR-T™) designed to overcome the limitations

of CAR and TCR approaches. The SIR-T™ platform underlying ABO-701 was developed by Preet M. Chaudhary, M.D., Ph.D., Professor of

Medicine and Chief of Jane Ann Nohl Division of Hematology and Center for the Study of Blood Diseases at University of Southern California

(USC) Keck School of Medicine and Director of USC Blood and Marrow Transplant and Cell Therapy Program. The patents covering the SIR-T™

platform are owned by Angeles Therapeutics, Inc. In pre-clinical studies, ABO-701 has demonstrated durable tumor control in mouse models

and modest levels of cytokine release – a profile that has been elusive to other engineered cell therapies in the solid tumors.

Abeona

expects to file an Investigational New Drug (IND) application and commence first-in-human studies with ABO-701 in the second half of

2027 while engaging a contract development and manufacturing organization for supply readiness in the meantime. This development plan

and timing allow the Company to maintain its focus on commercializing ZEVASKYN.

part of the Company’s portfolio optimization, Abeona has deprioritized its in-house ophthalmology programs.

First

Quarter 2026 Financial Results

Abeona

reported net product revenue of $8.7 million in the first quarter ending March 31, 2026. This represents a quarter-over-quarter increase

in net product revenue of $6.3 million compared to $2.4 million in the fourth quarter of 2025.

Cost

of sales for the first quarter of 2026 was $2.7 million, primarily driven by scaling of commercial ZEVASKYN. This represents a quarter-over-quarter

increase in cost of sales of $1.7 million compared to $1.0 million in the fourth quarter of 2025, reflecting three patient treatments

in the first quarter of 2026 versus one patient treatment in the prior quarter.

Total

research and development (R&D) expenses were $9.6 million for the first quarter of 2026 compared to $9.9 million in the first quarter

of 2025. The first quarter of 2026 includes a single up-front payment of $7.0 million for in-licensing of the PSMA-SIR-T™ asset,

now ABO-701. Excluding this transaction, R&D spending decreased by $7.4 million. The reduction in expenses was primarily due to costs

capitalized into inventory and engineering runs and other production costs that are no longer considered research and development due

to FDA approval of ZEVASKYN in April of 2025.

Selling,

general and administrative (SG&A) expenses for the first quarter of 2026 were $19.5 million, a $9.7 million increase over the first

quarter of 2025. This increase primarily reflects Abeona’s commercial transition following the April 2025 FDA approval of ZEVASKYN,

including $5.4 million in personnel and stock-based compensation, $1.9 million of certain engineering and training expenses previously

classified as R&D that were transitioned to SG&A post-approval, and the remainder due to other commercial costs related to ZEVASKYN.

Net

loss was $(17.1) million for the quarter ending March 31, 2026, or $(0.30) per basic and diluted common share. Net loss for the first

quarter of 2025 was $(12.0) million, or $(0.24) per basic and diluted common share.

Cash,

cash equivalents and short-term investments totaled $168.3 million as of March 31, 2026, compared to $191.4 million as of December 31,

2025.

Conference

Call Details

The

Company will host a conference call and webcast on Wednesday, May 13, 2026, at 8:30 a.m. ET to discuss its financial results and corporate

progress. To access the call, dial 888-506-0062 (U.S. toll-free or, 973-528-0011 (international) and Entry Code: 305519 five minutes

prior to the start of the call. A live, listen-only webcast with slides can be accessed on the Investors & Media section of Abeona’s

website at https://investors.abeonatherapeutics.com/events. An archived webcast replay will be available for 30 days following the call.

About

Abeona Therapeutics

Abeona

Therapeutics Inc. is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s

ZEVASKYN® (prademagene zamikeracel) is the first and only autologous cell-based gene therapy for the treatment of wounds

in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The Company’s fully integrated cell and

gene therapy cGMP manufacturing facility in Cleveland, Ohio serves as the manufacturing site for ZEVASKYN commercial production. The

Company’s development portfolio features ABO-701 (PSMA-SIR-T™), a potentially first-in-class engineered T-cell therapy targeting

PSMA, engineered to overcome the core failures of cell therapies in solid tumors. For more information, visit www.abeonatherapeutics.com.

ZEVASKYN®,

Abeona Assist™, Abeona Therapeutics®, and their related logos are trademarks of Abeona Therapeutics Inc.

About

Prostate Cancer

Prostate

cancer is the most frequently diagnosed malignancy in men in the United States and remains a leading cause of cancer-related mortality.

Most prostate cancer-related deaths are due to advanced disease, and high-grade localized disease almost inevitably progresses to advanced

prostate cancer. Despite advances in androgen receptor pathway inhibitors, chemotherapy, and radioligand therapies, patients with advanced

prostate cancer survive for a median of less than 2 years from starting therapy in the metastatic setting, underscoring the need for

novel therapeutic strategies.

About

Angeles Therapeutics

Angeles

Therapeutics was founded by Preet M. Chaudhary, M.D., Ph.D. For inquiries regarding the SIR-T™ platform, please contact Angeles

Therapeutics at info@angelestherapeutics.com or visit www.angelestherapeutics.com.

Forward-Looking

Statements

This

press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as

amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted

to identify forward-looking statements by such terminology as “may,” “will,” “believe,” “anticipate,”

“expect,” “intend,” “potential,” and similar words and expressions (as well as other words or expressions

referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual

results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous

risks and uncertainties, including but not limited to, our ability to successfully commercialize and market ZEVASKYN, including manufacturing

sufficient batches of ZEVASKYN to meet demand; the therapeutic potential of ZEVASKYN; whether the unmet need and market opportunity for

ZEVASKYN are consistent with the Company’s expectations; continued interest in our portfolio; our ability to submit an investigational

new drug application for ABO-701 and enroll patients in clinical trials; the outcome of future meetings with and inspections by the FDA

or other regulatory agencies, including those relating to preclinical programs and to the cGMP manufacturing of ZEVASKYN; the ability

to achieve or obtain necessary regulatory approvals for our pre-clinical programs; our ability to execute on our key business priorities;

the impact of any changes in the financial markets and global economic conditions, including those resulting from changes to U.S. or

other countries’ trade policy, such as current or future tariffs; risks associated with data analysis and reporting; and other

risks disclosed in the Company’s most recent Annual Report on Form 10-K and subsequent periodic reports filed with the Securities

and Exchange Commission. The Company undertakes no obligation to revise these forward-looking statements or to update them to reflect

events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or

otherwise, except as required by the federal securities laws.

Contacts:

Investor

and Media

Abeona

Therapeutics

ir@abeonatherapeutics.com

Investor

Lee

M. Stern

Meru

Advisors

lstern@meruadvisors.com

Abeona

Therapeutics Inc. and Subsidiaries

Condensed

Consolidated Statements of Operations and Comprehensive Loss

in thousands, except share and per share amounts)

(Unaudited)

For the three months ended March 31,

2026

2025

Revenues:

Product revenue, net

$ 8,720

$ —

Costs and expenses:

Cost of sales

2,696

—

Research and development

9,555

9,941

Selling, general and administrative

19,502

9,786

Total costs and expenses

31,753

19,727

Loss from operations

(23,033 )

(19,727 )

Interest income

1,354

1,310

Interest expense

(830 )

(998 )

Change in fair value of warrant liabilities

5,386

7,245

Other income, net

141

Loss before income taxes

(17,073 )

(12,029 )

Income tax expense

—

Net loss

$ (17,075 )

$ (12,029 )

Basic and dilutive loss per common share

$ (0.30 )

$ (0.24 )

Weighted average number of common shares outstanding - basic and diluted

56,620,920

49,778,801

Other comprehensive loss:

Change in unrealized losses related to available-for-sale debt securities

(159 )

(75 )

Comprehensive loss

$ (17,234 )

$ (12,104 )

Abeona

Therapeutics Inc. and Subsidiaries

Condensed

Consolidated Balance Sheets

in thousands, except share and per share amounts)

(Unaudited)

March 31, 2026

December 31, 2025

ASSETS

Current assets:

Cash and cash equivalents

$ 61,374

$ 78,437

Short-term investments

106,897

112,967

Accounts receivable, net

6,200

6,147

Inventory

6,054

5,493

Other receivables

509

568

Prepaid expenses and other current assets

1,951

1,294

Total current assets

182,985

204,906

Property and equipment, net

10,564

9,921

Operating lease right-of-use assets

4,118

3,962

Other assets

827

781

Total assets

$ 198,494

$ 219,570

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$ 4,071

$ 7,889

Accrued expenses

5,368

8,467

Current portion of long-term debt

13,333

12,222

Current portion of operating lease liability

1,272

864

Payable to licensor

7,000

—

Accrued taxes and other current liabilities

128

Total current liabilities

31,046

29,570

Long-term operating lease liabilities

3,814

4,069

Long-term debt

4,754

7,813

Deferred revenue

425

—

Warrant liabilities

13,516

18,902

Total liabilities

53,555

60,354

Commitments and contingencies

Stockholders’ equity:

Preferred stock - $0.01 par value; authorized 2,000,000 shares; No shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

—

Common stock - $0.01 par value; authorized 200,000,000 shares; 56,866,381 and 55,043,413 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively

568

550

Additional paid-in capital

903,542

900,603

Accumulated deficit

(759,150 )

(742,075 )

Accumulated other comprehensive (loss) income

(21 )

138

Total stockholders’ equity

144,939

159,216

Total liabilities and stockholders’ equity

$ 198,494

$ 219,570

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Cover

May 13, 2026

Cover [Abstract]

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ABEONA

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-Publisher SEC

-Name Exchange Act

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-Section 12

-Subsection b-2

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Local phone number for entity.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

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- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

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- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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- Definition

Trading symbol of an instrument as listed on an exchange.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

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