Form 8-K

8-K — ABEONA THERAPEUTICS INC.

Accession: 0001493152-26-037575

Filed: 2026-08-13

Period: 2026-08-13

CIK: 0000318306

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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2026-08-13

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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): August 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)

(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))

Title

of Each Class

Trading

Symbol

Name

of each exchange on which registered

Common

Stock, $0.01 par value

ABEO

The

Nasdaq Capital Market

Securities

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

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.

August 13, 2026, Abeona Therapeutics Inc. issued a press release regarding its financial results for the quarter ended June 30, 2026.

A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated into this Item 2.02 by reference.

The

information in Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed”

for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), 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 (the “Securities Act”), 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 August 13, 2026

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:

August 13, 2026

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Abeona

Therapeutics® Reports Second Quarter 2026 Results and Provides Business Update

Q2 net ZEVASKYN® revenue increased 31% quarter-over-quarter to $11.4 million –

Five patients treated with ZEVASKYN in Q2 2026 and three treatments in Q3 2026 to-date; since launch, 12 treatments completed –

Expanding QTC network now includes seven sites nationwide; growing number of QTCs progressing patients through treatment process

–

$146.8 million in cash, cash equivalents and short-term investments as of June 30, 2026 –

CLEVELAND,

August 13, 2026 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the second quarter of 2026 and provided

an update on commercial execution for ZEVASKYN (prademagene zamikeracel).

Commercial

Update

Steady

launch-year growth for ZEVASKYN. Commercial execution continued to strengthen during the second quarter of 2026 with five patients

treated with ZEVASKYN. In the third quarter of 2026 to-date, three patients have completed treatments. Since launch, 12 patient treatments

have been completed. Revenue was not recognized for two patients due to low manufacturing yield or not meeting lot release specifications.

Expanded

qualified treatment center (QTC) network and increased patient onboarding. Abeona continues to expand the ZEVASKYN QTC network, and

the number of QTCs that have treated patients with ZEVASKYN has increased. Key recent milestones include:

- NewYork-Presbyterian/Columbia

University Irving Medical Center and Children’s Hospital of Philadelphia (CHOP) were

activated as QTCs during the second quarter of 2026.

- CHOP

and University of Texas Medical Branch (UTMB) have commenced collection of patient biopsies,

and CHOP has treated its first patient with ZEVASKYN.

- In

the third quarter of 2026, Abeona announced the activation of Cincinnati Children’s

as the newest ZEVASKYN QTC. Cincinnati Children’s is one of the largest epidermolysis

bullosa treatment centers in the U.S.

Secured

CMS New Technology Add-On Payment (NTAP) status for ZEVASKYN. Effective October 1, 2026, ZEVASKYN will have NTAP status under the

fiscal year 2027 Hospital Inpatient Prospective Payment System Final Rule from the Centers for Medicare & Medicaid Services (CMS).

NTAP provides a pathway for eligible hospitals to receive a supplemental payment from CMS, in addition to the base diagnosis-related

group (DRG) payment, when treating Medicare beneficiaries with ZEVASKYN. This designation is expected to support hospital adoption and

help facilitate access for Medicare patients, who represent approximately 10 percent of RDEB patients.

Continued

engagement raising RDEB community awareness. The Company presented 5-year long-term follow-up data after ZEVASKYN application from

the VIITAL Phase 3 clinical study and a case report from the longest follow-up of 12 years from the Phase 1/2a study. Presentations were

made at key medical congresses, including the Society for Investigative Dermatology (SID) and Society for Pediatric Dermatology (SPD)

annual meetings, as well as the debra Care Conference, to drive physician awareness, patient identification, and enable patient referral

to the expanding QTC network.

“Our

confidence in ZEVASKYN’s substantial opportunity is reinforced by our launch progress and experience to date as we engage with

a growing number of patients and expand our QTC network,” said Vish Seshadri, Ph.D., Chief Executive Officer of Abeona Therapeutics.

“As early real-world experience with ZEVASKYN matures across activated sites, we expect to drive broader adoption and long-term

growth.”

Second

Quarter 2026 Financial Results

Net

ZEVASKYN revenue for the quarter ended June 30, 2026 increased 31% quarter-over-quarter to $11.4 million, compared to $8.7 million in

the first quarter of 2026. While five patients were treated with ZEVASKYN during the second quarter of 2026, revenue was recognized for

four treatments as one batch yielded fewer than the threshold number of sheets for revenue recognition.

Research

and development (R&D) expenses were $5.0 million for the second quarter of 2026 compared to $9.6 million in the first quarter of

2026, which included the one-time, up-front cost of $7.0 million for in-licensing ABO-701.

Selling,

general and administrative expenses were $15.8 million for the second quarter of 2026, compared to $19.5 million for the first quarter

of 2026. The decrease primarily reflects fewer engineering runs and less manufacturing training costs in the second quarter of 2026.

Net

loss was $(20.2) million, or $(0.35) per basic and diluted common share, for the quarter ended June 30, 2026. Net loss for the first

quarter of 2026 was $(17.1) million, or $(0.30) per basic and diluted common share.

Cash,

cash equivalents and short-term investments totaled $146.8 million as of June 30, 2026, compared to $191.4 million as of December 31,

2025.

Conference

Call Details

The

Company will host a conference call and webcast on August 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: 245916 five minutes prior to the

start of the call. A live, listen-only webcast 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.

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 maintain existing and obtain additional regulatory approvals of

ZEVASKYN® and any future product candidates; our ability to successfully commercialize and market ZEVASKYN® and any future product

candidates, if approved, and the timing of any commercialization and marketing efforts; our ability to manufacture sufficient batches

of ZEVASKYN® to meet demand; our ability to manufacture ZEVASKYN® batches that meet certain product release specifications that

were required by FDA at the time of BLA approval and implemented based on a limited clinical dataset; the FDA’s willingness to

revise such release specifications to reflect real-world manufacturing experience; our ability to manufacture from provided biopsy material

a ZEVASKYN® batch for which revenue may ultimately be recognized, which depends on such factors as qualified treatment centers obtaining

biopsy samples from ZEVASKYN® patients of sufficient quality to act as starting material for manufacturing ZEVASKYN®, patient-to-patient

variability in cell growth during the ZEVASKYN® manufacturing process, patient health deterioration in close proximity to ZEVASKYN®

treatment such that treatment is no longer possible, and expiration of ZEVASKYN®’s 84-hour shelf-life before surgical application

of ZEVASKYN® can be performed; our ability to activate additional qualified treatment centers to administer ZEVASKYN® on patients;

the ability of qualified treatment centers to enroll patients for treatment or administer ZEVASKYN® on patients; our ability submit

an investigational new drug application for ABO-701 and enroll patients in new clinical trials; our ability to access additional financial

resources and/or our financial flexibility to reduce operating expenses if required; our ability to obtain additional equity funding

from current or new stockholders; the potential impact of unpredicted changes in the structure and/or administration of the United States

government or its agencies; our ability to out-license technology and/or other assets, deferring and/or eliminating planned expenditures,

restructuring operations and/or reducing headcount, and sales of assets; the dilutive effect that raising additional funds by selling

additional equity securities would have on the relative equity ownership of our existing investors, including under our existing at-the-market

sale agreement; the outcome of any interactions with the FDA or other regulatory agencies relating to any of our products or product

candidates; our ability to continue to secure and maintain regulatory designations for our product candidates; our ability to develop

manufacturing capabilities compliant with current good manufacturing practices for our product candidates; our ability to manufacture

cell and gene therapy products and produce an adequate product supply to support clinical trials and potentially future commercialization;

the rate and degree of market acceptance of our product candidates for any indication once approved; our ability to meet our obligations

contained in license agreements to which we are party; and macroeconomic uncertainty resulting from changes to U.S. trade policy, including

current or future tariffs or other trade restrictions.

Contacts:

Investor

and Media

Greg

Gin

VP,

Investor Relations and Corporate Communications

Abeona

Therapeutics

ir@abeonatherapeutics.com

Investor

Lee

M. Stern

Meru

Advisors

lstern@meruadvisors.com

ABEONA

THERAPEUTICS INC. AND SUBSIDIARIES

Condensed

Consolidated Statements of Operations

(In

thousands, except share and per share amounts)

(Unaudited)

For the three months ended June 30,

For the six months ended June 30,

2026

2025

2026

2025

Revenues:

Product revenue, net

$ 11,380

$ —

$ 20,100

$ —

License and other revenues

—

400

—

400

Total revenues

11,380

400

20,100

400

Costs and expenses:

Cost of sales

4,177

—

6,873

—

Royalties

—

100

—

100

Research and development

5,021

5,943

14,576

15,884

Selling, general and administrative

15,835

17,149

35,337

26,935

Total costs and expenses

25,033

23,192

56,786

42,919

Loss from operations

(13,653 )

(22,792 )

(36,686 )

(42,519 )

Interest income

1,355

1,027

2,709

2,337

Interest expense

(696 )

(957 )

(1,526 )

(1,955 )

Change in fair value of warrant liabilities

(7,191 )

(5,388 )

(1,805 )

1,857

Gain from sale of priority review voucher, net

—

152,366

—

152,366

Other (loss) income, net

(6 )

230

Income (loss) before income taxes

(20,191 )

124,345

(37,264 )

112,316

Income tax expense

—

15,512

Net (loss) income

$ (20,191 )

$ 108,833

$ (37,266 )

$ 96,804

Basic (loss) income per common share

$ (0.35 )

$ 2.07

$ (0.66 )

$ 1.89

Dilutive (loss) income per common share

$ (0.35 )

$ 1.71

$ (0.66 )

$ 1.47

Weighted average number of common shares outstanding:

Basic

57,048,385

52,524,510

56,835,833

51,159,240

Dilutive

57,048,385

66,640,620

56,835,833

65,111,330

ABEONA

THERAPEUTICS INC. AND SUBSIDIARIES

Condensed

Consolidated Balance Sheets

(In

thousands, except share amounts)

(Unaudited)

June 30, 2026

December 31, 2025

Cash, cash equivalents and short-term investments

$ 146,826

$ 191,404

Total assets

$ 179,507

$ 219,570

Total liabilities

$ 51,449

$ 60,354

Total stockholders’ equity

$ 128,058

$ 159,216

Common stock outstanding

57,225,919

55,043,413

Common stock and common stock equivalents*

71,098,537

69,103,212

*Common stock and common stock equivalents:

Common stock

57,225,919

55,043,413

Common stock warrants (pre-funded)

4,933,489

5,113,321

Common stock and pre-funded warrants

62,159,408

60,156,734

Options to purchase common stock

168,670

176,019

Conversion option to redeem common stock

614,251

Warrants to purchase common stock

8,156,208

Total common stock and common stock equivalents

71,098,537

69,103,212

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