Abeona updates FDA Pre-IND progress for ABO-701

Abeona Therapeutics reported that it held a pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration regarding ABO-701, its engineered T-cell therapy targeting Prostate-Specific Membrane Antigen for prostate cancer.

Rhea-AI Filing Summary

Abeona Therapeutics reported that it held a pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration regarding ABO-701, its engineered T-cell therapy targeting Prostate-Specific Membrane Antigen for prostate cancer. The company believes the meeting was constructive and is still aiming to submit an IND application for ABO-701 in 2027, in line with its prior timeline. Management notes there is no assurance the FDA will not request additional studies or data, or that any eventual IND submission will be accepted or allow clinical trials to begin, and highlights that development plans may change based on FDA feedback, preclinical results, manufacturing considerations, financing, and other risks described in its SEC filings.

Insights

Biotech regulatory and pipeline analyst

Abeona confirms ABO-701 is progressing toward a planned 2027 IND, with regulatory risk still high.

Abeona describes its Pre-IND meeting with the FDA for ABO-701, a novel engineered T-cell therapy for prostate cancer, as constructive. Importantly, the company reiterates a target to file an IND in 2027, consistent with prior guidance.

The update does not include new data, but it shows regulatory engagement on ABO-701 is underway. However, Abeona emphasizes that the FDA may require more studies or information and may not accept the IND or authorize clinical trials, underlining substantial development and regulatory risk.

The company also points to typical constraints for early-stage programs: evolving FDA feedback, results from preclinical studies, manufacturing factors, and its ability to secure funding. Future SEC reports with updated risk factors and pipeline timelines will be important to understand how this program advances.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Key Terms

Pre-Investigational New Drug application, Investigational New Drug, forward-looking statements, Prostate-Specific Membrane Antigen, +1 more

5 terms

Pre-Investigational New Drug application regulatory

"participated in a pre-Investigational New Drug application (“Pre-IND”) meeting with the U.S. Food and Drug Administration"

A pre-investigational new drug application is an early meeting and written exchange between a drug developer and the regulatory agency to review plans before formally submitting an Investigational New Drug (IND) application. It matters to investors because it helps identify scientific, safety, manufacturing or data gaps early—like a rehearsal that can reduce the risk of costly delays or extra work and give a clearer idea of development timelines and regulatory hurdles.

Investigational New Drug regulatory

"continues to target submission of an IND application for ABO-701 in 2027"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

forward-looking statements regulatory

"contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

Prostate-Specific Membrane Antigen medical

"engineered T-cell therapy, targeting Prostate-Specific Membrane Antigen to treat prostate cancer"

A protein that sits on the surface of prostate cells, often much more abundant on prostate cancer cells, used as a biological “flag” that diagnostic scans and targeted treatments can home in on. Investors care because products that detect or bind this marker—like imaging agents or targeted drugs—can improve diagnosis and therapy, create new revenue streams, and face regulatory milestones that materially affect a company’s value.

Risk Factors regulatory

"other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including the “Risk Factors” section"

Risk factors are elements or conditions that could cause an investment's value to decrease or lead to potential losses. They are like warning signs or obstacles that can affect the success of an investment, making it uncertain or more unpredictable. Recognizing risk factors helps investors understand the possible challenges and make more informed decisions.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Abeona Therapeutics (ABEO) announce about its ABO-701 program?

Abeona Therapeutics reported holding a Pre-IND meeting with the FDA for ABO-701, its engineered T-cell therapy for prostate cancer. The company views the discussion as constructive and continues to aim for an IND submission in 2027, subject to regulatory feedback and development progress.

What is ABO-701 in Abeona Therapeutics' pipeline?

ABO-701 is described as a radically novel engineered T-cell therapy targeting Prostate-Specific Membrane Antigen to treat prostate cancer. It remains in preclinical development, with Abeona working toward an Investigational New Drug (IND) application following its Pre-IND interaction with the FDA.

When does Abeona Therapeutics (ABEO) plan to submit the IND for ABO-701?

Abeona continues to target submitting an IND application for ABO-701 in 2027. The company notes this timeline is consistent with prior expectations but may change depending on FDA feedback, preclinical results, manufacturing considerations, and other development factors.

Did the FDA approve Abeona Therapeutics’ ABO-701 to start clinical trials?

The filing does not report any FDA approval to start clinical trials for ABO-701. Abeona only states that it held a Pre-IND meeting and is targeting an IND submission in 2027, with no assurance that the FDA will accept the application or authorize trials.

What risks did Abeona Therapeutics highlight around ABO-701 development?

Abeona cites risks including the need to advance ABO-701 through preclinical development, uncertain FDA feedback and IND acceptance, manufacturing considerations, and dependence on additional funding. It also references broader risks described in its latest Form 10-K and subsequent SEC reports.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 06/04/2026 - 07:30 AM Learn about SEC filing dates

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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): June 3, 2026

ABEONA THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

Delaware		001-15771		83-0221517
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer 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 ☐

If 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 8.01. Other Events

On June 3, 2026, Abeona Therapeutics Inc. (the “Company”) participated in a pre-Investigational New Drug application (“Pre-IND”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding ABO-701, a recently licensed radically novel engineered T-cell therapy, targeting Prostate-Specific Membrane Antigen to treat prostate cancer. While official minutes of the meeting have not yet been received, we believe the meeting was constructive and continues to target submission of an IND application for ABO-701 in 2027, consistent with our previously stated timeline.

We can provide no assurance that the FDA will not require additional studies, data, or information before accepting an IND submission for ABO-701, or that any IND submission, if submitted, will be accepted by the FDA or result in authorization to commence clinical trials. Our development plans remain subject to ongoing evaluation and may be revised based on, among other things, feedback received from the FDA, results of preclinical studies, manufacturing considerations, and other factors.

Cautionary Note Regarding Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements 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. Forward-looking statements include, but are not limited to, statements regarding the Company’s expectations with respect to the timing of the IND submission for ABO-701, the Company’s clinical and regulatory development plans, and other statements that are not historical facts. These forward-looking statements are based on the Company’s current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including, but not limited to: the Company’s ability to successfully advance ABO-701 through preclinical development; the timing, scope, and outcome of regulatory interactions, including receipt of official minutes from the Pre-IND meeting; the FDA’s acceptance of any IND submission; the Company’s ability to access additional financial resources or its financial flexibility to reduce operating expenses if required; the Company’s ability to obtain additional equity funding from current or new stockholder; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequent periodic reports. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this report. The Company disclaims any obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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: June 4, 2026

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