Abeona Therapeutics closes $155M voucher sale, reports $225M cash

Rhea-AI Filing Summary

On June 27, 2025 Abeona Therapeutics Inc. (“Abeona”) closed the previously announced sale of its Rare Pediatric Disease Priority Review Voucher (PRV) to an undisclosed buyer for $155 million in gross cash proceeds under the asset purchase agreement dated May 9, 2025. The voucher had been granted by the FDA on April 28, 2025 following approval of Abeona’s BLA for ZEVASKYN™ (prademagene zamikeracel). The transaction is reported in this Form 8-K under Item 2.01.

In a press release furnished with the filing (Exhibit 99.1) the company disclosed that, including the net PRV proceeds, unaudited cash, cash equivalents, restricted cash and short-term investments stood at approximately $225 million as of June 30, 2025. Management notes the figure is preliminary, unaudited and subject to quarter-end closing procedures; the independent auditor has not reviewed the estimate.

The agreement itself will be filed with Abeona’s forthcoming Form 10-Q. No other material liabilities, guidance changes or pro-forma financials were provided.

The sale injects substantial non-dilutive capital and materially strengthens the company’s liquidity profile while removing the PRV from Abeona’s asset base.

Positive

• $155 million cash infusion from completed PRV sale on June 27, 2025
• Liquidity of approximately $225 million in cash and investments reported as of June 30, 2025 (unaudited)

Negative

• Disclosed liquidity figure is preliminary, unaudited and subject to revision

Insights

Financial Analyst

TL;DR: $155 M cash inflow pushes ABEO liquidity to ~$225 M, markedly de-risking near-term funding needs.

The completed PRV sale delivers a significant, one-time, non-dilutive cash injection. Combined cash and investments of roughly $225 million, even after normal burn, should extend operating runway and strengthen bargaining power for future partnerships or financings. Because the PRV’s value is now monetised, there is no further upside from expedited FDA review, but the immediate liquidity arguably outweighs that optionality. The disclosure is unaudited yet still material. Overall impact: positive.

Biotech Industry Specialist

TL;DR: Monetisation of FDA voucher converts a government incentive into cash, supporting development of ZEVASKYN and pipeline.

Priority Review Vouchers in rare diseases have recently fetched $100-$110 million; Abeona’s $155 million price is at the upper end of historical ranges, suggesting strong demand. Converting the voucher to cash enables reinvestment in clinical and commercial activities without shareholder dilution. Management’s preliminary $225 million cash pool positions the company to advance prademagene zamikeracel launch preparations. Caveat: figures remain subject to audit, and loss of the voucher removes an accelerated-review asset, although Abeona has already used it. Net takeaway is clearly positive.

8-K Event Classification

4 items: 2.01, 2.02, 8.01, 9.01

4 items

Item 2.01 Completion of Acquisition or Disposition of Assets Financial

The company completed a significant acquisition or sale of business assets.

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 8.01 Other Events Other

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

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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 27, 2025

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
of 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))

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 ☐

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 2.01 Completion of Acquisition or Disposition of Assets.

On June 27, 2025, Abeona Therapeutics Inc. (the “Company”) completed the previously disclosed sale (the “Asset Sale”) of its Rare Pediatric Disease Priority Review Voucher (“PRV”) to the buyer. The Company was awarded the voucher on April 28, 2025, under a U.S. Food and Drug Administration (“FDA”) program intended to encourage the development of certain rare pediatric disease product applications. The Company received the PRV upon approval of the Company’s biologics license application for ZEVASKYN™ (prademagene zamikeracel).

The Asset Sale was completed pursuant to the terms of an asset purchase agreement dated May 9, 2025 (the “PRV Asset Purchase Agreement”). Pursuant to the PRV Asset Purchase Agreement, the Company received gross proceeds of $155 million from the buyer upon the closing of the Asset Sale.

The foregoing description of the PRV Asset Purchase Agreement does not purport to be complete and is qualified in its entirety by the full text of the PRV Asset Purchase Agreement, a copy of which will be filed with the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2025.

Item 2.02 Results of Operations and Financial Condition.

On July 2, 2025, the Company issued a press release in relation to the Asset Sale, in which the Company announced that as of June 30, 2025, including the net proceeds from the Asset Sale, the Company’s unaudited cash, cash equivalents, restricted cash and short-term investments were approximately $225 million. The press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

The information contained in this item, including Exhibit 99.1, is being furnished and 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, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

As noted above, on July 2, 2025, the Company announced that as of June 30, 2025, including the net proceeds from the Asset Sale, the Company’s unaudited cash, cash equivalents, restricted cash and short-term investments were approximately $225 million.

The foregoing unaudited cash, cash equivalents, restricted cash and short-term investments information provided in this Current Report on Form 8-K is based on preliminary unaudited information and management estimates for the quarter ended June 30, 2025, is not a comprehensive statement of the Company’s financial results as of and for the fiscal quarter ended June 30, 2025 or any other period, and is subject to completion of the Company’s financial closing procedures. The Company’s independent registered public accounting firm has not conducted a review of and does not express an opinion or any other form of assurance with respect to this preliminary estimate.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press release dated July 2, 2025, entitled “Abeona Therapeutics® Closes Sale of Rare Pediatric Disease Priority Review Voucher for $155 Million.”
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: July 2, 2025

\

FAQ

What asset did Abeona Therapeutics (ABEO) sell in June 2025?

Abeona sold its Rare Pediatric Disease Priority Review Voucher (PRV) awarded by the FDA.

How much did Abeona receive from the PRV sale?

The company received $155 million in gross cash proceeds.

What is Abeona’s cash position after the transaction?

Including net proceeds, unaudited cash, cash equivalents, restricted cash and short-term investments were about $225 million as of June 30, 2025.

When was the priority review voucher originally granted to Abeona?

The FDA awarded the voucher on April 28, 2025 upon approval of ZEVASKYN.

Where will the PRV asset purchase agreement be filed?

Abeona will file the agreement with its Form 10-Q for the quarter ended June 30, 2025.

Is the disclosed cash figure audited?

No. Management states the amount is preliminary and unaudited; the auditor has not reviewed it.