8-K

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, 2022

ABEONA

THERAPEUTICS INC.

(Exact name of registrant as specified in its charter)

Delaware	001-15771	83-0221517
(State<br> or other jurisdiction of<br><br> incorporation)	(Commission<br> <br><br>File Number)	(I.R.S.<br> Employer <br><br>Identification No.)

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1330Avenue of the Americas, 33rd Floor,

NewYork, NY 10019

(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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement<br> 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<br> of Each Class	Trading<br> Symbol	Name<br> of each exchange on which registered
Common Stock, $0.01 par value	ABEO	Nasdaq Capital Markets

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 2.02.	Results of Operations and Financial Condition.

On May 13, 2022, Abeona Therapeutics Inc. issued a press release regarding its results of operations and financial condition for the first quarter 2022. The full text of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein.

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, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press release dated May 13, 2022, entitled “Abeona Therapeutics Reports First Quarter 2022 Financial Results”
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

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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<br> Vazzano
Title:	Chief<br> Financial Officer

Date: May 13, 2022

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Exhibit99.1

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AbeonaTherapeutics Reports First Quarter 2022 Financial Results

Dispositionof MPS programs to reduce operating expenses and

extendprojected cash runway into 2Q 2023

FocusR&D resources on EB-101 pivotal phase 3 VIITAL™ topline data expected in 3Q 2022

NEW YORK and CLEVELAND, May 13, 2022 – Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced financial results for the first quarter of 2022. The Company will host a conference call and webcast on Tuesday, May 17, 2022, at 8:30 a.m. ET, to discuss its financial results and business update.

“During the quarter, we took significant steps to preserve our capital with the goal to fund operations over the next 12 months with existing cash resources,” said Vish Seshadri, Chief Executive Officer of Abeona. “First, we began off-loading our MPS assets to reduce cash burn. Second, having completed accrual for the EB-101 pivotal Phase 3 VIITAL™ study, we are now focusing R&D resources on generating topline results in the third quarter of 2022, while aggressively exploring partnerships for commercialization of EB-101. Furthermore, we have initiated steps toward regaining compliance with Nasdaq listing requirements.”

FirstQuarter and Recent Highlights

●	Completed<br> patient enrollment in pivotal Phase 3 VIITAL™ study evaluating EB-101 for recessive dystrophic epidermolysis bullosa (RDEB),<br> and anticipate topline data readout in the third quarter of 2022.
●	Additional<br> long-term follow up data up to eight years and quality of life data from a completed Phase 1/2 study evaluating EB-101 for RDEB will<br> be presented at the Society of Investigative Dermatology (SID) Annual Meeting, which will be held on May 18-21, 2022 in Portland,<br> OR. The data will be featured in an oral presentation entitled “Long-term efficacy and safety of investigational autologous<br> gene-corrected skin sheets (EB-101) for recessive dystrophic epidermolysis bullosa (RDEB).”
●	Reported<br> non-human primate data for AAV204, a novel adeno-associated virus (AAV) capsid from Abeona’s AIM™ capsid library, highlighting<br> its ability to produce more robust transduction in the macula area of the eye following para-retinal administration, which unlike<br> subretinal administration does not create a retinal detachment. The data was featured at the Association for Research and Vision<br> in Ophthalmology (ARVO) 2022 Annual Meeting.
●	Appointed<br> Joseph Vazzano as Chief Financial Officer, who brings valuable experience while serving as the Chief Financial Officer at Avenue<br> Therapeutics, Inc. where he secured multiple equity financings.

NasdaqCompliance Plan

●	Requested<br> a 180-calendar day extension to regain compliance with the Nasdaq Capital Market’s minimum closing bid price requirement of<br> $1.00 per share.
●	As<br> part of the Company’s strategy to regain compliance, Abeona intends to seek approval of a reverse stock split of the outstanding<br> shares of common stock at a Special Meeting of stockholders at 10:00 am ET on June 14, 2022. Stockholders as of May 3, 2022, the<br> record date, are entitled to attend the online Special Meeting, view the proxy statement and vote at: www.virtualshareholdermeeting.com/ABEO2022SM.
●	On<br> May 2, 2022, Abeona completed a $25 million private placement offering of convertible redeemable preferred stock. Holders of the<br> preferred stock will vote together with the Company’s common stockholders on a proposal to effect a reverse stock split of<br> the Company’s common stock at the Special Meeting.

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FirstQuarter Financial Results

The unaudited interim condensed consolidated financial statements for the quarter ended March 31, 2022, which were filed on Form 10-Q on May 13, 2022, have been prepared on the going concern basis, which assumes the Company will have sufficient cash to pay its operating expenses, as and when they become payable, for a period of at least 12 months from the date the financial report is issued.

Cash, cash equivalents, restricted cash and short-term investments totaled $37.2 million as of March 31, 2022. Net cash used in operating activities was $13.7 million for the three months ended March 31, 2022.

License and other revenues in the first quarter of 2022 were $0.3 million, compared to nil in the first quarter of 2021. The revenue in the first quarter of 2022 consisted mainly of the recognition of deferred revenue related to grants for the ABO-102 and ABO-101 development programs.

Research and development (R&D) expenses for the three months ended March 31, 2022 were $10.5 million, compared to $8.3 million for the same period of 2021. General and administrative (G&A) expenses were $4.2 million for the three months ended March 31, 2022, compared to $6.3 million for the same period of 2021.

Net loss was $20.8 million for the first quarter of 2022, or $0.14 loss per common share as compared to a net loss of $16.0 million, or $0.17 loss per common share, in the first quarter of 2021. The net loss in the first quarter of 2022 includes $6.2 million in non-cash impairment charges resulting from the disposition of the ABO-102 and ABO-101 development programs as the Company focuses resources on its EB-101 pivotal program and preclinical eye gene therapy programs. The impairment charges have no impact on the Company’s cash position or cash flow from operating activities and do not have an impact on future operations.

ConferenceCall Details

Abeona Therapeutics will host a conference call and webcast on Tuesday, May 17, 2022, at 8:30 a.m. ET, to discuss its financial results and business update. To access the call, dial 877-545-0320 (U.S. toll-free) or 973-528-0002 (international) and Entry Code: 221025 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at www.abeonatherapeutics.com. The archived webcast replay will be available for 30 days following the call.

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AboutAbeona Therapeutics

Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s lead clinical program is EB-101, its investigational autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa in Phase 3 development. The Company’s development portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical need. Abeona’s novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases. Abeona’s fully integrated cell and gene therapy cGMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL™ study and is capable of clinical and potential commercial production of AAV-based gene therapies. For more information, visit www.abeonatherapeutics.com.

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Forward-LookingStatements

Thispress release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, asamended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attemptedto identify forward-looking statements by such terminology as “may,” “will,” “believe,” “estimate,”“expect,” and similar 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 bysuch forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limitedto the potential impacts of the COVID-19 pandemic on our business, operations, and financial condition; continued interest in our raredisease portfolio; our ability to potentially commercialize our EB-101 product candidate; obtaining a strategic partnership to take overdevelopment activities for ABO-102 and the successful discontinuation of development activities for our ABO-101 program; the outcomeof any future meetings with the U.S. Food and Drug Administration or other regulatory agencies; the impact of competition; the abilityto secure licenses for any technology that may be necessary to potentially commercialize our product candidates; the ability to achieveor obtain necessary regulatory approvals; the impact of changes in the financial markets and global economic conditions; risks associatedwith data analysis and reporting; reducing our operating expenses and extending our cash runway; our ability to execute our operatingplan and achieve important anticipated milestones; and other risks disclosed in the Company’s most recent Annual Report on Form10-K and other periodic reports subsequently filed with the Securities and Exchange Commission. The Company undertakes no obligationto revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this pressrelease, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.

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Investorand Media Contact:

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Greg Gin

VP, Investor Relations and Corporate Communications

Abeona Therapeutics

ir@abeonatherapeutics.com

AbeonaTherapeutics Inc. and Subsidiaries

CondensedConsolidated Statements of Operations and Comprehensive Loss

($ in thousands, except share and per share amounts)

(unaudited)

	For the three months ended March 31,
	2022			2021
Revenues:
License and other revenues	$	346		$	-
Expenses:
Research and development		10,545			8,317
General and administrative		4,224			6,280
Licensed technology impairment charge		1,355			-
Lease impairment charge		1,561			-
Construction-in-progress impairment charge		3,252			-
Total expenses		20,937			14,597
Loss from operations		(20,591	)		(14,597	)
Interest and miscellaneous income		1			15
Interest expense		(201	)		(1,420	)
Net loss	$	(20,791	)	$	(16,002	)
Basic and diluted loss per common share	$	(0.14	)	$	(0.17	)
Weighted average number of common
shares outstanding – basic and diluted		144,877,693			94,234,653
Other comprehensive income:
Change in unrealized gains related to available-for-sale debt securities		3			13
Comprehensive loss	$	(20,788	)	$	(15,989	)

AbeonaTherapeutics Inc. and Subsidiaries

CondensedConsolidated Balance Sheets

($ in thousands, except share and per share amounts)

(unaudited)

			December 31, <br> 2021
ASSETS
Current assets:
Cash and cash equivalents	20,326		$	32,938
Short-term investments	10,989			12,086
Restricted cash	5,891			5,891
Accounts receivable	-			3,000
Prepaid expenses and other current assets	1,998			2,377
Total current assets	39,204			56,292
Property and equipment, net	8,408			12,339
Right-of-use lease assets	7,540			9,403
Licensed technology, net	-			1,384
Other assets	20			168
Total assets	55,172		$	79,586
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	1,601		$	4,325
Accrued expenses	4,206			5,585
Current portion of lease liability	1,822			1,818
Current portion of payable to licensor	4,708			4,599
Deferred revenue	-			296
Total current liabilities	12,337			16,623
Payable to licensor	3,919			3,828
Other long-term liabilities	200			200
Long-term lease liabilities	7,273			7,560
Total liabilities	23,729			28,211
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, 2022 and December 31, 2021, respectively	-			-
Common stock - 0.01 par value; authorized 200,000,000 shares; 147,079,899 and 147,205,422 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively	1,471			1,472
Additional paid-in capital	706,433			705,570
Accumulated deficit	(676,431	)		(655,640	)
Accumulated other comprehensive loss	(30	)		(27	)
Total stockholders’ equity	31,443			51,375
Total liabilities and stockholders’ equity	55,172		$	79,586

All values are in US Dollars.