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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 11, 2023
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 | 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 11, 2023, Abeona Therapeutics Inc. issued a press release regarding its results of operations and financial condition for the first quarter of 2023. 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.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press release dated May 11, 2023 | |
| 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 11, 2023
Exhibit 99.1
Abeona Therapeutics Reports First Quarter 2023 Financial Results
Continues to make progress toward Biologics License Application (BLA) submission for EB-101 in late-2Q/early-3Q 2023; submitted request for pre-BLA meeting
Additional Phase 3 VIITAL™ study results presented at International Societies for Investigative Dermatology 2023 Meeting further highlights EB-101 value proposition in RDEB
Multiple presentations on animal proof-of-concept data from its AAV ophthalmology program at upcoming 26th Annual Meeting of American Society of Gene & Cell Therapy
Reiterates cash runway guidance into 3Q 2024, beyond anticipated timing for EB-101 BLA potential approval
CLEVELAND, May 11, 2023 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the first quarter of 2023 and provided an update on progress toward achieving key corporate objectives.
“We remain focused on completing our EB-101 Biologics License Application for recessive dystrophic epidermolysis bullosa (RDEB) and are making good progress towards this goal,” said Vish Seshadri, Chief Executive Officer of Abeona. “We are also excited to be presenting encouraging results from animal proof-of-concept studies from our AAV ophthalmology program at the ASGCT annual meeting next week.”
First Quarter and Recent Portfolio Update
EB-101 for RDEB
| ● | Abeona continues to make progress toward submitting a BLA for EB-101 to the U.S. Food and Drug Administration (FDA) in late second quarter to early third quarter of 2023. The Company has submitted a pre-BLA meeting request to the FDA in advance of the anticipated BLA submission. If the BLA is approved, Abeona anticipates being granted a Priority Review Voucher (PRV), which can be used to receive expedited review by the FDA of a subsequent marketing application for a different product or sold to another company. |
| ● | Abeona announced today in a separate press release that additional data from the pivotal Phase 3 VIITAL study of investigational EB-101 in RDEB was presented during an oral session at the International Societies for Investigative Dermatology (ISID) Meeting. The positive top-line efficacy and safety data from the VIITAL study was reported in November 2022. |
| ● | As part of its commercial planning, the Company continues to engage with stakeholders across the healthcare system, including public and private payors, and healthcare providers to better understand market access and pricing for EB-101. |
Preclinical programs
| ● | Abeona’s preclinical programs are investigating the use of novel adeno-associated virus (AAV) capsids in AAV-based therapies for serious genetic eye diseases. The Company has been granted pre-Investigational New Drug Application meetings for two of its programs to take place in the second quarter of 2023. |
| ● | Abeona will present new preclinical data at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) taking place from May 16-20, 2023 in Los Angeles, CA. The Company’s presentations will include data on three internally developed investigational preclinical gene therapy product candidates from its AAV ophthalmology program, including ABO-504 for Stargardt disease, ABO-503 for X-linked retinoschisis (XLRS) and ABO-505 for autosomal dominant optic atrophy (ADOA). |
First Quarter Financial Results
Cash, cash equivalents, restricted cash and short-term investments totaled $40.7 million as of March 31, 2023, compared to $52.5 million as of December 31, 2022. Net cash used in operating activities was $11.7 million for the three months ended March 31, 2023. Abeona estimates that its current cash and cash equivalents, restricted cash and short-term investments are sufficient resources to fund operations into the third quarter of 2024.
“Our operating cash burn for the first quarter of 2023 and projected operating cash burn for the second quarter of 2023 include BLA submission and personnel costs, which we expect will be substantially lower in the second half of 2023,” said Joe Vazzano, Chief Financial Officer of Abeona.
License and other revenues in the first quarter of 2023 were nil, compared to $0.3 million in the first quarter of 2022. Research and development expenses for the three months ended March 31, 2023 were $8.0 million, compared to $10.5 million for the same period of 2022. General and administrative expenses were $4.0 million for the three months ended March 31, 2023, compared to $4.2 million for the same period of 2022. Net loss was $9.1 million for the first quarter of 2023, or $0.54 loss per common share as compared to a net loss of $22.0 million, or $3.80 loss per common share, in the first quarter of 2022.
Portfolio Update Conference Call
The Company will host a conference call and webcast on Tuesday, May 23, 2023, at 8:30 a.m. ET, to discuss the first quarter and recent portfolio update, and its data presentations at the ISID and ASGCT meetings. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 885338 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.
About Abeona 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, engineered cell therapy currently in development for recessive dystrophic epidermolysis bullosa. 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 produced 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.
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,” 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 by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to, the timing and outcome of our Biologics License Application submission to the FDA for EB-101; continued interest in our rare disease portfolio; our ability to enroll patients in clinical trials; the outcome of future meetings with the FDA or other regulatory agencies, including those relating to preclinical programs; the ability to achieve or obtain necessary regulatory approvals; the impact of any changes in the financial markets and global economic conditions; 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 the 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.
Investor and Media Contact:
Greg Gin
VP, Investor Relations and Corporate Communications Condensed Consolidated Statements of Operations and Comprehensive Loss
Abeona Therapeutics
ir@abeonatherapeutics.com
ABEONA THERAPEUTICS INC. AND SUBSIDIARIES
(In thousands, except share and per share amounts)
(Unaudited)
| For the three months ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenues: | ||||||||
| License and other revenues | $ | — | $ | 346 | ||||
| Expenses: | ||||||||
| Research and development | 8,041 | 10,545 | ||||||
| General and administrative | 3,997 | 4,224 | ||||||
| Impairment of licensed technology | — | 1,355 | ||||||
| Impairment of right-of-use lease assets | — | 1,561 | ||||||
| Impairment of construction-in-progress | — | 3,252 | ||||||
| Total expenses | 12,038 | 20,937 | ||||||
| Loss from operations | (12,038 | ) | (20,591 | ) | ||||
| Interest income | 364 | 7 | ||||||
| Interest expense | (101 | ) | (201 | ) | ||||
| Change in fair value of warrant liabilities | 2,265 | (1,253 | ) | |||||
| Other income (loss) | 403 | (6 | ) | |||||
| Net loss | $ | (9,107 | ) | $ | (22,044 | ) | ||
| Basic and diluted loss per common share | $ | (0.54 | ) | $ | (3.80 | ) | ||
| Weighted average number of common shares outstanding – basic and diluted | 16,904,024 | 5,795,107 | ||||||
| Other comprehensive income (loss): | ||||||||
| Change in unrealized gains (losses) related to available-for-sale debt securities | 64 | (3 | ) | |||||
| Comprehensive loss | $ | (9,043 | ) | $ | (22,047 | ) | ||
ABEONA THERAPEUTICS INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
|
March 31, 2023 (Unaudited) |
December 31, 2022 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 4,680 | $ | 14,217 | ||||
| Short-term investments | 35,684 | 37,932 | ||||||
| Restricted cash | 338 | 338 | ||||||
| Other receivables | 519 | 188 | ||||||
| Prepaid expenses and other current assets | 1,623 | 424 | ||||||
| Total current assets | 42,844 | 53,099 | ||||||
| Property and equipment, net | 5,298 | 5,741 | ||||||
| Right-of-use lease assets | 5,104 | 5,331 | ||||||
| Other assets | 99 | 43 | ||||||
| Total assets | $ | 53,345 | $ | 64,214 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,857 | $ | 1,811 | ||||
| Accrued expenses | 2,569 | 3,991 | ||||||
| Current portion of lease liability | 1,789 | 1,773 | ||||||
| Other current liabilities | 205 | 204 | ||||||
| Total current liabilities | 7,402 | 7,779 | ||||||
| Payable to licensor | 4,263 | 4,163 | ||||||
| Long-term lease liabilities | 5,530 | 5,854 | ||||||
| Warrant liabilities | 17,392 | 19,657 | ||||||
| Total liabilities | 34,605 | 37,453 | ||||||
| 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, 2023 and December 31, 2022, respectively | — | — | ||||||
| Common stock - $0.01 par value; authorized 200,000,000 shares; 17,929,344 and 17,719,720 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 179 | 177 | ||||||
| Additional paid-in capital | 723,069 | 722,049 | ||||||
| Accumulated deficit | (704,443 | ) | (695,336 | ) | ||||
| Accumulated other comprehensive loss | (65 | ) | (129 | ) | ||||
| Total stockholders’ equity | 18,740 | 26,761 | ||||||
| Total liabilities and stockholders’ equity | $ | 53,345 | $ | 64,214 | ||||