Abeona Therapeutics Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Abeona Therapeutics Inc. has filed its 2023 annual report (10-K) detailing its financial performance and business operations.</b>

AI Summary

ABEONA THERAPEUTICS INC. (ABEO) filed a Annual Report (10-K) with the SEC on March 18, 2024. Abeona Therapeutics Inc. filed its 2023 Form 10-K on March 18, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal business is in Pharmaceutical Preparations. Abeona Therapeutics Inc. was formerly known as Plasmatech Biopharmaceutical Inc. The company is incorporated in Delaware.

Why It Matters

For investors and stakeholders tracking ABEONA THERAPEUTICS INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Abeona's financial health and strategic direction for the fiscal year 2023, crucial for investors assessing its current standing and future prospects. Understanding the details within this report is essential for stakeholders to evaluate the company's progress in the pharmaceutical sector, particularly in its specific therapeutic areas.

Risk Assessment

Risk Level: medium — ABEONA THERAPEUTICS INC. shows moderate risk based on this filing. The company operates in the highly regulated pharmaceutical industry, facing risks related to clinical trial success, regulatory approvals, and market competition, as is typical for companies at this stage.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess Abeona's operational progress and potential for future growth.

Key Numbers

• 2023-12-31 — Fiscal Year End (CONFORMED PERIOD OF REPORT)
• 2024-03-18 — Filing Date (FILED AS OF DATE)
• 2023 — Fiscal Year (FILING VALUES)
• 1231 — Fiscal Year End (FISCAL YEAR END)

Key Players & Entities

• ABEONA THERAPEUTICS INC. (company) — COMPANY CONFORMED NAME
• 2023 (date) — FISCAL YEAR END
• 2024-03-18 (date) — FILED AS OF DATE
• 2834 (industry) — STANDARD INDUSTRIAL CLASSIFICATION
• DE (location) — STATE OF INCORPORATION
• 1934 Act (regulation) — SEC ACT
• 001-15771 (identifier) — SEC FILE NUMBER
• 6555 CARNEGIE AVE, 4TH FLOOR (address) — BUSINESS ADDRESS

FAQ

Industry Context

Abeona Therapeutics Inc. operates in the pharmaceutical preparations industry, focusing on developing therapies for rare genetic diseases.

Regulatory Implications

The pharmaceutical industry is subject to stringent regulations from bodies like the FDA, impacting drug development, approval processes, and market access.

What Investors Should Do

1. Review Abeona's financial statements for the fiscal year ended December 31, 2023.
2. Analyze the risk factors section for potential challenges and uncertainties.
3. Examine any disclosed business developments or strategic initiatives for the upcoming year.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-18: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This filing is the annual report for the fiscal year 2023, providing updated financial and operational information compared to previous filings.

Key Financial Figures

• $0.01 — nge on which registered Common Stock, $0.01 par value ABEO Nasdaq Capital Marke
• $996,000 — wound care supplies could be as high as $996,000 per year. RDEB patients also have per

Filing Documents

• form10-k.htm (10-K) — 1841KB
• ex14.htm (EX-14) — 41KB
• ex19.htm (EX-19) — 64KB
• ex21.htm (EX-21) — 2KB
• ex23-1.htm (EX-23.1) — 3KB
• ex23-2.htm (EX-23.2) — 3KB
• ex31-1.htm (EX-31.1) — 18KB
• ex31-2.htm (EX-31.2) — 18KB
• ex32.htm (EX-32) — 12KB
• ex97.htm (EX-97.DESCRIPTION) — 60KB
• 0001493152-24-010190.txt (&nbsp;) — 8168KB
• abeo-20231231.xsd (EX-101.SCH) — 52KB
• abeo-20231231_cal.xml (EX-101.CAL) — 81KB
• abeo-20231231_def.xml (EX-101.DEF) — 267KB
• abeo-20231231_lab.xml (EX-101.LAB) — 475KB
• abeo-20231231_pre.xml (EX-101.PRE) — 382KB
• form10-k_htm.xml (XML) — 1133KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 27 Item 1B. Unresolved Staff Comments 55 Item 1C. Cybersecurity 55 Item 2.

Properties

Properties 56 Item 3.

Legal Proceedings

Legal Proceedings 56 Item 4. Mine Safety Disclosures 56 Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 57 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 58 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 69 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 69 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 69 Item 9A.

Controls and Procedures

Controls and Procedures 69 Item 9B. Other Information 70 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 70 Part III Item 10. Directors, Executive Officers and Corporate Governance 71 Item 11.

Executive Compensation

Executive Compensation 71 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 71 Item 13. Certain Relationships and Related Transactions, and Director Independence 71 Item 14. Principal Accounting Fees and Services 71 Part IV Item 15. Exhibits, Financial Statement Schedules 72 Item 16. Form 10-K Summary 73

Signatures

Signatures 74 1 FORWARD-LOOKING This Form 10-K (including information incorporated by reference) contains statements that express management's opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, "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. Words such as "expects," "anticipates," "intends," "plans," "believes," "could," "would," "seeks," "estimates," and variations of such words and similar expressions, and the negatives thereof, are intended to identify such forward-looking statements. Such "forward-looking statements" speak only as of the date made and are not guarantees of future performance and involve certain risks, uncertainties, estimates, and assumptions by management that are difficult to predict. Various factors, some of which are beyond the Company's control, could cause actual results to differ materially from those expressed in, or implied by, such forward-looking statements. In addition, we disclaim any obligation to update any forward-looking statements to reflect events or circumstances after the date of this report, except as may otherwise be required by the federal securities laws. Forward-looking Application for pz-cel and the timing thereof; our plans to continue development of AAV-based gene therapies designed to treat ophthalmic and other diseases and next-generation AAV-based gene therapies; the achievement of or expected timing, progress and results of clinical development, clinical trials and potential regulato

Business

Business Abeona Therapeutics Inc., a Delaware corporation (together with our subsidiaries, "we," "our," "Abeona" or the "Company"), is a clinical-stage biopharmaceutical company developing cell and gene therapies for life-threatening diseases. Our lead clinical program is for prademagene zamikeracel ("pz-cel"), our investigational autologous, COL7A1 gene-corrected epidermal sheets currently in development for recessive dystrophic epidermolysis bullosa ("RDEB"). Pz-cel has been granted Orphan Drug and Rare Pediatric Disease ("RPD") designations by the U.S. Food and Drug Administration ("FDA") and Orphan Drug Designation by the European Medicines Agency ("EMA"). We plan to continue development of adeno-associated virus ("AAV") based gene therapies designed to treat ophthalmic diseases with high unmet medical need using the novel AIM capsid platform that we have exclusively licensed from the University of North Carolina at Chapel Hill ("UNC"), and internal AAV vector research programs. Abeona's novel, next-generation AAV capsids are being evaluated to improve tropism profiles for a variety of devastating diseases. Our Mission and Strategy Abeona is a fully-integrated cell and gene therapy company featuring research and clinical development programs, in-house manufacturing facilities, and scientific and clinical leadership. Our mission is to create, develop, manufacture, and deliver cell and gene therapies to transform the lives of people impacted by life-threatening diseases. In 2023, we continued to make progress toward fulfilling our goal of harnessing the promise of genetic medicine and redefining the standard of care through cell and gene therapies. In September 2023, we submitted a Biologics License Application ("BLA") for pz-cel to the FDA. In November 2023, the FDA accepted and granted priority review for our BLA for pz-cel. Under the Prescription Drug User Fee Act ("PDUFA"), the FDA has set a target action date of May 25, 2024. We partner with leading

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View this 10-K filing on SEC EDGAR