ABEO Abeona Therapeutics Inc.

1.54
-0.02  -1%
Previous Close 1.56
Open 1.56
52 Week Low 0.9895
52 Week High 5.19
Market Cap $151,732,693
Shares 98,527,723
Float 84,138,026
Enterprise Value $61,875,138
Volume 1,570,376
Av. Daily Volume 2,559,145
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Drug Pipeline

Drug Stage Notes
ABO-102
Sanfilippo syndrome type A (MPS IIIA)
Phase 1/2
Phase 1/2
Phase 1/2 enrollment to be completed 1Q 2021.
EB-101 - VITAL
Recessive dystrophic epidermolysis bullosa (RDEB)
Phase 3
Phase 3
Phase 3 enrollment to be completed 1H 2021.
ABO-202
CLN1 disease (Infantile Batten disease)
Phase 1/2
Phase 1/2
Phase 1/2 trial planned.
ABO-101
Sanfilippo syndrome type B (MPS IIIB)
Phase 1/2
Phase 1/2
Phase 1/2 presentation at WORLDSymposium February 12, 2020 noted trial has been well-tolerated to date, with no treatment-related severe adverse events.

Latest News

  1. NEW YORK and CLEVELAND, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced financial results for the third quarter 2020 and recent business progress.

    "Abeona remains committed to pursuing the development of our portfolio of advanced and early stage programs toward providing our novel gene and cell therapies to patients who currently have no approved treatment options," said Michael Amoroso, Chief Operating Officer of Abeona. "In particular, we are continuing to propel our clinical programs in recessive dystrophic epidermolysis bullosa (RDEB) and Sanfilippo syndrome type A (MPS IIIA) and type B (MPS IIIB) to drive Abeona's long-term growth and unlock…

    NEW YORK and CLEVELAND, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced financial results for the third quarter 2020 and recent business progress.

    "Abeona remains committed to pursuing the development of our portfolio of advanced and early stage programs toward providing our novel gene and cell therapies to patients who currently have no approved treatment options," said Michael Amoroso, Chief Operating Officer of Abeona. "In particular, we are continuing to propel our clinical programs in recessive dystrophic epidermolysis bullosa (RDEB) and Sanfilippo syndrome type A (MPS IIIA) and type B (MPS IIIB) to drive Abeona's long-term growth and unlock shareholder value."

    Third Quarter and Recent Highlights

    Corporate and Business Development Updates

    • In August 2020, Abeona entered into definitive agreements with Taysha Gene Therapies to license its rights to ABO-202, an AAV-based gene therapy for CLN1 disease (also known as infantile Batten disease). As part of the transaction, Abeona received initial cash proceeds of $7.0 million in October 2020. Abeona is also eligible to receive up to $56.0 million upon the achievement of certain clinical, regulatory and sales milestones, plus royalty-based payments based on net sales.
    • In October 2020, Abeona entered into a license agreement with Taysha Gene Therapies with respect to certain intellectual property rights, materials, and know-how relating to a potential AAV-based gene therapy for Rett syndrome. In connection with the agreement, Abeona received a one-time upfront payment of $3.0 million and is eligible to receive up to $56.5 million upon the achievement of certain clinical, regulatory and sales milestones, plus royalty-based payments based on net sales.
    • In October 2020, Michael Amoroso, Senior Vice President and Chief Commercial Officer at Abeona, was promoted to Chief Operating Officer. In this newly created role, Mr. Amoroso's responsibilities are broadened to include oversight and leadership of all operations.
    • Abeona continues to work with Jefferies LLC as its financial advisor in the review of strategic options focused on advancing the Company's mission and maximizing stakeholder value.

    EB-101 (Autologous, Gene-Corrected Cell Therapy)

    • Patient enrollment is ongoing for Abeona's EB-101 pivotal Phase 3 VIITAL™ study for RDEB. The Company currently anticipates completing enrollment in the VIITAL study in the first half of 2021, depending upon the impact from the COVID-19 pandemic, including travel restrictions and safety concerns.

    ABO-102 and ABO-101 (AAV-based Gene Therapies)

    • Target enrollment in the ABO-102 Transpher A study for MPS IIIA (15 to 22 patients) has been achieved. To date, 18 patients have been dosed in the Transpher A study, including 12 patients dosed in cohort 3. Abeona intends to continue enrolling patients into the study through the first quarter of 2021 given the lack of treatment options for MPS IIIA and encouraging efficacy and safety data from cohort 3.
    • In the ABO-101 Transpher B study for MPS IIIB, 11 patients have been dosed to date, including 4 patients dosed in cohort 3. The Company anticipates completing target enrollment in the Transpher B study (15 to 20 patients) in the first quarter of 2021.
    • In the third quarter, Abeona presented its plan toward registration of ABO-102 for MPS IIIA (Sanfilippo syndrome type A) during a kick-off meeting under the European Medicines Agency's (EMA) PRIority MEdicines (PRIME) program that offers a path for accelerated assessment of promising therapies targeting unmet medical needs. Based on the meeting, along with previous input from the Committee for Medicinal Products for Human Use and the Pediatric Committee of the EMA, Abeona anticipates submitting a marketing authorization application for EU conditional approval of ABO-102 for MPS IIIA after completion of two-year follow-up of the last patient treated in the Transpher A study. Regarding the U.S. regulatory path for ABO-102 in MPS IIIA, Abeona plans to request a meeting with the FDA to take place in the first quarter of 2021, depending on FDA's availability.

    Manufacturing Activities

    • Process development at the Company's GMP manufacturing facility in Cleveland, Ohio is ongoing that will enable production of the retrovirus used for EB-101 manufactured at the facility, allowing for increased control of the supply chain and product quality, as well as reduced costs. In addition, Abeona continues process development activities to enable in-house manufacturing of commercial supply of ABO-102 and ABO-101.

    Third Quarter Financial Results

    Cash, cash equivalents, receivables and short-term investments totaled $103.9 million as of September 30, 2020, compared to $129.3 million as of December 31, 2019. Accounts receivable were $7.0 million at September 30, 2020, which was paid by the customer in October 2020. Net cash used in operating activities was $10.7 million for the third quarter of 2020.

    License and other revenues for the third quarter of 2020 were $7.0 million, comprised of initial proceeds from the ABO-202 transaction, compared to zero revenues in the year-ago quarter.  

    Research and development (R&D) expenses were $8.0 million for the third quarter of 2020 and $20.9 million for the nine months ended September 30, 2020, compared to $10.9 million and $39.0 million in the comparable periods in 2019. The decrease in R&D expenses was primarily due to decreased manufacturing, clinical and non-clinical development activities arising from the effects of the COVID-19 pandemic, and cost savings associated with the decision to internally manufacture retrovirus for the EB-101 program.

    General and administrative (G&A) expenses were $4.4 million for the third quarter of 2020 and $16.4 million for the nine months ended September 30, 2020, compared to $4.7 million and $16.0 million in the comparable periods in 2019. The decrease in G&A expenses in the third quarter of 2020 was primarily due to decreased salary and related costs. The increase in G&A expenses in the nine months ended September 30, 2020 was primarily from severance costs associated with management changes, partially offset by decreased professional fees.

    Net loss was $7.2 million for the third quarter of 2020 and $68.4 million for the nine months ended September 30, 2020, compared to net loss of $17.4 million and $59.9 million for the comparable periods in 2019. The increase in net loss for the nine months ended September 30, 2020 includes the non-cash impairment charge of $32.9 million related to the termination of the license agreement with REGENXBIO.

    Conference Call Details

    Abeona Therapeutics will host a conference call and webcast tomorrow, Tuesday, November 10, 2020 at 8:30 a.m. ET, to discuss its third quarter 2020 financial results and business update. To access the call, dial 844-369-8770 (U.S. toll-free) or 862-298-0840 (international) 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 gene and cell therapies for serious diseases. Abeona's clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa in Phase 3 development, as well as ABO-102 and ABO-101, novel AAV-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively, in Phase 1/2 development. The Company's portfolio also features AAV-based gene therapies for ophthalmic diseases with high unmet medical needs. Abeona's novel, next-generation AIM™ capsids have shown potential to improve tropism profiles for a variety of devastating diseases. Abeona's fully functional, gene and cell therapy GMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL™ study and is capable of clinical and 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.  These statements include statements about the Company's clinical trials and its products and product candidates, future regulatory interactions with regulatory authorities, as well as the Company's goals and objectives. We have attempted to 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 by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to the potential impacts of the COVID-19 pandemic on our business, operations, and financial condition, our ongoing strategic review of our business and pre-clinical and clinical programs, including the sale of the Company or potential partnering or sale of such programs or the suspension of one or more of our pre-clinical or clinical programs, continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the outcome of any future meetings with the U.S. Food and Drug Administration or other regulatory agencies, the impact of competition, the ability to secure licenses for any technology that may be necessary to commercialize our products, the ability to achieve or obtain necessary regulatory approvals, the impact of changes in the financial markets and global economic conditions, risks associated with data analysis and reporting, and other risks as may be detailed from time to time in the Company's Annual Reports on Form 10-K and quarterly reports on Form 10-Q and other periodic reports filed by the Company 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 presentation, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws. 



    Abeona Therapeutics Inc. and Subsidiaries 
    Condensed Consolidated Statements of Operations and Comprehensive Loss 
    (unaudited) 
                    
     For the three months ended

    September 30,
     For the nine months ended

    September 30,
      2020   2019   2020   2019 
    Revenues:       
    License and other revenues$7,000,000  $-  $7,000,000  $- 
    Total revenues 7,000,000   -   7,000,000   - 
            
    Expenses:       
    Research and development 7,969,000   10,917,000   20,896,000   38,961,000 
    General and administrative 4,432,000   4,700,000   16,382,000   15,971,000 
    Depreciation and amortization 847,000   2,032,000   3,746,000   5,747,000 
    Licensed technology impairment charge -   -   32,916,000   - 
    Total expenses 13,248,000   17,649,000   73,940,000   60,679,000 
            
    Loss from operations (6,248,000)  (17,649,000)  (66,940,000)  (60,679,000)
            
    Interest and miscellaneous income 338,000   277,000   1,261,000   828,000 
    Interest and other expense (1,327,000)  -   (2,727,000)  - 
    Net loss$(7,237,000) $(17,372,000) $(68,406,000) $(59,851,000)
            
    Basic and diluted loss per common share$(0.08) $(0.35) $(0.73) $(1.22)
            
    Weighted average number of common       
    shares outstanding – basic and diluted 93,772,712   49,721,753   93,199,679   48,883,883 
            
    Other comprehensive income/(loss):       
    Change in unrealized (losses)/gains related to available-for-sale debt securities (116,000)  -   17,000   - 
            
    Comprehensive loss$(7,353,000) $(17,372,000) $(68,389,000) $(59,851,000)





    Abeona Therapeutics Inc. and Subsidiaries
    Condensed Consolidated Balance Sheets
    (unaudited)
        
        
    ASSETSSeptember 30,

    2020
     December 31,

    2019
        
    Current assets:   
    Cash and cash equivalents$8,424,000  $129,258,000 
    Receivables 7,000,000   - 
    Short-term investments 88,447,000   - 
    Prepaid expenses and other current assets 689,000   3,132,000 
    Total current assets 104,560,000   132,390,000 
        
    Property and equipment, net 12,095,000   13,157,000 
    Right-of-use lease assets 7,295,000   8,047,000 
    Licensed technology, net 1,881,000   36,178,000 
    Goodwill 32,466,000   32,466,000 
    Other assets and restricted cash 1,068,000   1,144,000 
    Total assets$159,365,000  $223,382,000 
        
    LIABILITIES AND STOCKHOLDERS' EQUITY   
        
    Current liabilities:   
    Accounts payable$1,262,000  $3,763,000 
    Accrued expenses 3,585,000   5,543,000 
    Loan payable 1,758,000   - 
    Current portion of lease liability 1,709,000   1,699,000 
    Payable to licensor 30,127,000   27,400,000 
    Deferred revenue 296,000   296,000 
    Total current liabilities 38,737,000   38,701,000 
        
    Long-term lease liability 5,517,000   6,251,000 
    Total liabilities 44,254,000   44,952,000 
        
    Commitments and contingencies -   - 
    Stockholders' equity:   
    Common stock - $0.01 par value; authorized 200,000,000 shares; issued and outstanding 84,516,161 at September 30, 2020 and 83,622,135 at December 31, 2019 845,000   836,000 
    Additional paid-in capital 669,125,000   664,064,000 
    Accumulated deficit (554,876,000)  (486,470,000)
    Accumulated other comprehensive income 17,000   - 
    Total stockholders' equity 115,111,000   178,430,000 
    Total liabilities and stockholders' equity$159,365,000  $223,382,000 
    Investor and Media Contact:
    
    Greg Gin
    VP, Investor Relations
    Abeona Therapeutics
    +1 (646) 813-4709
    

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  2. NEW YORK and CLEVELAND, Oct. 27, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced that Michael Amoroso, Senior Vice President and Chief Commercial Officer at Abeona, has been promoted to Chief Operating Officer and will serve as the Company's principal executive and operating officer, effective November 1, 2020. In this newly created role at Abeona, Mr. Amoroso's responsibilities will broaden to include oversight and leadership of all operations; including but not limited to, research and clinical development, regulatory, medical, commercial, corporate affairs and business development.

    "Michael has more than 20 years of strategic and operational leadership…

    NEW YORK and CLEVELAND, Oct. 27, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced that Michael Amoroso, Senior Vice President and Chief Commercial Officer at Abeona, has been promoted to Chief Operating Officer and will serve as the Company's principal executive and operating officer, effective November 1, 2020. In this newly created role at Abeona, Mr. Amoroso's responsibilities will broaden to include oversight and leadership of all operations; including but not limited to, research and clinical development, regulatory, medical, commercial, corporate affairs and business development.

    "Michael has more than 20 years of strategic and operational leadership experience in the biotechnology and pharmaceutical industries, including working within commercialization teams across clinical development, regulatory affairs, and medical affairs in major global markets," said Steven H. Rouhandeh, Chairman of Abeona's Board of Directors. "His recent and highly relevant experience with the commercial development of novel therapies for underserved patient populations will serve Abeona well as the Company seeks to further advance its clinical programs toward providing novel gene and cell therapies to patients who currently have no approved treatment options."

    Mr. Amoroso stated, "Abeona has a significant foundation in place with a compelling vision, great people, deep science and a robust pipeline of advanced and early stage programs. The experienced and talented team at Abeona remains committed to serving the patients with recessive dystrophic epidermolysis bullosa (RDEB) and Sanfilippo syndrome, and we are focused on completing enrollment in our EB-101 pivotal Phase 3 study for RDEB and Phase 1/2 studies of ABO-102 and ABO-101 for Sanfilippo syndrome type A (MPS IIIA) and Sanfilippo syndrome type B (MPS IIIB), respectively."

    Mr. Amoroso has served as Senior Vice President and Chief Commercial Officer of Abeona since July 2020. Prior to joining Abeona, Mr. Amoroso held various senior level commercial positions at leading biopharmaceutical companies, including Kite, Eisai Inc., Celgene Corporation (now a subsidiary of Bristol-Myers Squibb Company), and Sanofi. At Kite, he was responsible for the company's worldwide commercial organization leading the commercialization efforts for the autologous CAR T-cell therapy, YESCARTA®, and the future cell therapy pipeline. Before Kite, Mr. Amoroso was Senior Vice President, Americas for Eisai's Commercial Oncology Business Group, where he was accountable for teams charged with creating and driving commercial strategy and implementation for the company's approved products and earlier-stage assets. Previously, Mr. Amoroso worked at Celgene for six years in several commercial roles before serving as the organization's Commercial Lead for CAR T-cell therapy programs. In this capacity, he helped Celgene develop an organizational model to commercialize cell therapies including specialized manufacturing and customer services for patients with lymphoma and myeloma. Before joining Celgene, Mr. Amoroso held various marketing and sales leadership positions over his 10-plus year tenure at Sanofi. Mr. Amoroso earned his M.B.A. in Management from the Stern School of Business, New York University, and his B.A. in Biological Sciences, summa cum laude, from Rider University.

    About Abeona Therapeutics

    Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. Abeona's clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa in Phase 3 development, as well as ABO-102 and ABO-101, novel AAV-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively, in Phase 1/2 development. The Company's portfolio of AAV-based gene therapies also features ABO-201 for CLN3 disease. Abeona's novel, next-generation AIM™ capsids have shown potential to improve tropism profiles for a variety of devastating diseases. Abeona's fully functional, gene and cell therapy GMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL™ study and is capable of clinical and 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. These statements include statements about the Company exploring all strategic options, including the sale of some or all of its assets or sale of the Company. We have attempted to 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 by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to the potential impacts of the COVID-19 pandemic on our business, operations, and financial condition, the outcome of the strategic review, continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the outcome of any future meetings with the U.S. Food and Drug Administration or other regulatory agencies, the impact of competition, the ability to secure licenses for any technology that may be necessary to commercialize our products, the ability to achieve or obtain necessary regulatory approvals, the impact of 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 quarterly reports on Form 10-Q and other 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
    Abeona Therapeutics
    +1 (646) 813-4709
    

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  3. Steven H. Rouhandeh Appointed as Chairman of the Board of Directors

    Jefferies LLC Retained as Financial Advisor to Assist with the Review of Strategic Options

    NEW YORK and CLEVELAND, Oct. 06, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced that its Board of Directors has formed a Special Committee to oversee and advise the executive leadership team on the operations of the Company, leveraging the respective medical, business development and financial expertise of its members. The Special Committee, which consists of current board members, is also working closely with the executive leadership team to develop the Company's strategic direction and leadership…

    Steven H. Rouhandeh Appointed as Chairman of the Board of Directors

    Jefferies LLC Retained as Financial Advisor to Assist with the Review of Strategic Options

    NEW YORK and CLEVELAND, Oct. 06, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced that its Board of Directors has formed a Special Committee to oversee and advise the executive leadership team on the operations of the Company, leveraging the respective medical, business development and financial expertise of its members. The Special Committee, which consists of current board members, is also working closely with the executive leadership team to develop the Company's strategic direction and leadership plan as it continues to advance its clinical programs toward providing novel gene and cell therapies to patients who currently have no approved treatment options. The Company also announced the appointment of Steven H. Rouhandeh as Chairman of its Board of Directors.

    Strategic Review

    Abeona has retained Jefferies LLC as its financial advisor to assist with the review of strategic options focused on advancing the Company's mission and maximizing stakeholder value. There can be no assurance this strategic review will result in the completion of any particular course of action. There is no defined timeline for completion of the review process and the Company does not intend to comment further unless a specific initiative is approved by the Board of Directors, the review process is concluded, or it is otherwise determined that other disclosure is appropriate.

    About Abeona Therapeutics

    Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. Abeona's clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa in Phase 3 development, as well as ABO-102 and ABO-101, novel AAV-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively, in Phase 1/2 development. The Company's portfolio of AAV-based gene therapies also features ABO-201 for CLN3 disease. Abeona's novel, next-generation AIM™ capsids have shown potential to improve tropism profiles for a variety of devastating diseases. Abeona's fully functional, gene and cell therapy GMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL™ study and is capable of clinical and 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. These statements include statements about the Company exploring all strategic options, including the sale of some or all of its assets or sale of the Company. We have attempted to 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 by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to the potential impacts of the COVID-19 pandemic on our business, operations, and financial condition, the outcome of the strategic review, continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the outcome of any future meetings with the U.S. Food and Drug Administration or other regulatory agencies, the impact of competition, the ability to secure licenses for any technology that may be necessary to commercialize our products, the ability to achieve or obtain necessary regulatory approvals, the impact of 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 quarterly reports on Form 10-Q and other 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
    Abeona Therapeutics
    +1 (646) 813-4709
    

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  4. NEW YORK and CLEVELAND, Sept. 28, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced changes in its executive leadership and Board of Directors. João Siffert, M.D. resigned from his positions as CEO, Head of Research and Development, and Chief Medical Officer, as well as member of the Board of Directors, on September 23, 2020. On September 27, 2020, Brian Pereira, M.D., Stefano Buono, Stephen B. Howell, M.D., George Migausky and Shawn Tomasello each announced that they had stepped down from the Board, effective immediately. No director gave any reason for their resignation and no director indicated any disagreements with the Company.

    The Company is reviewing…

    NEW YORK and CLEVELAND, Sept. 28, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced changes in its executive leadership and Board of Directors. João Siffert, M.D. resigned from his positions as CEO, Head of Research and Development, and Chief Medical Officer, as well as member of the Board of Directors, on September 23, 2020. On September 27, 2020, Brian Pereira, M.D., Stefano Buono, Stephen B. Howell, M.D., George Migausky and Shawn Tomasello each announced that they had stepped down from the Board, effective immediately. No director gave any reason for their resignation and no director indicated any disagreements with the Company.

    The Company is reviewing and exploring all strategic options and alternatives focused on advancing the Company's mission and maximizing stakeholder value, including the sale of some or all of its assets or sale of the Company. There can be no assurance this strategic review will result in the completion of any particular course of action. There is no defined timeline for completion of the review process.

    About Abeona Therapeutics

    Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. Abeona's clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa in Phase 3 development, as well as ABO-102 and ABO-101, novel AAV-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively, in Phase 1/2 development. The Company's portfolio of AAV-based gene therapies also features ABO-201 for CLN3 disease. Abeona's novel, next-generation AIM™ capsids have shown potential to improve tropism profiles for a variety of devastating diseases. Abeona's fully functional, gene and cell therapy GMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL™ study and is capable of clinical and 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. These statements include statements about the Company exploring all strategic options, including the sale of some or all of its assets or sale of the Company. We have attempted to 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 by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to the potential impacts of the COVID-19 pandemic on our business, operations, and financial condition, continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the outcome of any future meetings with the U.S. Food and Drug Administration or other regulatory agencies, the impact of competition, the ability to secure licenses for any technology that may be necessary to commercialize our products, the ability to achieve or obtain necessary regulatory approvals, the impact of 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 quarterly reports on Form 10-Q and other 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 presentation, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.

    Investor Contact:
    Greg Gin
    VP, Investor Relations
    Abeona Therapeutics
    +1 (646) 813-4709
    
    
    Media Contact:
    Scott Santiamo
    Director, Corporate Communications
    Abeona Therapeutics
    +1 (718) 344-5843
    

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  5. NEW YORK and CLEVELAND, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced that the Company will participate in the following upcoming investor conferences.

    • João Siffert, M.D., Chief Executive Officer, will conduct virtual one-on-one meetings with institutional investors at Citi's 15th Annual BioPharma Virtual Conference on Wednesday, September 9, 2020.

    • Dr. Siffert will present at the Wells Fargo Virtual Healthcare Conference on Thursday, September 10, 2020 at 10:00 a.m. ET. A live webcast of the presentation will be available on the investor section of the Abeona Therapeutics website at www.abeonatherapeutics.com. The webcast replay will be available…

    NEW YORK and CLEVELAND, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced that the Company will participate in the following upcoming investor conferences.

    • João Siffert, M.D., Chief Executive Officer, will conduct virtual one-on-one meetings with institutional investors at Citi's 15th Annual BioPharma Virtual Conference on Wednesday, September 9, 2020.



    • Dr. Siffert will present at the Wells Fargo Virtual Healthcare Conference on Thursday, September 10, 2020 at 10:00 a.m. ET. A live webcast of the presentation will be available on the investor section of the Abeona Therapeutics website at www.abeonatherapeutics.com. The webcast replay will be available within 24 hours of the live presentation and will be accessible for 30 days.

    About Abeona Therapeutics

    Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. Abeona's clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa in Phase 3 development, as well as ABO-102 and ABO-101, novel AAV-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively, in Phase 1/2 development. The Company's portfolio of AAV-based gene therapies also features ABO-201 for CLN3 disease. Abeona's novel, next-generation AIM™ capsids have shown potential to improve tropism profiles for a variety of devastating diseases. Abeona's fully functional, gene and cell therapy GMP manufacturing facility produces EB-101 for the pivotal Phase 3 VIITAL™ study and is capable of clinical and commercial production of AAV-based gene therapies. For more information, visit www.abeonatherapeutics.com.

    Investor Contact:

    Greg Gin

    VP, Investor Relations

    Abeona Therapeutics

    +1 (646) 813-4709

    Media Contact:

    Scott Santiamo

    Director, Corporate Communications

    Abeona Therapeutics

    +1 (718) 344-5843

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