Abeona Therapeutics

Abeona Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in the development of gene therapy for severe and life-threatening rare diseases. It programs include EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB), ABO-102 (AAV-SGSH), an adeno-associated virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA), and ABO-101 (AAV NAGLU), an AAV based gene therapy for Sanfilippo syndrome type B (MPS IIIB). The company was founded in 1974 and is headquartered in New York, NY.

Earnings data Q4 2020

Earnings data Q1 2021

Earnings data Q2 2021

Earnings data Q3 2021

Earnings data Q4 2021

Earnings data Q1 2022

Earnings data Q2 2022

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Earnings data Q4 2022

Earnings data Q1 2023

Earnings data Q2 2023

Earnings data Q3 2023

Earnings data Q4 2023

Earnings data Q1 2024

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Earnings data Q3 2024

Abeona Therapeutics excels in Q4 with EB-101 advancements and growth prospects

Abeona Therapeutics showcased strong financial performance and clinical advancements with EB-101 in Q4 2022.
While facing challenges in pricing negotiations and upcoming competition, the company is well-positioned for growth.
Opportunities lie in partnerships for commercialization, market acceptance of EB-101, and the potential of gene therapy programs.

Abeona Therapeutics reports strong Q1 performance and eyes future growth

Abeona Therapeutics showcased strong performance in Q1 2023 with positive data from EB-101 and AAV ophthalmology programs, driving patient confidence and market positioning.
The company's engagement with stakeholders, successful completion of key submission steps, and promising proof-of-concept data present opportunities for future growth.
Challenges include aligning pricing considerations post VIITAL results, meeting submission requirements, and addressing analyst inquiries on program priorities and study findings.

Abeona Therapeutics advances EB-101 with $100M voucher, faces commercialization challenges

Abeona Therapeutics showcased progress on EB-101 and financial stability despite a net loss in Q2 2023.
Challenges include financial losses, commercial launch readiness, and securing partnerships.
Opportunities lie in potential BLA approval, market expansion, and advancements in AAV-based therapies.
The company's focus on EB-101 and strategic planning for commercialization are key strengths.

Abeona Therapeutics advances BLA submission for pz-cel, eyes commercialization

Abeona Therapeutics is making significant strides in product approval and commercialization strategies.
The company's financial stability and market-focused approach position it well for future growth.
While challenges exist, opportunities for expansion through FDA approval and market engagement are promising.

Abeona Therapeutics advances towards U.S. commercialization with FDA acceptance

Abeona Therapeutics showcased strong progress towards U.S. commercialization with FDA acceptance for pz-cell BLA. The company's financial performance for 2023 was solid, and engagement with key stakeholders bodes well for market entry. Challenges in FDA response timelines and manufacturing inspections need careful management.

Abeona Therapeutics advances pz-cel resubmission and strengthens financial position

Abeona Therapeutics shows strong progress in addressing regulatory and commercialization aspects for pz-cel
Financial stability improved through successful underwritten offering, enhancing market position
Challenges remain in FDA feedback, site onboarding, PRV market dynamics, and self-launch commitment
Clear opportunities exist in collaborations, market potential, growth timeline, and strategic positioning

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Abeona Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in the development of gene therapy for severe and life-threatening rare diseases. It programs include EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB), ABO-102 (AAV-SGSH), an adeno-associated virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA), and ABO-101 (AAV NAGLU), an AAV based gene therapy for Sanfilippo syndrome type B (MPS IIIB). The company was founded in 1974 and is headquartered in Cleveland, OH.

NEW YORK and CLEVELAND, Ohio, May 04, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced the presentation of new preclinical data on AAV204 at the Association for Research and Vision in Ophthalmology (ARVO) Annual Meeting, taking place on May 1-4, 2022 in Denver, CO and virtually on May 11-12, 2022. The data was featured in a poster presentation entitled “AAV204, a Novel AAV Capsid, Demonstrates Superior Macular Transduction Following Para-Retinal Administration in Non-Human Primates.”

Abeona Therapeutics Announces AAV204, a Novel AAV Capsid, Demonstrated Robust Macular Transduction Following Para-Retinal Administration in Non-Human Primates

NEW YORK and CLEVELAND, April 29, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced that preclinical data on AAV204, a novel adeno-associated virus (AAV) capsid from Abeona's in-licensed AIM™ capsid library, will be presented at the Association for Research and Vision in Ophthalmology (ARVO) Annual Meeting, to be held on May 1-4, 2022 in Denver, CO and virtually on May 11-12, 2022.

Abeona Therapeutics Announces Presentation at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

NEW YORK and CLEVELAND, April 29, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced that it has entered into a securities purchase agreement with certain institutional investors to purchase 1,000,006 shares of Series A convertible redeemable preferred stock and 250,005 shares of Series B convertible redeemable preferred stock. Each share of Series A and Series B preferred stock has a purchase price of $19.00, representing an original issue discount of 5% of the $20.00 stated value of each share. Each share of Series A and Series B preferred stock is convertible into shares of Abeona's common stock at an initial conversion price of $0.45 per share. Shares of the Series A and Series B preferred stock are convertible at the option of the holder at any time following the Company's receipt of stockholder approval for a reverse stock split of the Company's common stock. Abeona will be permitted to redeem the Series A preferred stock at its option upon the fulfillment of certain conditions and subject to certain limitations. The Company and the holders of the Series A and Series B preferred stock will also enter into a registration rights agreement to register the resale of the shares of common stock issuable upon conversion of the Series A and Series B preferred stock. Total gross proceeds from the offerings, before deducting discounts, placement agent's fees and other estimated offering expenses, is approximately $25 million.

Abeona Therapeutics Announces Pricing of $25 Million Private Placement of Convertible Redeemable Preferred Stock

EB-101 pivotal phase 3 VIITAL™ study in RDEB achieves target enrollment; top-line data expected in third quarter of 2022; gained FDA alignment on CMC requirements for EB-101 including characterization and validation plans

Abeona Therapeutics Announces Strategy Update and 2021 Financial Results

NEW YORK and CLEVELAND, March 28, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that Vish Seshadri, Ph.D., Chief Executive Officer of Abeona Therapeutics, will participate in a panel discussion titled, “Cell Therapy: How the Definition has Expanded with Time, and the Potential Applications for Rare Diseases,” at the Cantor Fitzgerald Virtual Rare Disease Summit on Wednesday, March 30, 2022 at 4:00 p.m. ET.

Abeona Therapeutics to Participate in the Cantor Fitzgerald Virtual Rare Orphan Disease Summit

Topline data from VIITAL™ expected in the third quarter of 2022 Topline data from VIITAL™ expected in the third quarter of 2022

Abeona Therapeutics Achieves Target Enrollment in Pivotal Phase 3 VIITAL™ Study of EB-101 in RDEB

Abeona Therapeutics (ABEO) appears to have found support after losing some value lately, as indicated by the formation of a hammer chart. In addition to this technical chart pattern, strong agreement among Wall Street analysts in revising earnings estimates higher enhances the stock's potential for a turnaround in the near term.

Here's Why Abeona Therapeutics (ABEO) Looks Ripe for Bottom Fishing

NEW YORK and CLEVELAND, Dec. 22, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today issued the following letter to shareholders.

Abeona Therapeutics Issues Letter to Shareholders

NEW YORK and CLEVELAND, Dec. 17, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the pricing of its underwritten public offering of 44,700,000 shares of its common stock and warrants to purchase 44,700,000 shares of its common stock at a combined offering price to the public of $0.39 per one share of common stock and one warrant to purchase one share of common stock. The warrants have an exercise price of $0.39 per share of common stock, are exercisable immediately, and will expire five years from the date of issuance. The aggregate gross proceeds from the offering are expected to be approximately $17.5 million, before deducting the underwriting discounts and commissions and other offering expenses payable by Abeona. The offering is expected to close on December 21, 2021, subject to the satisfaction of customary closing conditions.

Abeona Therapeutics Announces Pricing of Public Offering of Common Stock and Warrants

The stock price of Abeona Therapeutics Inc (NASDAQ: ABEO) fell by over 25% pre-market today. This is why it happened.

Abeona Therapeutics Stock (ABEO): Why The Price Fell Today

NEW YORK and CLEVELAND, Dec. 16, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that it intends to offer and sell shares of its common stock and warrants to purchase common stock in an underwritten public offering pursuant to an existing shelf registration statement. All of the securities in the offering are to be sold by Abeona. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Abeona Therapeutics Announces Public Offering of Common Stock and Warrants

Abeona Therapeutics (ABEO) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it. This, combined with strong agreement among Wall Street analysts in revising earnings estimates higher, indicates a potential trend reversal for the stock in the near term.

Down 15.2% in 4 Weeks, Here's Why Abeona Therapeutics (ABEO) Looks Ripe for a Turnaround

NEW YORK and CLEVELAND, Nov. 18, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced its sponsorship of the second annual Venture Into Cures, a virtual event supporting EB Research Partnership's mission to find a cure for epidermolysis bullosa (EB). The event will take place virtually on November 18, 2021 at 8:00 p.m. ET/ 5:00 p.m. PT.

Abeona Therapeutics Announces Support of EB Research Partnership's Venture Into Cures Event to Raise Awareness for Education and Research of Epidermolysis Bullosa

NEW YORK and CLEVELAND, Nov. 17, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that information about the company's ABO-102 pivotal Transpher A study in Sanfilippo syndrome type A (MPS IIIA) will be presented at the 14th International Congress of Inborn Errors of Metabolism (ICIEM). The meeting will take place virtually and at the Hilton Sydney in Sydney, Australia on November 21-23, 2021.

Abeona Therapeutics Announces Presentation on Pivotal Transpher A Study of ABO-102 in MPS IIIA at the 14th ICIEM Conference

NEW YORK and CLEVELAND, Nov. 16, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that Vish Seshadri, Ph.D., Chief Executive Officer of Abeona, will participate virtually in a fireside chat at the Jefferies London Healthcare Conference being held November 16-19, 2021.

Abeona Therapeutics Announces Participation at the Jefferies London Healthcare Conference

Phase 3 VIITAL™ study on track to complete enrollment in first quarter 2022 with final patients identified and under screening

Abeona Therapeutics Reports Third Quarter Financial Results

NEW YORK and CLEVELAND, Oct. 21, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that Vish Seshadri, Ph.D., M.B.A., Chief Executive Officer of Abeona, is scheduled to present at the Jefferies Gene Therapy/Editing Summit on Wednesday, October 27, 2021, at 3:30 p.m. ET.

Abeona Therapeutics to Present at Jefferies Gene Therapy/Editing Summit

NEW YORK and CLEVELAND, Oct. 13, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced two presentations of previously disclosed clinical data at upcoming scientific congresses in October 2021. The presentations include a poster presentation on the long-term wound healing and pain relief data from the Phase 1/2a EB-101 trial at the 2021 Pediatric Dermatology Research Alliance (PeDRA) Annual Conference, held virtually October 14-15, 2021; and an oral presentation on the pivotal trial of the Company's investigational AAV-based gene therapy ABO-102 in MPS IIIA at the virtual 28th Annual Congress of the European Society of Gene & Cell Therapy (ESGCT), October 19-22, 2021.

Abeona Therapeutics Announces Clinical Data Presentations at Upcoming Scientific Congresses

NEW YORK and CLEVELAND, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Jon Voss as Vice President, Head of Quality. Mr. Voss, who has been advising the Company as a consultant, will now serve in a leadership role to further strengthen Abeona's quality system and oversee all quality functions.

Abeona Therapeutics Appoints Gene Therapy Quality Leader Jon Voss as Vice President, Head of Quality

Steven H. Rouhandeh to retire as Chairman of the Board; Michael Amoroso appointed Chairman of the Board

Abeona Announces New Chairman, Executive Leadership Promotions and Key Talent Additions for Final Push Towards Two Biologics License Application (BLA) Filings

NEW YORK and CLEVELAND, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that members of the company's management will present and conduct one-on-one meetings at the following virtual investor conferences:

Abeona Therapeutics to Present at Upcoming Investor Conferences

NEW YORK and CLEVELAND, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Edward Carr as Chief Financial Officer and Principal Financial Officer, effective immediately. Mr. Carr had served as Abeona's Chief Accounting Officer since January 2019.

Abeona Therapeutics Appoints Edward Carr as Chief Financial Officer

Second clinical trial site activated in EB-101 pivotal Phase 3 VIITAL™ study

Abeona Therapeutics Reports Second Quarter Financial Results

Abeona Therapeutics Inc (NASDAQ: ABEO) has completed a Type B meeting with the FDA regarding the pivotal trial for its ABO-102 gene therapy for Sanfilippo syndrome type A (MPS IIIA).  ABO-102 is currently being evaluated in the single-arm Transpher A study in patients with MPS IIIA.

Abeona Stock Gains As It Concludes Type B Meeting With FDA For MPS IIIA Gene Therapy

Transpher A; pivotal study for intended registration of ABO-102 for MPS IIIA disease

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