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Form 8-K - Current report - Item 2.02 Item 9.01

Abeona Therapeutics Inc

Abeona Therapeutics has revealed affirmative outcomes for its Phase 3 VIITAL study of EB-101 in recessive dystrophic epidermolysis bullosa. According to CEO Vish Seshadri, "We are of the opinion that the VIITAL study results showcase the potential value of EB-101". In line with this, the company has expressed plans to put forward a Biologics License Application to the FDA in late Q2 or early Q3 of 2023 by leveraging these results. Additionally, Abeona is continuing to make progress with adeno-associated virus (AAV)-based gene therapy options for Stargardt Disease, X-linked Retinoschisis, and Autosomal Dominant Optic Atrophy in preparation for IND studies. The company's revenues for 2022 amounted to $1.4 million, with resources enough to support operations until Q3 2024, as estimated by Abeona. As a professional financial analyst, this information provides a glimpse of Abeona's current activities, potential for future growth, and overall financial standing.

$ABEO reports positive Phase 3 results and plans for BLA submission

Announcement: ABEO 8-K Special Filing

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Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405]

First Part of Analysis - Performance Analysis:

Overall, Abeona Therapeutics Inc. had a mixed performance in 2022. The company announced positive topline data from the VIITAL study, demonstrating statistically significant improvements in wound healing and pain reduction in chronic RDEB wounds. This was a great achievement for the company and gave it momentum to file a BLA for EB-101 to the FDA in late second quarter of 2023 or early third quarter of 2023. On the downside, the company had a decrease of 53% in license and other revenues, from $3.0 million in 2021 to $1.4 million in 2022. At the same time, total expenses decreased by 44%, from $92.8 million in 2021 to $52.3 million in 2022 due mainly to a decrease in research and development and general and administrative expenses.

In terms of the competitive position, Abeona Therapeutics Inc. operates in the clinical-stage biopharmaceutical industry, which is growing at a rapid pace. Based on the positive topline results from the VIITAL study, the company's EB-101 therapy for RDEB could have the potential to become a game-changer in the treatment of life-threatening diseases. However, the industry is highly competitive, with many players jostling for market share in the fast-growing regenerative medicine space.

The CEO and management are confident about the future prospects of the company, as evidenced by the planned BLA filing for EB-101 in late second quarter of 2023 or early third quarter of 2023. The company's pipeline programs involving novel AAV capsids, which are under preclinical development, could also expand the company's target market and provide growth opportunities.

There may be factors that could impact the company's future performance, including regulatory approvals, pricing pressures, competition, clinical trials outcome, and the ongoing impact of COVID-19 on its operations.

Second Part of Analysis - Forward-Looking Analysis:

From a forward-looking perspective, Abeona Therapeutics Inc. is in a strong position to leverage its breakthrough results from the VIITAL study to drive future growth. Key drivers could be the successful commercial launch of EB-101 in late 2023/early 2024, depending on the FDA's regulatory approval timeline, and the success of the ongoing preclinical programs for the company's gene therapy candidates.

In addition, Abeona Therapeutics Inc. has announced plans to prepare its current Good Manufacturing Practices (“cGMP”) commercial facility in Cleveland, Ohio for manufacturing EB-101 drug product to support its planned BLA filing. The completion of this manufacturing facility would provide a competitive advantage for the company through reduced costs and increased efficiency.

The company has well-defined strategies to mitigate potential risks and uncertainties, including partnering with other biopharmaceutical companies, acquiring intellectual property, and entering into licensing agreements to build its product portfolio. Abeona Therapeutics Inc. acknowledges that the success of its long-term strategy is subject to various risks and uncertainties, including regulatory approvals and competition, which could impact its future growth potential.

Overall, while the company faces risks and uncertainties, Abeona Therapeutics Inc. seems poised to capitalize on the positive results from its EB-101 therapy program and emerging opportunities in the biopharmaceutical industry.

Analysis: Abeona Therapeutics' Mixed Performance in 2022, Positive Momentum with EB-101 Therapy

Announcement: ABEO 10-K Annual Report

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Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend]

Announcement: ABEO SC 13G/A Statement of acquisition of beneficial ownership by individuals - amendment

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