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Abeona Therapeutics Inc. (NASDAQ: ABEO) is a prominent clinical-stage biopharmaceutical company dedicated to the development of innovative gene therapies for life-threatening rare genetic disorders. By leveraging cutting-edge biotechnology, Abeona is making significant strides in transforming treatment paradigms for diseases with high unmet medical needs.
Core Business
Abeona's primary focus is on gene therapies and plasma-based products aimed at rare genetic diseases. The company's leading programs include pz-cel (prademagene zamikeracel, formerly known as EB-101), an investigational autologous gene-corrected epidermal graft for treating recessive dystrophic epidermolysis bullosa (RDEB), and several adeno-associated virus (AAV)-based gene therapies. These include therapies for Sanfilippo syndrome types A and B, juvenile Batten disease, infantile Batten disease, and Fanconi anemia.
Recent Achievements and Current Projects
In recent developments, Abeona completed its first U.S. Biologics License Application (BLA) submission for pz-cel in September 2023. The FDA's Priority Review of this application has a target action date of May 25, 2024. Moreover, the company has initiated commercial readiness activities, including discussions with treatment sites and payer engagements, anticipating a potential U.S. launch. Abeona's financial condition has been significantly bolstered by a $75 million underwritten offering in May 2024 and a $50 million credit facility obtained in January 2024.
Strategic Partnerships and Financial Highlights
Abeona's collaborations with institutional investors and organizations like Taysha Gene Therapies have been instrumental in advancing its clinical programs. With a robust balance sheet, the company raised an additional $25 million in July 2023 to support commercial preparations, and as of the latest financial reports, holds sufficient resources to fund operations into 2026.
Product Pipeline
Abeona's development portfolio includes:
- pz-cel for RDEB
- abo-102 for Sanfilippo syndrome type A
- abo-101 for Sanfilippo syndrome type B
- abo-201 and abo-202 for juvenile and infantile Batten disease
- abo-301 for Fanconi anemia
- abo-302 utilizing CRISPR/Cas9-based gene editing
- EB-201 for epidermolysis bullosa
Through its fully integrated cell and gene therapy cGMP manufacturing facility, Abeona is equipped to support both clinical and potential commercial production needs.
Looking Forward
With its strong pipeline and strategic financial maneuvers, Abeona Therapeutics is well-positioned to achieve critical milestones in the near future. The company remains committed to bringing transformative therapies to patients with unmet needs, driving forward its mission to change the landscape of gene therapy.
Abeona Therapeutics Inc. (Nasdaq: ABEO) reported its third quarter 2020 financial results, highlighting a net loss of $7.2 million, down from a $17.4 million loss in Q3 2019. The company received $7 million from licensing agreements with Taysha Gene Therapies for ABO-202 and $3 million for Rett syndrome gene therapy. R&D expenses decreased to $8 million due to COVID-19 impacts. Abeona continues clinical trials for RDEB and MPS IIIA/B, aiming for regulatory submissions in 2021. Cash reserves were $103.9 million as of September 30, 2020.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the promotion of Michael Amoroso to Chief Operating Officer, effective November 1, 2020. This newly created role expands his oversight to include all company operations, encompassing research, clinical development, and business strategies. Amoroso brings over 20 years of experience in biotechnology, previously holding senior positions at Kite and Celgene. The company's focus remains on advancing significant clinical programs for rare diseases, including pivotal studies for recessive dystrophic epidermolysis bullosa and Sanfilippo syndrome.
Abeona Therapeutics Inc. (NASDAQ: ABEO) has appointed Steven H. Rouhandeh as Chairman of its Board of Directors. The company has also established a Special Committee to guide executive leadership on operations and strategic direction, working closely with its team to advance gene and cell therapies. In addition, Abeona has engaged Jefferies LLC as a financial advisor to explore strategic options to enhance stakeholder value, with no specific timeline for this review. The company is known for its innovative clinical programs focusing on serious diseases and aims to maximize its mission.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced significant changes in its leadership and Board of Directors on September 28, 2020. João Siffert, M.D. resigned as CEO and other key positions on September 23, followed by the resignation of five Board members on September 27. The company is now exploring various strategic options, including potential asset sales, though no specific timelines or outcomes are guaranteed. Abeona is focused on developing gene and cell therapies for serious diseases, with several clinical programs underway, including EB-101, ABO-101, and ABO-102.
Abeona Therapeutics Inc. (Nasdaq: ABEO) reported significant changes in its leadership as CEO João Siffert, M.D. resigned, along with several board members on September 23 and 27, 2020. The company is now evaluating strategic options, including potential asset sales, although no specific timeline or outcomes are guaranteed. Abeona specializes in gene and cell therapies for serious diseases, with ongoing clinical programs in Phase 1/2 and Phase 3 development. The company highlights its AAV-based gene therapies and GMP manufacturing capabilities, essential for its clinical trials.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced its participation in key investor conferences in September 2020. CEO João Siffert will engage in virtual one-on-one meetings at Citi’s 15th Annual BioPharma Virtual Conference on September 9. Additionally, he will present at the Wells Fargo Virtual Healthcare Conference on September 10 at 10:00 a.m. ET, with a live webcast available on Abeona’s website. Abeona focuses on gene and cell therapies for serious diseases, including programs for recessive dystrophic epidermolysis bullosa and Sanfilippo syndrome.
Abeona Therapeutics Inc. (Nasdaq: ABEO) and Taysha Gene Therapies have entered into agreements for the licensing and purchase of inventory related to ABO-202, a gene therapy for CLN1 disease, also known as infantile Batten disease. Taysha will pay Abeona $7 million upfront, plus potential milestone payments up to $56 million and royalties on sales. The therapy aims to deliver a functional copy of the PPT1 gene, addressing a critical unmet medical need. Abeona will focus on advancing its other clinical programs post-agreement.
Abeona Therapeutics (Nasdaq: ABEO) reported significant clinical advancements and financial results for Q2 2020. The firm resumed patient enrollment in pivotal studies for RDEB and MPS IIIA, with new patients treated in both programs. Abeona aims for a 2023 EU marketing application for ABO-102 and anticipates commercial launches of EB-101 in late-2022. Financially, the company held $107.9 million in cash, with a net loss of $13 million for Q2. Leadership strengthened with a new Chief Commercial Officer and board members, enhancing strategic direction.
Abeona Therapeutics announced results from two poster presentations at the Society for Pediatric Dermatology's Annual Meeting regarding its EB-101 treatment for recessive dystrophic epidermolysis bullosa (RDEB). The data revealed that EB-101 treatment led to significant and durable healing of large, chronic wounds, resulting in long-term pain relief lasting up to five years. Additionally, a literature review of 65 studies highlighted the substantial clinical, economic, and humanistic burden associated with RDEB, affecting patients and their families.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced Michael Amoroso as the new Senior Vice President and Chief Commercial Officer, effective immediately. With over 20 years of experience in biotechnology and pharmaceuticals, Amoroso aims to lead the company's commercial strategies for its gene therapies, including the pivotal Phase 3 study of EB-101 for recessive dystrophic epidermolysis bullosa (RDEB). His previous roles at Kite and other major firms equip him with expertise in product commercialization, essential for Abeona’s growth and market strategy.
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