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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 (ABEO) reported significant progress in Q1 2021, focusing on gene therapies for rare diseases. Notable highlights include ongoing patient enrollment in the pivotal Phase 3 VIITAL™ study for EB-101, expected to complete in 2021, and positive interim data for ABO-102 and ABO-101 presented at the WORLDSymposium. The company also strengthened its leadership team, enhancing corporate governance. Financially, Abeona's cash reserves decreased to $86.8 million, with a net loss of $16 million, significantly lower than the previous year's loss. A conference call is scheduled for May 25, 2021, to discuss results.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced new preclinical data to be presented at the ARVO 2021 Annual Meeting, highlighting a dual AAV vector strategy to treat Stargardt disease, caused by ABCA4 gene mutations. The data shows potential for effective gene reconstitution, which may lead to full-size ABCA4 protein expression. This study could influence future clinical development plans. The oral presentation will occur on May 4, 2021, focused on gene therapy for ocular diseases, underlining Abeona's commitment to advanced gene and cell therapies.
Abeona Therapeutics has appointed Dr. Leila Alland and Mr. Donald Wuchterl as independent board members. This strategic addition aims to enhance the company's focus on gene and cell therapies. They bring extensive experience in clinical development, manufacturing, and biologics. Dr. Alland has a notable background in oncology and previously worked with major pharmaceutical companies, while Mr. Wuchterl has over 29 years in life sciences, particularly in GMP manufacturing. Their expertise is expected to guide Abeona's corporate strategy and operational execution as the company progresses in developing therapies for serious diseases.
Abeona Therapeutics has announced the addition of two new independent members, Faith L. Charles and Mark Alvino, to its Board of Directors, enhancing its leadership with significant biotechnology expertise. Charles, a partner at Thompson Hine, has extensive experience in corporate transactions and life sciences. Alvino, President at Hudson Square Capital, brings over 25 years of financial and strategic insight. The company aims to leverage this new board composition to drive growth, improve governance, and increase shareholder value in the competitive gene and cell therapy industry.
Abeona Therapeutics announced updates on its clinical programs and financial results for Q4 and full year 2020. The pivotal Phase 3 VIITAL study of EB-101 for RDEB has treated its fourth patient, following a successful Type B meeting with the FDA on endpoints. Interim data from MPS IIIA and IIIB programs showed promising results, with 19 patients dosed in the ABO-102 study. As of December 31, 2020, cash reserves totaled $95 million. The net loss for 2020 was $84.2 million, impacted by a non-cash impairment charge. A conference call is scheduled for March 25, 2021.
Abeona Therapeutics Inc. has appointed Michael Amoroso as its new CEO, following his role as COO. This transition is aimed at ensuring continuity and reflects the company's strong operational performance. During his time as COO, Amoroso oversaw key aspects including research and clinical development, leading to significant milestones in Abeona's clinical programs. The company is focused on developing innovative gene and cell therapies for serious diseases, including ongoing trials for treatment options aimed at rare conditions.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced its participation in the 10th Annual SVB Leerink Global Healthcare Conference on February 24, 2021, at 11:20 am EST. A live webcast of the presentation will be accessible on the company's investor website, with an archived replay available for 30 days. Abeona is focused on developing gene and cell therapies for serious diseases, with key programs including EB-101 for epidermolysis bullosa and AAV-based therapies for Sanfilippo syndrome. Their GMP facility supports the production of these therapies.
Abeona Therapeutics announced new positive data from ongoing Phase 1/2 trials for ABO-102 and ABO-101, treating MPS IIIA and MPS IIIB. Notably, ABO-102 preserved neurocognitive development in young patients for 2.5 to 3 years post-treatment, with dose-dependent reductions in biomarkers. Both therapies demonstrated favorable safety profiles, without severe adverse events reported. The company plans to discuss data with the FDA to explore the potential for a Biologics License Application for ABO-102. An investor webinar is scheduled for February 16, 2021.
Abeona Therapeutics has successfully completed a Type B meeting with the FDA regarding the co-primary endpoints for the Phase 3 VIITAL™ study of EB-101, a treatment for recessive dystrophic epidermolysis bullosa (RDEB). The study aims to enroll 10-15 patients with over 35 chronic wound sites. The co-primary endpoints include a 50% healing threshold and pain reduction upon wound dressing changes, evaluated at Week 24. Previous trials showed durable wound healing effects with no pain at treated sites lasting 2-5 years. The company is preparing for patient enrollment in 2021.
Abeona Therapeutics (Nasdaq: ABEO) announced interim results from its ABO-102 and ABO-101 Phase 1/2 studies for MPS IIIA and MPS IIIB, respectively. These results will be presented at the 17th Annual WORLD Symposium on February 12, 2021. The Transpher A study focuses on ABO-102's ability to preserve neurocognitive development in young patients, while Transpher B will provide insights into ABO-101's effects. Both therapies target rare lysosomal storage diseases with no approved treatments. Abeona holds multiple designations from regulatory agencies for these therapies.
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