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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) has priced an underwritten public offering of 44.7 million shares of common stock and warrants at a combined price of $0.39 per share. The offering aims to raise approximately $17.5 million in gross proceeds, with the closing expected on December 21, 2021. Funds will support clinical development of its pipeline products and general corporate purposes. The securities are offered under a shelf registration statement declared effective by the SEC.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced an underwritten public offering of its common stock and warrants to purchase common stock, subject to market conditions. The offering will be conducted under an existing shelf registration statement. Abeona plans to utilize the net proceeds for clinical development, working capital, and corporate purposes. Cantor Fitzgerald & Co. serves as the sole book-running manager. Important details regarding the offering are included in the filed prospectus with the SEC.
Abeona Therapeutics (Nasdaq: ABEO) announced its sponsorship of the virtual event Venture Into Cures on November 18, 2021, supporting the EB Research Partnership's mission to find a cure for epidermolysis bullosa (EB). The event will feature stories from EB patients, world-renowned speakers, and celebrity performers to raise funds for research. Abeona is advancing its Phase 3 VIITAL™ study of EB-101, a promising treatment for recessive dystrophic epidermolysis bullosa, with the goal of addressing the urgent medical need faced by patients.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the presentation of data from its pivotal Transpher A study for ABO-102 gene therapy targeting Sanfilippo syndrome type A at the 14th International Congress of Inborn Errors of Metabolism (ICIEM) from November 21-23, 2021. The interim results will be shared by Dr. Nicholas Smith, highlighting a positive correlation between cognitive functioning measures in young children. This event underscores Abeona's commitment to advancing its gene therapy offerings for serious diseases.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced participation of CEO Vish Seshadri at the Jefferies London Healthcare Conference from November 16-19, 2021. A pre-recorded webcast will be accessible on their investor webpage starting November 18, 2021. Abeona, a clinical-stage biopharmaceutical company, focuses on gene and cell therapies for serious diseases, including its Phase 3 investigational therapy for epidermolysis bullosa and gene therapies for Sanfilippo syndromes. The company operates a cGMP manufacturing facility for its therapies.
Abeona Therapeutics Inc. (Nasdaq: ABEO) reported Q3 2021 results and progress on key projects. The Phase 3 VIITAL™ study for EB-101 is on track to finish patient enrollment in Q1 2022, with top-line data expected by Q3 2022. The company anticipates submitting Biologics License Applications (BLA) for both EB-101 and ABO-102 in late 2022 to early 2023. A settlement with REGENXBIO has been reached, resolving a dispute and allowing resource focus on pipeline advancement. As of September 30, 2021, cash was $67 million, with a net loss of $7 million for the quarter.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced that CEO Vish Seshadri, Ph.D., M.B.A., will present at the Jefferies Gene Therapy/Editing Summit on October 27, 2021, at 3:30 p.m. ET. The presentation will be available live and archived on the company’s investor website. Abeona is focused on gene and cell therapies for serious diseases, with key projects including the Phase 3 autologous gene-corrected therapy EB-101 for epidermolysis bullosa, and AAV-based therapies for Sanfilippo syndrome types A and B, currently in Phase 1/2 development.
Abeona Therapeutics (Nasdaq: ABEO) announced two upcoming presentations of clinical data at scientific congresses in October 2021. The first presentation will showcase long-term wound healing and pain relief data from the Phase 1/2a EB-101 trial at the PeDRA Annual Conference on October 14-15, 2021. The second presentation will discuss interim results from the pivotal trial of investigational gene therapy ABO-102 in MPS IIIA at the ESGCT Congress from October 19-22, 2021. These events highlight Abeona's advancements in gene therapy for rare diseases.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the appointment of Jon Voss as Vice President, Head of Quality. Voss, previously a consultant, brings over 30 years of quality experience in gene therapy and biopharmaceuticals, having held senior roles at Cellectis, Sarepta Therapeutics, and Genzyme. His leadership is expected to enhance Abeona’s quality processes as the company prepares for two Biologics License Application submissions for its therapies, EB-101 and ABO-102, currently in pivotal studies.
Abeona Therapeutics Inc. announced significant leadership changes, including the retirement of Steven Rouhandeh as Chairman and the appointment of Michael Amoroso as his successor, effective October 15, 2021. Dr. Vishwas Seshadri will become CEO on the same date, enhancing leadership direction as the company prepares for Biologics License Application submissions for its gene therapies, EB-101 and ABO-102. Additional promotions within the executive team include Brendan O'Malley as General Counsel and Brian Kevany as Chief Technical Officer, among others, to support growth and operational capacity.
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