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Abeona Therapeutics Inc. develops and commercializes cell and gene therapies for serious diseases. Its updates center on ZEVASKYN (prademagene zamikeracel), an autologous cell-based gene therapy for wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa, including qualified treatment center activations, commercial launch activity, manufacturing and patient-treatment progress.
Company news also covers financial results, corporate progress, employee inducement equity awards under Nasdaq rules, board and committee changes, and development work involving AAV-based gene therapies and next-generation AAV capsids for ophthalmic and other serious diseases.
Abeona Therapeutics reported its 2022 Q2 financial results, announcing a net loss of $12.1 million or $2.08 per share, improved from a $15.2 million loss in Q2 2021. Cash and equivalents stood at $26 million, with operating cash usage reduced to $9 million, down from $13.7 million in Q1 2022. The company entered an exclusive license agreement with Ultragenyx for ABO-102, allowing it to extend its cash runway, crucial for the upcoming Phase 3 VIITAL™ data readout of EB-101 expected in Q4 2022. Additionally, significant progress was noted in pain reduction and wound healing associated with EB-101.
Abeona Therapeutics (Nasdaq: ABEO) announced it regained compliance with Nasdaq's minimum bid price requirement as of July 18, 2022. The company needed its common stock to maintain a closing bid price of at least $1.00 for 10 consecutive trading days, which it successfully achieved. Abeona focuses on developing cell and gene therapies for serious diseases, including its lead program, EB-101, for epidermolysis bullosa, currently in Phase 3. The company also develops AAV-based gene therapies for ophthalmic conditions.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced its participation in the Jefferies Healthcare Conference on June 9, 2022, at 3:30 p.m. EDT. Management will present updates on the company's advancements in cell and gene therapy. A live webcast will be available on the Investors section of Abeona's website, and the presentation will be archived for 30 days. Abeona focuses on developing therapies for serious diseases, with its lead program, EB-101, in Phase 3 development for recessive dystrophic epidermolysis bullosa.
Abeona Therapeutics Inc. (Nasdaq: ABEO) has received an additional 180-day extension from Nasdaq until November 14, 2022, to meet the $1.00 minimum bid price requirement for continued listing. The stock must maintain a closing bid price of at least $1.00 for 10 consecutive trading days to demonstrate compliance. If successful, Nasdaq will confirm compliance; otherwise, the stock may face delisting. Abeona plans to propose a reverse stock split to help achieve this goal at a special stockholder meeting scheduled for June 14, 2022.
Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results for Q1 2022, highlighting a net loss of $20.8 million, or $0.14 per share. The company is focused on extending its cash runway, having off-loaded MPS assets and emphasizing the EB-101 pivotal Phase 3 study, with topline data expected in Q3 2022. Cash resources stood at $37.2 million. Recent developments include a $25 million private placement and a plan to regain Nasdaq compliance, which may involve a reverse stock split. Abeona will discuss these results in a conference call on May 17, 2022.
Abeona Therapeutics Inc. (Nasdaq: ABEO) presented new preclinical data on AAV204 at the ARVO Annual Meeting, showcasing its potential as a novel AAV capsid for ophthalmic applications. The study involved administering AAV204 to non-human primates, which demonstrated superior GFP expression in the macula and optic nerve compared to AAV8. This less invasive para-retinal administration method resulted in no clinically relevant inflammation. The AIM™ capsid library, which includes AAV204, targets various tissues for gene therapy, potentially improving treatment outcomes for serious diseases.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced the presentation of preclinical data on AAV204 at the ARVO Annual Meeting, scheduled for May 1-4, 2022. The data highlights AAV204's superior ability to achieve robust transduction in the macula area of the eye through para-retinal administration in non-human primates, a method that avoids the need for subretinal detachment. The poster presentation is set for May 3, 2022, demonstrating the potential of Abeona's AIM™ capsid library to improve genetic therapy delivery.
Abeona Therapeutics Inc. (Nasdaq: ABEO) announced a securities purchase agreement to raise approximately $25 million through the sale of 1,000,006 shares of Series A and 250,005 shares of Series B convertible redeemable preferred stock at a discounted price of $19.00 each. These preferred stocks are convertible into common stock at an initial price of $0.45 per share, contingent on stockholder approval for a reverse stock split. The offerings are expected to close by May 2, 2022, subject to customary conditions.
Abeona Therapeutics (ABEO) has achieved target enrollment in its pivotal Phase 3 VIITAL™ study for EB-101, focusing on recessive dystrophic epidermolysis bullosa (RDEB), with topline results expected in Q3 2022. The company secured FDA alignment on Chemistry, Manufacturing, and Controls (CMC) for EB-101. Abeona plans to concentrate on EB-101 while seeking a commercialization partner and will discontinue development of ABO-101 for MPS IIIB. The company reported cash resources of $50.9 million as of December 31, 2021, down from $96 million in 2020, indicating a need to manage expenses to extend cash runway into mid-2023.
Abeona Therapeutics (Nasdaq: ABEO) announced CEO Vish Seshadri's participation in a panel at the Cantor Fitzgerald Virtual Rare Disease Summit on March 30, 2022, at 4:00 p.m. ET. The discussion will focus on the evolving definition of cell therapy and its applications for rare diseases.
Abeona is known for its gene and cell therapies aimed at serious diseases, including Phase 3 development of EB-101 for epidermolysis bullosa, and Phase 1/2 therapies ABO-102 and ABO-101 for Sanfilippo syndrome.