Abeona Therapeutics

Abeona Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in the development of gene therapy for severe and life-threatening rare diseases. It programs include EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB), ABO-102 (AAV-SGSH), an adeno-associated virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA), and ABO-101 (AAV NAGLU), an AAV based gene therapy for Sanfilippo syndrome type B (MPS IIIB). The company was founded in 1974 and is headquartered in New York, NY.

NEW YORK and CLEVELAND, March 16, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that additional data from its pivotal Phase 3 VIITAL™ study of EB-101 for recessive dystrophic epidermolysis bullosa (RDEB) has been accepted for an oral presentation at the inaugural International Societies for Investigative Dermatology (ISID) Meeting, being held May 10-13, 2023 in Tokyo, Japan. Abeona previously reported positive top-line efficacy and safety data from the VIITAL study in November 2022.

Abeona Therapeutics Announces Acceptance of Abstract on EB-101 Phase 3 VIITAL™ Study Results for Oral Presentation at International Societies for Investigative Dermatology (ISID) 2023 Meeting

Advancing AAV-based gene therapy candidates toward IND studies on encouraging animal proof of concept data in Stargardt Disease, X-linked Retinoschisis (XLRS), and Autosomal Dominant Optic Atrophy (ADOA)

Abeona Therapeutics Announces Update on AAV Ophthalmology Program

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Following positive topline data from Phase 3 VIITAL™ study of EB-101 with both co-primary endpoints met, Abeona plans to submit BLA to U.S. FDA in 2Q 2023

Abeona Therapeutics Reports Third Quarter 2022 Financial Results

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NEW YORK and CLEVELAND, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) announced today that it has entered into a securities purchase agreement to sell 7,065,946 shares of its common stock, and, in lieu of shares of common stock, pre-funded warrants exercisable for 543,933 shares of common stock, and accompanying warrants to purchase 7,609,879 shares of its common stock to a group of new and existing institutional investors in a private placement. The offering price for each share of common stock and accompanying warrant was $4.60, and the offering price for each pre-funded warrant and accompanying warrant was $4.59, which equals the offering price per share of the common stock and accompanying warrant, less the $0.01 per share exercise price of each pre-funded warrant. Each accompanying warrant will represent the right to purchase one share of the Company's common stock at an exercise price of $4.75 per share of common stock. The pre-funded warrants and the accompanying warrants will be exercisable immediately, and will expire five years from the date of issuance. Gross proceeds of the private placement are expected to be approximately $35,000,000, before deducting placement agent fees and other expenses. The private placement is expected to close on November 7, 2022, subject to the satisfaction of customary closing conditions.

Abeona Therapeutics Announces $35 Million Private Placement Financing

Co-primary endpoint measuring > 50% wound healing, other endpoints measuring > 75% and complete wound healing at six months all met

Abeona Therapeutics Announces Positive Topline Results with Both Co-Primary Endpoints Met in Pivotal Phase 3 VIITAL™ Study of EB-101

Results from the pivotal VITAL study, using EB-101 for the treatment of patients with RDEB are expected to be released before the end of 2022. Should EB-101 be approved by FDA for RDEB, it would give company a Priority Review Voucher, which could be sold for around $100 million or more to another pharmaceutical company.

Abeona: Pivotal Data Readout EB-101 Before Year End Could Boost Shareholder Value

NEW YORK and CLEVELAND, Oct. 19, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the database lock on October 18, 2022 for the pivotal Phase 3 VIITAL™ study of its investigational autologous, engineered cell therapy, EB-101, in patients with recessive dystrophic epidermolysis bullosa (RDEB). With the database now locked, the Company remains on track to report topline results in the next two to three weeks, consistent with guidance provided in early-October.

Abeona Therapeutics Announces Database Lock for Pivotal Phase 3 VIITAL™ Study of EB-101 in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB)

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Topline VIITAL™ study results expected within the next month Topline VIITAL™ study results expected within the next month

Abeona Therapeutics Announces Completion of Patient Follow-up in Pivotal Phase 3 VIITAL™ Study of EB-101 in Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB)

NEW YORK and CLEVELAND, Sept. 22, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Vish Seshadri, Chief Executive Officer of Abeona, will participate in a fireside chat at the Jefferies Cell and Genetic Medicine Summit on Friday, September 30, 2022 at 8:30 a.m. ET. The Company will also participate in one-on-one investor meetings at the conference.

Abeona Therapeutics to Participate in the Jefferies Cell and Genetic Medicine Summit

NEW YORK and CLEVELAND, Sept. 13, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that Vish Seshadri, Chief Executive Officer of Abeona, will participate in a panel discussion at the Cantor Fitzgerald Cell and Genetic Medicines Conference on Thursday, September 15, 2022. The panel discussion, entitled, “Late Stage and Commercial Gene & Cell Therapy Warriors: How They Got to/Crossed the Finish Line,” is scheduled to begin at 2:30 p.m. ET. The Company will also participate in one-on-one investor meetings at the conference.

Abeona Therapeutics to Participate in the Cantor Fitzgerald Cell and Genetic Medicines Conference

Disposition of MPS programs allows Abeona to extend runway of current cash into 2Q 2023

Abeona Therapeutics Reports Second Quarter 2022 Financial Results

NEW YORK and CLEVELAND, July 20, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it received notice from The Nasdaq Stock Market LLC (Nasdaq) on July 19, 2022 informing Abeona that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the “Rule”) for continued listing on The Nasdaq Capital Market. In order to regain compliance with the Rule, the Company's common stock was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days. That requirement was met on July 18, 2022.

Abeona Therapeutics Regains Compliance with Nasdaq Listing Requirements

NEW YORK and CLEVELAND, June 06, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced that company management is scheduled to present at the Jefferies Healthcare Conference on Thursday, June 9, 2022, at 3:30 p.m. EDT.

Abeona Therapeutics to Present at the Jefferies Healthcare Conference

NEW YORK and CLEVELAND, May 19, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced that the Company has been granted an additional 180-day period from Nasdaq's Listing Qualification Department, through November 14, 2022, to regain compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Company's common stock continues to trade on the Nasdaq Capital Market under the symbol "ABEO."

Abeona Therapeutics Granted Second 180-Day Period by Nasdaq to Regain Compliance with Minimum Bid Price Rule

Abeona Therapeutics Inc. (NASDAQ:ABEO ) Q1 2022 Earnings Conference Call May 17, 2022 8:30 AM ET Company Participants Vishwas Seshadri - Chief Executive Officer Joseph Vazzano - Chief Financial Officer Brian Kevany - Chief Technical Officer, Head of Research Greg Gin - Vice President, Investor Relations and Corporate Communications Conference Call Participants Maury Raycroft - Jefferies Rick - Cantor Fitzgerald Operator Good morning ladies and gentlemen, thank you for standing by. Welcome to the Abeona Q1 2022 earnings call.

Abeona Therapeutics (ABEO) CEO, Vishwas Seshadri on Q1 2022 Results - Earnings Call Transcript

Disposition of MPS programs to reduce operating expenses and  extend projected cash runway into 2Q 2023

Abeona Therapeutics Reports First Quarter 2022 Financial Results

NEW YORK and CLEVELAND, Ohio, May 04, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced the presentation of new preclinical data on AAV204 at the Association for Research and Vision in Ophthalmology (ARVO) Annual Meeting, taking place on May 1-4, 2022 in Denver, CO and virtually on May 11-12, 2022. The data was featured in a poster presentation entitled “AAV204, a Novel AAV Capsid, Demonstrates Superior Macular Transduction Following Para-Retinal Administration in Non-Human Primates.”

Abeona Therapeutics Announces AAV204, a Novel AAV Capsid, Demonstrated Robust Macular Transduction Following Para-Retinal Administration in Non-Human Primates

NEW YORK and CLEVELAND, April 29, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced that preclinical data on AAV204, a novel adeno-associated virus (AAV) capsid from Abeona's in-licensed AIM™ capsid library, will be presented at the Association for Research and Vision in Ophthalmology (ARVO) Annual Meeting, to be held on May 1-4, 2022 in Denver, CO and virtually on May 11-12, 2022.

Abeona Therapeutics Announces Presentation at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

NEW YORK and CLEVELAND, April 29, 2022 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, today announced that it has entered into a securities purchase agreement with certain institutional investors to purchase 1,000,006 shares of Series A convertible redeemable preferred stock and 250,005 shares of Series B convertible redeemable preferred stock. Each share of Series A and Series B preferred stock has a purchase price of $19.00, representing an original issue discount of 5% of the $20.00 stated value of each share. Each share of Series A and Series B preferred stock is convertible into shares of Abeona's common stock at an initial conversion price of $0.45 per share. Shares of the Series A and Series B preferred stock are convertible at the option of the holder at any time following the Company's receipt of stockholder approval for a reverse stock split of the Company's common stock. Abeona will be permitted to redeem the Series A preferred stock at its option upon the fulfillment of certain conditions and subject to certain limitations. The Company and the holders of the Series A and Series B preferred stock will also enter into a registration rights agreement to register the resale of the shares of common stock issuable upon conversion of the Series A and Series B preferred stock. Total gross proceeds from the offerings, before deducting discounts, placement agent's fees and other estimated offering expenses, is approximately $25 million.

Abeona Therapeutics Announces Pricing of $25 Million Private Placement of Convertible Redeemable Preferred Stock

EB-101 pivotal phase 3 VIITAL™ study in RDEB achieves target enrollment; top-line data expected in third quarter of 2022; gained FDA alignment on CMC requirements for EB-101 including characterization and validation plans

News for Abeona Therapeutics Stock (ABEO)