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.

Earnings data Q4 2020

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Abeona Therapeutics excels in Q4 with EB-101 advancements and growth prospects

Abeona Therapeutics showcased strong financial performance and clinical advancements with EB-101 in Q4 2022.
While facing challenges in pricing negotiations and upcoming competition, the company is well-positioned for growth.
Opportunities lie in partnerships for commercialization, market acceptance of EB-101, and the potential of gene therapy programs.

Abeona Therapeutics reports strong Q1 performance and eyes future growth

Abeona Therapeutics showcased strong performance in Q1 2023 with positive data from EB-101 and AAV ophthalmology programs, driving patient confidence and market positioning.
The company's engagement with stakeholders, successful completion of key submission steps, and promising proof-of-concept data present opportunities for future growth.
Challenges include aligning pricing considerations post VIITAL results, meeting submission requirements, and addressing analyst inquiries on program priorities and study findings.

Abeona Therapeutics advances EB-101 with $100M voucher, faces commercialization challenges

Abeona Therapeutics showcased progress on EB-101 and financial stability despite a net loss in Q2 2023.
Challenges include financial losses, commercial launch readiness, and securing partnerships.
Opportunities lie in potential BLA approval, market expansion, and advancements in AAV-based therapies.
The company's focus on EB-101 and strategic planning for commercialization are key strengths.

Abeona Therapeutics advances BLA submission for pz-cel, eyes commercialization

Abeona Therapeutics is making significant strides in product approval and commercialization strategies.
The company's financial stability and market-focused approach position it well for future growth.
While challenges exist, opportunities for expansion through FDA approval and market engagement are promising.

Abeona Therapeutics advances towards U.S. commercialization with FDA acceptance

Abeona Therapeutics showcased strong progress towards U.S. commercialization with FDA acceptance for pz-cell BLA. The company's financial performance for 2023 was solid, and engagement with key stakeholders bodes well for market entry. Challenges in FDA response timelines and manufacturing inspections need careful management.

Abeona Therapeutics advances pz-cel resubmission and strengthens financial position

Abeona Therapeutics shows strong progress in addressing regulatory and commercialization aspects for pz-cel
Financial stability improved through successful underwritten offering, enhancing market position
Challenges remain in FDA feedback, site onboarding, PRV market dynamics, and self-launch commitment
Clear opportunities exist in collaborations, market potential, growth timeline, and strategic positioning

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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 Cleveland, OH.

Animal proof-of-concept for AAV-based gene therapies for Stargardt disease, X-linked retinoschisis and autosomal dominant optic atrophy Animal proof-of-concept for AAV-based gene therapies for Stargardt disease, X-linked retinoschisis and autosomal dominant optic atrophy

Abeona Therapeutics Announces New Preclinical Data from its AAV Ophthalmology Program at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT)

Continues to make progress toward Biologics License Application (BLA) submission for EB-101 in late-2Q/early-3Q 2023; submitted request for pre-BLA meeting

Abeona Therapeutics Reports First Quarter 2023 Financial Results

CLEVELAND, May 11, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced an oral presentation of additional data from the Company's pivotal Phase 3 VIITAL™ study evaluating its investigational EB-101 for recessive dystrophic epidermolysis bullosa (RDEB). The data presentation occurred earlier today during the inaugural International Societies for Investigative Dermatology (ISID) Meeting in Tokyo, Japan.

Abeona Therapeutics Announces Additional Phase 3 VIITAL™ Study Results for EB-101 Presented at the International Societies for Investigative Dermatology 2023 Meeting

Abeona: BLA Submission Of EB-101 Gets The Ball Rolling.

Abeona: BLA Submission Of EB-101 Gets The Ball Rolling

CLEVELAND, April 10, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the acceptance of three abstracts at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) taking place from May 16-20, 2023 in Los Angeles, CA. Accepted abstracts include new data on three internally developed investigational preclinical gene therapy product candidates from its adeno-associated virus (AAV) ophthalmology program, including ABO-504 for Stargardt disease, ABO-503 for X-linked retinoschisis (XLRS) and ABO-505 for autosomal dominant optic atrophy (ADOA).

Abeona Therapeutics Announces Multiple Abstracts Accepted from its AAV Ophthalmology Program at the 26th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT)

Expects to submit BLA for EB-101 to FDA in late-2Q/early-3Q 2023 based on positive Phase 3 VIITAL™ study results announced in 4Q 2022

Abeona Therapeutics Reports Full Year 2022 Financial Results and Provides Corporate Update

NEW YORK and CLEVELAND, March 24, 2023 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced it has granted equity awards to new employees who joined Abeona.

Abeona Therapeutics Announces New Employee Inducement Grants

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, 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.

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