- Adds a once-daily, oral therapy candidate for eosinophilic esophagitis with FDA Orphan Drug and Fast Track Designations –

- 新增一种每日一次、口服的嗜酸性粒细胞性食管炎候选疗法，该疗法已获得美国食品药品监督管理局（FDA）的孤儿药资格认定和快速通道资格认定 –

– ABO-801 acquired for $20 million equity consideration at closing with no upfront cash payment –

– ABO-801 以2,000万美元的股权对价在交割时收购，无需预付现金 –

– Private placement financing includes leading life sciences investors –

– 私募融资包括领先的生命科学投资者 –

CLEVELAND, Nov. 09, 2026 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the acquisition of APT-1011 (now ABO-801), a product candidate for eosinophilic esophagitis (EoE), from Ellodi Pharmaceuticals, and entered into a securities purchase agreement for a $30 million private placement financing.

克利夫兰，2026年11月9日（环球电讯社）——Abeona Therapeutics Inc.（纳斯达克股票代码：ABEO）今日宣布从Ellodi Pharmaceuticals公司收购嗜酸性粒细胞性食管炎（EoE）候选药物APT-1011（现更名为ABO-801），并签署证券购买协议，进行3,000万美元的私募融资。

The acquisition, with no upfront cash consideration and the private placement financing, reflects Abeona’s disciplined approach to capital allocation..

此次收购无需支付前期现金对价，并结合私募配售融资，体现了Abeona在资本配置方面的审慎策略。

“The acquisition of ABO-801 is an important step in building Abeona into a diversified commercial-stage company with multiple opportunities for value inflection, adding an asset with substantial revenue potential in a rapidly growing disease,” said Vish Seshadri, Ph.D., Chief Executive Officer of Abeona Therapeutics.

Abeona Therapeutics 首席执行官 Vish Seshadri 博士表示：“收购 ABO-801 是将 Abeona 打造为一家拥有多个价值拐点机会的多元化商业化阶段公司的重要一步，此举增加了一项在快速增长疾病领域具有巨大收入潜力的资产。”

“ABO-801 brings an established clinical foundation, with learnings from two completed Phase 3 studies that inform the design of the planned Phase 3 study. We believe Abeona is well positioned to advance a differentiated and convenient potential treatment for people living with EoE.”.

“ABO-801拥有坚实的临床基础，其两项已完成的III期研究所得经验为计划中的III期研究设计提供了依据。我们相信，Abeona公司处于有利地位，能够推进一种具有差异化且便捷的嗜酸性粒细胞性食管炎（EoE）潜在治疗方案，造福EoE患者。”

“We are excited to partner with Abeona as ABO-801 advances into its next stage of development. We have strong conviction in the team and the opportunity and believe ABO-801 has the potential to offer a differentiated profile in EoE, supported by once-daily dosing and low systemic exposure,” said Lucian Iancovici, M.D., Partner, TPG..

TPG合伙人Lucian Iancovici医学博士表示：“随着ABO-801进入下一阶段的开发，我们很高兴与Abeona建立合作伙伴关系。我们对团队和这一机遇充满信心，并相信ABO-801有望在嗜酸性食管炎（EoE）治疗中展现出差异化的优势，其支持依据包括每日一次给药和低全身暴露量。”

ABO-801 Overview

ABO-801 概述

Potential to address an important need in EoE.

有望满足嗜酸性粒细胞性食管炎（EoE）领域的一项重要需求。

ABO-801 is a once-daily oral disintegrating tablet formulation of fluticasone propionate being developed for EoE, a chronic inflammatory disease of the esophagus characterized by symptoms including difficulty swallowing and food impaction. Approximately 360,000 patients in the United States have been diagnosed with EoE..

ABO-801 是一种每日一次口服的丙酸氟替卡松崩解片剂，正在开发用于治疗嗜酸性粒细胞性食管炎（EoE）。EoE 是一种慢性的食管炎症性疾病，其症状包括吞咽困难和食物嵌塞。在美国，约有36万名患者被诊断为 EoE。

ABO-801 is designed to dissolve rapidly in the mouth and deliver topical corticosteroid therapy directly across the esophagus, with very low systemic exposure. Its once-daily formulation is intended to provide a convenient option for chronic disease management while limiting systemic corticosteroid exposure.

ABO-801 旨在口腔内迅速溶解，并将局部皮质类固醇疗法直接递送至食管，同时保持极低的全身暴露量。其每日一次的制剂设计旨在为慢性疾病管理提供一种便捷的方案，同时限制全身性皮质类固醇的暴露。

ABO-801 has received Orphan Drug designation from the U.S. Food and Drug Administration for the treatment of EoE.

ABO-801 已获得美国食品药品监督管理局授予的孤儿药资格，用于治疗嗜酸性粒细胞性食管炎（EoE）。

Extensive clinical foundation.

广泛的临床基础。

ABO-801 has been evaluated in a 24-patient Phase 1/2a study, a 106-patient Phase 2b dose-ranging study and two completed Phase 3 studies that enrolled a combined 361 patients, with additional longer-term treatment experience through an Expanded Access Program involving 265 cumulative participants. Across the clinical program, ABO-801 has demonstrated histologic and endoscopic activity, with encouraging evidence of symptomatic activity and a favorable safety profile.

ABO-801 已在一项纳入 24 名患者的 1/2a 期研究、一项纳入 106 名患者的 2b 期剂量范围研究以及两项共纳入 361 名患者的已完成 3 期研究中进行了评估，并通过一项累计纳入 265 名参与者的扩大 access 项目积累了更长期的治疗经验。在整个临床开发计划中，ABO-801 展现出组织学和内镜下活性，并有令人鼓舞的症状改善证据以及良好的安全性特征。

Although neither Phase 3 study met its prespecified co-primary patient-reported symptom endpoint, both demonstrated statistically significant improvements in several endoscopic measures and yielded important insights that are informing the design of a planned future Phase 3 study. Abeona anticipates initiating the planned Phase 3 study in mid-2027 and, subject to the timing of study initiation and enrollment, currently anticipates topline results by the end of 2028..

尽管两项III期研究均未达到其预设的共同主要患者报告症状终点，但两者均在多项内镜指标上显示出统计学意义上的显著改善，并提供了重要见解，为计划中的未来III期研究的设计提供了依据。Abeona预计将于2027年年中启动该计划中的III期研究，并根据研究启动和入组的时间安排，目前预计在2028年底获得顶层结果。

Transaction Terms and Private Placement Financing

交易条款与私募融资

Disciplined asset-purchase structure.

纪律严明的资产收购结构。

Under the terms of the asset purchase agreement, Abeona agreed to issue Ellodi $20 million of Abeona common stock, with no upfront cash consideration. Ellodi is also eligible to receive payments of $30 million upon FDA approval of ABO-801 and up to an additional $30 million upon achievement of specified sales milestones.

根据资产购买协议的条款，Abeona同意向Ellodi发行价值2,000万美元的Abeona普通股，且不支付任何前期现金对价。此外，Ellodi还有资格在ABO-801获得美国食品药品监督管理局（FDA）批准时获得3,000万美元的付款，并在达到特定销售里程碑时获得最高3,000万美元的额外付款。

In addition, Ellodi is eligible to receive tiered royalties on net sales of ABO-801 ranging from low to mid teen percentages..

此外，Ellodi 有资格根据 ABO-801 的净销售额收取分层特许权使用费，费率范围为低两位数至中两位数百分比。

$30 million PIPE financing.

3000万美元的私募股权投资（PIPE）融资。

Abeona entered into a securities purchase agreement with a group of investors for a private placement of 6,400,000 shares of common stock at a purchase price of $3.75 per share and pre-funded warrants to purchase up to 1,600,043 shares of common stock at a purchase price of $3.7499 per pre-funded warrant, expected to result in $30 million in gross proceeds before fees and expenses..

Abeona 与一组投资者签订了证券购买协议，以每股 3.75 美元的价格私募发行 6,400,000 股普通股，并以每份预融资权证 3.7499 美元的价格发行最多可购买 1,600,043 股普通股的预融资权证，预计将在扣除费用和支出前筹集 3,000 万美元的总收益。

The financing included participation from leading life sciences investors, including current shareholder Nantahala Capital, along with Marshall Wace, Monashee Investment Management, Perceptive Advisors, TPG, and a group of leading healthcare-focused funds. The Company intends to use the net proceeds from the private placement for general corporate purposes, including funding the development of the Company’s product candidate pipeline and supporting commercialization efforts for ZEVASKYN..

本次融资吸引了领先的生命科学投资者参与，包括现有股东南塔哈拉资本（Nantahala Capital），以及马歇尔·韦斯（Marshall Wace）、莫纳西投资管理公司（Monashee Investment Management）、珀ceptive顾问公司（Perceptive Advisors）、TPG和一组专注于医疗保健的领先基金。公司计划将私募发行的净收益用于一般企业用途，包括为公司产品候选管线开发提供资金，并支持ZEVASKYN的商业化工作。

Morgan Stanley is acting as the sole placement agent for the private placement.

摩根士丹利担任此次私募配售的唯一配售代理。

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the Securities Act), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws.

本次私募配售拟出售的证券未根据经修订的《1933年证券法》（以下简称“《证券法》”）或任何州或其他适用司法管辖区的证券法律进行注册，除非依据《证券法》及适用州或其他司法管辖区证券法律的注册要求完成注册或适用豁免，否则不得在美国境内要约或出售。

Abeona has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the shares of common stock issued in the private placement no later than the 15th day after the closing of the private placement..

Abeona 已同意在美国证券交易委员会提交一份注册声明，以登记在私募配售中发行的普通股的转售，且不晚于私募配售结束后的第15天。

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus..

本新闻稿不构成出售要约或购买这些证券的要约邀请，也不得在任何此类要约、邀请或销售属违法的司法管辖区进行任何此类要约、邀请或销售。根据转售注册声明进行的任何证券发售仅可通过招股说明书进行。

About Abeona Therapeutics

关于 Abeona Therapeutics

Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company building a portfolio of therapies for rare and serious diseases with multiple opportunities for value creation. The Company’s portfolio includes ZEVASKYN

Abeona Therapeutics Inc. 是一家处于商业化阶段的生物制药公司，致力于构建针对罕见病和严重疾病的疗法组合，拥有多重价值创造机会。该公司的产品组合包括 ZEVASKYN

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(prademagene zamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa; ABO-801, a Phase 3-ready product candidate for eosinophilic esophagitis; and ABO-701 (PSMA-SIR-T™), an investigational engineered T-cell therapy targeting PSMA.

（prademagene zamikeracel），首款且唯一一款用于成人和儿童隐性营养不良性大疱性表皮松解症患者伤口治疗的自体细胞基因疗法；ABO-801，一种处于三期临床试验准备阶段的嗜酸性粒细胞性食管炎候选产品；以及 ABO-701（PSMA-SIR-T™），一种针对 PSMA 的在研工程化 T 细胞疗法。

For more information, visit .

更多信息，请访问。

www.abeonatherapeutics.com

www.abeonatherapeutics.com

.

。

ZEVASKYN

泽瓦斯基恩

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®

, Abeona Assist

，Abeona Assist

®

®

, Abeona Therapeutics

，Abeona Therapeutics

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®

, and their related logos are trademarks of Abeona Therapeutics Inc.

，及其相关标志均为Abeona Therapeutics Inc.的商标。

Forward-Looking Statements

前瞻性陈述

This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted to identify forward-looking statements by such terminology as “may,” “will,” “believe,” “anticipate,” “intend,” “potential,” and similar words and expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements.

本新闻稿包含某些构成1933年《证券法》（经修订）第27A条和1934年《证券交易法》（经修订）第21E条所指的前瞻性陈述，这些陈述涉及风险和不确定性。我们已尝试通过“可能”、“将”、“相信”、“预期”、“打算”、“潜在”等术语以及类似词语和表述（以及其他提及未来事件、条件或情况的词语或表述）来识别前瞻性陈述，这些词语和表述旨在标识前瞻性陈述。

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to our ability to consummate the private placement financing or realize the anticipated benefits from the transactions; ABO-801 may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or anticipated in this press release; our ability to maintain existing and obtain additional regulatory approvals of ZEVASKYN® and any future product candidates; our ability to successfully commercialize and market ZEVASKYN® and any future product candidates, if approved, and the timing of any commercialization and marketing efforts; the potential impact of unpredicted changes in the structure and/or administration of the United States government or its agencies; the dilutive effect that raising additional funds by selling additional equity securities may have on the relative equity ownership of our existing investors,; the outcome of any inter.

实际结果可能因各种重要因素、众多风险和不确定性而与上述前瞻性陈述所指示的结果存在重大差异，包括但不限于：我们完成私募融资或实现交易预期收益的能力；ABO-801 在临床开发中可能无法按预期时间表推进，或可能根本无法获得所需的监管批准；临床试验可能无法证实本新闻稿中描述或预期的任何安全性、效价或其他产品特性；我们维持 ZEVASKYN® 及任何未来候选产品的现有监管批准并获得额外批准的能力；我们在获批后成功商业化并推广 ZEVASKYN® 及任何未来候选产品的能力，以及任何商业化和推广工作的时间安排；美国政府或其机构在结构和/或管理方面出现不可预见的变化所带来的潜在影响；通过出售额外股权证券筹集额外资金可能对我们现有投资者的相对股权所有权产生的稀释效应；任何中间结果。