Scinai files an application for

Scinai 提交了一份申请

Euro 12 million

1200万欧元

grant to fund next stage of development

资助下一阶段发展的拨款

Pincell's monoclonal antibody, PC111, is in development for treating Pemphigus,

Pincell的单克隆抗体PC111正在开发用于治疗天疱疮，

Steven Johnson's

史蒂文·约翰逊的

Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)

综合征（SJS）和中毒性表皮坏死松解症（TEN）

PC111 has already received an Orphan Drug Designation in Pemphigus by the European Medicine's Agency

PC111已获得欧洲药品管理局授予的天疱疮孤儿药资格。

An application will be filed with the FDA for Orphan Drug and Breakthrough Designation in Pemphigus, as well as in SJS/TEN

将向FDA提交天疱疮以及SJS/TEN的孤儿药和突破性疗法认定申请。

Scinai sees potential for accelerated approval given the severity of these diseases, PC111's innovative, non-immunosuppressive mode of action and the lack of effective alternative treatments

鉴于这些疾病的严重性、PC111的创新性和非免疫抑制作用机制，以及缺乏有效的替代疗法，Scinai认为有加速审批的潜力。

JERUSALEM

耶路撒冷

,

，

March 27, 2025

2025年3月27日

/PRNewswire/ --

/PRNewswire/ --

Scinai Immunotherapeutics Ltd.

斯奇奈免疫治疗有限公司

(Nasdaq:

（纳斯达克：

SCNI

中国新闻社（SCNI）

), a biopharmaceutical company specializing in inflammation and immunology (I&I) biological products and in providing CDMO services through its Scinai Bioservices unit, today announced that it entered into a binding option agreement for the acquisition of the Italian biotech company Pincell srl.

），一家专注于炎症和免疫学（I&I）生物制品的生物制药公司，并通过其Scinai Bioservices部门提供CDMO服务，今天宣布已就收购意大利生物技术公司Pincell srl达成具有约束力的期权协议。

In anticipation of the signing of the option agreement, the parties have prepared together a grant application, submitted today by the wholly owned Polish subsidiary of Scinai, seeking

鉴于即将签署期权协议，各方已共同准备了一份拨款申请书，该申请书已由Scinai的全资波兰子公司于今日提交，寻求

Euro 12 million

1200万欧元

of non-dilutive capital to fund the next stage of development of PC111. To facilitate the submission of the application, Pincell exclusively licensed PC111 to the subsidiary.  The grant application is under the European Funds for a Modern Economy (FENG) program in

非稀释性资本，以资助PC111下一阶段的开发。为便于提交申请，Pincell已将PC111独家授权给子公司。该资助申请属于欧洲现代经济基金（FENG）计划。

Poland

波兰

. Subject to prior clearance of certain Italian regulatory formalities, an award decision is expected by mid-July/beginning of August.

在完成某些意大利监管程序的预先审批后，预计将在七月中旬至八月初作出裁决。

About PC111

关于 PC111

PC111, a fully human, monoclonal antibody that binds to the human soluble Fas ligand and thus blocks its activation of apoptosis of skin cells (keratinocytes). This pathway has a major role in several skin blistering disorders, characterized by a very high unmet medical need with significant market sizes.

PC111，一种全人源单克隆抗体，可与人可溶性Fas配体结合，从而阻断其引发皮肤细胞（角质形成细胞）凋亡的激活。该通路在多种皮肤水疱疾病中起主要作用，这些疾病具有非常高的未满足医疗需求，并且市场潜力巨大。

Importantly, PC111 does not suppress the immune system, at variance with many other biologicals treating inflammatory conditions that can lead to significant, at times fatal side effects..

重要的是，PC111不会抑制免疫系统，这点与许多其他治疗炎症性疾病的生物制剂不同，那些制剂可能会导致显著的、有时甚至是致命的副作用。

Pincell has successfully developed a proprietary FasL humanized mouse model, with which it studied the involvement of the Fas/FasL pathway in these diseases, and that can be successfully used in other dermatological and non-dermatological diseases, where this pathway may play a key role in disease development and progression..

Pincell 已成功开发出一种独有的 FasL 人源化小鼠模型，利用该模型研究了 Fas/FasL 通路在这些疾病中的参与情况，并且该模型还可以成功应用于其他皮肤病和非皮肤病的研究，其中该通路可能在疾病的发展和进展中起到关键作用。

Pincell has carried out a large number of in-vitro, ex-vivo and in-vivo experiments using PC111 without steroids in validated models of pemphigus, to prove that soluble FasL is a critical target in this disease. Most importantly, Pincell has demonstrated that PC111 can block blister formation without steroids in a transgenic humanized FasL mouse model of pemphigus, indicating that the antibody can work also in a humanized setting and thus suggesting that it may be a novel targeted therapy for this disease at the clinical level.

Pincell 在经过验证的天疱疮模型中，使用不含类固醇的 PC111 进行了大量体外、离体和体内实验，以证明可溶性 FasL 是该疾病的关键靶点。最重要的是，Pincell 已经证明，在天疱疮的转基因人源化 FasL 小鼠模型中，PC111 可以在无类固醇的情况下阻止水疱形成，这表明该抗体在人源化环境中同样有效，从而提示它可能是一种针对该疾病的新靶向临床治疗手段。

As there is abundant and convincing data supporting the critical role of soluble FasL also in the pathogenesis of SJS/TEN, PC111 could inhibit the mechanisms underlying the progression of this disease, as shown by the in vivo model where it ameliorates ocular conjunctivitis and edema, two main early features of this disease in humans, as well as its progression towards more severe forms..

由于有大量且令人信服的数据支持可溶性FasL在SJS/TEN发病机制中的关键作用，PC111可能抑制这一疾病进展的潜在机制，这在体内模型中得到了验证，该模型显示它能够改善眼部结膜炎和水肿，这是该疾病在人类中的两个主要早期特征，并能阻止其向更严重形式的发展。

About Pemphigus, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis

关于天疱疮、史蒂文斯-约翰逊综合征和中毒性表皮坏死松解症

Pemphigus, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN) are severe dermatological conditions that significantly impact the skin and mucous membranes. Pemphigus is an autoimmune disorder characterized by painful blisters and sores, often requiring long-term immunosuppressive medications for disease management, which are associated with a 5-10% mortality.

天疱疮、史蒂文斯-约翰逊综合征 (SJS) 和中毒性表皮坏死松解症 (TEN) 是严重影响皮肤和黏膜的严重皮肤病。天疱疮是一种自身免疫性疾病，表现为疼痛的水疱和溃疡，通常需要长期使用免疫抑制药物进行管理，其死亡率为 5-10%。

Stevens-Johnson Syndrome is a rare but serious reaction to medications or infections, with a mortality rate of around 5-10%. Toxic Epidermal Necrolysis, the most severe form of SJS, involves extensive skin peeling and blistering over more than 30% of the body surface, with mortality rates ranging from 30-40%.

史蒂文斯-约翰逊综合征是一种罕见但严重的药物或感染反应，死亡率约为5-10%。毒性表皮坏死松解症（TEN）是SJS最严重的形式，表现为超过30%体表面积的广泛皮肤剥脱和水疱，死亡率为30-40%。

These conditions highlight a significant unmet medical need for more effective treatments and better management strategies to improve patient outcomes and reduce mortality rates..

这些条件突显了对更有效治疗和更好管理策略的重大未满足医疗需求，以改善患者预后并降低死亡率。

Amir Reichman

阿米尔·赖希曼

, CEO of Scinai stated: 'We are truly excited to have the opportunity to acquire Pincell and develop, in collaboration with the Pincell team, PC111 to treat these devastating skin disorders.  Prof.

Scinai首席执行官表示：“我们非常兴奋有机会收购Pincell，并与Pincell团队合作开发PC111，用于治疗这些严重的皮肤疾病。教授。

Carlo Pincelli

卡洛·平切利

, founder and chief medical officer of Pincell, is considered a global leader in the dermatology field and in research relating to Pemphigus, and SJS/TEN. Dr.

，Pincell的创始人兼首席医疗官，被认为是皮肤病学领域以及与天疱疮和SJS/TEN相关研究的全球领导者。

Antonino (Tony) Amato

安东尼诺（托尼）阿马托

, Chairman and CEO of Pincell, is a recognized and highly accomplished executive in the bio-pharmaceutical sector, with significant international experience in senior management, clinical development and regulatory matters. Their skills and experience are highly complementary to our own and together we expect to advance the development of PC111 expeditiously.'.

“Pincell公司董事长兼首席执行官，是生物制药领域公认的、成就斐然的高管，在高级管理、临床开发和监管事务方面拥有丰富的国际经验。他们的技能和经验与我们高度互补，我们预计共同努力将加速推进PC111的开发。”

Mr. Reichman added: 'In addition, the grant we have applied for is under an EU program well suited to our development plans based on advice of a consultant in

里希曼先生补充说：“此外，我们申请的资助是在一个欧盟项目之下，这个项目非常符合我们基于顾问建议的发展计划。

Poland

波兰

who has helped prepare and process a number of other successful applications. While the application only covers the next stage of development, under current regulations we will have the opportunity to apply for successive grants in similar amounts if we achieve the target development milestones outlined in the initial application.

谁帮助准备和处理了其他一些成功的申请。虽然该申请仅涵盖下一阶段的开发，但根据现行规定，如果我们实现初始申请中概述的目标开发里程碑，我们将有机会申请类似金额的后续资助。

As a result, the vast majority of the funding required for the project could be provided in the form of non-dilutive grants, limiting our obligation to provide only one –fifth (.

因此，项目所需的绝大部分资金可以以非稀释性赠款的形式提供，这使得我们仅需承担五分之一的义务。

Euro 3 million

300万欧元

) of the budgeted amounts from our capital or capital raised via our Polish special purpose subsidiary. Combined with the potential for accelerated approval given the severity and lack of effective alternative treatments, we find the opportunity particularly appealing and a very good fit with our own I&I focus.'.

）来自我们资本或通过我们在波兰的特殊目的子公司筹集的资本的预算金额。结合因疾病严重性和缺乏有效替代疗法而加速审批的可能性，我们认为这一机会特别有吸引力，并且与我们自身的I&I重点非常契合。

Dr.

博士

Antonino Amato

安东尼诺·阿马托

, Chairman and CEO of Pincell, commented: 'We are very pleased to join forces with Scinai, a company with a great expertise in R&D of inflammatory skin diseases, as well as in the development and manufacturing of biologics. Their scientific knowledge, international reach and access to capital represent the ideal match to our development plans and needs.

皮恩塞尔公司董事长兼首席执行官评论道：“我们非常高兴能与Scinai公司联手，该公司在炎症性皮肤病的研发以及生物制品的开发和生产方面具有深厚的专业知识。他们的科学知识、国际影响力和资本获取能力正好符合我们的开发计划和需求。”

I am sure that this partnership will prove effective in the advancement of PC111 in the fight against Pemphigus and SJS/TEN, as well as, potentially, against other underserved dermatological and non-dermatological diseases involving the FasL/Fas receptor pathway in their pathomechanisms.'.

我确信，这种合作关系将证明在推进PC111对抗天疱疮和SJS/TEN，以及潜在对抗其他未满足需求的皮肤病和非皮肤病（在其发病机制中涉及FasL/Fas受体通路）方面是有效的。

Option Terms

期权术语

The option agreement allows Scinai, in return to an upfront payment, to exercise, at its sole discretion (pending on Scinai meeting closing requirements and approval of the Golden Power regulatory clearance by the Italian government), a full sale and transfer of Pincell's shares to Scinai by the end of 2025.

期权协议允许Scinai在支付预付款后，自行决定（前提是Scinai满足交割要求并获得意大利政府对Golden Power监管审批）在2025年底前行使完全购买并转让Pincell股份给Scinai的权利。

If such share sale and transfer is exercised, Pincell's current shareholders will be eligible for development milestone payments and royalties out of future net sales of PC111 in the low single digits. In addition, the management team of Pincell will join Scinai's wholly owned, newly created subsidiary in .

如果行使这样的股份出售和转让，Pincell 的现有股东将有资格获得未来 PC111 净销售额的个位数低比例的开发里程碑付款和特许权使用费。此外，Pincell 的管理团队将加入 Scinai 全资新成立的子公司。

Poland

波兰

and Pincell's founder, Prof.

以及Pincell的创始人，教授。

Carlo Pincelli

卡洛·平切利

, will join Scinai's Scientific Advisory Board.

，将加入Scinai的科学顾问委员会。

About Scinai Immunotherapeutics

关于Scinai免疫治疗学

Scinai Immunotherapeutics Ltd. (Nasdaq:

Scinai免疫治疗有限公司（纳斯达克：

SCNI

中国科学院神经科学研究所

) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (NanoAbs) targeting diseases with large unmet medical needs, and the other a boutique Biologics CDMO providing biological drug development, analytical methods development, clinical GMP manufacturing, and pre-clinical and clinical trial design and execution services to early stage biotech companies.

是一家拥有两个互补业务部门的生物制药公司，一个专注于内部开发炎症和免疫学（I&I）生物治疗产品，首先通过一条创新且风险降低的纳米级VHH抗体（NanoAbs）管线，针对具有重大未满足医疗需求的疾病；另一个则是一家精品生物制品合同开发与生产组织（CDMO），为早期生物技术公司提供生物药物开发、分析方法开发、临床GMP生产以及临床前和临床试验设计与执行服务。

.

。

Company website:

公司网站：

www.scinai.com

www.scinai.com

About Pincell srl

关于Pincell srl

PinCell is a biotechnology company targeting a novel pathological pathway to develop first-in-class anti-inflammatory therapies for the treatment of rare, severe and highly undertreated skin diseases. Based in

PinCell 是一家生物技术公司，专注于开发针对一种新的病理途径的首创抗炎疗法，用于治疗罕见、严重且治疗不足的皮肤疾病。公司位于

Milan, Italy

意大利米兰

, PinCell was founded in

，PinCell成立于

October 2008

2008年10月

as an academic spin-off of the University of Modena and Reggio Emilia by the world class dermatology experts Prof.

作为摩德纳和雷焦艾米利亚大学的学术分支，由世界级皮肤病学专家教授创立。

Carlo Pincelli

卡洛·平切利

and Prof.

和教授。

Alessandra Marconi

亚历山德拉·马可尼

. It has previously received seed funding from Sofinnova Partners to develop proof-of-concept data for its lead candidate PC111.

此前，它已从Sofinnova Partners获得种子资金，用于为其主要候选药物PC111开发概念验证数据。

Company website:

公司网站：

www.pincell.it

www.pincell.it

Company Contacts

公司联系人

Investor Relations | +972 8 930 2529 |

投资者关系 | +972 8 930 2529 |

ir@scinai.com

ir@scinai.com

CDMO and Partnering | +972 8 930 2529 |

CDMO与合作 | +972 8 930 2529 |

bd@scinai.com

bd@scinai.com

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as 'expect,' 'believe,' 'intend,' 'plan,' 'continue,' 'may,' 'will,' 'anticipate,' and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. These forward-looking statements, including statements relating to the exercise of the Binding Option Agreement and  the grant application under the FENG program in .

本新闻稿包含1995年私人诉讼改革法案意义下的前瞻性陈述。诸如“预期”、“相信”、“打算”、“计划”、“继续”、“可能”、“将”、“预计”等词语及类似表达旨在识别前瞻性陈述。所有陈述，除历史事实陈述外，均为前瞻性陈述。这些前瞻性陈述，包括与行使具有约束力的期权协议及FENG计划下的拨款申请相关的陈述。

Poland

波兰

, reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to;  the risk that Scinaiwe won't exercise the Binding Option Agreement, that the Sale and Transfer of Pincell's shares will be delayed or not occur; that ownership of Pincell will not benefit Scinai  as  currently contemplated; that development of Pincell's antibody, PC111 will be delayed or not be successful; that the award decision for the grant application under the FENG program in .

，反映了管理层对某些当前和未来事件的现时观点，并受各种风险、不确定性和假设的影响，这些因素可能导致结果与Scinai免疫治疗有限公司管理层的预期有重大差异。风险和不确定性包括但不限于：Scinai可能不会行使具有约束力的期权协议；Pincell股份的出售和转让可能会被延迟或无法完成；拥有Pincell可能不会如目前设想的那样使Scinai受益；Pincell的抗体PC111的开发可能会延迟或不成功；在FENG计划下拨款申请的获奖决定可能会出现不确定性。

Poland

波兰

will be delayed or that one or more grant requests, current or in the future,  will not be approved; raise any capital under SEPA or that we will not otherwise benefit from the SEPA as currently anticipated; lower than anticipated revenues of Scinai's CDMO business; the risk that Scinai's expanded presence in the U.S.

将会被延迟，或者一个或多个目前或未来的资助请求将不被批准；无法根据SEPA筹集资金，或者我们无法如预期般从SEPA中受益；Scinai的CDMO业务收入低于预期；Scinai在美国扩展业务的风险。

will not significantly enhance the prospects of its CDMO unit; the risk that the Company will otherwise be unable to  remain compliant with the continued listing requirements of Nasdaq; failure to sign agreements with other potential clients of the CDMO business; a delay in the commencement and results of pre-clinical and clinical studies, including the Phase 1/2a study for psoriasis, the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other NanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of NanoAbs will not be met or that Scinai will not be successful in bringing the NanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for NanoAbs, if any; the risk that our business strategy may not be successful; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in .

不会显著增强其CDMO部门的前景；公司可能无法遵守纳斯达克持续上市要求的风险；未能与其他潜在CDMO业务客户签署协议；临床前和临床研究（包括针对银屑病的1/2a期研究）的启动和结果延迟；Scinai无法开展或研发活动结果不理想的风险，包括计划中的体内研究和临床试验；Scinai可能无法成功扩展其CDMO业务或授权引进其他NanoAbs的风险；Scinai可能无法以有利条款（或根本无法）获得额外资金的风险；NanoAbs的治疗和商业潜力无法实现或Scinai无法成功将NanoAbs推向商业化的风险；NanoAbs的临床前和临床试验数据（如有）延迟的风险；我们的商业战略可能无法成功的风险；Scinai获取额外产品机会权利的能力；Scinai能否以可接受的条款或根本无法达成合作；Scinai制造设施获得监管批准的时间。

Jerusalem

耶路撒冷

, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading 'Risk Factors' in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ('SEC') on .

，如果需要的话；制造设施将无法用于各种应用及其他疫苗和治疗技术的风险；以及药物开发涉及漫长且昂贵的过程且结果不确定的风险。有关影响公司的风险和不确定性的更详细信息，请参阅公司向证券交易委员会（“SEC”）提交的20-F表格年度报告中标题为“风险因素”的部分。

May 15, 2024

2024年5月15日

, and the Company's subsequent filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason.

，并且公司随后向美国证券交易委员会提交的文件。Scinai 不承担因任何原因修改或更新任何前瞻性陈述的义务。

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标志 -

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SOURCE Scinai Immunotherapeutics Ltd.

来源：Scinai免疫治疗有限公司

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