Total Deal Value of up to $301 Million includes $16 Million Upfront, up to $285 Million in Clinical Development, Regulatory and Commercial Milestones, Plus Commercial Royalties

交易总价值高达3.01亿美元，其中包括1600万美元的预付款，高达2.85亿美元的临床开发、监管和商业里程碑，以及商业版税

Kiora to webcast investor conference call at 5:30 pm today; details below

Kiora将于今天下午5:30在线直播投资者电话会议；详情如下

Encinitas, California and Clermont-Ferrand, France--(Newsfile Corp. - January 31, 2024) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX), a clinical-stage biotech company developing treatments for orphan retinal diseases, today announced that it has entered a strategic development and commercialization agreement with Théa Open Innovation (TOI), a sister company of the global ophthalmic specialty company Laboratoires Théa (Théa).

加利福尼亚州恩西尼塔斯（Encinitas）和法国克莱蒙特·费兰德（Clermont Ferrand）--（Newsfile Corp.-2024年1月31日）--开发孤儿视网膜疾病治疗的临床阶段生物技术公司Kiora Pharmaceuticals，Inc.（纳斯达克：KPRX）今天宣布，已与Théa Open Innovation（TOI）达成战略开发和商业化协议，全球眼科专业公司Laboratoires Théa（Théa）的姊妹公司。

Under the agreement, Kiora granted TOI exclusive worldwide development and commercialization rights, excluding Asia, to KIO-301 for the treatment of degenerative retinal diseases. In exchange, Kiora will receive an upfront, payment of $16 million; up to $285 million upon achievement of pre-specified clinical development, regulatory and commercial milestones; tiered royalties of up to low 20% on net sales; and reimbursement of KIO-301 research and development expenses..

根据该协议，Kiora授予KIO-301全球独家开发和商业化权利，不包括亚洲，用于治疗退行性视网膜疾病。作为交换，基奥拉将获得1600万美元的预付款；达到预先规定的临床开发，监管和商业里程碑后，高达2.85亿美元；分层版税净销售额高达20%；以及KIO-301研发费用的报销。。

'Our partnership with TOI provides us the strategic, financial and commercial resources that we believe will help to bring innovative treatments to market for patients living with inherited retinal disease,' said Brian Strem, Ph.D., CEO of Kiora. 'Based on the Phase I/II (ABACUS) data of KIO-301 in Retinitis Pigmentosa (RP), we have started to implement our plan to initiate our Phase 2, multicenter, controlled clinical trial for retinitis pigmentosa, in early 2024 with the goal of reporting results in H1 2025 and explore other retinal disease where KIO-301 may be applicable.'.

Kiora首席执行官布莱恩·斯特姆（BrianStrem）博士说：“我们与TOI的合作关系为我们提供了战略、财务和商业资源，我们相信这将有助于为遗传性视网膜疾病患者的创新治疗推向市场。”根据KIO-301在视网膜色素变性（RP）中的I/II期（ABACUS）数据，我们已开始实施计划，于2024年初启动我们的视网膜色素变性2期多中心对照临床试验，目标是在2025年上半年报告结果，并探索KIO-301可能适用的其他视网膜疾病。”。

Data from ABACUS, reported in November 2023, demonstrated meaningful vision improvements in patients with late-stage RP. Findings included significant improvement in visual field, concordant trended improvements in visual acuity and tests of functional vision relating to the use of sight in everyday activities.

2023年11月报告的ABACUS数据显示，晚期RP患者的视力有了显着改善。研究结果包括视野显着改善，视力呈一致趋势改善，以及与日常活动中视力使用相关的功能性视力测试。

In addition, functional MRI demonstrated increased visual cortex activity (region of the brain responsible for processing vision) relative to baseline at two and 14 days after treatment..

此外，功能性MRI显示，在治疗后两天和14天，相对于基线，视觉皮层活动（负责处理视觉的大脑区域）增加。。

'This partnership confirms our commitment to advancing innovation in the treatment of unmet need for ophthalmic diseases,' said Jean-Frédéric Chibret, President of the Théa group. 'KIO-301 fits ideally into our range of therapeutic solutions as a cutting-edge product intended to return vision to patients suffering from hereditary retinal diseases thanks to an innovative small molecule.

THA集团总裁让·弗雷德里克·奇布雷特（JeanFrédéricChibret）说：“这一合作关系证实了我们致力于推动治疗眼科疾病未满足需求的创新。”KIO-301作为一种尖端产品，非常适合我们的治疗方案范围，该产品旨在通过创新的小分子使患有遗传性视网膜疾病的患者恢复视力。

Promising clinical trial results recently reported at the American Academy of Ophthalmology meeting on KIO-301 give us further confidence in the program and the potential to bring a new treatment option to patients suffering from rare diseases.'.

最近在美国眼科学会KIO-301会议上报告的有希望的临床试验结果使我们对该计划更有信心，并有可能为患有罕见疾病的患者带来新的治疗选择。”。

The strategic partnership covers retinitis pigmentosa and potentially other indications in ophthalmology across all global geographies, excluding China, Japan, and certain other countries in Asia. Kiora is primarily responsible for the design and implementation of clinical development through phase 2 whereas Théa will assume primary responsibility for phase 3 clinical trials as well as for securing regional marketing authorizations.

该战略伙伴关系涵盖了全球所有地区（不包括中国、日本和亚洲某些其他国家）的视网膜色素变性和眼科潜在的其他适应症。Kiora主要负责第二阶段临床开发的设计和实施，而Théa将主要负责第三阶段临床试验以及确保区域营销授权。

Upon approval in respective regions, Théa will be responsible for all commercial activities including sales, marketing and market access..

经各地区批准后，THA将负责所有商业活动，包括销售、营销和市场准入。。

KIO-301 is a small molecule, referred to as a molecular photoswitch, designed to confer light-sensing capabilities to Retinal Ganglion Cells (RGCs), a special cell type of the retina. In healthy eyes, light detection is primarily performed by photoreceptors (rods and cones). In patients with numerous types of inherited retinal disease, mutations in one of more than hundreds of known genes can lead to the death of photoreceptors.

KIO-301是一种小分子，被称为分子光开关，旨在赋予视网膜神经节细胞（RGC）（视网膜的一种特殊细胞类型）感光能力。在健康的眼睛中，光线检测主要由光感受器（视杆细胞和视锥细胞）进行。在患有多种遗传性视网膜疾病的患者中，数百种已知基因之一的突变可导致光感受器死亡。

This retinal degeneration results in lost vision for the patient. KIO-301 is able to selectively enter RGCs downstream of degenerated photoreceptors and once inside, KIO-301 interacts with voltage-gated ion channels. When light hits RGCs, KIO-301 alters its shape to change the flow of current, thereby activating the neurons, and resulting in signaling the brain.

这种视网膜变性导致患者视力丧失。KIO-301能够选择性地进入退化光感受器下游的RGC，一旦进入，KIO-301就会与电压门控离子通道相互作用。当光线照射RGC时，KIO-301会改变其形状以改变电流，从而激活神经元，从而向大脑发出信号。

When light is removed, KIO-301 reverts to its lower energy shape, stopping the signaling to the brain. In this way, the molecule acts as a light switch within the eye..

当光线被移除时，KIO-301会恢复到其较低能量的形状，停止向大脑发出信号。通过这种方式，分子在眼睛内充当光开关。。

Investor Webcast

投资者网络广播

Kiora will host an investor call today (Jan 31, 2024) at 5:30 pm ET (2:30 pm PT) to discuss the partnership.

Kiora将于今天（2024年1月31日）美国东部时间下午5:30（太平洋时间下午2:30）主持一次投资者电话会议，讨论合作关系。

The live webcast may be accessed by clicking here or from the homepage of the Investor Relations section of Kiora's website (ir.kiorapharma.com). Investors interested in a direct dial-in number may email investors@kiorapharma.com ahead of the call.

现场直播可通过点击此处或Kiora网站（ir.kiorapharma.com）投资者关系部分的主页访问。有兴趣直接拨打电话的投资者可通过电子邮件investors@kiorapharma.com在通话之前。

A replay of the webcast will be available for 90 days following the call under the 'News & Events' section of Kiora's Investor Relations website.

通话结束后90天内，Kiora投资者关系网站的“新闻与事件”部分将提供网络广播的重播。

About Kiora Pharmaceuticals

关于Kiora Pharmaceuticals

Kiora Pharmaceuticals is a clinical-stage biotechnology company developing and commercializing products for the treatment of orphan retinal diseases. KIO-301 is being developed for the treatment of retinitis pigmentosa, choroideremia, and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration.

Kiora Pharmaceuticals是一家临床阶段的生物技术公司，开发和商业化用于治疗孤儿视网膜疾病的产品。KIO-301正在开发用于治疗色素性视网膜炎，脉络膜血症和Stargardt病。它是一种分子光开关，有可能恢复遗传性和/或年龄相关性视网膜变性患者的视力。

KIO-104 is being developed for the treatment of posterior non-infectious uveitis. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase. In addition to news releases and SEC filings, we expect to post information on our website (www.kiorapharma.com) and social media accounts that could be relevant to investors.

KIO-104正在开发用于治疗后部非感染性葡萄膜炎。它是二氢乳清酸脱氢酶的下一代，非甾体，免疫调节和小分子抑制剂。除了新闻发布和SEC备案外，我们还希望在我们的网站（www.kiorapharma.com）和社交媒体账户上发布可能与投资者相关的信息。

We encourage investors to follow us on Twitter and LinkedIn as well as to visit our website and/or subscribe to email alerts..

我们鼓励投资者在Twitter和LinkedIn上关注我们，并访问我们的网站和/或订阅电子邮件提醒。。

About Théa and Théa Open Innovation

关于THA和THA开放式创新

Théa is the leading independent European pharmaceutical company specialized in the research, development, and commercialization of eye-care products. Based in Clermont-Ferrand, France, this family-owned company has continued to expand by opening more than 35 affiliates and offices in Europe, North Africa, North and South America, and the Middle East.

THA是欧洲领先的独立制药公司，专门从事眼部护理产品的研究、开发和商业化。这家家族企业总部位于法国克莱蒙特·费兰德（Clermont Ferrand），在欧洲、北非、北美和南美以及中东开设了35多家分支机构和办事处，继续扩张。

Its products are available in 75 countries. Théa Open Innovation (TOI) is a sister company of Théa. TOI's mission is to set up partnerships with companies and universities to help bring the most innovative products in ophthalmology to the market..

其产品遍布75个国家。THA开放创新（TOI）是THA的姊妹公司。TOI的使命是与公司和大学建立合作伙伴关系，帮助将眼科领域最具创新性的产品推向市场。。

www.laboratoires-thea.com; www.theaopeninnovation.com

www.laboratories-thea.com；www.theaopeninnovation.com

Forward-Looking Statements

前瞻性声明

Some of the statements in this press release are 'forward-looking' and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These 'forward-looking' statements include statements relating to, among other things, the development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-301 and KIO-104, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all, the ability of KIO-301 to improve vision in everyday activities, the potential to expand KIO-301 to other indications including choroideremia and Stargardt disease, Kiora's ability to expand clinical development into the U.S.

本新闻稿中的一些声明是“前瞻性”的，是根据1995年《私人证券诉讼改革法案》的安全港条款做出的。这些“前瞻性”声明包括与Kiora开发阶段产品（包括KIO-301和KIO-104）的开发和商业化工作以及其他监管或营销批准工作以及成功相关的声明，这些批准或成功可能无法及时或根本无法获得或实现，KIO-301在日常活动中改善视力的能力，将KIO-301扩展到其他适应症（包括脉络膜血症和Stargardt病）的潜力，Kiora将临床开发扩展到美国的能力。

and the EU, the timing of results of the ABACUS study and timing and design of the ABACUS II study, the expectation that the partnership with TOI will help to bring treatments to market. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability to conduct clinical trials on a timely basis, the ability to obtain any required regulatory approvals, whether future trials of KIO-301 will yield similar results for participants, market and other conditions, and certain risk factors described under the heading 'Risk Factors' contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 23, 2023, or described in Kiora's other public filings.

欧盟，ABACUS研究结果的时间安排以及ABACUS II研究的时间安排和设计，以及与TOI的合作将有助于将治疗方法推向市场的期望。这些声明涉及风险和不确定性，可能导致结果与本新闻稿中的声明存在重大差异，包括及时进行临床试验的能力，获得任何必要监管批准的能力，KIO-301的未来试验是否会对参与者、市场和其他条件产生类似的结果，以及Kiora于2023年3月23日向SEC提交的10-K表格年度报告中“风险因素”标题下描述的某些风险因素，或Kiora的其他公开文件中描述的某些风险因素。

Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any oblig.

Kiora的结果也可能受到Kiora目前不知道的因素的影响。本新闻稿中的前瞻性声明仅在本新闻稿发布之日起生效。基奥拉明确否认任何义务。

Contacts:

联系人：

Investors

投资者

investors@kiorapharma.com

investors@kiorapharma.com

Media

媒体

kiora@crowepr.com

kiora@crowepr.com

Crowe PR

Crowe PR

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/196399

要查看此新闻稿的源版本，请访问https://www.newsfilecorp.com/release/196399