Recent Strategic Partnership and Financing Expected to Fund Operations Through 2026

最近的战略伙伴关系和融资预计将为2026年的运营提供资金

Encinitas, California--(Newsfile Corp. - March 25, 2024) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ('Kiora' or the 'Company') today announced its 2023 financial results and provided an update on its retinal disease development pipeline. The Company's major initiatives planned for 2024 are to initiate Phase 2 clinical development of KIO-301, a small molecule photoswitch, for the treatment of inherited retinal diseases, starting with retinitis pigmentosa (RP); and further development of KIO-104, an intravitreal, anti-inflammatory for treatment of non-infectious uveitis.

加利福尼亚州恩西尼塔斯——（新闻文件公司——2024年3月25日）——Kiora Pharmaceuticals，Inc.（纳斯达克：KPRX）（“Kiora”或“公司”）今天宣布了2023年的财务业绩，并提供了视网膜疾病发展管道的最新信息。该公司计划于2024年开展的主要举措是启动KIO-301（一种小分子光开关）的第二阶段临床开发，用于治疗遗传性视网膜疾病，从色素性视网膜炎（RP）开始；KIO-104是一种玻璃体内抗炎药，用于治疗非感染性葡萄膜炎。

The $16 million upfront payment from Kiora's development and commercialization partnership with Théa Open Innovation (TOI) for KIO-301 and its $15 million private placement are expected to be sufficient to fund the Company through 2026, excluding any potential partnership milestones or warrant exercises..

Kiora与Théa Open Innovation（TOI）为KIO-301开发和商业化合作伙伴关系支付的1600万美元预付款及其1500万美元的私人配售预计足以为该公司提供2026年之前的资金，不包括任何潜在的合作里程碑或认股权证练习。。

'Our greatest priorities this year are to advance KIO-301 and KIO-104 to assess their further potential to benefit patients,' said Brian M. Strem, Ph.D., chief executive officer of Kiora. 'Both products are clinically validated drug candidates based on proprietary and innovative small molecules targeting rare retinal diseases with large unmet needs..

Kiora首席执行官布莱恩·斯特雷姆（BrianM.Strem）博士说，今年我们最优先考虑的是推进KIO-301和KIO-104，以评估其进一步造福患者的潜力这两种产品都是经过临床验证的候选药物，基于针对罕见视网膜疾病的专有和创新小分子，这些疾病的需求尚未得到满足。。

Kiore’s pipeline of drug candidates against rare retinal diseases.

Kiore针对罕见视网膜疾病的候选药物管道。

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'KIO-301 could potentially become the first vision restoring option for patients with inherited retinal degenerative diseases like RP. Ongoing development will be collaboratively guided and fully funded by our partner, TOI. Should KIO-301 gain marketing authorization, it would provide Kiora with meaningful commercial milestones and royalties up to the low 20s (%) with a partner who has a proven track-record of leadership in the eye space.

“KIO-301有可能成为RP等遗传性视网膜退行性疾病患者的第一个视力恢复选择。正在进行的开发将由我们的合作伙伴TOI合作指导和充分资助。如果KIO-301获得营销授权，它将为Kiora提供有意义的商业里程碑和版税，最高可达20岁以下（%），合作伙伴在眼部领域拥有可靠的领导记录。

Working with TOI, we are finalizing details of the randomized, double-masked, controlled, dose-ascending Phase 2 trial in RP and look forward to providing more specifics on expected enrollment and results timelines..

与TOI合作，我们正在最终确定RP中随机，双盲，对照，剂量递增的2期临床试验的细节，并期待着提供有关预期入组和结果时间表的更多细节。。

'The balance sheet provides us the financial ability to fund further development of KIO-104 for the treatment of posterior non-infectious uveitis. Because non-infectious uveitis can be sight threatening, there is a strong market need for new, steroid sparing therapeutic approaches. The active compound in KIO-104 is a highly potent, disease modifying anti-inflammatory agent belonging to a class of drugs helping hundreds of thousands of patients with systemic autoimmune diseases including multiple sclerosis and rheumatoid arthritis.

“资产负债表为我们提供了进一步开发KIO-104治疗后部非感染性葡萄膜炎的资金能力。由于非感染性葡萄膜炎可能会威胁视力，因此市场迫切需要新的保留类固醇的治疗方法。KIO-104中的活性化合物是一种高效，改善疾病的抗炎剂，属于一类药物，可帮助数十万患有系统性自身免疫性疾病（包括多发性硬化症和类风湿性关节炎）的患者。

By delivering KIO-104 directly to the eye, we believe we can reduce the negative effects of retinal inflammation without the associated potential side effects of systemic anti-inflammatory drugs or chronic steroid exposure. Beyond non-infectious uveitis, the mechanism of action of KIO-104 could apply to other retinal conditions, such as proliferative vitreoretinopathy (PVR), a complication following retinal detachment repair, where nonclinical work is ongoing.'.

通过将KIO-104直接输送到眼睛，我们相信我们可以减少视网膜炎症的负面影响，而不会产生全身抗炎药或慢性类固醇暴露的潜在副作用。除了非感染性葡萄膜炎外，KIO-104的作用机制还可以应用于其他视网膜疾病，例如增生性玻璃体视网膜病变（PVR），这是视网膜脱离修复后的并发症，目前正在进行非临床工作。”。

'Orphan indications involve efficient, cost-effective paths to market,' added Melissa Tosca, EVP Finance. 'For 2024, we expect to increase our R&D spend, with expenses for KIO-301 offset by quarterly reimbursement from TOI. Further, we anticipate G&A expenses to remain relatively flat for the year. We believe this balances our desire to achieve meaningful development while maintaining a strong cash position expected to fund operations through 2026.'.

财务副总裁梅丽莎·托斯卡（MelissaTosca）补充说，孤儿指征涉及高效、经济的市场途径2024年，我们预计将增加研发支出，KIO-301的费用将被TOI的季度报销所抵消。此外，我们预计今年的总务管理费用将保持相对平稳。我们认为，这平衡了我们实现有意义发展的愿望，同时保持了强劲的现金状况，预计将为2026年的运营提供资金。”。

Kiora has strengthened its fundamentals by advancing its pipeline, entering a strategic partnership, and strengthening its balance sheet.

Kiora通过推进其管道、建立战略伙伴关系和加强其资产负债表来加强其基本面。

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Achieved and Upcoming Milestones:

已取得和即将取得的里程碑：

Notable milestones that Kiora achieved in 2023 and year-to-date 2024 include the following:

Kiora在2023年和2024年至今取得的显著里程碑包括：

KIO-301

KIO-301

Entered a strategic partnership granting TOI exclusive worldwide development and commercialization rights, excluding Asia, to KIO-301 for the treatment of retinal degenerative diseases. Under the terms of the deal, Kiora received an upfront payment of $16 million and is eligible to receive up to an additional $285 million in development, regulatory, and commercial milestones; tiered royalties of up to low 20s on net sales; and reimbursement of KIO-301 research and development expenses..

加入了一项战略合作伙伴关系，授予KIO-301除亚洲以外的全球独家开发和商业化权利，用于治疗视网膜退行性疾病。根据交易条款，Kiora收到了1600万美元的预付款，并且有资格在开发、监管和商业里程碑方面获得额外的2.85亿美元；净销售额不超过20岁的分层版税；以及KIO-301研发费用的报销。。

Completed enrollment and reported topline results from ABACUS-1. Results demonstrated KIO-301 was safe and tolerable with improvements consistent across multiple measures, including improved visual field, visual acuity, and functional vision (navigating in real-world simulations). In addition, functional MRI measures showed reactivation of the specific regions of the brain responsible for vision..

已完成注册并报告了ABACUS-1的topline结果。结果表明，KIO-301是安全且可耐受的，并且在多种测量中都有一致的改进，包括改善的视野，视力和功能视力（在现实世界的模拟中导航）。此外，功能性MRI测量显示大脑负责视觉的特定区域重新激活。。

Held a Type B, pre-IND meeting with the US FDA regarding Kiora's proposed clinical development plans and received feedback on trial design, including approvable endpoints, details for the control group, and outstanding non-clinical requirements, all consistent with Kiora's current plans.

就Kiora提出的临床开发计划与美国FDA举行了B型IND前会议，并收到了关于试验设计的反馈，包括可批准的终点，对照组的细节以及突出的非临床要求，所有这些都与Kiora目前的计划一致。

KIO-100 Family (KIO-104, KIO-101)

KIO-100家族（KIO-104、KIO-101）

The publication of results from a Phase 1 double-masked study of KIO-101 in the medical journal Pharmaceutics, documenting a 12-day treatment of KIO-101 topically at multiple doses was well tolerated in healthy volunteers and patients with inflammation of the eye. There was a significant decrease in conjunctival hyperemia in the treatment group compared to the placebo group..

在医学杂志Pharmaceutics上发表了KIO-101第一阶段双盲研究的结果，记录了健康志愿者和眼部炎症患者对KIO-101多剂量局部治疗12天的耐受性良好。与安慰剂组相比，治疗组结膜充血明显减少。。

Granted US and European patents covering local ocular delivery of the KIO-100 family of non-steroidal, anti-inflammatory small molecules.

授予美国和欧洲专利，涵盖KIO-100家族非甾体抗炎小分子的局部眼部递送。

Kiora anticipates achieving the following clinical and regulatory milestones:

Kiora预计将实现以下临床和监管里程碑：

KIO-301

KIO-301

Report additional ABACUS-1 data, including quantitative functional MRI measures showing reactivated brain activity in the visual cortex in a time-dependent manner.

报告其他ABACUS-1数据，包括定量功能MRI测量，显示视觉皮层中大脑活动以时间依赖的方式重新激活。

Complete comprehensive design, under the joint Kiora-TOI steering committee, of a randomized, controlled, multicenter, double-masked, dose-ascending Phase 2 study of KIO-301 in retinitis pigmentosa with initiation expected as early as the fourth quarter of 2024.

在Kiora-TOI联合指导委员会的领导下，完成了一项针对色素性视网膜炎的KIO-301的随机，对照，多中心，双盲，剂量递增的2期研究的全面设计，预计最早将于2024年第四季度开始。

Pursue Orphan Drug Designations for KIO-301 for choroideremia and Stargardt disease in the US and EU.

在美国和欧盟寻求针对脉络膜血症和Stargardt病的KIO-301孤儿药指定。

KIO-104

KIO-104

Initiate supportive non-clinical research to inform and optimize Phase 2 and registration studies in 2024.

在2024年启动支持性非临床研究，以告知和优化第二阶段和注册研究。

Plan a multicenter, randomized, double-masked, dose-ascending Phase 2 study of KIO-104 for the treatment of non-infectious uveitis.

计划对KIO-104进行多中心，随机，双盲，剂量递增的2期研究，用于治疗非感染性葡萄膜炎。

Perform additional pre-clinical proof-of-concept studies of KIO-104 in proliferative vitreoretinopathy, a rare but serious complication of retinal reattachment procedures beginning in 2024.

在增殖性玻璃体视网膜病变中对KIO-104进行额外的临床前概念验证研究，这是一种罕见但严重的视网膜复位手术并发症，始于2024年。

Financial Results

财务业绩

Kiora ended the year with $2.5 million in cash and cash equivalents and $2.0 million in tax receivables. In February of 2024, Kiora received an additional $16 million for an upfront payment from TOI and raised $13.8 million in net proceeds from a private placement offering. The Company's cash and cash equivalents as of March 24, 2024, exceeds $30 million and the Company believes this will fund operations through 2026..

Kiora年末拥有250万美元的现金和现金等价物以及200万美元的应收账款。2024年2月，Kiora从TOI收到了另外1600万美元的预付款，并从私募发行中筹集了1380万美元的净收益。截至2024年3月24日，该公司的现金和现金等价物超过3000万美元，该公司相信这将为2026年的运营提供资金。。

In 2023, research and development expenses were $4.0 million, net of $1.7 million in offsetting tax credits, compared to $3.5 million, net of $1.5 million in offsetting tax credits, for 2022. Research and development expenses for the fourth quarter of 2023 were $1.1 million, net of $0.5 million in offsetting tax credits, compared to $0.8 million, net of $0.4 million in offsetting tax credits for the fourth quarter of 2022.

2023年，研发费用为400万美元，扣除了170万美元的抵减税款，而2022年为350万美元，扣除了150万美元的抵减税款。2023年第四季度的研发费用为110万美元，扣除了50万美元的抵消税收抵免，而2022年第四季度的研发费用为80万美元，扣除了40万美元的抵消税收抵免。

The increase in R&D in 2023 was primarily due to greater investment in clinical trial-related activities for KIO-301 and personnel-related expenses for the R&D team. Kiora anticipates R&D expenses will increase as it begins planning and enrollment of patients in Phase 2 clinical trials, with trial-related expenses for KIO-301 offset by reimbursement from TOI..

2023年研发的增加主要是由于KIO-301临床试验相关活动的投资增加以及研发团队的人员相关费用增加。Kiora预计，随着开始计划和招募2期临床试验的患者，研发费用将增加，KIO-301的试验相关费用将被TOI的报销所抵消。。

General and administrative expenses for 2023 were $4.7 million compared to $8.3 million for 2022. General and administrative expenses for the fourth quarter of 2023 were $0.9 million, compared to $2.8 million in the fourth quarter of 2022. The reduction in general and administrative expenses for the full year and fourth quarter of 2023 were primarily related to lower professional service fees, driven by reduced external accounting and auditing services.

2023年的一般和管理费用为470万美元，而2022年为830万美元。2023年第四季度的一般和管理费用为90万美元，而2022年第四季度为280万美元。2023年全年和第四季度一般和管理费用的减少主要是由于外部会计和审计服务减少，专业服务费用降低。

Kiora expects that general and administrative expenses will remain relatively consistent for the near future..

基奥拉预计，在不久的将来，一般费用和管理费用将保持相对一致。。

Net loss was $12.5 million for 2023 compared to $13.6 million for 2022. Net loss was $2.3 million for the fourth quarter of 2023 compared to $2.5 million for the fourth quarter of 2022.

2023年的净损失为1250万美元，而2022年为1360万美元。2023年第四季度净亏损230万美元，而2022年第四季度净亏损250万美元。

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。。

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, Kiora's ability to execute on development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-104, KIO-301, KIO-201 and KIO-101, 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 sufficiency of existing cash on hand to fund operations for specific periods, the ability to timely complete planned initiatives for 2024, including phase 2 clinical development of KIO-301 and KIO-104, the potential for KIO-301 to be the first treatment options for patients with inherited degenerative diseases like RP, Kiora's plans to further fund development of KIO-104, the potential for KIO-104 to reduce inflammation, the timing of topline results from a Phase 2b trial of KIO-104, the potential for KIO-104 to apply to other retinal inflammatory diseases, and expected trends for research and development and general and administrative spending in 2024.

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开发和商业化工作的执行能力以及与Kiora开发阶段产品（包括KIO-104、KIO-301、KIO-201和KIO-101）有关的其他监管或营销批准工作及其成功相关的声明，这些批准或成功可能无法及时获得或实现，或者根本无法获得或实现，现有现金足以为特定时期的运营提供资金，能够及时完成2024年计划的举措，包括KIO-301和KIO-104的第二阶段临床开发，KIO-301可能成为患有遗传性退行性疾病，如RP，Kiora计划进一步资助KIO-104的开发，KIO-104减轻炎症的潜力，KIO-104 2b期试验的结果，KIO-104应用于其他视网膜炎症性疾病的潜力，以及2024年研发和一般及行政支出的预期趋势。

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 satisfy the closing conditions related to the offering ,the ability to conduct clinical trials on a timely basis, 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 25, 2024 or described in Kiora's other public fi.

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，其中包括满足与发行相关的交割条件的能力、及时进行临床试验的能力、市场和其他条件以及Kiora 2024年3月25日提交SEC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其他公共fi中描述的某些风险因素。

Contacts:

联系人：

Investors

投资者

Investors@kiorapharma.com

Investors@kiorapharma.com

Media

媒体

Kiora@crowepr.com

Kiora@crowepr.com

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