Thea Open Innovation SAS

Encinitas, California--(Newsfile Corp. - October 29, 2024) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced it received regulatory approval to initiate a Phase 2 clinical trial to investigate KIO-301 for vision restoration in patients with retinitis pigmentosa. The ABACUS-2 trial will be a 36 patient, multi-center, double-masked, randomized, controlled, multiple dose study enrolling patients with ultra-low vision or no light perception regardless of their underlying gene mutation associated with retinitis pigmentosa. Dosing of the first patient with KIO-301 is expected to begin next year following validation of novel functional vision endpoints. These functional assessments may serve as approvable primary endpoints in subsequent registration studies in the United States, Europe and other major regions. "There are unfortunately no approved therapies for patients with retinitis pigmentosa," said Eric Daniels, M.D., Chief Development Officer at Kiora. "This study represents a significant step toward addressing this challenge. Prior to submission for approval, we engaged with European and US regulators to incorporate their expectations and guidance for approvable endpoints. Consistent with historical approval in other inherited retinal disease, both regulatory bodies emphasized the need to measure a therapy's effect on everyday functional vision. For this reason, we are investing time upfront to validate the functional endpoints for ABACUS-2, increasing our likelihood of success in a potential single Phase 3 trial for market approval in the US and Europe. This validation work is being performed, in collaboration with our partner Théa Open Innovation, with the support of the Choroideremia Research Foundation as part of a grant to design a standard endpoint for investigational therapies of inherited retinal diseases." Kiora has identified and is now contracting with trial sites and clinical investigators at major inherited retinal disease reference centers across Australia. Patients will be randomized 2:1 to receive KIO-301 intravitreally or control. Treatment will be delivered to both eyes. Participants will be randomized to receive either a high dose (100 micrograms) or low dose (50 micrograms) of KIO-301 and after trial participants receive three consecutive doses (6 weeks apart), they will be followed for three months. Following this phase of the study, patients in the control arm may elect to cross-over into the active arm. Primary endpoints will consist of safety and tolerability, and key efficacy assessments include: functional vision; visual acuity as measured by the Berkeley Rudimentary Vision Test; visual fields as measured by perimetry, and a validated ultra-low vision quality-of-life questionnaire. The trial will be conducted across five centers within Australia. "In a short window since entering our partnership with Kiora, tremendous progress has been made on advancing KIO-301 toward ABACUS-2," said Dr. Céline Olmiere, Head of Théa Open Innovation. "What makes KIO-301 compelling is that it appears, based on the Phase 1b data, to have potential for meaningful vision restoration. Further, because of its unique mechanism of action, it has the potential to work across all 150-plus underlying gene mutations associated with retinitis pigmentosa and other inherited retinal diseases." KIO-301 is a small molecule that acts as a light-sensitive photoswitch that has the potential to return vision to patients living with reduced sight due to inherited retinal diseases. The novel compound is activated in the presence of light and deactivated in the absence of light. Because hundreds of gene mutations underlie inherited retinal diseases like retinitis pigmentosa, there is an important need for therapies like KIO-301 that have the potential to act in a gene mutation agnostic manner. KIO-301 targets and enters specialized cells of the retina (retinal ganglion cells or RGCs) that are located 'downstream' of degenerated rods and cones, the cells normally responsible for converting light to vision. KIO-301, when inside RGCs, is activated by visible light and confers light-sensing capabilities by altering the flow of ions in and out of the cell, thus giving RGCs the ability to facilitate visual processing. This is a reversible process allowing turning on and off the RGCs in the presence and absence of light. About Kiora Pharmaceuticals Kiora Pharmaceuticals is a clinical-stage biotechnology company developing and commercializing products for the treatment of 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. KIO-104 is being developed for the treatment of retinal inflammation. 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. We encourage investors to follow us on Twitter and LinkedIn as well as to visit our website and/or subscribe to email alerts. About Théa Open Innovation Théa Open Innovation (TOI) is a sister company of Théa, the leading independent European pharmaceutical company specialized in the research, development, and commercialization of eye care products. TOI's mission is to establish partnerships with startups, biotech companies, and universities to help bring the most cutting-edge eye care products to the market. For more information, visit www.theaopeninnovation.com Forward-Looking Statements 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 and KIO-301, 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 projected cash runway, and Kiora's plans to further fund development of KIO-104. 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 filings including on Form 10-Q filed with the SEC on August 9, 2024. 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 obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law. Contacts: Investors investors@kiorapharma.com To view the source version of this press release, please visit https://www.newsfilecorp.com/release/228101 SOURCE Kiora Pharmaceuticals, Inc. Released October 29, 2024

Encinitas, California--(Newsfile Corp. - August 9, 2024) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") announces second quarter 2024 financial results and provides an update on its pipeline of therapeutics for the treatment of retinal diseases. During the quarter, Kiora finalized the trial design for the Phase 2 study (ABACUS-2) of KIO-301, a novel molecular photoswitch, for the treatment of retinitis pigmentosa through our partnership with Théa Open Innovation (TOI). In parallel, the Company is planning its Phase 2 clinical trial (CLARITY) of KIO-104, a small molecule targeting the treatment of multiple retinal inflammatory diseases. Kiora ended the quarter with $27.8 million in cash, cash equivalents and short-term investments. Additionally, the Company has near-term receivables from R&D reimbursements from TOI and research incentive tax credits totaling an additional $3.7 million. This provides Kiora with an expected runway into 2027, before any potential partnership milestones. "We are advancing two exciting and potential first-in-class small molecules toward Phase 2 trials," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "Our cash position allows us to invest time upfront to design and implement robust studies, which can reduce time to market and increase our chances for approval and commercial success. "KIO-301 is our small molecule photoswitch for the treatment of inherited retinal diseases, such as retinitis pigmentosa (RP). Under our development and commercialization partnership with TOI, we are responsible for conducting the Phase 2 clinical trial. Strategic benefits from this partnership include reimbursement for KIO-301 R&D as well as potential milestone payments when pre-defined clinical development triggers are met. "A key initiative in the second quarter was to gain clarity on details of the approvable endpoints for KIO-301. Through multiple interactions with the FDA and European regulators, functional vision testing, such as navigation course and object identification, remains the path to approval. While we deployed functional vision testing in our ABACUS-1 trial, we sought to further refine the assessments being used, and have begun clinical validation of these improvements prior to our planned initiation of our Phase 2 ABACUS-2 trial later this year. The goal of the clinical validation, supported in part by a grant from the Choroideremia Research Foundation (CRF), is to finalize endpoints to be used for the ABACUS-2 trial and become a standard measure for clinical trials of vision restoring therapeutics. ABACUS-2 follows on the positive data reported in ABACUS-1, reported at the most recent American Academy of Ophthalmology and the Association for Research in Vision and Ophthalmology annual conferences. "KIO-104 is a potent, locally delivered small molecule we are developing to treat several inflammatory retinal diseases. The goal is to offer patients and providers the hope of an alternative to chronic steroid use or systemic anti-inflammatory drugs, both of which can lead to complications. KIO-104 acts by suppressing the number and function of specific T cells causing damaging levels of inflammation. Early next year we plan to initiate a Phase 2 trial, building on positive Phase 1b results, where we will explore multiple doses and enroll patients with several forms of inflammatory retinal disease, such as non-infectious uveitis, diabetic macular edema and retinal vein occlusion. Findings in the study will inform a dose expansion trial in one or more specific indications. Additional non-clinical work is currently underway to support final trial design and we anticipate initiating the clinical trial early next year." Chief Financial Officer, Melissa Tosca, added, "We maintained our strong cash position, ending the second quarter with effectively $31.5 million and a cash runway of more than two years, excluding any potential milestone payments or warrant exercise accelerators. This provides us the financial resources to implement, complete and report data on two robust Phase 2 studies." Milestones achieved during and after the end of the second quarter of 2024 include: KIO-301 Received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) for the treatment of a group of inherited retinal diseases (IRDs) that include retinitis pigmentosa, choroideremia and more. Reported quantitative functional MRI results at the Association of Research in Vision and Ophthalmology (ARVO) annual conference from ABACUS-1, showing a statistically significant increase in neural activity over baseline specifically within the brain's visual processing center. This increase in observed brain activity was time-dependent and concordant with previously reported improvements in visual field, visual acuity, and functional vision improvements. Received grant funding from the CRF in support of validating functional vision assessments for patients with profound blindness to be used in ABACUS-2 and other inherited retinal disease clinical trials. KIO-104 Initiated Investigational New Drug enabling preclinical work in support of planned phase 2 retinal inflammation clinical trial. Developed framework of Phase 2 clinical trial (CLARITY) design for KIO-104 in the treatment of retinal inflammatory diseases. Corporate Promoted Melissa Tosca to Chief Financial Officer. Appointed Lisa Walters-Hoffert as an independent member to the Company's Board of Directors. Kiora anticipates achieving the following clinical and regulatory milestones: KIO-301 2H 2024: Complete clinical validation of functional vision endpoints for ABACUS-2 2H 2024: Receive approval to initiate Phase 2 ABACUS-2 study KIO-104 2H 2024: Complete non-clinical, Phase 2 enabling package 1H 2025: Initiate Phase 2 CLARITY study Second Quarter Financial Highlights Kiora ended the second quarter of 2024 with $27.8 million in cash and cash equivalents and short-term investments. In addition, the Company recorded $1.3 million in collaboration receivables from TOI for reimbursed R&D expenses and $2.3 million R&D incentive tax credits. Revenue was $20,000 for the second quarter of 2024, compared to no revenue in the second quarter of 2023. The revenue was recognized as part of the grant received from Choroideremia Research Foundation in support of validating functional vision assessments for patients with profound blindness. Kiora spent $2.0 million on research and development in the second quarter of 2024. After $1.1 million in offsetting expense reimbursement credits related to the strategic development and commercialization agreement with TOI, Kiora is recording net research and development expenses of $0.9 million, compared to $1.4 million for the second quarter of 2023. General and administrative expenses were $1.5 million for the second quarter of 2024, compared to $1.1 million for the second quarter of 2023. The increase is due in part to technical accounting advisory services related to the strategic development and commercialization agreement with TOI, a benchmarking survey, and legal and other advisory services related to the reverse stock split. Net loss was $2.2 million for the second quarter of 2024 compared to a net loss of $2.6 million for the second quarter of 2023. The decrease in net loss is primarily attributed to offsetting KIO-301 expense credits of $1.1 million dollars related to the strategic development and commercialization agreement of KIO-301 with TOI. About 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. 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. We encourage investors to follow us on Twitter and LinkedIn as well as to visit our website and/or subscribe to email alerts. Contacts: Investors investors@kiorapharma.com Forward-Looking Statements 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 projected cash runway, 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. 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 filings including on Form 10-Q filed with the SEC on August 9, 2024. 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 obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law. ### CONDENSED CONSOLIDATED BALANCE SHEETS CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) (unaudited) To view the source version of this press release, please visit https://www.newsfilecorp.com/release/219299 SOURCE Kiora Pharmaceuticals, Inc. Released August 9, 2024

Encinitas, California--(Newsfile Corp. - July 30, 2024) - Kiora Pharmaceuticals (NASDAQ: KPRX) ("Kiora" or the "Company") today announced it has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) for the treatment of a group of inherited retinal diseases (IRDs) that include retinitis pigmentosa (RP), choroideremia and more. The broad designation covers KIO-301, a small molecule photoswitch, for the treatment of non-syndromic rod-dominant retinal dystrophies. This classification of dystrophies, in simplified terms, refers to rare diseases from underlying genetic mutations resulting in predominantly and primarily the degeneration of rod photoreceptors, the cells responsible almost entirely for night vision as well as peripheral and non-color vision. In RP, which today has no approved therapeutics, rods degenerate first followed by degeneration of cone photoreceptors, the cells responsible for color and central vision. This degenerative process causes partial or severe loss of vision and may result in complete blindness. There are approximately 92 million rods in the human eye compared to approximately 6 million cones. "This designation provides Kiora and our development and commercialization partner, Théa Open Innovation, with at least ten years of market exclusivity, exclusive of patent protection, in Europe. This is in addition to other regulatory and market access benefits," said Eric Daniels, M.D., Chief Development Officer of Kiora Pharmaceuticals. "With Orphan Drug Designation already granted in the U.S., KIO-301 is well positioned for expediated regulatory guidance, review, and market exclusivity in two major marketplaces. We are finalizing the design and planning to initiate the Phase 2 trial of KIO-301 (ABACUS-2) later this year." In addition to market exclusivity, additional benefits of Orphan Medicinal Product Designation includes: A centralized process for EU market approval; Reduced or waived fees for regulatory activities; and EMA scientific advice and protocol assistance to optimize trial design. A centralized process for EU market approval; Reduced or waived fees for regulatory activities; and EMA scientific advice and protocol assistance to optimize trial design. The European Union provides Orphan Medicinal Product Designation to incentivize drug developers to bring products for rare diseases to market that may otherwise not be developed. The designation is granted after a critical review and only if a drug candidate meets specific criteria, which incudes but is not limited to the following: The investigational therapy is medically plausible and intended to treat a serious or life-threatening disease; and The condition affects no more than 5 in 10,000 people in the EU. The investigational therapy is medically plausible and intended to treat a serious or life-threatening disease; and The condition affects no more than 5 in 10,000 people in the EU. Kiora's upcoming ABACUS-2 trial of KIO-301 for vision restoration in individuals with RP, will be a multi-center, double-masked, randomized, controlled, multiple-dose study. KIO-301 is a small molecule photoswitch designed to selectively confer light-sensing capabilities to retinal ganglion cells following the degeneration of photoreceptors in inherited retinal diseases like retinitis pigmentosa. This represents a novel, gene-mutation agnostic, non-cell or gene therapy approach to addressing vision loss in IRDs. In January 2024, Kiora, along with Théa Open Innovation (TOI), a sister company of the global ophthalmic specialty company Laboratoires Théa (Théa), agreed to an exclusive worldwide co-development and commercialization agreement, excluding Asia, for KIO-301 in the treatment of retinal diseases. About 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. 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. We encourage investors to follow us on Twitter and LinkedIn as well as to visit our website and/or subscribe to email alerts. Forward-Looking Statements 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 and KIO-301, 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 projected cash runway, and Kiora's plans to further fund development of KIO-104. 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 filings including on Form 10-Q filed with the SEC on May 10, 2024. 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 obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law. Contacts: Investors investors@kiorapharma.com Media kiora@crowepr.com To view the source version of this press release, please visit https://www.newsfilecorp.com/release/218152 SOURCE Kiora Pharmaceuticals, Inc. Released July 30, 2024