Kiora Pharmaceuticals — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported total revenue of $1.0 million for the quarter ended September 30, 2026, compared to $0 in the same period in 2025, driven by collaboration revenue from the KIO-301 agreement with Chong Kun Dang Pharmaceutical Corporation (CKD).
• Net loss for the quarter was approximately $1.7 million ($0.28 per basic and diluted share), compared to a net income of approximately $27,000 ($0.01 per share) in the prior-year quarter.
• Research and development expenses were $1.9 million for the quarter, down from $2.7 million in 2025; net R&D expenses after collaboration credits from Théa were $1.0 million versus $1.1 million in 2025.
• General and administrative expenses were $1.6 million for the quarter, up from $1.4 million in 2025, primarily due to higher legal fees and investor relations costs.
• Ended the quarter with $16.3 million in cash and short-term investments, down from $17.1 million as of December 31, 2025.
• Recorded $0.6 million in collaboration receivables and $1.6 million in tax and other receivables as of September 30, 2026.
• Total assets were $22.4 million as of September 30, 2026, compared to $24.3 million at December 31, 2025.
• Total liabilities were $7.1 million as of September 30, 2026, compared to $8.1 million at December 31, 2025.
• Stockholders' equity decreased to $15.3 million from $16.1 million at the end of 2025.

Guidance and Future Outlook:

• Plans to initiate a multinational Phase 3 registration clinical trial for KIO-401 in patients with Central Retinal Artery Occlusion (CRAO) in the United States, Europe, and other territories.
• Submitted a Type B pre-IND FDA meeting request to discuss the investigational new drug application pathway, trial design, and approvable endpoints for KIO-401.
• Submitted a request for FDA orphan drug designation for KIO-401 in CRAO to secure development incentives and market exclusivity.
• KIO-301 (ABACUS-2 trial) is on track to report topline data by the end of 2027.
• Management intends to maintain a streamlined operation, aligning spending with development milestones while funding pre-trial activities for KIO-401.
• Resources are allocated to fund initial preclinical evaluation of next-generation calpain inhibitors in ophthalmic and non-ophthalmic indications.

Business Segments and Product Lines:

• In-licensed exclusive development and commercialization rights (outside Asia) to KIO-401 (mitucapistat), an oral calpain inhibitor, from Senju Pharmaceutical Co., Ltd., supported by existing Phase 2 and Phase 3 data from Japan.
• KIO-301 is in Phase 2 development for advanced retinitis pigmentosa; the ABACUS-2 trial is actively enrolling and dosing patients in the 100 mg dose cohort.
• Out-licensed development and commercial rights for KIO-301 in South Korea to Chong Kun Dang Pharmaceutical Corporation (CKD).
• Discontinued further research and development investment in KIO-104 in October 2026; plans to report KLARITY study results and evaluate partnering opportunities.
• Appointed Keith Lane as EVP of Clinical Development and Regulatory Affairs to lead the expanded leadership team.
• KIO-301 collaboration with Théa Open Innovation continues to reimburse all associated research and development expenses.

Market and Competitive Landscape:

• KIO-401 targets acute ischemic ophthalmic conditions, specifically CRAO and non-arteritic anterior ischemic optic neuropathy (NAION), which currently lack approved pharmacologic treatments or interventions to restore vision.
• Japanese Phase 2a data for KIO-401 showed statistically significant visual acuity improvement compared to a prospective observational registry (p=0.0398).
• Japanese Phase 3 data showed a statistically significant improvement among patients legally blind at baseline (p=0.0195), though overall visual acuity comparison was not statistically significant (p=0.0949).
• The company aims to establish KIO-401 in CRAO and expand into additional ophthalmic indications.

Risks and Challenges:

• Forward-looking statements involve risks including uncertainties in preclinical and clinical development, regulatory review, and the possibility that results from previous studies will not be reproduced.
• Regulatory feedback may require changes to proposed trial designs, endpoints, or timelines.
• There is no guarantee that orphan drug designation will be granted or that anticipated incentives and exclusivity will be available.
• Risks include the cost, timing, enrollment, and outcomes of clinical trials, as well as the ability to maintain collaboration reimbursements and manage operating expenses.
• Potential dilution to existing stockholders and the ability to obtain sufficient capital to fund planned development activities are cited risks.

Management Commentary and Tone:

• CEO Brian M. Strem stated that the addition of KIO-401 transforms Kiora into a late-stage retinal therapeutics company, building on existing CMC, non-clinical, and clinical data.
• EVP Keith J. Lane expressed encouragement regarding the separation between KIO-401 and placebo and the trajectory in visual acuity, supporting the potential for a sufficiently powered registration study.
• CFO Melissa Tosca noted that the current cash position enables funding of pre-trial activities and that the decision to discontinue KIO-104 supports financial flexibility.
• Management emphasized a disciplined approach to align spending with development milestones.

Other Key Points:

• KIO-401 is an oral neuroprotective calpain inhibitor supported by existing Phase 2 and Phase 3 studies conducted in Japan.
• The company holds exclusive rights to KIO-401 outside of Asia.
• KIO-301 collaboration with CKD generated $1.0 million in collaboration revenue in the third quarter of 2026.
• Kiora is eligible for potential development milestone payments, regulatory milestones, and royalties from the CKD partnership if KIO-301 advances.
• The company has expanded its patent portfolio, contributing to increased legal fees in general and administrative expenses.
• Intangible Assets and In-Process R&D remained at $2.1 million as of September 30, 2026.
• Contingent consideration liability increased to $3.1 million from $2.9 million at the end of 2025.