Kiora Pharmaceuticals (NASDAQ: KPRX) has announced its third-quarter 2024 financial results, highlighting advancements in its pipeline of therapeutics for retinal diseases. The company's investigational new drug application was approved to initiate ABACUS-2, a Phase 2 study of KIO-301 for retinitis pigmentosa, and the design of the Phase 2 KLARITY trial of KIO-104 for multiple retinal inflammatory diseases was finalized. These developments mark significant progress in Kiora's efforts to address unmet needs in treating retinal diseases.
Financial Stability and R&D Investment
Kiora ended the third quarter with a robust financial position, holding $29.0 million in cash, cash equivalents, and short-term investments, along with $1.8 million in collaboration receivables related to the Théa Open Innovation partnership. The company's net loss for the quarter was $3.4 million, a notable decrease from the $5.8 million loss in the same period last year. Research and development expenses totaled $2.2 million, offset by $0.9 million in reimbursements from Théa, reflecting efficient cost management. The company anticipates its current cash reserves will sustain operations into 2027, beyond the expected data readouts from the ABACUS-2 and KLARITY trials.
ABACUS-2: Phase 2 Study of KIO-301 for Retinitis Pigmentosa
The ABACUS-2 trial is a 36-patient, multi-center, double-masked, randomized, controlled, multi-dose study evaluating KIO-301 in patients with ultra-low vision or no light perception due to retinitis pigmentosa. KIO-301, a novel molecular photoswitch, has the potential to restore vision regardless of the underlying genetic mutation, addressing a market of over 150 mutations associated with retinitis pigmentosa. Dosing of the first patient is scheduled to begin next year, pending completion of validation work around functional vision endpoints. According to Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora, demonstrating improvement in functional vision is essential for marketing authorization and reimbursement.
KLARITY: Phase 2 Trial of KIO-104 for Inflammatory Retinal Diseases
KIO-104, a locally delivered small molecule, is being developed to treat inflammatory retinal diseases, offering an alternative to chronic steroid use or systemic anti-inflammatory drugs. The Phase 2 KLARITY trial will explore multiple doses of KIO-104 in patients with inflammatory retinal diseases, including posterior non-infectious uveitis and diabetic macular edema. The study findings will inform a dose expansion trial in specific indications. KIO-104 acts by suppressing specific types of T cells and their resulting cytokines, which underlie damaging inflammation.
Strategic Focus and Future Outlook
Kiora's strategic decision to focus on KIO-301 and KIO-104, discontinuing development of KIO-201, reflects prudent resource allocation. The Théa partnership provides significant value by funding KIO-301 development, allowing internal resources to be directed toward KIO-104. Melissa Tosca, Kiora's Chief Financial Officer, noted that the company continues to efficiently manage cash while creating value by investing in its pipeline. R&D expenses are expected to increase as patient enrollment begins in the KLARITY trial. The company maintains a cash runway into 2027, before any potential partnership milestones, and beyond the expected data readouts from ABACUS-2 and KLARITY.
