Press release·03/25/2025 11:10:54

Financial Overview and Outlook for Kiora Pharmaceuticals

Revenue and Profitability

Kiora Pharmaceuticals, a clinical-stage specialty pharmaceutical company, reported a significant increase in revenue in 2024 compared to the prior year. The company recognized $16 million in collaboration revenue from a strategic development and commercialization agreement with Théa Open Innovation (TOI) for its KIO-301 product. This agreement provided an upfront payment as well as the potential for up to $285 million in future milestone payments and tiered royalties on net sales.

In addition, the company received $20,000 in grant revenue in 2024. In contrast, Kiora did not generate any revenue in 2023. The increase in revenue in 2024 resulted in net income of $3.6 million for the year, compared to a net loss of $12.5 million in 2023. This turnaround was driven by the TOI agreement as well as careful management of expenses.

Expenses and R&D Investments

Kiora’s total operating expenses decreased slightly from $12.6 million in 2023 to $11.5 million in 2024. This was due to a $2.9 million decrease in the change in fair value of contingent consideration, partially offset by increases in general and administrative expenses ($0.9 million) and research and development expenses ($3.8 million).

The increase in R&D spending was primarily focused on the company’s two lead product candidates:

• KIO-301 for vision restoration: Expenses increased by $1.8 million due to preclinical, CMC, and clinical trial activities.
• KIO-104 for retinal inflammation: Expenses increased by $0.7 million for preclinical and CMC work.

Kiora also recorded a $2.0 million impairment charge related to the KIO-201 program, as the company made a strategic decision to cease further development or partnership for this asset.

Cash Position and Funding

As of December 31, 2024, Kiora had $3.8 million in cash and cash equivalents, as well as $23.0 million in short-term investments. This represents a significant improvement from the prior year, driven by the $16 million upfront payment from the TOI agreement.

The company believes it has sufficient cash to fund planned operations into 2027, providing runway to advance its KIO-301 and KIO-104 programs. However, Kiora will likely need to raise additional capital through equity or debt financing, collaborations, or other arrangements to support the continued development and potential commercialization of these product candidates.

Pipeline Progress and Outlook

Kiora’s lead programs, KIO-301 and KIO-104, made important advancements in 2024 and have promising outlooks:

KIO-301 for Vision Restoration

• Kiora initiated a Phase 1b clinical trial (the ABACUS study) for KIO-301 in 2022 and completed patient dosing in 2023, with positive topline results announced in November 2023.
• In October 2024, Kiora and partner TOI received regulatory approval to initiate a Phase 2 trial (ABACUS-2) to further investigate KIO-301 for vision restoration in patients with retinitis pigmentosa. Dosing of the first patient is expected in the first half of 2025.
• The successful Phase 1b results and upcoming Phase 2 trial provide momentum for KIO-301’s development. The program is also supported by an orphan drug designation from the FDA.

KIO-104 for Retinal Inflammation

• Kiora received approval to start enrolling patients in a Phase 2 trial for KIO-104 in retinal inflammation, with enrollment expected to begin in the first half of 2025.
• Clinical proof-of-concept for KIO-104’s active pharmaceutical ingredient has been demonstrated in prior non-clinical and clinical studies, showing potential to treat conditions like diabetic macular edema and posterior non-infectious uveitis.

In contrast, Kiora made the strategic decision in 2023 to halt development of its anterior segment assets, KIO-101 and KIO-201. The company is now actively pursuing partnership opportunities for the KIO-101 program, while fully impairing the remaining KIO-201 asset.

Conclusion

Kiora Pharmaceuticals had a transformative year in 2024, transitioning to profitability through a significant collaboration agreement for its lead asset KIO-301. The company’s pipeline of ophthalmology products, particularly KIO-301 and KIO-104, continue to advance with upcoming clinical milestones.

While Kiora has sufficient cash to fund operations into 2027, additional financing will likely be needed to support the continued development and potential commercialization of its product candidates. The company’s ability to execute on its clinical programs and secure future partnerships or funding will be critical to its long-term success.