Welcome to our dedicated page for KIORA PHARMACEUTICALS news (Ticker: KPRX), a resource for investors and traders seeking the latest updates and insights on KIORA PHARMACEUTICALS stock.
Overview
Kiora Pharmaceuticals Inc (NASDAQ: KPRX) is a clinical-stage biotechnology company dedicated to the development and commercialization of innovative therapies targeting orphan retinal diseases. Specializing in advanced treatments for inherited retinal degenerations and ocular inflammatory conditions, Kiora employs cutting-edge platforms such as a molecular photoswitch and next-generation DHODH inhibitors. These proprietary technologies underscore the company’s commitment to addressing large unmet needs in the ophthalmic market.
Core Technologies and Drug Candidates
The company focuses on two primary therapeutic candidates:
- KIO-301: Developed as a molecular photoswitch, KIO-301 is designed to restore vision in patients suffering from inherited retinal disorders such as retinitis pigmentosa, choroideremia, and Stargardt disease. By conferring light-sensing properties to retinal cells beyond the degenerated photoreceptors, KIO-301 demonstrates a novel, gene-mutation agnostic approach that is particularly promising in addressing a broad spectrum of retinal degenerations.
- KIO-104: This candidate is a next-generation, non-steroidal, immuno-modulatory small molecule. By inhibiting dihydroorotate dehydrogenase (DHODH), KIO-104 aims to reduce ocular inflammation, offering an alternative to chronic steroid use and systemic anti-inflammatory drugs. The mechanism of action provides a focused local treatment for conditions such as posterior non-infectious uveitis and retinal macular edema without systemic side effects.
Clinical Development and Regulatory Strategy
Kiora’s pipeline reflects a robust clinical development strategy with ongoing and upcoming Phase 2 trials designed to validate both efficacy and functional outcomes. The company’s efforts include the use of standardized, real-world functional vision assessments developed in collaboration with leading clinical experts and supported by external foundations. Regulatory milestones such as Orphan Medicinal Product Designation in both the U.S. and Europe ensure a streamlined pathway for approval and market exclusivity, reinforcing the scientific and regulatory rigor behind its programs.
Strategic Partnerships and Industry Position
Kiora has formed vital partnerships with esteemed industry players, ensuring not only collaborative product development but also enhanced financial support and reimbursement of research expenditures. These alliances strengthen the company’s market position by allowing for accelerated clinical trials and resource efficiency. The integration of comprehensive, functional endpoints in clinical studies highlights Kiora's commitment to developing therapies that have a meaningful impact on patient quality of life.
Market Relevance and Competitive Advantage
Operating in the high-stakes arena of orphan retinal diseases, Kiora leverages a unique blend of molecular innovation and targeted ocular therapy. Its product candidates are distinguished by:
- An innovative approach that bypasses the limitations of conventional treatments.
- Mechanisms that offer therapeutic benefits across diverse genetic mutations or inflammatory conditions.
- Strategic regulatory advantages including orphan designations that underscore its potential for market exclusivity.
Conclusion
Kiora Pharmaceuticals Inc remains committed to advancing transformative therapies aimed at preserving and restoring vision. Through its focused research on molecular photoswitch technology and targeted anti-inflammatory agents, the company demonstrates both deep industry expertise and a robust scientific foundation. Its strategic clinical trials, innovative drug development approach, and strong regulatory alignments set the stage for meaningful contributions to the treatment of orphan retinal diseases and ocular inflammatory conditions.
Kiora Pharmaceuticals (NASDAQ: KPRX) reported its 2024 financial results and pipeline updates for retinal disease treatments. The company secured approvals for two Phase 2 trials: KLARITY (KIO-104 for retinal inflammation) and ABACUS-2 (KIO-301 for retinitis pigmentosa), with data expected in 2026.
Financial highlights include $26.8 million in cash and investments, plus $0.9 million in receivables, providing runway into 2027. The company reported net income of $3.6 million for 2024, compared to a $12.5 million loss in 2023, primarily due to $16 million in collaboration revenue from Laboratoires Théa.
R&D expenses reached $7.8 million in 2024, offset by $2.9 million in reimbursements from Théa. G&A expenses were $5.5 million, expected to remain consistent in 2025.
Kiora Pharmaceuticals (NASDAQ: KPRX) has announced that their preclinical study abstract for KIO-104 in treating proliferative vitreoretinopathy (PVR) will be presented at the ARVO 2025 Annual Meeting in Salt Lake City. The study demonstrates KIO-104's potential as a therapeutic candidate for both preventing and treating PVR.
The presentation, titled 'KIO-104, a novel small molecule inhibitor of DHODH, effectively prevents proliferative vitreoretinopathy in a rabbit model,' will showcase research evaluating multiple dose levels' effectiveness in reducing scar formation and magnitude in a retinal detachment model. KIO-104 functions by suppressing T cell division and function, potentially offering a new approach to reducing inflammation that leads to scar formation.
Currently, there are no approved treatments for PVR, a condition characterized by scar formation and retinal detachment following eye surgery or trauma. KIO-104 is simultaneously undergoing Phase 2 clinical trials for macular edema treatment.
Kiora Pharmaceuticals (NASDAQ: KPRX) has secured a new composition-of-matter patent (US-12209073-B2) for a specific crystalline form of KIO-104, their novel non-steroidal anti-inflammatory compound. The patent extends protection until 2043 and covers a unique polymorph that offers enhanced molecular stability and solubility, important for optimizing drug manufacturing.
The company is preparing to launch the KLARITY study, a Phase 2 clinical trial in the first half of 2025, which will evaluate KIO-104 in up to 28 patients with macular edema. The compound, as a locally delivered small molecule DHODH inhibitor, aims to provide an alternative to steroids or systemic anti-inflammatory drugs for treating retinal inflammation.
Kiora Pharmaceuticals (NASDAQ: KPRX) has received regulatory approval to begin KLARITY, a Phase 2 clinical trial for KIO-104 in treating retinal macular edema. The trial will evaluate a locally delivered small molecule as an alternative to steroids or systemic anti-inflammatory drugs.
The multi-center, open-label study will include up to 28 patients and will be conducted in two parts: Part A (Dose Optimization) will assess safety and efficacy of three injections every two weeks in 8 subjects across two cohorts (3.5 μg and 10 μg doses), while Part B (Cohort Expansion) will investigate different dosing regimens at intervals of 2 or 4 weeks.
KIO-104 works by suppressing T cell numbers and function in the eye through DHODH inhibition, targeting inflammation-related vision conditions including diabetic retinopathy, non-infectious uveitis, retinal vein occlusion, and post pseudophakic cataract surgery.
Kiora Pharmaceuticals (NASDAQ: KPRX) reported Q3 2024 financial results and pipeline updates. The company received approval for ABACUS-2, a Phase 2 study of KIO-301 for retinitis pigmentosa, and finalized the Phase 2 KLARITY trial design for KIO-104. Financial position remains strong with $29.0 million in cash and equivalents, plus $1.8 million in collaboration receivables from Théa partnership. Q3 net loss was $3.4 million, improved from $5.8 million in Q3 2023. R&D expenses were $2.2 million, offset by $0.9 million in Théa reimbursements. The company expects runway into 2027, beyond anticipated clinical trial readouts.
Kiora Pharmaceuticals (NASDAQ: KPRX) received regulatory approval to initiate ABACUS-2, a Phase 2 clinical trial for KIO-301 in retinitis pigmentosa patients. The trial will involve 36 patients across five Australian centers, with participants randomized 2:1 to receive KIO-301 or control. The study will evaluate two dosage levels (50 and 100 micrograms) administered intravitreally every 6 weeks. KIO-301 is a photoswitch molecule designed to restore vision by targeting retinal ganglion cells, potentially benefiting patients regardless of their specific gene mutation. The trial's primary endpoints include safety and tolerability, with efficacy measured through functional vision assessments.
Kiora Pharmaceuticals (NASDAQ: KPRX) has announced its participation in three upcoming investor conferences. The presentations will be available live and on-demand for 90 days on the company's IR homepage.
The conferences include:
- The Lytham Partners Fall 2024 Investor Conference on October 1, 2024, at 10:15 am EDT, featuring CFO Melissa Tosca.
- The Maxim Virtual Healthcare Conference | Ophthalmology Panel on October 15, 2024, at 11:00 am EDT, with CEO Brian M. Strem, Ph.D.
- The LD Micro Conference on October 29, 2024, at 4:00 pm EDT, presented by CFO Melissa Tosca.
Investors can register for each event through provided links and arrange meetings with management where applicable.
Kiora Pharmaceuticals (NASDAQ: KPRX) reported its Q2 2024 financial results and provided updates on its retinal disease drug development pipeline. Key highlights include:
1. Finalized trial design for Phase 2 study (ABACUS-2) of KIO-301 for retinitis pigmentosa treatment.
2. Planning Phase 2 clinical trial (CLARITY) of KIO-104 for multiple retinal inflammatory diseases.
3. Ended Q2 with $27.8 million in cash, cash equivalents, and short-term investments, plus $3.7 million in near-term receivables.
4. Expected cash runway into 2027, before potential partnership milestones.
5. Revenue of $20,000 in Q2 2024, compared to no revenue in Q2 2023.
6. Net loss of $2.2 million in Q2 2024, down from $2.6 million in Q2 2023.
Kiora Pharmaceuticals (NASDAQ: KPRX) has announced its participation in two upcoming investor conferences. On August 13, 2024, at 3:00 pm Eastern Time, CEO Brian Strem will present at the Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase. Additionally, on August 15, 2024, Strem will present at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference.
Both presentations will be available via live webcast, with registration links provided. Replays of the presentations will be accessible on-demand for 90 days on Kiora's investor relations homepage (ir.kiorapharma.com). These conferences offer investors an opportunity to gain insights into Kiora's latest developments and future prospects.
Kiora Pharmaceuticals (NASDAQ: KPRX) has received Orphan Medicinal Product Designation from the European Medicines Agency for KIO-301, a small molecule photoswitch, to treat inherited retinal dystrophies (IRDs) including retinitis pigmentosa. This designation provides at least ten years of market exclusivity in Europe, along with other regulatory benefits. Kiora is finalizing the design of the Phase 2 trial (ABACUS-2) for KIO-301, set to begin later this year.
KIO-301 is designed to restore light-sensing capabilities to retinal ganglion cells in patients with IRDs. In January 2024, Kiora partnered with Théa Open Innovation for worldwide co-development and commercialization of KIO-301, excluding Asia. The upcoming ABACUS-2 trial will be a multi-center, double-masked, randomized, controlled, multiple-dose study focusing on vision restoration in individuals with retinitis pigmentosa.
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