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Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) is a clinical-stage biotechnology company committed to the development and commercialization of innovative treatments for orphan retinal diseases. The company's lead product candidate, KIO-301, is aimed at treating inherited retinal diseases such as retinitis pigmentosa, choroideremia, and Stargardt disease. KIO-301 is a molecular photoswitch with the potential to restore vision in patients suffering from inherited and age-related retinal degeneration.
Kiora’s second key asset, KIO-104, is being developed to treat posterior non-infectious uveitis. It is a next-generation, non-steroidal, immuno-modulatory, small-molecule inhibitor of dihydroorotate dehydrogenase, with the promise of reducing retinal inflammation without the adverse effects associated with systemic anti-inflammatory drugs or chronic steroid use.
Most recently, Kiora announced its third quarter 2023 financial results and discussed the advancement of KIO-301 for other inherited retinal diseases. The ABACUS-1 study, a Phase 1b clinical trial of KIO-301, demonstrated safety and tolerability, along with significant improvements in visual field and functional vision. These promising results have paved the way for the company to initiate the ABACUS-2 trial, a Phase 2 study involving up to 20 patients with retinitis pigmentosa.
The company also entered into a strategic development and commercialization agreement with Théa Open Innovation (TOI), providing up to $285 million in potential milestone payments, alongside reimbursement of research and development expenses. This partnership will help Kiora accelerate the development and commercialization of KIO-301 globally, excluding Asia.
Moreover, Kiora announced a successful securities purchase agreement, raising up to $45 million to support its ongoing development activities. Recent strategic partnerships and financial maneuvers are expected to fund the company’s operations through 2026, offering a robust financial foundation for future growth.
Operating from Encinitas, California, Kiora continues to pioneer in the biotech space, aiming to bring transformative therapies to market for patients suffering from rare retinal diseases. The company remains focused on delivering innovative solutions that address significant unmet medical needs in ophthalmology.
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.
Kiora Pharmaceuticals (NASDAQ: KPRX) has announced that Eric Daniels, M.D., its Chief Development Officer, will present at the Jones Trading Healthcare Seaside Summit on July 15, 2024, at 6:15 PM Eastern Time.
This presentation will be accessible to investors both live and on-demand via a specific registration link, and an on-demand replay will be available for 90 days on Kiora's Investor Relations homepage.
Following the presentation, Kiora invites verified retail and institutional investors to submit questions regarding their clinical development plans, the science behind their investigational therapies, and financials. The Q&A portal opens on July 16 at 9:00 AM EDT and closes on July 19 at 11:00 AM EDT.
Questions can be submitted and upvoted through the dedicated Q&A portal.
Kiora Pharmaceuticals (NASDAQ: KPRX) has appointed Lisa Walters-Hoffert as an independent member of its Board of Directors, effective July 1, 2024. Walters-Hoffert, a seasoned biotech executive, will serve as chair of the audit committee and join the compensation committee. Concurrently, Ken Gayron will step down from the board due to other commitments.
Lisa Walters-Hoffert brings extensive experience in strategic development, governance, finance, and capital markets to Kiora. Her appointment comes at a time when Kiora is advancing its pipeline of retinal disease treatments. Recently, Kiora has reported promising data on KIO-301 for retinal diseases, established a strategic co-development partnership, and secured financial resources to support its operations for at least the next two years, including investment in KIO-104 for inflammatory retinal diseases.
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