Kiora Pharmaceuticals Reports Fourth-Quarter and Full-Year 2025 Results; Company Advances Retinal Disease Pipeline with Two Active Phase 2 Clinical Trials Ready to Announce with Confidence?
Encinitas, California--(Newsfile Corp. - March 25, 2026) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided a year-end business update on its pipeline of small molecules for the treatment of retinal diseases.
Key fourth-quarter, full-year 2025, and recent corporate highlights include:
Advanced KIO-301 from regulatory clearance to patient dosing in ABACUS-2, a Phase 2 randomized, controlled clinical trial in patients with advanced retinitis pigmentosa.
Strengthened the strategic global commercial network for KIO-301 through an option agreement with Senju Pharmaceutical Co. Ltd. covering key Asian markets with potential deal value of up to $110 million plus royalties, if exercised.
Advanced KIO-104 from regulatory clearance to patient dosing in KLARITY, a Phase 2 dose-escalating trial evaluating the treatment of macular edema due to retinal inflammation.
Ended 2025 with $17.1 million in cash, cash equivalents, and short-term investments, plus $3.5 million in receivables consisting of $1.5 million in collaboration receivables, $1.0 million in tax receivables, and $1.0 million in research credit and other receivables.
Reported fourth-quarter and full-year 2025 net cash used in operating activities of $2.2 million and $10.0 million, respectively.
Identified the potential for platform expansion of KIO-300 as an ion-channel modulator through a preclinical ex vivo proof of concept study in the treatment of epilepsy.
Based on current operating plans, expects existing cash, cash equivalents, and short-term investments to fund operations into late 2027, beyond anticipated topline data readouts for ABACUS-2 and KLARITY.
"Our success in 2025 was defined by transitioning from trial preparation to trial execution for our two lead programs," said Brian M. Strem, Ph.D., President and Chief Executive Officer of Kiora. "We started the year with approvals to begin KLARITY and ABACUS-2 and exited the year with both Phase 2 trials underway, actively recruiting and dosing patients. These milestones meaningfully advanced our goal of delivering new treatment options for patients with retinal diseases and position us for anticipated clinical data in the first half of 2027.
"For KIO-301, we completed validation of the functional vision endpoints to support later-stage development; activated multiple trial sites for the 36-patient ABACUS-2 ascending dose, randomized, controlled, clinical trial; and dosed the first cohort of patients. Further, we received approval following a planned safety review checkpoint to complete the remaining patients in the 50µg dose as well as clearance to then initiate the 100µg dose cohort. Based on the current enrollment rate and follow-up, the six-week dosing period, and the three-month follow-up, we anticipate an initial data readout in the third quarter of 2027. Combined with the Senju regional partnership and our collaboration with Laboratoires Théa, we believe we finished 2025 with considerable momentum across the business and support from strong development and commercial partners.
"The potential of KIO-300 as an ion-channel modulator platform extends beyond ophthalmic indications. As an example, last year our discovery team demonstrated preclinical ex vivo proof of concept in the treatment of epilepsy. The platform may also have broader relevance in other therapeutic spaces where ion-channel modulators may dampen excess excitatory effects in cells that contribute to unwanted disease-related signaling.
"For KIO-104, we initiated and began dosing patients in KLARITY and cleared the early planned safety review checkpoint. This Phase 2 trial is a two-stage study designed to evaluate multiple doses of KIO-104 in patients with macular edema due to retinal inflammation. Findings from the initial stage will inform the dose-expansion stage in one or more specific indications."
Fourth-Quarter and Full-Year Financial Highlights
"With two Phase 2 trials now active, we enter the year with continued operational focus and financial discipline," said Melissa Tosca, Chief Financial Officer of Kiora. "We ended 2025 with a strong cash position, support from our strategic collaboration partners, and a projected cash runway into late 2027. Importantly, we believe this runway extends beyond the anticipated initial data readouts from both ongoing clinical trials, positioning us to execute our near-term milestones and continue advancing our pipeline."
Cash Position:
Research and Development:
R&D expenses for the fourth quarter of 2025 were $2.9 million before recognizing $1.8 million in reimbursable expenses from Théa, compared with $1.9 million before recognizing $0.7 million in reimbursable expenses from Théa in the fourth quarter of 2024.
R&D expenses for 2025 were $10.8 million before recognizing $7.1 million in reimbursable expenses from Théa, compared with $7.8 million in 2024 before recognizing $2.9 million in reimbursed R&D expenses from Théa.
The increases in R&D expense for the quarter and year were driven primarily by clinical trial activities for KIO-301 and KIO-104.
General and Administrative:
G&A expenses were $1.5 million in the fourth quarter of 2025, compared with $1.3 million in the fourth quarter of 2024.
G&A expenses were $5.8 million in 2025, compared with $5.5 million in 2024.
The increases in G&A expense for the quarter and year were primarily related to personnel and associated activities.
Net Income (Loss):
The Company reported a net loss of $6.5 million in the fourth quarter of 2025, compared with a net loss of $4.2 million in the fourth quarter of 2024.
The Company reported a net loss of $10.8 million for 2025, compared with net income of $3.6 million in 2024.
The increase in net loss for the quarter was driven primarily by a non-cash impairment charge related to KIO-104, resulting from changes in equity market-based valuation inputs. This charge does not reflect any change in development timelines, probability of technical success, or Kiora's strategic focus on KIO-104. The year-over-year shift to a net loss was primarily due to the recognition of the $16.0 million upfront payment from Théa as collaboration revenue in 2024.
About Kiora Pharmaceuticals
Kiora Pharmaceuticals is a clinical-stage biotechnology company developing advanced therapies for retinal disease. We target critical pathways underlying retinal diseases using innovative small molecules to slow, stop, or restore vision loss. KIO-301 is being developed initially for the treatment of retinitis pigmentosa, with potential to expand into choroideremia and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-104 is being developed for the treatment of macular edema due to retinal inflammation. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase (DHODH).
In addition to news releases and SEC filings, we expect to post information on our website, www.kiorapharma.com, and social media accounts that could be relevant to investors. We encourage investors to follow us on X and LinkedIn as well as to visit our website and/or subscribe to email alerts.
Forward-Looking Statements
Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, Kiora's ability to execute on development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-104 and KIO-301, as well as the success thereof, with such approvals or success may not be obtained or achieved on a timely basis or at all, the sufficiency of existing cash and short-term investments on hand to fund operations for specific periods, the timeline of anticipated readouts, the potential for cash runway extension through partnership milestones, the potential to add trial centers, expand the geographic footprint of trials and/or accelerate enrollment, the potential for KIO-301 and KIO-104 to address multiple indications, and the possibility of future registration studies and global commercialization. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability to conduct clinical trials on a timely basis, market and other conditions and certain risk factors described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 25, 2026 or described in Kiora's other public filings, including on Form 10-Q filed with the SEC on November 7, 2025. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law.
Contacts:
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Source: Kiora Pharmaceuticals, Inc.
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