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Encinitas, California--(Newsfile Corp. - November 7, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced third quarter 2025 financial results and provided an update on its pipeline of small molecules for the treatment of retinal diseases.
Key third quarter and 2025 year-to-date corporate highlights include:
Continued recruitment and patient dosing in KLARITY, an open-label Phase 2 clinical trial evaluating KIO-104 for the treatment of patients with retinal inflammation.
Continued recruitment and patient dosing in the ABACUS-2 trial, a Phase 2, randomized, controlled clinical trial of KIO-301 for vision restoration in patients with retinitis pigmentosa.
In the third quarter of 2025, Kiora received $1.2 million in reimbursed R&D expenses from Théa Open Innovation ("Théa") for activities related to KIO-301 performed in the second quarter of 2025. The Company billed $1.5 million in the third quarter of 2025 for reimbursable R&D expenses, of which $0.3 million was received within the quarter.
Ended the quarter with $19.4 million in cash, cash equivalents and short-term investments, along with $1.2 million in collaboration receivables and $1.5 million in tax and research credit receivables.
Maintained projected cash runway into late 2027, a timeframe beyond anticipated data readouts for both KLARITY and ABACUS-2, with potential for further extension through achievement of partnership milestones.
"Both of our Phase 2 clinical trials continue to recruit, screen, and dose participants. Further, we continue to explore adding more trial centers to expand the geographic footprint and accelerate enrollment in both trials," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "For ABACUS-2, screening and enrollment has been expanded by patients who participated in Kiora's functional endpoint validation study. This endpoint validation study remains open for patients with less severe vision loss, representing an additional population of individuals potentially helped by KIO-301. We are also maintaining close collaboration with our partners, Théa and Senju, who will be instrumental in potential registration studies and global commercialization.
"KLARITY enrollment is targeting patients with one of several inflammatory retinal diseases that cause macular edema in this two-stage, multi-dose study. As part of the design, we have a pre-defined sentinel assessment of safety and tolerability.
"Collectively, the progress across both studies represents the execution of our strategy to advance a diversified pipeline targeting rare and common retinal diseases, with each asset having potential to address several indications."
Third Quarter Financial Highlights
"Our cash position continues to support an anticipated runway into late 2027, well beyond the anticipated clinical readouts for both ABACUS-2 and KLARITY," said Melissa Tosca, Chief Financial Officer. "This outlook is further supported by an approximate $1.0 million income tax receivable, resulting from changes under the OBBBA enacted in July 2025 that modified the treatment of capitalized R&D. These revisions provide greater flexibility in applying prior R&D expenses against net income. We continue to manage our capital efficiently, maintaining a stable G&A spend while increasing R&D investment that is partially offset by reimbursement from our strategic partner."
Kiora ended the third quarter of 2025 with $19.4 million in cash, cash equivalents, and short-term investments. The Company also recorded $1.2 million in collaboration receivables from Théa for reimbursable R&D expenses and $1.5 million in tax and other receivables, of which 1.0 million is from income tax receivables and $0.5 million is related to research tax credits.
R&D expenses for the third quarter of 2025 were $2.7 million, before recognizing $1.7 million in reimbursable expenses from Théa. In comparison, R&D expenses for the third quarter of 2024 were $2.1 million, with $0.9 million in offsetting reimbursable expenses from Théa. The increase in R&D for the third quarter of 2025 was mainly attributed to clinical trial activities. G&A expenses were $1.4 million for the third quarter of 2025, consistent with $1.4 million in the third quarter of 2024.
The Company reported net income of $27 thousand for the third quarter of 2025, compared to a net loss of $3.4 million in the third quarter of 2024. The improvement was driven by favorable tax impacts, noncash gains from the remeasurement of existing contingent consideration liabilities, and continued control of operating costs.
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 plans 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 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, 2025 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:
Investors
Investors@kiorapharma.com
Financial Tables Follow
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, |
|
| December 31, | ||||
ASSETS |
|
|
|
|
| |||
Current Assets: |
|
|
|
|
| |||
Cash and Cash Equivalents |
| $ | 5,508,899 |
|
| $ | 3,792,322 | |
Short-Term Investments |
| 13,866,546 |
|
| 22,999,760 | |||
Prepaid Expenses and Other Current Assets |
| 650,429 |
|
| 2,042,487 | |||
Collaboration Receivables |
| 1,213,226 |
|
| 601,197 | |||
Tax and Other Receivables |
| 1,454,756 |
|
| 270,246 | |||
Total Current Assets |
| 22,693,856 |
|
| 29,706,012 | |||
Non-Current Assets: |
|
|
|
|
| |||
Property and Equipment, Net |
| 101,807 |
|
| 5,232 | |||
Restricted Cash |
| 4,520 |
|
| 4,057 | |||
Intangible Assets and In-Process R&D, Net |
| 6,687,100 |
|
| 6,687,100 | |||
Operating Lease Right-of-Use Assets |
| 318,036 |
|
| 57,170 | |||
Other Assets |
| 58,135 |
|
| 24,913 | |||
Total Assets |
| $ | 29,863,454 |
|
| $ | 36,484,484 | |
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
| |||
Current Liabilities: |
|
|
|
|
| |||
Accounts Payable |
| $ | 241,471 |
|
| $ | 415,590 | |
Accrued Expenses |
| 2,153,906 |
|
| 4,588,657 | |||
Accrued Collaboration Credit |
| 29,057 |
|
| 981,111 | |||
Operating Lease Liabilities |
| 155,926 |
|
| 23,355 | |||
Total Current Liabilities |
| 2,580,360 |
|
| 6,008,713 | |||
Non-Current Liabilities: |
|
|
|
|
| |||
Contingent Consideration |
| 2,883,423 |
|
| 4,191,490 | |||
Deferred Tax Liability |
| 490,690 |
|
| 490,690 | |||
Deferred Collaboration Revenue |
| 1,250,000 |
|
| — | |||
Non-Current Operating Lease Liabilities |
| 248,239 |
|
| 33,815 | |||
Total Non-Current Liabilities |
| 4,872,352 |
|
| 4,715,995 | |||
Total Liabilities |
| 7,452,712 |
|
| 10,724,708 | |||
Commitments and Contingencies (Note 10) |
|
|
|
|
| |||
Stockholders' Equity: |
|
|
|
|
| |||
Preferred Stock, $0.01 Par Value: 10,000,000 shares authorized; 3,750 |
| 4 |
|
| 4 | |||
Common Stock, $0.01 Par Value: 150,000,000 shares authorized; 3,433,491 |
| 272,006 |
|
| 267,679 | |||
Additional Paid-In Capital |
| 170,083,195 |
|
| 169,156,374 | |||
Accumulated Deficit |
| (147,700,755) |
|
| (143,382,122) | |||
Accumulated Other Comprehensive Loss |
| (243,708) |
|
| (282,159) | |||
Total Stockholders' Equity |
| 22,410,742 |
|
| 25,759,776 | |||
Total Liabilities and Stockholders' Equity |
| $ | 29,863,454 |
|
| $ | 36,484,484 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE (LOSS) INCOME
(unaudited)
|
| Three Months Ended September 30, |
|
|
| Nine Months Ended September 30, | ||||||||||||
|
| 2025 |
|
|
| 2024 |
|
|
| 2025 |
|
| 2024 | |||||
Revenue: |
|
|
|
|
|
|
|
|
|
| ||||||||
Collaboration Revenue |
| $ | — |
|
| $ | — |
|
| $ | — |
|
| $ | 16,000,000 | |||
Grant Revenue |
|
| — |
|
|
| — |
|
|
| — |
|
| 20,000 | ||||
Total Revenue |
|
| — |
|
|
| — |
|
|
| — |
|
| 16,020,000 | ||||
Operating Expenses: |
|
|
|
|
|
|
|
|
|
| ||||||||
General and Administrative |
|
| 1,443,827 |
|
|
| 1,380,997 |
|
|
| 4,287,075 |
|
| 4,215,411 | ||||
Research and Development |
|
| 2,729,891 |
|
|
| 2,184,991 |
|
|
| 7,852,267 |
|
| 5,917,868 | ||||
Collaboration Credits |
|
| (1,658,248) |
|
|
| (867,760) |
|
|
| (5,310,288) |
|
| (2,200,298) | ||||
In-Process R&D Impairment |
|
| — |
|
|
| 2,008,000 |
|
|
| — |
|
| 2,008,000 | ||||
Change in Fair Value of Contingent Consideration |
|
| (1,721,033) |
|
|
| (1,103,991) |
|
|
| (1,308,067) |
|
| (995,951) | ||||
Total Operating Expenses |
|
| 794,437 |
|
|
| 3,602,237 |
|
|
| 5,520,987 |
|
| 8,945,030 | ||||
Operating (Loss) Income |
|
| (794,437) |
|
|
| (3,602,237) |
|
|
| (5,520,987) |
|
| 7,074,970 | ||||
Other Income (Expense), Net: |
|
|
|
|
|
|
|
|
|
| ||||||||
Interest Income, Net |
|
| 201,822 |
|
|
| 248,840 |
|
|
| 703,692 |
|
| 813,989 | ||||
Other Expense, Net |
|
| (23,708) |
|
|
| (59,929) |
|
|
| (133,517) |
|
| (70,724) | ||||
Total Other Income, Net |
|
| 178,114 |
|
|
| 188,911 |
|
|
| 570,175 |
|
| 743,265 | ||||
(Loss) Income Before Income Tax Benefit |
|
| (616,323) |
|
|
| (3,413,326) |
|
|
| (4,950,812) |
|
| 7,818,235 | ||||
Income Tax Benefit |
|
| 643,129 |
|
|
| — |
|
|
| 632,179 |
|
| — | ||||
Net (Loss) Income |
| $ | 26,806 |
|
| $ | (3,413,326) |
|
| $ | (4,318,633) |
|
| $ | 7,818,235 | |||
Net (Loss) Income Attributable to Common Shareholders |
| $ | 26,806 |
|
| $ | (3,413,326) |
|
| $ | (4,318,633) |
|
| $ | 7,818,235 | |||
Net (Loss) Income per Common Share - Basic |
| $ | 0.01 |
|
| $ | (0.81) |
|
| $ | (1.04) |
|
| $ | 2.08 | |||
Weighted Average Shares Outstanding - Basic |
|
| 4,289,853 |
|
|
| 4,214,950 |
|
|
| 4,165,568 |
|
| 3,757,467 | ||||
Net (Loss) Income per Common Share - Diluted |
| $ | 0.01 |
|
| $ | (0.81) |
|
| $ | (1.04) |
|
| $ | 1.91 | |||
Weighted Average Shares Outstanding - Diluted |
|
| 4,361,740 |
|
|
| 4,214,950 |
|
|
| 4,165,568 |
|
| 4,092,880 | ||||
|
|
|
|
|
|
|
|
|
| |||||||||
Other Comprehensive (Loss) Income: |
|
|
|
|
|
|
|
|
|
| ||||||||
Net (Loss) Income |
| $ | 26,806 |
|
| $ | (3,413,326) |
|
| $ | (4,318,633) |
|
| $ | 7,818,235 | |||
Unrealized Gain (Loss) on Marketable Securities |
|
| 11,214 |
|
|
| 76,435 |
|
|
| (16,001) |
|
| 73,607 | ||||
Foreign Currency Translation Adjustments |
|
| (9,153) |
|
|
| 94,094 |
|
|
| 54,451 |
|
| 33,988 | ||||
Comprehensive (Loss) Income |
| $ | 28,867 |
|
| $ | (3,242,797) |
|
| $ | (4,280,183) |
|
| $ | 7,925,830 | |||
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/273499
