Encinitas, California--(Newsfile Corp. - August 8, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced second quarter 2025 financial results and provided an update on its pipeline of therapeutics for the treatment of retinal diseases.
Key second quarter and 2025 year-to-date corporate highlights include:
KIO-104
Initiated KLARITY, a Phase 2 clinical trial evaluating KIO-104 for the treatment of patients with retinal inflammation.
Strengthened and extended market exclusivity of KIO-104 into 2043 (absent any patent term extensions) with receipt of a patent covering methods for optimizing treatment of ocular inflammatory diseases.
KIO-301
Entered into an option agreement, which would allow for a strategic partnership with Senju Pharmaceutical Co., Ltd. ("Senju") to develop and commercialize KIO-301 in key countries in Asia, including Japan and China, which, if exercised, would have a potential deal value of up to $110 million plus royalties.
Initiated the Phase 2 ABACUS-2 clinical trial of KIO-301 for vision restoration in patients with retinitis pigmentosa.
ABACUS-2 uses a validated efficacy endpoint to assess functional vision outcomes in patients with moderate to advanced vision loss due to retinal degeneration. These functional vision assessments will likely serve as the approvable endpoint for a future registration trial(s) of KIO-301.
Operations and Financials
Received $1.3 million in reimbursed Q1 2025 R&D expenses from Théa Open Innovation ("Théa") for activities related to KIO-301.
Recorded deferred revenue of $1.25 million related to a non-refundable option fee from Senju, comprising part of the KIO-301 partnership.
Ended the quarter with $20.7 million in cash, cash equivalents and short-term investments, along with $2.4 million in collaboration receivables and $0.7 million in research incentive tax credits.
Maintained projected cash runway into late 2027, a timeframe beyond anticipated data readouts for KLARITY and ABACUS-2, with potential for further extension through achievement of partnership milestones.
"In the second quarter, we materially advanced our Phase 2 clinical programs through site activations and initiating patient recruiting efforts," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "For KIO-301, having a validated functional vision assessment to serve as a critical endpoint for both ABACUS-2 and a potential registration study(s) represents both progress and promise for those affected by inherited retinal diseases. We continue to bring online ABACUS-2 sites and anticipate many eligible patients will come from the functional vision assessment validation study, facilitating enrollment targets and timelines. Strategically, we expanded our global commercialization network by entering a partnership with Senju, adding to our ability to ensure KIO-301 can potentially benefit the global population in need. Similarly, the KLARITY clinical trial is actively recruiting patients to assess KIO-104 across several inflammatory retinal diseases, including posterior non-infectious uveitis and diabetic macular edema. Due to our efficient capital management, our anticipated runway remains into late 2027 based on existing cash reserves, beyond the anticipated readouts for ABACUS-2 and KLARITY."
Second Quarter Financial Highlights
Kiora ended the second quarter of 2025 with $20.7 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, $1.25 million in collaboration receivables from Senju related to the option fee and $0.7 million in research incentive tax credits.
The Company reported a net loss of $2.2 million for the second quarter of 2025 consistent with the net loss of $2.2 million in the second quarter of 2024.
R&D expenses for the second quarter of 2025 were $2.6 million, before recognizing $1.7 million in reimbursable expenses from Théa. In comparison, R&D expenses for the second quarter of 2024 were $2.0 million, with $1.1 million in offsetting reimbursable expenses from Théa. The increase in R&D for the second quarter of 2025 was mainly attributable to clinical trial activities. G&A expenses were $1.4 million for the second quarter of 2025, down from $1.5 million in the second quarter of 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 for the treatment of retinitis pigmentosa, 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 ability to timely complete planned initiatives for 2025, including Phase 2 clinical development of KIO-301 and KIO-104, the completion of enrollment and the timing of topline results from the ABACUS-2 Phase 2 trial, the potential for KIO-301 to be the first treatment options for patients with inherited degenerative diseases like RP, the potential for KIO-104 to reduce inflammation, the timing of topline results from the Phase 2 KLARITY trial of KIO-104, the potential for KIO-104 to apply to other retinal inflammatory diseases, expected trends for research and development and general and administrative spending in 2025, the expectations for market exclusivity of KIO-104, the potential proceeds that could be received from the Senju strategic partnership, and the expected endpoints for future KIO-301 trials. 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 August 8, 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
CONDENSED CONSOLIDATED BALANCE SHEETS
June 30, 2025 (unaudited) | December 31, 2024 | |||||
ASSETS | ||||||
Current Assets: | ||||||
Cash and Cash Equivalents | $ | 1,028,324 | $ | 3,792,322 | ||
Short-Term Investments | 19,637,812 | 22,999,760 | ||||
Prepaid Expenses and Other Current Assets | 957,095 | 2,042,487 | ||||
Collaboration Receivables | 2,418,022 | 601,197 | ||||
Tax Receivables | 696,002 | 270,246 | ||||
Total Current Assets | 24,737,255 | 29,706,012 | ||||
Non-Current Assets: | ||||||
Property and Equipment, Net | 106,843 | 5,232 | ||||
Restricted Cash | 4,461 | 4,057 | ||||
Intangible Assets and In-Process R&D, Net | 6,687,100 | 6,687,100 | ||||
Operating Lease Right-of-Use Assets | 349,017 | 57,170 | ||||
Other Assets | 61,007 | 24,913 | ||||
Total Assets | $ | 31,945,683 | $ | 36,484,484 | ||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
Current Liabilities: | ||||||
Accounts Payable | $ | 282,537 | $ | 415,590 | ||
Accrued Expenses | 2,540,493 | 4,588,657 | ||||
Accrued Collaboration Credit | 219,625 | 981,111 | ||||
Operating Lease Liabilities | 143,327 | 23,355 | ||||
Total Current Liabilities | 3,185,982 | 6,008,713 | ||||
Non-Current Liabilities: | ||||||
Contingent Consideration | 4,604,456 | 4,191,490 | ||||
Deferred Tax Liability | 490,690 | 490,690 | ||||
Deferred Collaboration Revenue | 1,250,000 | - | ||||
Non-Current Operating Lease Liabilities | 287,079 | 33,815 | ||||
Total Non-Current Liabilities | 6,632,225 | 4,715,995 | ||||
Total Liabilities | 9,818,207 | 10,724,708 | ||||
Commitments and Contingencies (Note 8) | ||||||
Stockholders' Equity: | ||||||
Preferred Stock, $0.01 Par Value: 10,000,000 shares authorized; 3,750 designated Series A, 0 shares issued and outstanding; 10,000 designated Series B, 0 shares issued and outstanding; 10,000 shares designated Series C, 0 shares issued and outstanding; 20,000 shares designated Series D, 7 shares issued and outstanding; 1,280 shares designated Series E, 0 shares issued and outstanding; 3,908 shares designated Series F, 420 issued and outstanding at June 30, 2025 and December 31, 2024, respectively | 4 | 4 | ||||
Common Stock, $0.01 Par Value: 150,000,000 shares authorized; 3,433,491 and 3,000,788 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | 272,006 | 267,679 | ||||
Additional Paid-In Capital | 169,828,797 | 169,156,374 | ||||
Accumulated Deficit | (147,727,561 | ) | (143,382,122 | ) | ||
Accumulated Other Comprehensive Loss | (245,770 | ) | (282,159 | ) | ||
Total Stockholders' Equity | 22,127,476 | 25,759,776 | ||||
Total Liabilities and Stockholders' Equity | $ | 31,945,683 | $ | 36,484,484 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE (LOSS) INCOME
(unaudited)
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||
Revenue: | ||||||||||||
Collaboration Revenue | $ | - | $ | - | $ | - | $ | 16,000,000 | ||||
Grant Revenue | - | 20,000 | - | 20,000 | ||||||||
Total Revenue | - | 20,000 | - | 16,020,000 | ||||||||
Operating Expenses: | ||||||||||||
General and Administrative | 1,353,850 | 1,537,973 | 2,843,248 | 2,834,414 | ||||||||
Research and Development | 2,590,489 | 2,048,665 | 5,122,376 | 3,732,877 | ||||||||
Collaboration and Research Credits | (1,685,917 | ) | (1,141,985 | ) | (3,652,040 | ) | (1,332,538 | ) | ||||
Change in Fair Value of Contingent Consideration | 137,774 | 120,234 | 412,966 | 108,040 | ||||||||
Total Operating Expenses | 2,396,197 | 2,564,887 | 4,726,550 | 5,342,793 | ||||||||
Operating (Loss) Income | (2,396,197 | ) | (2,544,887 | ) | (4,726,550 | ) | 10,677,207 | |||||
Other Income (Expense), Net: | ||||||||||||
Interest Income, Net | 225,237 | 342,102 | 501,870 | 565,149 | ||||||||
Other (Expense) Income, Net | (93,556 | ) | (18,861 | ) | (109,809 | ) | (10,795 | ) | ||||
Total Other Income, Net | 131,680 | 323,241 | 392,060 | 554,354 | ||||||||
(Loss) Income Before Income Tax Expense | (2,264,516 | ) | (2,221,646 | ) | (4,334,490 | ) | 11,231,561 | |||||
Income Tax (Expense) Benefit | 112,057 | - | (10,949 | ) | - | |||||||
Net (Loss) Income | $ | (2,152,459 | ) | $ | (2,221,646 | ) | $ | (4,345,439 | ) | $ | 11,231,561 | |
Net (Loss) Income Attributable to Common Shareholders | $ | (2,152,459 | ) | $ | (2,221,646 | ) | $ | (4,345,439 | ) | $ | 11,231,561 | |
Net (Loss) Income per Common Share - Basic | $ | (0.54 | ) | $ | (0.53 | ) | $ | (1.10 | ) | $ | 3.19 | |
Weighted Average Shares Outstanding - Basic | 3,989,042 | 4,170,627 | 3,936,649 | 3,526,211 | ||||||||
Net (Loss) Income per Common Share - Diluted | $ | (0.54 | ) | $ | (0.53 | ) | $ | (1.10 | ) | $ | 2.79 | |
Weighted Average Shares Outstanding - Diluted | 3,989,042 | 4,170,627 | 3,936,649 | 4,031,174 | ||||||||
Other Comprehensive (Loss) Income: | ||||||||||||
Net (Loss) Income | $ | (2,152,459 | ) | $ | (2,221,646 | ) | $ | (4,345,439 | ) | $ | 11,231,561 | |
Unrealized Loss on Marketable Securities | (11,116 | ) | (2,828 | ) | (27,215 | ) | (2,828 | ) | ||||
Foreign Currency Translation Adjustments | 62,532 | 21,467 | 63,604 | (60,106 | ) | |||||||
Comprehensive (Loss) Income | $ | (2,101,044 | ) | $ | (2,203,007 | ) | $ | (4,309,050 | ) | $ | 11,168,627 | |
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/261730