Kiora Pharmaceuticals Reports First Quarter Results; Initiating Two Phase 2 Trials for Treatment of Retinal Diseases; Cash and Short-term Investments Expected to Fund Operations into Late 2027
- Extended cash runway into late 2027, beyond anticipated data readouts for both Phase 2 trials
- Received approval to initiate two Phase 2 clinical trials for retinal diseases
- Secured $1.8 million in reimbursed R&D expenses from partnership with Théa Open Innovation
- Strong cash position of $24.1 million plus $2.0 million in receivables and tax credits
- Net loss of $2.2 million in Q1 2025 compared to net income in Q1 2024
- Increased R&D expenses expected throughout 2025
- Higher G&A expenses year-over-year ($1.5M vs $1.3M)
Insights
Kiora advances two Phase 2 retinal disease programs with strong $24.1M cash position extending operations into late 2027, significantly de-risking near-term development.
Kiora has positioned itself for a critical inflection point with the advancement of two Phase 2 trials targeting significant unmet needs in retinal diseases. Their lead candidate KIO-301 for retinitis pigmentosa is progressing to the ABACUS-2 trial following regulatory feedback focusing on functional vision improvements as the approvable endpoint. This approach of conducting a functional endpoint validation study before the main Phase 2 trial shows strategic regulatory navigation in a difficult indication with no approved treatments.
Their second program, KIO-104, targets inflammatory retinal conditions like posterior non-infectious uveitis and diabetic macular edema. The KLARITY Phase 2 trial is ready to enroll patients in Q2 2025. What's particularly promising is the local delivery approach designed to avoid the well-documented side effects of chronic steroid use or systemic anti-inflammatories - addressing a key clinical challenge in managing these conditions.
The financial position is exceptionally strong for a clinical-stage biotech. The
The
The company's development strategy appears clinically sound, targeting indications with significant unmet need while maintaining strong fiscal discipline that substantially de-risks their development timeline through multiple data readouts.
Encinitas, California--(Newsfile Corp. - May 9, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today announced first quarter 2025 financial results and provided an update on its pipeline of therapeutics for the treatment of retinal diseases.
Key first quarter and 2025 year-to-date corporate highlights include:
- Received approval to initiate KLARITY, a Phase 2 clinical trial evaluating KIO-104 for the treatment of retinal inflammation.
Reported preclinical data on KIO-104 at ARVO 2025, further supporting its potential as a treatment for inflammatory and proliferative retinal diseases.
Continued patient enrollment in the ongoing functional endpoint study, work designed to validate functional vision outcomes and serve as an on-ramp study to ABACUS-2. This validation effort supports discussions with regulatory bodies that have indicated that this assessment is the likely approvable endpoint for the future registration trial of KIO-301.
Received
$1.8 million in reimbursed Q4 2024 R&D expenses from Théa Open Innovation (Laboratoires Théa) for activities related to KIO-301.Ended the quarter with
$24.1 million in cash, cash equivalents and short-term investments, along with$2.0 million in collaboration receivables and tax credits.Extended the 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 first quarter, we continued preparations to initiate enrollment in two Phase 2 clinical trials in retinal diseases," said Brian M. Strem, Ph.D., President & Chief Executive Officer of Kiora. "The KLARITY study will evaluate KIO-104 in patients with retinal inflammation, while ABACUS-2 will evaluate KIO-301 in patients with retinitis pigmentosa.
"For KIO-301, we are approved to initiate ABACUS-2, a multi-center, double-masked, randomized, controlled, multi-dose study in 36 patients with ultra-low vision or no light perception due to retinitis pigmentosa. Based on feedback from regulators, retinal specialists, and patient groups, we recognize the need to demonstrate improvements in measures of functional vision as a pathway to market. Accordingly, we are dedicating the appropriate time to tailor clinically meaningful endpoints for this patient population, one for which no 'off-the-shelf' solution exists. We are currently activating sites for ABACUS-2, and as an on-ramp study, we anticipate that patients enrolled in the validation study will be eligible for ABACUS-2, serving to meet our recruitment goals.
"KIO-104 is our potent, locally delivered small molecule DHODH inhibitor being developed to treat inflammatory retinal diseases. Our aim is to provide an alternative to chronic steroid use or systemic anti-inflammatory drugs, which carry known side effects and risks. Building on encouraging data from our first-in-human study, we are now approved, activating sites, and expect to enroll our first patient in the second quarter of this year. This Phase 2 trial will evaluate two doses of KIO-104 across several inflammatory retinal diseases, including posterior non-infectious uveitis and diabetic macular edema. Results from the initial stage will inform dose expansion into one or more specific indications."
Kiora's Chief Financial Officer, Melissa Tosca, added, "We ended the quarter with a cash runway extending into late 2027, positioning us well beyond the anticipated data readouts for ABACUS-2 and KLARITY. This extended runway reflects both the reimbursed expenses from our Laboratoires Théa partnership, totaling
First Quarter Financial Highlights
Kiora ended the first quarter of 2025 with
The Company reported a net loss of
R&D expenses for the first quarter of 2025 were
G&A expenses were
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, and expected trends for research and development and general and administrative spending in 2025. 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 May 9, 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
KIORA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, 2025 (unaudited) | December 31, 2024 | |||||
| ASSETS | ||||||
| Current Assets: | ||||||
| Cash and Cash Equivalents | $ | 3,771,024 | $ | 3,792,322 | ||
| Short-Term Investments | 20,334,831 | 22,999,760 | ||||
| Prepaid Expenses and Other Current Assets | 941,542 | 2,042,487 | ||||
| Collaboration Receivables | 1,337,604 | 601,197 | ||||
| Tax Receivables | 722,290 | 270,246 | ||||
| Total Current Assets | 27,107,291 | 29,706,012 | ||||
| Non-Current Assets: | ||||||
| Property and Equipment, Net | 4,984 | 5,232 | ||||
| Restricted Cash | 4,081 | 4,057 | ||||
| Intangible Assets and In-Process R&D, Net | 6,687,100 | 6,687,100 | ||||
| Operating Lease Right-of-Use Assets | 152,083 | 57,170 | ||||
| Other Assets | 64,323 | 24,913 | ||||
| Total Assets | $ | 34,019,862 | $ | 36,484,484 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current Liabilities: | ||||||
| Accounts Payable | $ | 942,492 | $ | 415,590 | ||
| Accrued Expenses | 3,522,003 | 4,588,657 | ||||
| Accrued Collaboration Credit | 738,584 | 981,111 | ||||
| Operating Lease Liabilities | 71,554 | 23,355 | ||||
| Total Current Liabilities | 5,274,633 | 6,008,713 | ||||
| Non-Current Liabilities: | ||||||
| Contingent Consideration | 4,466,682 | 4,191,490 | ||||
| Deferred Tax Liability | 490,690 | 490,690 | ||||
| Non-Current Operating Lease Liabilities | 87,470 | 33,815 | ||||
| Total Non-Current Liabilities | 5,044,842 | 4,715,995 | ||||
| Total Liabilities | 10,319,475 | 10,724,708 | ||||
| Commitments and Contingencies (Note 8) | ||||||
| Stockholders' Equity: | ||||||
| Preferred Stock, | 4 | 4 | ||||
| Common Stock, | 267,679 | 267,679 | ||||
| Additional Paid-In Capital | 169,304,991 | 169,156,374 | ||||
| Accumulated Deficit | (145,575,102 | ) | (143,382,122 | ) | ||
| Accumulated Other Comprehensive Loss | (297,185 | ) | (282,159 | ) | ||
| Total Stockholders' Equity | 23,700,387 | 25,759,776 | ||||
| Total Liabilities and Stockholders' Equity | $ | 34,019,862 | $ | 36,484,484 |
KIORA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE (LOSS) INCOME
(unaudited)
| Three Months Ended March 31, | ||||||
| 2025 | 2024 | |||||
| Revenue: | ||||||
| Collaboration Revenue | $ | - | $ | 16,000,000 | ||
| Total Revenue | - | 16,000,000 | ||||
| Operating Expenses: | ||||||
| General and Administrative | 1,489,398 | 1,296,441 | ||||
| Research and Development | 2,531,887 | 1,684,212 | ||||
| Collaboration and Research Credits | (1,966,123 | ) | (190,553 | ) | ||
| Change in Fair Value of Contingent Consideration | 275,192 | (12,194 | ) | |||
| Total Operating Expenses | 2,330,354 | 2,777,906 | ||||
| Operating (Loss) Income | (2,330,354 | ) | 13,222,094 | |||
| Other Income (Expense), Net: | ||||||
| Interest Income, Net | 276,633 | 223,047 | ||||
| Other (Expense) Income, Net | (16,253 | ) | 8,066 | |||
| Total Other Income, Net | 260,380 | 231,113 | ||||
| (Loss) Income Before Income Tax Expense | (2,069,974 | ) | 13,453,207 | |||
| Income Tax Expense | (123,006 | ) | - | |||
| Net (Loss) Income | $ | (2,192,980 | ) | $ | 13,453,207 | |
| Net (Loss) Income Attributable to Common Shareholders | $ | (2,192,980 | ) | $ | 13,453,207 | |
| Net (Loss) Income per Common Share - Basic | $ | (0.52 | ) | $ | 4.67 | |
| Weighted Average Shares Outstanding - Basic | 4,217,007 | 2,881,796 | ||||
| Net (Loss) Income per Common Share - Diluted | $ | (0.52 | ) | $ | 3.46 | |
| Weighted Average Shares Outstanding - Diluted | 4,217,007 | 3,891,722 | ||||
| Other Comprehensive (Loss) Income: | ||||||
| Net (Loss) Income | $ | (2,192,980 | ) | $ | 13,453,207 | |
| Unrealized Loss on Marketable Securities | (16,099 | ) | - | |||
| Foreign Currency Translation Adjustments | 1,072 | (81,573 | ) | |||
| Comprehensive (Loss) Income | $ | (2,208,007 | ) | $ | 13,371,634 | |
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FAQ
What are the main clinical trials Kiora Pharmaceuticals (KPRX) is initiating in 2025?
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