Kiora Pharmaceuticals Reports Third Quarter 2026 Financial Results and Provides Corporate Update
KIO-401 adds a planned registration trial, while Kiora expects spending to increase when enrollment and dosing begin.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Kiora Pharmaceuticals (KPRX) reported a third-quarter net loss of approximately $1.7 million and added a late-stage retinal drug to its pipeline. Loss per share was $0.28, versus earnings of $0.01 a year earlier. Collaboration revenue was $1.0 million, versus none. Cash and short-term investments totaled approximately $16.3 million, down from $17.1 million at December 31, 2025.
Kiora licensed KIO-401 rights outside Asia from Senju and plans a multinational Phase 3 trial for central retinal artery occlusion, an eye artery blockage. A Japanese Phase 3 study showed numerical overall visual-acuity improvement (p=0.0949), with statistically significant improvement in patients legally blind at baseline (p=0.0195). FDA meeting and orphan designation requests are pending. KIO-301 is enrolling its 100 μg cohort, with topline data expected by end-2027. Kiora discontinued further KIO-104 research and development investment.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointKIO-401 license adds exclusive development and commercialization rights outside Asia from Senju.
- Moderate pointKIO-401 Phase 2a showed improved visual acuity versus a prospective observational registry, p=0.0398.
- Moderate point. Forward-looking: it has not happened yet and may not happen.KIO-401 development plan targets a single multinational Phase 3 registration trial for central retinal artery occlusion.
- Moderate pointKIO-301 collaboration provides reimbursement of all associated research and development expenses from Théa Open Innovation.
- Moderate pointThird-quarter collaboration revenue reached $1.0 million from CKD, versus none in the prior-year quarter.
- Moderate pointThird-quarter research and development expenses fell to $1,949,864 from $2,729,891 a year earlier.
5 minor points
- Minor pointKIO-401 Phase 3 legally blind baseline subgroup showed statistically significant visual-acuity improvement, p=0.0195.
- Minor point. Forward-looking: it has not happened yet and may not happen.KIO-301 ABACUS-2 is enrolling and dosing the 100 μg cohort; Kiora expects topline data by end-2027.
- Minor point. Forward-looking: it has not happened yet and may not happen.KIO-301 South Korean rights licensed to CKD, with potential milestones and royalties if advanced further.
- Minor pointNine-month research and development expenses fell to $6,150,705 from $7,852,267 a year earlier.
- Minor point. Forward-looking: it has not happened yet and may not happen.Kiora plans initial preclinical evaluation of next-generation calpain inhibitors in ophthalmic and non-ophthalmic indications.
Negative
- Major pointThird-quarter net loss was $1,749,521, or $0.28 per share, versus $26,806 income, or $0.01 per share.
- Moderate pointKIO-401 Phase 3 overall visual-acuity comparison showed only numerical improvement, p=0.0949.
- Moderate pointKIO-401 FDA discussions on the IND pathway, trial design and endpoints remain pending after a meeting request.
- Moderate point. Forward-looking: it has not happened yet and may not happen.KIO-401 spending is expected to increase with enrollment and dosing.
- Moderate point. Forward-looking: it has not happened yet and may not happen.KIO-104 further research and development investment was discontinued; Kiora plans results reporting and partnering evaluation.
- Moderate pointThird-quarter collaboration credits fell to $885,559 from $1,658,248, alongside lower reimbursable KIO-301 expenses.
- Moderate pointCommon shares outstanding increased to 4,424,387 at September 30, 2026, from 3,761,739 at December 31, 2025.
12 minor points
- Minor pointNine-month net loss widened to $6,246,515, or $1.12 per share, from $4,318,633, or $1.04 per share.
- Minor pointCash and short-term investments declined to approximately $16.3 million from $17.1 million at December 31, 2025.
- Minor pointKIO-401 orphan designation is requested, not granted; incentives and exclusivity eligibility remain conditional.
- Minor pointThird-quarter general and administrative expenses increased to $1,580,111 from $1,443,827 a year earlier.
- Minor pointNine-month general and administrative expenses increased to $4,575,882 from $4,287,075 a year earlier.
- Minor pointNine-month collaboration credits fell to $3,455,046 from $5,310,288 a year earlier.
- Minor pointThird-quarter contingent-consideration valuation produced a $46,169 expense, versus a $1,721,033 benefit a year earlier.
- Minor pointNine-month contingent-consideration valuation produced a $143,010 expense, versus a $1,308,067 benefit a year earlier.
- Minor pointThird-quarter net interest income decreased to $146,306 from $201,822 a year earlier.
- Minor pointNine-month net interest income decreased to $431,876 from $703,692 a year earlier.
- Minor pointThird-quarter income taxes shifted to a $165,000 expense from a $643,129 benefit a year earlier.
- Minor pointNine-month income taxes shifted to a $165,800 expense from a $632,179 benefit a year earlier.
News Explained
Kiora licensed South Korean development and commercial rights for KIO-301 to CKD; if the asset advances, Kiora is eligible for potential development and regulatory milestone payments and royalties.
Key Figures
- Cash and short-term investments
- $16.3 million
- September 30, 2026; versus $17.1 million at December 31, 2025
- Collaboration revenue
- $1.0 million
- Third quarter 2026; no comparable revenue in third quarter 2025
- Net loss
- $1.7 million
- Third quarter 2026; versus $26,806 net income in third quarter 2025
- Loss per share
- $(0.28)
- Basic and diluted, third quarter 2026; versus $0.01 income per share in third quarter 2025
- Phase 2a visual-acuity comparison
- p=0.0398
- Improvement versus a prospective observational registry in Japan
- Phase 3 overall visual-acuity comparison
- p=0.0949
- Randomized, double-masked study in Japan; numerical improvement reported
- Phase 3 legally blind subgroup
- p=0.0195
- Statistically significant visual-acuity improvement among patients legally blind at baseline
Previous Earnings Reports
-
Q2 report cited $16.8 million cash and a $2.1 million net loss; shares rose 3.13%.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
calpain inhibitor medical
pre-ind regulatory
orphan drug designation regulatory
investigational new drug application regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
San Diego, California--(Newsfile Corp. - November 12, 2026) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) ("Kiora" or the "Company") today reported financial results for the third quarter ended September 30, 2026, and provided a business update highlighted by the in-licensing of KIO-401, a late-stage, oral neuroprotective calpain inhibitor. The addition transforms Kiora's development pipeline, bringing in an asset supported by existing Phase 2 and Phase 3 studies conducted in Japan. Kiora is planning a multinational registration clinical trial in patients who have experienced profound vision loss due to a central retinal artery occlusion (CRAO).
Third Quarter 2026 and Recent Highlights
- Acquired late-stage lead asset: In-licensed exclusive development and commercialization rights, outside of Asia, to KIO-401 (mitucapistat), an oral calpain inhibitor supported by Phase 2 and Phase 3 clinical data from studies conducted in Japan, from Senju Pharmaceutical Co., Ltd.
- KIO-401 FDA engagement underway: Submitted a Type B pre-IND FDA meeting request to begin discussions regarding the investigational new drug application (IND) pathway, trial design and approvable endpoints for KIO-401.
- KIO-401 orphan drug designation requested: Submitted a request for FDA orphan drug designation for KIO-401 in CRAO. If granted, designation would provide development incentives and eligibility for market exclusivity following approval.
- KIO-301 ABACUS-2 trial is progressing: The clinical trial is actively enrolling and dosing patients in the 100 μg dose cohort.
- KIO-301 development and commercial network expanded: Out-licensed development and commercial rights for KIO-301 in South Korea to Chong Kun Dang Pharmaceutical Corporation (CKD).
- Expanded leadership team: Appointed Keith Lane, MBA, former Chief Scientific Officer of Ora, Inc., as EVP of Clinical Development and Regulatory Affairs. Mr. Lane has overseen more than 100 clinical trials, including more than 10 global, pivotal Phase 3 ophthalmic studies.
- Cash position: Ended the quarter with approximately
$16.3 million in cash and short-term investments plus$2.2 million in collaboration, tax and other receivables.
KIO-401: Transforming Kiora's Development Pipeline
"The addition of KIO-401 transforms Kiora into a late-stage retinal therapeutics company," said Brian M. Strem, Ph.D., President and Chief Executive Officer of Kiora. "We are building on the significant amount of CMC, non-clinical and clinical data that already exists on KIO-401 through Senju's previous and ongoing efforts. With exclusive rights outside Asia, we are preparing for a single, Phase 3 registration trial of KIO-401 in patients across the United States, Europe and other territories. We believe an effective oral therapy that restores greater amounts of vision following an acute ischemic event could offer meaningful patient benefit and significant commercial value. Our strategy is to establish KIO-401 in CRAO and build on that foundation through additional ophthalmic indications, such as non-arteritic anterior ischemic optic neuropathy (NAION)."
"Calpains are calcium-activated enzymes that, when dissociated from the endogenous inhibitor, initiate and regulate programmed cell death via the breakdown of multiple proteins essential to cell function and survival. KIO-401 is designed to inhibit this adverse activity, keeping cells alive and buying time for the body to restore homeostasis. Beyond KIO-401, we see opportunities for next-generation products and could cost-effectively evaluate one or more preclinical candidates in indications ranging from chronic ophthalmic diseases to neurodegenerative conditions or cardiovascular diseases."
Patients with CRAO and NAION often experience sudden, permanent vision loss. Neither condition has an approved pharmacologic treatment nor any intervention that has demonstrated meaningful success in returning vision after these acute events. In Japan, the Phase 2a study reported a statistically significant visual-acuity improvement compared with a prospective observational registry (p=0.0398). The subsequent randomized, double-masked Phase 3 study showed a numerical improvement in the overall visual-acuity comparison (p=0.0949), with a statistically significant improvement among patients who were legally blind (as defined by the World Health Organization) at baseline (p=0.0195). These findings inform Kiora's planned design of a larger trial to evaluate clinical benefit.
"The separation between KIO-401 and placebo and the continued trajectory in visual acuity in the active-treatment group through the final 12-week assessment provide further encouragement that a sufficiently powered registration study could support approval in the United States, Europe and other regions," said Keith J. Lane, MBA, Executive Vice President of Clinical Development and Regulatory Affairs of Kiora. "To gain clarity as soon as possible, we've already submitted the meeting request to begin dialogue with the FDA regarding the IND pathway, trial design and endpoints for our planned CRAO registration trial. Further, we submitted a request to the FDA in early November for orphan drug designation for KIO-401 in CRAO. If granted, it would provide development incentives and eligibility for market exclusivity following approval."
KIO-301 and Portfolio Priorities
KIO-301 remains in Phase 2 development for patients living with vision loss due to advanced retinitis pigmentosa. ABACUS-2 is enrolling patients in the 100 μg cohort with strong patient demand to participate in the trial. Kiora remains on track for topline data by the end of 2027, while its collaboration with Théa Open Innovation provides reimbursement of all associated research and development expenses. The Company also expanded KIO-301's regional partnerships during the quarter through a license of South Korean rights to CKD. Should the asset be advanced further, Kiora is eligible for potential development milestone payments, additional regulatory milestones and royalties.
As announced in October 2026, Kiora discontinued further research and development investment in KIO-104. The Company plans to report results from patients enrolled in the KLARITY study and evaluate partnering opportunities.
Third Quarter 2026 Financial Results
"Our current cash position enables us to fund pre-trial activities needed to prepare KIO-401 for its next stage of development, including CMC and regulatory work ahead of enrollment and dosing, when spending will increase," said Melissa Tosca, CPA, Chief Financial Officer of Kiora. "Reimbursement of KIO-301-related research and development expenses and our decision to discontinue KIO-104 support this financial flexibility. We will continue to maintain a streamlined operation, aligning spending with development milestones. Our resources also allow us to fund initial preclinical evaluation of next-generation calpain inhibitors in ophthalmic and non-ophthalmic indications. This disciplined approach enables us to advance these activities and seek greater clarity on Phase 3 trial requirements."
Kiora ended the third quarter with approximately
Collaboration revenue was
Research and development expenses were approximately
General and administrative expenses were approximately
Net loss for the third quarter of 2026 was approximately
About Kiora Pharmaceuticals
Kiora Pharmaceuticals develops small-molecule treatments for vision-threatening retinal diseases. Its pipeline includes KIO-401, an investigational, oral neuroprotective therapy for acute ischemic ophthalmic conditions, and KIO-301, a partnered molecular photoswitch being evaluated for advanced retinitis pigmentosa.
For more information, visit www.kiorapharma.com.
Forward-Looking Statements
Some of the statements in this press release are "forward-looking" statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include, without limitation, statements concerning Kiora's planned development and potential commercialization of KIO-401; the anticipated timing, design, initiation, conduct, enrollment, dosing, endpoints, follow-up periods and results of clinical trials in CRAO and NAION; the potential to incorporate additional patient follow-up without extending overall trial timelines; the potential efficacy, safety, therapeutic benefit and commercial opportunity of KIO-401; the interpretation and applicability of clinical results generated by Senju Pharmaceutical in Japan; anticipated regulatory interactions, feedback and approvals, including discussions regarding the IND pathway and registration requirements in the United States and Europe; requests for orphan drug designation and the potential availability of related development incentives and market exclusivity; the potential development and preclinical evaluation of next-generation calpain inhibitors in ophthalmic and non-ophthalmic indications; the ability to leverage existing clinical development infrastructure and maintain streamlined operations; the expected progression of the KIO-301 program and reimbursement of associated research and development expenses; the Company's plans for KIO-104; the sufficiency of the Company's existing cash and investments to fund pre-trial activities and initial preclinical evaluations; and the expected capital requirements associated with its development programs.
These forward-looking statements are based on management's current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Such risks include, among others, uncertainties associated with preclinical and clinical development and regulatory review; the possibility that results observed in previous studies will not be reproduced in future studies; the possibility that regulatory feedback will require changes to proposed trial designs, endpoints, follow-up periods or development timelines; the possibility that orphan drug designation will not be granted or that anticipated incentives or exclusivity will not be available; the cost, timing, enrollment, conduct and outcomes of clinical trials; the Company's ability to maintain anticipated collaboration reimbursements and manage operating expenses; the ability to obtain sufficient capital to fund planned development activities; the availability and terms of future financings; potential dilution to existing stockholders; the Company's ability to execute its development strategy and licensing obligations; and other risks described under "Risk Factors" in Kiora's Annual Report on Form 10-K filed with the SEC on March 25, 2026, and in its subsequent filings with the SEC.
Kiora's results may also be affected by factors of which the Company is not currently aware. Forward-looking statements speak only as of the date of this release. Except as required by law, Kiora undertakes no obligation to publicly update or revise any forward-looking statement to reflect subsequent events, circumstances or changes in expectations.
Financial Tables Follow
CONDENSED CONSOLIDATED BALANCE SHEETS
| September 30, 2026 (unaudited) | December 31, 2025 | ||||
| ASSETS | |||||
| Current Assets: | |||||
| Cash and Cash Equivalents | $ | 5,570,640 | $ | 8,696,570 | |
| Short-Term Investments | 10,716,331 | 8,392,513 | |||
| Prepaid Expenses and Other Current Assets | 1,008,822 | 1,141,804 | |||
| Collaboration Receivables | 636,756 | 1,522,770 | |||
| Tax and Other Receivables | 1,579,103 | 1,793,459 | |||
| Prepaid Collaboration Expenses | 402,437 | 201,332 | |||
| Total Current Assets | 19,914,089 | 21,748,448 | |||
| Non-Current Assets: | |||||
| Property and Equipment, Net | 88,192 | 91,672 | |||
| Restricted Cash | 4,765 | 4,566 | |||
| Intangible Assets and In-Process R&D, Net | 2,063,100 | 2,063,100 | |||
| Operating Lease Right-of-Use Assets | 219,565 | 285,827 | |||
| Other Assets | 84,351 | 59,687 | |||
| Total Assets | $ | 22,374,062 | $ | 24,253,300 | |
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||
| Current Liabilities: | |||||
| Accounts Payable | $ | 209,074 | $ | 1,060,306 | |
| Accrued Expenses | 2,147,562 | 2,406,731 | |||
| Operating Lease Liabilities | 162,095 | 164,461 | |||
| Total Current Liabilities | 2,518,731 | 3,631,498 | |||
| Non-Current Liabilities: | |||||
| Contingent Consideration | 3,082,326 | 2,939,316 | |||
| Deferred Tax Liability | 102,152 | 102,152 | |||
| Deferred Collaboration Revenue | 1,250,000 | 1,250,000 | |||
| Non-Current Operating Lease Liabilities | 124,694 | 203,798 | |||
| Total Non-Current Liabilities | 4,559,172 | 4,495,266 | |||
| Total Liabilities | 7,077,903 | 8,126,764 | |||
| Commitments and Contingencies (Note 9) | |||||
| Stockholders' Equity: | |||||
| Preferred Stock, | 4 | 4 | |||
| Common Stock, | 281,915 | 275,289 | |||
| Additional Paid-In Capital | 175,723,637 | 170,314,656 | |||
| Accumulated Deficit | (160,463,791) | (154,217,276) | |||
| Accumulated Other Comprehensive Loss | (245,606) | (246,137) | |||
| Total Stockholders' Equity | 15,296,159 | 16,126,536 | |||
| Total Liabilities and Stockholders' Equity | $ | 22,374,062 | $ | 24,253,300 |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||
| Revenue: | |||||||||||
| Collaboration Revenue | $ | 1,000,000 | $ | - | $ | 1,000,000 | $ | - | |||
| Total Revenue | 1,000,000 | - | 1,000,000 | - | |||||||
| Operating Expenses: | |||||||||||
| General and Administrative | $ | 1,580,111 | $ | 1,443,827 | $ | 4,575,882 | $ | 4,287,075 | |||
| Research and Development | 1,949,864 | 2,729,891 | 6,150,705 | 7,852,267 | |||||||
| Collaboration Credits | (885,559) | (1,658,248) | (3,455,046) | (5,310,288) | |||||||
| Change in Fair Value of Contingent Consideration | 46,169 | (1,721,033) | 143,010 | (1,308,067) | |||||||
| Total Operating Expenses | 2,690,585 | 794,437 | 7,414,551 | 5,520,987 | |||||||
| Operating Loss | (1,690,585) | (794,437) | (6,414,551) | (5,520,987) | |||||||
| Other Income (Expense), Net: | |||||||||||
| Interest Income, Net | 146,306 | 201,822 | 431,876 | 703,692 | |||||||
| Other Expense, Net | (40,242) | (23,708) | (98,040) | (133,517) | |||||||
| Total Other Income, Net | 106,064 | 178,114 | 333,836 | 570,175 | |||||||
| Loss Before Income Tax (Expense) Benefit | (1,584,521) | (616,323) | (6,080,715) | (4,950,812) | |||||||
| Income Tax (Expense) Benefit | (165,000) | 643,129 | (165,800) | 632,179 | |||||||
| Net (Loss) Income | $ | (1,749,521) | $ | 26,806 | $ | (6,246,515) | $ | (4,318,633) | |||
| Net (Loss) Income Attributable to Common Shareholders | $ | (1,749,521) | $ | 26,806 | $ | (6,246,515) | $ | (4,318,633) | |||
| Net (Loss) Income per Common Share - Basic | $ | (0.28) | $ | 0.01 | $ | (1.12) | $ | (1.04) | |||
| Weighted Average Shares Outstanding - Basic | 6,295,123 | 4,289,853 | 5,556,915 | 4,165,568 | |||||||
| Net (Loss) Income per Common Share - Diluted | $ | (0.28) | $ | 0.01 | $ | (1.12) | $ | (1.04) | |||
| Weighted Average Shares Outstanding - Diluted | 6,295,123 | 4,361,740 | 5,556,915 | 4,165,568 | |||||||
| Other Comprehensive Loss: | |||||||||||
| Net (Loss) Income | $ | (1,749,521) | $ | 26,806 | $ | (6,246,515) | $ | (4,318,633) | |||
| Unrealized (Loss) Gain on Marketable Securities | (11,184) | 11,214 | (30,520) | (16,001) | |||||||
| Foreign Currency Translation Adjustments | 21,375 | (9,153) | 31,050 | 54,451 | |||||||
| Comprehensive (Loss) Income | $ | (1,739,331) | $ | 28,867 | $ | (6,245,985) | $ | (4,280,183) | |||

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/323497
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were Kiora Pharmaceuticals' third-quarter 2026 financial results?
Kiora reported a $1,749,521 net loss, or $0.28 per basic and diluted share, for the quarter ended September 30, 2026. The prior-year quarter produced $26,806 in net income, or $0.01 per basic and diluted share. Collaboration revenue was $1,000,000, compared with none a year earlier.
What did Kiora's KIO-401 Japanese Phase 3 study show?
The randomized, double-masked Phase 3 study showed numerical overall visual-acuity improvement (p=0.0949) and statistically significant improvement among patients legally blind at baseline under the World Health Organization definition (p=0.0195). Kiora plans a larger multinational registration trial for central retinal artery occlusion.
How is Kiora funding KIO-301 development?
Théa Open Innovation reimburses all associated KIO-301 research and development expenses under its collaboration with Kiora. Lower preclinical and manufacturing costs after activities supporting ABACUS-2 were completed contributed to lower reimbursable expenses and collaboration credits in the third quarter.
What does Kiora's current cash position cover for KIO-401?
Kiora says its current cash position supports pre-trial manufacturing and regulatory work needed to prepare KIO-401 for its next development stage. Spending is expected to increase when enrollment and dosing begin. Resources also support initial preclinical evaluation of next-generation calpain inhibitors.