Kiora Pharmaceuticals Granted U.S. Patent Covering Additional Formulations for the KIO-100 Family of Anti-Inflammatory Compounds

Rhea-AI Summary

Kiora Pharmaceuticals (NASDAQ: KPRX) announced that the U.S. Patent and Trademark Office issued U.S. patent US-12,472,263 on December 1, 2025 covering additional, novel formulations of the KIO-100 family, including a specific formulation of the API in KIO-104.

The API in KIO-104 is a non-steroidal DHODH inhibitor formulated for local retinal delivery. The company is actively screening and dosing in the multicenter Phase 2 KLARITY trial, enrolling up to 28 patients across retinal inflammatory conditions including posterior non-infectious uveitis and diabetic macular edema. KIO-104 previously demonstrated clinical proof-of-concept in a Phase 1 trial in non-infectious uveitis.

Positive

• U.S. patent US-12,472,263 issued on December 1, 2025
• Patent covers a novel formulation of KIO-104 API
• Phase 2 KLARITY trial actively screening and dosing patients
• KIO-104 showed clinical proof-of-concept in Phase 1

Negative

• Phase 2 trial size limited to up to 28 patients
• No Phase 2 efficacy or regulatory readouts reported yet

News Market Reaction

-2.53% 1.7x vol

5 alerts

-2.53% News Effect

-17.7% Trough in 5 hr 22 min

-$189K Valuation Impact

$7M Market Cap

1.7x Rel. Volume

On the day this news was published, KPRX declined 2.53%, reflecting a moderate negative market reaction. Argus tracked a trough of -17.7% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $189K from the company's valuation, bringing the market cap to $7M at that time. Trading volume was above average at 1.7x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

KLARITY sample size: up to 28 patients Patent number: US-12,472,263 Phase 2 trial: Phase 2 +1 more

4 metrics

KLARITY sample size up to 28 patients Phase 2 KLARITY trial in retinal inflammatory conditions

Patent number US-12,472,263 New U.S. patent on KIO-100 family formulations

Phase 2 trial Phase 2 KLARITY study of KIO-104 for retinal inflammation

Phase 1 proof-of-concept Phase 1 Prior clinical proof-of-concept in non-infectious uveitis

Market Reality Check

Price: $2.18 Vol: Volume 42,932 vs. 20-day ...

normal vol

$2.18 Last Close

Volume Volume 42,932 vs. 20-day average 53,057 (relative volume 0.81x), showing subdued trading. normal

Technical Price $2.14 is trading below the 200-day MA $2.79, reflecting a prior downtrend before this patent news.

Peers on Argus

While KPRX was up 2.91%, key biotech peers like APRE, GNPX, CYCCP, INAB, and PCS...

While KPRX was up 2.91%, key biotech peers like APRE, GNPX, CYCCP, INAB, and PCSA showed declines between about -0.53% and -5.61%, pointing to a stock-specific move driven by the patent news rather than a sector-wide rally.

Historical Context

5 past events · Latest: Dec 01 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 01	Patent & pipeline	Positive	-2.5%	New U.S. patent on KIO-100/KIO-104 formulations and Phase 2 KLARITY progress.
Nov 07	Earnings & trials	Positive	+0.4%	Q3 2025 update with $19.4M cash, two actively enrolling Phase 2 retinal trials.
Oct 30	Collaboration news	Positive	+0.8%	Joined RARE-X Vision Consortium to support rare ocular disorder research and data.
Oct 15	Conference participation	Neutral	-0.7%	Planned presentations at Maxim Growth Summit and Eyecelerator @ AAO 2025.
Sep 04	Investor conference	Neutral	-2.5%	On-demand presentation at H.C. Wainwright conference outlining retinal disease pipeline.

Pattern Detected

Recent fundamentally positive updates (pipeline progress, collaborations, earnings) have usually seen modestly positive or mixed price reactions, while the latest patent and KIO-104 update coincided with a negative move, indicating occasional divergences between news quality and near-term trading.

Recent Company History

Over the last few months, Kiora reported Q3 2025 results with cash of $19.4 million and runway into late 2027, while advancing two Phase 2 retinal trials (KLARITY for KIO-104 and ABACUS-2 for KIO-301). The company joined the RARE-X Vision Consortium and presented at multiple ophthalmology and investor conferences to highlight its retina-focused pipeline. Today’s news adds a U.S. patent (US-12,472,263) covering novel formulations in the KIO-100/KIO-104 family, complementing earlier clinical and corporate progress by strengthening intellectual property around its anti-inflammatory ocular candidate.

Market Pulse Summary

This announcement expands Kiora’s intellectual property with U.S. patent US-12,472,263, covering add...

Analysis

This announcement expands Kiora’s intellectual property with U.S. patent US-12,472,263, covering additional formulations in the KIO-100 family and specifically the API in KIO-104, a DHODH inhibitor for retinal inflammation. It complements the ongoing Phase 2 KLARITY trial in up to 28 patients and prior Phase 1 proof-of-concept in non-infectious uveitis. Investors may monitor enrollment progress, future efficacy and safety readouts, and how this strengthened IP base supports KIO-104’s positioning versus steroid and biologic therapies.

Key Terms

active pharmaceutical ingredient, API, dihydroorotate dehydrogenase, Phase 2, +3 more

7 terms

active pharmaceutical ingredient medical

"expanding the potential therapeutic utility of the active pharmaceutical ingredient (API) in KIO-104"

The active pharmaceutical ingredient (API) is the chemical or biological substance in a medicine that produces the intended therapeutic effect, separate from inactive ingredients like fillers, binders or coatings. Investors watch APIs closely because their source, patent status, manufacturing cost, quality controls and supply reliability drive a drug’s safety, regulatory approval, margin and commercial potential—like the engine in a car determining performance and value.

API medical

"the potential therapeutic utility of the active pharmaceutical ingredient (API) in KIO-104"

An API, or Application Programming Interface, is a set of rules that allows different software programs to communicate and work together smoothly, much like a waiter translating your order into the kitchen and then bringing your meal back. For investors, APIs are important because they enable real-time access to financial data, trading systems, and other digital services, making it easier to make informed decisions quickly and efficiently.

dihydroorotate dehydrogenase medical

"small molecule inhibitor of dihydroorotate dehydrogenase (DHODH)"

Dihydroorotate dehydrogenase is an enzyme that helps cells make the basic building blocks of DNA and RNA by acting like a machine on a factory assembly line that produces those components. It matters to investors because drugs that block or modify this enzyme can slow rapidly dividing cells—useful in cancer and autoimmune diseases—so clinical trial results, regulatory decisions, or licensing deals involving this target can materially affect a company’s prospects and valuation.

Phase 2 medical

"A Phase 2 clinical trial (KLARITY) of KIO-104 for the treatment of retinal inflammation"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

Phase 1 medical

"previously demonstrated clinical proof-of-concept in a Phase 1 trial in non-infectious uveitis."

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

macular edema medical

"up to 28 patients with macular edema, a condition where inflammation causes a build-up of fluid"

Macular edema is a buildup of fluid in the macula, the small central part of the eye responsible for sharp, straight-ahead vision, which causes blurred or distorted sight as if looking through a smudged camera lens. For investors it matters because the condition drives demand for treatments, influences clinical trial results and regulatory approvals, and can change a company’s sales and valuation when new drugs or devices prove effective or fail.

uveitis medical

"Phase 1 trial in non-infectious uveitis. We're now enrolling in a Phase 2 study"

Uveitis is inflammation inside the eye that can damage tissues responsible for clear vision, causing pain, light sensitivity, blurred sight, or permanent vision loss if untreated. For investors, it matters because it represents a medical condition with significant unmet need and chronic treatment requirements, influencing the size of potential drug or device markets, clinical trial design and endpoints, regulatory hurdles, and long-term revenue prospects — similar to how chronic engine trouble signals ongoing repair and maintenance demand.

AI-generated analysis. Not financial advice.

Encinitas, California--(Newsfile Corp. - December 1, 2025) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) today announced that the U.S. Patent and Trademark Office issued a new patent (US-12,472,263) on additional and novel formulations of the KIO-100 family of compounds, This patent allows for additional delivery options, expanding the potential therapeutic utility of the active pharmaceutical ingredient (API) in KIO-104.

This newly issued patent specifically covers a novel formulation of the API in KIO-104. The API in KIO-104 is a non-steroidal anti-inflammatory, small molecule inhibitor of dihydroorotate dehydrogenase (DHODH). A Phase 2 clinical trial (KLARITY) of KIO-104 for the treatment of retinal inflammation is actively screening and dosing patients.

"We believe DHODH inhibitors have significant potential to slow, stop or reverse inflammatory-related vision loss, where steroids or other biologics are not providing appropriate benefit today," said Brian M. Strem, PhD, President & Chief Executive Officer of Kiora Pharmaceuticals. "KIO-104, our DHODH inhibitor formulated for local delivery into the retina, previously demonstrated clinical proof-of-concept in a Phase 1 trial in non-infectious uveitis. We're now enrolling in a Phase 2 study to evaluate higher doses of KIO-104 in multiple retinal inflammatory conditions including posterior non-infectious uveitis and diabetic macular edema."

The multicenter KLARITY study will investigate KIO-104 in up to 28 patients with macular edema, a condition where inflammation causes a build-up of fluid behind part of the retina and can be associated with adverse vision changes and permanent scarring. KIO-104, as a potent, locally delivered small molecule, could provide a needed alternative to steroids or systemic anti-inflammatory drugs.

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 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.

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Contact:
investors@kiorapharma.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/276367

FAQ

What did Kiora (KPRX) announce on December 1, 2025 regarding patents?

Kiora announced issuance of U.S. patent US-12,472,263 covering novel formulations of the KIO-100 family, including KIO-104.

How does the new patent affect KIO-104 development for KPRX?

The patent covers additional delivery formulations for the KIO-104 API, potentially expanding therapeutic delivery options.

What is the status of Kiora's KIO-104 Phase 2 KLARITY trial (KPRX)?

The multicenter Phase 2 KLARITY study is actively screening and dosing patients, enrolling up to 28 participants.

Which retinal conditions is KIO-104 being studied for in the KLARITY trial?

KLARITY is evaluating KIO-104 for posterior non-infectious uveitis and diabetic macular edema and related macular edema.

What mechanism of action does KIO-104 use as noted by KPRX?

KIO-104's API is a non-steroidal small molecule inhibitor of dihydroorotate dehydrogenase (DHODH) formulated for local retinal delivery.