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Kiora (NASDAQ: KPRX) partners with CKD on KIO-301 for retinitis pigmentosa

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Kiora Pharmaceuticals, Inc. (KPRX) entered into an Exclusive License and Development Agreement with Chong Kun Dang Pharmaceutical Corporation (CKD) covering its KIO-301 molecular photoswitch program. CKD receives an exclusive, sublicensable license to develop, manufacture, commercialize and seek regulatory approvals for KIO-301 in South Korea for retinitis pigmentosa and other ophthalmic diseases.

Under the agreement, Kiora will receive a $1 million up-front payment and is eligible for additional development, regulatory and sales milestone payments, plus double digit royalties on net sales in South Korea, subject to adjustments. CKD will lead development and commercialization in South Korea, while Kiora expects CKD, Laboratoires Théa and Senju Pharmaceutical to coordinate a single global Phase 3 trial for KIO-301 in retinitis pigmentosa.

Kiora highlights that this deal fills the last major unpartnered market for KIO-301 and allows internal resources to focus on KIO-104 for retinal inflammation and fibrosis and evaluation of ion channel modulators for non-ophthalmic uses, alongside potential strategic pipeline-expansion transactions.

Positive

  • $1 million up-front payment plus potential milestones and royalties provides non-dilutive funding tied to KIO-301’s progress in South Korea.
  • Exclusive partnership with CKD completes KIO-301’s coverage across major markets and supports a single global Phase 3 strategy for retinitis pigmentosa.
  • Kiora can redirect internal resources toward advancing KIO-104 and ion channel modulators while partners drive KIO-301 commercialization.

Negative

  • None.

Filing Explained

The August 19 8-K reports the agreement, whose stated effective date is August 20; it sets the licensing terms, but the global Phase 3 coordination and milestone or royalty receipts remain anticipated or contingent, not completed or received.

Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Upfront payment $1 million Cash payment CKD will pay Kiora under the South Korea KIO-301 license
Royalties double digit Royalty rate on net sales of KIO-301 in South Korea, subject to adjustment
Retinitis pigmentosa patients in South Korea more than 10,000 Estimated number of people in South Korea living with retinitis pigmentosa
Agreement effective date August 20, 2026 Effective date of the Exclusive License and Development Agreement with CKD
Press release date August 19, 2026 Date Kiora announced the KIO-301 South Korea license with CKD
Exclusive License and Development Agreement regulatory
"entered into an Exclusive License and Development Agreement with CKD"
molecular photoswitch medical
"KIO-301 is a molecular photoswitch designed to restore light sensitivity"
A molecular photoswitch is a small molecule that changes its shape or chemical behavior when exposed to specific wavelengths of light, acting like a tiny light-controlled switch inside a material or device. Investors care because this light-driven on/off control enables precise, remote operation of drugs, sensors, data storage and smart materials, creating opportunities for products with better performance, lower side effects, or new business models.
retinitis pigmentosa medical
"being developed initially for retinitis pigmentosa, an inherited retinal disease"
Retinitis pigmentosa is a group of inherited disorders that slowly damage the light-sensing cells in the retina, causing progressive loss of peripheral and night vision and often leading to legal blindness. It matters to investors because the condition defines a clear patient population and long-term need for treatments, making clinical trial design, potential market size, and regulatory approval pathways central considerations when valuing companies developing diagnostics or therapies.
orphan designation regulatory
"anticipated qualification of KIO-301 for orphan designation in South Korea"
Orphan designation is a regulatory label granted to a drug or therapy intended to treat a rare disease, which typically affects a small number of patients. It matters to investors because it unlocks incentives—such as development cost reductions, tax credits, priority review and a period of market exclusivity—that improve the commercial and regulatory prospects of a product; think of it as a government-backed head start and safety net for a niche but potentially high-value medicine.
dihydroorotate dehydrogenase (DHODH) medical
"KIO-104 is a small-molecule inhibitor of dihydroorotate dehydrogenase (DHODH)"
Dihydroorotate dehydrogenase (DHODH) is an enzyme inside cells that helps make the chemical building blocks needed for DNA and RNA. Investors care because drugs that block DHODH can slow rapidly dividing cells or modulate the immune system, making it a common target for cancer, autoimmune and antiviral therapies; progress in clinical trials, regulatory decisions, patents or competition around DHODH inhibitors can significantly affect a biotech’s risk and value.

FAQ

What agreement did Kiora Pharmaceuticals (KPRX) sign with Chong Kun Dang in South Korea?

Kiora signed an Exclusive License and Development Agreement granting CKD exclusive rights to develop, manufacture and commercialize KIO-301 in South Korea for retinitis pigmentosa and other ophthalmic diseases, while CKD leads local development and regulatory activities.

How much upfront cash does Kiora (KPRX) receive from the CKD KIO-301 deal?

Kiora will receive a $1 million upfront payment from CKD. In addition, Kiora is eligible for further development, regulatory and sales milestone payments and double digit royalties on net sales of KIO-301 in South Korea.

What future payments can Kiora (KPRX) earn from the KIO-301 South Korea license?

Beyond the $1 million upfront, Kiora may earn development, regulatory and sales milestone payments plus double digit royalties on CKD’s net sales of KIO-301 in South Korea, with royalty percentages subject to specified adjustments.

How does the CKD partnership affect Kiora’s (KPRX) global Phase 3 plans for KIO-301?

Kiora expects CKD, Laboratoires Théa and Senju Pharmaceutical to coordinate a single, global Phase 3 trial of KIO-301 in retinitis pigmentosa, integrating South Korea into a unified global development strategy.

What strategic focus does Kiora (KPRX) outline after partnering KIO-301 globally?

With KIO-301 partnered in major markets, Kiora plans to focus resources on KIO-104 for retinal inflammation and fibrosis, evaluate ion channel modulators for uses beyond the eye, and consider strategic transactions to expand its pipeline.

How many people are estimated to have retinitis pigmentosa in South Korea, according to KPRX’s release?

The release cites CKD’s statement that more than 10,000 people in South Korea are estimated to be living with retinitis pigmentosa, a rare inherited retinal disease with limited treatment options.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Learn about SEC filing dates
0001372514false00013725142026-08-192026-08-19

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549

FORM 8-K
CURRENT REPORT PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): August 19, 2026

Kiora Logo.jpg
KIORA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
001-3667298-0443284
(Commission File Number)(IRS Employer Identification No.)

169 Saxony Rd.
Suite 212
Encinitas, CA 92024
(858) 224-9600
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class:Trading Symbol(s)Name of each exchange on which registered:
Common Stock, $0.01 par valueKPRXNASDAQ
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐



Item 1.01.    Entry Into a Material Definitive Agreement.

License Agreement

Effective August 20, 2026, Kiora Pharmaceuticals, Inc. (the “Company”) entered into an Exclusive License and Development Agreement (the “Agreement”) with Chong Jun Dang Pharmaceutical Corporation (“CKD”) with respect to the Company’s KIO-301 molecular photoswitch product (the “Product”). Under the Agreement, the Company granted to CKD an exclusive, sublicensable license to develop, manufacture, commercialize, and file for regulatory approvals with respect to the Product in South Korea (the “Territory”) for use in the field of retinitis pigmentosa and/or any other disease in ophthalmology (the “Field”).

CKD will be responsible for development and commercialization activities in South Korea. Kiora anticipates that its development and commercialization partners — Laboratoires Théa, Senju Pharmaceutical and CKD — will coordinate efforts to efficiently conduct a single, global Phase 3 clinical trial for KIO-301 in retinitis pigmentosa.

Under the Agreement, CKD will pay the Company an up-front payment of $1.0 million. The Company is also eligible to receive milestone payments upon and subject to the achievement of certain specified clinical development, regulatory and sales milestones. In addition, the Company is eligible to receive double digit royalties based on a specified percentage of net sales of the Product in the Territory, subject to adjustment in certain circumstances. Either party may terminate the Agreement in its entirety upon certain customary events.

The foregoing description of the Agreement is qualified in its entirety by reference to the full text of the Agreement, a copy of which are attached hereto as Exhibit 10.1, and which is incorporated herein in its entirety by reference. The representations, warranties and covenants contained in the Agreement were made only for purposes of the Agreement and as of specific dates, were solely for the benefit of the parties to the Agreement and may be subject to limitations agreed upon by the contracting parties.


Item 7.01 Regulation FD Disclosure.

On August 19, 2026, the Company issued a press release announcing the signing of the Agreement with CKD (the “August 19, 2026 Press Release”). A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

The information furnished under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.






Item 9.01.    Financial Statements and Exhibits.
(d) Exhibits.
Exhibit 
Number
Title
10.1†*
Exclusive License and Development Agreement, effective as of August 20, 2026, by and between Kiora Pharmaceuticals, Inc. and CKD
99.1
Press Release of Kiora Pharmaceuticals, Inc., dated as of August 19, 2026
104Cover Page Interactive Data File (embedded within the Inline XBRL document).

†Certain confidential portions of this exhibit were omitted because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.
*Schedules and exhibits have been omitted from this exhibit pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to furnish copies of any of the omitted schedules and exhibits upon request by the U.S. Securities and Exchange Commission.



SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
KIORA PHARMACEUTICALS, INC.
By:/s/ Melissa Tosca
Melissa Tosca
Chief Financial Officer
(Principal financial and accounting officer)
Date: August 19, 2026



Exhibit 99.1
Kiora Pharmaceuticals Licenses South Korean Ophthalmic Development and Commercialization Rights for KIO-301 to Chong Kun Dang Pharmaceutical Corporation

ENCINITAS, Calif., August 19, 2026 — Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX) (“Kiora”) today announced that it has licensed the development and commercialization rights for KIO-301 in South Korea for ophthalmic indications to Chong Kun Dang Pharmaceutical Corporation (CKD). CKD, based in Seoul, is one of South Korea’s leading pharmaceutical companies. Under the agreement, Kiora will receive a $1 million upfront payment and is eligible to receive development and regulatory milestone payments, as well as royalties on future sales of KIO-301 in South Korea.

“KIO-301 is a molecular photoswitch designed to restore light sensitivity in degenerated retinal cells through a novel and elegant gene mutation-agnostic mechanism,” said Young-Joo Kim, President of CKD. “Retinitis pigmentosa is a rare inherited retinal disease with limited treatment options, leaving the vast majority of patients without access to an appropriate therapy. In South Korea, more than 10,000 people are estimated to be living with the condition. We look forward to working with Kiora and its global partners as KIO-301 advances through development.”

Under the agreement, CKD will be responsible for development and commercialization activities in South Korea. Kiora anticipates that its development and commercialization partners — Laboratoires Théa, Senju Pharmaceutical and CKD — will coordinate efforts to efficiently conduct a single, global Phase 3 clinical trial for KIO-301 in retinitis pigmentosa.

“This agreement expands our development and commercialization network for KIO-301 across major global markets, including the U.S., Europe, Japan, China and now South Korea,” said Brian M. Strem, Ph.D., President and Chief Executive Officer of Kiora Pharmaceuticals. “CKD brings established clinical, regulatory and commercial capabilities that can support development and commercialization of KIO-301 in South Korea, the sole major market in the world that was not partnered until this deal.

“With established global partners in place for KIO-301, we will focus internal resources on advancing KIO-104 for retinal inflammation and fibrosis, evaluating our ion channel modulators for therapeutic applications outside the eye (for instance, in epilepsy), while also evaluating potential strategic transactions to expand our pipeline.”

KO Law PC served as legal counsel to Kiora in connection with the licensing transaction.

About KIO-301
KIO-301 is a molecular photoswitch being developed initially for retinitis pigmentosa, an inherited retinal disease that leads to progressive vision loss. The therapy is designed to restore light sensitivity to retinal ganglion cells after photoreceptors have degenerated. Because KIO-301 is designed to work independent of the underlying genetic mutation, it may have potential applications across multiple inherited retinal diseases, including retinitis pigmentosa, choroideremia and Stargardt disease.

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 potential to expand into other inherited retinal diseases. 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 macular edema due to retinal inflammation. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase (DHODH).





Exhibit 99.1
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, which such approvals or success may not be obtained or achieved on a timely basis or at all, the potential for pipeline expansion, the strategy to pursue a global Phase 3 trial for KIO-301 with Kiora’s commercialization partners, the potential for KIO-301 and KIO-104 to address multiple indications, the potential to receive milestone and royalty payments under the agreement with CKD, the anticipated qualification of KIO-301 for orphan designation in South Korea, and the possibility of future global registration studies and 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, 2026 or described in Kiora's other public filings. 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


Filing Exhibits & Attachments

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