Kala Bio And Virotek Finalize Definitive Agreement Establishing Exclusive U.S. Distribution Partnership For Ophthalmology Genetic Testing Program

(MENAFN- GlobeNewsWire - Nasdaq) Agreement Grants Kala Exclusive U.S. Rights to Market and Distribute Virotek's Ophthalmology Genomic Testing Program

ARLINGTON, Mass., Sept. 03, 2026 (GLOBE NEWSWIRE) -- Kala Bio, Inc. (Nasdaq: KALA) ("Kala") and Virotek Inc. ("Virotek") today announced that they have finalized a definitive exclusive distribution and reseller agreement (the "Agreement") and related quality, brand, and data protection agreements. Under the Agreement, Kala will be the exclusive distributor and reseller in the United States for an initial one-year term, with continued exclusivity contingent on Kala achieving agreed commercial milestones for Virotek's ophthalmology genetic testing and screening program. The Agreement follows the non-binding letter of intent announced by the companies on September 1, 2026, and takes effect on September 4, 2026.

Under the Agreement, Kala holds the exclusive right to market, promote, distribute, and resell Virotek's ophthalmology genomic program throughout the United States for an initial one-year term, with exclusivity contingent on Kala achieving agreed commercial milestones. Virotek continues to operate the program's infrastructure, kit supply, specimen processing, and clinical reporting, and will provide training and program materials to Kala's channel partners. The companies have agreed to a profit-sharing structure for the program, effective once Virotek recovers its program costs. This release does not set out additional commercial and financial terms of the Agreement.

The Agreement also includes a right of first refusal in favour of Kala for certain ophthalmology products and services that Virotek may propose to sell or license to a third party. It also establishes a framework under which the companies may, by mutual agreement, activate additional clinical verticals over time, including oncology, a preventive-health testing franchise, telehealth, and white-label distribution channels.

According to third-party market research, the U.S. genetic testing market was valued at approximately $5.7 billion in 2025 and is projected to reach approximately $6.9 billion in 2026. In ophthalmology, peer-reviewed prevalence studies estimate that inherited retinal diseases affect approximately 1 in 3,450 individuals, and U.S. registry data identified more than 40,000 new diagnoses of retinitis pigmentosa, choroideremia, and achromatopsia over a seven-year period. Kala believes that non-invasive, specialist-administered collection, combined with broad multi-gene panel coverage, positions the program to address diagnostic demand in this population, and that the oncology and preventive-health verticals contemplated by the Agreement address substantially larger patient populations. Kala has not established, and this release does not contain, any revenue projections from the Agreement.

The Agreement reflects Kala's capital allocation strategy of building operating scale through a series of staged, capital-efficient partnerships, growth initiatives, and acquisition opportunities. Kala's approach is to pursue opportunities it believes can contribute to its operating base and be accretive over time, while preserving flexibility to evaluate additional opportunities as they arise. Kala believes that a staged approach allows the company to manage execution risk, deploy capital selectively against demonstrated milestones, and build a platform intended to support long-term growth. There can be no assurance that any particular transaction, including this one, will produce the results Kala anticipates.

Over time, the companies may explore U.S.-based laboratory capacity for the program, in addition to Virotek's existing accredited laboratory operations, subject to further agreement on scope, cost, and timing.

"This agreement grants Kala exclusive U.S. rights to a commercially active genomic testing program in ophthalmology, a field in which Kala has operated for more than a decade. Our strategy is to build operating scale through disciplined, staged transactions. This is a step we can take now while we continue to evaluate other opportunities. We are moving into execution with the Virotek team," said Avi Minkowitz, Chief Executive Officer of Kala.

"Signing this agreement moves us from intent to execution. Kala's commercial reach and public-company platform provide our ophthalmology program with a fast path to eye care practices, telehealth channels, and patients across the United States. We're already working together on the roadmap to expand into oncology and preventive health," said Dr. Saeid Babaei, Chairman and Chief Executive Officer of Virotek.

About Kala Bio, Inc. (NASDAQ: KALA)
KALA BIO, Inc. is a clinical-stage biopharmaceutical company building a dedicated, on-premises AI infrastructure platform for the biotechnology industry. The Company's dual strategy combines a proprietary biologics pipeline-including its mesenchymal stem cell secretome (MSC-S) platform and FDA Orphan Drug- and Fast Track-designated product candidates-with a scalable AI platform-as-a-service business designed to deploy secure, purpose-built AI solutions directly within biotech and pharmaceutical client environments.

Through its exclusive worldwide license for the Researgency AI research platform from Younet, Kala intends to serve as the dedicated AI infrastructure partner for the biotechnology industry, enabling organizations of all sizes to unlock the value of their proprietary biological data without surrendering control. Kala is advancing an agentic transformation strategy for biomedical organizations through Researgency.ai, a platform designed to enable scalable, governed deployment of AI agents across research, documentation, and operational workflows. The Company's focus on enterprise security, real-time performance, and seamless integration positions it at the forefront of innovation in the life sciences AI sector.

Kala believes the future of biomedical innovation is in agentic systems.

For more information, visit and Researgency.ai

About Virotek

Virotek is a Wyoming-based corporation offering precision health and clinical genomics products and services to healthcare providers and organizations that span the full continuum of care - from preventive risk assessment, through early cancer detection, to personalized treatment guidance - delivered from a single, integrated platform. For more information, visit Virotek.io.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's strategic initiative to build an AI infrastructure platform for the biotechnology industry; plans to develop and deploy the Researgency AI platform both internally and to external clients; expectations regarding the potential benefits of AI-driven analytical tools; plans to reassess historical datasets and identify new therapeutic indications; expectations regarding the AI drug discovery market and industry trends; expectations regarding the Company's ability to generate recurring platform revenue; plans regarding potential partnerships, client deployments, or technology licensing opportunities; expectations regarding the Company's competitive position and the differentiation of its on-premises deployment model; the potential exercise of development continuation or renewal options under the Agreement; and other statements that are not historical facts. It also includes statements regarding the proposed distribution partnership with Virotek, including the negotiation and execution of definitive agreements and the anticipated benefits and timing thereof.

The Company used words like "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions to identify these forward-looking statements. These statements involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance, or achievements to be materially different from those expressed or implied by such statements. Important factors that could cause such differences include, but are not limited to: risks that AI technologies may not produce expected results in drug discovery or development; risks related to the development, deployment, and performance of the Researgency platform; risks that the Company may not successfully attract or retain external platform clients; risks that the platform-as-a-service business model may not generate anticipated revenues; risks that the Company's product candidates may not be successfully developed or commercialized; risks related to the Company's limited cash resources and ability to continue as a going concern; risks that the third-party information contained herein was not accurate at the time it was published and/or does not accurately predict the future; risks related to the Company's ability to raise future capital and the possibility that market conditions may limit the Company's ability to raise capital on favorable terms; risks related to the Company's ability to regain compliance with Nasdaq listing requirements; competition from larger, better-resourced companies including major technology and pharmaceutical companies; dependence on key personnel and third-party technology providers; the accuracy of third-party market forecasts and projections cited herein; risks that the Company may elect not to expand or continue its deployment of the Researgency platform beyond the initial term; risks that Younet may not perform its obligations under the Agreement; and other risks detailed in the "Risk Factors" section of the Company's Annual Report on Form 10-K as they may be revised in the Company's Quarterly Reports on Form 10-Q and Current Reports on Form 8-K and other filings with the Securities and Exchange Commission.

Forward-looking statements speak only as of the date of this release, and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

Contact:
Avi Minkowitz
Chief Executive Officer, KALA BIO, Inc.
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Dr. Saeid Babaei
Chairman and Chief Executive Officer, Virotek Inc.
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