ARLINGTON, Mass., Sept. 01, 2026 (GLOBE NEWSWIRE) -- Kala Bio, Inc. (Nasdaq: KALA) ("Kala") and Virotek Inc. ("Virotek"), a CLIA-registered precision health and clinical genomics company, today announced that they have entered into a letter of intent (the "LOI") outlining the principal terms under which the companies intend to negotiate a definitive agreement appointing Kala as the exclusive distributor and reseller in the United States of Virotek's genetic testing and screening program for ophthalmological indications.
Under the framework outlined in the LOI, Kala would market, promote, and distribute Virotek's ophthalmology genetic testing and screening program to eye care practices, telehealth platforms, and other channels across the United States, while Virotek continues to operate the program's underlying CLIA-registered laboratory infrastructure, kit fulfillment, specimen processing, and clinical reporting. The companies have also outlined a framework under which the collaboration could, by mutual agreement, expand over time into additional clinical verticals, including oncology and a preventive-health testing franchise, as well as telehealth and white-label channels.
The proposed partnership extends a therapeutic area Kala already knows well. Kala Bio Inc., formerly Kala Pharmaceuticals, built and commercialized two FDA-approved ophthalmic therapies before divesting that commercial franchise to Alcon in 2022. Kala's clinical-stage pipeline remains centred on the eye. Virotek's ophthalmology genetic testing and screening program gives Kala a commercial, revenue-generating opportunity in the same clinical area the company has been built around, alongside Kala's existing relationships across the U.S. eye care community.
The LOI and the proposed transaction remain subject to, among other things, the negotiation and execution of definitive agreements, and other customary conditions, including required corporate, regulatory, and Nasdaq approvals. The companies are targeting execution of definitive agreements within approximately 30 days of signing the LOI, although there can be no assurance that definitive agreements will be reached on these or any terms, or at all.
"We believe this is an accretive step in developing KALA Bio's ophthalmic underpinning and in creating a path toward near-term revenue, while we continue to optimize KALA for growth. Kala's mission is to put clinically validated, data-driven diagnostics into the hands of the clinicians and patients who need them most. Virotek's ophthalmology genetic testing program is exactly the kind of revenue-generating, accredited platform we believe belongs in Kala's commercial network, and it sits squarely within the therapeutic area Kala was built around. We look forward to moving quickly toward a definitive agreement," said Avi Minkowitz, CEO of Kala.
"Kala's commercial reach gives our ophthalmology program a fast, credible path to patients across the U.S., and we're glad to be building that with a partner who already knows this space well." Dr. Saeid Babaei, Chairman and CEO of Virotek, added.
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 www.kalarx.com 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.
am@kalarx.com
www.kalarx.com | www.Researgency.ai
Virotek Inc.
info@virotek.io
