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.