News Release Details

Latest in string of wins underscores Kneat's market-leading position in digital validation for Life Science industry

LIMERICK, Ireland, April 24, 2023 /CNW/ - kneat.com, inc. (TSX: KSI) (OTC: KSIOF), a leader in digitizing and automating validation and quality processes, is pleased to announce it has signed a Master Services Agreement ("the Agreement") with one of the top 20 contract development and manufacturing organizations ("CDMO") in the world, as ranked by 2021 revenue. The Agreement is effective immediately, does not expire, and allows the company to scale Kneat across all its business divisions and affiliates.

Implementation of the software, which is initially for computer systems validation, is expected to go live in Q3 2023. The organization, which employs over 20,000 people, serves companies operating across all stages of pharmaceutical research, development and manufacturing, from more than 100 facilities worldwide.

With services ranging from basic research and diagnostic services to clinical development and manufacturing, Kneat's newest large customer holds excellent potential to expand beyond its initial implementation of Kneat.  Leveraging the Kneat platform across multiple business divisions, sites, and processes is a common next step for large new customers, often requiring a number of licenses multiples that of the initial order.   

CDMOs are an increasingly relevant component of the supply chain in the life science industry.  Annual global revenues for CDMOs are projected to grow at a CAGR of 10% over the next several years, to $160B USD in 2028, according to Valuates Reports.  This strong growth is due in part to the advantages CDMOs offer as therapies become more precise and diverse.  Their use enables pharmaceutical companies to focus on their core business of R&D and to avoid building their own in-house manufacturing capabilities.

Eddie Ryan, Chief Executive Officer of Kneat, commented, "Today's win affirms the progress we are making consolidating our leadership in validation for the life science space.  We expect that more companies in the supply chain will look to benefit from the Kneat platform, which is proving to be an invaluable tool for automating processes that value data integrity."

VALIDATE EU

Today's announcement comes on the heels of Kneat's first user conference for European customers, VALIDATE EU, in Dublin, Ireland. At the sold-out, two-day conference, which is unique in its exclusive focus on digital validation, 20 speakers shared their experiences and results with digitalization of their validation processes with 150 validation and quality professionals. Delegates from all parts of the pharmaceutical supply chain were in attendance, including from 10 of the top 15 global pharmaceutical companies.  Six of these global pharmaceutical companies shared their digital validation journeys using Kneat, from selection through to successful global roll out. Kneat customers have been eager to share their stories to help revolutionize the speed, precision, transparency, and intelligence of validation in the Life Sciences sector. Companies will only author official case studies about products if they actually experience compelling ROI and end user satisfaction. At Kneat we are very proud of our customer satisfaction and many Kneat clients, including several global enterprises, have authored case studies on their own implementation of Kneat and quantifying their results, including:    

• Biogen, which reported productivity improvements greater than 100%, Cycle time improvements greater than 50% and Equipment Change Over resource cycle time efficiency improvements of 85%
• Merck, Sharpe and Dohme, which reported a more than 50% reduction in Cycle time for test execution; a simplification of process steps from fifteen to just eight on average; and the elimination of reliance on three different quality management systems;
• and Fujirebio, which reported a 53% reduction in time for computer system validation projects; a reduction in the number of working days for script execution from 15 to just seven on average; and the elimination of reliance on a time-consuming 'hybrid' validation system.

These and many other client authored case studies can be found in Kneat's library of client stories. Kneat is planning to host an even larger number of customers, validation professionals and industry stakeholders at its third VALIDATE conference in North America in the fall.

About Kneat

Kneat, a Canadian company with operational headquarters in Limerick, Ireland, develops and markets the next generation Kneat Gx SaaS platform. Multiple business work processes can be configured on the platform from equipment to computer validation, through to quality document management. Kneat's software allows users to author, review, approve, execute testing online, manage any exceptions, and post-approve final deliverables in a controlled FDA 21 CFR Part 11/ EU Annex 11-compliant platform. Macro and micro report dashboards enable powerful oversight into all systems, projects and processes globally. Customer case studies are reporting productivity improvements in excess of 100% and a higher data integrity and compliance standard. For more information visit www.kneat.com

Cautionary and Forward-Looking Statements

Except for the statements of historical fact contained herein, certain information presented constitutes "forward-looking information" within the meaning of applicable Canadian securities laws. Such forward-looking information includes, but is not limited to, the relationship between Kneat and the customer, Kneat's business development activities, the use and implementation timelines of Kneat's software within the customer's validation processes, the ability and intent of the customer to scale the use of Kneat's software within the customer's organization and the compliance of Kneat's platform under regulatory audit and inspection. While such forward-looking statements are expressed by Kneat, as stated in this release, in good faith and believed by Kneat to have a reasonable basis, they are subject to important risks and uncertainties. As a result of these risks and uncertainties, the events predicted in these forward-looking statements may differ materially from actual results or events. These forward-looking statements are not guarantees of future performance, given that they involve risks and uncertainties.

Kneat does not undertake any obligation to release publicly revisions to any forward-looking statement, except as may be required under applicable securities laws. Investors should not assume that any lack of update to a previously issued forward-looking statement constitutes a reaffirmation of that statement. Continued reliance on forward-looking statements is at an investor's own risk.