Gencure

“Meetings held and written actions undertaken were documented in the minutes of the meetings of biobridge global's board of directors.”

“In determining the top management official's compensation, the organization relied on biobridge global's process to assist in compensation decisions. The process of determining the top management compensation is disclosed on their form 990.”

“The organization relied on biobridge global's process to assist in compensation decisions. The process of determining other officer's compensation is disclosed on their form 990.”

“Biobridge global is the sole member of the corporation.”

“The organization engages an outside accounting firm to prepare the form 990. Once prepared, the return is reviewed by the financial management staff from biobridge global, a related organization. A copy of the form 990 is provided to the executive committee of the board of directors of biobridge global prior to filing.”

“A copy of the organization's conflict of interest policy is provided annually to all officers, key employees, and board of directors of biobridge global. In addition, questionnaires are given out on an annual basis to all officers, key employees and board of directors which cover business and family relationships and various activities that have occurred over the course of the year. Every attempt is made to ensure that all forms are returned. Individuals who fail to return the requested forms or provide incomplete information are contacted by the organization. In the event of a conflict of interest, the member subject to the conflict of interest must leave the discussion and voting on a transaction or arrangement that results in a conflict of interest. A committee of non-interested representatives shall be appointed to investigate alternatives to the proposed transaction or arrangement. The party with a conflict of interest is not permitted to advocate to other representatives prior to the vote. The committee is responsible for exercising due diligence in determining that the transaction is not more materially advantageous than a deal with a non-interested transaction.”

“Any documents subject to open record requirements are made available upon request.”

“GenCure enables progress in the field of advanced therapies (also known as cell & gene therapies) by offering process and analytical development, bioproduction; in-process and release testing, while leveraging a unified quality management system. We partner with our users with the end goal of clinical development in mind, supporting development of therapies often originating from academic research institutions.”

“During the reporting year, the organization advanced its enterprise-wide quality and operational infrastructure through several key initiatives. The ISO 9001:2015 certification was successfully renewed and extended to the GenCure site, reinforcing alignment across the Quality Management System and ensuring consistent standards across manufacturing, testing, and clinical operations. A full GMP compliance audit was also completed, verifying adherence to FDA regulations and confirming cGMP readiness across bioproduction and testing facilities. The organization also advanced its quality assurance framework through successful execution of process validation and system qualification activities. These efforts ensured that critical production and testing systems operate consistently within defined parameters, supporting product integrity and regulatory compliance. By validating key processes and qualifying essential systems, the organization reinforced its readiness for scale-up and sustained operational excellence. Operational performance improved significantly, with cleanroom utilization averaging 27 days per month-a fourfold increase over Q4 2023 figures. This achievement met the corporate target of a 20% year-over-year production increase, reflecting enhanced throughput and resource optimization. To support additional growth, the organization prepared its site for activation of new liquid nitrogen cryogenic storage, expanding cryopreservation capacity. Additionally, a relocation into additional administrative and warehouse suites consolidated logistics and production support functions, streamlining operations and improving infrastructure integration. These accomplishments demonstrate the organization's commitment to quality, compliance, and scalable growth in support of its mission.”