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The Management Board of Bioceltix S.A. with its registered office in Wrocław (the “Company”, the “Issuer”) hereby announces that on April 13, 2026, it concluded an advisory agreement with a specialized advisory entity regarding support for the development process of the Company’s stem cell-based veterinary medicinal products in the U.S. market.
The agreement was concluded with an independent advisor possessing extensive and documented experience in cooperation with the U.S. Food and Drug Administration (FDA), including the Center for Veterinary Medicine (CVM). Under the agreement, the advisor undertook to provide consulting services in the field of regulatory strategy, preparation of documentation, and support for the Company in the process of obtaining the possibility to conduct regulatory dialogue with the FDA/CVM.
The advisor acts as an independent contractor, without the right to represent the Company towards third parties, except in cases agreed by the parties. The agreement includes standard provisions regarding confidentiality, intellectual property protection, and liability of the parties, whereby all results of the advisory work and intellectual property rights shall be vested in the Company. The agreement has been concluded for the period necessary to perform its scope, no longer than 3 years (within the agreement it will be possible to carry out advisory projects concerning all medicinal products developed by the Company). The advisor’s remuneration will be calculated based on an hourly rate specified in the agreement for the work actually performed. The remaining provisions of the agreement do not deviate from standard provisions used in this type of advisory agreements.
The scope of work specified in the agreement includes, in particular:
- preparation and conduct of a kick-off meeting and ongoing consultations,
- analysis and verification of information and development of a regulatory strategy for the Company’s products,
- collection, review and assessment of scientific and regulatory data,
- preparation of a potential Product Development Plan along with a potential Gap Analysis,
- support in establishing a representative in the USA,
- assistance in configuring electronic systems for submission of documentation to the FDA,
- assistance, through preparation and opening of appropriate regulatory pathways, in the preparation of confidential documentation submitted to the FDA/CVM, including, among others, INAD (Investigational New Animal Drug, i.e. a formal application submitted to the FDA/CVM enabling the conduct of research and development of a veterinary medicinal product prior to its marketing authorization) and VMF (Veterinary Master File, i.e. documentation containing detailed information, among others, on manufacturing, packaging or storage processes of medicinal products, used to support drug approval applications without disclosing trade secrets),
- preparation of applications and documents for meetings with the FDA/CVM,
- preparation for meetings and participation in meetings with the FDA/CVM,
- ongoing advisory services during the project implementation.
Based on information obtained from the advisor and initial project assumptions, the anticipated schedule of work includes:
- preparatory stage (kick-off, data analysis, information gathering),
- configuration of FDA electronic systems,
- preparation of an application for a fee waiver (so-called Sponsor Fee Waiver),
- opening of the INAD pathway,
- preparation for meetings with the FDA/CVM.
The above activities should conclude with the submission of a request for a meeting with the FDA/CVM.
The Company estimates that the total time required to reach the first meeting with the FDA/CVM is approximately 6 to 9 months, noting that this is only an indicative timeframe.
The key objective of the activities carried out by the Issuer under the concluded agreement is to lead to a meeting between the Company and the FDA/CVM and to obtain feedback regarding the possibilities and methods of development of the Company’s products in the U.S. market.
Preliminary consultations conducted with the advisor indicate that the Company qualifies for a fee waiver for opening the INAD pathway, which, however, does not determine the effectiveness of such an application. The final decision in this matter will be made by the FDA. In the event of a negative decision regarding the fee waiver application, the Company will be required to pay an administrative fee of USD 165,441.
The Management Board of the Issuer has considered this information to be material due to the potential impact of the agreement on the future commercialization process of the Company’s products and on the future financial standing of the Issuer. The conclusion of the agreement constitutes an important step towards the Company’s entry into the U.S. market and the initiation of formal regulatory dialogue with the FDA/CVM. The information and recommendations obtained under the cooperation may be of key importance for the development, registration and commercialization of the Company’s products in the U.S. market.
Signatures of persons representing the Company:
Łukasz Bzdzion – President of the Management Board
Paweł Wielgus – Member of the Management Board
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