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Regulatory press release

Cessatech: CT001 soon available for US hospitals in collaboration with STAQ Pharma, for acute pain management in children

Cessatech
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  • Successful completion of technology transfer of CT001 with STAQ Pharma supporting near term product availability
  • CT001 is expected to reach the first hospitals in the US within the coming months
  • The finalisation of marketing and training material is currently in progress

Copenhagen, Denmark - 31 October 2025 - Cessatech A/S ("Cessatech" or "the Company") today announces the successful completion of the technology transfer of CT001, marking a significant step towards making the product available to the first hospitals in the United States for acute pain management in children.

This milestone represents an important advancement in Cessatech's mission to deliver innovative treatments that address unmet medical needs in paediatric care. The Company is collaborating closely with Ventis Pharma as its commercial partner and STAQ Pharma as the manufacturing partner to bring CT001 to the US market.

Finalisation of marketing and training materials is currently underway, and CT001 is expected to become available to the first US hospitals in the coming months.

In parallel, CT001 is being evaluated by the European Medicines Agency (EMA) through a Paediatric-Use Marketing Authorisation (PUMA) application - a dedicated regulatory pathway for medicines intended specifically for use in children. CT001 is being developed for the management of acute pain in children aged 1-17 years, with the aim of providing a safe, effective, and consistent treatment option where current alternatives remain limited.

Comments from the CEO, Jes Trygved
"Our collaboration with STAQ Pharma marks an important step in bringing CT001 to patients in the United States. STAQ Pharma's strong expertise in sterile manufacturing ensures a high-quality product for hospitals, and with marketing and training materials now being finalised, we are excited to soon make CT001 available for children in need of better pain management options."

About STAQ Pharma and Ventis Pharma
STAQ Pharma is a hospital-backed, FDA-registered outsourcing facility that manufactures nasal sprays and sterile compounded medications under cGMP standards. Its mission is to ensure safety, transparency, availability, and quality in delivering critical drugs to hospitals and care centers - especially in times of drug shortages. Ventis Pharma is a biopharmaceutical commercial company dedicated to developing and formulating innovative pain-management therapies. Its mission is to deliver safe, long-acting, low-toxicity solutions.

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