Key Cessatech priorities for the rest of the year

• The US launch is almost there
• More paediatric data to be presented at IASP 2024, World Congress on Pain
• Commercial partnerships for Europe is also a key priority

On 2 August 2024 Cessatech A/S ("Cessatech" or the "Company") has given an update for its key priorities for the remaing part of this year. The  short update includes the Company's key priorities and some of the most important events for the remaining part of 2024.

The US launch is almost there
Timing of first sale - Both teams have been very busy preparing for the launch under the Early Access Program in the US - and we are still waiting for the final approvals before we can initiate the first sale. Moving to a new manufacturing setup takes time and much effort, both we are almost there. We expect first sales during second half of 2024 (previously first half of 2024).   

Key material is ready - Brand name, final packaging and much marketing material is done and and we are eager to share this once the launch of the first CT001 packs is official, but we are very satisfied with the design and the quality and have received very positive feedback from the physicians that has seen the material.  The visual material will always be interesting for a launch, even if it is an Early Access Program, and the teams have worked hard to optimize and finalize. 

More paediatric data to be presented at IASP 2024, World Congress on Pain
At IASP 2024, the World Congress on Pain, which will take place 5-9 August in Amsterdam, Cessatech will be presenting a Poster with results from our modeling and simulation studies 0207 and 0208, based the new developed unified PK-PD model, encompassing all available  paediatric and adult study data (0201, 0204, 0205, and 0206) are shared. This presentation represents a culmination of our recent research efforts and provides valuable insights into CT001's efficacy across different age groups. The unified PK-PD model is a significant advancement in our understanding of drug combination’s behavior and will play a crucial role in our regulatory submissions and commercial launch strategies.

Short update on Paediatric Safety Study 0202 - We are pleased to report that the final CT001 pediatric safety study is well underway at emergency departments across Spain and the United Kingdom. This study is an important milestone in developing new evidence-based medicines for children and providing hospitals with alternatives to off-label, unapproved treatments in pediatric patients, as is current practice. Early reports from all sites have been positive, providing encouraging initial results. Notably, our preliminary data show only a few adverse events (AEs), which are mainly mild and common. These initial safety findings suggest a favorable risk profile for CT001 in pediatric patients, although it's important to note that CT001 is not yet an approved medication. This ongoing study represents a significant step in our commitment to improving pediatric care and ensuring the safe, effective treatment of pain in children. We are eager to continue pursuing this important goal and to further validate the safety of CT001.

Commercial partnerships for Europe is also a key priority​​​​​​​
Commercial partnership for Europe is also a key priority for the Company. While we have focused significantly on the US partnership and the upcoming launch of CT001, we have in parallel continued our process for developing our partnership strategy in Europe.

The European partnership process was initiated in 2023, and we anticipate announcing an update during the second half of 2024. We are pleased to report that we have engaged in numerous productive discussions and are optimistic about establishing an effective model for Europe. We look forward to presenting more on the structure later this year.