Cessatech

1.Data from Study 0202 – any potential impact for later commercialization or EMA approval process?

• We believe the top-line data shared, is really good – and most importantly it fits very well with the predicted data from Study 0208. An overall pain reduction of 75% is considered very good. 
• There is not much data in acute pain on children, but two larger studies (+400 children), had a reduction in pain of -64% and -60% (the last being an IV administration study).  
• It is a bit early to evaluate if this will have a large impact on commercialization or EMA process, but it will for sure support the case in many ways.

2.Feedback from sites involved in the Study 0202 – and any other options for use in for instance dental clinics?

• As the Chief Investigator of Study 0202 mentioned; The response from children and their families often said more than any statistic: within minutes, children were visibly more settled, parents looked reassured, and you could see the relief on everyone’s faces. This has been very much the same feedback from the other sites involved in the study. 
• We know that our US partner is very interested in the dental clinics, and this will also be considered in European markets, especially at the larger clinics, but we also know that regulations vary across the European markets. 

3.US update and setup – when is the launch anticipated, and how big is the market for ‘early access program’?

• We have been delayed in the US, mainly due to the manufacturing setup. Last year we decided to find another manufacturer with more experience within sterile nasal production. More updates on this partnership will come in the second part of 2025.  
• We are about to initiate the stability studies and once these have been completed and accepted, we can release for launch, hopefully end 2025
• The market for the early access program is basically covering all states in the US. 

4.Timing of direct issue – and the investors involved, how long does this take the company?

• As the US launch has been slightly delayed, we preferred to raise some capital instead of using the loan facility. Originally, we only planned for +10 mill dkk but we had much interest from several investors to we increased the target to app 15 mill dkk. 
• The list of investors is mainly professional individuals, and family offices with their investors. 
• As we have no further planned development activities for 2H of 2025 we have a good cash position and can focus more on the US setup. This should be sufficient for 2025-2026 not accounting for the anticipated income. 

5.When can we expect any news or progress on the pipeline and CT002?

• We have focused mainly on CT001, as we wanted to prove that we are on track and close to finalization before we initiate more on the pipeline – and hopefully our future commercial setup will also accelerate this process
• We have had talks with our commercial partners related to CT002 and it is likely that they will be involved in the further development
• We have done some work on CT002; patents, early formulations and obviously an endorsed PIP from EMA, but we will wait with clinical studies until we are fully on track with US.