Newsletter #4 - Nov 2021, Preparing for next year...

Preparing for next year...
We continue to make good progress with the clinical activities for CT001, and 2022 will be a very interesting year for the company. We have started the work on our US development strategy and with the first US patent we are off to a really good start. We have also started interacting with US companies and authorities, more to come in 2022. 

We continue to strengthen the team, and with Benedikte Bandak as Head of Clinical Development and Operations we are now ready for executing on the late-stage development phase - see medwatch-link for a brief introduction.

US patent - issuance of first US patent covering CT001 
The United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11.160.799 to the Company, which is directed to a storage stable pre-filled and ready to use nasal spray device - a method of treating or preventing pain in a child by use of said device. We are very pleased with the issuance of the US patent which constitutes an important element and foundation for our further activities and considerations for the US, one of the most important markets.

A short update on the ongoing trials: 0204, 0206 and 0205
Trial 0204 should have data before end of the year, the team is working on validation and analysis so there should not be any delays. 
Trial 0206 is off to a good start, but will be somewhat delayed, especially given the COVID situation in Denmark as hospitals are struggling and trials are down prioritised. We expect to complete recruitment in Q1 2022. 
Trial 0205 (a non-hospital study) is pending approval from EC/DKMA which hopefully will be before end of the year, but could go into early 2022. 
Overall it should not impact the final timelines for our development plan.

Stock warrants status 25 Nov - 16 Dec 
The IPO from Dec 2020 included a warrant, and the warrant is due during next month. During the exercise period, holders of warrants of series TO 1 have the right to subscribe for new shares in Cessatech A/S. Upon full exercise of warrants of series TO 1, Cessatech will receive approximately DKK 25.2 million before issue costs.  Proceeds will mainly be used to finance the completion of the ongoing trials and trial 0202 and modelling. Management and Board of Directors (who have warrants) all intend to exercise their warrants. More information will be provided within next weeks.