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First quarter report Q1-2023

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  • Study 0205 is progressing, with last patient expected in Q3
  • Protocol finalized for study 0202, ready for submission in Q2
  • Good progress with the commercialization strategy

Cessatech A/S (“Cessatech” or the “Company”) today releases its results for the period 1 January – 31 March 2023. The first quarter report is available as an attached document to this press release and on www.cessatech.com under Investor/Filings & Reports. The Company is progressing well with planned activities, finalization of recruitment of pivotal study 0205 is expected in the third quarter of 2023 (a randomised double-blind placebo-controlled trial with 220 adults following impacted mandibular third molar extraction) and study 0202 is ready for submission and will be initiated later this year.

Please submit questions to our Q1-Release Q&A session to info@cessatech.com which will be released Tuesday 16 May afternoon 16.00

First quarter financial results 2023 (1 January - 31 March):

  • Net revenue was KDKK 0
  • Operating result was KDKK -5.661
  • Net result was KDKK -4.365
  • Cash at bank end of the period was KDKK 16.442
  • Earnings per share* was KDKK -0,32
  • Solidity** was 92% 

*Earnings per share (DKK per share): Operating result divided by the average number of shares during the period. The total number of shares as of 31 March 2023 amounted to 13.788.755 shares, the average number of shares during the third quarter was 13.788.755.
 **Solidity: Total equity divided by total capital and liability.

Highlights during first quarter 2023

  • Continue enrolment for study 0205
  • Successful completion of second usability test with 8 HCPs
  • Finalized protocol for study 0202 and clinical sites identified, ready for submission (in Q2)
  • Continued optimization of analytical methods and promising stability data for CT001
  • AGM and appointment of new chairman of the board, Martin Olin
  • Business development activities to support the future commercial partnership model

“During the first quarter of 2023 focus was on ensuring progress in our clinical activities. Having implemented actions to improve recruitment levels into our pivotal 0205 study we are now confident that recruitment will be finalized during Q3 with top-line results following shortly after. We also finalized the protocol of our 0202-safety study which we expect to submit to authorities for approval during the second quarter of this year. Additionally, we continued to work on our commercialisation strategy in both the EU and US for CT001 and look forward to moving our plans forward in this area in the coming time” says Jes Trygved, CEO

For more information about Cessatech, please contact:
Jes Trygved, CEO
Phone: +45 9387 2309
E-mail: jes.trygved@cessatech.com
www.cessatech.com

About Cessatech
Cessatech A/S is a Danish pharmaceutical company committed to developing and commercialising evidence-based and innovative medicines for children for the treatment of paediatric acute pain. Its lead asset (CT001) is an analgesic nasal spray for the treatment of acute and planned painful procedures in children. The advantages include needle-free administration, being easy to administer, a fast-acting therapeutic effect, and being medically approved for children. CT001 is at its pivotal stage of clinical development.

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