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Second quarter report Q2-2023

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  • US co-development and commercialization partnership signed for CT001 - potential income already from 2024
  • Strong clinical progress
    • Pivotal study 0205 recruitment on track - last patient expected Q3-2023
    • Clinical Trial Application (CTA) for study 0202 submitted and under review by competent authorities
  • Post-period event: Loan facility agreement signed to support US launch and strengthening the cash position

Cessatech A/S (“Cessatech” or the “Company”) today releases its results for the period 1 April – 30 June 2023. The second quarter report is available as an attached document to this press release and on www.cessatech.com under Investor/Filings & Reports. A US partnership agreement has been finalized, which is expected to be transformative to the Company with income anticipated potentially already from 2024. The Company has advanced 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 currently undergoing competent authority review and will be initiated later this year.  

Second quarter financial results 2023 (1 April - 30 June):

  • Net revenue was KDKK 0
  • Operating result was KDKK -6.185
  • Net result was KDKK -5.304
  • Cash at bank end of the period was KDKK 12.435
  • Earnings per share* was KDKK -0,38
  • Solidity** was 76% 

*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 30 June 2023 amounted to 13.788.755 shares, the average number of shares during the second quarter was 13.788.755.
 **Solidity: Total equity divided by total capital and liability.

Highlights during second quarter 2023

  • US co-development and commercialization partnership for CT001
  • Continue good enrolment for study 0205, last patient expected during Q3-2023
  • CT001 shelf-life study completed with more than two years at controlled room temperature
  • CTA for study 0202 submitted for competent authority review in selected countries
  • Progress with EU business development activities to support the future commercial partnership model

“During the second quarter of 2023 we were extremely pleased to enter a US partnership with Ventis Pharma to secure the future development and commercialisation of CT001 in the important and large US market. This transformational deal is part of our commercial strategy to leverage the value of our products in different geographical areas and ensure our much-needed solution for pain management in children experiencing acute pain, can reach the patients who need it. At the same time, we continued to build momentum in our clinical development activities, submitting a clinical trial application for our 0202 study. We also look forward to completing patient recruitment in the coming months in our pivotal study with 0205.”  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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