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Second quarter report Q2-2022 – green light for the pivotal trial 0205

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Cessatech A/S (“Cessatech” or the “Company”) today releases its results for the period 1 April – 30 June 2022. The second 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 with planned activities: Recruitment of trial 0206 was completed (a trial to investigate the pharmacokinetics in children aged 1-17 undergoing elective surgical procedures) and finally regulatory approval was received and thereby a green light to initiate recruitment of the pivotal trial 0205 with CT001, a randomised double-blind placebo controlled trial with 220 patients in adult following impacted mandibular third molar extraction. First patient is expected during Q3 2022.

Second quarter 2022 (1 April - 30 June):

  • Net revenue was KDKK 0
  • Operating result was KDKK -3.940
  • Net result was KDKK -3.319
  • Cash at bank end of the period was KDKK 17.846
  • Earnings per share* was KDKK -0,54
  • Solidity** was 91% 

*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 2022 amounted to 6.112.535 shares, the average number of shares during the second quarter was 6.112.535. **Solidity: Total equity divided by total capital and liability.

Highlights during second quarter 2022

  • Last patient dosed in pharmacokinetics trial 0206
  • Initiated and completed the first usability test on the device for CT001
  • Regulatory approval by authorities for pivotal trial 0205
  • Business development activities to support a future partnership model
  • Continue to build the organisation to execute the final development of CT001

“During the second quarter of 2022 we finalised the recruitment of our Phase 2 trial 0206, the pharmacokinetic study with CT001 and very importantly, obtained regulatory approval for our pivotal trial 0205, a randomised double-blind placebo controlled study with 220 patients. We expect to dose the first patients shortly, bringing us in a selected group of companies in late stage development. We look forward to a very exciting year for the Company with a rich news flow“ 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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