Fourth quarter report Q4-2021 - preparing for the pivotal trial
Cessatech A/S (“Cessatech” or the “Company”) today releases its results for the period 1 October – 31 December 2021. The fourth 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 is progressing (a trial to investigate the pharmacokinetics in children aged 1-17 undergoing elective surgical procedures) and we are currently finalising the preparation for the initiation of our pivotal trial with CT001 (0205). We anticipate the results from trial 0204 in Q1 2022.
Fourth quarter 2021 (1 October – 31 December):
- Net revenue was KDKK 0
- Operating result was KDKK -4.399
- Net result was KDKK -3.594
- Cash at bank end of the period was KDKK 3.275
- Earnings per share* was KDKK -0,92
- Solidity** was 86%
*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 December 2021 amounted to 6.112.535 shares, the average number of shares during the fourth quarter was 4.080.967 There has been an increase in the number of shares in Q4 related to the exercise of warrant TO 1.
**Solidity: Total equity divided by total capital and liability.
Highlights during fourth quarter 2021
- Improved recruitment for trial 0206
- Final statistical analysis of trial 0204, final results should be ready any day
- Successful warrant TO 1 exercise, overall exercise rate of approximately 97 percent
- Announced the issuance of the company’s first US patent covering CT001
- Preparation of US regulatory strategy
- Continue to build the organisation to execute the final development of CT001
“During the fourth quarter of 2021 we saw improved recruitment in our Phase 2 (0206) pharmacokinetic study with CT001. We had hoped to initiate our pivotal trial (0205), a randomised, double-blind study comparing the analgesic effect of CT001 for treatment of acute pain in adults undergoing surgical removal of an impacted mandibular third molar, by the end of last year. However, formal approval of the trial is still pending from regulatory authorities and we now expect to start this study shortly. CT001 is a unique asset for the company and we look forward to a rich newsflow from the product during the first half of 2022. Like others in our industry we have also been impacted by the COVID 19 pandemic, although we very much anticipate that this will be less of an issue during the coming year. “ says Jes Trygved, CEO