Tillkännagivande • Apr 29
Cessatech A/S to Report Q1, 2026 Results on May 28, 2026 Cessatech A/S announced that they will report Q1, 2026 results on May 28, 2026 Tillkännagivande • Jan 29
Cessatech A/S to Report Fiscal Year 2025 Results on Feb 27, 2026 Cessatech A/S announced that they will report fiscal year 2025 results on Feb 27, 2026 Board Change • Dec 30
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. No highly experienced directors. Director Rachel Gravesen was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Tillkännagivande • Oct 15
Cessatech A/S to Report Q3, 2025 Results on Nov 13, 2025 Cessatech A/S announced that they will report Q3, 2025 results on Nov 13, 2025 Tillkännagivande • Aug 16
Cessatech A/S and Proveca Ltd Announce the Marketing Authorisation Application (MAA) for Acute Pain Management in Children Cessatech A/S and Proveca Ltd. announced that the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for CT001 (a prescription only medicine), confirming that the submission is complete and that the formal scientific review has started. This event marks a significant milestone in Proveca's and Cessatech's mission to bring an innovative treatment candidate to paediatric patients in Europe. CT001 is being developed for acute pain management in children aged 1-17 years with the goal of addressing a clear unmet medical need where current options are limited and inconsistent in meeting patient and caregiver expectations. If approved, CT001 has the potential to become the first and only nasal treatment specifically designed for the management of moderate to severe acute pain in children aged 1-17 year. PUMA is a type of application to the EMA to get a medicine approved specifically for use in children, across the EU. Proveca and Cessatech extend their sincere appreciation to all participants, investigators, study-site teams and the parents and families who took part in the clinical programmes. Their commitment and trust have been essential in advancing this potential therapy toward patients in need. Following validation, the EMA's Committee for Medicinal Products for Human Use (CHMP) has initiated its assessment of CT001. While the outcome of regulatory reviews cannot be guaranteed, both Cessatech and Proveca look forward to a potential EMA approval, pending a positive benefit-risk assessment. Tillkännagivande • Jul 23
Cessatech A/S to Report Q2, 2025 Results on Aug 21, 2025 Cessatech A/S announced that they will report Q2, 2025 results on Aug 21, 2025 Tillkännagivande • Jun 19
Cessatech A/S Announces Promotion of Chief Scientific Officers, Effective June 19, 2025 Cessatech A/S and the Board of Directors announced the promotion of Chief Scientific Officers (CSO) Martin Juhl as a member of the Executive Management team, effective June 19, 2025. The appointment is a direct recognition of Martin's significant impact on the company. This expansion of the leadership team strengthens Cessatech's capacity to execute on its mission to develop vital new treatments for children together with its collaboration partners. Martin has proved invaluable and have been an integral part of delivering progress to date and his strategic insight and drive is an important addition to the executive management of the company. Martin Juhl is a seasoned drug-development leader with expertise spanning the entire development process. He built his foundation through 14 years at H. Lundbeck A/S and brings exceptional academic credentials: a PhD from DTU, a diploma in Pharmaceutical Medicine from Basel, three separate programs at Harvard University, and a Fulbright Scholarship at the University of Illinois. Tillkännagivande • Jun 13
Cessatech A/S has completed a Follow-on Equity Offering in the amount of DKK 14.645083 million. Cessatech A/S has completed a Follow-on Equity Offering in the amount of DKK 14.645083 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 1,151,343
Price\Range: DKK 12.72
Transaction Features: Subsequent Direct Listing Tillkännagivande • May 02
Cessatech A/S Completes Patient Recruitment of Its Final Study Paediatric Study 0202 in the Development Program of CT001 Cessatech A/S announced that it has completed the patient recruitment of its final study Paediatric Study 0202 in the development program of CT001. Study 0202 is the final required clinical study that will evaluate the safety and efficacy profile for CT001 in 150 children, with top-line results expected soon. The company and its partner will initiate the EMA process for submission later this year. CT001 is a nasal spray under development for treatment of acute and procedural pain in children. The development of CT001 in Europe is done in line with an endorsed paediatric investigation plan (PIP) by EMA's Paediatric Committee. Tillkännagivande • Apr 16
Cessatech A/S to Report Q1, 2025 Results on May 15, 2025 Cessatech A/S announced that they will report Q1, 2025 results on May 15, 2025 Tillkännagivande • Jan 30
Cessatech A/S to Report Fiscal Year 2024 Results on Feb 28, 2025 Cessatech A/S announced that they will report fiscal year 2024 results on Feb 28, 2025 Tillkännagivande • Oct 15
Cessatech A/S to Report Q3, 2024 Results on Nov 13, 2024 Cessatech A/S announced that they will report Q3, 2024 results on Nov 13, 2024 Tillkännagivande • Jul 23
Cessatech A/S to Report Q2, 2024 Results on Aug 21, 2024 Cessatech A/S announced that they will report Q2, 2024 results on Aug 21, 2024 Tillkännagivande • Jul 06
Cessatech A/S Announces Board Changes Cessatech A/S announced that at its Extraordinary General Meeting held on July 5, 2024, noted that Peter Birk Rasmussen was leaving the Board of Directors. The general meeting unanimously resolved to elect Anders Dyhr Dombernowsky-Toft as a new board member. Tillkännagivande • May 29
Cessatech A/S Reports First Patient Dosed in Final Safety Study 0202 of Lead Product Candidate CT001 Cessatech A/S announced that the Safety Study 0202 has now been initiated with dosing of the first patient. The trial will assess safety, tolerability, analgesic effect, and feasibility of CT001 in 150 paediatric patients with moderate to severe pain, in the emergency setting. The paediatric investigation plan (PIP) for CT001 nasal spray has been approved by the European Medicines Agency, and Safety Study 0202 is part of the clinical development plan for treatment of acute pain in children. Tillkännagivande • Apr 16
Cessatech A/S to Report Q1, 2024 Results on May 15, 2024 Cessatech A/S announced that they will report Q1, 2024 results on May 15, 2024 New Risk • Mar 03
New major risk - Negative shareholders equity The company has negative equity. Total equity: -kr.1.9m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr.20m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Negative equity (-kr.1.9m). Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (26% increase in shares outstanding). Market cap is less than US$100m (€13.4m market cap, or US$14.5m). Tillkännagivande • Feb 27
Cessatech A/S, Annual General Meeting, Mar 27, 2024 Cessatech A/S, Annual General Meeting, Mar 27, 2024. New Risk • Feb 07
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 26% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr.22m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Revenue is less than US$1m. Minor Risks Shareholders have been diluted in the past year (26% increase in shares outstanding). Market cap is less than US$100m (€14.7m market cap, or US$15.8m). Tillkännagivande • Oct 26
Cessatech A/S Announces the Paediatric Committee Agrees to Reduce the Number of Required Children in the Final Clinical Study with CT001 from 300 to 150 Children Cessatech A/S announced that EMA's Paediatric Committee (PDCO) has agreed to reduce the number of required children in the final clinical study with CT001 from 300 to 150 children. Study 0202 is the final required clinical study that will evaluate the safety profile for CT001 in children. The company presented new data from both adult and paediatric studies to PDCO and with this additional information, the PDCO agreed to the proposed changes to the clinical development program for CT001. The significant reduction of children means that study 0202 can be completed faster and at a significant lower cost than previously assumed. The study is now approved by the competent authorities in Spain and UK where the study will recruit. The company expects the study to start during First Quarter 2024. CT001 is a nasal spray under development for treatment of acute and procedural pain in children. The development of CT001 in Europe is done in line with an approved paediatric investigation plan (PIP) by EMA's Paediatric committee. Tillkännagivande • Oct 18
Cessatech A/S to Report Q3, 2023 Results on Nov 16, 2023 Cessatech A/S announced that they will report Q3, 2023 results on Nov 16, 2023 Tillkännagivande • Sep 22
Cessatech Announces Last Participant Dosed in Pivotal Trial 0205 with Lead Candidate CT001 Cessatech A/S announced that the last participant has been randomized in clinical trial 0205, investigating the postoperative analgesic efficacy of CT001 in adults, following impacted mandibular third molar extraction, a randomised, double-blind placebo-controlled trial with 220 participants. The trial is part of the Paediatric Investigation Plan (PIP) for CT001 nasal spray that has been agreed by the European Medicines Agency. The trial is conducted in adults as it is considered unethical to perform placebo-controlled pain trials in children. The previous trials 0201, 0204, and 0206 will be combined in a final modelling and simulation study to evaluate the dose response profile for CT001. The last clinical safety study 0202 is expected to be initiated later this year. Tillkännagivande • Sep 12
Cessatech A/S Announces EMA's Paediatric Committee Agrees to Paediatric Investigational Plan for CT002 for Procedural Sedation Cessatech A/S announced that EMA's Paediatric Committee (PDCO) has agreed to the Paediatric Investigational Plan (PIP) for CT002 for procedural sedation. CT002 is the second asset in Cessatech's pipeline that has been selected for development. Cessatech A/S has had discussions with EMA's Paediatric Committee and aligned the development plan for CT002. This includes both non-clinical, clinical discussions and quality aspects to ensure the necessary data are obtained to support a potential future authorisation of CT002 in children. The Paediatric Investigational Plan includes two clinical studies, a quality-related study and a modelling and simulation study. No pre-clinical studies are required. The development program will ensure that children in the future may be offered an easy to administer, non-invasive nasal spray for medical procedural sedation. The advantages of an agreed Paediatric Investigational Plan (PIP) for CT002 with the objective of market exclusivity of a PUMA authorization, are a significantly reduced risk profile, much shorter development timelines and especially much lower development costs compared to a full development program of a new molecular entity. Once the agreed studies have been performed, the efficacy and safety will be evaluated - and a PUMA/MA authorization may be granted. CT002 will be tested in children undergoing MRI scanning, which often requires a full anaesthetic procedure, involving an intravenous (IV) sedative-hypnotic agent. The intravenous process is a very unpleasant experience for the child, the parents and to the physicians involved. CT002 is a non-invasive nasal spray designed to overcome this hurdle with a good sedative profile. It is estimated that there are more than +30 million paediatric medical procedures annually in Europe alone, that would normally require a form of sedation. The approval of the CT002 PIP development program is in line with the company's previous communicated strategy to build a differentiated franchise within sedative and acute pain management for children. This second PIP agreement with the European Medicines Agency validates Cessatech's ability to develop innovative solutions for children. The actual initiation of the CT002 development program and related development costs and timelines will be linked to the commercial partnerships. Tillkännagivande • Jul 26
Cessatech A/S to Report Q2, 2023 Results on Aug 24, 2023 Cessatech A/S announced that they will report Q2, 2023 results on Aug 24, 2023 Tillkännagivande • Feb 16
Cessatech A/S, Annual General Meeting, Mar 17, 2023 Cessatech A/S, Annual General Meeting, Mar 17, 2023. Tillkännagivande • Feb 02
Cessatech A/S to Report Fiscal Year 2022 Results on Mar 03, 2023 Cessatech A/S announced that they will report fiscal year 2022 results on Mar 03, 2023 Board Change • Feb 02
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. No experienced directors. No highly experienced directors. Independent Member of the Board of Directors Charlotte Videbaek is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Dec 31
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. No experienced directors. No highly experienced directors. Independent Member of the Board of Directors Charlotte Videbaek is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Tillkännagivande • Sep 23
Cessatech Reports Successful Outcome of Pharmacokinetic Trial in Children of Lead Candidate Cessatech A/S announced positive topline outcome of its Phase 1 pharmacokinetics trial with CT001 in children, which met the primary endpoint of the trial. The trial was designed as a non-randomised, open-label study carried out in 25 children aged 1-17 years who needed premedication for placement of a peripheral venous catheter for general an aesthesia related to a surgical procedure. The primary endpoint was successfully met by obtaining pharmacokinetic data in children, showing relevant clinical exposure ranges in all age groups. The pharmacokinetic data in children are needed for the planned modelling and simulation studies of CT001 (study 0207 and 0208). Modelling and simulation studies may under the right circumstances replace traditional trials through extrapolation of e.g. efficacy from adults to children and thus a minimum of clinical trials need to be done in children during drug development. The reported side effects were mainly of mild intensity and CT001 was considered to be safe and well tolerated in the trial. The most common side effects reported for CT001 were nausea and vomiting. There was a high acceptance rate of CT001 intranasal administration with 25 patients that received at least one dose all responded yes for acceptance, except for one who did not provide response. Tillkännagivande • Sep 07
Cessatech A/S Reports First Patient Dosed in Pivotal Trial of Lead Product Candidate Cessatech A/S announced that the pivotal trial 0205 has now been initiated with the dosing of the first patient. The trial will investigate the postoperative analgesic efficacy of CT001, in adult participants following impacted mandibular third molar extraction, a randomised, double-blind placebo controlled trial with 220 patients. The paediatric investigation plan (PIP) for CT001 nasal spray has been approved by the European Medicines Agency, and trial 0205 is part of the clinical development plan for treatment of acute pain in children. First patient has been dosed in pivotal trial of lead candidate CT001. The pivotal trial, trial 0205, will investigate the postoperative analgesic efficacy of CT001, in adult participants following impacted mandibular third molar extraction, a randomised, double-blind placebo controlled trial with 220 patients. Patient recruitment has now started, and anticipate to finalise recruitment by the first part of 2023. Tillkännagivande • Jul 01
Cessatech A/S Announces Pivotal Trial 0205 Has Obtained Regulatory Approval Cessatech A/S announced that the pivotal trial 0205 has obtained regulatory approval and thereby green light by the authorities and is now ready to initiate patient recruitment. The trial will investigate the postoperative analgesic efficacy of CT001, in adult participants following impacted mandibular third molar extraction, a randomised,double-blind placebo controlled trial with 220 patients. The paediatric investigation plan (PIP) for CT001 nasal spray has been approved by the European Medicines Agency and trial 0205 is a part of the clinical development plan for treatment of acute pain in children. Tillkännagivande • May 17
Cessatech Reports Last Patient Dosed in Pharmacokinetic Trial in Children of Lead Candidate Cessatech A/S announced that the pharmacokinetic trial (0206) in children has finalised recruitment of all planned patients. The trial is designed as a non-randomised, open-label study in 25 children aged 1-17 years needing premedication for placement of a peripheral venous catheter for general anaesthesia related to a surgical procedure. The analgesic and sedative properties of the CT001 nasal spray is expected to be beneficial in this setting. The pharmacokinetic data in children are needed for the planned modelling and simulation studies of CT001. Modelling and simulation studies may under the right circumstances replace traditional trials through extrapolation of e.g. efficacy from adults to children and thus a minimum of clinical trials need to be done in children during drug development. In the 0206 trial, pharmacokinetic data for all relevant age groups will be obtained for use in the planned modelling and extrapolation studies. Tillkännagivande • Mar 10
Cessatech Reports Successful Outcome of Bioavailability Trial 0204 with CT001 Cessatech A/S announced topline results of its Phase 1 bioavailability trial (0204) with CT001 in healthy adults (NCT04807335). In this randomised, three-treatment, three-period, single dose crossover trial 15 healthy subjects were allocated to treatment with CT001, IV ketamine, and IV sufentanil at three different dosing visits. The objective of the trial was to investigate the absorption of CT001 across nasal mucosa (also known as bioavailability) compared to marketed intravenous solutions of the two analgesic drugs composing CT001. Additionally, the safety and tolerability of CT001 was assessed during the trial. Approximately 40% of sufentanil and 50% of ketamine was absorbed into the systemic circulation when administered via the nasal spray as compared to intravenous infusions in the subjects, meeting the objective of the trial. The reported side effects were of mild severity and CT001 was assessed to be safe and well tolerated in the trial. The most common side effects reported for CT001 was headache. Tillkännagivande • Feb 24
Cessatech A/S Expects to Report on its Bioavailability Trial 0204 Within Few Weeks Cessatech A/S announced that the results of the bioavailability trial (0204) has been slightly delayed and will be announced within a few weeks. The trial includes adult healthy volunteers in a randomised three-treatment, three-period, single dose crossover design with a wash-out period of minimum 5 days and maximum 3 weeks. The study will investigate the absorption of CT001 nasal spray across nasal mucosa (also known as bioavailability) compared to marketed intravenous solutions of the two analgesic drugs in a standardised set-up with healthy volunteers. Tillkännagivande • Aug 20
Cessatech Reports First Patient Dosed in Pharmacokinetic Trial in Children of Lead Product Candidate Cessatech A/S announced that the pharmacokinetic trial (0206) in children has been initiated according to plan and that the first patient has been dosed. The trial is designed as a non-randomized, open-label study in 25 children aged 1-17 years needing premedication for placement of a peripheral venous catheter for general anaesthesia related to a surgical procedure. Patients participating in the trial will receive CT001 nasal spray as premedication before placement of a peripheral venous catheter. The analgesic and sedative properties of the CT001 nasal spray is expected to be beneficial in this setting. The pharmacokinetic data in children are needed for the planned modelling and simulation studies of CT001. Modelling and simulation studies may under the right circumstances replace traditional trials through extrapolation of e.g. efficacy from adults to children and thus a minimum of clinical trials need to be done in children during drug development. In the 0206 trial pharmacokinetic data for all relevant age groups will be obtained for use in the planned modelling and extrapolation studies. The paediatric investigation plan (PIP) for CT001 nasal spray has been approved by the European Medicines Agency in November 2019 and trial 0206 is a part of the clinical development plan for treatment of acute pain in children. Tillkännagivande • May 31
Cessatech Reports Last Subject Dosed in Bioavailability Trial of Lead Product Candidate Cessatech announced that the 12-subject bioavailability trial has had the last subject dosed in this randomized three-treatment, three-period, single dose crossover trial. The trial investigates the absorption of CT001 nasal spray across nasal mucosa (also known as bioavailability) compared to marketed intravenous solutions of the two analgesic drugs in a standardised set-up with healthy volunteers. After 'last subject, last visit', the bioanalyses will be performed during Third Quarter and final results are expected during Q4'2021. font-weight:700The paediatric investigation plan (PIP) for CT001 nasal spray has been approved by the European Medicines Agency in November 2019 and this trial is a part of the clinical development plan for CT001 for treatment of acute pain in children. font-weight:700Comment from Jes Trygved, CEO of Cessatech: am very pleased with the fast recruitment into this trial which constitutes an important part of Pediatric Investigational Plan for CT001. There is an urgent need for better treatment of acute pain in children and thus look forward to presenting the results of the trial later this year. Again, are on track with the ambition plan set forward last year, a great effort by the team. 