Pressreleases, rapporter och nyheter för Cessatech
Vid den allmänna bolagsstämman valdes Mikkel Rostock-Jensen till ordförande. Stämman konstaterades vara laglig och beslutskapabel. Alla förslag hade redan fått starkt stöd genom poströster och fullmakter. Årsberättelsen för 2025 godkändes enhälligt, liksom beslutet att överföra det konsoliderade underskottet på 10,904 tDKK till nästa räkenskapsår. Charlotte Videbæk, Flemming Steen Jensen, Martin Olin och Rachel Curtis Gravesen omvaldes till styrelsen, och Martin Olin valdes senare till styrelseordförande. PricewaterhouseCoopers återvaldes till revisor. Inga andra ärenden diskuterades, och mötet avslutades. För mer information om Cessatech, kontakta Jes Trygved, VD.
Cessatech's Board of Directors is calling for the Annual General Meeting on March 30, 2026, at 9:00 am CET at the company's address in Hellerup, Denmark. The agenda includes the election of a meeting chairman, a report on the company's activities over the past year, approval of the 2025 Annual Report, a resolution on covering losses, election of board members and an auditor, and other business. The board proposes Mikkel Rostock-Jensen as chairman, suggests noting the management's report, adopts the 2025 Annual Report, carries forward a net loss of tDKK 10,904, re-elects current board members, and re-elects PricewaterhouseCoopers as auditor. Shareholders can vote by proxy or mail, with forms available on the company's website. Proposals require a simple majority to pass. Shareholders must register by March 23, 2026, and request admission by March 27, 2026. Additional documents and information are accessible on the company's website.
Under 2025 redovisade företaget en nettoomsättning på 5,718 KDKK och ett rörelseresultat på -14,967 KDKK. Nettoresultatet var -10,904 KDKK och kassabehållningen vid periodens slut uppgick till 8,591 KDKK. Resultatet per aktie var -0.60 KDKK och soliditeten låg på 91%. Styrelsen och VD föreslår att ingen utdelning betalas ut för 2025. Årsredovisningen kommer att presenteras för godkännande vid årsstämman den 28 mars 2026. Under året uppnådde företaget flera milstolpar, inklusive positiva resultat från en klinisk studie för CT001, erhållande av positivt yttrande under EU:s medicintekniska förordning och inlämning av en ansökan om marknadsföringstillstånd för pediatrisk användning till EMA. Företaget stärkte sin finansiella ställning genom en riktad nyemission som inbringade cirka 15 miljoner DKK och utökade sitt samarbete i USA med STAQ Pharma. Dessutom förstärktes ledningen med utnämningen av Martin Juhl som Chief Scientific Officer.
Cessatech is preparing for the US launch of a product in collaboration with Ventis Pharma and STAQ Pharma, focusing on finalizing marketing and training materials. Development batches have been produced, and stability studies are underway to meet FDA requirements. A poster presentation on CT001 will occur at the SPPM meeting in Denver in March 2026. In 2025, Cessatech received a positive MDR opinion for CT001 and submitted a Marketing Authorisation Application to the EMA. New patents were granted in the US and Asia-Pacific. Sarah Margaux Toft-Jørgensen joined as Senior Director of Finance & Investor Relations. CEO Jes Trygved expressed satisfaction with 2025's progress and anticipates a productive 2026, with a focus on the US and European markets.
Cessatech A/S has released its financial results for the third quarter of 2025, covering the period from July 1 to September 30. The company reported a net revenue of KDKK 1,243, an operating result of KDKK -3,967, and a net result of KDKK -3,050. By the end of the period, the cash at bank was KDKK 9,090, with earnings per share at KDKK -0.16 and a solidity of 84%. CEO Jes Trygved commented on the company's progress, highlighting the closure of clinical activities for CT001 and the completion of the US manufacturing tech transfer. He mentioned ongoing efforts to enhance organizational capabilities and planning for the next phase of CT001, with a focus on upcoming US activities. For further information, Jes Trygved can be contacted via phone or email.
Cessatech A/S has successfully completed the technology transfer of CT001, a treatment for acute pain management in children, marking a significant step towards its availability in the United States. The company is working with Ventis Pharma and STAQ Pharma to bring CT001 to the US market, with marketing and training materials being finalized. The product is expected to be available in US hospitals soon. Additionally, CT001 is under evaluation by the European Medicines Agency for use in children aged 1–17 years. Cessatech aims to provide a safe and effective treatment option where current alternatives are limited. STAQ Pharma, known for its expertise in sterile manufacturing, and Ventis Pharma, focused on innovative pain-management therapies, are key partners in this initiative.
Cessatech A/S has released its financial results for the second quarter of 2025, covering the period from April 1 to June 30. The company reported a net revenue of KDKK 1.243, an operating loss of KDKK 3.554, and a net loss of KDKK 2.785. The cash at bank at the end of the period was KDKK 15.051, with earnings per share at KDKK -0.16. The company's solidity was 75%. Recent developments include significant operational and regulatory progress, with advancements in US manufacturing tech-transfer and the development of the CT001 dossier for EMA submission. The organization has strengthened its team by promoting Martin Juhl to the Executive Management team and has improved its financial position through a directed issue of DKK 14.6 million. Positive results from Study 0202 are seen as a critical milestone for regulatory submissions and future commercial activities.
Cessatech A/S and Proveca Ltd have announced that the European Medicines Agency (EMA) has validated their Marketing Authorisation Application for CT001, a prescription medicine for managing acute pain in children aged 1-17. This validation signifies the start of the formal scientific review process by the EMA. CT001 aims to address an unmet medical need by providing a nasal treatment for moderate to severe acute pain in children, potentially becoming the first of its kind if approved. The application follows a licensing agreement between Cessatech and Proveca, completed less than a year ago, and is a result of comprehensive clinical development efforts. Both companies express gratitude to all involved in the clinical programs and look forward to the possibility of EMA approval. CT001 is a nasal spray combining ketamine and sufentanil, developed with an emphasis on efficacy, safety, and usability in children. Proveca is a UK-based pharmaceutical company focusing on paediatric medicines, while Cessatech is involved in the development of innovative treatments.
Studie 0202 visade lovande resultat med en smärtreduktion på 75%, vilket är positivt jämfört med tidigare studier på barn. Det är dock för tidigt att säga hur detta påverkar kommersialisering eller EMA-godkännande. Feedback från deltagande platser var positiv, med synlig lindring hos barn och föräldrar. Användning i tandkliniker övervägs, särskilt i större europeiska kliniker, men regler varierar. I USA har lanseringen försenats på grund av tillverkningsproblem, men förväntas ske i slutet av 2025. Marknaden för tidig tillgång täcker hela USA. Företaget har valt att öka kapitalmålet till cirka 15 miljoner DKK på grund av investerarintresse, vilket ger en god kassaposition för 2025-2026. Fokus har legat på CT001 innan ytterligare utveckling av CT002, där kommersiella partnerskap kan spela en roll. Kliniska studier för CT002 skjuts upp tills USA-lanseringen är på rätt spår. För mer information, kontakta Jes Trygved, VD för Cessatech.
Cessatech A/S has announced the promotion of Martin Juhl to the Executive Management team, recognizing his significant contributions as Chief Scientific Officer. This move is intended to enhance the company's ability to develop new treatments for children. Martin Juhl, with extensive experience in drug development and impressive academic credentials, has been instrumental in the company's progress. CEO Jes Trygved praised Martin's efforts and leadership, noting his strategic insights as vital for the company's growth. Cessatech is currently developing CT001, a nasal spray for acute pain in children, with European development aligned with EMA's Paediatric Committee guidelines. Proveca holds exclusive rights to market CT001 outside North America.
Cessatech A/S announced a capital increase through the issuance of shares to a select group of professional investors, known as a Directed Issue. The capital increase, amounting to DKK 230,268.60, has been registered with the Danish Business Authority. This raises the company's total share capital to DKK 3,715,287.40, with the number of shares increasing to 18,576,437. The new shares, priced at DKK 12.72 each, were issued without preferential rights for existing shareholders and were facilitated by Sedermera Corporate Finance AB. These shares are expected to begin trading shortly and are identical to existing shares, carrying no transfer restrictions or special rights. Cessatech utilized Sedermera Corporate Finance AB and Elmann Advokatpartnerselskab as financial and legal advisors, respectively. The press release includes a disclaimer about jurisdictional restrictions and clarifies that it does not constitute an offer or solicitation for securities. It also contains forward-looking statements subject to risks and uncertainties.
Cessatech A/S announced a decision by its board to increase the company's share capital by issuing 1,163,123 new shares, raising approximately DKK 14.8 million before transaction costs. The shares were priced at DKK 12.72 each, determined via an accelerated bookbuilding process managed by Sedermera Corporate Finance AB. The capital raise aims to strengthen Cessatech's financial position ahead of the U.S. commercial launch of their product CT001, following positive developments in their regulatory and development milestones. The board opted for a directed share issue, citing it as more efficient and less costly than a rights issue, despite the deviation from shareholders' preferential rights. This decision will result in a 6.3% dilution for existing shareholders not participating in the issue. The new shares will be identical to existing shares and are expected to be registered and traded shortly after June 5, 2025. The press release includes a disclaimer about the non-distribution of information in certain jurisdictions and clarifies that it does not constitute an offer or solicitation to buy securities. It also contains forward-looking statements about the company's future activities and financial outlook.
