Cessatech

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.

Cessatech A/S has announced plans to conduct a directed share issue to raise a minimum of DKK 10 million from institutional and professional investors. This move aims to strengthen the company's financial position in preparation for the U.S. launch of their product, CT001. The subscription process will be facilitated through an accelerated bookbuilding procedure led by Sedermera Corporate Finance AB. The company has recently achieved significant development milestones, including a positive MDR assessment for CT001 and the completion of key studies under the EMA approved PIP program. Cessatech is finalizing preparations for the CT001 EMA submission and the U.S. manufacturing setup, with the product launch anticipated in 2025. The directed issue will not offer preferential rights to existing shareholders, and the details of the share pricing and allocation will be announced soon. The company has also engaged legal and financial advisors to assist with this process. This announcement is subject to regulatory requirements, and the information is intended for qualified investors under EU regulations.

Cessatech A/S has announced positive top-line results from its Paediatric Study 0202, which is part of the development program for CT001, an intranasal, needle-free analgesic for acute paediatric pain. The study showed a rapid and meaningful reduction in pain scores, confirming the safety and tolerability of CT001. This marks a significant milestone towards regulatory submission in Europe, with plans to initiate the EMA submission process later this year. The study involved 152 children with moderate to severe pain and demonstrated a quick onset of pain relief, with 55% of patients reporting reduced pain at 15 minutes and 89% at 30 minutes. No unexpected adverse effects were noted, and the treatment was well-received by children, parents, and physicians. CT001 is being developed in line with a paediatric investigation plan endorsed by the EMA. Proveca, a UK-based company, holds exclusive rights to market CT001 outside North America. The study's chief investigator and Cessatech's executives highlighted the treatment's efficacy and potential to provide meaningful pain relief for children.

Cessatech A/S has released its financial results for the first quarter of 2025, covering the period from January 1 to March 31. Key figures include a net revenue of KDKK 1,243, an operating result of KDKK -5,610, and a net result of KDKK -4,296. The company had KDKK 6,598 in cash at the end of the period, with earnings per share at KDKK -0.25 and a solidity of 39%. CEO Jes Trygved highlighted the positive assessment of CT001 MDR, which will be part of an EMA submission planned for later this year. Efforts continue on manufacturing and launch preparations for CT001 in the US market. Progress has been made with the Paediatric Safety Study 0202, which has concluded, with data analysis ongoing and top-line results expected in May.