Cessatech A/S has successfully completed a directed share issue raising approximately DKK 14.8 million to strengthen its financial position ahead of the anticipated U.S. commercial launch of its lead pediatric pain treatment CT001. The Danish biotechnology company issued 1,163,123 shares at DKK 12.72 per share through an accelerated bookbuilding process led by Sedermera Corporate Finance AB.
Positive Clinical Results Drive Funding Decision
The funding announcement coincided with the release of positive top-line results from Cessatech's final CT001 Study 0202, an open-label pediatric trial that met all primary endpoints. The study demonstrated that 55% of patients achieved pain relief (pain score ≤4/10) after 15 minutes, increasing to 89% after 30 minutes. Overall pain reduction reached 75% after 30 minutes and 86% after 60 minutes, with no drug-related unexpected adverse effects reported.
"The completion of the 0202 study marks the fourth out of the five goals set out in Cessatech's 2023-2025 plan with only commercial launch of CT001 in the U.S. under the FDA early access program remaining," the company stated. The study represents the final required clinical study under the EMA approved Pediatric Investigation Plan (PIP) program.
Regulatory Progress and Manufacturing Preparations
Cessatech has made significant regulatory progress throughout 2025, including receiving a positive Medical Device Regulation (MDR) assessment for CT001. The intranasal, needle-free treatment has demonstrated superior efficacy in pediatric populations, with simulated pain reduction showing -87% improvement compared to -52%, -32%, and +10% for sufentanil, ketamine, and placebo respectively.
The company is currently finalizing its U.S. manufacturing setup, which will enable its commercial partner Ventis Pharma to release CT001 for distribution and begin marketing activities. Despite obstacles in the U.S. setup, Cessatech anticipates launching during 2025 under the FDA early access program.
Strategic Rationale for Directed Issue
The board of directors chose a directed share issue over a rights offering after comprehensive analysis, citing several strategic advantages. "A rights issue would be significantly more time- and resource consuming compared to the Directed Issue," the company explained, noting that a directed approach allows management to focus on value-creating activities while reducing exposure to market price fluctuations.
The subscription price was determined through an accelerated bookbuilding procedure, which the board considers ensured appropriate market pricing. The new shares will result in approximately 6.3% dilution for existing shareholders who did not participate in the issue.
Global Partnership Strategy
Beyond the U.S. market, Cessatech has established a worldwide commercial partnership with Proveca Ltd, excluding the United States. Proveca, a global pharmaceutical company specializing in pediatric medicines, has been granted exclusive commercialization rights and a non-exclusive option to license Cessatech's CT002 program.
The company has also extended its loan facility agreement to DKK 10 million with maturity until April 2026, providing additional financial flexibility. To date, Cessatech has not drawn on this facility, which can potentially be converted into shares under market conditions.
Market Position and Future Outlook
CT001 addresses a significant unmet medical need in pediatric pain management by offering an opioid-sparing alternative. The treatment's needle-free intranasal delivery system provides particular advantages for children, with data showing enhanced drug exposure in younger patients and superior efficacy compared to existing treatments.
With the completion of Study 0202, Cessatech can now initiate the EMA submission process for later this year. The company's 2023-2025 strategic plan is nearing completion, with only the U.S. commercial launch remaining as the final milestone.
The new shares are expected to be registered with the Danish Business Authority around June 5, 2025, and admitted to trading on Spotlight Stock Market shortly thereafter. All new shares will be identical to existing shares with full voting and dividend rights applying from registration.
