Cereno builds momentum for major clinical milestones

This material has been prepared for marketing purposes and is not and shall not be considered to constitute a prospectus under applicable laws and regulations. The full terms and conditions of the rights issue and further information about the company have been set out in the EU Growth Prospectus which was published and published on cerenoscientific.com on May 5, 2023.

Cardiovascular disease is the leading cause of death globally, killing almost twice as many people as cancer. The term includes all diseases that involve the heart and/or blood vessels. A majority of the complications associated with cardiovascular disease are caused by blood clots. Among other serious complications, these blockages in the blood vessels can lead to heart attacks, secondary heart failure, cardiac arrhythmias, and stroke.

Cereno Scientifics The company's goal is to develop innovative treatments with the aim of prolonging life and improving the quality of life for people suffering from common and rare cardiovascular diseases. The company's lead drug candidate CS1 was noticed by FDA 2020 when it was granted orphan drug status for the treatment of the rare cardiovascular disease pulmonary arterial hypertension (PAH).

CS1 showed several signs of efficacy in preclinical PAH models, including pulmonary pressure reduction, reverse remodeling, antifibrotic, anti-inflammatory and antithrombotic properties. The FDA decision was a sign that the US regulatory authorities have strong confidence that the drug candidate has the potential to provide significant benefits for PAH patients.

Dr Raymond Benza, a global PAH key opinion leader and principal investigator for the phase II study, is also convinced of CS1's potential:

“CS1 has to definitely be tested in PAH – it could be game-changing for patients.”

Phase II study with CS1

Since the FDA's decision, CS1 has entered Phase II clinical development. The study is being conducted in collaboration with the global healthcare company Abbott, which provides its CardioMEMS HF System-technology for daily lung pressure measurements during the study period.

Despite an initial delay in patient recruitment due to the pandemic, the Phase II study is now progressing steadily. In February, Cereno reported that all nine selected study sites in the US had been activated. Since then, the pre-screening process has begun at all sites, identifying several suitable patients for recruitment into the study.

Cereno recently announced that 16 patients have been enrolled, nine of whom have been implanted with Abbott's CardioMEMS HF system. Five patients have been randomized and are undergoing active treatment, while two patients have completed the study.

In a recent interview with BioStock, Cereno's CEO told Sten R Sorensen that the recruitment of the 30 PAH patients to be included in the study is proceeding as planned. Furthermore, top-line results from the Phase II study are expected by the end of the year, which brings Cereno closer to potentially offering PAH patients a new disease-modifying treatment.

Cereno's CMO Bjorn Dahlof was pleased with the active recruitment process:

“I am very pleased to see continued progress in the Phase II study of CS1 in PAH. I look forward to following the progress as more and more patients complete each of the various steps towards the completion of the study and the subsequent analysis of the study results.”

Capital raising for continued advancement

The latest milestones achieved with CS1 are signs of significant progress for Cereno, which has the ambition to develop new and better treatments for cardiovascular diseases.

To continue the rapid development of CS1 and reach new important milestones, the company aims to secure additional capital. The company now aims to raise approximately SEK 110 million before transaction costs through a rights issue.

See CEO Sten R. Sörensen and CMO Bjorn Dahlof, in an interview about the rights issue here.

Watch Sten R. Sörensen present the company here.

The offer in summary

Cereno Scientific is currently conducting a rights issue of a maximum of approximately SEK 110 million. The issue is being conducted with the aim of:

• Complete the ongoing Phase II clinical trial with CS1 in the rare disease PAH, approximately 50 percent.
• Complete the preclinical development and preparatory activities needed to submit an application to initiate a Phase I clinical study with the drug candidate CS014, approximately 25 percent.
• Continue the preclinical development program for the drug candidate CS585, approximately 25 percent.

Terms and conditions for the rights issue