This material has been prepared for marketing purposes and is not and should not be considered a prospectus under applicable laws and regulations. The full terms of the rights issue and further information about the company have been presented in the EU Growth Prospectus published on cerenoscientific.com on May 5, 2023.
Cereno Scientific is a biotechnology company whose goal is to develop safe and effective treatments for cardiovascular diseases. The company's vision is to prolong and improve the quality of life for patients suffering from cardiovascular diseases.
The company's most advanced drug candidate CS1 is being developed for the treatment of the rare disease pulmonary arterial hypertension (PAH). The goal of developing CS1 is to offer a disease-modifying drug that can potentially slow or reverse the progression of the disease. This will thereby significantly improve the patient's quality of life and lead to increased survival.
CS1 is an HDAC (histone deacetylase) inhibitor that acts as an epigenetic modulator with a unique efficacy profile for the treatment of PAH. Patient recruitment for a phase II study with nine participating clinics in the US is currently underway in collaboration with the global healthcare company Abbott.
»16 patients have been recruited, of whom nine have been implanted with the Abbott CardioMEMS HF system. Five patients have been randomized and are on active treatment, while two patients have completed the study. Recruitment of the 30 PAH patients to be included in the study is proceeding according to plan. Top-line results from the Phase II study are expected by the end of the year, bringing us closer to potentially offering patients with PAH a new disease-modifying treatment« — Sten R Sörensen, CEO Cereno Scientific
Preclinical candidates prepared for Phase I
Cereno Scientific also has two drug candidates in preclinical development: CS014 and CS585. CS014, like CS1, is an HDAC inhibitor with epigenetic effects. CS014 is being developed as a treatment to effectively prevent thrombosis (blood clots) without an increased risk of bleeding – a complication that can lead to heart attacks or strokes. There is a great medical need for thrombosis prevention as current drugs carry an increased risk of bleeding. The goal is to be able to start a phase I study with CS014 during the first half of 2024 in the indication of prevention of venous or arterial thrombosis.
Cereno's second preclinical drug candidate, CS585, was recently licensed from University of Michigan after promising preclinical results. In its preclinical program, CS585 has shown signs of efficacy in preventing thrombosis without increased bleeding risk. Cereno assesses that CS585 has the potential to become the most effective treatment among IP receptor agonists for indications such as PAH and thrombosis prevention. However, a specific indication has not yet been selected for further clinical development as an evaluation in the preclinical program is still ongoing.
Read the latest news in Cereno's preclinical development here.
Rights issue to enable continued development
Given that all three drug candidates are currently at critical stages of development, Cereno intends to raise capital to enable a continued high pace of activity to the next value-enhancing milestones. The company is therefore conducting a rights issue of units of approximately SEK 110 million.
The rights issue is already 70 percent secured. One percent is covered by subscription commitments from the board and management, while the remaining 69 percent is covered by guarantee commitments.
One unit includes new shares and one warrant of series TO3. For further information, read more here.
CEO comments
Cereno believes that the company, with its long experience in developing cardiovascular drugs, a strong network of experts and partners, has the potential to completely change how cardiovascular diseases will be treated in the future with its three drug candidates.
BioStock spoke with Cereno's CEO Sten R Sorensen to find out more.
Sten, the Phase II study with CS1 is progressing according to plan. What do you think makes CS1 so promising?
– Both doctors and patients express a great need for better treatments for the fatal rare disease PAH. The need is particularly great for treatments that can potentially stop or delay the progression of the disease, such as our drug candidate CS1. In contrast to the alternatives available today that only relieve symptoms. Our drug candidate CS1 has a unique efficacy profile and the potential to offer a safe, effective and disease-modifying treatment option for patients suffering from PAH.
– The goal of developing CS1 is to offer a disease-modifying drug that can potentially slow or reverse the progression of the disease, thereby prolonging patients' lives and improving their quality of life.
The Phase II study has suffered some delays, mainly due to the effects resulting from the pandemic. Are you more optimistic about how the study is progressing today?
“The team, together with our partner Abbot and our CRO, is working well with the participating clinics in the study to support continued progress with both patient recruitment and the clinical study. I am pleased to report that the study is progressing well.”
– 16 patients have been recruited, of which nine have been implanted with the Abbott CardioMEMS HF system. Five patients have been randomized and are on active treatment, while two patients have completed the study. Recruitment of the 30 PAH patients to be included in the study is proceeding according to plan.
– Top-line results from the Phase II study are expected by the end of the year, bringing us closer to potentially offering patients with PAH a new disease-modifying treatment.
Cereno is now raising capital through a rights issue. How far will this capital take you?
– All three of our drug candidates are currently in significant stages of development and thus a capital injection will enable continued rapid development to the next value-enhancing milestones. The issue proceeds will be distributed as follows:
– Approximately 50 percent will be allocated to completing the ongoing Phase II clinical study with CS1 in the rare disease PAH.
– Approximately 25 percent will be used for the completion of preclinical development and preparatory activities required to submit an application to initiate a Phase I clinical study with CS014.
– The remaining 25 percent will be used to continue preclinical development with CS585.
You have also announced that you are starting a process to change marketplace to Nasdaq First North Growth Market. Can you tell us more about this?
– The potential benefits of moving the company’s shares to the First North marketplace have been carefully evaluated by both the board of directors and our advisors. Their assessment shows that such a change will significantly increase the market’s awareness of Cereno and positively impact our relationships with potential investors, as well as open up opportunities for those investors who cannot invest in companies traded on the Spotlight Stock Market. In light of these factors, the move to First North is seen as a natural progression in the company’s development, which is expected to generate significant value for our shareholders.
– In summary, Cereno is convinced that the change of marketplace will promote a positive development for our future growth and development.
Finally, what are you most looking forward to in the rest of 2023?
– The remainder of 2023 is extremely promising for our company as we approach significant milestones in our development programs. I look forward to the completion of our Phase II clinical trial in PAH and the subsequent top-line results by the end of the year, as well as the submission of our preclinical documentation to obtain approval to initiate a first-in-man study with CS014 in H1 2024. These achievements will bring us closer to our ultimate goal of developing innovative treatments to extend life and improve quality of life for patients with common and rare cardiovascular diseases.
– Finally, I also look forward to expanding our reach and engagement with specialist biotech investors worldwide, along with seeking potential collaborations with pharmaceutical companies, all to showcase the enormous potential of our exciting pipeline in pulmonary arterial hypertension (PAH) and thrombosis.