Cereno Scientific has three drug candidates in development for the treatment of common and rare cardiovascular diseases. Now, the company is carrying out a rights issue of approximately SEK 110 million to continue advancing all three projects. Additionally, Cereno is pursuing a move to Nasdaq First North Growth Market to increase market awareness and open possibilities with potential investors. To discuss all this and more, BioStock talked to Cereno’s CEO Sten R Sörensen.
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 and conditions of the rights issue and more information about the company have been presented in the EU Growth Prospectus published at cerenoscientific.com on 5 May 2023.
Cereno Scientific is a biotech company whose goal is to develop safe and effective treatments for cardiovascular diseases (CVDs). The company’s vision is to extend and improve the quality of life for patients suffering from CVDs.
The company’s most advanced drug candidate CS1 is being developed as a treatment for the rare disease pulmonary arterial hypertension (PAH). The aim of CS1’s development is to offer a disease-modifying drug that can potentially slow down, or reverse, the course of disease and thus significantly improve the patient’s quality of life and offering an opportunity for extending 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 USA is currently ongoing in collaboration with the global healthcare company Abbott.
»16 patients have been enrolled, with nine having received implantation with Abbot’s CardioMEMS HF System. Five patients have been randomised and are in active treatment, while two patients have completed the study. Recruitment of the 30 PAH patients to be included in the study is on track. The Phase II study’s top-line results are expected at the end of the year, bringing us closer to potentially being able to offer patients with PAH a new disease-modifying treatment.« — Sten R Sörensen, CEO Cereno Scientific
Preclinical candidates prepped for phase I
Cereno Scientific 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 increased risk of bleeding – a complication that can lead to heart attacks or strokes. There is a great unmet medical need in thrombosis prevention as currently available drugs on the market come with an increased risk of bleeding. The aim is to be able to start a phase I study with CS014 in the first half of 2024 in the indication prevention of venous or arterial thrombosis.
Cereno’s second preclinical candidate drug, CS585, was recently licensed from University of Michigan following promising results in preclinical studies. CS585 has in its preclinical programme shown efficacy in preventing thrombosis without increased risk of bleeding. Cereno believes that CS585 has the potential to be the most effective treatment among IP receptor agonists for indications like PAH and thrombosis prevention. However, a specific indication has yet to be assigned for clinical development as evaluation in the preclinical programme is still ongoing.
Read the latest news in Cereno’s preclinical development here.
Rights issue drives further development
Considering that all three drug candidates are currently in significant stages of development, Cereno is seeking a capital injection to enable continued high rate of activities to the next value-increasing milestones. The company is thus carrying out a rights issue of units of approximately SEK 110 million.
The rights issue is already secured to 70.0 per cent. 1.0 per cent is covered through subscription commitments from the Board of Directors and management, while the other 69.0 per cent is covered through underwriting commitments.
The unit includes new shares and a warrant of series TO3. Read more details here.
Comments from the CEO
Cereno believes that, with its long experience in cardiovascular drug development, strong expert networks and collaborative partners, the company has the potential to completely change the way cardiovascular diseases will be treated in the future with its three drug candidates.
BioStock spoke with Cereno’s CEO Sten R Sörensen to learn more.
Sten, the phase II trial with CS1 is progressing steadily. For those who are not aware, what is CS1 and why is it so promising?
– There is a significant need expressed by physicians and patients for better treatments for the fatal rare disease PAH. The need is especially high for treatments that can potentially stop or delay the disease progression, such as our drug candidate CS1, and not only alleviate the symptoms like the current alternatives available on the market. Our drug candidate CS1 has a unique efficacy profile, and the potential to offer a safe, efficacious, and disease-modifying treatment option for patients suffering from PAH.
– The aim of CS1’s development is to offer a disease-modifying drug that potentially can slow down, or reverse, the course of disease and thus prolong the patients’ life and improve the patient’s quality of life.
The phase II study has run into some delays, mainly due to post-pandemic headwinds. Are you more optimistic about the progression of the trial today?
– The team, together with our partner Abbot and our CRO, are working well with the participating clinics in the study to support steady advancements in patient recruitment as well as during the study period. I am pleased to share that the study is proceeding well.
– 16 patients have been enrolled, with nine having received implantation with Abbot’s CardioMEMS HF System. Five patients have been randomised and are in active treatment, while two patients have completed the study. Recruitment of the 30 PAH patients to be included in the study is on track.
– The Phase II study’s top-line results are expected at the end of the year, bringing us closer to potentially being able to offer 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 enables continued timely development to the next value-increasing milestones. The funds from the rights issue will be allocated accordingly:
– Approximately 50 percent will go towards completing the ongoing clinical phase II study with CS1 in the rare disease PAH.
– About 25 per cent will go towards completing the preclinical development and the preparatory activities needed to file an application to initiate a clinical phase I study with CS014.
– The remaining 25 per cent will be used to continue the preclinical development with CS585.
You have also announced initiating a process to change marketplace to Nasdaq First North Growth Market. Could you tell us more about this?
– The potential benefits of transitioning the company’s shares to First North marketplace has been carefully evaluated by the Board as well as by our advisors. Their assessment concludes that such a change will significantly increase market awareness of Cereno and positively impact our relationships with potential investors as well as open possibilities to those investors not able to invest in companies traded on Spotlight Stockmarket. Considering these factors, transitioning to First North is viewed as a natural progression in the company’s development and is expected to generate substantial value for our shareholders. In summary, Cereno firmly believes that this marketplace transition will foster a positive trajectory for our future growth and development.
Lastly, what are you most looking forward to during the rest of 2023?
– The rest of 2023 holds tremendous promise for our company as we approach significant inflection points in our development programs. I am eagerly looking forward to the completion of our Phase II clinical study in PAH and the subsequent top-line results at the end of the year, as well as the submission of our preclinical documentation for CS014’s permission to start a first-in-man study in H1 2024. These achievements will bring us closer to our ultimate goal of developing innovative treatments to prolong life and improve quality of life for patients with common and rare cardiovascular disease.
– Finally, I also look forward to expanding our reach and engagement with specialised biotech investors across the globe, along with seeking potential collaborations with pharmaceutical companies, all aimed at showcasing the immense potential of our exciting pipeline in pulmonary arterial hypertension (PAH) and thrombosis.The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.