Cardiovascular disease (CVD) is the leading cause of death worldwide, accounting for almost twice as many deaths worldwide as cancer. The societal costs are staggering: more than USD 200 billion is spent annually in the EU to cover CVD-related costs. In the US, the figure is close to USD 600 billion. These figures are expected to double by the mid-2030s, so the demand for better treatments is high. Helping to meet this demand is the goal of Cereno Scientific, a biotechnology company that develops new treatments for both common and rare cardiovascular diseases.
One of the main problems with current CVD treatments, such as Warfarin or Heparin, which both act as anticoagulants to dissolve blood clots, is that they increase the risk of bleeding. This can be life-threatening for patients who have had a stroke, heart attack or other thrombotic event. Cereno's main goal is to develop drugs with better efficacy that still act on the blood's coagulation mechanism to dissolve blood clots, while reducing the risk of bleeding.
Pipeline with a diversity of candidates
The company has three pipeline programs under development: CS1, CS014 and CS585. CS1 is Cereno's lead program, currently in Phase II clinical development for the treatment of a rare CVD called pulmonary arterial hypertension (PAH). Read more here. The candidate, which is an HDACi (histone deacetylase inhibitor), is based on a therapeutic approach based on the potential for epigenetic modulation. This is a way to regulate the expression of certain genes without changing the genetic material – an approach that has shown antifibrotic, anti-inflammatory, pressure-reducing as well as antithrombotic properties. Read more about the method here.
CS014 and CS585 are part of Cereno's preclinical programs conducted in collaboration with the University of Michigan (UoM). Principal Investigator Dr. Michael Holinstat, now Cereno's Director of Translational Research, initiated the preclinical studies with compounds from Cereno's R&D program. CS014 is also an HDACi, while CS585 is a stable, selective and potent prostacyclin receptor agonist with the potential to improve mechanisms relevant to selected CVD. Read the latest on these programs here.
Move to Nasdaq First North
As the Phase II CS1 study nears completion and both preclinical programs are scheduled to enter Phase I, Cereno has reached a mature stage in its development where it wants to attract more international partners and investors in the industry. This prompted the company to apply for a change of marketplace from Spotlight Stock Market to Nasdaq First North Growth Market.
The application was approved and the first day of trading in Cereno's shares on First North was yesterday.
BioStock contacted Cereno's CEO Sten R Sorensen to find out more about the thoughts behind the decision to change the list.
Sten, why is it the right time to change trading venue for Cereno?
– We are at an exciting stage for the company right now. Our clinical program CS1 is in an ongoing Phase II study, our preclinical program CS014 is progressing well towards a Phase I study and our program CS585 is in its preclinical development program. The board assessed that a change of marketplace to First North will increase the market's awareness of Cereno and have a positive impact on relationships with commercial partners and other stakeholders. Therefore, it was decided that a change of marketplace to First North would be the natural next step in Cereno's development and is considered to be value-creating for our shareholders.
Since you are targeting a broader group of shareholders, can you briefly describe the value drivers that Cereno has to offer and a pitch to potential new investors?
– Cereno, with our long experience in drug development, strong network of experts and partners, and three innovative drug candidates, has the opportunity to completely change how cardiovascular diseases will be treated in the future.
– Our lead candidate CS1 has a unique efficacy profile for the treatment of PAH. The goal of developing CS1 is to offer a disease-modifying drug that can potentially slow, or reverse, the progression of the disease and thereby improve the patient's quality of life and prolong the patient's life. We are currently conducting a Phase II study in collaboration with the global healthcare company Abbott to investigate the safety and tolerability of CS1 as well as exploratory efficacy in PAH patients. We expect to complete the study by the end of 2023.
– We expect to initiate a phase I study with CS014 already in H1 2024. CS014 as an HDAC inhibitor with epigenetic effects is a completely new method for thromboprevention with the potential to effectively reduce the risk of developing thrombosis without increased bleeding risk, as shown in preclinical studies. HDAC inhibition as thrombosis prevention has the potential to fundamentally change the treatment landscape and meet the great medical need for effective and safe treatment alternatives.
– The third drug candidate is CS585, which has not yet been assigned a specific CVD indication for clinical development as evaluation in the preclinical program is still ongoing.
– In summary, we have a promising portfolio of three drug candidates under development as treatments in CVD with the potential to prolong life and improve quality of life for patients who currently lack sufficient treatment options and thus represent a major market opportunity for Cereno.