We are thrilled about our listing on Nasdaq First North Growth Market, it is a pivotal milestone in our journey as a biotech company. This occasion not only validates the hard work and dedication of our exceptional team but also marks a significant step towards fulfilling our mission of advancing scientific innovation for the betterment of human health. We remain steadfast in our commitment to bringing innovative treatments for patients with common and rare cardiovascular disease and are excited about the opportunities that lie ahead as we continue to further develop our portfolio and create value for our stakeholders.
Thank you to everyone who participated in our recent rights issue. The valuable contributions have not only paved the way for further development of our promising drug candidates, but also brought us even closer to the opportunity to offer innovative treatments that could potentially change the way patients with cardiovascular diseases are treated in the future.
I am pleased with the progress in the study and anticipate that we can keep a steady pace through to the end of recruitment this summer. CS1 is a drug candidate with significant potential to offer a disease-modifying treatment alternative for people living with the devastating disease PAH.
The unmet medical need for patients with PAH is a treatment challenge. We believe our drug candidate CS1 has the potential to meet that challenge, to make a major difference in the future treatment landscape and I am happy that we now can announce real progress in patient recruitment in this innovative study.
We are pleased to enter this licensing agreement with the University of Michigan. It is a great fit with our growth strategy and provides value to our portfolio within pulmonary arterial hypertension (PAH) and thrombosis. The extension of our preclinical collaboration agreements with UoM are based on a fruitful outcome of ongoing 24-month programs signed in the spring of 2021.
I am pleased to report that the first patent in Europe for our preclinical drug candidate CS585 has now been formally issued by the European Patent Office as a final step of the approval process. This is a great milestone as it expands patent protection for our preclinical program and is an important aspect of preparing the future commercial positioning, together with a strong clinical data set.
I am pleased to announce that we have decided to initially focus our clinical development of CS014 as a treatment for the prevention of thrombosis. This enables the development team to effectively design the final stages of the preclinical program in preparation for Phase I studies. Venous thromboembolism and arterial thrombosis in stroke and MI are affecting many patients every year; thrombosis, being behind most cardiovascular complications, is the number one killer in the world. As we have now narrowed our focus from cardiovascular disease in general to thrombosis, further preclinical and clinical studies will be key in deciding the initial thrombosis indication. The first indication will be one where CS014 is deemed to have the highest potential to deliver on the high unmet patient need of a more effective anti-thrombotic treatment without bleeding.
The unmet medical need for patients with PAH is tremendous. We believe our drug candidate CS1 has the very highly sought-after potential to reverse the progression of PAH, and not only alleviate the symptoms as is the case with today’s available drug treatments. CS1 has a disease modifying potential to improve both patient quality of life and prolong life expectancy. The impact the lingering covid-19 pandemic in the US has had on the study’s start-up timeline, does not reduce our drive to pursue a better treatment option for patients and their families affected by PAH. The ongoing Phase II study with CS1 in PAH has the potential to make a major difference in the future treatment landscape.
The understanding of cardiovascular disease and the important need for innovation is a topic close to our experts’ hearts. Their solid backgrounds in cardiology plays a central role in our continued work to develop preventive medicine to treat cardiovascular disease and this series will provide valuable insights that we are happy to share.
I am very pleased to welcome Etienne Adriansen to Cereno. He will be a strong addition to our Executive Management Team, heading up our business development and commercialization efforts. Etienne brings extensive experience from strategic portfolio management, commercialization, licensing and business transactions, and he will play a significant role in establishing strategic partnerships for Cereno. Etienne will ensure commercial viability of our highly promising drug portfolio with CS1 in Phase II, and two preclinical programs, CS014 and CS585, both in preparation for clinical development.
We have a highly promising drug portfolio with CS1 in Phase II and two preclinical programs CS014 and CS585, both in preparation for clinical development. I strongly believe that we are on the cusp of a new era with a more mature Cereno with an experienced leadership team with the right skill set to support the company and our ambition. I am pleased to have Björn now spearheading our research and clinical development and I am happy to welcome Josefine to level up our IR & communications activities.
The development of our lead drug candidate CS1 is currently progressing in a Phase II study with active patient recruitment across sites in the US. I am pleased to, in parallel, have news related to CS1’s growing patent portfolio as it is an important aspect of preparing the future commercial positioning, together with a strong clinical data set.
This is the fourth announcement in a short period of time that is related to the expansion of patent protection for assets in our portfolio. I am pleased to see the progress we are making with our intellectual property rights (IPR) as it is important for the future commercial potential of the company as well as our clinical and preclinical drug candidates.
This is a great milestone for our preclinical Prostacyclin Receptor Agonist Program and drug candidate CS585 as the second patent family significantly broadens the patent protection. A strong IPR foundation is crucial to build the commercial opportunities of our preclinical programs, especially favorable in this early stage.
We are pleased to strengthen the protection around our drug candidate CS1. The addition of also covering Australia for CS1’s second patent family, together with previously granted key markets Japan, Russia and the US is part of our ongoing strategic IPR work to secure an advantageous position ahead of future developments.
We are happy to have Dr. Michael Holinstat join Cereno to spear head our preclinical stage assets. He has extensive experience in early-stage drug development, especially within cardiovascular diseases.
I look forward to working closer with the Cereno team and their early-stage development assets. With my experience within cardiovascular diseases and network, I hope I can positively contribute to Cereno’s portfolio development.
Cereno faces exciting and important challenges with both the Phase II clinical program and two preclinical programs in cardiovascular disease. We look forward to taking part of Rein's long experience of strategy and financing work, with a broad network in the Nordic region and the US, and believe that he will make a significant contribution to Cereno's further company development.
It will be fun to work with Cereno, a company with strong roots and knowledge of the development of new concepts for the treatment of cardiovascular diseases. The company is at an exciting stage, both the clinical and the preclinical projects will show the continued way forward for the company's development. I look forward to being able to contribute my experiences to support a continued positive development for Cereno.
We started working with Dr. Michael Holinstat and his research team at University of Michigan about a year ago. The promising results delivered with CS014 in initial animal studies made the decision easy to extend the collaboration to a full preclinical program.
I’m pleased to continue to work with CS014 and Cereno. The results from the initial studies show promising potential of this program and we look forward to fully delineating the role of CS014 for intervention in a preclinical program.
The preclinical development with CS585 will start immediately under the lead of Dr Michael Holinstat. We are glad to be working together with a research team of this caliber and anticipate a positive journey ahead for both CS585 and Cereno.
My research team and I look forward to continue into a preclinical development program for CS585 together with Cereno. The drug candidate has already provided promising data.
After the intense work with CS1, first in successful preclinical and Phase I studies and now preparing for a Phase II study, we are excited to have the study start in sight. We do, however, first have a set of milestones ahead such as obtaining permission to start the study (IND acceptance) that we are looking forward to check-off. Looking at the overarching confirmed timeline though, we are nearly aligned with the original estimation of the study results announcement, which ultimately is one of the key milestones for us.
We are pleased to enter this agreement with the University of Michigan after our initial evaluation of this promising drug candidate. This is a great fit with our strategy to develop new treatments for common and rare cardiovascular diseases. We are excited to kick this off and, if successful, for the commercial value we believe this will add to Cereno as the candidate progresses through the drug development process.
Japan is one of the world’s largest pharmaceutical markets, only behind the US and marginally China. The patent protection for CS1 now covering two of the major global markets is an attractive IPR position ahead of future developments.
Working to continuously strengthen our IPR around our drug candidates and technology is an important part of our strategy aimed at optimally positioning Cereno for commercial success.
Securing IPR is crucial within drug development and, thus, our strategy and activities are constantly evaluated as we advance in our clinical development.
We are confident that we have found a competent partner for our Phase II study in the CRO Worldwide Clinical Trials. They have extensive experience in conducting studies in cardiovascular disease in general and PAH in particular. They also have the right network of clinicians and study sites to set us up for success. It is beneficial to now get their input in finalizing the study protocol and regulatory study documentation to facilitate the process in the best way possible and, ultimately, start the study. We are excited to kick-off the new year and look forward to the study milestones ahead.
We are looking forward to the final results from the clinical study and, together with our secured financing up to 106 MSEK, this paves the way for our continued development work with the purpose to document CS1’s efficacy for preventive thrombosis treatment in patients.
We are very pleased to have started this clinical study with CS1, a new potential medicine to prevent thrombosis-related disease.