Cereno Scientific publishes interim report for Q2 2021
The Board and Chief Executive Officer of Cereno Scientific AB here presents the interim report for Q2, 1 April – 30 June, 2021.
Summary of the second quarter, April – June 2021
Cereno Scientific Group
Second quarter (1 April – 30 June 2021)
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -4 756 911 (-4 021 921)
- Earnings per share was SEK -0.07 (-0.1) before dilution and SEK -0.03 (-0.09) after dilution
- The equity/assets ratio was 84.5% (94.9%)
Parent company
Second quarter (1 April – 30 June 2021)
- Net sales were SEK 0 (0)
- Result after financial items was SEK -4 913 851 (-4 019 006)
- Earnings per share was SEK -0.07 (-0.1) before dilution and SEK -0.03 (-0.09) after dilution
- The equity/assets ratio was 84.5% (94.9%)
Significant events during the second quarter
- In April, the timeline was set for the upcoming clinical phase II with drug candidate CS1 following the signing of the final agreements with clinical research organization Worldwide Clinical Trials. If the study timeline is followed according to plan, the study will start in September 2021 with study results expected in H2 2022.
- At the end of April, a collaboration agreement for the full preclinical development program of CS585 was signed with the University of Michigan. The development agreement includes the successful transition of CS585 to a clinical Phase I program. The IND-enabling work will in most part be conducted at the University of Michigan, a top-ranked public research university in the US with an extensive track record of successful collaborations with industry. CS585 is in development within cardiovascular diseases.
- At the beginning of May, it was announced that the collaboration agreement for CS014 with the University of Michigan will be extended to include a full preclinical development program. The objective of the signed development agreement is to successfully bring CS014 into a clinical Phase I program. The IND-enabling work will in most part be conducted at the University of Michigan, a top-ranked public research university in the US with an extensive track record of successful collaborations with industry. CS014 is in development within cardiovascular diseases.
- In May, Dr. Michael Holinstat, Ph.D., FAHA, joined as Director of Translational Research at Cereno. The role marks a further focus on the importance of Cereno’s early-stage development, for which Dr. Holinstat leads the two current preclinical programs at the University of Michigan. The expansion of the Cereno team adds capacity and secures expert knowledge important to the company’s portfolio development.
- In June, intellectual property rights (IPR) for drug candidate CS1’s second patent family has been granted in Australia. This is a result of Cereno’s continuous work in securing IPR for its assets to strengthen the commercial positioning. This patent for Australia will be valid through 2035, with the possibility of a patent extension of additional five years maximum.
Significant events after end of period
- In August, it was announced that a collaboration agreement was entered with global healthcare company Abbott regarding use of its CardioMEMS™ HF System in the upcoming Phase II study with Cereno’s drug candidate CS1. The technology will be used to remotely and continously monitor the pulmonary pressure in the Phase II study evaluating CS1 for the treatment of PAH. The CardioMEMS device allows Cereno to use a smaller-sized patient population for the Phase II study, which is both time and cost efficient.
Letter from the CEO
The second quarter of the year has continued to be characterized by intensive work with preparations for the start of our Phase II study with CS1. In parallel, we have expanded our pipeline with two preclinical development programs in collaboration with the University of Michigan and secured stronger patent protection for CS1 in Australia. Recently, we were also able to announce that we have partnered with the global healthcare company Abbott to use their innovative CardioMEMS HF System hemodynamic monitoring system in the Phase II study with CS1. This not only helps us to be able to carry out a more time- and cost-effective study, but also signals a quality seal on our drug candidate and our abilities externally. In summary, a very productive first half of 2021.
Ongoing preparations for Phase II study with CS1
The team has successfully worked closely with the contract research organization (CRO) Worldwide Clinical Trials that will run the project management of the study when it is underway, the manufacturing partner Galenica to secure substance to use in the study and a number of other partners needed for the study. Another important activity is the ongoing discussions that have taken place for some time with selected clinical sites and physicians in the US for participation in the study. We have also expanded our internal team before the study initiation to have the right competence and capacity to handle the study's planning, regulatory requirements and logistics for its execution. In other words, the study preparations continue so that we are standing ready to go on all fronts when it is time.
Collaboration with Abbott in the Phase II study – a milestone
Our recently communicated partnership and collaboration with Abbott in the Phase II study with CS1 in PAH is a significant milestone for Cereno. The benefits of using their hemodynamic monitoring device in the study include, among other things, time and cost savings due to the smaller patient base required thanks to the fact that we can continuously collect information about the study participants' lung pressure. The collaboration also contributes to strengthening the study's credibility, execution and Cereno as a company. Abbott, as one of the major global players, is showing confidence in our research and capabilities through their choice to partner with us to test their monitoring device in a new disease. We have already received feedback from experts in the field of cardiovascular disease who see the quality seal a collaboration with Abbott adds to the Phase II study and Cereno. It is motivating to receive positive feedback on how the study can hopefully in several ways completely change and improve how PAH patients are cared for and treated in the future.
Initiated preclinical development programs
Our two preclinical development programs, CS585 and CS014, at the University of Michigan have now been initiated according to plan. Over a two-year period ahead, the development will be executed with the aim of preparing the drug candidates to start Phase I clinical programs. The collaboration with Dr Holinstat and his research group has successfully started during the summer and we look forward with great expectations to the further development of our pipeline together.
Extended equity research coverage promotes understanding
A few days ago, an initial coverage report was released by Redeye as the start of an initiative where we engage equity analysts to follow the company. The main intention is to increase the visibility of Cereno within Sweden. It is also of importance for us to enable investors and stakeholders to develop a better understanding of the business. We thus hope to be able to offer a new media to those who want to delve deeper through this third-party perspective.
Autumn and winter 2021
During autumn, I look forward to initiating the Phase II study in PAH with CS1 with our very competent and passionate team as well as continue to drive a positive development of our promising pipeline. In addition to the development work, we also have plans to participate in partnering conferences to meet potential stakeholders for our projects, participate in medical and scientific congresses to continue to establish our science among experts in cardiovascular disease. We appreciate the support and the growing interest from our shareholders and the market. The hope is to be able to meet existing and potential shareholders in safe forms in the near future. We will continue to frequently communicate about our plans and progress in various channels to reach out with our information and spread our message about Cereno's vision to provide better treatments to patients with common and rare cardiovascular diseases.
August 2021
Sten R. Sörensen
CEO, Cereno Scientific
Financial calendar
Interim report Q3 2021 16 November 2021
Year-end report 2021 9 February 2022
For further information, please contact:
Daniel Brodén, CFO
Tel: +46 768 66 77 87
Email: info@cerenoscientific.com
www.cerenoscientific.se
About Cereno Scientific AB
Cereno Scientific is a clinical stage biotech company within cardiovascular diseases. The lead drug candidate, CS1, is a Phase II candidate in development for the treatment of the rare disease pulmonary arterial hypertension (PAH) and thrombotic indications. CS1 is an HDAC (Histone DeACetylase) inhibitor that acts as an epigenetic modulator with anti-thrombotic, anti-inflammatory, anti-fibrotic and pressure-relieving properties, all relevant for PAH. A clinical phase II study for CS1 in PAH is expected to be initiated in September 2021 under its US FDA granted orphan drug designation (ODD) status. In addition, Cereno has two promising preclinical development programs targeted at treating cardiovascular diseases. The company is headquartered in AstraZeneca’s BioVenture Hub, Sweden, and has a US subsidiary Cereno Scientific Inc. based in Kendall Square in Boston, Massachusetts, US. Cereno is listed on the Swedish Spotlight Stock Market (CRNO B). More information on www.cerenoscientific.com.