Cereno Scientific publishes interim report Q1 2021
The Board and Chief Executive Officer of Cereno Scientific AB here presents the interim report for Q1, 1 January – 31 March, 2021.
Summary of the first quarter, January – March 2021
Cereno Scientific Group
First quarter (1 January – 31 March 2021)
- Net Sales were SEK 0 (0)
- Result after financial items was SEK -3 903 947 (-3 752 667)
- Earnings per share was SEK -0,05 (-0,9) before dilution and SEK -0,03 (-0,09) after dilution
- The equity/assets ratio was 87.2% (93.8%)
Parent company
First quarter (1 January – 31 March 2021)
- Net sales were SEK 0 (0)
- Result after financial items was SEK -3 904 688 (-3 755 523)
- Earnings per share was SEK 0,05 (-0,9) before dilution and SEK -0,03 (-0,09) after dilution
- The equity/assets ratio was 87.2% (93.8%)
Significant events during the first quarter
- Early January 2021, a letter of intent with the global contract research organization (CRO) Worldwide Clinical Trials was signed. Worldwide will provide support and guidance in the final preparatory steps as well as conduct the clinical Phase II study with drug candidate CS1 in rare disease pulmonary arterial hypertension (PAH).
- In conjunction with a Scientific Advisory Board meeting in January, Dr. Raymond L. Benza M.D., FACC, FAHA, FACP, US, was appointed to the Cereno Scientific Advisory Board. Benza is a global thought leader in pulmonary arterial hypertension (PAH) and has been working as an advisor to the company’s Phase II program with drug candidate CS1 in PAH.
- At the end of January, an expansion of the intellectual property rights (IPR) for drug candidate CS1 across two different patent families was announced. The patent granted in Canada belongs to the company’s first patent family, and the patent granted in Russia belongs to the company’s second patent family. This is a result of Cereno’s continuous work in securing IPR for its assets to strengthen the commercial positioning.
- In March, the rights to in-license a preclinical program from the University of Michigan, US, were obtained through an option agreement. The agreement grants Cereno the exclusive rights to evaluate the project in a preclinical development program during a time period of up to 27 months. If the evaluation is successful, Cereno can exclusively in-license the project for further clinical development and commercialization. This marks an expansion of Cereno’s project portfolio with a promising preclinical program in cardiovascular diseases.
Significant events after end of period
- 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 first patient 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, took on the role 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 expertise and secures knowledge important to the company’s portfolio development.
Letter from the CEO
Cereno started the year with giant strides. During the first quarter, work has intensified around our upcoming Phase II study and recently the study timeline was confirmed starting in September 2021. In parallel, our project portfolio has expanded with a new preclinical project, CS585, and development programs have been initiated for both our preclinical projects in collaboration with the University of Michigan. Overall, the goal for the company's development has been upgraded and we now have an exciting, broader and more risk-balanced project portfolio with a clear direction and a plan ahead of us to execute.
Phase II study with CS1 to start September 2021
The first months of the year have involved intensive work for our partners, CRO, manufacturing partners, scientific advisors, and ourselves in the preparations for the Phase II study. The aim is to study CS1's safety, tolerability and to do an exploratory efficacy evaluation in patients with the rare disease PAH. The plan is also to establish dose selection for later studies. The study will be conducted at approximately six clinical centers in the US with a total of 30 patients. The first patient is planned to be treated in the study in September 2021 and we are in phase with the preparations that remain before the study can start.
Expanded project portfolio with preclinical CS585
In March, we added a third project to our drug development portfolio. Cereno received the rights to in-license CS585, a preclinical phase project, through an option agreement with the University of Michigan. In practice, this means that we have exclusive rights to evaluate the project in a preclinical development program. In the event of a successful evaluation, we can exclusively in-license the project for further clinical development and commercialization. The expansion of the portfolio marked a significant milestone for the company, where we see that CS585 will be another contributing factor to a growing and higher company value for Cereno.
Research collaboration with University of Michigan for the preclinical programs
We initiated our first collaboration with the University of Michigan in the US about a year ago with good results in initial studies for the CS014 program. When deciding on the further development of our preclinical programs, the University of Michigan was one of the top choices with their extensive experience of successfully collaborating with the pharmaceutical industry. The university also has one of the largest annual academic research budgets of any university in the US, which means access to both top-ranked researchers and facilities. We are therefore very pleased that Dr. Michael Holinstat and his research group at the university will now lead the work there with our two preclinical programs, CS585 and CS014. For both projects, full preclinical development programs have now been initiated with the goal of achieving the requirements to be able to start first-in-man studies, clinical phase I studies, within about two years.
Strengthened positioning for CS1
New patents were recently granted for CS1, which extended the drug candidate's patent protection to two of the world's largest pharmaceutical markets, Japan and the US. In addition, patent registrations were granted in Canada and Russia.
Engaged scientific advisors
At the end of May, we will hold this year's second meeting with the company's scientific advisory board. On the agenda is a company update followed by presentations and discussions around our Phase II study and our new preclinical development programs. As our scientific advisory board consists of leading opinion leaders with roles in both academia and clinical reality, we look forward to hearing their insights and updates from the field.
Outlook
Our expanded project portfolio sets the future direction for Cereno's development. We have a strong position with unique drug candidates that may make a significant difference in the treatment of cardiovascular diseases and meet the great medical needs of affected patients.
Gothenburg, May 2021
Sten R. Sörensen
CEO, Cereno Scientific
Financial calendar
Annual General Meeting 9 June 2021
Interim report Q2 2021 25 August 2021
Interim report Q3 2021 November 2021
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.