Cereno Scientific publishes year-end report for 2020 (1 January – 31 December 2020)
The Board and Chief Executive Officer of Cereno Scientific AB here presents the year-end report for the year 2020.
Summary of the year-end report, January – December 2020
Cereno Scientific Group
Full year (1 January – 31 December 2020)
- Net Sales were 0 SEK
- Loss after financial items was SEK 16 017 060
- Loss per share was SEK 0.22 before dilution and SEK 0.21 after dilution
- The equity/assets ratio was 88.9 %
Fourth quarter (1 October – 31 December 2020)
- Net Sales were 0 SEK
- Loss after financial items was SEK 5 109 959
- Loss per share was SEK 0.07 before dilution and SEK 0.07 after dilution
Parent company
Full year (1 January – 31 December 2020)
- Net sales were SEK 0 (0)
- Loss after financial items was SEK 16 015 061 (15 279 801)
- Loss per share was SEK 0.22 (0.38) before dilution and SEK 0.21 (0.36) after dilution
- The equity/assets ratio was 88.9 % (93.1%)
Fourth quarter (1 October – 31 December 2020)
- Net sales were SEK 0 (0)
- Loss after financial items was SEK 5 102 567 (-3 703 583)
- Loss per share was SEK 0.07 (0.09) before dilution and SEK 0.07 (0.09) after dilution
Significant events during the fourth quarter
- In October, Cereno confirmed that the record date for distribution of warrants of series TO1 and TO2 to current shareholders is on the 9 October 2020 and first day of trading in the warrants is on the 14 October 2020.
- In December, the agreement with Mangold Fondkommission to act as liquidity provider for the company’s share was terminated. The share has a good spread and a liquidity provider is therefore no longer needed.
Significant events after the end of the period
- Early January, 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 within 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.
Letter from the CEO
During the fourth quarter, we have worked intensively on both our clinical and preclinical projects. Later this year, a Phase II study is planned to start in pulmonary arterial hypertension (PAH) with our drug candidate CS1. The preparations are many and running at a good pace. This year will further mean intensified work with continued research around our preclinical projects. All in all, this contributes to a strengthen commercial positioning for Cereno together with the new, important additions to our patent portfolio. Our main principle for 2021 is to accelerate even further, which is made possible by our strengthened financials.
Preparations ahead Phase II study with CS1 in PAH
At the center of our focus is the preparation for the upcoming clinical Phase III study with CS1 in PAH. It is an important study both for the company and the patients that today are affected by PAH with lacking treatment options. That is why the advisory pre-IND meeting with the US FDA marked an important milestone for us in December, and at the same time being the kick-off for the IND-application process for permission to start the study in the US. The next milestone achieved was at the beginning of January when we started a partnership with the global contract research organization (CRO) Worldwide Clinical Trials that will support the preparations ahead of study start as well as execute the study in the US.
Expansion of the scientific advisory board
We have during 2020 had a close collaboration with our scientific advisory board and advisors to set our research and development up for success in the best possible way. We have built a strong network surrounding us with key expertise within our main areas of focus. Dr. Raymond L. Benza is a global thought leader within the rare disease PAH and have important experience from several previously conducted clinical studies, which have given us invaluable insights, including how our PAH study in the US should be best designed to show the efficacy data both regulatory authorities would like to see as a basis for approval and doctors to prescribe the drug to patients. In January, Dr. Benza was appointed to Cereno’s scientific advisory board and he will contribute with a new and important perspective during our continued clinical development.
Strengthening our IPR
We were recently granted three new patents in the key markets Japan, Canada and Russia that expanded the intellectual property rights (IPR) to more regions. This means that CS1’s patent protection now has expanded to cover two of the world’s largest pharmaceutical markets, Japan and the US. A robust IPR portfolio is a contributing to a beneficial position of Cereno for commercial success and often a key question in discussions with potential partners.
Priorities ahead
We have entered a new year with strengthened financials following the capital raising during the fall of 2020 and have now an exciting spring ahead. In addition to the preparatory work with our Phase II study with CS1 in PAH, will our work to continue development of our preclinical NCE-program be an important part of our operations. This will be done through continuation of our collaboration with the University of Michigan in the US that, during the year, have conducted preclinical studies to in-depth study the properties of substances in the NCE-program.
We also plan to continue to participate in investor events and biotech congresses to build relationships and raise awareness of Cereno on a national as well as international arena.
We have an exciting project portfolio of clinical and preclinical drug candidates that attracts attention. Cereno has carved out a unique position to in the future be able to meet the major unmet needs for new disease-modifying treatment alternatives for patients with common and rare cardiovascular diseases.
Gothenburg, February 2021
Sten R. Sörensen
CEO, Cereno Scientific
Financial calendar
Annual report 2020 5 May 2021
Interim report, January-March 2021 19 May 2021
Annual General Meeting 9 June 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 leading clinical stage biotech company within cardiovascular epigenetic modulation. 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. A clinical phase II study program for CS1 in PAH is expected to be initiated in mid-2021 under its US FDA granted orphan drug designation (ODD) status. In addition, Cereno has a preclinical HDAC inhibitor development program targeted at treating cardiovascular diseases. The company is headquartered in AstraZeneca's BioVenture Hub, Sweden, and has an American subsidiary, Cereno Scientific Inc., with an office in Kendall Square in Boston, Massachusetts, US. Cereno is listed on the Swedish stock market Spotlight, ticker: CRNO B, ISIN SE0008241558. More information on www.cerenoscientific.com.