Cereno Scientific publishes year-end report for 2021 (1 January – 31 December)

Report this content

The Board and Chief Executive Officer of Cereno Scientific AB here presents the year-end report for the year 2021.

Summary of the year-end report, January – December 2021

Cereno Scientific Group

Full year (1 January – 31 December 2021)

  • Net Sales were SEK 0 (0)
  • Result after financial items was SEK -16,254,890 (-16,017,958)
  • Earnings per share was SEK -0.15 (-0.22) before dilution and SEK -0.11 (-0.21) after dilution
  • The equity/assets ratio was 94.1% (88.9%)
  • Cash and bank balance was SEK 89,634,757 (66,004,352)

Fourth quarter (1 October – 31 December 2021)

  • Net Sales were SEK 0 (0)
  • Result after financial items was SEK -4,237,723 (-5,109,959)
  • Earnings per share was SEK -0.04 (-0.07) before dilution and SEK -0.03 (-0.07) after dilution

Parent company

Full year (1 January – 31 December 2021)

  • Net Sales were SEK 0 (0)
  • Result after financial items was SEK -16,576,604 (-16,015,061)
  • Earnings per share was SEK -0.16 (-0.22) before dilution and SEK -0.12 (-0.21) after dilution
  • The equity/assets ratio was 94.1% (88.9%)
  • Cash and bank balance was SEK 89,594,519 (65,955,827)

Fourth quarter (1 October – 31 December 2021)

  • Net sales were SEK 0 (0)
  • Result after financial items was SEK -4,401,536 (-5,102,567)
  • Earnings per share was SEK -0.04 (-0.07) before dilution and SEK -0.03 (-0.07) after dilution

Significant events during the fourth quarter

  • In early October, Cereno announced that warrants of series TO1 were subscribed to approximately 96.9 per­cent and Cereno received approximately SEK 95.3 mil­lion before issue costs. The warrants were issued during the fourth quarter of 2020 and a total of 33,442,470 warrants were exercised at a subscription price of SEK 2.85 per share.
  • In December, it was announced that intellectual prop­erty rights for drug candidate CS1’s third patent family had been granted in Russia. This is the first patent grant in the third patent family, adding to Cereno’s extensive patent protection across nearly all global key markets.

Significant events after end of period

  • In January, Cereno obtained additional intellectual property rights for drug candidate CS1 in the major market Japan. The patent is part of the third patent family which now has protection in Russia as well as Japan. It adds to the growing IPR portfolio for CS1 covering almost all global markets.
  • Later in January, it was announced that the progress made in preclinical program CS014 had triggered an undisclosed milestone payment to Emeriti Bio from which CS014 was acquired in 2019. CS014 is currently undergoing a preclinical development program in col­laboration with the University of Michigan. Based on this progress a new patent application has been filed.

Letter from the CEO

During the fourth quarter a major focus has been on activating clinical centers to enable enrollment of patients into our Phase II study with CS1 in PAH, for which we were granted FDA IND acceptance in September. In parallel with the clinical activities, the development of our two preclinical programs in collaboration with University of Michigan have continued progressing and follow the plan that was prepared earlier in the year. For the fourth consecutive quarter we also announced further strengthening of our IPR position with the first patents granted in the third patent family for CS1. The fourth quarter was also characterized by our attendance at key events and conferences, building relationships and raising awareness of Cereno among investors as well as the scientific community.

Working towards patient enrollment in Phase II study

After receiving IND acceptance from FDA to initiate our Phase II study with drug candidate CS1 in September we have been working with our partners on the activities that are required to enroll patients in the study. An important element is to identify and activate the US clinical centers where the study will be conducted. Whereas the initial plan was to enroll patients across six centers, we have subsequently decided to expand this to up to nine centers for pre-emptive risk mitigation purposes. This will enable us to respond better to potential challenges related to the ongoing pandemic. Once a clinical center is activated patient screening can begin and shortly thereafter the first patients can be enrolled. A total of 30 patients will participate in the study and we expect to share topline data by the end of 2022.

Continued progress of preclinical development programs

In parallel with the activities related to the clinical Phase II study with CS1, we have continued the development of our two preclinical programs, CS014 and CS585. CS014 is a new histone deacetylase inhibitor (HDACi) program and is Cereno’s second HDACi program based on epigenetic modulation following the ongoing development of CS1. The CS585 program comprises selective, potent, and stable prostacyclin receptor (IP) analogs and has demonstrated potential to significantly advance treatments within selected cardiovascular diseases in initial studies. Both programs are being evaluated as treatments of cardiovascular diseases. I am very satisfied to note that the two programs are making good progress and follow the plans that were prepared and initiated during the spring in collaboration with the University of Michigan and led by Dr Mike Holinstat. The progress of the CS014 program triggered a milestone payment as part of our agreement with Emeriti Bio in January and based on the new data generated in the program, a new patent application has been filed. We plan to share more details about these two promising programs during 2022.

Further strengthening of intellectual property position for CS1

During the fourth quarter we again further expanded our patent protection of CS1. This time with the first patent to be granted in the third patent family for CS1 for the Russian market. In January we added the second patent to the third patent family, this time in one of the world’s largest pharmaceutical markets, Japan. We now have patents granted across all three patent families for CS1 covering Australia, Canada, Japan, Russia, Europe and the US. Protecting our innovations is an important element in our efforts to optimize the commercial positioning of our portfolio pipeline and I am therefore very pleased with the work that is being done in this area.

Presenting Cereno at scientific and investor events

Early December, we were excited to have our CMO Björn Dahlöf attending and presenting at this year’s Global CardioVascular Clinical Trialists (CVCT) Forum. The CVCT is a global annual event that brings together leading stakeholders and experts to discuss clinical trials in the CVD space. I am proud to have the co-founders and co-chairmen of this prestigious conference, Dr Faiez Zannad and Dr Bertram Pitt, as part of our Scientific Advisory Board. We have attended the Forum before, but this time we were invited to give a presentation in a session about the evolving landscape of PAH trials with a focus on redefining clinically meaningful endpoints. To this end, Björn presented our Phase II study in PAH providing insights on the topic from a biotech industry perspective. As such, Cereno is always looking for innovative and efficient approaches to clinical trial designs. For the PAH study we have achieved that by including elements such as validated risk score as a secondary endpoint and the use of Abbott’s CardioMEMS system for continuous monitoring of the patients’ pulmonary pressure. Also presenting at the session from the industry perspective were representatives from Merck and Abbott. We are delighted to be invited and be part of such an important event alongside global thought leaders and industry majors within CVD.

Furthermore, I have had the opportunity to present Cereno’s significant progress and future plans at a number of investor events during the fourth quarter. It was great to finally meet investors again in person at Aktiespararna’s “Stora Aktiedagen” held in Stockholm in December.

Looking forward to 2022

When I reflect on 2021 it has been a year of significant progress for Cereno, and I am proud of what we have achieved with the support of our large network of partners, collaborators and not least our investors. With the 95 million SEK that was raised with the exercised TO1 warrant program we can continue developing our three programs at full speed in 2022. It is an exciting time for Cereno, and I am looking forward to another great year where we continue our journey towards bringing innovative treatments to patients affected by common and rare cardiovascular diseases.

February 2022

Sten R. Sörensen
CEO, Cereno Scientific

Financial calendar

Annual report 2021                                                          6 April 2022

Interim report Q1                                                             19 May 2022

Annual general meeting                                                   1 June 2022

For further information, please contact:
Daniel Brodén, CFO
Tel: +46 768 66 77 87
Email: info@cerenoscientific.com

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. In addition, Cereno has two promising preclinical development programs targeted at treating cardiovascular diseases. The CS585 program consists of stable, selective, and potent IP (prostacyclin) receptor agonists and the CS014 program comprises HDAC inhibitors with epigenetic effects. 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.