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Cereno Scientific publishes interim report for Q3 2020 (1 January – 30 September 2020)

By September 30, 2020January 11th, 2021No Comments

THU, NOV 19, 2020 08:33 CET

The Board and Chief Executive Officer of Cereno Scientific AB here presents the interim report for the third quarter 2020.

Summary of the interim report

Cereno Scientific Group

Year to date (1 January – 30 September 2020)

  • Net Sales were 0 SEK
  • Loss after financial items was SEK 10 907 101
  • Loss per share was SEK 0.27 before dilution and SEK 0.25 after dilution
  • The equity/assets ratio was 86.3 %

Third quarter (1 July 2020 – 30 September 2020)

  • Net Sales were 0 SEK
  • Loss after financial items was SEK 3 132 513
  • Loss per share was SEK 0.08 before dilution and SEK 0.07 after dilution

Parent company

Year to date (1 January – 30 September 2020)

  • Net sales were SEK 0 (0)
  • Loss after financial items was SEK 10 912 494 (11 576 217)
  • Loss per share was SEK 0.27 (0.29) before dilution and SEK 0.25 (0.27) after dilution
  • The equity/assets ratio was 86.3 % (96.0 %)

Third quarter (1 July 2020 – 30 September 2020)

  • Net sales were SEK 0 (0)
  • Loss after financial items was SEK 3 139 695 (2 990 667)
  • Loss per share was SEK 0.08 (0.07) before dilution and SEK 0.07 (0.07) after dilution

Significant events during Q3

  • In September, Cereno announced that the company will enter the rare disease space with lead drug candidate CS1 as an epigenetic modulator with orphan drug potential. The initial focus will be on pulmonary arterial hypertension (PAH), a form of high blood pressure in the lungs.
  • Cereno held an extraordinary general meeting which, in accordance with the proposal from the Board of Directors, resolved to adopt new Articles of Association with amended limits for share capital and the number of shares.
  • Cereno completed a directed share issue of units of approximately SEK 60 million, entered into a loan agreement and issued warrants to current shareholders.

Significant events after the end of the period

  • 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.

Letter from the CEO

The third quarter of 2020 marked a shift for Cereno. We announced a revised strategy of focusing on rare diseases with orphan drug potential with our lead drug candidate CS1 and successfully concluded a financing round that secures the start of a Phase IIa study and op­erations. Starting immediately, we are rapidly taking steps to establish the company into the rare disease space with our drug candidate CS1 and continuing to build on our expertise in the cardiovascular treatment space.

Focus on rare diseases
Behind the shift in focus to rare diseases with orphan drug potential lies a comprehensive assessment around the clinical development possibilities for CS1 led by top commercial, scientific and regulatory advisors in Europe and the US. What was initiated as an exploratory discus­sion with our scientific advisors resulted in an orphan drug designation (ODD) for CS1 granted by the American reg­ulatory agency US FDA in March 2020. Thus, anchoring our initial focus on the debilitating rare disease pulmonary arterial hypertension (PAH), a form of high blood pressure in the lungs. The ODD status is a validation of the major unmet clinical needs within the treatment of PAH and that CS1 has fulfilled the criteria of showing a potential to pro­vide significant benefit to these patients. In addition, an ODD status brings several incentives to facilitate the drug development. It is an important milestone to achieve with­in rare diseases development and is a well-regarded qual­ity stamp from one of the key leading regulatory agencies worldwide.

Phase IIa study with CS1 in PAH
Next in the clinical development program for our drug candidate CS1 in rare disease PAH is a Phase IIa study, where we will evaluate the effect in patients. Preparato­ry work is currently underway in close collaboration with Dr. Raymond L. Benza, a top global thought leader in PAH who sees a great potential for CS1. Initiation of the ap­plication process for regulatory permission to start the Phase IIa study is planned towards the end of this year. We are keeping a high pace forward and are looking forward to being able to share more about the study program as it progresses.

Priorities ahead
In parallel with the work streams for the clinical development for CS1, we are continuously working on securing appropriate IPR protection for our pipeline – CS1 and our preclinical NCE program. It is a significant part of building a strong business case within the biotech industry, and we hope to have more news to share here over the coming months.

With a revised focus and new clinical development strategy, we also hold a key priority to get our company and our intensified ambitions known among new as well as existing stakeholders.

Cereno is advancing on an exciting path and we are looking forward to ultimately be able to bring a new disease-modifying treatment option to patients with common and rare cardiovascular diseases.

Gothenburg, November 2020

Sten R. Sörensen
CEO, Cereno Scientific

Financial calendar

Year-end report, January-December 2020                                25 February 2021

Annual report  2020                                                                         5 May 2021

Interim report, January-March 2021                                          19 May 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-reducing properties, all relevant for PAH. A clinical phase II study program for CS1 in PAH is planned to start during first half of 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 office in Kendall Square in Boston, Massachusetts, US. Cereno is listed on the Swedish Spotlight Stock Market (CRNO B). More information on www.cerenoscientific.com.