Interim Report Q1 2020-01-01 – 2020-03-31

14 May, 2020

The Board and Chief Executive Officer of Cereno Scientific AB here with present the Interim Report for the first quarter 2020.

Summary of the Interim Report

Cereno Scientific Group

 (2020-01-01 – 2020-03-31)

  • Net Sales were 0 SEK.
  • Loss after financial items was SEK -3,752,667.
  • Loss per share was SEK -0.09 before dilution and SEK -0.09
    after dilution*.
  • The equity/assets ratio was 93.8 %.

Parent company

Three months (1 January 2020 – 31 March 2020)

  • Net sales were SEK 0 (0).
  • Loss after financial items was SEK -3,753,523 (-5,333,633).
  • Loss per share was SEK -0.09 (-0.28) before dilution and SEK -0.09
    (-0.24) after dilution*.
  • The equity/assets ratio was 93.8% (42.0%).

Amounts in parentheses: Prior year comparative period.Equity/assets ratio: Shareholders’ equity divided by total assets.Earnings per share: Profit/loss for the period divided by 40,219,312 shares as of 31 March 2020 and 19,181,302 shares as of 31 March 2019.*Diluted earnings per share: Profit/loss for the period divided by shares outstanding and warrants as of the balance sheet date, 31 March 2020 and 31 March 2019, respectively.The “company” or “Cereno Scientific” refers to Cereno Scientific AB, Corporate Registration Number 556890-4071.

Significant events during the first quarter of 2020

  • On 10 March, Cereno Scientific announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s lead compound CS1, for the treatment of Pulmonary Arterial Hypertension (PAH).
  • Due to the global spread of the Sars-cov-2 virus, Cereno Scientific announced on March 30 that the company will postpone the planned Phase II clinical trial with the company’s lead compound CS1. The start of the study was previously planned for mid-year 2020. Cereno Scientific is adjusting planned activities to start by the end of the year, but is prepared for further adjustments if needed, due to the uncertainty of the further development of the pandemic.

Significant events after the end of the period

  • On 2 April, Cereno Scientific announced that the company is strengthening its clinical expertise by recruiting Dr. Raymond L. Benza, Professor of Medicine and Director, Division of Cardiovascular Medicine, at the Ohio State University Wexner Medical Center in Columbus, USA, as Scientific Advisor to the company.
  • On 13 May, Cereno Scientific announced that the company has expanded its global footprint by establishing a subsidiary with new office space located in Kendall Square at the Cambridge Innovation Center (CIC), Cambridge, Boston, Massachusetts.

CEO Sten R. Sörensen comments

The 2019 finished strongly and during the first quarter of 2020, we continued to advance the development of our drug candidates in epigenetic modulation, through HDAC inhibition, for cardiovascular and rare diseases.  Below is a summary of Q1 2020 highlights and recent corporate updates.

Orphan drug status granted by the FDA
In March, we received the positive news that the U.S. Food and Drug Administration (FDA) had granted orphan drug status (ODD) for our lead compound, CS1, for the treatment of Pulmonary Arterial Hypertension (PAH). PAH is a fatal disease that involves high blood pressure in the pulmonary arteries, where the increased pressure is mainly caused by changes in the blood vessels in the lungs.The granted ODD gives us the opportunity to conduct a clinical development programme aimed at registration for the relatively rare and serious disease PAH, with the objective that our lead compound, CS1, will help a patient group with extensive medical needs. The obtained ODD status brings several benefits, which in combination, can entail a more rapid and simpler path to market approval and launch.

Strengthened clinical expertise with new scientific advisor in PAH
To further strengthen our clinical expertise and expand our knowledge base in PAH, which is a new indication for us, we have recruited a top international expert to support the company. It is a pleasure to welcome Dr. Raymond L. Benza, Professor of Medicine and Director, Divison of Cardiovascular Medicine, at Ohio State University Wexner Medical Center in Columbus, USA, who will be a scientific advisor to the company.Dr. Raymond L. Benza is an internationally renowned clinician and researcher. Dr. Benza will support the development of products in our focus areas, thrombosis and fibrosis-related rare cardiovascular diseases such as PAH, which is one of his primary clinical interests.

CS1 Clinical Trial Impacted by COVID-19
The recent period has been dominated by the global spread of COVID-19. In March, we announced the postponement of the planned clinical phase II trial of CS1 in Bulgaria and Russia.Considering the prevailing situation, there are currently no possibilities of starting the phase II trial in orthopedic surgery because elective knee joint surgery has been deprioritized in hospitals in favor of the care of COVID-19 patients. The start of the trial was formerly scheduled to begin in mid-2020. We are adapting the planned activities for a start at the end of the year but are also preparing for further adjustments if required due to the uncertainty about the continued development of the pandemic.

Advanced CS014 and CS036
Development work is ongoing with both CS014 and CS036, two early development programmes in the preclinical phase that were acquired in 2019.

Established US subsidiary
In May, we announced that we have expanded our footprint into the United States with a subsidiary with office space in Kendall Square at the Cambridge Innovation Center (CIC), located in Cambridge, Boston, Massachusetts.  The CIC is one of the industry’s most recognized biotechnology hubs and has supported more than 6,000 companies in the life science and technology fields. The United States is the world’s largest financial market and Cambridge, Boston, is considered one of the leading biotech clusters in the world.The new office is a natural progression for us to scale up collaborations and networks with business partners and potential investors in the United States.

Gothenburg, 14 May 2020
Sten R. Sörensen, CEO Cereno Scientific AB

About Cereno Scientific

• Thrombosis – causes the most deaths globally

Thrombosis-related disease (occluding blood clots) is the leading cause of illness and death worldwide. Myocardial infarction and stroke, which in most cases are caused by thrombosis, cause great suffering for the individual and high costs for society.

• Current treatments are inadequate – high risk of bleeding and suboptimal preventive effect

Blood-thinning medications are widely used today to prevent blood clots. They act by inhibiting coagulation or blood platelets. This treatment is associated with a relatively high risk for serious bleeding complications, resulting in insufficient prevention effect with current drugs, since the most effective doses cannot be used, or in some cases, treatment must be discontinued due to the risk of bleeding. This entails a high risk of new blood clots.

• Cereno Scientific works with the body’s own intelligent blood clot-busting system to improve the preventive treatment of blood clots with reduced risk of bleeding side effects

Cereno Scientific’s first drug candidate, CS1, is based on the body’s own intelligent defence systems against blood clots. Cereno Scientific considers that the company’s concept is unique because there are currently no clinical therapies that optimise the body’s clot dissolving system (the fibrinolytic system) that is triggered when blood clotting (coagulation) begins after a vascular injury has occurred.CS1 is expected to provide an opportunity for effective preventive treatment of blood clots and a lower risk of bleeding than is the case with today’s treatments with blood-thinning drugs.

• Documented effect on risk markers for blood clots and proven preventive effect

CS1 has documented effect on risk markers in experimental studies and early human studies. Preventive effect against thrombosis has been demonstrated in in vivo studies in animals. Indication of clinical preventive effect against heart attacks and stroke has been shown in several large independent epidemiological studies. The first clinical study with CS1 showed positive results regarding safety, desirable pharmacokinetic properties and effect on a biomarker for the risk of thrombosis. Data shows that treatment with CS1 significantly lowers PAI-1 levels. PAI-1 is the factor that inhibits t-PA, which is the substance the body itself uses to dissolve blood clots.

• Expanded indication targets

Cereno Scientific has expanded its future plans through a possible broadening of indications and is evaluating the potential for epigenetic modulation in rare diseases related to pulmonary fibrosis, thrombosis, inflammation and high blood pressure in the pulmonary circulation. Cereno Scientifics aim is to form a platform of drug candidates that affects the field of epigenetic modulation through “HDAC inhibition” (Histone DeACetylase inhibition).

• Known substance that has been used for over 40 years in large patient populations indicates low development risk

CS1 is a new innovative formulation of a known substance that minimises the risk for unwanted side effects and indicates a relatively low development risk.

• Relatively short time to market and possible collaboration agreement with major pharmaceutical company

The company intends to seek collaboration agreements with major pharmaceutical companies for further development towards larger thrombosis prevention indications such as heart attack and stroke. In conjunction with the Phase II program, contacts with potential partners are expected to increase.

• Large market potential

CS1 has an intelligent mechanism with a possible broad indication window towards large thrombosis-related diseases, with long treatment times (preventive treatment) and therefore a large value and market potential. The company has an approved patent in the US and Australia for use of CS1. The approved patent provides Cereno Scientific with a platform for a significant market potential in the US, the world’s largest drug market — a market that, for drug-related treatment of thrombosis alone, has estimated sales of approximately USD 10 billion annually and continues to grow. Furthermore, the FDA has granted the company’s lead compound, CS1, orphan drug status for the indication Pulmonary Arterial Hypertension (PAH).

• HDAC inhibitor development program

Cereno Scientific has a preclinical HDAC inhibitor development program. In 2019, the compounds CS014 and CS036, were acquired from Emeriti Bio AB Inorbit Therapeutics AB. The acquisitions mean that Cereno Scientific has a portfolio of drug candidates with the potential for more indications in cardiovascular diseases.

Operations

Cereno Scientific is developing a pipeline of preventive therapeutics that work through epigenetic modulation for cardiovascular diseases and rare diseases to meet significant unmet clinical needs. Cereno Scientifics aim is to form a platform of drug candidates that affects the field of epigenetic modulation through “HDAC inhibition” (Histone DeACetylase inhibition).

Cereno Scientific’s first drug candidate, CS1, is expected to provide an opportunity for effective preventive treatment of blood clots and a lower risk of serious bleeding complications than today’s treatments with blood-thinning drugs. CS1 is an innovative formulation of a known compound and, as such, is expected to have a relatively short development time. Cereno Scientific’s concept is based on many years of research, and its effectiveness has been documented in experimental animal studies, clinical studies and epidemiological studies, the latter have seen a reduced risk of both heart attack and stroke. CS1 has a unique mechanism of action, a potentially wide range of indication opportunities connected to major thrombosis-related diseases and, consequently, a large market potential. Furthermore, Cereno Scientific has expanded its future plans for CS1 by increasing its potential target indications. In addition to the ability to prevent thrombosis, opportunities have been identified for CS1 to inhibit – or even reduce already established – fibrosis development. It opens up for additional benefits in cardiovascular indications such as atrial fibrillation, heart failure, chronic kidney damage and a number of rare thrombosis diseases with significant development of fibrosis. The FDA has granted ODD for the indication Pulmonary Arterial Hypertension (PAH) to the company’s lead compund CS1. Cereno Scientific also has a preclinical HDAC inhibitor development program. The company is headquartered and operates in AstraZeneca’s BioVentureHub. For more information, see www.cerenoscientific.com.

Company structure and shareholding
On December 20, 2019, a US subsidiary, Cereno Scientific Inc. was formed. The company is a wholly owned subsidiary of Cereno Scientific AB.

Company share
Cereno Scientific’s B shares were listed on Spotlight Stock Market on 22 June 2016. Spotlight Stock Market is an affiliate of ATS Finance AB, which is a securities company under the supervision of Finansinspektionen, the Swedish financial supervisory authority. Spotlight Stock Market operates a multilateral trading facility (MTF), which is not a regulated market. On 31 March 2020, share capital was divided across 40,219,312 shares. The company has two classes of shares (of which 722,248 Class A shares). The Class A share carries the right to ten (10) votes per share. Each Class B share carries the right to one (1) vote per share. Each share gives equal rights to the company’s assets and earnings. The quote value (share capital divided by number of shares) amounts to SEK 0.10.

Warrants of series 2016/2019
At the Annual General Meeting on 29 January 2016, it was resolved to issue 325,289 warrants (series 2016/2019) through a private placement, thus entitling to a subscription of 325,289 Class B shares. During the third quarter of 2017, the company repurchased 65,058 warrants at the issue price. The repurchased warrants have been cancelled; of the original 325,289 warrants, 260,231 now remain. After the completed preferential issue in June 2019, the restated number of shares that the options give entitlement to is 275,736 and the restated subscription price is SEK 5.66. The warrants can be used for subscribing Class B shares during the period 1 March 2019 – 1 December 2020. For information regarding holders of warrants, refer to the Listing Memorandum.

Warrants of convertible loans
The financing agreement concluded with the European High Growth Opportunities Securitization Fund on 1 March 2019 and consisted of convertible loans and associated warrants. The company no longer has any outstanding convertible loans. The number of warrants outstanding at the balance sheet date, 31 March 2020, was 2,247,569. After the completed preferential issue in June 2019, the restated number of shares that the options give entitlement to is 2,270,044. Of the warrants, 1,142,306 have a maturity of five years from the respective registration dates, with subscription prices between SEK 3.60 and 8.40. The 1,105,263 warrants issued on 1 March 2019 have a subscription price of SEK 1.90 and a maturity of six years, with a lock-up period during the first year in which the options may not be sold or utilised.

Warrants of series OP 2018/2022
The Extraordinary General Meeting on 23 October 2018 resolved to issue 647,256 warrants and/or employee warrants (series OP 2018/2022) entitled to subscription of 647,256 Class B shares. 323,628 warrants and/or employee warrants have a subscription price of SEK 15.00 per warrant, and 323,628 of the warrants and/or employee warrants have a subscription price of SEK 30.00 per warrant. 617,256 warrants were cancelled in the second quarter of 2019 at no cost to the company, after which 30,000 warrants are outstanding. After the completed preferential issue in June 2019, the restated number of shares that the options give entitlement to is 31,787. Of the 30,000 warrants outstanding, 15,000 now have a restated subscription price of SEK 14.16 and 15,000 have a restated subscription price of SEK 28.31. The warrants can be used for subscribing Class B shares during the period 24 July 2022 – 23 October 2022.
Warrants of series 2019/2023 N01 and series 2019/2023 S01
The Extraordinary General Meeting on 28 August 2019 resolved to issue 650,000 warrants, of which 450,000 relate to key persons (series 2019/2023 N01) and 200,000 relate to operational Board members (series 2019/2023 S01), giving an entitlement to subscribe for a total of 650,000 class B shares. The warrants have a subscription price of SEK 15.26 per warrant, and can be used for subscribing for Class B shares during the period 1 April – 31 October 2023.

Warrants of series 2019/2023 SAB01
On 6 September 2019, the Board of Directors of Cereno Scientific resolved to issue at most 300,000 warrants to members of the company’s Scientific Advisory Board (series 2019/2023 SAB01). Each warrant bears the right to a new subscription of 1 Class B share in the company during the period from 1 April 2023 to 31 October 2023. The subscription price is SEK 15.26 per share.

Financial performance
During the first quarter, the company mainly invested in the development and production of clinical supplies. At the end of the first quarter, the company had a cash balance of approximately SEK 18.9 million and an equity/assets ratio of 93.8%.

Audit

The company’s auditor has not audited the Interim Report.

Principles of preparation for the Interim Report

The accounts in this Interim Report have been prepared in accordance with the Annual Accounts Act and the Swedish Accounting Standards Board BFNAR 2012:1 Annual Report and Consolidated Accounts (K3).

Upcoming financial reports

Half-year Report, 2020                                                                      28 August 2020

Interim Report, Q3 2020                                                                   19 November 2020

AGM

The Annual General Meeting will be held on 10 June at 11:00 in Gula salongen at the University of Gothenburg’s premises at Universitetsplatsen 1, Gothenburg.

The Board of Directors and CEO certify that this Interim Report provides a true and fair view of the company’s operations.

Gothenburg, 14 May 2020

The Board and Chief Executive Officer of Cereno Scientific AB

For further information, please contact:
Daniel Brodén – CFO
Tel: +46 768 66 77 87
E-mail: info@cerenoscientific.com
www.cerenoscientific.se

About Cereno Scientific AB
Cereno Scientific is developing a pipeline of preventive therapeutics to treat cardiovascular and rare diseases by epigenetic modulation through histone deacetylase inhibition (HDACi). The company’s lead program, CS1, is a phase II dual-acting antithrombotic drug aimed at venous thrombosis and stroke prevention for atrial fibrillation. Cereno Scientific also evaluates the potential of epigenetic modulation for rare diseases related to pulmonary fibrosis, thrombosis, inflammation and high blood pressure in the pulmonary circulation system. The FDA has granted ODD for the indication Pulmonary Arterial Hypertension (PAH) to the company’s lead compound CS1. Cereno Scientific also has a preclinical HDAC inhibitor development program. The company is located in AstraZeneca’s BioVenture Hub. Cereno Scientific’s B share has been listed on Spotlight Stock market since June 2016 with the ticker CRNO B, ISIN SE0008241558.

Interim Report Q1