Cereno Scientific publishes interim report for Q1 2022

The Board and Chief Executive Officer of Cereno Scientific AB here presents the interim report for Q1, 1 January – 31 March, 2022.

Summary of the first quarter, January – March 2022

Cereno Scientific Group

First quarter (1 January – 31 March 2022)

• Net Sales were SEK 0 (0)
• Result after financial items was SEK -5,246,969 (-3,903,947)
• Earnings per share was SEK -0.05 (-0.05) before dilution and SEK -0.04 (-0.03) after dilution
• The equity/assets ratio was 93.4% (87.2%)
• Cash and bank balance was SEK 77,268,668 (60,071,685)

Parent company

First quarter (1 January – 31 March 2022)

• Net Sales were SEK 0 (0)
• Result after financial items was SEK -5,247,501 (-3,904,688)
• Earnings per share was SEK -0.05 (-0.05) before dilution and SEK -0.04 (-0.03) after dilution
• The equity/assets ratio was 93.4% (87.2%)
• Cash and bank balance was SEK 77,221,636 (60,021,845)

Significant events during the first quarter

• In January, Cereno obtains additional patent protection for Phase II drug candidate CS1 in 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.
• Late January, it was announced that a milestone has been reached as part of preclinical CS014 program. The progress made in the preclinical program triggered an undisclosed milestone payment to Emeriti Bio from which CS014 was acquired in 2019. Based on this progress a new patent application has been filed. CS014 is currently undergoing a preclinical development program in a research collaboration with the University of Michigan, Ann Arbor, USA.
• In mid-February, the company held a webcast focused on the Phase II study with drug candidate CS1 in PAH. Presentations were held on the background, design, and plan for the Phase II study by CEO Sten R. Sörensen, CMO Dr. Björn Dahlöf, Dr. Raymond Benza, Principal Investigator for the study and Dr. Philip Adamson, Vice President and Chief Medical Officer at study collaborator Abbott. A link to the recording is available on Cereno’s website.
• In February, it was made public that Cereno strength­ens its Executive Management Team with a Head of Clinical Operations. Fredrik Frick will be responsible for all Cereno’s clinical activities globally, providing lead­ership, project management and program oversight for the preparation and execution of international clinical development programs. Frick starts the role in May.
• In March, it was announced that the European Patent Office (EPO) has granted a patent for CS1’s second patent family. The new patent adds to the existing in­tellectual property rights (IPR) for this strategically im­portant market which now covers two of Cereno’s three patent families.

Significant events after end of period

• In late April, the company nominates a drug candidate in the preclinical CS585 program for continued development in cardiovascular disease after completing initial preclinical studies. The drug candidate was nominated after demonstrating highest potential in cardiovascular disease among a set of similar molecules. CS585 will continue its preclinical development program, which is executed as a research collaboration with the University of Michigan.
• In early May, the nomination of drug candidate CS014 was announced for continued development in cardiovascular disease. After completing the first half of the preclinical development program, CS014 was nominated after demonstrating highest potential in cardiovascular disease among a set of similar molecules. The preclinical development program for CS014 is currently ongoing in a research collaboration with the University of Michigan, Ann Arbor, USA.
• In May, Cereno announced that an abstract on preclinical drug candidate CS585 has been accepted as an oral presentation by the Scientific Program Committee at the European Hematology Association (EHA) 2022 Hybrid Congress in Vienna, Austria, on June 9-12, 2022. The abstract: “CS585 is a first-in-class compound targeting the IP receptor for prevention of thrombosis without increased risk of bleeding” will be presented by Dr. Michael Holinstat, lead of Cereno’s preclinical development programs at University of Michigan and Director of Translational Research at Cereno.
• In mid-May, it was announced that an abstract regard­ing the design of the Phase II study with drug candidate CS1 in pulmonary arterial hypertension (PAH) has been accepted as a poster presentation at the 15th Annual World Congress on Pulmonary Vascular Disease in Athens, Greece, on June 22-26, 2022. The abstract was a collaboration between Dr. Raymond Benza, principal investigator (PI) for the Phase II study, global partner Abbott and Cereno.
• Also in May, an abstract on preclinical drug candidate CS014 was accepted at the ESC Congress 2022 hosted by the European Cardiology Society in Barcelona, Spain, on August 26-29. The abstract has been selected for an oral moderated poster presentation and is titled “CS014 is a novel HDAC inhibitor regulating platelet activity, fibrinolysis and clot stability for prevention of thrombo­sis without increased risk of bleeding.” It will be present­ed by Dr. Michael Holinstat, lead of Cereno’s preclinical development programs at University of Michigan and Director of Translational Research at Cereno.

Letter from the CEO

The first months of 2022 have shown significant progress for each of our three development programs. The clinical phase II study with CS1 has advanced well with site selection, ethical approvals, and contracting an expanded number of centers. A highlight for me was, together with our CMO Björn Dahlöf, hosting our first webcast on the Phase II study with Principal Investigator (PI) and world-renowned PAH expert Dr. Raymond Benza, together with our collaboration partner Abbott represented by CMO Philip Adamson. The webcast yielded positive feedback from investors as well as industry colleagues. For each of our two high-potential preclinical candidates, CS585 and CS014, new exciting data has seen the light. I am thus very pleased to share our advances in building the awareness of and position for Cereno in the medical community with several scientific abstracts accepted to top congresses in the coming months. We have kickstarted 2022 with an impressive news flow and I am thrilled for what lies ahead for Cereno.

Two nominated preclinical drug candidates with significant potential in CVD

It is exciting to follow the positive progress of our two preclinical development programs. These programs are being conducted in a research collaboration between Cereno and University of Michigan lead by Dr. Michael Holinstat, Associate Professor of Internal Medicine, Division of CV Medicine at University of Michigan who is also Director of Translational Research at Cereno. Each preclinical program has, since the initiation in May 2021, advanced well and shown very promising results thus far halfway through the 24-month period. We recently announced that we have nominated a candidate drug from each program. The nomination of a candidate is based on it having a high potential in cardiovascular disease to move forward in development towards an IND submission – a great milestone for a program. Both these drug candidates, CS585 and CS014, now continue their preclinical development programs in preparation for Phase I studies. I am pleased to report that our aim to have three programs in clinical development within the next two years is thus on track.

Building awareness and a position in the scientific community

We have received no less than three invitations to present our preclinical data and Phase II study design at top medical congresses in the last few weeks. There is a lot of work going into first the research and development and then the preparation and submission of abstracts. It is, however, a pinnacle in our continued efforts to build our position within the cardiovascular disease area. I am excited that Dr. Raymond Benza and Dr. Michael Holinstat will present results from our collaborative efforts at these congresses. It makes an impressive statement and further enables Cereno to gain recognition among the major leading pharmaceutical companies and potential future partners in cardiovascular disease.

Update on CS1 clinical Phase II study in PAH

A Cereno Phase II study investigator meeting was held in May. This is an important milestone from a study management perspective. Cereno was joined by PI Dr. Raymond Benza, Philip Adamson, CMO at study collaborator Abbott and representatives from our CRO Worldwide Clinical Trials for a great agenda and presentations for the staff at all the clinical sites identified for the study. An important aspect, which I believe came across well, was for those that work to identify, recruit, and meet the patients in the study to understand the potential CS1 has to truly transform treatment and, ultimately, improve the quality of life for patients with PAH.

Strengthened IPR for CS1

There are several key work streams related to our drug candidate CS1 in parallel to the Phase II study. One is the continuous work to build our IP portfolio, which I was happy to see materialize in several markets during the first quarter. Our patent protection for CS1 in Europe and Japan, two of the largest markets for pharmaceutical products globally, has now been further strengthened for the second and third patent families respectively.

External factors affecting operations

We are humble toward the uncertainties caused by both the lingering persistence of the covid-19-pandemic and more recently the geopolitical turbulence around the world due to the war in Ukraine. Our ongoing clinical study is executed in the US where the effects of the pandemic are still being felt and we have experienced certain cautiousness or longer processing time for regulatory authorities in relation to ethical approvals as well as contracting procedures at major academic institutions, both of which have taken longer time than initially estimated. Both have expanded the time to initial patient enrolment which we still have to report. However, these factors have been mitigated by an expanded number of centers from six to ten, enabling us to keep our targeted top line data milestone to the end of 2022. At time of writing, we do not see an immediate concern. We are, however, continuously taking measures to reduce the risk of impact in our preclinical and clinical development studies.

What lies ahead

Cereno is growing and maturing together with the progress of our development portfolio. We now have one drug candidate in clinical Phase II and two preclinical candidates, which form a strong portfolio with a significant potential to transform treatments within cardiovascular disease. In two years’ time, we expect to have three drug candidates advancing forward in clinical stage. I am therefore pleased to welcome Fredrik Frick who joined as Head of Clinical Operations this month to help Cereno prepare for this next stage. I believe that Fredrik will complement and strengthen our management team with his proven track record of working within all facets of drug development.

Lastly, I am glad to share that following the positive response from our first webcast to our investment community in March focused on the Phase II study with CS1 we have decided to hold a Cereno Capital Market Day at the beginning of the fall. I hope that you will be able to join us, in person or virtually, and I look forward to sharing more information in due course.

Sten R. Sörensen
CEO, Cereno Scientific

Financial calendar

Annual general meeting                                                   1 June, 2022

Interim report Q2                                                             25 August, 2022

Interim report Q3                                                             November, 2022

For further information, please contact:
Daniel Brodén, CFO
Tel: +46 768 66 77 87
Email: info@cerenoscientific.com
www.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). CS1 is an HDAC (histone deacetylase) inhibitor that acts as an epigenetic modulator with pressure-reducing, reverse-remodeling, anti-inflammatory, anti-fibrotic and anti-thrombotic properties, all relevant for PAH. A clinical Phase II study is ongoing to evaluate CS1’s safety, tolerability and efficacy in patients with PAH. A collaboration agreement with global healthcare company Abbott allows Cereno to use their cutting-edge technology CardioMEMS HF System in the study. Cereno also has two promising preclinical drug candidates in development for cardiovascular disease through research collaborations with the University of Michigan. Drug candidate CS585 is a stable, selective, and potent prostacyclin receptor agonist. It has been documented in preclinical studies to target the IP receptor for prevention of thrombosis without increased risk of bleeding. Drug candidate CS014 is a novel HDAC inhibitor with epigenetic effects. In preclinical studies it has been documented to regulate platelet activity, fibrinolysis and clot stability for prevention of thrombosis without increased risk of bleeding. The company is headquartered in Gothenburg, 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.