Cereno Scientific publishes interim report for Q2 2022

The Board and Chief Executive Officer of Cereno Scientific AB here presents the interim report for Q2 2022.

Summary of the second quarter, April – June 2022

Cereno Scientific Group

Second quarter (April 1– June 30, 2022)

• Net Sales were SEK 0 (0)
• Result after financial items was SEK -6,518,033 (-4,756,911)
• Earnings per share was SEK -0.06 (-0.07) before dilution and SEK -0.04 (-0.03) after dilution
• The equity/assets ratio was 87.9% (84.5%)
• Cash and bank balance was SEK 63,257,948 (41,425,474)

Parent company

Second quarter (April 1 – June 30, 2022)

• Net Sales were SEK 0 (0)
• Result after financial items was SEK -6,747,978 (-4,913,851)
• Earnings per share was SEK -0.06 (-0.07) before dilution and SEK -0.04 (-0.03) after dilution
• The equity/assets ratio was 87.9% (84.8%)
• Cash and bank balance was SEK 63,214,536 (41,026,206)

Significant events during the first quarter

• 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) was 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 was 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.
• In May, it was announced that a Head of Preclinical Development was recruited to strengthen Cereno’s Executive Management Team. Nick Oakes was appoint-ed Head of Preclinical Development bringing significant experience within preclinical research and development in cardiovascular disease, a key factor for the success of Cereno’s continued pipeline development.

Significant events after end of period

• Early July, Cereno shared that the first patient was enrolled in the Phase II study in PAH with drug candidate CS1. Based on the timing of enrollment and several factors mainly related to the activation of clinical sites, the study timeline was adjusted by about a quarter and top-line results are now estimated for Q1 2023. The number of study sites has been increased to include about 10 clinics across the US with potential for further expansion to facilitate meeting the Q1 timeline.
• At the end of July, it was reported that a block trade of Serie TO2 warrants was executed. In connection with the transaction subscription commitments for the exercise of warrants of series TO2 were undertaken by the buyers. The sellers have also undertaken subscription commitments for warrants that they still own.
• On August 30, Cereno will hold its inaugural Capital Markets Day in central Stockholm. The program will provide an update on the pipeline, clinical and preclinical development, and growth strategy from both the company as well as external collaborators. Registration to participate in-person or digitally is available on the company’s website.

Letter from the CEO

The first half-year of 2022 has been intense across our business operations. Growth and progress have been evident in our development programs, but, also significantly impor­tant has been our increasing footprint in the medical community. The single most exciting highlight just after the period ended was, however, the news of the first patient enrolled in the Phase II study with CS1 in PAH. We are keeping momentum and have an exciting fall and winter ahead of us in our quest to develop better and safer innovative treatments for cardiovascular disease.

First patient in CS1’s Phase II study

We were thrilled to see the first patient enrolled in the Phase II study this past July. It really is a significant mile­stone in our progress towards demonstrating that our drug candidate CS1, with its unique efficacy profile, has the po­tential to offer a safe, efficacious, and disease-modifying treatment option for patients suffering from the severe rare disease PAH. The plan forward is to continue work­ing closely with the active clinical sites to support patient recruitment and, as often happens, the enrollment pace starts to speed up following the first patient entering the study. As we have communicated previously, the lingering covid-19 pandemic in the US did affect the start-up timeline resulting in an adjusted timeline of about a quarter meaning that top-line results are now estimated for Q1 2023. There are several pertinent milestones related to the study that will be reported during the fall and winter as they happen to further ensure that we provide all interested stakeholders with updates on the study's progress.

Nominations of drug candidates in our preclinical programs

The nomination of drug candi­dates in each of our preclinical programs CS585 and CS014 during spring signifies great progress and proven science in our preclinical development, albeit in an early development stage. These preclinical programs are developed in collab­oration with the University of Michigan and have already yielded promising preclinical data that was accepted and presented at premier medical congresses in the last few months. To that end, we are pleased to know that our aim to have three promising clinical development programs in the portfolio within the next two years is on track.

Presentations at reputable medical congresses

During summer, we have had no less than three abstracts presented at top medical congresses across Europe and the US. There was the promising preclinical data for both CS585 and CS014 as well as the innovative study design of our Phase II study with CS1.

We have shown with preclinical data that we have two strong drug candidates in CS585 and CS014 demonstrat­ing effect in thrombosis prevention without increased risk of bleeding; These findings may be very significant with thrombosis being a key mechanism in many complications in cardiovascular disease. Furthermore, there is a strong unmet medical need for new drugs providing prevention of thrombosis without increased risk of bleeding as available anti-thrombotic drugs do pose an increased risk of bleeding for pa­tients. Thus, no surprise that our abstracts earned their place in the spotlight at several congresses and garnered interest from the medical community.

Strengthening the executive team

I am very pleased that in the last months, we have announced appointments of both a Head of Clinical Operations and Head of Preclinical Development. The addition of Fredrik Frick and Nick Oakes adds two more experienced research and development (R&D) executives to our management team, which will provide the leadership needed as we continue to grow Cereno. The development of our pipeline is a critical success factor in order to deliver on our vision to make available innovative drugs for patients with rare and common cardiovascular diseases. I look forward to seeing their combined efforts in moving our clinical and preclinical portfolio to the next level together with our existing team of experienced professionals, advisors, and long-term consultants.

Outlook

The company and our portfolio are right now well-positioned for continued growth. We are in the beginning stages of carving out a place as a serious player in the global PAH pipeline. I am particularly pleased to see us establishing our footprint among the top thought leaders in cardiovascular disease, which I believe will only continue to strengthen through our clear and consistent presence across key platforms such as medical congresses. Later this year, I look forward to us bringing our perspective as an innovator in CVD at the renowned CVCT forum to which we have, as last year, been invited again. But there are many events ahead before we get to that.

At the end of August, Cereno will be participating at the ESC congress in Barcelona – the top cardiovascular congress in Europe. In addition to a poster presentation on CS014, where new exciting data will be presented, we have planned to hold meetings with our Scientific Advisory Board to further refine our preclinical and clinical development programs for the three drug candidates in our pipeline. It is a great opportunity to strengthen our relationship with thought leaders in the industry and get to hear from some of the best in the medical community.

I am also very excited to host our inaugural “Cereno Capital Markets Day” on August 30th in Stockholm. We have put together a comprehensive program providing insights into our strategy and operations. In attendance and presenting will be external thought leaders as well as members of Cereno’s Executive Management Team. Please see our website for details on how to register to attend or find the link for the webcast.

Lastly, as many might know, there is a warrant program of Series TO2 being executed during September. More information specifically around this will follow in due course.

To sum up, I believe Cereno is well on its way of bringing great change to the cardiovascular disease space. This year, we have already delivered on several milestones with many additional significant milestones coming up around the corner. I would like to express my appreciation to all our shareholders for your continued support and for sharing our vision of developing innovative treatments for rare and common cardiovascular disease.

Sten R. Sörensen
CEO, Cereno Scientific

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.