Cereno Scientific publishes interim report for Q3 2022

The Board and Chief Executive Officer of Cereno Scientific AB here presents the interim report for Q3, 1 July – 30 September, 2022.

Summary of the third quarter, July – September 2022

Cereno Scientific Group

Third quarter (1 July – 30 September)

• Net Sales were SEK 0 (0)
• Result after financial items was SEK -7,248,364 (-3,356,309)
• Earnings per share was SEK -0.07 (-0.05) before dilution and SEK -0.05 (-0.02) after dilution
• The equity/assets ratio was 93.2% (89.9%)
• Cash and bank balance was SEK 36,569,272 (28,583,402)

Parent company

Third quarter (1 July – 30 September)

• Net Sales were SEK 0 (0)
• Result after financial items was SEK -7,215,192 (-3,356,528)
• Earnings per share was SEK -0.07 (-0.05) before dilution and SEK -0.05 (-0.02) after dilution
• The equity/assets ratio was 93.2% (89.9%)
• Cash and bank balance was SEK 36,527,454 (28,536,156)

Significant events during the 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 topline results are thus 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 timeline.
• In August, Cereno’s innovative Phase II study design in PAH with CS1 was accepted for presentation at the CHEST annual meeting on Oct 16-19 in Nashville, US. The abstract was selected for an oral presentation and is titled “An innovative Phase 2 clinical trial design for the assessment of CS1 – a novel therapy in the treatment of pulmonary arterial hypertension.” It was presented by Dr. Raymond Benza, study's Principal Investigator (PI) and Chair of its Clinical Steering Committee and Professor and Director of the Division of Cardiovascular Diseases at the Ohio State University Wexner Medical Center.
• In mid-August, Cereno reported that two new patents were granted in drug candidate CS1’s second and third patent families, respectively, in the US.
• On August 26, Cereno reported that the first patient received their first dose of drug candidate CS1 in the Phase II study in pulmonary arterial hypertension (PAH). Prior to the dosing, the patient has undergone a screening process, implantation of the CardioMEMS HF System to monitor lung pressure during the study, and a full baseline evaluation including a 6-minute walk test, echocardiography, and MRI to enable exploration of CS1’s efficacy. Each patient undergo a 12-week drug treatment period and a two-week follow-up period.
• At the end of August, Dr. Michael Holinstat, lead of Cereno’s preclinical development programs at University of Michigan and Director of Translational Research at Cereno, presented an abstract at the ESC Congress 2022 in Barcelona, Spain. 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.”
• On August 30, Cereno held its inaugural Capital Markets Day in central Stockholm. The program pro­vided an update on the pipeline, clinical and preclini­cal development, and growth strategy from both the company as well as external collaborators. A record­ing of the event is available on the company website, www.cerenoscientific.com, in the Investors-section.
• In early September, Cereno’s patent protection for drug candidate CS1 was expanded through its second patent family by a granted patent in Mexico.
• In early September, a patent was granted in the second patent family for the preclinical Prostacyclin Receptor Agonist (PCA) Program, which includes drug candi­date CS585. This broadened the patent protection and strengthened CS585's future commercial position in the US.
• In September, Cereno’s drug candidate CS1 obtained strengthened patent protection through its third patent family with issued patents in Australia and South Korea.
• In late September, Cereno obtained the first patent in Europe, in the second patent family, for the preclinical Prostacyclin Receptor Agonist Program, which includes drug candidate CS585. The patent expands the intellec­tual property rights (IPR) for CS585 to Europe, one of the largest markets in cardiovascular disease.
• At the end of September, it was concluded that the war­rants of series TO2 were subscribed to approximately 93.4 percent. Cereno received approximately SEK 61.3 million before issue costs during the month of October.

Significant events after end of period

• In October, Cereno expanded patent protection for drug candidate CS1 through its second patent family by obtaining patents in Israel and in Malaysia.
• In October, in connection with Cereno receiving the cash from the warrant of Serie TO2, a loan of SEK 5 million was also amortized according to the terms. This is the second and last installment on the loan which is from 2020.

Letter from the CEO

We are nearing the end of a fruitful and productive year filled with milestones in our clinical and preclinical development as well as in operations. Our organization has continued to mature with the addition of several experienced experts in our executive management team. There is a high operational activity across all parts of Cereno as we continue to deliver on our commitment to developing innovative treatments for common and rare cardiovascular diseases with great unmet needs.

CS1’s Phase II study in rare disease PAH entered recruitment-stage

We know from thought leaders and physicians that there is a huge need for better and safer treatments for the severe rare disease PAH. The need is especially high for treatments that not only alleviate the symptoms as today’s available treatments but have the potential to stop or delay the disease progression, such as our drug candidate CS1. At present, the global market for PAH is estimated to be nearly USD 6.5 billion with the anticipation of a doubling in the next five years. Thus, the ongoing Phase II study with CS1 in PAH has the potential to make a major difference in the future treatment landscape.

A significant milestone was met when the first patient in the Phase II study was enrolled in July and entered the treat­ment period at the end of August. This was a highly mean­ingful step in our progress toward 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. We have, thus far, seen a significant impact on the study’s start-up timeline that can be attrib­uted to the lingering covid-19 pandemic in the US. We have experienced more than double as long processing times at regulatory authorities than previously seen. This, in turn, has delayed the necessary documenta­tion needed for each clinical site to be activated and able to open for patient recruitment. The last few months have been filled with intensive activities for our team and the CRO managing the study as we have continuously worked closely with the clinical sites to support activation and, once ready, patient recruitment.

Strengthened patent protection across the portfolio

At Cereno, we are continuously working to strengthen the patent protection for all candidates in our portfolio. It is often a crucial factor in the long-term success of a drug, especially from a commercial perspective. I am pleased that we have secured and further expanded the patent portfolio for our drug candidate CS1 during the period.

At the same time, we have also reached two key patent milestones for our Prostacyclin Receptor Agonist (PCA) Program and drug candidate CS585. First, we obtained the first patent acceptance in Europe, thus expanding the geographical reach of the program’s patent protection. Secondly, the patent protection was broadened for the PCA Program and CS585 with the acceptance of a second patent in the US, which strengthens its future commercial position in this very important market. Activities related to intellectual property rights (IPR) for the CS014 program are also ongoing as is normal procedure at this stage of development.

Cereno Capital Markets Day – A science-heavy agenda

I hope you had the chance to attend or watch the live stream of our Capital Markets Day that we held at the end of August. We much enjoyed going deeper into the science of our R&D programs together with external world-lead­ing thought leaders such as Dr. Benza, Dr. Holinstat and Dr. Adamson. In addition to our clinical Phase II program in PAH, we also presented a closer look at our preclinical drug candidates than we have previously had the opportunity to do. So if you are interested to learn more about Cereno and our assets, I would urge you to watch the recording of the day as it provides a comprehensive view of the company both as seen by the executive management team, executive management of our collaborative partner for the Phase II study, Abbott, as well as by external thought-leaders in the field of PAH and thrombosis. The recording as well as the slides presented of each segment on the agenda can be found on our website, www.cerenoscientific.com, in the Investors-section.

Two promising preclinical programs

Preparations and work to get our two preclinical candidates ready for clinical phase studies are at full pace to meet our aim of achieving clinical-stage readiness within the next year and a half to two years. Our Head of Preclinical Development, Nick Oakes, started at Cereno in August and has been spearheading the ramp-up of these activities. I am very glad to have him on board and look forward to being able to share more about the progress of CS585 and CS014 with you as soon it is possible.

There are major unmet needs in cardiovascular disease, and we believe our preclinical programs can be developed into better and safer treatment alternatives for many patients. The increased risk of bleeding is a major challenge inherent in current therapies for thrombosis prevention. The medical need for better anti-thrombotics, i.e. less bleeding prob­lems, is thus high in this huge growing market estimated to reach about USD 70 billion by 2030, and signifies a very large business potential for new therapies that can meet this need. The results from our two preclinical programs are thus highly relevant as both candidates, with two different therapeutic modes of action, have documented the ability to prevent thrombosis without showing an increased risk of bleeding, presented at medical congresses this summer and fall. These are very promising results and our Director of Translation Research, Michael Holinstat, has recorded presentations explaining the findings in more detail, which are available on our website in the Newsroom-section.

Outlook

I will be presenting at investor events during the coming months to provide business updates both in Stockholm and live-streamed. The team is diligently working according to our vision, strategy and development plan objectives, while keeping appraised of any potential impact of the geopolitical uncertainties that are still very much present in society.

To summarize, several key milestones have been reached already this year and there is a high operational activity at Cereno as we continue to deliver on our commitment to developing innovative treatments for common and rare cardiovascular disease where great unmet medical needs exist. To pursue our ambitions, capital and shareholder interest is a key requirement and to this end, at the end of September, we concluded the warrants of Series TO2 with over 90 % (94.3) percent of the warrants being subscribed. It is a testament to the continuous support from our shareholders and the recognition of our promising drug portfolio. I would like to extend a thank you to everyone supporting us on our exciting journey forward.

Sten R. Sörensen
CEO, Cereno Scientific

For further information, please contact:
Hans Naess, Interim CFO
Tel: +46 793 407 900
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.