Cereno Scientific publishes the interim report for Q1 2023 ( January 1 – March 31)

The Board and Chief Executive Officer of Cereno Scientific AB here present the interim report for Q1 2023 ( January 1 – March 31).

Summary of the interim report for Q1 2023 ( January 1 – March 31)

Cereno Scientific Group

• Net Sales were SEK 0 (0)
• Result after financial items was SEK 4,409,588 (-5,246,969)
• Earnings per share was SEK -0.03 (-0.05) before dilution and SEK -0.03 (-0.04) after dilution
• The equity/assets ratio was 94.3% (93.4%)
• Cash and bank balance was SEK 44,622,145 SEK (77,268,668)

Parent company

• Net Sales were SEK 0 (0)
• Result after financial items was SEK -4,469,970 (-5,247,501)
• Earnings per share was SEK -0.03 (-0.05) before dilution and SEK -0.03 (-0.04) after dilution
• The equity/assets ratio was 95.8% (93.4%)
• Cash and bank balance was SEK 41,281,024 (77,221,636)

Significant events during the first quarter

• In January, it was announced that an abstract on preclinical drug candidate CS585 had been accepted as a moderated poster presentation at ACC.23/WCC. The scientific congress is hosted by the American College of Cardiology Together With WCC (World Congress of Cardiology), in New Orleans, US, on March 4-6, 2023. The abstract titled “CS585 is a novel orally available prostacyclin receptor agonist with long-term in vivo inhibition of platelets and thrombosis formation in mouse without increased risk of bleeding” will be presented by Dr. Michael Holinstat, lead of Cereno’s development programs at the University of Michigan and Director of Translational Research at Cereno.
• At the end of January, the company announced the appointment of Etienne Adriansen to the newly created position as Chief Business Officer, as of March 1, 2023.This appointment adds commercial expertise and capacity to Cereno's Executive Management Team as business development is an active and important component of the company’s growth strategy.
• In early February, Cereno launched an Insights Series providing a unique view into different aspects of cardiovascular disease treatment landscape through interviews and conversations with Cereno’s leadership, collaborative partners, and global thought leaders. The videos were mainly recorded in conjunction with the European Society of Cardiology (ESC) Congress in Barcelona late August 2022, and are centered around PAH and thrombosis.
• In February, Cereno announced the progress with its CS1 Phase II trial in PAH. All 9 clinical sites have been activated and the protocol changed to broader patient inclusion criteria and three patients were reported to be randomized and have entered the treatment period. Top-line results are expected at the end of 2023.
• In February it was announced that Cereno’s preclinical drug candidate CS014 will continue toward clinical development for thrombosis prevention. CS014 has, in preclinical studies, demonstrated anti-thrombotic properties without bleeding, supporting the selection of target indication with the aim of preventing thrombosis. The drug candidate is currently in the final stages of its preclinical development program, and a Phase I study is expected to start in 2024.
• In early March, it was announced that Cereno’s drug candidate CS585’s second patent family has obtained a formally issued patent in Europe, one of the largest markets in cardiovascular disease. This strengthens and broadens the intellectual property rights (IPR) for CS585 which currently is in a preclinical development program in collaboration with the University of Michigan.

Significant events after the end of the period

• In early April, it was announced that Cereno has signed a license agreement for the drug candidate CS585 with the University of Michigan. The signed agreement pro­vides Cereno the exclusive rights to CS585 for further development and commercialization. Cereno also ex­tends the preclinical collaboration agreements it has with UoM for the two programs CS585 and CS014.
• In early April, Cereno announced progress in the recruit­ment of patients into the study in the rare disease PAH with its lead candidate drug CS1. Now, a total of 10 pa­tients have been enrolled into the study which plans to study 30 patients.
• At the end of April, Cereno’s Board of Directors decided to carry out a rights issue of units of approximately SEK 110 million to enable the continued development of the company’s three drug candidates to the next value-in­creasing milestones. The subscriptions period takes place during May 8 – 24. In conjunction with this, Cereno also announced the intention to change marketplace to Nasdaq First North Growth Market.
• An abstract on the preclinical drug candidate CS585 was accepted as an oral presentation at the scientific confer­ence Vascular Discovery 2023: From Genes to Medicine hosted by the American Heart Association, in Boston, Massachusetts, US, May 10-13, 2023. The abstract titled “The eicosanoid analogue CS585 represents a first-in-class in prevention of platelet activation and thrombosis through direct activation of the prostacyclin receptor” will be presented by Adriana Yamaguchi, Postdoctoral Research Fellow at the University of Michigan.
• In early May, Cereno reported that two patients suc­cessfully completed the treatment period with drug candidate CS1 in the ongoing Phase II study in the rare disease PAH.
• In May, the nomination committee's proposed res­olutions for the 2023 annual general meeting were published and included the new election of Joakim Söderström as chairman of the board. The nomination committee also proposes that the board be consolidated to include five members and no deputies. More infor­mation can be found on the company’s website in the Corporate governance-section.
• In May, the company shared an updated progress report of the Phase II study in pulmonary arterial hypertension (PAH) with drug candidate CS1. The study is proceed­ing well with currently 16 patients enrolled in the study, 9 patients having received CardioMEMS HF System implantation, 5 patients randomized and in active treatment, and 2 patients having completed the study. Recruitment of the 30 PAH patients to be included in the study is on track and top-line results are anticipated at year-end 2023.
• In May, it was announced that an abstract on preclinical drug candidate CS585 was accepted as an oral pres­entation by the Scientific Program Committee at the European Hematology Association (EHA) 2023 Hybrid Congress in Frankfurt, Germany, on June 8-11. The ab­stract “Sustained inhibition of platelet activity and throm­bosis via IV and oral administration of CS585” 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.

CEO letter

The first quarter of 2023 for us at Cereno meant a primary focus on our ongoing Phase II study with CS1, aimed at treating the rare disease PAH. I am delighted to report that we have made significant headway in the study; in mid-May, 16 patients had been enrolled in the study, 9 patients had received CardioMEMS HF System implantation, 5 patients had been randomized and in active treatment, and 2 patients had completed the study. We anticipate a further stable recruitment rate in the coming weeks, and our timeline to report top-line results from the study by the end of 2023 remains unchanged. We are also pleased to announce that our two preclinical drug candidates have continued to make excellent progress in their respective development programs. Additionally, we are excited that we have exercised our option to license CS585, which further strengthens our portfolio and supports our growth strategy. Our portfolio now consists of three drug candidates in development, all of which have the potential to prolong life and improve the quality of life for people with common and rare cardiovascular disease.

Increased recruitment rate in the Phase II study with PAH

Earlier, we announced that we have worked intensively together with our collaboration partner Abbott and the CRO that operates the study and the participating clinics to increase the recruitment rate for the study. We see positive results of our efforts. All nine participating clinics are now activated, and patient recruitment is underway. In mid-May, 16 patients had been enrolled in the study, 9 patients had received CardioMEMS HF System implantation, 5 patients had been randomized and in active treatment, and 2 pa­tients had completed the study. We are optimistic that we will meet our objective of recruiting 30 eligible patients for the study in the forthcoming months, and thus, we expect to report top-line results by the end of 2023 as previously communicated.

We acknowledge the immense medical need for individuals with PAH, which today presents a treatment challenge. We remain confident that our drug candidate CS1 holds the po­tential to rise to this challenge and make a difference in the future treatment options available to those affected by PAH.

CS014 is being developed for thrombosis prevention

We made a significant decision during the quarter to pre­pare CS014 for continued clinical development as a treat­ment to prevent thrombosis. CS014 has shown promising antithrombotic properties in the ongoing preclinical pro­gram, while the side effect profile has been shown to be favorable as it does not increase the risk of bleeding. This is a highly sought-after property for an anti-thrombotic drug as there is currently no treatment alternative with such a profile. The preclinical program is currently in the final stages of mandatory safety studies, and preparations for a Phase I study are underway in parallel. If all goes according to plan, we will initiate a First Time In Man (FTIM) Phase I clinical study with CS014 in the first half of 2024. Further preclinical and clinical studies will be crucial to select the first anti-thrombotic indication – venous throm­boembolism or arterial thrombosis – where CS014 has high potential to fill the great clinical need for a more effective antithrombotic treatment without bleeding.

In April, we extended the collaboration agreement for pre­clinical development with the University of Michigan under the leadership of Dr. Holinstat.

License agreement signed for preclinical CS585

Since the spring of 2021 when we entered into an agree­ment for CS585 with the University of Michigan, we have seen promising results from the ongoing preclinical devel­opment program. We are therefore pleased that we have now signed a license agreement, which gives Cereno ex­clusive rights to CS585 for further drug development and commercialization. CS585 has the potential to add value to our portfolio in PAH and thrombosis. Results from pre­clinical studies show that CS585 has a promising efficacy profile with sustained preventive effect against blood clot formation (thrombosis) without an increased risk of bleed­ing. CS585's potential is currently being evaluated in sev­eral cardiovascular diseases, and the indication for clinical development is not yet decided.

The collaboration agreement on preclinical development with the University of Michigan led by Dr. Holinstat was furthermore extended at the beginning of April. In addition, CS585 reached a major milestone during the quarter as the first patent in Europe was formally issued. Securing IPR for a development asset together with clinical documentation is an important aspect in preparation for future commer­cialization of your drug candidate.

Visibility at several scientific congresses

We are continuing to actively establish the company, our research, and innovative drug candidates in the medical community. During the first quarter, we presented preclin­ical data at American College of Cardiology Together With WCC (World Congress of Cardiology), in New Orleans, US, on March 2023. In addition, we have several new abstracts on preclinical data accepted to be presented at premier scientific congresses over the coming months.

Outlook for 2023

The year 2023 is a momentous one for Cereno as we ap­proach the completion of our first Phase II study. This marks a significant milestone not just for our team, but for every­one involved in the development of CS1, individuals with PAH, and our valued shareholders. The completion of our Phase II study is expected to further strengthen our posi­tion as a leading biotech company with a promising drug development portfolio and is set to leverage our credibility among external stakeholders.

Currently, we have one drug candidate in clinical Phase II and two in preclinical development, which, when taken together, form a broad portfolio with considerable poten­tial to transform the treatment landscape of cardiovascular disease. In just over a year, we anticipate having two drug candidates in clinical development and one close to being Phase I ready.

Just like other biotech companies, we require regular capital injections to continue developing our portfolio. All three of our drug candidates are currently in significant development stages and thus, a capital injection enables continued development to the next value-increasing mile­stones. Cereno is currently carrying out a rights issue with a subscription period from May 8 – May 24, 2023. In connection with this, we also intend to change the marketplace to Nasdaq First North Growth Market in order to be better positioned for both national and international investors. More information about this can be found on our website.

We are continuously making new strides toward our vision of developing new treatments to prolong life and improve quality of life for people with common and rare cardiovas­cular diseases. We see that our commitment to innovation and dedication to advancing treatments for the benefit of patients with common and rare cardiovascular diseases will continue to drive our success.

Thank you for your continued support.

Sten R. Sörensen, CEO Cereno Scientific

For further information, please contact:

Jonas Fogelberg, Interim CFO
Email: info@cerenoscientific.com
http://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 CS014 is a novel HDAC inhibitor with epigenetic effects, selected for prevention of thrombosis as target indication. In preclinical studies it has been documented to regulate platelet activity, fibrinolysis and clot stability for prevention of thrombosis without increased risk of bleeding. Thrombosis prevention in venous or arterial and cardiovascular disease has been selected as the first indication area for CS014. Drug candidate CS585 is a prostacyclin receptor agonist that has been documented in preclinical studies to target the IP receptor 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.