Cereno Scientific publishes the interim report for Q2 2023 ( April 1 – June 30)

The Board and Chief Executive Officer of Cereno Scientific AB here present the interim report for Q2 2023 ( April 1 – June 30).

Summary of the interim report for Q2 2023 ( April 1 – June 30)

Cereno Scientific Group

• Result after financial items was SEK 10,686,053 (-6,518,033)
• Earnings per share was SEK -0.05 (-0.06) before dilution and SEK -0.04 (-0.04) after dilution
• The equity/assets ratio was 95.4% (93.2%)
• Cash and bank balance was SEK 85,291,722 SEK (63,257,948)

Parent company

• Result after financial items was SEK -10,697,871 (-6,747,978)
• Earnings per share was SEK -0.05 (-0.06) before dilution and SEK -0.04 (-0.04) after dilution
• The equity/assets ratio was 95.4% (93.2%)
• Cash and bank balance was SEK 85,291,725 (63,214,536)

Significant events during the first quarter

• In early April, it was announced that Cereno had signed a license agreement for the drug candidate CS585 with the University of Michigan. The signed agreement pro­vided Cereno the exclusive rights to CS585 for further development and commercialization. Cereno also ex­tended 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. A total of 10 patients had been enrolled in 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 subscription 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” was 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 proposed 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 proceeded well with 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.
• 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” was presented by Dr. Michael Holinstat, lead of Cereno’s pre­clinical development programs at University of Michigan and Director of Translational Research at Cereno.

Significant events after the end of the period

• On June 14, Cereno Scientific’s shares of Series B com­menced trading on Nasdaq First North Growth Market.
• An oral presentation on drug candidate CS585 washeld at the 31st Congress of the International Societyon Thrombosis and Haemostasis (ISTH 2023 Congress),in Montreal, Canada on June 24-28, 2023. The abstracttitled “CS585 is a novel and highly selective IP receptoragonist for prevention of thrombosis” was presented by Dr. Michael Holinstat, lead of Cereno’s development programs at University of Michigan and Director of Translational Research at Cereno.
• In June, the company shared data received from a pa­tient case study initiated by an investigator on the first patient that completed the Phase II study of CS1 in the rare disease pulmonary arterial hypertension (PAH) at the site. The case study was based on one patient and was performed to control the utility of CardioMEMS™HF System (Abbott, Inc.), an innovative technology used to daily monitor pulmonary pressure and other cardiopulmonary function in patients in the study. It indicated that drug candidate CS1 had a positive effect on pulmonary arterial pressure and cardiac function. It further indicated the utility of CardioMEMS in evaluating drug medication effectiveness in PAH.
• In July, Cereno participated in the 8th Annual DrugDiscovery & Development Symposium arranged by the Pulmonary Vascular Research Institute (PVRI) on July 10-11, 2023. Raymond Benza, PI of the Phase II study ofCS1 and member of Cereno’s scientific advisory board, co-chairs the event while Björn Dahlöf, Cereno’s Chief Medical Officer (CMO), presented the company and its HDAC-focused portfolio.
• Two abstracts on the preclinical drug candidates CS014and CS585, respectively, were accepted as moderated ePoster presentations at the ESC Congress 2023 hosted by the European Society of Cardiology, in Amsterdam, Netherlands, on August 25-28, 2023.
• Eva Jagenheim has been appointed Chief Financial Officer (CFO). Jagenheim has broad experience in finance and the Swedish biotech sector. She will join the company on August 28, 2023.

CEO letter

This is the first quarterly report we share as a Nasdaq First North company – an important milestone in the history of Cereno. Overall, the second quarter of 2023 can be summarized as an important period for the company's growth and long-term strategy. In addition to the business activities, the development of our whole portfolio has purposely proceeded forward. We have also reported significant news for our CS1 candidate that has indicated a remarkable potential for effect in patients with PAH. The three innovative drug candidates in our portfolio are all taking important steps toward the ultimate goal of improving the quality of life as well as prolonging life for people with common and rare cardiovascular disease.

CS1 shows remarkable pulmonary pressure reduction in a PAH patient
We shared the remarkable outcome of a patient case study earlier this summer from the ongoing study. The investigator who initiated the case study was intrigued by the effect of CS1 and how convenient the daily remote monitoring using CardioMEMS HF System was. In only 12 weeks of treatment with CS1, the patient’s PAH disease improved noticeably. We noted that CS1 showed a 30% reduction in PAH and a 20% increase in cardiac output. The patient’s overall functional status was changed from NYHA/WHO functional class II to I at the end of the treatment period, meaning that she had next to normal functional physical capacity. This patient had been on a stable standard of care treatment for PAH for the last three years without achieving the same results, which strongly speaks for CS1’s effect on PAH. With these positive initial findings, we are optimistic about the Phase II study outcome and CS1’s potential.

Two new clinics open to complete patient recruitment in the CS1 study
During the second quarter, we have seen further significant progress in our patient recruitment with 25 patients enrolled and 16 patients in active treatment to date. Although this is highly positive, it is still lower than the patient recruitment pace anticipated. We have, therefore, now initiated the activation of two new specialist clinics with large capacities. We are highly optimistic about an increased recruitment pace as the new clinics have already identified suitable patients before activation, and more patients are also lined up for screening in September and October at existing clinics. We believe that opening the two new clinics with known large capacities will further support patient recruitment to complete the study and mitigate any further changes to the study timelines. The study’s top-line results are now estimated to be reported during Q1 2024.

Data quality control of CardioMEMS initiated to obtain CS1 efficacy data in Q4 2023
We are excited to be able to share that we have launched an initiative for data quality control of CardioMEMS HF System. Our discussions for this initiative were triggered by remarkable positive findings on CS1 efficacy on PAH as was observed in the patient case study reported in June. With this quality control, we aim to provide an opportunity to optimize patients' study protocol adherence and data transfer quality of CardioMEMS, which in turn will support a higher level of standardization of study data. The intention is to create an optimal, conclusive data set for when the top-line results are analyzed with a strong, clear indication of the effect of CS1 as measured by the CardioMEMS HF System. Our aim is to provide a report from the data quality control during Q4 2023, which will then also include efficacy data on more than half of the study population receiving CS1. We are eager to see the results as CS1 has thus far indicated to be an efficacious treatment alternative in PAH.

Preclinical candidates continue to progress
The extended preclinical development programs of CS014 and CS585 have continued to progress during the quarter in collaboration with the University of Michigan. In April, we signed an agreement with the University of Michigan to obtain exclusive rights for further development and commercialization of CS585. The drug candidates show promising data as we continue development toward Phase I studies.

We are especially looking forward to advancing our drug candidate CS014, in development for the prevention of thrombosis, arterial and venous, over the upcoming months. The next major milestone for the program is to obtain a permit from the Swedish Medical Products Agency (Läkemedelsverket) and the Ethical Review Authority (Etikprövningsmyndigheten) to allow us to start a Phase I study in H1 2024.

The development program of CS585 is progressing with the aim of working toward completing the preclinical program in 2024.

Leveraging our exposure to potential industrial partners
We are continuing to actively participate in scientific congresses and medical meetings to increase the reach of our innovative drug candidates to the scientific community and industrial potential development partners to leverage Cereno’s business development objectives for our programs. During the last few months, we presented preclinical data 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 European Hematology Association (EHA) 2023 Hybrid Congress in Frankfurt, Germany, on June 8-11, 31st Congress of the International Society on Thrombosis and Haemostasis (ISTH 2023 Congress), in Montreal, Canada on June 24-28, 2023; as well as the upcoming ESC Congress 2023 hosted by the European Society of Cardiology, in Amsterdam, Netherlands, on August 25-28, 2023. Our CMO Björn Dahlöf was also invited to speak at the invitation-only event 8th Annual Drug Discovery & Development Symposium arranged by the Pulmonary Vascular Research Institute (PVRI) on July 10-11, 2023, to talk about HDAC inhibition in PAH in general, and CS1 in PAH, in particular, as well as the ongoing study. In addition, we have several new abstracts and publications on preclinical data in preparation over the coming months.

Initiating the next growth period for the company
On June 14, 2023, we rang the Nasdaq bell marking the start of the trading of the Cereno share on the marketplace Nasdaq First North Growth Market. As we approach several key milestones for our portfolio and expect high interest from the national and international investor community, the uplisting from Spotlight Stock Market to Nasdaq First North Growth Market is a natural next step in Cereno’s growth journey. In connection with the move to a new marketplace, we carried out a rights issue enabling us to proceed with further development of our promising drug candidates.

We are evolving our team to support the new requirements that come with a Nasdaq listing. A new CFO, Eva Jagenheim, joins us on August 28, bringing a wealth of experience and valuable financial expertise from previous roles in public biotech companies.

We are very excited about the progress of our portfolio over the last period and especially the encouraging efficacy findings on CS1 from our patient case in our lead program in PAH. We are now set to drive our ambitions forward with the aim to offer innovative treatments that could potentially significantly improve the quality of life and life expectancy for patients with common and rare cardiovascular disease.

Thank you for your continued support of our exciting journey.

Sten R. Sörensen, CEO

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 Nasdaq First North (CRNO B). More information on www.cerenoscientific.com.