Cereno Scientific confirms new clinic activated in the Phase II study of drug candidate CS1 in rare disease PAH

Cereno Scientific (Nasdaq First North: CRNO B), a company developing innovative treatments for common and rare cardiovascular disease, today announced that a new clinic has been activated in the ongoing Phase II study of CS1 in the rare disease pulmonary arterial hypertension (PAH). The clinic is located in Austin, Texas, and starts recruiting patients immediately. The Phase II study is now actively running at 10 specialist clinics in the US with yet another new clinic currently in the late-stage start-up process.

“We are very pleased to report that we have now activated a new clinic in the ongoing Phase II study, which we believe will be a significant contributor to the recruitment of patients with PAH into our study. We now get access to a new patient pool that will support us in reaching full patient recruitment to the study according to our plan to report top-line results in Q2 2024. We have already seen some positive indications of a possible efficacy from CS1 in the PAH disease, with remarkable data in a patient case study reported this summer, which was later supported by positive findings in the DQCR-initiative reported in October. Most recently, as reported in November, an inquiry for Cereno to request “compassionate use” for CS1, which we now are actively pursuing with priority,” said Sten R. Sörensen, CEO at Cereno Scientific.

The Phase II study of CS1 in the rare disease pulmonary arterial hypertension (PAH) is now actively recruiting patients at 10 specialist clinics in the US, and one additional new clinic is in the process of opening. An investigator-initiated patient case study performed on the first patient having completed the study at the clinic where the investigator was based showed remarkable efficacy data. In 12 weeks of treatment with CS1, the patient showed a 30% pulmonary pressure reduction 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. A data quality control review (DQCR) initiative was performed confirming the utility of the CardioMEMS HF System (Abbott Inc.) and showed that CS1 has a clinically meaningful reduction of pulmonary pressure, a key marker of the PAH disease burden. The initial findings are, however, not a guarantee of the final study result. Currently, a request for expanded access to CS1 (also called “compassionate use”) is being prepared upon inquiry from patients and investigators in the study. The study is designed to randomize 30 PAH patients and the top-line result of the Phase II study is estimated to be reported in Q2 2024.

For further information, please contact:

Tove Bergenholt, Director IR & Communications

Email: tove.bergenholt@cerenoscientific.com

Phone: +46 732-366 246

Sten R. Sörensen, CEO

Email: sten.sorensen@cerenoscientific.com

Phone: +46 73-374 03 74

About the Phase II study of CS1

The Phase II study of CS1 in the rare disease pulmonary arterial hypertension (PAH) is actively recruiting patients at 10 specialist clinics in the US, and one new clinic is in the process of opening. An investigator-initiated patient case study performed on the first patient having completed the study at the clinic where the investigator was based showed remarkable efficacy data. In 12 weeks of treatment with CS1, the patient showed a 30% pulmonary pressure reduction 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. A data quality control initiative was performed confirming the utility of the CardioMEMS HF System (Abbott Inc.) and showed that CS1 has a clinically meaningful reduction of pulmonary pressure, a key marker of the PAH disease burden. The initial findings are, however, not a guarantee of the final study result. The study is designed to randomize 30 PAH patients and the top-line result of the Phase II study is estimated to be reported in Q2 2024.

About Cereno Scientific AB

Cereno Scientific develops innovative treatments for common and rare cardiovascular disease. The lead drug candidate, CS1, is a HDAC (histone deacetylase) inhibitor that acts as an epigenetic modulator with pressure-reducing, reverse-remodeling, anti-inflammatory, anti-fibrotic and anti-thrombotic properties. A Phase II study is ongoing to evaluate CS1’s safety, tolerability, and efficacy in patients with the rare disease pulmonary arterial hypertension (PAH). A collaboration agreement with global healthcare company Abbott allows Cereno to use their cutting-edge technology CardioMEMS HF System in the study. Two initiatives performed during the ongoing Phase II study have shown positive findings suggesting the potential clinical benefit of CS1 in PAH patients. These initial findings are, however, not a guarantee of the final study results that are expected in Q2 2024. After requests by investigators in the Phase II study, a “compassionate use” application for CS1 is currently being pursued. Cereno also has two promising preclinical drug candidates in development through research collaborations with the University of Michigan. Investigational drug CS014 is a HDAC inhibitor in development as a treatment for arterial and venous thrombosis prevention. The innovative drug candidate represents a groundbreaking approach to antithrombotic treatment potentially without the associated increased risk of bleeding in humans. CS014 is a new chemical entity with a multi-fold mechanism of action as an epigenetic modulator – regulating platelet activity, fibrinolysis, and clot stability for the prevention of thrombosis without increased risk of bleeding as documented in preclinical studies. Drug candidate CS585 is a prostacyclin receptor agonist that has been documented in several preclinical studies to target the IP receptor for prevention of thrombosis without increased risk of bleeding, which also has been recognized in the medical community. CS585 was in-licensed from the University of Michigan in 2023. 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.