Cereno Scientific

Scale-up of manufacturing can be described as the process of increasing the production of a drug to commercial-scale, instead of the laboratory-scale batches being produced for early clinical trials.

"I am very pleased that we have agreed with CordenPharma to initiate the scale-up manufacturing of CS1. This is a key milestone for Cereno marking a starting step of our pivotal clinical trial program, which we anticipate to be pursued after our currently ongoing Phase II study in PAH. With often long lead times in drug development, we are with this agreement ensuring that there will be a supply of CS1 when we are ready to initiate the next clinical trial with CS1. With this contract, we are also securing long-term availability of CS1 supply for the Extended Access that was requested from the FDA last week. Now we can be assured that there is a continuous supply of CS1 available for the patients who are to continue treatment after the Phase II study. We are deeply committed to patients with the rare disease PAH and we hope, in the future, to be able to support many more patients to fight this deadly disease. This is a key step on that journey," said Sten R. Sörensen, CEO at Cereno Scientific.

CordenPharma is a CDMO partner supporting biotech and pharma innovators of complex modalities in the advancement of their drug development lifecycle. Harnessing the collective expertise of the teams across a globally integrated facility network, CordenPharma provides bespoke outsourcing services spanning the complete supply chain, from early clinical-phase development to commercialization. With scientific expertise and partnership at its core, CordenPharma provides customers high-value, end-to-end services with a strategic focus on Peptides, Oligonucleotides, customized Lipid Excipients, Lipid NanoParticles (LNPs), sterile Injectables, and the extensive supply of Small Molecules (both Highly Potent and Regular Potency). The CordenPharma Group is comprised of 12 facilities across Europe and North America.

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, with one additional new clinic currently in late-stage start-up process. In 2023, the company reported positive findings from the ongoing study suggesting a potential positive effect of drug candidate CS1 in patients with the severe rare disease PAH. First, a patient case study performed on the first patient who had completed the study at a specific clinic showed remarkable efficacy data. In 12 weeks of treatment with CS1, the patient showed a 30% reduction in pulmonary pressure 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 she had next to normal functional physical capacity with CS1. In addition, Cereno reported in October 2023 that a Data Quality Control Review (DQCR) was concluded with positive findings. The data quality of the CardioMEMS HF System (Abbott Inc.) measurements was found satisfactory with adherence to study protocol and with timely data transfers from the patient's home to the clinic. Efficacy findings showed a clinically meaningful reduction of pulmonary pressure in several patients, included in the data quality control, of a similar or greater magnitude as in the Patient Case. The initial findings are, however, not a guarantee of the final study result. The review included data obtained by the CardioMEMS HF System from the first 16 patients enrolled in the study and the reported findings can be read in full in a previous announcement. A request for expanded access to CS1 (also called "compassionate use") was submitted to the FDA on January 3, 2024, upon inquiry from 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.

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.