Cereno Scientific expands patent protection for PAH drug candidate CS1’s third patent family in Brazil

Cereno Scientific (Nasdaq First North: CRNO B), a pioneering biotech developing innovative treatments for rare and common cardiovascular disease, today announced that a new granted patent in CS1’s third patent family has been issued in Brazil.

“I am happy to announce another granted patent for our leading drug candidate, CS1, in Phase II development for the rare disease Pulmonary Arterial Hypertension (PAH). We are continuously working to expand the patent protection for our assets. The newly granted patent is Cereno’s first in Brazil, a major pharmaceutical market, and will play an important role in strengthening the commercial potential of CS1,” said Sten R. Sörensen, CEO, Cereno Scientific.

The newly granted patent in Brazil for Cereno’s third patent family related to drug candidate CS1, is titled "Delayed release pharmaceutical formulations comprising valproic acid, and uses thereof”. The patent has been given the patent number BR 11 2018 070626 4. The third patent family for CS1 has previously been issued in the US, Europe, Japan, Mexico, Australia, India, Russia, South Korea, South Africa and Israel.

About CS1

Drug candidate CS1 is an HDAC inhibitor that works through epigenetic modulation, being developed as a treatment for the rare disease PAH. CS1 has the potential to be an effective, safe and disease-modifying drug. CS1’s unique efficacy profile fits well with the pathogenetic mechanisms of PAH and is believed to be able to address today’s major unmet need for better treatment alternatives. The aim of CS1’s development is to offer improved quality of life and prolonged life for patients with PAH.

Cereno Scientific has over the last year reported encouraging findings from the ongoing Phase II study suggesting a potential positive effect of drug candidate CS1 in patients with the severe rare disease PAH.

Since January 30th, 2024, CS1 is approved by the FDA for Expanded Access, an extension of the ongoing Phase II trial evaluating CS1 in PAH. The Expanded Access Program (EAP) will provide Cereno with the opportunity to, under a formal FDA-approved protocol, collect safety and efficacy data from long-term exposure to CS1 in patients with PAH. This initiative not only supports the treatment of PAH patients but also enables Cereno to gather additional CS1 usage documentation for regulatory discussions and Phase IIb/III pivotal study design planning. Currently site-specific contracts and IRB approvals are being progressed.

Patient recruitment to the Phase II trial CS1-003 was closed on July 1st, 2024, based on a recommendation by the Study Clinical Steering Committee, which concluded that there is sufficient data for evaluating the next steps in development. Topline results will be shared in Q3, 2024.

For further information, please contact:

Henrik Westdahl, Director IR & Communications

Email: henrik.westdahl@cerenoscientific.com

Phone: +46 70-817 59 96

Sten R. Sörensen, CEO

Email: sten.sorensen@cerenoscientific.com

Phone: +46 73-374 03 74

About Cereno Scientific AB

Cereno Scientific develops innovative treatments for rare and common cardiovascular disease. The lead drug candidate, 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. A Phase II trial 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 trial. Two initiatives performed during the ongoing Phase II trial 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 trial results that are expected in Q3 2024. Since January 2024, we are delighted that the FDA´s Expanded Access Program will enable patients with PAH, a serious life-threatening disease condition, to gain access to CS1 where no comparable alternative therapy options are available. Cereno’s pipeline comprises two additional programs in development through research collaborations with the University of Michigan. Investigational drug CS014 is an HDAC inhibitor in Phase I development as a treatment for arterial and venous thrombosis prevention. The innovative drug candidate represents a groundbreaking approach to antithrombotic treatment. 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 an increased risk of bleeding as documented in preclinical trials. On 28th of June, 2024, Cereno initiated a first-in-human Phase I trial of CS014. Preclinical candidate CS585 is an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular disease. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Pulmonary Hypertension and thrombosis prevention without increased risk of bleeding. CS585 was in-licensed from the University of Michigan in 2023. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. Based in Kendall Square, Boston, Massachusetts, US. Cereno is listed on the Nasdaq First North (CRNO B). The Certified Advisor is Carnegie Investment Bank AB, CA@carnegie.se. More information is on www.cerenoscientific.com.