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Cash position and revenue for the 1st semester of 2016

Toulouse, FRANCE, Ann Arbor, UNITED STATES, July 28, 2016

– (FR0012616852 – CEREN), an international biopharmaceutical company dedicated to the discovery and development of innovative HDL therapies (“good cholesterol”) for treating cardiovascular and metabolic diseases, today announces its cash position and revenue for the first semester of 2016.

• A solid cash position of €32.9m at June 30, 2016 Cash and cash equivalents totaled €32.9m* including the gross earnings generated by the Company’s spectacular IPO that enabled it to successfully raise €53.4m in March 2015. In line with expectations, Cerenis Therapeutics did not generate any revenue during the first semester of 2016. As announced at the time of its IPO, Cerenis Therapeutics is currently pursuing the clinical development of CER-001, an HDL mimetic, as part of the phase II study for the post Acute Coronary Syndrome (postACS) indication, CARAT, and the phase III study for the FPHA (Familial Primary Hypoalphalipoproteinemia, an orphan disease indication), TANGO. The first patients have been recruited, respectively during the third and the fourth quarter of 2015, and the studies are proceeding according to expectations. Cerenis is also pursuing the preclinical development of CER-209, a novel agonist of the P2Y13 receptor for the treatment of atherosclerosis and liver steatosis.

• Several major publications marked the 1 st semester of 2016 CER-001: publication of the LOCATION clinical study results in the renowned scientific journal ATHEROSCLEROSIS Last May, the publication of the LOCATION clinical study results in the world-renowned scientific journal of the European Atherosclerosis Society (EAS), ATHEROSCLEROSIS, offers a valuable validation of the functionality of CER-001, demonstrating the mimetic’s capacity to penetrate the vessel walls, to preferentially target atherosclerotic plaques and to increase cholesterol efflux capacity. The LOCATION study, whose positive results were announced in July 2015, are reassuring prior to the publication of the CARAT study results, planned for first quarter of 2017, as the targeting of atherosclerotic plaques was observed at the dose of 3 mg/kg, dose used in this phase II clinicalstudy in post-ACS patients which intends to demonstrate plaque regression. 2/3 The press release on results of the LOCATION study is available on Cerenis’ website in the section Media/Press releases. Click here to access.

CER-209: positive preclinical results demonstrate its active role to treat atherosclerosis and nonalcoholic steatohepatitis (NASH) At the 25th Conference of the Asian Pacific Association for the Study of the Liver (APASL), held in Tokyo in February 2016, Cerenis presented preclinical results of CER-209 (“P2Y13 receptor agonist CER-209 decreases both atherosclerosis and liversteatosisin vivo”1 ), a selective novel agonist of the P2Y13 receptor (P2Y13R) that caused an increased uptake of high-density lipoprotein-cholesterol (HDL-c) in the liver which is associated with stimulation of bile acid secretion. Repeated dose administration of CER-209 stimulated the apoA-Isynthesis and formation ofsmall HDL particles, known to be atheroprotective. CER-209-treated plasma samples had high cholesterol efflux capacity for the mobilization of cellular cholesterol in vitro compared with the placebo group. CER-209 induced a decrease in atherosclerotic plaques in aorta and carotids as well as a remarkable decrease in the steatosis in a validated preclinical model.

In a poster presentation, “P2Y13 receptor agonist CER-209, an anti-atherosclerotic compound, decreases liver steatosis in vivo” 2 , Cerenis presented results of CER-209, a selective novel agonist of the P2Y13 receptor (P2Y13R). In this preclinical model, CER-209 resulted in a marked reduction in overall steatohepatitis as determined by reductions in cholesterol, triglycerides and fatty acids compared with placebo. Furthermore, CER-209 produced considerable decreases in liver enzymes (ALT and AST) in the plasma. These effects suggest the restoration of liver integrity and indicate a strong potential for CER-209 to treat liver disease such as NASH and non-alcoholic fatty liver disease (NAFLD) associated with cardiovascular disease.

These are important findings given the current lack of treatment options for NASH and introduce P2Y13R as a new therapeutic target for this disorder. CER-209 exerts its beneficial effect on liver steatosis via a specific action on the cholesterol elimination pathways. Considering the fact that cardiovascular risk is further increased in patients with NASH and NAFLD diseases, CER-209 has a strong potential to become a reference treatment for atherosclerosis, NASH and NAFLD. ohepatitis (NASH).