Cerenis Therapeutics: Cash position and revenue for Q3 2015

Regulatory News:

Cerenis Therapeutics (Paris:CEREN) (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 at 30 September, 2015, and its revenue for the third quarter of 2015.

• A solid cash position of €46,3 m at September 30, 2015

Cash and cash equivalents totaled €46,3 m¹ including the gross product generated by the spectacular IPO that enabled the company to successfully raise €53.4m in March. In line with expectations, Cerenis Therapeutics did not record any revenue over the first nine months of 2015.

As announced at the time of the company’s IPO, efforts are currently focused on the development of phase II study for the post Acute Coronary Syndrome indication (CARAT) and the preparation of the phase III study for the treatment of patients affected by Familial Hypoalphalipoproteinemia (FPHA) orphan disease, in particular with apoA-I and ABCA1 deficiencies (TANGO).

• A dynamic clinical newsflow demonstrating CER-001 efficiency

In accordance with the development plan, the company announced during the third quarter the first patients enrollment into the phase II CARAT trial, which assesses reduction in atherosclerotic plaque using CER-001 in post-ACS patients. The first patient in TANGO trial will be enrolled during the last quarter of 2015.

Lastly, new data for CER-001 have been presented by the Professor Stephen Nicholls at the sicentific congress of the 2015 American Heart Association (AHA). The data, which demonstrate the atherosclerosis regression at the dose of 3 mg/kg in patients with a baseline pourcentage of atheroma volume (PAV²) higher or equal to 30%, enable to reassert Cerenis Therapeutics’ strong conviction in CER-001 efficiency and to confirm the optimal design of both CARAT and TANGO studies. Last September, the company announced the publication of positive preclinical data in the world-renowned scientific journal PLOS ONE. These data also demonstrate the ability of natural HDL and their mimetic, CER-001, to inhibit the formation of atherosclerotic plaque with better efficacy at lower doses. Finally, CER-001 proof of concept had been yet strengthened following the publication of LOCATION study last July.

• Investors Forum calendar

Cerenis Therapeutics announces its participation to several major Investors Forum:

• Institutional investors

19^th ODDO Forum
Date: 7-8 january, 2016
Place: Lyon, France

JP Morgan 34^th Annual Healthcare Conference
Date: 11- 14 january, 2016
Place: San Francisco, USA

BioMed by Invest Securities
Date: 27 january, 2016
Place: Paris, France

• Individual investors

Actionaria Forum
Date: 20-21 november, 2015
Place: Paris, France

1: Unaudited data
2: Marker directly linked to the risk of cardiovascular outcomes

About Cerenis Therapeutics: www.cerenis.com

Cerenis Therapeutics is an international biopharmaceutical company dedicated to the discovery and development of innovative HDL therapies for the treatment of cardiovascular and metabolic diseases. HDL is the primary mediator of the reverse lipid transport, or RLT, the only natural pathway by which excess cholesterol is removed from arteries and is transported to the liver for elimination from the body.

Cerenis is developing a portfolio of HDL therapies, including HDL-mimetics for the rapid regression of atherosclerotic plaque in high-risk patients such as post-ACS patients and patients with HDL deficiency, and drugs which increase HDL for patients with low number of HDL particles to treat atherosclerosis and associated metabolic diseases.

Cerenis is well positioned to become one of the leaders in the HDL therapeutic market, with a broad portfolio of programs being developed.

Since its inception in 2005, the company has been funded by top tier investors: Sofinnova Partners, HealthCap, Alta Partners, EDF Ventures, Daiwa Corporate Investment, TVM Capital, Orbimed, IRDI/IXO Private Equity and Bpifrance (Fund for Strategic Investment) and last March successfully completed an IPO on Euronext raising €53.4m.

About CER-001:

CER-001 is an engineered complex of recombinant human apoA-I, the major structural protein of HDL, and phospholipids. It has been designed to mimic the structure and functions of natural, nascent HDL, also known as pre-beta HDL. Its mechanism of action is to increase apoA-I and the number of HDL particles transiently, to stimulate the removal of excess cholesterol and other lipids from tissues including the arterial wall and to transport them to the liver for elimination through a process called Reverse Lipid Transport. Phase II studies have provided important data demonstrating the efficacy of CER-001 in regressing atherosclerosis in several distinct vascular beds in patients representing the entire spectrum of cholesterol homeostasis. The totality of the data to date indicates that CER-001 performs all of the functions of natural pre-beta HDL particles and has the potential to be the best-in-class HDL mimetic on the market.

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