OSE Pharma to attend "French Life Science Days” June 17th to 18th 2015, New York

Regulatory News:

OSE Pharma SA (ISIN: FR0012127173; Mnémo: OSE), a biotechnology company based in France, developing T specific immunotherapy treatments against invasive and metastatic cancers, is pleased to attend the second edition of the French Life Science Days organized by France Biotech on June 17 ^th to 18^th, 2015 in New York.

The « French Life Science Days » aims to bring together listed French companies and North American financial community in order to allow innovative companies to promote their business to healthcare investors in the United States.

On June 18th, 2015, 18 French companies specialized in Cleantech, Medtech or Biotech as OSE Pharma, will get the opportunity to present their company and to meet US investors.

« Participating to « French Life Science Days » will help us to increase our visibility to the international financial community in a highly promising field: Immunotherapy, the new weapon in the fight against invasive cancers, highlighted during the last ASCO’s Congress. We are convinced that the US investors will appreciate our product portfolio specificity and our development strategy» explained Dominique Costantini, CEO of OSE Pharma.

About the "French Life Science Days”

This second edition aims at fostering and boosting the connections between French listed companies and investors worldwide in an effort to facilitate exchanges and demonstrate the solidity of our own financial community. This "French Life Science days” initiative brings together key Parisian players (brokers, analysts, auditors, lawyers and communication agencies) to form a sponsorship committee that will support life sciences entrepreneurs. During this occasion, the French biotech companies listed on the NYSE Euronext exchange will introduce themselves to international investors.

About France Biotech

France Biotech brings together the main French life science companies and their expert partners. Its mission is to support the development of the French life sciences by advocating for a favorable regulatory and fiscal environment. In 2004, France Biotech successfully lobbied the French government to create a special fiscal status for innovative start-ups and continues to act as an advocate for the French innovative sector. The organization is currently chaired by Pierre-Olivier Goineau, Co-Founder and CEO of ERYTECH Pharma. France Biotech has over 150 members and its board of directors is composed of 17entrepreneurs in the life sciences.

For more information: http www.france-biotech.org

About OSE Pharma

OSE Pharma is a European cancer immunotherapy company with a multi-epitope technology named Memopi® that directs the body’s immune system to generate a specific cytotoxic T response to prevent cancer cell growth.

OSE Pharma’s lead product, Tedopi®, combines 10 "neo-epitopes” directed against five tumour associated antigens. In its most advanced application, it is about to enter a pivotal Phase III study in patients with advanced non-small cell lung cancer (NSCLC) who express HLA-A2 and failed first line therapy. Tedopi® has orphan drug status in the USA and is considered as personalized medicine in Europe in HLA-A2 positive patients.

OSE Pharma is also planning a new Phase II clinical trial in combination with another immunotherapy treatment in NSCLC.

Tedopi® targets five tumour associated antigens (TAA), selected because their presence is linked to a poor prognosis and the severity of various cancers. Tedopi® contains ten optimized epitopes, or "neo- epitopes”, designed on the binding of HLA-A2 and TCR. These neo-epitopes generate strong specific T cytotoxic responses that fight cancer and prevent tumour escape.

OSE PHARMA: a new T specific immunotherapy weapon against advanced cancers

• Immunotherapy in oncology is becoming a clinical reality and raises hope for patients by mobilizing their own immune defence to fight against cancer.
• For OSE Pharma’s lead product Tedopi®: the Phase 3 clinical programme is scheduled in 2015 and will be active in Europe and in the USA, in order to obtain registration in non-small cell lung cancer. The study will recruit patients with invasive/metastatic non-small cell lung cancer (NSCLC), expressing the HLA-A2 receptor (45% of the NSCLC population).
• Tedopi® is a patented combination of 10 epitopes. The epitopes (small peptides triggering immune response) are optimized. They have been selected and modified for a stronger binding with immune response receptors (HLA-A2 and TCR). These neo-epitopes trigger a stronger immune response and target 5 tumor associated antigens expressed in several cancers.
• Tedopi® will enter in new therapeutic combinations in Phase 2 studies with industrial partnerships (other immunotherapy treatments or targeted therapies) to increase clinical efficacy while maintaining high quality of life with late-stage patients.
• Tedopi® has been granted "orphan drug” status in the USA and is considered a personalised medicine in Europe, enabling accelerated clinical development.

PIVOTAL PHASE 3 STUDY IN LUNG CANCER LAUNCHED IN 2015 IN EUROPE AND IN THE USA Tedopi® has been tested in a phase 2 study in patients with non-small cell lung cancer¹ (NSCLC- the most common form of lung cancer). These patients were HLA-A2 positive, had an invasive or metastatic disease and had received at least one previous line of treatment. The results of this phase 2 trial showed that Tedopi® generated a significant increase in the survival times of patients with NSCLC, which correlates with immune response.

This study showed a one year survival rate of 59% for the group treated with Tedopi®. This compares favourably with the 33% one year survival rate in patients treated with currently approved second line treatments². The median survival in the group treated was 17 months, compared with 12 months in the group of patients who did not receive the treatment. In addition, 25% of patients treated were still alive after 4 years, with a good quality of life, which is important for patients suffering from principally metastatic tumours³.

OSE Pharma is currently preparing to start a phase 3 study of Tedopi®. The trial protocol is common to Europe and to the USA. The launch of the Phase 3 study of Tedopi® is planned for the second half of 2015.

It will look to enrol 500 patients with invasive/metastatic non-small cell lung cancer (NSCLC), expressing the HLA-A2 receptor. Tedopi® will be used as a second line treatment for patients for whom first line treatments (such as chemotherapy) have not been able to control their disease. Preparatory works and manufacturing of the clinical supplies have started. An agreement has been signed in January 2015 with Orion-Symbec, CRO based in Great-Britain for this international Phase 3 study.

ADVANCED LUNG CANCER: A STRONG MEDICAL NEED

Lung cancer is the deadliest cancer in the world. In 2012, there were 1.58 million new diagnosed lung cancer cases and 1.39 million deaths from this disease globally⁴. Despite the different treatments available today (surgery, radiotherapy, chemotherapy, targeted therapy), the relative survival rates of these patients at metastatic stage remains very low³.

Given the large incidence of NSCLC, OSE Pharma estimates that the potential global sales at peak for Tedopi® for this single indication could be about €2 billion⁴.

Disclaimer:

This press release may expressly or implicitly contain forward-looking statements relating to OSE Pharma and its activity. Although OSE Pharma’s management believes that the expectations reflected in these forward-looking statements are reasonable, investors are cautioned that such statements are related to known or unknown risks, uncertainties and other factors that could lead actual results, financial conditions, performance or achievements to differ materially from OSE Pharma’s results, financial conditions, performance or achievements expressed, projected or implied by such information and forward-looking statements.

Other than as required by applicable law (article 223-1 et seq of the General Regulation of the AMF), OSE Pharma issues this press release at the date hereof and does not undertake any obligation to update or revise any forward-looking information or statements.

These risks and uncertainties include among other things, the uncertainties inherent in future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives,

For a description of risks and uncertainties which could lead to discrepancies between actual results, financial condition, performance or achievements and those contained in the forward-looking statements, please refer to Chapter 4 "Risk Factors" of the company’s Documents de Base filed with the AMF under number I. 14-056 on September, 17th 2014 and Chapter 2 "Risk Factors related to the Offer" in the prospectus approved by the AMF under number 15-078 on 6th March 2015, which can be found on the websites of the AMF (www.amf-france.org) and of OSE Pharma (www.osepharma.com).

¹ NSCLC– 88% of lung cancers

² (Cielanu T et al 2012) (Hanna N et al 2004) (Garassino MC et al 2013)

³ Overall survival rate after 5 years: 1% for metastatic cancers – American Cancer Society – 22/05/2013

⁴ Based on independent studies, source international epidemiologic data, Globocan 2012

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