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cobas® HPV test

Products Next higher product group diagnostic test, indication
Period Status 2014-04-01 registration start
Organisation Organisation Roche Molecular Systems Inc.
  Group Roche (Group)

Genticel S.A.. (1/25/16). "Press Release: Business Update – Fourth Quarter 2015". Paris & Toulouse.

Cash & cash equivalents and liquid investments of €21.7 million as at December 31, 2015, in line with Company expectations

> First patient treated in U.S. phase 1 clinical trial of GTL001
> Benedikt Timmerman resumes CEO position at Genticel

Post-quarter close

> Rémi Palmantier, PhD, appointed Chief Scientific Officer to accelerate Company’s development

> Agreement to evaluate Roche Molecular System’s cobas® HPV test in preparation for phase 3 program of GTL001

Genticel (Euronext Paris & Brussels: FR00011790542 – GTCL), a clinical-stage biotechnology company and developer of innovative immunotherapies to prevent cancers caused by the human papillomavirus (HPV), today announced its cash & cash equivalents and liquid investments position and its highlights from the fourth quarter of 2015.


As at December 31, 2015, Genticel's net cash & cash equivalents and liquid investments position was €21.7 million (vs. €21.5 million as at September 30, 2015), fully in line with pipeline development advances and company expectations.

Cash burn during the fourth quarter (i.e., €3.7 million) was driven by continuing investments in the ongoing GTL001 (ProCervix) phase 2 in Europe as well as the initiation of a GTL001 U.S. phase 1 trial.

The 2015 fourth quarter cash burn was mostly offset by the payment of the 2014 “Research Tax Credit” (€2.6 million) and by €0.8 million of a repayable advance received from Bpifrance, as part of the Company’s participation in the collaborative Magenta project1.

Given the current development stage of its immunotherapeutic candidates, Genticel has as of yet no sales turnover to report.


> First patient treated in U.S. phase 1 clinical trial of GTL001, Company’s immunotherapeutic candidate against HPV 16/18 Infections

On October 29, 2015, the Company announced that the first patient of the U.S. phase 1 clinical trial had been treated with GTL001, the Company’s first-in-class immunotherapeutic candidate against HPV 16/18 infections.

In this U.S. phase 1 trial, Genticel is evaluating GTL001’s safety and tolerance profile in 20 women aged 25 to 65, a subject population that includes women older than those previously studied in Europe. The study is being conducted at 4 investigational sites in the U.S.


> Benedikt Timmerman resumes CEO position at Genticel

On December 2, 2015, the Company’s Supervisory Board reappointed Benedikt Timmerman, founder and member of the Executive Management Board, as Chief Executive Officer. As a reminder, last July the Company announced that its Supervisory Board had named Martin Koch, Genticel’s CFO, to replace Mr. Timmerman as Genticel’s CEO during his recovery from an accident.


> Genticel appoints Rémi Palmantier, PhD, as Chief Scientific Officer to accelerate its development

On January 5, 2016, Genticel announced the appointment of a seasoned scientist with broad international experience, Rémi Palmantier, PhD, as Chief Scientific Officer. Dr. Palmantier joins Genticel from GSK Vaccines, where he was most recently Senior Director, R&D, for the global portfolio of immunotherapies for chronic diseases. Dr. Palmantier will support the Company’s strategy to expand its pipeline of innovative immunotherapies and to target various types of infectious diseases and cancers, beyond its advanced program of HPV immunotherapeutics.

Marie-Christine Bissery, PhD, Pharm.D, member of Genticel's Management Board and previous Chief Scientific Officer, was appointed Chief Development Officer and is responsible for overseeing all project management activities in the Company.

> Genticel to evaluate Roche Molecular System’s cobas® HPV test in preparation for phase 3 program of GTL001

On January 7, 2016, the Company announced that it had signed an agreement with Roche Molecular Systems Inc. to evaluate Roche’s cobas® HPV Test in preparation for the planned phase 3 trial of GTL001, Genticel’s most advanced immunotherapeutic candidate against HPV 16/18 infections. The cobas® HPV Test is currently the only HPV assay which is both EU-labeled and FDA-approved and provides specific genotyping information, notably for HPV 16 and 18, the highest-risk types targeted by GTL001. The ability to evaluate this broadly available commercial test is an important milestone that will help the Company anticipate requirements for the planned phase 3 program of GTL001 and identify the patient population that will benefit most from treatment.


? DSMB bi-annual review meeting of GTL001 phase 2 study January 26, 2016
? 2015 Annual Results March 15, 2016
? Business & Cash Position Update 1st Quarter 2016 April 28, 2016
? Annual General Meeting, Paris, France June 9, 2016
? Eurogin 2016, Salzburg, Austria June 15 to 18, 2016

1 Preclinical in vivo studies with GTL002, Genticel’s second immunotherapeutic candidate.

About Genticel

Aiming to solve a public health issue.

Among the 300 million women around the world currently infected with HPV, 500,000 new cases of cervical cancer are identified each year and 275,000 women succumb to the disease. 70% of cervical cancer cases are caused by 2 HPV types and Genticel aims to eliminate them at an early stage with GTL001, its first-in-class immunotherapeutic candidate. The company has already completed patient recruitment for the phase 2 clinical trial of GTL001 in Europe.
Offering a promising technological platform.

Genticel’s versatile platform, Vaxiclase, is ideally suited for the development of immunotherapies against multiple infectious or cancerous diseases. Genticel’s second candidate, GTL002, is a multivalent HPV immunotherapeutic candidate designed with Vaxiclase. It targets the six most relevant HPV types in terms of global epidemiology and is currently in preclinical development.

Focusing on value creation.

Respectively, the peak sales potentials of GTL001 and GTL002 are estimated at over €1 billion and €2 billion per year. In addtion to this attractive HPV product pipeline, Genticel’s versatile technological platform, Vaxiclase, has already generated significant interest in the pharmaceutical industry, as illustrated by the partnership agreement signed in 2015 with the Serum Institute of India Ltd. (SIIL), the world’s largest producer of vaccine doses. This partnership could generate up to $57 million in revenues for Genticel, before royalties on sales. It will enable SIIL to develop acellular multivalent combination vaccines against a variety of infectious diseases, including whooping cough.

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This press release and the information it contains does not constitute an offer or solicitation to buy, sell or hold Genticel shares in any country. This press release may contain forward-looking statements by the company with respect to its objectives. These statements are based on the current estimates and forecasts of the company’s management and are subject to risks and uncertainties such as the company’s ability to implement its chosen strategy, customer market trends, changes in technologies and in the company’s competitive environment, changes in regulations, clinical or industrial risks and all risks linked to the company’s growth. These factors as well as other risks and uncertainties may prevent the company from achieving the objectives outlined in the press release. No guarantee is given on forward-looking statements which are subject to a number of risks, notably those described in the registration document filed with the French Markets Authority (the AMF) on 1 April 2015 under number R.15-015 and those linked to changes in economic conditions, the financial markets, or the markets on which Genticel is present. Genticel products are currently used for clinical trials only and are not otherwise available for distribution or sale.

Valerie Leroy Investor Relations & Corporate Communications +33 6 33 34 37 30

US - LifeSci Advisors Brian Ritchie +1 212 915 2578 Europe - ACTUS Corinne Puissant +33 1 53 67 36 77

ALIZE RP Caroline Carmagnol & Florence Portejoie +33 6 64 18 99 59 / +33 6 47 38 90 04

Record changed: 2017-04-12


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