GENTICEL : BUSINESS UPDATE - THIRD QUARTER 2014

information fournie par Actusnews •23/10/2014 à 20:50

• Net cash and equivalents of €35.2 million as of September 30, 2014
• Progress of ProCervix Phase II trial
• New data on HPV prevalence
  

GENTICEL (Euronext Paris and Brussels: FR0011790542 - GTCL), a French biotechnology company and leading developer of therapeutic vaccines, today announces its net cash position and its highlights from the third quarter of 2014.

Financial highlights as of September 30, 2014
As of September 30, 2014, Genticel's net cash & equivalents position was at €35.2 million (vs. €36.9 million on June 30, 2014), fully in line with the company's expectations.

Over the third quarter of 2014, the company received from Bpifrance the sum of €349,000—in the form of redeemable advances and subsidies—as part of a collaborative project focused on the preclinical development of Multivalent HPV, Genticel's second therapeutic candidate vaccine.

In addition, during this third quarter, the company submitted to Bpifrance a project completion report for a redeemable advance provided during the preparation of the Phase II trial currently underway with ProCervix. The project's success led Bpifrance to accept the final report and provided the company with €481,000 on September 4, 2014.

Furthermore, on September 30, 2014, the company recorded for 2014 €1.7 million in research tax credit, called “ crédit d'impôt recherche” in France.

Given the current development stage of its therapeutic vaccines candidates and the company's value-creation strategy for these assets, Genticel has no revenue to report yet.

Other highlights from the third quarter of 2014

Progress in patient recruitment for the ProCervix Phase II trial
The recruitment of female participants, infected with HPV 16 and/or 18 but without any high-grade cervical lesions, for this clinical trial is moving forward at a very satisfactory pace. More than half of the participants were already recruited by June 30, 2014—sooner than the company had anticipated.

Dr Sophie Olivier, Genticel's Chief Medical Officer, stated: "Recruitment is moving at a fast pace. In addition, after over eight months of recruitment, no participants, having been administered the vaccine, have withdrawn from the trial because of side effects. This shows that these women are determined to put an end to their infections from the most aggressive HPV strains and leads us to believe that the treatment is well tolerated."

New data on the estimated prevalence of HPV among women
In its August 22 publication, the Information Center on HPV of the Catalan Institute of Oncology (ICO HPV) reported that 13.5% of all women over the age of 15 were currently asymptomatic carriers of HPV. This estimate suggests that there are more than 350 million women worldwide over the age of 15 who are asymptomatic carriers of HPV, of whom more than 126 million are carriers of HPV 16 or HPV 18.
Benedikt Timmerman, Chief Executive Officer of Genticel stated: "The latest results from ICO HPV, which is recognized worldwide for its epidemiological research on HPV-related illnesses, suggest that infections by these viruses are far from being under control and are even increasing. These new figures provide further support for Genticel's strategy of developing therapeutic vaccines for women who are HPV positive but who do not yet have any high-grade or cancerous lesions. One should keep in mind that there are currently no therapeutic options for these women."

Upcoming events:

Genticel will take part in various investor events over the coming months:

About Genticel
Genticel is a French biopharmaceutical company specialized in the development of therapeutic vaccines aimed at eliminating, at an early stage, the human papillomavirus (HPV) responsible for cervical cancer.

Genticel is developing ProCervix, a first therapeutic vaccine in Phase II clinical trials, designed to eliminate cervical cells infected with HPV 16 and/or HPV 18. The company has also established Vaxiclase, a technology platform ideally adapted for use in early-intervention immunotherapies against multiple infectious or cancerous diseases. This platform is being used to develop a second therapeutic vaccine candidate, now in its preclinical stage, targeting six of the most pertinent HPV strains in terms of global epidemiology.

Genticel is based in Paris and Toulouse and was awarded the 2013 Innovation Prize by the ‘Grands Prix de l'Economie'.

Since April 4, 2014, Genticel shares have been listed on the regulated Euronext markets in Paris and Brussels.

For more information, please visit www.genticel.com

About the Information Centre on HPV
The Centre is being developed by the Institut Català d'Oncologia (ICO), located in Barcelona, Spain. The Centre was originally launched by ICO with the collaboration of WHO's Immunization, Vaccines and Biologicals (IVB) department and support from the Bill and Melinda Gates Foundation. The work has also been partially supported by public grants from the European Commission (7th Framework Programme grant HEALTH-F3-2010-242061, PREHDICT).

The HPV Information Centre compiles, processes, and disseminates country-specific information related to HPV and cervical cancer to facilitate global, regional- and country-specific decisions on current and novel options for the prevention of cervical cancer. The Centre provides an efficient web-based communication between the research field, the medical communities and the public health professionals and decision-makers on a worldwide scale.
For more information, click on www.hpvcentre.net/