Genticel: Business update – third quarter 2014

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 and 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 €1.7 million in research tax credit for 2014, 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 as yet no revenue to report. 

Other highlights from the third quarter of 2014

Progress in patient recruitment for the ProCervix Phase II trial

The recruitment for this clinical trial of female participants infected with HPV 16 and/or 18, but without any high-grade cervical lesions, 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, said: “Recruitment is moving at a fast pace. In addition, after over eight months of recruitment, having been administered the vaccine, no participants have withdrawn from the trial because of side effects.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 said: “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.”