Business Update - 2nd Quarter 2014
- Net cash position at €36.9 million as of June 30, as forecasted
- ProCervix's phase II study on track
GENTICEL (Euronext Paris and Brussels: FR0011790542 - GTCL), a French biotechnology company and leading developer of therapeutic vaccines, provides an update on its cash position as of June 30, 2014 and announces the milestones it achieved during the 2014 2nd quarter.
Financial highlights as of June 30, 2014
As of June 30, GENTICEL's net cash position was at €36.9 million, as planned.
GENTICEL received on June 30, 2014 the amount of €1,897,458 in research tax credit (Crédit Impôt Recherche [CIR]) for the year 2013. It is to date the most significant tax credit granted to the company, which reflects the expected increase in R & D activity.
The company will also be receiving €947,000 during the 2nd half of the 2014 year in the form of redeemable advances and subsidies as part of its participation in certain projects supported by Bpifrance.
As presented during its IPO, GENTICEL points out that it is still in the development phase of its therapeutic vaccine candidates. Therefore it has no revenue to report.
Milestones achieved during 2nd Quarter 2014
- 50% of patients recruited in ProCervix's phase II study
- DSMB (Data & Safety Monitoring Board) endorses the unchanged continuation of the clinical trial
Benedikt Timmerman, the founder and CEO of GENTICEL, said: “After successfully attaining a capital increase of €34.7 million, a strong indicator of investor and shareholder confidence, we now have the appropriate financial means to develop our portfolio of therapeutic vaccines. As announced on July 10 and in line with our objectives, we have already recruited half of the targeted number of patients for the phase II RHEIA-VAC efficacy trial of our therapeutic vaccine candidate, ProCervix. This once again demonstrates the company's ability to fulfill its commitments. Moreover, the DSMB also approved the continuation of the trial with no change, a positive decision with which we are very satisfied.”
Results for the first half of 2014 to be published on September 25, 2014 (after stock exchange closing)
About ProCervix
ProCervix is a therapeutic vaccine designed to induce a curative cellular immune response in patients infected with HPV16 and/or HPV18. The high-risk human papillomavirus HPV16 and/or HPV18 types are responsible for 70% of cervical cancers worldwide. It is a potential blockbuster. At peak, it could be prescribed to about 1.3 million women per year and lead to sales of more than
€1 billion.
About the clinical trial RHEIA-VAC (Research on HPV Eradication In Adults by VACcination):
RHEIA-VAC is a phase II study of the ProCervix therapeutic vaccine. It is used for HPV 16 and/or 18 infected women, who have normal cervical cytology or ASCUS(1)/LSIL(2) (mild cervical cellular dyskaryosis). RHEIA-VAC is a double-blinded, randomized and placebo-controlled efficacy study. This study is being carried out in 39 investigation sites across 7 European countries (Belgium, Finland, France, Germany, the Netherlands, Spain and the UK). Viral clearance at 12 months is the primary endpoint. In a previous phase I study, ProCervix showed a favorable safety and tolerability profile.
(1) ASCUS: Atypical Squamous Cells of Undetermined Significance
(2) LSIL: Low grade Squamous Intra-epithelial Lesions
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. Besides ProCervix, a second therapeutic vaccine candidate targeting six of the most pertinent strains of HPV is currently in preclinical stage. Vaxiclase, the technology platform, used in this product is ideally adapted for developing early-intervention immunotherapies against multiple infectious or cancerous diseases.
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 GENTICEL's Investor website www.genticel-bourse.com
| CONTACT GENTICEL | INVESTOR CONTACT | PRESS CONTACT |
| Benedikt Timmerman Chief Executive Officer [email protected] |
Corinne Puissant Edouard de Maissin Tel.: +33 (0)1 53 67 35 71 [email protected] |
Alexandra Prisa Tel.: +33 (0)1 53 67 35 79 [email protected] |
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