GENTICEL : Business Update - Second Quarter 2015

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Cash & cash equivalents and liquid investments of € 25.2 million
as at June 30, 2015, in line with Company expectations

 

  • Promising pharmacology in vivo results of GTL001 (ProCervix) presented at AACR Annual Meeting 2015
  • Positive proof of concept results of GTL002, Genticel's multivalent HPV therapeutic vaccine candidate based on proprietary Vaxiclase platform
  • Genticel received FDA clearance of IND application for U.S. phase 1 clinical trial of GTL001 (ProCervix)

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 second quarter of 2015.


Financial highlights

As at June 30, 2015, Genticel's net cash & cash equivalents and liquid investments position was € 25.2 million (vs. € 29.1 million on March 31, 2015), fully in line with the company's expectations.

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


Business highlights

  • Promising pharmacology in vivo results of GTL001 (ProCervix) presented at AACR Annual Meeting 2015

The results of this study indicate that GTL001 has the potential to eradicate ongoing HPV 16 infections, while also providing protection against possible future HPV 18 infections, and vice-versa. These data also suggest that it should be possible to both protect and treat patients with multiple different antigens for a given cancer.

  • Positive in vivo preclinical proof of concept results of GTL002 (Multivalent HPV), Genticel's new therapeutic vaccine candidate based on proprietary Vaxiclase platform

Genticel's GTL002 multivalent vaccine candidate was tested in several in vivo preclinical studies. In these studies, it triggered an immune response against each of the targeted 6 high-risk oncogenic HPV types and was able to eradicate tumors.

  • Genticel Received FDA Clearance of IND Application for U.S. Phase 1 Clinical Trial of GTL001 (ProCervix), Company's First-in-Class HPV Therapeutic Vaccine Candidate

The U.S. phase 1 study is designed to evaluate the tolerability and safety of GTL001 as a therapeutic vaccine in 20 women aged 25 to 65 infected with HPV 16 and/or 18. Three investigational sites will be recruiting these patients during the second half of 2015.

Corporate highlights

In April 2015, the Company appointed Valerie Leroy as Senior Director, Corporate Communications & Investor Relations. Her primary objective is to increase Genticel's visibility across the financial community, the media and the general public.

During the quarter, Genticel participated in several meetings in Europe and in the US to share the progress it has made in its development programs with the public, the investor community and potential partners.

Notably, Genticel attended the annual VFB (Flemish Investor Federation) Retail Investor Meeting in Brussels, the Small & MidCap spring event in Paris, the BioEquity 2015 meeting in Vienna and France Biotech Life Sciences Days in New York.


Post quarter close news

  • Genticel CFO, Martin Koch, appointed CEO to replace Benedikt Timmerman during temporary medical leave of absence due to accidental lower limb fractures

On July 2, 2015, the Company announced that, upon the proposal of Benedikt Timmerman, Genticel's Supervisory Board has appointed Martin Koch, CFO, as the Company's CEO for the next 3 months while Mr. Timmerman recovers from several accidental lower limb fractures. Mr. Timmerman remains on Genticel's Executive Management Board and will provide strategic counsel to the team during this period before resuming his position this fall.

  • GTL001 (ProCervix) phase 2 trial to continue as planned after 3rd DSMB review

On July 7, 2015, the Company announced that the independent Data Safety Monitoring Board (DSMB) recommended the continuation, per protocol, of its phase 2 clinical trial of GTL001 (known in Europe as ProCervix) in patients infected with HPV 16 and/or 18, the two HPV types responsible for 70% of cervical cancer cases. Half of the 236 vaccinated patients have reached 12 months post-vaccination. Patient and physician engagement remains extremely strong, with 98 percent of the patients still actively participating in the study.
 

Results for the first half of 2015 will be published on September 21, 2015 (after markets close).


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 (known in Europe as ProCervix), its first-in-class immunotherapeutic vaccine 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 therapeutic vaccine 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.

For more information, visit us at www.genticel.com

Disclaimer
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.

GENTICEL INVESTORS MEDIA
Valerie Leroy
Investor Relations & Corporate Communications
+33 6 33 34 37 30
investors@genticel.com
 
US
Brian Stollar – Life Sci Advisors
+1 212 915 2577
bstollar@lifesciadvisors.com
 
Europe
Corinne Puissant - ACTUS
+33 1 53 67 36 77
cpuissant@actus.fr
 
Caroline Carmagnol et
Florence Portejoie - ALIZE RP

+33 6 64 18 99 59 / +33 6 47 38 90 04
genticel@alizerp.fr
 

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