GENTICEL : Business Update - Third Quarter 2015

information fournie par Actusnews •28/10/2015 à 18:45

Cash & cash equivalents and liquid investments of € 21.5 million
as at September 30, 2015, in line with Company expectations.

• Independent Data Safety Monitoring Board recommends continuation per protocol of Genticel's Phase 2 clinical trial of GTL001 (ProCervix), Company's first-in-class HPV therapeutic vaccine
• US patent granted for use of Genticel's antigen delivery vectors in combination therapy to treat cancer

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 third quarter of 2015.

FINANCIAL HIGHLIGHTS

As at September 30, 2015, Genticel's net cash & cash equivalents and liquid investments position was € 21.5 million (vs. € 25.2 million on June 30, 2015), fully in line with pipeline development advances and the company's expectations.

Cash burn during the third quarter (i.e. €3.7 million) was driven by continuing investments in the ongoing GTL001 (ProCervix) phase 2 in Europe as well as the set-up of a GTL001 phase 1 in the USA. In this study, the safety profile of GTL001 will be evaluated notably in a yet to be studied population of women older than 50. This study follows the Investigational New Drug (IND) granted in June by the FDA to GTL001.

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

BUSINESS HIGHLIGHTS

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

On July 7, 2015, the Company announced that the independent Data Safety Monitoring Board 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.

• US patent granted for use of Genticel's antigen delivery vectors in combination therapy to treat cancer

A new U.S. Patent No. 9,095,537, entitled “Therapy of cancer based on targeting adaptive, innate and/or regulatory component of the immune response,” was granted in the United States that encompasses the use of the Company's CyaA-based vectors and their derived products such as GTL001 in the treatment of cancer, notably in combination therapy with TLR agonists. This new patent expands the Company's potential to progress in therapeutic areas beyond early stage disease and protects its technology for use in multiple indications - from viral infection to cancer - in all major markets.

CORPORATE HIGHLIGHTS

• 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 had appointed Martin Koch, CFO, as the Company's CEO for the 3 months that followed while Mr. Timmerman recovered from several accidental lower limb fractures. Mr. Koch's mandate as CEO has since been extended by the Supervisory Board till year-end to give Mr. Timmerman the time needed to fully complete his rehabilitation program. Mr. Timmerman remains on Genticel's Executive Management Board and provides strategic counsel to the team.

POST QUARTER CLOSE NEWS

• New corporate website

On October 7, 2015, Genticel launched a new corporate website that aims to provide its visitors with a new source of structured information on the Company, its antigen delivery vectors and its therapeutic vaccines candidates for the millions of women infected with HPV, the cause of cervical cancer.

Upcoming meetings

• KBC Biotech & Healthcare Seminar, New York November 10, 2015
• Actionaria, Paris November 20 & 21, 2015
• DeGroof Petercam Healthcare Seminar, Brussels November 25, 2015
• European Midcap Event, Geneva December 9 & 10, 2015
• JP Morgan Healthcare Conference, San Francisco January 11 to 15, 2016

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.