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Genticel (GTCL) FR0011790542


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BUSINESS UPDATE - FIRST QUARTER 2016

Jeudi 28 Avr 2016 à 18:35

Cash & cash equivalents and liquid investments of €18.8 million as at March 31, 2016, in line with Company expectations
 

  • Rémi Palmantier, PhD, appointed Chief Scientific Officer to accelerate Company's development
  • Agreement concluded to evaluate Roche Molecular System's cobas® HPV test in preparation for Phase 3 program of GTL001
  • Initial Results at 12 months from Phase 2 trial of Genticel's HPV Immunotherapeutic Candidate, GTL001
  • 2015 Annual Results and Strategic Update for 2016

Post-quarter close

  • Additional Results at 12 months from Phase 2 trial of Genticel's HPV Immunoûtherapeutic Candidate, GTL001

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 first quarter of 2016.

FINANCIAL HIGHLIGHTS

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

Cash burn during the first quarter (i.e., €3.0 million) was driven by continuing investments in the ongoing GTL001 (ProCervix) Phase 2 in Europe as well as the GTL001 U.S. phase 1 trial.

Consequently, as at March 31, 2016, Genticel's net cash & cash equivalents and liquid investments position was €18.8 million (vs. €21.8 million as at December 31, 2015), fully in line with pipeline development advances and company expectations.

The Company's funding, focused on the clinical development of GTL001 and GTL002, is thus secured until 2018.

BUSINESS HIGHLIGHTS

  • Rémi Palmantier, PhD, appointed Chief Scientific Officer to accelerate Company's development

On January 5, 2016, Genticel announced the appointment of a seasoned scientist with broad international experience, Rémi Palmantier, PhD, as Chief Scientific Officer. Dr. Palmantier joins Genticel from GSK Vaccines, where he was most recently Senior Director, R&D, for the global portfolio of immunotherapies for chronic diseases. Dr. Palmantier will support the Company's strategy to expand its pipeline of innovative immunotherapies and to target various types of infectious diseases and cancers, beyond its advanced program of HPV immunotherapeutics.

  • Evaluation by GENTICEL of the HPV cobasÒ test of Roche Molecular Systems in preparation of GTL001's Phase 3

On January 7, 2016, the Company announced an agreement with Roche Molecular Systems Inc. to evaluate Roche's cobas® HPV Test in preparation for the planned Phase 3 trial of GTL001. The cobas® HPV Test is currently the only HPV assay which is both EU-labeled and FDA-approved and provides specific genotyping information, notably for HPV 16 and 18, the highest-risk types targeted by GTL001. The ability to evaluate this broadly available commercial test is an important milestone that will help the Company anticipate requirements for the planned Phase 3 programs of GTL001 and identify the patient population that will benefit most from treatment.

  • Genticel reports initial results at 12 months from Phase 2 trial of HPV immunotherapeutic candidate, GTL001

On January 27, 2016, Genticel announced initial results from the ongoing randomized, double-blind, placebo controlled Phase 2 clinical study of its immunotherapeutic candidate, GTL001, designed to clear HPV 16 and/or 18 infection. While there was no statistical difference in viral clearance between treatment and placebo in the overall study population at 12 months, there was a clear separation in 2 predefined subgroups, namely patients with normal cytology and patients less than 30 years old at baseline. The independent DSMB (Data Safety and Monitoring Board) recommended on January 26, 2016, the continuation of the study per protocol. The positive results obtained in the subgroup of patients with normal cytology are of particular value to Genticel because this subgroup coincides with the population evaluated in the Phase 1 study, which already showed a trend of efficacy, and because patients with normal cytology represent at least 70% of the overall target population. Further data will be collected at 15, 18 and 24 months. The next update will be reported in Q3 2016 and will provide viral clearance data at 15 and 18 months.

  • Annual results 2015 and strategic update for 2016

On March 14, 2016, Genticel presented its 2015 full year results in accordance with International Financial Reporting Standards (IFRS) and provided a strategic update for 2016. The 2015 net loss of (€11.2 million) and the financial position with cash & cash equivalents and liquid investments of €21.8 million as at December 31, 2015 were consistent with the Company's expectations. The Company also announced the deferment by 12 months of the industrial GMP production at commercial scale planned for GTL001 Phase 3 and of the semi-industrial production planned for GTL002 Phase 1 trial. Investments will be focused on the ongoing GTL001 clinical trials, the Phase 2 study in Europe and the Phase 1 study in the United States. The implementation of the proposed measures could result in a workforce reduction of approximately 30% in the Company's Labège laboratories and in support functions. Genticel is complying with French law, notably with respect to its legal obligation to duly inform and consult its employee representatives on the workforce reduction plan. The shift of investments including postponing production and focusing on GTL001 clinical activities will extend the Company funding well into 2018.

POST QUARTER CLOSE NEWS

  • Additional results at 12 months from Phase 2 trial of Genticel's HPV immunotherapeutic candidate, GTL001

On April 20, 2016, Genticel announced additional results at 12 months from Phase 2 trial of Genticel's HPV immunotherapeutic candidate, GTL001. Post-hoc analyses demonstrated a trend towards statistical significance in the subgroup of patients with undetermined cellular anomalies (ASCUS[1]). Based on these results, the combined group of patients with normal cytology (NILM1) and patients with undetermined cellular anomalies (ASCUS1) also demonstrates a statistically significant separation (p= 0.0029). This combined group of patients who do not yet have low-grade lesions (LSIL1) comprises the vast majority[2] (over 80%) of the HPV-positive women GTL001 aims to treat.

  • Publication of Genticel's first Shareholder Newsletter

On April 21, 2016, the Company announced the publication of its first Shareholder Newsletter. This newsletter is meant to be a a regular means of exchange, rich in information, to apprise the public of the Company's strategy and keep it updated on Genticel's progress. Notably, this first issue contains information on HPV and on GTL001 Phase 2 trial objectives, population and outlook. It is available on the Company's website, in the Investors > Shareholder information section.

FINANCIAL AGENDA

  • 9 June Annual General Meeting – 5, rue Tronchet – Paris – France – 10 am
  • 28 July Business & Cash Position Q2 2016
  • 22 September Half-Year Results 2016
  • 27 October Business & Cash Position Q3 2016

This calendar is for information purposes only and may be amended if necessary.

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, its first-in-class immunotherapeutic candidate. GTL001 is more than halfway through a 24-month proof of concept Phase 2 trial 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 immunotherapeutic candidate 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 US INVESTORS MEDIA
Valerie Leroy
Investor Relations & Corporate Communications
+ 33 6 33 34 37 30
investors@genticel.com
Life Sci Advisors
Brian Ritchie
+1 212 915 2578
britchie@lifesciadvisors.com
ALIZE RP
Caroline Carmagnol et
Florence Portejoie
+33 6 64 18 99 59 / +33 6 47 38 90 04
genticel@alizerp.fr
 

[1]NILM: Negative for Intraepithelial Lesion or Malignancy; ASCUS: Atypical Squamous Cells of Undetermined Significance; LSIL: Low-grade squamous intraepithelial lesion.

[2]Wright et al. Primary cervical cancer screening with human papillomavirus: End of study results from the ATHENA study using HPV as the first-line screening test. Gynecol Oncol 2015: 136; 189-197


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