BUSINESS UPDATE - SECOND QUARTER 2016

Cash & cash equivalents and liquid investments of €14.7 million as at June 30, 2016, in line with Company's expectations

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  Additional results at 12 months from GTL001 phase 2 trial

  
  


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  Publication in 'Clinical Cancer Research' of GTL001 Phase 1 trial results

  
  


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  Completion of 5-year stability assays of GTL001 and Roche's cobas® HPV test evaluation

  
  


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  Presentation of clinical results of GTL001 and preclinical results of GTL002 at the EUROGIN 2016 congress

  
  


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  Interim analysis at 18 months of GTL001 Phase 2 trial

  
  

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 2016.

Financial highlights

As at June 30, 2016, Genticel's net cash & cash equivalents and liquid investments position was €14.7 million (vs. €18.8 million on March 31, 2016), fully in line with the company's expectations. The higher cash consumption in Q2 versus Q1 2016 reflects the increased level of investments in R&D expenditures as well as one-time restructuring costs due to a partial reduction in the workforce, as previously announced. It is important to note that the cash balance as at June 30 does not include the 2015 Research Tax Credit (CIR), which is still to be received for the R&D expenditures made in 2015.

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

Business highlights

• Additional results at 12 months from GTL001 phase 2 trial

On April 20, 2016, the Company announced that post-hoc analyses demonstrated a trend towards statistical significance in the subgroup of patients with undetermined cellular anomalies (ASCUS). Based on these results, the combined group of patients with normal cytology (NILM) and patients with undetermined cellular anomalies (ASCUS) also demonstrated a statistically significant separation (p= 0.0029).

• Publication in 'Clinical Cancer Research' of GTL001 Phase 1 trial results

On June 1, 2016, the Company announced that the publication authored by Prof. Pierre Van Damme, MD, PhD, chairman of the Vaccine & Infectious Disease Institute of the University of Antwerp (Belgium) and entitled “GTL001, a therapeutic vaccine for women infected with human papillomavirus 16 or 18 and normal cervical cytology: results of a Phase 1 clinical trial” was available online in Clinical Cancer Research.

• Completion of 5-year stability assays of GTL001 and Roche's cobas^® HPV test evaluation

On June 13, 2016, the Company announced that it had confirmed the ability to use widely available genotyping HPV tests in the planned phase 3 program of GTL001, Genticel's most advanced immunotherapeutic candidate against HPV 16/18 infections. The Company also reported that GTL001 drug product had completed stability assays demonstrating a five-year shelf life.

• Presentation of clinical results for GTL001 and preclinical results for GTL002 at the Eurogin 2016 congress

On June 15, 2016, the Company announced its participation at the EUROGIN (European Research Organisation on Genital Infection and Neoplasia) 2016 Congress held from June 15 to 18, 2016 in Salzburg, Austria, where the Company presented the interim results at 12 months of the European phase 2 trial of GTL001 in addition to providing further preclinical proof of concept data for GTL002.

• Interim analysis at 18 months of GTL001 Phase 2 trial

On June 23, 2016, the Company announced interim results at 18 months in the phase 2 trial of its HPV16/18 immunotherapeutic candidate GTL001. While this new interim analysis showed no new unexpected safety events, viral clearance in the treated total population or in the subgroups did not differ statistically from the natural clearance in the placebo group.

Post-quarter close

• Appointment of Eumedix as strategic advisor to support Company's access to innovative drug candidates

On July 6, 2016, the Company announced that it had engaged Eumedix, a leading European corporate finance specialist, as strategic advisor to support Genticel in evaluating its strategic options, with a particular focus on facilitating the Company's access to innovative drug candidates. Genticel will be carrying out this process in parallel with the assessment of its current HPV program. The Company also announced that the independent Data Safety and Monitoring Board (DSMB) found no safety concerns in the ongoing phase 2 trial with GTL001, which is an important result for its partnership with Serum Institute of India Ltd in vaccine applications.

Upcoming publications

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 clinical efficacy is being evaluated in a 24-month proof of concept Phase 2 trial in Europe.

Offering a promising technological platform.

Genticel's versatile platform, Vaxiclase, is well suited for the development of immunotherapies against multiple infectious or cancerous diseases. A partnership on the use of Vaxiclase has already been established with Serum Institute of India Ltd (SILL), the largest producer of vaccine dose worldwide. This agreement covers territories outside of the USA and Europe, and 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.

More information at www.genticel.com

 

Forward Looking Statement

This press release contains forward-looking statements that are not promises or guarantees and involve substantial risks and uncertainties. The Company's product candidates have not been approved for sale in any jurisdiction. Among the factors that could cause actual results to differ materially from those described or projected herein are uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, the risk that historical preclinical results may not be predictive of future clinical trial results, and the risk that historical clinical trial results may not be predictive of future trial results. A further list and description of these risks, uncertainties and other risks can be found in the Company's regulatory filings with the French “Autorité des Marchés Financiers”,
including in the Company's Annual Report for the year ended December 31, 2015 and future filings and reports by the Company which are available on the Company's website.. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Genticel undertakes no obligation to update or revise the information contained in this Press Release, whether as a result of new information, future events or circumstances or otherwise.

Source: Actusnews