DGAP-News: Neovacs S.A.: 2014 half-year results


DGAP-News: Neovacs S.A. / Key word(s): Half Year Results
Neovacs S.A.: 2014 half-year results

18.09.2014 / 08:00

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2014 half-year results

  - First half results in line with expectations

  - Available cash ensures continued operation through to June 2015

  - Neovacs' first "Road Show" in New York at the occasion of "French
    Biotech Day"

  - Clinical study of TNFa Kinoid in rheumatoid arthritis

  - Preparation of Phase IIb study of INFa Kinoid in Lupus 

Paris, 18 September 2014 - Neovacs (Alternext Paris: ALNEV, FR0004032746),
a leader in active immunotherapies for the treatment of autoimmune
diseases, today announced its results for the six months to 30 June 2014,
as approved by the Board of Directors on 17 September 2014.

2014 half-year results

<pre>

in K EUR                               30 June 2014         30 June   2013
Revenues                                         55                     10
Operating costs                              -4,576                 -3,656
                Of which R&D                  3,594                  2,719
Operating profit/loss                        -4,518                 -3,646
Net financial income/expense                    -64                    -37
Pretax profit/loss                           -4,582                 -3,683
Exceptional items                                49                     -6
Research Tax Credit                             673                    409
Net profit/loss                              -3,861                 -3,279

Closing cash                                  2,860                  8,259


</pre>

- Strict cost management

In the first half of 2014, operating costs came to EUR4.6 million, from
EUR3.7 million in the same period in the previous year. This 25% increase
is the logical result of the beginning of the active stage of Phase IIb
clinical trials of TNF-Kinoid in rheumatoid arthritis (enrolment of 140
patients in a limited time frame) and the resumption of preclinical
programmes for VEGF Kinoid in DMLA and solid tumours. Thus R&D expenditure
continued to represent three-quarters of total operating costs at EUR3.6
million for the period, from EUR2.7 million in the first half of 2013. At
the same time, the company has operated a policy of strict control over
administrative costs, which account for 20% of total operating costs.
As a result, the operating loss was 24% higher, at EUR4.5 million (from
EUR3.6 million in the six months to 30 June 2013). The net loss also
increased by EUR0.4 million, to EUR3.9 million at 30 June 2014 (including
tax income of EUR0.6 million related to Research Tax Credits).

- Available cash ensures continued operation through to June 2015

Total cash stood at EUR2.9 million at 30 June 2014. This will be boosted by
the payment of the Research Tax Credit at the end of September 2014 (a
total of EUR1.1 million relating to the 2013 financial year) and by the
equity finance line made available by Kepler Cheuvreux.
As previously indicated, available cash is sufficient to ensure the
company's continued operation until June 2015, and will finance notably the
monitoring of patients included in the clinical trial of TNF-Kinoid in
rheumatoid arthritis as well as the preparation of clinical batches
required for the launch of the Phase IIb trial of IFN-Kinoid in lupus.

- Outlook 

Neovacs' first "Road Show" in New York
At the occasion of the "French Biotech Day" organised by France Biotech,
Neovacs presented itself over the course of a week to some twenty US
investors, explaining its technology, clinical and preclinical portfolio,
target market and key strengths over existing treatments in target
pathologies. These meetings helped increase awareness of the company
amongst American investors, and thus gave the company new prospects for
partnerships and financing.

Clinical study of TNFa Kinoid in rheumatoid arthritis
Encouraged by positive results from the previous Phase I and IIa studies,
at the end of 2013 Neovacs began enrolment of 140 patients for this study
of effectiveness to be carried out in 40 centres in 10 European countries.
The enrolment of patients was completed in 14 weeks, confirming the
interest amongst both patients and doctors for a new therapeutic pathway in
this indication.
Given the good tolerance to the product, the independent monitoring body
(DSMB) has twice unanimously recommended continuation of the study.
The results of this study should be known before year end.

Preparation of Phase IIb study of INFa Kinoid in Lupus
The results obtained by Neovacs in the Phase I/IIa, trials together with
the validation of the target Interferon in other clinical studies carried
out by major pharmaceuticals companies, have convinced the company to carry
out a Phase IIb effectiveness trial as soon as possible.
This initiative has also been supported by results obtained internally and
published during EULAR in Paris in June 2014.
Clinical batches for this study are now being prepared. The protocol has
been submitted for validation by an expert committee. Some 240 patients,
from Europe, Asia and South America, will be included.

Identification of four preclinical projects
In the spring of 2014, Neovacs decided to resume preclinical activity in
AMD and solid tumour indications for VEGF-Kinoid, chronic infectious
diseases with INFa-Kinoid and in allergies by targeting cytokine IL4. The
aim is to identify the project or projects which can be taken forward to
the clinical development phase.


About Neovacs 
Neovacs is a biotechnology company focused on an active immunotherapy
technology platform (Kinoids) with applications in autoimmune and/or
inflammatory diseases. On the basis of the company's proprietary technology
for inducing a polyclonal immune response (covered by six patent families
that run until at least 2023) Neovacs is focusing its development efforts
on two active immunotherapies: TNF-Kinoid is being developed for the
treatment of TNF-mediated autoimmune diseases such as rheumatoid arthritis
and Crohn's disease, whereas IFNα-Kinoid is being developed for the
indication of lupus. Neovacs is also conducting preclinical works on
IFNα-Kinoid in certain chronic viral infections, VEGF-Kinoid in Age-related
Macular Degeneration (AMD) and solid tumors, and IL-4-Kinoid for the
treatment of allergies. The goal of the Kinoid approach is to enable
patients to have access to safe treatments with efficacy that is sustained
in these life-long diseases.
For more information on Neovacs, visit www.neovacs.fr



Press & Financial Communication France - Publicis 
  
Stéphanie Tabouis                                  
Aubane de Gélis 
+33 (0) 1 44 82 46 35                                                
+33 (0) 1 44 82 46 38
stéphanie.tabouis@consultants.publicis.fr                 
aubane.de-gelis@consultants.publicis.fr



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Language:    English                                             
Company:     Neovacs S.A.                                        
             3-5, Impasse Reille                                 
             75014 Paris                                         
             France                                              
Phone:       +33 (0)1 53 10 93 00                                
Fax:         +33 (0)1 53 10 93 03                                
E-mail:      www.neovacs.fr                                      
Internet:    info@neovacs.fr                                     
ISIN:        FR0004032746                                        
WKN:         A1CVKR                                              
Listed:      Freiverkehr in Stuttgart; Frankfurt in Open Market  
 
 
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