DGAP-News: Neovacs S.A. / Key word(s): Miscellaneous
Neovacs S.A.: FINANCIAL RESULTS FOR 2014
27.02.2015 / 08:00
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PRESS RELEASE
FINANCIAL RESULTS FOR 2014
- FY2014 in line with Company expectations
- Solid cash position of EUR5.6 million; financial structure
significantly strengthened by equity line of up to EUR20 million
- Inititation of two clinical trials of IFNα-Kinoid in SLE as part of new
therapeutic focus
Paris, February 27, 2015 - NEOVACS (Alternext Paris: ALNEV), a leader in
active immunotherapies for the treatment of autoimmune diseases, today
announced its full-year 2014 financial results, as approved by its Board of
Directors on February 26, 2015.
Full Year 2014 Results
Summary financial information
<pre>
In KEUR 2014 2013
Revenues 161 44
Operating costs 9,815 7,941
of which, R&D 7,753 6,194
Operating profit/loss -9,654 -7,898
Pretax profit/loss -9,812 -8,028
Exceptionnal items -7 10
Research tax credit -2,306 -1,148
Net profit /loss -7 513 -6 870
</pre>
Revenues for the year ended December 31, 2014 were EUR161,046, mainly
comprised of the reimbursement of salary and other expenses related to two
employees who performed work for another company during 2014. As Neovacs
is still a development stage enterprise, it does not generate sales
revenue.
Operating costs increased by 22% year-over-year to EUR9.8 million in 2014,
an increase that was primarily the result of the continuation of the Phase
IIb clinical study in Rheumatoid Arthritis that the Company initiated in
2013. R&D expenses were 79% of the Company's total operating costs for
2014, while general and administrative expenditures remained under tight
control.
Consequently, full-year operating losses were EUR9.7, an increase compared
to 2013 (EUR7.9 million). After taking into account EUR2.3 million in
Research Tax Credit, the net loss for the year ended 31 December 2014 was
EUR7.5 million. This compares to a net loss of EUR6.9 million for the same
period in 2013.
Significant strengthening of financial resources
In order to address its long term financing needs, Neovacs secured a
flexible, multiyear equity financing with Kepler Cheuvreux in November
2014. The equity line, through which Neovacs can access up to EUR20 million
is arranged in three tranches of optional equity financing, one of EUR7
million and two of EUR6.5 million each. Less than half of the first tranche
of financing has been utilized to date.
Available cash balances as of December 31, 2014 were EUR5.6 million, in
line with the Company's projections based on its clinical program. Taking
into account the equity financing, Neovacs has the financial resources to
cover its expenditures for the next 12 months.
The Company has no debt and benefits from a sound balance sheet.
2014 highlights:
Phase IIb clinical trial of TNF-Kinoid in Rheumatoid Arthritis (RA)
Neovacs initiated mid-2013 a phase IIb clinical trial of TNF-Kinoid in RA,
following positive Phase IIa results obtained in 2012[1]. This
international, double blind versus placebo study recruited 140 RA patients
naïve to anti-TNF treatments. Its primary endpoint was clinical efficacy as
measured by changes in DAS28 and ACR20 scores.
The results of the clinical trial were published in December 2014. Although
the study confirmed the good safety profile and immunogenicity of the
product, it failed to meet its primary endpoint. Several hypotheses are
currently being evaluated to determine why TNF-Kinoid did not demonstrate
clinical efficacy in RA.
Preparation of IFNα-Kinoid studies in Systemic Lupus Erythematosus (SLE or
lupus)
In 2014, Neovacs continued to monitor patients from the phase I/II clinical
trial of IFNα-Kinoid in SLE who still present Kinoid-induced antibody
titers. New data generated from this follow-up analysis allowed the Company
to present two posters[2,3], at the EULAR (European League Against
Rheumatism)annual meeting in June 2014 and the American College for
Rheumatology (ACR)annual meeting in November 2014. These results further
support the superiority of a polyclonal antibody strategy over monoclonal
antibodies in the treatment of SLE.
Based on these positive results, Neovacs made the strategic decision to
initiate two clinical trials with IFNα-Kinoid in SLE:
- A 160-patient phase IIb clinical trial in Europe, Asia and Latin
America;
- A 50-patient phase I/II clinical trial in the United States
Preliminary preparation for the clinical trials began in Q4 2014. Most
notably, Neovacs secured a sourcing agreement to supply IFNα. Neovacs also
formed a Clinical Advisory Board dedicated to lupus in November 2014.
Preclinical development program of VEGF-Kinoid
In February 2014, Neovacs resumed preclinical activity on VEGF-Kinoid, an
anti-VEGF immunotherapy developed in Age-Related Macular Degeneration (AMD)
and solid tumors. Neovacs presented promising results for VEGF-Kinoid in
AMD at the EVER conference in 2009[4]. First results from this preclinical
activity are expected in the third quarter of 2015, with the goal of
initiating clinical studies in 2016 for the most advanced VEGF-Kinoid
program.
Outlook for 2015:
New members join Scientific Advisory Board (SAB)
Neovacs formed a scientific committee comprised of leaders in immune
therapy, chronic inflammatory and autoimmune diseases in October 2014, with
the goal of strengthening the Company's scientific base. The U.S.-based SAB
meets several times a year under the Chairmanship of Prof. Jacques
Banchereau, PharmD, Ph.D. Neovacs announced changes in its SAB membership
to reflect the shift in the Company's therapeutic focus in favor of
IFNα-Kinoid and VEGF-Kinoid in February 2015.
Miguel Sieler, Chief Executive Officer of Neovacs, concluded:"Financial
results for 2014 are in line with our expectations and reflect a prudent
management of expenditures despite the increase in clinical activity over
the year. Thanks to a solid cash balance, strengthened by the equity
financing in place with Kepler Cheuvreux, we have the financial resources
necessary to pursue our clinical development program in 2015. We are
integrating what we have learned in our previous trial as we are now
focusing our efforts on IFNα-Kinoid and VEGF-Kinoid, two products with vast
clinical potential and encouraging preliminary data."
[1] Results published in January 2012. Press release here:
http://neovacs.fr/news-and-media/press-releases/?y=2012
[2] "Serum IFN-alpha, but not IFN-beta or IFN omega, correlates with IFN
signature in SLE patients" EULAR14-SCIE-3726. Abstract available at
https://b-com.mci-group.com/AbstractList/EULAR2014.aspx
[3] "Potent, broad, and specific neutralizing capacities of polyclonal
anti-interferon alpha antibodies induced by IFN-Kinoid in SLE patient"
EULAR14-SCIE-3713. Abstract available at
https://b-com.mci-group.com/AbstractList/EULAR2014.aspx
[4] European Association for Vision and Eye Research (EVER) 2009, September
30-October 3, Portoroz, Slovenia. Abstract 4352.
About Neovacs
Created in 1993, Neovacs is today a leading 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 five patent families that potentially run until 2032) Neovacs is
focusing its clinical development efforts on IFNα-Kinoid, an immunotherapy
being developed for the indication of lupus. Neovacs is also conducting
preclinical development works on other therapeutic vaccines in the fields
of auto-immune diseases, oncology and 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, please visit www.neovacs.fr
Contacts
NEOVACS
Nathalie Trépo
+33 (0)1 53 10 93 00
ntrepo@neovacs.com
Press - Financial Communications- Publicis
Stéphanie Tabouis
+33 (0) 1 44 82 46 35
stéphanie.tabouis@consultants.publicis.fr
Investor Relations - Financial Communications Germany - MC Services
Raimund Gabriel
+49-89-210228-30
raimund.gabriel@mc-services.eu
Press - U.S. Inquiries - The Ruth Group
Melanie Sollid-Penton
1.646.536.7023
msollid@theruthgroup.com
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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: Regulated Unofficial Market in Stuttgart; Open Market in
Frankfurt
End of News DGAP News-Service
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DGAP-News: Neovacs S.A.: FINANCIAL RESULTS FOR 2014
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