DGAP-News: Neovacs S.A. / Key word(s): Half Year Results
Neovacs S.A.: Half-year results 2016 and update on operational development
30.09.2016 / 17:45
The issuer is solely responsible for the content of this announcement.
HALF-YEAR RESULTS 2016 AND UPDATE ON OPERATIONAL DEVELOPMENT
- Cash position significantly strengthened by successful capital increase
- Phase IIb clinical trial in lupus expanded into the United States
Paris, September 30, 2016 - NEOVACS (Alternext Paris: ALNEV PEA-PME
eligible), a leader in active immunotherapies for the treatment of
autoimmune diseases, today announced its 2016 first half financial results,
as approved by its Board of Directors on September 29, 2016.
Miguel Sieler, CEO of Neovacs, said: "During the first half of 2016,
Neovacs completed a successful capital increase that significantly
strengthened the company's financial position and enabled us to continue
our work in lupus and dermatomyositis. Indeed, in the first half of the
year, Neovacs advanced its Phase IIb clinical study in lupus, accelerating
patient enrollment and obtaining two important approvals from health
authorities in South Korea and the United States, enabling us to expand the
study into these two countries. Moreover, to be prepared for the eventual
submission for regulatory approval of our product for lupus, we have
created, in collaboration with Stellar Biotechnologies, the production
company Neostell. We have already initiated the necessary studies to move
from clinical-scale production to larger commercial-scale batches."
HALF-YEAR 2016 RESULTS*
Summary financial information
In KEUR June 30,2016 June 30,2015
Revenues 104 94
Operating costs 7, 971 5, 714
of which, R&D 6, 213 4, 724
Operating profit/loss (7, 868) (5, 620)
Financial results (42) (205)
Pretax profit/loss (7, 910) (5, 825)
Exceptional items (41) (48)
Research tax credit 1, 171 1, 003
Net profit /loss (6 779) (4 870)
Increased R&D expenses in line with expectations
For the six months ended June 30, 2016, operating expenses amounted to EUR
7.8 million. This increase in line with the guidance reflects the funding
of the Phase IIb clinical study in lupus, especially the geographical
expansion into the US, increased patient enrollment and preparation of
clinical batches for the next phase III study. In parallel, Neovacs
prepared for the initiation of a Phase IIa study in Europe for the
treatment of dermatomyositis with IFN-K. The company is also pursuing
preclinical work in AMD (age-related macular degeneration), solid tumors
(VEGF-K), allergies (IL4 / IL-13) and diabetes type I (IFN-K).
Research and development expenses in the first half of 2016 were EUR 6.2
million, compared to EUR 4.7 million in the first half of 2015, and
accounted for almost 80% of operating expenses.
As a result, the operating loss was EUR 7.9 million for the first half of
2016, compared to EUR 5.6 million for the same period in 2015, in line with
Inclusive of the tax income related to the research tax credit (CIR) of EUR
1.2 million, net loss was EUR 6.8 million, compared to EUR 4.9 million for
the same period in 2015.
Significantly strengthened financial position
A capital increase with preferential subscription rights of EUR 8.0 million
completed on June 23, 2016 strengthened the financial structure of the
company. Cash and cash equivalents amounted to EUR 9.2 million at June 30,
2016 compared to EUR 6.0 million at June 30, 2015.
The Company also has two equity lines with Kepler Cheuvreux totaling EUR 13
million, which it could potentially use to have a net working capital
sufficient to meet its obligations for the next twelve months.
KEY HIGHLIGHTS IN THE FIRST HALF OF 2016: COMPLETED SIGNIFICANT STEPS TO
ENSURE THE CONTINUITY OF DEVELOPMENT PLAN
- Creation of a joint production company with Stellar Biotechnologies,
which has collaborated with Neovacs for many years. Neostell will be
located in the Ile-de-France area and is expected to manufacture all
kinoids for Neovacs, starting with IFNa Kinoid. Neostell also plans to
manufacture and sell other KLH-based immunotherapy products for third-party
customers worldwide. The trigger investments for this production unit are
expected after the announcement of the Phase IIb study results of IFNa
Kinoid in lupus, currently led by Neovacs.
- Continuation of the Phase IIb study of IFNa Kinoid in lupus whose
objective is to evaluate the biological and clinical efficacy of IFNa
Kinoid in patients with moderate to severe forms of lupus.
- Obtaining approval of authorities in South Korea and in the US to expand
the Phase IIb study in lupus into those countries. This clinical trial is
expected to enroll 178 patients in 19 countries in Latin America, Asia,
Europe and the United States.
- Authorization by European authorities to initiate the clinical Phase IIa
study in dermatomyositis. This multicenter study plans to enroll 30 adult
patients in Europe (France, Italy, Germany, UK and Switzerland) and will
evaluate the immunogenicity, tolerability and the biological and clinical
efficacy of IFNa kinoid.
- Successful capital increase raising 8 million euros. This significantly
strengthened the Company's financial postition, providing additional
resources to finance operations, in particular, preclinical, clinical and
external costs related to the development of IFNa Kinoid for the treatment
OUTLOOK FOR THE SECOND HALF OF 2016: TOP PRIORITY -IFNa KINOID & REDUCTION
OF THE EXPENSES FOR THE PHASE IIb STUDY
- Advance the Phase IIb study with IFNa Kinoid in lupus
The company carried out the bulk of spending for this study in the 1st half
of 2016, it will continue to focus on the most advanced product of its
technology: IFNa Kinoid in lupus, without the need for additional
This product is currently in a Phase IIb study. Neovacs plans to enroll 178
patients in 19 countries in Asia, Europe, Latin America and the United
- Initiate a Phase IIa study with IFNa Kinoid in dermatomyositis
The company plans to initiate a Phase IIa study in dermatomyositis, in
close cooperation with European disease specialists. This multicenter study
plans to enroll 30 patients in Europe (France, Italy, Germany, UK and
Switzerland). The trial will be in two parts: the first part will document
the immune response induced by IFNa Kinoid and the second part will
evaluate the safety and efficacy - biologically and clinically - of IFNa
- Neovacs' International Scientific Board to meet in New York
Neovacs has appointed to its International Scientific Board a group of
renowned scientists, which should enable the company to find new and
interesting scientific collaborations for the development of its
therapeutic vaccines and their applications. This Board is expected to meet
before the end of this year to discuss recent scientific findings (or
publications) linking the role of IFNa to several autoimmune diseases.
- Neovacs to participate at BIO Europe 2016
To support its growth, the company is seeking new partnerships and is
talking with several international and regional firms. To this end, Neovacs
will present at attend BIO Europe 2016 to be held in Cologne November 7-9,
2016. This is a major partnering event for the biotechnology industry.
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 IFN?-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
+33 (0)1 53 10 93 00
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Company: Neovacs S.A.
3-5, Impasse Reille
Phone: +33 (0)1 53 10 93 00
Fax: +33 (0)1 53 10 93 03
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