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 K€ |
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 |
) |
*unaudited figures
Increased R&D expenses in line with
expectations
For the six months ended June 30, 2016,
operating expenses amounted to € 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 € 6.2 million, compared to € 4.7 million in the
first half of 2015, and accounted for almost 80% of operating
expenses.
As a result, the operating loss was € 7.9
million for the first half of 2016, compared to € 5.6 million for
the same period in 2015, in line with expectations.
Inclusive of the tax income related to the
research tax credit (CIR) of € 1.2 million, net loss was € 6.8
million, compared to € 4.9 million for the same period in 2015.
Significantly strengthened financial
position
A capital increase with preferential
subscription rights of € 8.0 million completed on June 23, 2016
strengthened the financial structure of the company. Cash and cash
equivalents amounted to € 9.2 million at June 30, 2016 compared to
€ 6.0 million at June 30, 2015.
The Company also has two equity lines with
Kepler Cheuvreux totaling € 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 position, providing additional resources to
finance operations, in particular, preclinical, clinical and
external costs related to the development of IFNa Kinoid for the
treatment of lupus.
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
lupusThe 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 investments. 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 States.
- 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 kinoid.
- 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 and attend BIO
Europe 2016 to be held in Cologne November 7-9, 2016. This is a
major partnering event for the biotechnology industry.
About NeovacsCreated 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
Charlene Masson
+33 (0)1 53 10 93 00
cmasson@neovacs.com
Press/U.S. Inquiries –
The Ruth Group
Lee Roth/Joseph Green
+1-646-536-7012 / 7013
lroth@theruthgroup.com / jgreen@theruthgroup.com
Investor Relations –
Financial Communications Germany – MC Services
Raimund Gabriel
+49-89-210228-30
raimund.gabriel@mc-services.eu
Neovacs (EU:ALNEV)
Historical Stock Chart
From Jun 2024 to Jul 2024
Neovacs (EU:ALNEV)
Historical Stock Chart
From Jul 2023 to Jul 2024