Neovacs reports full-year 2018 Financial results and provides
corporate update
RESS RELEASE
· PRESS RELEASE
· PRESS
RELEASE
NEOVACS REPORTS FULL-YEAR 2018 FINANCIAL
RESULTS AND PROVIDES CORPORATE UPDATE
- KEY OPINION LEADERS VALIDATE THE THERAPEUTIC POTENTIAL OF IFNα
KINOID IN LUPUS TREATMENT FOLLOWING THE RESULTS OF THE PHASE
IIB CLINICAL STUDY
- SUCCESSFUL IN VIVO PROOF OF CONCEPT FOR ITS IL-4 / IL-13
KINOID A NEW THERAPEUTIC VACCINE TO TREAT MITE-INDUCED
ASTHMA
- PATENT REGISTERED IN EUROPE AND THE U.S. FOR IL-4 / IL-13
KINOID, CANDIDATE VACCINE IN THE TREATMENT OF
ALLERGIES
- FINANCIAL VISIBILITY BEYOND 12 MONTHS
- NET LOSS REDUCTION BY € 4M
Paris, March 25, 2019,
7:30 am CET – NEOVACS (Euronext
Growth Paris: ALNEV), a leader in active immunotherapies
for the treatment of autoimmune diseases, provides today a
corporate update and reports its financial results for the 12
months ended December 31, 2018, as approved by the Company’s Board
of Directors on March 22, 2019.
Miguel Sieler, CEO of Neovacs, said: " 2018 was
marked by significant progress in our clinical and preclinical
development programs. The results of the lupus phase IIb study1
have led international scientific experts to reaffirm the
therapeutic potential of our flagship product, IFNα kinoid, to
treat lupus. At the same time, we announced very promising
pre-clinical results with our product IL-4 / IL-13 Kinoid, a
therapeutic vaccine candidate for allergies. This work has been
supported by significant investments and mobilized our teams for
the success of future milestones for society.”
1 Press Release published July 3rd 2018: Neovacs announces the
results of its phase iib study for IFNα kinoid in the treatment of
lupus which allows to proceed with the clinical development into
phase III
KEY 2018 ACHIEVEMENTS
The results of its Phase IIb study for IFNα kinoid in
the treatment of lupus which permitted to proceed with the
clinical development towards Phase III
The biological objective and three out of four clinical
objectives were met:
Highly statistically significant efficacy in reduction of
interferon signature
Lack of statistically significant clinical efficacy measured by
BICLA1 score
Statistical trend on clinical efficacy measured by
SRI-42 with reduction of steroid ≤5mg/day
Statistically significant clinical efficacy on the LLDAS3
score
Favorable safety profile of IFNα Kinoid treatment
Biosense Global exercised its option as
stipulated in the license agreement signed on February 2017 for a
global value of up to 65 million euros.
Biosense Global acquired exclusive rights to develop and
commercialize IFNα Kinoid for the treatment of Lupus in China
Continuation of the development of the IFNα kinoid in
South Korea with our partner Chong Kun Dang (CKD)
pharmaceuticals on the basis of the licensing
agreement signed in December 2015, for a potential overall value of
5M€. This agreement covers the development and the
commercialization of IFNα Kinoid in South Korea for Lupus and
Dermatomyositis indications. Within this agreement both partners
have agreed to prepare the filing for an “ODD” in South Korea,
based on the results of the Phase IIb trial in Lupus with IFNα
Kinoid. Neovacs had already received in 2016 an “Investigational
New Drug” (IND) of South Korean Health authorities to include 5
investigational centers in its global Phase IIb trial for IFNα
Kinoid. Neovacs was able therefore to gain the support of Korean
Opinion Leaders in Lupus for its innovative therapeutic approach
and to include Korean patients in the study.
Neovacs and Centurion Pharma continue their
collaboration in Lupus based on the results of the Phase IIb trial
with IFNα Kinoid Through this contract Centurion Pharma
has acquired an exclusive commercial license for Turkey.
Successful in vivo Proof of Concept for
its IL-4 / IL-13 Kinoid a new Therapeutic Vaccine to treat
Mite-induced Asthma The IL-4 / IL-13 Kinoid, a therapeutic
vaccine from Neovacs' innovative technology is designed to target
allergic diseases such as asthma and food allergies. The results
obtained in this preclinical study show that the vaccine is able to
inhibit bronchoconstriction, and therefore to restore breathing
capacity.
Financing secured from the ANR – The French
National Research Agency – to develop the IL-4/IL-13 kinoid
as an allergy treatment The AllergyVACS project aims to
formulate Kinoid vaccines that neutralize the IL-4 and IL-13
cytokines, providing long-term protection against allergies.
Neovacs issued a press release in December 2018 and filed a patent
with the relevant authorities after obtaining preclinical proof of
concept in an asthma model
Filing of a patent in Europe and the United States for
its therapeutic vaccine candidate kinoid IL-4 / IL-13 for the
treatment of allergies
Strengthened of intellectual property in U.S, Europe,
Russia and Japan, as part of Neovacs’
international development strategy, its patent: “Method for
treating Interferon alpha related conditions”, has been extended to
cover U.S, Europe, Russia, Japan and Hong Kong from previously
being awarded in China and Mexico. This reinforces the intellectual
property portfolio of the IFNα Kinoid vaccine until at least 2032,
as well as the global protection of its technology platform and its
applications.
Appointment of the Clinical Advisory board to design the
Phase III study for IFN-k in lupus This CAB under
the Chairmanship of Pr Frédéric Houssiau was held in Paris on the
11th of February 2019.
Appointments to the Executive Committee
Vincent Serra, PhD is appointed Chief Scientific Officer.
Valerie Salentey, Pharm D, is appointed Head of Regulatory
Affairs
FULL-YEAR 2018 FINANCIAL
RESULTS
Summary financial information
In 000’s Euros |
December 31st 2018 |
December 31st 2017 |
Revenues |
145 |
|
834 |
|
Operating Costs |
13 225 |
|
19,163 |
|
of which R&D |
10 591 |
|
16 475 |
|
Operating income/(loss) |
(13,080 |
) |
(18,329 |
) |
Financial results |
(473 |
) |
(636 |
) |
Operating income before tax |
(13,552 |
) |
(18,965 |
) |
Non recurring result |
(3 |
) |
105 |
|
Research tax credit |
(2,775 |
) |
(4,022 |
) |
Net income/(loss) |
(10,780 |
) |
(14,838 |
) |
KEY ELEMENTS OF THE FULL YEAR 2018 RESULTS
For the year ended December 31st 2018, Néovacs recorded an
operating loss of €13.1 million compared to a loss of €18.3 million
in 2017. This reduction in the operating loss (+€5.2m) is in
line with the development plan reflecting a 31% drop in operating
costs following completion of the Phase IIb clinical study for
which the results were announced on July 3rd 2018. Indeed,
R&D expenditure of €10.6 million (which represents 80% of
operating costs) were for the most part (62%) directed towards
clinical development costs.
In parallel, the company continued to maintain strict control
over SG&A costs. Administrative expenditure amounted to €2.6
million representing 20% of operating costs and headcount remained
stable for the year at 25.
Financial results showed a small improvement (€0.2 m) as a
result of amortization of early bond redemption premiums.
At the net income level, Néovacs reduced the net loss by €4.1
million to €10.8 million compared to a loss of €14.9 million in
2017.
THE FINANCIAL SITUATION AS AT DECEMBER 31ST
2018
As at December 31st, 2018, the cash position
amounted to €1.4 million compared to €5.1 million at the end of
2017. The cash consumption in 2018 was essentially
attributable to the funding of the completion of key R&D
programs such as delivering the results for the main Phase IIb
study and the in vivo Proof of Concept for IL-4 / IL-13 Kinoid to
treat asthma.
Since the beginning of 2019 however, the
financial structure has been significantly reinforced by the:
€2 million
received from the drawdown against the equity financing line
provided by Kepler Cheuvreux (Equity Line 3)
€10 million convertible bond issuance spread over 24 months (Ornane
– bond convertible into new or existing shares or refundable in
cash) without warrants.
Based on R&D cost forecast, the company is
financed for the next 12 months. These will focus on
financing the progress of the patients already treated as part of
the 5 year follow up program included in the protocol for the Phase
IIb study and the potentially value creating Kinoid preclinical
studies for Type 1 diabetes and allergies.
The full annual financial report for 2018 will
be published and filed with the market authorities AMF on April
30th 2019. It will be available on the company’s website
(www.neovacs.fr)
About NeovacsListed on Euronext
Growth Paris since 2010, 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 four 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 and dermatomyositis. Neovacs
is also conducting preclinical development works on other
therapeutic vaccines in the fields of auto-immune diseases,
oncology, allergies and Type 1 diabetes. 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.
www.neovacs.fr
Contacts
NEOVACS – Corporate Communication & Investor
RelationsCharlène Masson+33 (0)1 53 10 93
00cmasson@neovacs.com
NEWCAP- Press relations
Annie-Florence Loyer +33 1 44 71 00 12 / + 33
6 88 20 35 59afloyer@newcap.fr
Léa Jacquin +33 1 44 71 20 41 /
+33 6 58 14 84 66ljacquin@newcap.fr
ORPHEON FINANCEFinancial Communication and Investor
Relations
James Palmer+33 7 60 92 77 74j.palmer@orpheonfinance.com
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