PRESS RELEASE
· PRESS RELEASE · PRESS RELEASE
HALF-YEAR 2018
FINANCIAL RESULTS
-
STRENGTHENED CASH POSITION: €4.7 M AT JUNE 30 2018 VS
€1.7 M AT JUNE 30 2017
-
LOWER OPERATING COSTS, CONSISTENT WITH THE END
OF THE IFNalpha KINOID PHASE IIB STUDY FOR LUPUS
TREATMENT
-
NET LOSS REDUCED BY 25%
-
2019 DEVELOPMENT PLAN CONFIRMED
Paris, Boston,
October 30, 2018, 05h50pm CET - NEOVACS (Euronext Growth Paris :
ALNEV), a leader in active immunotherapies for the
treatment of autoimmune diseases, provided today business update
and reported its financial results for the six-months ended June
30, 2018, approved by the Board of Directors on October 30,
2018.
Miguel Sieler, CEO of
Neovacs, commented: "The end of the first half
2018 was marked by the publication of the clinical results of the
IFNalpha Kinoid
Phase IIb study for lupus treatment. With these results validating
our technology, Neovacs has received the endorsement of the
scientific community and its international licensees enabling us to
pursue the development of the vaccine. We are now working on the
preparatory requirements to conduct the international Phase III
study for this treatment. At the same time, we continue to pursue
the development of our preclinical programs to treat type 1
diabetes with IFNalpha Kinoid and allergies with Kinoid IL4/IL13."
Neovacs' objective for 2019
remains the publication of the results of the preclinical programs,
the signature of a new partnership for IFNalpha Kinoid to
treat lupus and the filing of an Orphan Drug Designation (ODD) in
South Korea, all in line with the development plan.
FIRST HALF 2018
RESULTS
The company's accounts for the
first half ending June 30, 2018 have been established according to
French GAAP and have been partially reviewed by the auditors and
approved by the Board of Directors on October 30, 2018.
Summary financial
information
| In 000's Euros |
June 30 2018 |
June 30 2017 |
| Revenues |
19 |
512 |
| Operating Costs |
6,640 |
10,755 |
| of which R&D |
5,161 |
9,351 |
| Operating income/(loss) |
(6,621) |
(10,244) |
| Financial results |
(582) |
(36) |
| Operating income before tax |
(7,203) |
(10,280) |
| Non recurring result |
(429) |
69 |
| Research tax credit |
(1,535) |
(2,086) |
| Net income/(loss) |
(6,096) |
(8,125) |
KEY HIGHLIGHTS OF THE FIRST
HALF 2018 RESULTS
The net loss was reduced by 25 % to €(6,1)m vs
€(8,1)m at June 30 2018.
The operating costs dropped by
40% compared to the first half of 2017, in line with published
forecasts. This reduction was consistent with the end of primary
Phase IIb clinical study for IFNalpha Kinoid in the treatment
of lupus. (The patients forming part of the active study will now
be followed over a 'long term study'). In parallel Neovacs
continues to invest in R&D for its clinical and preclinical
programs (IL4/IL 13 Kinoid for allergy treatment and
IFNalpha Kinoid for type 1 diabetes) and to pursue
pharmaceutical development in anticipation of Phase III and
commercialization. R&D expenditure continue to represent the
vast majority of the company's operating costs (78%) which also
enabled Neovacs to benefit from a significant research tax
credit during the period of €1, 5 m. At the same time, SG&A
costs were strictly controlled.
The financial results increased
to a charge of €582k vs €36k as a consequence of the cost of bond
redemption. Non-recurring items amounted to €429k due to the impact
of early bond conversion versus €69k in H1 2017.
STRENGTHENING OF
THE FINANCIAL SITUATION AS AT JUNE 30 2018
The cash position of €4.7m as at
June 30, 2018 is a significant improvement on the situation at the
end of June 2017 which stood at €1.8m, and remains solid versus
December 31 2017 (€5.1m). The financial structure was strengthened
during the first quarter 2018 through the issue of convertible bond
of € 3.8m placed with three European investors (maturity February
26, 2020). In addition, the company realized a €1.0m private
placement rights issue with two French institutional investors.
At June 30, 2018 Neovacs'
financial runway extends until the second quarter 2019, taking into
account the cash in hand of €4.7 m, the pre-financed Research tax
credit booked in H1 2018 of €1.5 m and the balance remaining on the
third and final financing facility with Kepler Cheuvreux of €5.0
m.
MAIN ACHIEVEMENTS IN THE FIRST HALF 2018
Strengthen 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 IFNalpha Kinoid vaccine until at
least 2032, as well as the global protection of its technology
platform and its applications.
Positive data
review from Last IDSMB, prior to Final Results of Phase IIb
clinical trial of IFNalpha Kinoid in
Lupus published in July 2018. The
committee inspected the data from the 185 patients recruited who
received the complete IFNalpha Kinoid vaccine or placebo
(ratio 1:1) according to the dosage criteria defined in the
protocol of the study. Following this review of tolerance and
safety data, the iDSMB recommended that the study be pursued with
no changes to the protocol.
UPCOMING
MILESTONES
Neovacs confirms its objectives following the
publication of the results of its phase IIb clinical study
published in the second half of 2018, in particular:
Finalization of a global
partnership for IFNalpha Kinoid in
lupus and DM, The Company is pursuing its discussions to obtain
a licensing partnership with a pharmaceutical group in view to
secure the Phase III development and future
commercialization of its IFNalpha Kinoid vaccine for the
treatment of lupus.
Obtain validation by Health
authorities in the U.S and in Europe of the Phase III clinical
program for lupus, notably following the publication of Phase IIb
results of IFNalpha Kinoid for lupus,.
File ODD request in South Korea
with our partner CKD. This is the only country where
lupus meets the conditions to be considered as an orphan
disease. Following the publication of the Phase IIb results
for lupus treatment with IFNalpha Kinoid, Neovacs and CKD plan
to file in South Korea a "Orphan Drug Designation" file. ODD
certification will allow CKD to request the registration of the
product with the health authorities. Once registered, the
commercialization of the product could be launched in South Korea
without the need to carry out a Phase III study.
Pursue and complete the ongoing
preclinical programs for IFNalpha Kinoid in
the treatment of Type 1 diabetes and IL4/IL13 Kinoid against
allergies.
The half year
report is available on Neovac's website, www.neovacs.fr
About
Neovacs
Listed 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 IFNalpha
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
Relations
Charlène Masson
+33 (0)1 53 10 93 14
cmasson@neovacs.com
NEWCAP-
Media
Annie-Florence Loyer
+33 1 44 71 00 12 / + 33 6 88 20 35 59
afloyer@newcap.fr
Léa Jacquin
+33 1 44 71 20 41 / +33 6 58 14 84 66
ljacquin@newcap.fr
ORPHEON FINANCE -
Financial Communication and Investor Relations
James Palmer
+33 7 60 92 77 74
j.palmer@orpheonfinance.com
Press release
This
announcement is distributed by West Corporation on behalf of West
Corporation clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: NEOVACS via Globenewswire
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