DGAP-News: Neovacs S.A. / Key word(s): Final Results
NEOVACS REPORTS FIRST-HALF 2015 FINANCIAL RESULTS
02.10.2015 / 08:00
---------------------------------------------------------------------
Press Release
NEOVACS REPORTS FIRST-HALF 2015 FINANCIAL RESULTS
Paris and Boston, October 2, 2015 - NEOVACS (Alternext Paris: ALNEV), a
leader in active immunotherapies for the treatment of autoimmune diseases,
today announced its results for the six months ended June 30, 2015, as
approved by the Board of Directors on October 1, 2015.
MAIN OPERATIONAL MILESTONES SINCE JANUARY 2015
- Initiation of Phase IIb clinical trial of IFNα-Kinoid to treat Systemic
Lupus Erythematosus (« SLE ») or lupus, based on promising preclinical
and clinical results to-date;
- Extension of IFNα-Kinoid development program to include
dermatomyositis, an orphan condition where a positive IFNα signature
plays a decisive role, following a recommendation by Neovacs'
Scientific Advisory Board (SAB);
- Formation of a Neovacs U.S. subsidiary to strengthen the Company's
presence in the country and expand clinical activity beyond the EU to
the U.S. market ;
- Significant strengthing of Company's cash position following a
successful capital increase subscribed by U.S. institutional investors.
Cash and cash equivalents totaled EUR12.3 million as of June 30, 2015.
"In first half of 2015, we actively pursued the development of IFNα-Kinoid,
our lead active immunotherapy product while maintaining tight control on
expenses. The funds we raised during June in the U.S. have strengthened our
cash position and given us the means to move forward on two key programs
for IFNα-Kinoid: first in SLE with the launch of IFN-K-002, a Phase IIb
clinical trial of IFNα-Kinoid ; secondly in dermatomyositis with a Phase
I/IIa trial expected to commence in the first half of 2016." commented
Miguel Sieler, CEO of Neovacs.
HALF-YEAR 2015 FINANCIAL HIGHLIGHTS
<pre>
in KEUR June 30, 2015 June 30, 2014
Revenues 94 57
Operating costs 5,714 4,576
Of which R&D 4,724 3,594
Operating profit/loss -5,620 -4,518
Net financial income/expense -205 -64
Pretax profit/loss -5,825 -4,582
Exceptional items -48 49
Research Tax Credit 1,003 673
Net profit/loss -4,870 -3,861
</pre>
Anticipated increase in R&D costs with the inititation of IFN-K-002
clinical trial in SLE
Operating costs were EUR5.7 million for the six months ended June 30, 2015,
a 25% increase compared to the period ended June 30, 2014. This increase
was primarily the result of the initiation of the Phase IIb clinical trial
of IFNα-Kinoid in SLE. R&D expenses were 82% of the Company's total
operating costs for the first half of 2015, totaling EUR4.7 million
compared to EUR3.6 million in the same period last year. General and
administrative expenditures remained under tight control while Neovacs
increased focus on its emerging R&D effort.
Consequently, half-year operating losses increased 24% to EUR5.6 million,
in line with Company expectations. This compares to EUR4.5 million in
operating losses in the first half of 2014.
After taking into account EUR1 million in Research Tax Credit, the net
loss for the six months ended June, 30 2015 was EUR4.8 million compared to
EUR3.9 million for the same period in 2014.
Significant strengthening of financial resources
Neovacs raised EUR7.5 million in June 2015 through a capital increase
subscribed by three U.S. institutional investors. The funds raised
significantly improved the Company's cash position and strengthened its
financial visibility.
To address its long term financing needs, Neovacs secured a flexible,
multiyear equity financing with Kepler Cheuvreux in November 2014. As
stated previously, this 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. However, Neovacs has
committed not to use this equity financing until after December 31, 2015.
As a result, available cash balances as of June 30, 2015 were EUR12.3
million, compared to EUR2.9 million as of June 30, 2015. Neovacs believes
it has the financial resources to cover its expenditures until September
2016. To increase its cash runway, the Company reserves the possibility to
utilize the 3rd tranche of optional equity financing set up with Kepler
Cheuvreux.
HALF-YEAR 2015 CLINICAL AND OPERATIONAL HIGHLIGHTS
- New members joined Neovacs' Scientific Advisory Board (SAB) to support
the shift in therapeutic focus, with a greater emphasis on pathologies
targeted by IFNα-Kinoid and VEGFα-Kinoid. Professor Banchereau, Ph.D.,
remained SAB chairman. The SAB guides Neovacs' clinical development
strategy.
- Preparation of IFN-K-002, a Phase IIb trial to assess the biological
efficacy and clinical response of IFNα-Kinoid in moderate to severe
forms of SLE in 19 countries in Europe, Asia and Latin America. The
Company plans to file an IND for a trial in SLE with IFNα-Kinoid (Phase
IIa) in the U.S. in early 2016.
- Expansion IFNα-Kinoid's clinical program to dermatomyositis, an orphan
indication in which a positive IFNα signature plays a decisive role.
Neovacs plans to conduct a multi-center Phase I/IIa trial of
IFNα-Kinoid in adult dermatomyositis in 30 patients in 2016.
- Strengthening of U.S. presence with the formation of a wholly-owned
U.S. subsidiary, Neovacs, Inc., headquartered in Boston. The role of
Neovacs, Inc. will be to raise the profile of the Company within the
medical and financial communities in the U.S.. Neovacs, Inc. will work
directly with the U.S. Food and Drug Administration as the Company
prepares to initiate clinical trials in the U.S.
- Collaboration agreement with Stellar Biotechnologies. The two companies
entered into an expanded supply agreement to meet Neovacs' requirements
for Keyhole Limpet Hemocyanin (KLH), a primary component of Neovacs'
proprietary Kinoid immunotherapy technology, for its planned clinical
trials and for expected commercial manufacturing of IFNα-Kinoid.
SUBSEQUENT EVENTS AND OUTLOOK
- Initiation of Phase IIb clinical trial in SLE. Neovacs has begun
enrolling patients in IFN-K-002, a Phase IIb clinical trial to evaluate
the efficacy of IFNα-Kinoid in SLE, after being granted first approvals
by regulatory agencies and ethics commitees in several European
countries. The first centers of the trial are now active. Results of
the clinical trial are expected in the first quarter of 2017.
- Presentation of extended follow-up data of IFNα-Kinoid in SLE during
Lupus 2015, the 11th International Congress on Systemic Lupus
Erythematosus (SLE), which took place from September 2-6, 2015 in
Vienna, Austria [1]. Collected as part of the extended follow-up study
of the Phase I/IIa trial of IFNα-Kinoid in lupus, this new data
demonstrates that IFNα-Kinoid induces a lasting, polyclonal, neutralizing
anti-IFNα response in SLE patients.
[1]J. Ducreux, et Al, Lupus 2015, Poster Session P04 Treatment.
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 indications of lupus and dermatomyositis. 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 - Investor Relations
Nathalie Trépo
+33 (0)1 53 10 93 00
ntrepo@neovacs.com
Investor Relations / Financial Communications - NewCap
Valentine Brouchot / Pierre Laurent
+33 (0)1 44 71 94 94
neovacs@newcap.fr
Investor Relations / Financial Communications Germany - MC Services
Raimund Gabriel
+49-89-21-02-28-30
raimund.gabriel@mc-services.eu
Press / U.S. Inquiries - The Ruth Group
Lee Roth
+1-646-536-70-23
lroth@theruthgroup.com
---------------------------------------------------------------------
02.10.2015 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
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
---------------------------------------------------------------------
399469 02.10.2015
DGAP-News: NEOVACS REPORTS FIRST-HALF 2015 FINANCIAL RESULTS
| Source: EQS Group AG