ERRATUM: NEOVACS PROVIDES BUSINESS UPDATE AND ANNOUNCES HALF-YEAR 2017 FINANCIAL RESULTS
(Thomson Reuters ONE) -
This is a correction of the announcement from 17:45 27.10.2017 CEST. Reason for
the correction:the release date of the data for Type 1 Diabete preclicical proof
of concept remains unchanged compared to previous annoucements, Neovacs will
publich these data before the end of 2017.*
PRESS RELEASE · PRESS RELEASE · PRESS RELEASE
NEOVACS PROVIDES BUSINESS UPDATE AND ANNOUNCES HALF-YEAR 2017 FINANCIAL RESULTS
* COMPLETED PATIENT ENROLLMENT IN PHASE IIb CLINICAL STUDY OF IFNalpha KINOID
FOR TREATMENT OF LUPUS
* RECEIVED U.S. FDA APPROVAL TO EXPAND ITS PHASE I/IIa CLINICAL STUDY WITH
IFNalpha KINOID FOR TREATMENT OF DERMATOMYOSITIS
* STRENGTHENED BALANCE SHEET THROUGH TWO TRANSACTIONS RESULTING IN
APPROXIMATELY ?10 MILLION
Paris, October 27, 2017, 5:45pm CET - NEOVACS (Alternext Paris: ALNEV PEA-PME
eligible), a leader in active immunotherapies for the treatment of autoimmune
diseases, provided today a business update and announced its financial results
for the six-months ended June 30, 2017, as approved by the Company's Board of
Directors on October 27, 2017.
Miguel Sieler, CEO of Neovacs, said: "During the first half of 2017, Neovacs
completed patient enrollment of its Phase IIb clinical trial in lupus. Our
priority is now to obtain the results from this study in June 2018. The company
also obtained approval from the U.S. Food & Drug Administration to extend to
the United States the Phase I/IIa clinical trial of IFNalpha Kinoid for an
additional indication, dermatomyositis. We believe these clinical development
milestones confirm the vast potential of IFNalpha Kinoid in multiple
indications. in this context we recently completed a successful $6 million
private placement with biotech-focused U.S. institutional investors. This has
significantly strengthened the Company's financial position, the funds will be
utilized to accelerate our robust R&D efforts."
KEY RECENT ACCOMPLISHMENTS
- Completed patient enrollment in phase the IIb clinical study of
IFNalpha Kinoid in lupus. 185 patients have been enrolled in this trial, and
top-line results are currently expected in the second quarter of 2018.
- Third positive data review by IDSMB follows completion of patient recruitment
in phase IIb lupus trial. The board reviewed the cumulative safety data,
identified no safety concerns and recommended the continuation of the study
without modification.
- Obtained U.S. FDA approval to conduct a Phase I/IIa study of IFNalpha Kinoid
in dermatomyositis. This clinical trial is expected to enroll 30 patients in
Europe and the U.S.
- Neovacs signed a license agreement with Centurion pharma to market IFN-Kinoid
for the treatment of lupus and dermatomyositis in Turkey
- Building of a strategic position in China, the world's 2(nd) largest
pharmaceutical market. Formed a partnership with Biosense Global for the
development and commercial rights for IFNalpha Kinoid for lupus and
dermatomyositis in China and other selected territories.
Neovacs was also granted a new patent from the Chinese Patent Office (SIPO),
titled: "Method of treatment of a disease related to the overexpression of
IFNalpha".
- Entered into collaboration with Sunnybrook Research Institute of Toronto,
Canada. This collaboration is focused on preclinical development of Neovacs'
VEGF Kinoid.
- First positive immunogenicity results for IFNalpha Kinoid in an animal model
of type-1 diabetes. Neovacs observed in treated NOD-Mice a significant level of
anti-interferon Alpha neutralizing antibodies. This study is conducted by
Neovacs in collaboration with Dr. Agnès Lehuen and Professor Christian Boitard
from the department of Immunology of Diabetes at the Hospital Cochin in Paris.
Additional preclinical proof-of-concept data are expected by year-end 2017.*
- Presented Kinoid technology and updates on clinical programs at Keystone
Symposia Conference.
EXPECTED UPCOMING MILESTONES
- Results of the phase IIb clinical study with IFNalpha Kinoid to treat Lupus
expected in Q2 2018. This fully-enrolled phase IIb trial is a randomized,
placebo-controlled, multicenter study in systemic lupus erythematosus (LES)
(study IFN-K-002). The objective of this study is to evaluate the biological and
clinical efficacy of IFNalpha Kinoid, the most advanced product candidate in
Neovacs' pipeline, in patients with moderate to severe Lupus. The trial is
currently taking place in 21 countries across Latin America, Asia, Europe, North
Africa, and the U.S.
- Conclude preclinical proof of concept studies with IFNalpha Kinoid for the
treatment of type-1 diabetes. The Company reported initial positive
immunogenicity data for IFN Kinoid in a relevant mice model for type-1
diabetes. Additional preclinical proof-of-concept data are expected by year-end
2017.*
- Accelerate patient enrollment in Phase I/IIa clinical study of IFNalpha Kinoid
in dermatomyositis following recent FDA acceptance of the IND to expand the
Phase I/IIa study into the U.S. The study is currently enrolling patients in
European countries. This multicenter, single blind study plans to enroll 30
patients in Europe and the U.S.
HALF-YEAR 2017 RESULTS
Summary financial information
--------------------------------------------------------
In K? June 30, 2017 June 30, 2016
--------------------------------------------------------
Revenues 512 104
--------------------------------------------------------
Operating costs 10,755 7,971
--------------------------------------------------------
of which, R&D 9,351 6,213
--------------------------------------------------------
Operating profit/loss (10,244) (7,868)
--------------------------------------------------------
Financial Results -36 -42
--------------------------------------------------------
Pretax profit/loss -10,280 -7,910
--------------------------------------------------------
Exceptional items 69 -41
--------------------------------------------------------
Research tax credit -2,086 -1,171
--------------------------------------------------------
Net profit /loss -8,125 -6,779
--------------------------------------------------------
KEY FIRST HALF 2017 FINANCIAL RESULTS
In the first half of 2017, the company received a payment of ?0.5M, following
the signing of an option to license contract with Biosense Global LLC, with a
total value of ?65 million.
In line with previously issued guidance, the Company's operating expenses
increased by 30% compared to June 30, 2016. This increase is the natural
consequence of significant R&D investments in all ongoing clinical and
preclinical development programs. This includes also costs associated with the
optimization of the production process for IFNalpha Kinoid in view of the
expected phase III study in lupus.
In order to support these R&D investments and in line with our strict financial
management policy, the Company reduced its administrative costs, which now
represent just 13% of operating expenses, compared to 22% on June 30, 2016.
R&D expenses in the first half of 2017 were supported by the 78% increase in
research tax credit payments, compared to the first half of 2016.
CASH POSITION
The Company's available cash and cash equivalents at June 30, 2017, amounted to
?1.8 million. However, this position increased significantly during the third
quarter of 2017 through the following:
* Successful capital increase with US institutional investors: ? 6 million
* Research tax credit: ?2 million
The Company still has available the full third line of financing through its
equity line agreement with Kepler Cheuvreux for a total amount of ?6.5 million.
The funds raised to date in 2017 and the capital available from the research tax
credit and the third line of financing from the equity line, are expected to
sufficiently support the company's strategic plans through June 2018.
The half-year financial results report is also available on the Neovacs website,
www.neovacs.fr/en/, section "Investors".
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 five 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(at)neovacs.com
NEWCAP- Press relations
Annie-Florence Loyer
+33 1 44 71 00 12 / + 33 6 88 20 35 59
afloyer(at)newcap.fr
Léa Jacquin
+33 1 44 71 20 41 / +33 6 58 14 84 66
ljacquin(at)newcap.fr
LIFESCI ADVISORS- Investor Relations / Financial Communications
Chris Maggos
+41 79 367 6254
chris(at)lifesciadvisors.com
Press release:
http://hugin.info/160718/R/2145599/822511.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions 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
Unternehmensinformation / Kurzprofil:
Datum: 30.10.2017 - 11:00 Uhr
Sprache: Deutsch
News-ID 565733
Anzahl Zeichen: 11440
contact information:
Town:
Paris
Kategorie:
Business News
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