4SC AG — Earnings Release 2009

May 15, 2009

News Details

Corporate | 15 May 2009 08:30

4SC AG publishes financial results for the first quarter 2009

4SC AG / Quarter Results

Release of a Corporate News, transmitted by DGAP - a company of EquityStory
AG.
The issuer / publisher is solely responsible for the content of this announcement.

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Planegg-Martinsried, 15 May 2009 - The Martinsried-based drug discovery and
development company 4SC AG (Frankfurt, Prime Standard: VSC) today published
its results according to IFRS (International Financial Reporting Standards)
for the first quarter 2009, which ended on 31 March 2009.

Highlights of the first quarter 2009:

* Begin of clinical phase II for lead compound 4SC-101 for a second
indication (Crohn's disease)
* Preparations underway for second phase II trials of 4SC-101 for
rheumatoid arthritis
* Successful completion of clinical phase I for cancer drug 4SC-201
* Liver carcinoma (HCC) selected as first indication for phase II study of
4SC-201 beginning shortly

Quarterly results

For the first quarter of 2009, 4SC AG posted sales of 0.5 million EUR from
research collaborations, down 21% from 0.6 million EUR for the same period
in the prior year. The significantly increased number of own pipeline
projects was accompanied by raising direct costs for development as well as
an expansion of personnel resources in the development department.
Consequently, research and development costs rose correspondingly by over
70% to 3.4 million EUR (first quarter 2008: 2.0 million EUR).

As anticipated, the operating loss rose from 2.3 million EUR in Q1 2008 to
3.9 million EUR. The net loss for the quarter after taxes increased from
2.2 million EUR to 3.7 million EUR. As the number of shares outstanding
increased significantly from averaged 19.0 to 28.5 million as a result of
last year's capital increase, diluted and undiluted earnings per share were
nearly unchanged at -0.13 EUR versus -0.12 EUR year-on-year. At the end of
the quarter funds totalled 17.4 million EUR (31 December 2008: 21.8 million
EUR). The equity ratio increased from 90.4% at 31 December 2008 to 92.1% at
the end of the reporting period.

Dr Ulrich Dauer, CEO of 4SC AG, commented: 'We made further clinical
progress last quarter thanks in part to our solid cash position. The
advances made attest to the value of the drug candidates acquired last
year. At the same time, we implemented further value-enhancing measures in
our development pipeline. Patient recruiting has begun for the phase IIa
study of 4SC-101 for a second indication, chronic inflammatory bowel
disorders. We are working intensively to ready the oncology project 4SC-201
for the start of the proof-of-concept studies on two types of cancer this
year. While the number of research projects has risen, our expenditures
will be focused exclusively on value-driving research and development so as
to ensure utilising our cash reserves as efficiently as possible.'

Efficacy studies for clinical candidates 4SC-101 and 4SC-201

During the period under review the clinical phase IIa proof-of-concept
study of 4SC-101 was initiated for chronic inflammatory bowel disease
(Crohn's disease). In this multicentric, single-arm, exploratory open-label
study, the candidate will be administered in pill form to 24 patients over
a 12-week period in a 35 mg dose. To date, available treatment options for
Crohn's disease have been inadequate. Thus the commercial potential of
4SC-101 will be considerable in the event of clinical success.

Simultaneously, the company made progress in preparations for a second
phase II study for rheumatoid arthritis (RA). The objective of this
randomised, placebo-controlled and blind study is to provide
proof-of-concept for the use of 4SC-101 in combination with the standard
medication Methotrexat (MTX) by RA patients as opposed to using MTX as a
monotherapy. In the first quarter of 2009, the necessary toxicological
studies of 4SC-101 in combination with MTX were concluded, meaning the new
set of trials can be filed for within the next few months.

Preparations are likewise underway for the start of the first phase II
study of 4SC-201, one substance of the Nycomed oncology pipeline acquired
in July 2008. These included the evaluation of data in the first quarter
2009 from the successfully completed phase I study. The results indicated a
stabilising of the progression of the disease with several patients with
different types of tumours. Based on these findings, 4SC AG selected
hepatocellular carcinoma (HCC) as the first indication for clinical phase
II trials. This type of liver cancer is world's third most frequent cause
of cancer mortality. With the drug Nexavar being the only approved
medication for the systemic treatment of advanced liver carcinoma at this
time, there is a tremendous need for new treatment options.

4SC AG also achieved improvements in the quarter facilitating the
advancement of clinical pipeline projects on a broad front. Four
preclinical development projects are in advanced preliminary phases for
submission of a clinical study plan. Preparations are furthermore underway
for the clinical start of 4SC-203 for acute myeloid leukaemia (AML), a
particularly aggressive form of blood cancer.

Outlook

The 4SC AG business strategy is designed specifically around developing
proprietary projects up to proof of clinical efficacy, at which point we
license them to partners in the pharmaceutical industry on attractive
financial terms. In view of the current situation on the financial markets,
the company will be even more diligent in the selective deployment of
financial resources for concrete value-enhancing measures in ongoing as
well as new clinical programmes. The company continues to enjoy the active
support and professional expertise of our largest shareholder Santo Holding
in communicating the sustainability of our business model to international
investors.

In the weeks ahead we look forward to the start of clinical phase II
studies for 4SC-201 for liver carcinoma. In the second quarter all
regulatory requirements for 4SC-101 should be met for the initiation of a
second phase II study for rheumatoid arthritis. This development program is
designed to demonstrate potentially enhanced efficacy of 4SC-101 in
combination with Methotrexat, with good tolerability, versus monotherapy
with Methotrexat. Also this year the company intends to enter clinical
phase I for either one ortwo other substances.

The full interim report was posted today on our website, www.4sc.com.

Teleconference and webcast

Today at 11 AM local time (10 AM GMT), 4SC AG will be holding a public
teleconference in English. Company management will be discussing the
financial results posted and significant developments in the first quarter
of 2009.

To participate in the teleconference, in Europe dial +49 (0)89 2030 3245 or
+44 (0)20 7138 0838; from the US dial +1 718 354 1362 (from other countries
just dial one of the D/UK/US numbers).

The required access code is 2414416.

We recommend dialling in 10 minutes prior to the start time.

An accompanying presentation is accessible on the internet at
http://www.euvisioncast.com (Meeting ID: 2414416; Meeting Password:
pw1830).

After the live presentation, an audio replay of the teleconference will be
made posted on our website www.4sc.de under the heading 'Investors'.

About 4SC AG:
4SC AG (ISIN DE0005753818) has been listed in the Prime Standard of
Frankfurt Stock Exchange since 15 December 2005. Founded in 1997 and now
with a staff of 90 employees, the company develops novel drug candidates
against inflammatory diseases and cancer. 4SC AG utilises its patent
protected platform, to create a sustainable project pipeline of drug
candidates, which are to be developed up to clinical efficacy in early
clinical phases ('proof of concept') and subsequently partnered with the
pharmaceutical industry in return for advance and milestone payments as
well as royalties. There are currently eight projects in the development
pipeline and a rich pool of further discovery projects. Clinical phase IIa
for the first project for the treatment of rheumatoid arthritis has already
successfully been completed and a clinical phase II trial in IBD (Crohn's
disease) has recently been started. An additional project for the treatment
of various cancers has successfully completed a clinical phase I trial and
will commence clinical phase II testing shortly. Further projects are in
advanced pre-clinical stages.
Further information is to be found at www.4sc.com.

Legal Note
This document may contain projections or estimates relating to plans and
objectives relating to our future operations, products, or services; future
financial results; or assumptions underlying or relating to any such
statements; each of which constitutes a forward-looking statement subject
to risks and uncertainties, many of which are beyond our control. Actual
results could differ materially, depending on a number of factors.

For more information please contact:
MC Services
Stefan Riedel
Tel.: +49 (89) 21 02 28 40
eMail: stefan.riedel@mc-services.eu

15.05.2009 Financial News transmitted by DGAP

Language: English
Issuer: 4SC AG
Am Klopferspitz 19a
82152 Martinsried
Deutschland
Phone: +49 (0)89 7007 63-0
Fax: +49 (0)89 7007 63-29
E-mail: public@4sc.com
Internet: www.4sc.de
ISIN: DE0005753818
WKN: 575381
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart

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