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WILEX AG: Innovative Cancer Therapies

WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

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Page 1: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

WILEX AG: Innovative Cancer Therapies

Page 2: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

2

Forward looking statements

This communication contains certain forward-looking statements, relating to the Company’s business, which canbe identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “will”“should” “future”, “potential” or similar expressions or by general discussion of strategy, plans or intentions ofthe Company. Such forward-looking statements involve known and unknown risks, uncertainties and otherfactors, which may cause our actual results of operations, financial condition, performance, or achievements, orindustry results, to be materially different from any future results, performance or achievements expressed orimplied by such forward-looking statements.

Such factors include, among others, the following: uncertainties related to results of our clinical trials, theuncertainty of regulatory approval and commercial uncertainty, reimbursement and drug price uncertainty, theabsence of sales and marketing experience and limited manufacturing capabilities, attraction and retention oftechnologically skilled employees, dependence on licenses, patents and proprietary technology, dependenceupon collaborators, future capital needs and the uncertainty of additional funding, risks of product liability andlimitations of insurance, limitations of supplies, competition from other biopharmaceutical, chemical andpharmaceutical companies, environmental, health and safety matters, availability of licensing arrangements,currency fluctuations, adverse changes in governmental rules and fiscal policies, civil unrest, acts of God, actsof war, and other factors referenced in this communication.

Given these uncertainties, prospective investors and partners are cautioned not to place undue reliance on suchforward-looking statements. We disclaim any obligation to update any such forward-looking statements toreflect future events or developments. RENCAREX® is a temporary development name.

This material is not intended as an offer or solicitation for the purchase or sale of shares of WILEX AG. This materialmay not be distributed within countries where it may violate applicable law.

Page 3: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

3

WILEX at a glance

Multi-drug

product

portfolio

Balanced R&D pipeline of which 2 compounds

are in pivotal registration Phase III trials

Strong IP Portfolio

Value

driven

strategy

Oncology focussed

Patient focussed therapies

targeting markets with high unmet medical need

Commercialisation through partnerships and alliances

Operational

excellenceExperienced management and staff with complementary backgrounds

and proven track record

Strong

financial

basis

Positioned for growth:

listed on Prime Standard of Frankfurt Stock Exchange

Page 4: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

4

Prevention of

Metastasis

after surgery

Treatment of

metastatic disease

Cancer disease life cycle

Patient selection for therapy

WILEX addresses markets

with high unmet medical need

… and patient focussed disease management

Diagnosis of

tumour

malignancy

Phase III

CA9-SCAN

Phase II

RENCAREX®

+ ILN / IFN

Phase II

WX-671

Phase III

RENCAREX®

Phase II

WX-671

Page 5: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

5

Broad late-stage oncology portfolio

Phase III

CancerWX-77x

~700,000

Pancreascancer

Breastcancer

WX-671

~338,000CA9-SCAN

(therapy guidingimaging agent)

~ 100,000-138,000

~ 43,000- 52,000

RCC*

Met. RCC

RENCAREX®

RENCAREX®

+ IFN / ILN2

Cases p.a.ApprovalPhase IIPhase IPre-clinicalIndicationProduct

*non-metastatic

**planned

Renal

mass

Head &

neck

cancer**

Page 6: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

6

RENCAREX®: tumour specific antibody

in Phase III development

U.S. and the EU in the indication RCCOrphan Drug

Status

ADCC (Antibody-Dependent-Cellular-Cytoxicity),

mode of action with proven track recordMode of Action

CA IX antigenTarget

Renal cell cancer (RCC)Indication

Chimeric monoclonal antibodyCompound

Class

Renal, bladder, head & neck, breast and colon cancerPotential

indications

RENCAREX® showed good safety, tolerance and

efficacy in Phase I and Phase II studies.

Development

status

Page 7: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

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RENCAREX® Phase III study design approved by

FDA (IND) and EMEA (scientific advice)

For European filing expected end 2008 at the earliestResults

Disease-free survival objectively determined by e.g. computer tomography

Study end

point for

approval

Post surgical treatment of RCC to prevent metastatic RCC;

Patients who, prior to surgery, have large tumours, lymph node involvement, blood

vessel infiltration or highly aggressive tumours

Indication

International double-blind placebo controlled Phase III study ongoing;

More than 160 sites in North and South America and Europe initiatedStudy design

856 patients targeted for enrolment;

Over 80% enrolled to dateEnrolment

Page 8: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

8

Patient withsymptoms Urologist

CT Scan

CA9-SCAN: State-of-the-art molecular

imaging of cancer

Today

Surgery

CA9-SCAN

Follow-up

(Diagnosis)

Clear cell

RCC

Renal

mass

positive

negative

Patient withsymptoms

Urologist

Tomorrow

SurgeryFollow-up

(Treatment & Diagnosis)

Page 9: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

9

CA9-SCAN with excellent predictive accuracy

Imaging diagnostic of malignant tumours by means of PET / CTMode of action

CA IX antigenTarget

Renal massIndication

Radioactive labelled antibody for Positron Emission Tomography (PET) / CTCompound

class

Impressive proof of concept study

Specificity 100%

Sensitivity 94%

IND Phase III approved by the FDA,

SPA requested (recommended by FDA)

Development of CA9-SCAN for other cancer indications planned

Development

status

Pivotal registration trial; expected second half of 2008Results

Renal, head & neckPotential

indications

Page 10: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

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WX-671: First of its class as specific

anti-metastatic approach

Anti metastatic, non-cytotoxic agentMode of action

Urokinase Plasminogen Activator (uPA) system and other serine proteasesTarget

Various solid cancerIndication

Oral small molecule serine protease inhibitor, orally available pro-drug of WX-UK1Compound

class

In preclinical studies highly effective in blocking metastatic spread and tumour growth

WX-671 (oral) and WX-UK1 (i.v.) tested in seven Phase I trials (>140 patients):

Shown to be safe and well-tolerated

Randomised Phase II programmes:

WX-671 plus Gemcitabine versus Gemcitabine alone in locally advanced, non-

resectable non-metastatic pancreatic cancer (ongoing)

WX-671 plus Capecitabine versus Capecitabine alone in first-line metastatic breast

cancer (planned)

Development

status

Preliminary results of WX-671 Phase II study in pancreatic cancer in 2008Results

Page 11: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

11

Guidance 2007; financial data

2007: 2.5 - 2.8 Mill. expected

Significant continuous growth

RevenuesCapital raised

~ 68 Mill. Euro private

~ 55 Mill. Euro IPO

Cash usage 2007

24 – 28 Mill. Euro

Infrastructure

53 staff

GLP & GMP facilities in Munich

Commercialization

Cash flow also expected in 2008

0,0

1,0

2,0

3,0

2005 2006 2007e

Page 12: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

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Guidance 2007; news flow*

IBA cooperation on registration trial for CA9-SCAN

WILEX will apply for a SPA for CA9-SCAN

FDA approval of CA9-SCAN registration trial

*Approx. planning

Approval for Phase II trial for WX-671 in patients with pancreatic cancer

Start of Phase II trial for WX-671 (pancreatic cancer)

WX-671 Phase Ib head & neck cancer study results

Results of WX-UK1/Capecitabine breast cancer trial

Filing of Phase II study WX-671 (breast cancer)

Update of Phase III RENCAREX®- trial

Futility analysis of the Phase III RENCAREX® trial

2 new Supervisory Board members elected with in-depth drug development

and marketing expertise, experienced CBO nominated

2007 cost guidance reduced by ~4 Mill. Euro

CA9-SCAN

WX-671

Other

RENCAREX®

Page 13: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

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Guidance 2008; financial calendar

*Approx. planning

20 February Annual report 2007 - Press / Analyst conference

10 April Quarterly report 1/2008

3 June Annual General Meeting

14 July Quarterly report 2/2008

13 October Quarterly report 3/2008

Page 14: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

14

Multi-drug

product

portfolio

Balanced R&D pipeline of which 2 compounds

are in pivotal registration Phase III trials

Strong IP Portfolio

Value

driven

strategy

Oncology focussed

Patient focussed therapies

targeting markets with high unmet medical needs

Commercialisation through partnerships and alliances

Operational

excellenceExperienced management and staff with complementary backgrounds

and proven track record

Strong

financial

basis

Positioned for growth:

listed on Prime Standard of Frankfurt Stock Exchange

Compelling Investment Proposition

Page 15: WILEX AG: Innovative Cancer Therapiesheidelberg-pharma.com/pdf/Download/200711 WILEX Therapies.pdf · Cancer disease life cycle Patient selection for therapy WILEX addresses markets

© WILEX AG

15

Contact

WILEX AG

Grillparzerstr. 10

81675 Munich / Germany

Tel.: +49 (0)89-41 31 38-0

Fax: +49 (0)89-41 31 38-99

Email: [email protected]

Website: www.wilex.com

ISIN: DE0006614720 / Symbol: WL6 / Reuters: WL6G.DE / Bloomberg: WL6G.GR