Fighting Cancer with NanoMedicine - MagForce€¦ · SN002 SN003 SN003 SN006 SN006 SN006 SN009...

MagForce AG Company Presentation Berlin / Martinsried, Germany

MAGFORCE AG FIGHTING CANCER WITH NANO MEDICINE

Ben J. Lipps Chief Executive Officer & Chairman of the Management Board

Deutsche Bank dbAccess German, Swiss & Austrian Conference

Berlin, Germany


EXECUTIVE SUMMARY

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Company Profile

• Headquartered in Berlin, Germany

• Current Management Team:

– B. Lipps, H. Tawfik, C. von Volkmann

• Frankfurt Stock Exchange (Entry Standard: MF6)

• Shares outstanding: 23.9 million

Achievements

• First and only nanotechnology device approved for the treatment of brain cancer (EU) – therapeutic potential and proof-of-principle for other solid tumors

• Three NanoActivators® installed in Germany for treatment of brain tumors / Glioblastoma

• USA subsidiary incorporated – MagForce USA, Inc.

• Pre-Sub meeting with FDA


NANOTHERM® THERAPY


NanoActivator®

Step 2

NanoTherm®

Step 1 Step 3

NanoPlan®

TUMOR THERAPY FROM THE INSIDE OUT: NANOTHERM® THERAPY

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Mode of action

• After the injection the treating physician plans a therapy session based on a simulation with NanoPlan ®

• The simulation takes into account the tumor size, distribution of the Nano-Therm® particles and tumor location

Brain (EU approved)

Pancreas (Phase II)

Prostate (Phase I)

Core

Coating

Functional surface (Aminosilane)

12nm

• NanoTherm® magnetic fluid injected directly into tumor tissue

• Nanoparticles remain in place due to their special coating

• Magnetic field causes NanoTherm® particles to oscillate and produce heat

• Heat destroys or makes cells susceptible to concomitant radio- or chemotherapy

Therapy component


GLIOBLASTOMA MULTIFORME: NANOPLAN®

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Jordan et al., Der Onkologe 2007; 13: 894-902

MRI of glioblastoma multiforme CT after instillation of the magnetic nanoparticles

Calculated temperature distribution: range from 40°C (blue line) to 50°C (red line)


PREVIOUS EUROPEAN CLINICAL TREATMENT EXPERIENCE

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Patients

Glioblastoma Multiforme 80

Prostate Cancer 29

Esophageal Cancer 10

Pancreatic Cancer 7

Other Indications ~20


POTENTIAL SOLID TUMOR CANCER TREATMENTS ENHANCED BY NANOTHERM® THERAPY

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2012 Estimated total number of cancer incidence per year in selected tumor indications 1

Germany EU27 World

+XX

Brain

Pancreas

Head & Neck

Prostate 899,100/year

14,700 69,700 278,700/year

323,800 70,800

15,600 95,400 634,800/year

214,100/year 6,200 37,000

1 Source: GLOBOCAN 2008, IARC 29. Apr. 2013; total numbers of estimated cancer incidence, all ages, both sexes; cartoon adapted to numbers of incidence in log scale


SIGNIFICANT MARKET POTENTIAL IN THE TREATMENT OF BRAIN AND PROSTATE CANCERS WITH REGIONAL EXPANSION

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Total numbers of cancer incidence in selected tumor indications 1

Germany EU27 World

Brain

Prostate 899,100 323,800 70,800

214,100 6,200 37,000

1 Source: GLOBOCAN 2008, IARC 29. Apr. 2013; total numbers of estimated cancer incidence, all ages, both sexes; cartoon adapted to numbers of incidence in log scale

USA

19,627

186,320

Projected Annual Medical Treatment Expense > 2 Billion Euros

Projected Annual Medical Treatment Expense > 10 Billion Euros

580,920 (65%)

62,827 (29%)


CLINICAL OVERVIEW


MAGFORCE CLINICAL DEVELOPMENT FOR NANOTHERM®

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Clinical Development Status/Targets:

• Brain tumors: post-marketing study to establish NanoTherm® therapy in the medical community

• Prostate carcinoma: focus on early to intermediate stage disease to prolong active surveillance period, support organ preservation, and enhance quality of life

• Pancreas carcinoma: provide additional therapy to expand currently limited treatment options, increase efficacy of available chemotherapy and prolong survival

SIGNIFICANT THERAPEUTIC POTENTIAL IN A VARIETY OF SOLID TUMOR INDICATIONS

INDICATION Feasibility Efficacy STATUS

Prostate carcinoma

Pancreatic carcinoma

Brain tumors EU approval

GBM post-marketing Initiating ongoing


APPROVAL STUDY DEMONSTRATES THAT NANOTHERM® THERAPY IS A UNIQUE METHOD TO SUCCESSFULLY TREAT GLIOBLASTOMA

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1 Maier-Hauff et al. (2010), Journal of Neurooncology 103(2): 317-324 2 Stupp et al. (2009), Lancet Oncology 10:459-466 3 Stupp et al. (2005), N Engl J Med 352:987-996

Phase II study results1 Clinical study highlights Results of phase II study with 59 patients published (recurrent GBM)

• Approval received in Europe for treatment of all (primary and recurring) brain tumors

• Concurrent therapy to radiotherapy

• Good safety profile and efficacy shown in clinical trials

• Viable treatment option for recurring GBM

• Well tolerated treatment with only low to moderate side effects

• Positive risk-benefit profile

6,2

14,6 13,4

23,2

After diagnosis of first tumorrecurrence

After diagnosis of primary tumor

Historical control ² ³ NanoTherm® therapy¹

+7.2 months of patient life

+8.6 months of patient life

NanoTherm® will First be Used as Additional Treatment for Recurring Glioblastoma and has Potential to Later Substitute Radiotherapy


END POINTS

NEW STUDY WITH NANOTHERM® IN RECURRENT GLIOBLASTOMA

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TIMELINE

SITES WITH ACTIVATOR

STUDY DESIGN

Open label, randomized 2:2:1, 3 arms, two-step design

STUDY OBJECTIVE

Efficacy and safety evaluation of NanoTherm® monotherapy and in combination with radiotherapy versus radiotherapy alone

PATIENTS NUMBER

285 patients

1-year survival rate from randomization; overall survival; progression free survival

Start 2014; 2 year recruitment phase + 1 year read out

University Hospitals (10 to 15 in total): In place: Berlin, Muenster Installation ongoing: Cologne, Kiel Next planned: Frankfurt, Nuremberg, Stuttgart

COMPANY INTENTION

Establish NanoTherm® with the medical community as a valued therapy for brain cancer


CHARACTERISTICS OF CURRENT NANOTHERM® TECHNOLOGY

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+ – Advantages

1. Thermotherapy with magnetic nanoparticles in combination with percutaneous radiotherapy is feasible and safe

2. Therapeutic temperatures can be reached in the treatment area

3. Promising therapeutic effect

4. Moderate side effect profile

5. Positive risk/benefit ratio

6. Enhances existing therapies

Impairments

1. Metallic bodies within 40 cm/15.7’’ from the treatment area are not allowed with current large NanoActivator®

2. MRI cannot be used for further diagnosis due to artifacts in region of nanoparticle placement - no other imaging procedures are affected – alternate procedures e.g. CT, PET, PET-CT


NANOTHERM® THERAPY REDUCES PROSTATE CANCER GROWTH IN THE ORTHOTOPIC DUNNING R3327 RAT MODEL

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Johannsen, M et al. Magnetic Fluid Hyperthermia (MFH) reduces prostate cancer growth in the orthotopic dunning R3327 rat model. The Prostate 64:283-292 (2005)

C1: Control growth C2: Magnetic fluid without magnetic field (no magnetic field exposure) C3: Normal saline with magnetic field T: Magnetic fluid with magnetic field (magnetic field exposure) NTT Effectiveness Activity: 50% mean tumor weight reduction 50.% mean tumor growth inhibition Mode of action: Necrosis, direct tumor tissue destruction

Tumor growth curves from tumor volume measurements using ultrasound

C2

C1 C3

T

Controls

NTT

Days after tumor induction

8 10 12 14 16 18 20

Tum

or

volu

me

(cm

3)

0

2

4

6

8

10

12

14

P<0.01

P<0.001


PROSTATE CARCINOMA: CLINICAL STUDIES WITH NANOTHERM® THERMOTHERAPY

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COMPLETED

• Low number of patients → but data are promising

• High number of patients had disease-related symptoms already at baseline which improved after NanoTherm® therapy

Monotherapy with NanoTherm® therapy:

Feasibility study in 10 patients with recurrent prostate cancer

Combination therapy with NanoTherm® therapy and 125I-Brachytherapy: Feasibility and safety study in 19 patients with intermediate primary prostate cancer


PROSTATE CARCINOMA: 5-YEAR PSA VALUE AFTER TREATMENT WITH COMBINATION THERAPY (NANOTHERM®/BRACHYTHERAPY); PROMISING REDUCTION

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Primary efficacy endpoint, 5-year PSA course (tumor control)

SN002 SN002

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SN006

SN006

SN006

SN009 SN009

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SN001 SN002 SN003 SN004 SN006 SN007 SN008 SN009 SN010

SN011 SN012 SN13 SN14 SN015 SN016 SN017 SN018 SN019


TREATMENT OF PROSTATE CANCER IN USA

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(1) AHRQ Number 204

• (1) 2011 – “An Evidence Review of Active Surveillance in Men with Localized Prostate Cancer”

– 240,000 men projected to be diagnosed with prostate cancer

– 33,000 men projected to die from prostate cancer

– Health Care Cost > $12B

• Men over 65 years of age – Fastest growing group

• MagForce USA NanoTherm® Therapy:

– Monotherapy – Focal treatment for intermediate primary prostate cancer

– Combination therapy (NanoTherm®/External Radiation) – treatment for recurrent prostate cancer


INVESTMENT OPPORTUNITY


LEAD INDICATION: GLIOBLASTOMA WITH SIGNIFICANT MARKET POTENTIAL

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HIGH MEDICAL NEED FOR IMPROVED GBM TREATMENT OPTIONS

• Less than 10% of patients are still alive 5 years after diagnosis

• Limited treatment advancements in the last 20 years

• 63,000 cases of brain cancers per year in the major markets: Germany, EU 27, and USA

• Glioblastoma multiforme (GBM) is the most malignant brain tumor

• Current standard therapy for GBM includes surgery, radio- and chemotherapy

• NanoTherm® therapy has synergistic effect with concurrent treatment

MEDICAL NEED

CURRENT STATUS

CURRENT TREATMENT


5-YEAR STRATEGIC PLAN

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Expansion of Brain Tumor Therapy

2013 2014 2015 2016 2017

2013 & 2014 • Install 10-15 NanoActivators in Germany & Europe & USA

2013 – 2017 • Conduct Post Marketing Study with Recurrent Glioblastoma in the US & Europe • PMA filing to the FDA

2014 + • Provide opportunity to treat commercial patients, in Germany, who are not eligible for inclusion in the Post

Marketing Study

2013 – 2014 • Define NanoTherm® Prostate Cancer Therapy Options • Registration in USA / EU to be determined

2018

Prostate Carcinoma Treatment


1. Sequential Strategy

• MagForce’s market roll-out can be executed sequentially, at a less

aggressive approach

• The overhead is kept on a minimum level and regional expansion will be

supported by strong cooperation partners that would receive significant

revenue shares

2. Accelerated Strategy

• With additional financing rounds, market entry could be accelerated

WORLDWIDE ROLL-OUT SCENARIOS FOR GBM AND PROSTATE CANCER TREATMENT

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Accelerated strategy Sequential strategy

5 Year Financial Target – Annual Revenues of EUR 100 - 150 Million

150m

100m

2019 2019


SUMMARY

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NanoTherm® therapy (NTT) is a unique and exciting therapy for treating solid tumors.

Estimated annual healthcare expense to treat brain and prostate cancers in Germany, USA & EU 27 exceeds 12 billion Euros.

MagForce has solid intellectual property protection and has the technical capability to establish with the medical community NTT as a valued Mono or Combined Therapy for the treatment of brain and prostate cancer.


MAGFORCE AG FIGHTING CANCER WITH NANO MEDICINE

Ben J. Lipps Chief Executive Officer & Chairman of the Management Board

Deutsche Bank dbAccess German, Swiss & Austrian Conference

Berlin, Germany

Fighting Cancer with NanoMedicine - MagForce€¦ · SN002 SN003 SN003 SN006 SN006 SN006 SN009...

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