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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
MagForce AG Company Presentation Berlin / Martinsried, Germany
EXECUTIVE SUMMARY
2
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
MagForce AG Company Presentation Berlin / Martinsried, Germany
NANOTHERM® THERAPY
MagForce AG Company Presentation Berlin / Martinsried, Germany
NanoActivator®
Step 2
NanoTherm®
Step 1 Step 3
NanoPlan®
TUMOR THERAPY FROM THE INSIDE OUT: NANOTHERM® THERAPY
4
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
MagForce AG Company Presentation Berlin / Martinsried, Germany
GLIOBLASTOMA MULTIFORME: NANOPLAN®
5
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)
MagForce AG Company Presentation Berlin / Martinsried, Germany
PREVIOUS EUROPEAN CLINICAL TREATMENT EXPERIENCE
6
Patients
Glioblastoma Multiforme 80
Prostate Cancer 29
Esophageal Cancer 10
Pancreatic Cancer 7
Other Indications ~20
MagForce AG Company Presentation Berlin / Martinsried, Germany
POTENTIAL SOLID TUMOR CANCER TREATMENTS ENHANCED BY NANOTHERM® THERAPY
7
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
MagForce AG Company Presentation Berlin / Martinsried, Germany
SIGNIFICANT MARKET POTENTIAL IN THE TREATMENT OF BRAIN AND PROSTATE CANCERS WITH REGIONAL EXPANSION
8
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%)
MagForce AG Company Presentation Berlin / Martinsried, Germany
CLINICAL OVERVIEW
MagForce AG Company Presentation Berlin / Martinsried, Germany
MAGFORCE CLINICAL DEVELOPMENT FOR NANOTHERM®
10
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 treat- ment 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
MagForce AG Company Presentation Berlin / Martinsried, Germany
APPROVAL STUDY DEMONSTRATES THAT NANOTHERM® THERAPY IS A UNIQUE METHOD TO SUCCESSFULLY TREAT GLIOBLASTOMA
11
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
MagForce AG Company Presentation Berlin / Martinsried, Germany
END POINTS
NEW STUDY WITH NANOTHERM® IN RECURRENT GLIOBLASTOMA
12
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
MagForce AG Company Presentation Berlin / Martinsried, Germany
CHARACTERISTICS OF CURRENT NANOTHERM® TECHNOLOGY
13
+ – 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
MagForce AG Company Presentation Berlin / Martinsried, Germany
NANOTHERM® THERAPY REDUCES PROSTATE CANCER GROWTH IN THE ORTHOTOPIC DUNNING R3327 RAT MODEL
14
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
MagForce AG Company Presentation Berlin / Martinsried, Germany
PROSTATE CARCINOMA: CLINICAL STUDIES WITH NANOTHERM® THERMOTHERAPY
15
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
MagForce AG Company Presentation Berlin / Martinsried, Germany
PROSTATE CARCINOMA: 5-YEAR PSA VALUE AFTER TREATMENT WITH COMBINATION THERAPY (NANOTHERM®/BRACHYTHERAPY); PROMISING REDUCTION
16
Primary efficacy endpoint, 5-year PSA course (tumor control)
SN002 SN002
SN003
SN003
SN006
SN006
SN006
SN009 SN009
0
2
4
6
8
10
12
14
16
18
20
SN001 SN002 SN003 SN004 SN006 SN007 SN008 SN009 SN010
SN011 SN012 SN13 SN14 SN015 SN016 SN017 SN018 SN019
MagForce AG Company Presentation Berlin / Martinsried, Germany
TREATMENT OF PROSTATE CANCER IN USA
17
(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
MagForce AG Company Presentation Berlin / Martinsried, Germany
INVESTMENT OPPORTUNITY
MagForce AG Company Presentation Berlin / Martinsried, Germany
LEAD INDICATION: GLIOBLASTOMA WITH SIGNIFICANT MARKET POTENTIAL
19
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
MagForce AG Company Presentation Berlin / Martinsried, Germany
5-YEAR STRATEGIC PLAN
20
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
MagForce AG Company Presentation Berlin / Martinsried, Germany
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
21
Accelerated strategy Sequential strategy
5 Year Financial Target – Annual Revenues of EUR 100 - 150 Million
150m
100m
2019 2019
MagForce AG Company Presentation Berlin / Martinsried, Germany
SUMMARY
22
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 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