19.02.2018

MagForce AG Publishes Shareholder Letter

  • USA: FDA IDE Approval to conduct a clinical trial with NanoTherm® therapy as focal ablation treatment for intermediate risk prostate cancer
  • Europe: financing agreement with the European Investment Bank (EIB) of up to EUR 35.0 million; key addition to Senior Team with the recruitment of Dr. Lutz Helmke, joining MagForce as Executive Vice President and Managing Director Europe
  • MagForce share included in the newly launched Scale 30 Index of Deutsche Börse (German Stock Exchange)

 

Berlin, Germany, and Nevada, USA, February 19, 2018 - MagForce AG (Frankfurt, Scale, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, today published its first Shareholder Letter 2018:

 

“Dear MagForce Shareholders,

 

I am very happy to tell you that the year 2018 begins with the news that we were all eagerly waiting for and that will allow us to progress in full speed now towards our set strategic goals: NanoTherm® therapy has been granted FDA IDE approval so that we can start our focal thermal ablation registration study in intermediate risk prostate cancer. This is a significant milestone in the development of NanoTherm® therapy for the treatment of prostate cancer patients in the USA and a significant step towards our goal - to supplement the current standard therapy with a less invasive, effective, and well-tolerated form of treatment. But let me come back to this in more detail a little later. I would like to use the opportunity to update you on our activities and progress that we have made on both of our defined paths:

 

Path 1: Treatment of brain cancer in Europe
Path 2: Treatment of intermediate risk prostate cancer in the USA

 

Treatment of Brain Cancer in Europe:

 

Our objectives are clear: MagForce AG is continuing to work relentlessy on making our innovative NanoTherm® therapy available to brain cancer patients across all of Europe. Due to the aggressiveness of glioblastoma, there is a limited time interval to achieve treatment. In order to give patients the benefit from our NanoTherm® treatment, access to therapy has to be fast.

 

Consequently, we are focusing on two main aspects in our European roll-out: This is for one the establishment of treatment centers in selected European countries to allow patients to be treated in their home countries. Our commercial and medical teams are in the due diligence process to identify suitable treatment centers, in a first step in Poland and Italy, and are working towards establishing sustainable relationships with the clinics and patient organizations in the respective areas. With patient enquiries steadily increasing and negotiations underway, we are confident, that we will soon be able to announce first cooperations with clinics outside of Germany. Our second focus is on easier reimbursement directly in the selected European countries where MagForce has the CE Mark tor the treatment of brain tumors.

 

To execute this strategy and reach our set commercialization objectives, MagForce AG has reached two important milestones:

 

  1. The financing agreement with the European Investment Bank (EIB) announced/signed in August 2017, allowing the Company to borrow up to EUR 35.0 million over the coming three years, has given us the financial base to significantly expand our marketing efforts and implement our European roll-out plan. We are currently working very closely together with the marketing department of the EIB in a comprehensive advertising campaign to increase the awareness of the value of NanoTherm® therapy and to encourage patients and neurosurgeons to consider NanoTherm® therapy as an innovative cancer therapy following diagnosis.
  2. I am delighted to announce a key addition to our Senior Team with the recruitment of Dr. Lutz Helmke, a seasoned manager from the medical technology industry. Dr. Helmke will be joining MagForce as Executive Vice President and Managing Director Europe. He has a profound expertise in the area of reimbursement. He started his career 25 years ago with a global marketing position at the Berlin based company Biotronik. After that he joined St. Jude Medical where he held different management positions for 22 years. When in Germany the DRG system was introduced (Diagnosis Related Groups, a billing system based on fixed payments for hospital patients) he established within St. Jude Medical a reimbursement department in order to advise German hospitals in DRG funding matters. For the last seven years he managed St. Jude’s neuromodulation division. Dr. Helmke holds a PHD in Chemistry and resides with his family in Berlin.

 

As part of our increased marketing efforts, we are continuing to participate in scientific conferences and congresses to increase the awareness of our unique therapy within the main target groups, such as patient advocacy groups, patients, their relatives, caregivers, and the medical community and are happy to report, that we have seen a growing interest from the medical community in our approach but also increasingly receive positive feedback from patients regarding their experiences with our NanoTherm® therapy. These examples, one of which we are showing in a new video on our website www.magforce.de, are an important driver for the commercialization of our innovative therapy.

 

Since the last Shareholder Letter we presented at EANS 2017, the International Brain Tumour Alliance (IBTA) Patient’s Advocate Conference, MEDICA 2017 as well as at the 22nd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO). We are very happy that the Team of Prof Dr Walter Stummer, Director of the Department of Neurosurgery at the University Hospital Münster, Germany, that is treating patients with NanoTherm® therapy, were once again chosen to present an abstract regarding their work with NanoTherm® at SNO which is a very a prestigious scientific conference.

 

Management is confident that the European expansion started in 2017, when combined with reimbursement approval in these countries, will significantly speed up revenue and profit generation in Europe.

 

Treatment of Intermediate Risk Prostate Cancer in the USA:

 

The U.S. Food and Drug Administration (FDA) has just granted our US subsidiary MagForce USA, Inc. the Investigational Device Exemption (IDE) to conduct a clinical trial with NanoTherm® therapy as focal ablation treatment for intermediate risk prostate cancer. The approval of this IDE now allows MagForce to conduct a pivotal clinical evaluation with our innovative therapy at selected medical centers in the US.

 

The purpose of this focal thermal ablation registration study that will enroll up to 120 men in a single arm study is to demonstrate that NanoTherm® can focally ablate cancer lesions for patients who have progressed  to intermediate risk Prostate Cancer stage and are under active surveillance. By focally ablating these cancer lesions, it is anticipated that patients will be able to be maintained in Active Surveillance Programs and to avoid definitive therapies such as surgery or whole gland radiation with their well-known side effects. Potentially 50,000 to 100,000 men in active surveillance programs in the US could benefit from this focal therapy after registration.

 

In order to conduct the study, we have already installed two NanoActivator® devices, magnetic field applicators in which the NanoTherm® therapy is performed, at University of Washington Medical Center in Seattle and at CHRISTUS Santa Rosa Hospital - Medical Center in San Antonio.

 

We are very excited to work with the teams of Dr. Ian M. Thompson, Jr., President of CHRISTUS Santa Rosa Hospital - Medical Center and Director, Cancer Therapy and Research Center, a National Cancer Institute-designated Cancer Center at the University of Texas Health Science Center at San Antonio, and Dr. Dan W. Lin, Chief of Urologic Oncology and Professor in the Department of Urology at the University of Washington School of Medicine in Seattle, who have agreed to be co-principal investigators in the Focal Thermal Ablation Registration study.

 

MagForce anticipates to initiate patient enrollment in this study in the coming months and I believe the registration trial will prove that NanoTherm® therapy can fulfill the desired outcome - allowing a man diagnosed with Prostate Cancer having the highest quality of life possible while delaying or even completely avoiding invasive treatments.

 

While we are approximately one year behind our schedule, we are still confident and will make every effort to achieve our original targets in terms of market entry and commercialization of NanoTherm® therapy in the USA.

 

Investor Relations

 

We are also happy to report that the MagForce share has been included in the newly launched Scale 30 Index of Deutsche Börse (German Stock Exchange). The selection index tracks the performance of the 30 most liquid companies listed in the SME segment Scale. Eligibility for index inclusion depends on order book turnover on Xetra and Börse Frankfurt. MagForce is listed in the Scale segment of Deutsche Börse that has replaced the Entry Standard for equities and corporate bonds in which the Company’s share has been included previously, since the Scale segment was launched in March 2017.

 

As in the past, the Company continues to work on increasing the awareness for its shares and its equity story in the financial community and sets great store on a regular dialog with its shareholders. The goal is to communicate the Company’s strategy and development reliably and transparently to gain investor confidence in MagForce and achieve a fair valuation of its shares.

 

Outside of the Annual General Meeting, management presented at various renowned investor conferences in Europe and in the US. During those events and in the course of the international road shows, MagForce handled numerous one-on-one meetings with existing and potential new international shareholders.

 

In the second half of 2017, MagForce presented at: Goldman Sachs Fourteenth Annual European Medtech and Healthcare Services Conference 2017 in London; Berenberg & Goldman Sachs Sixth German Corporate Conference 2017 in Munich; German Equity Forum and at the Prior Kapitalmarktkonferenz in Frankfurt. During the first half of 2018, MagForce will present at various conferences in Europe and in the USA, we will shortly announce our participation in detail. 

 

Supervisory Board extends Management contracts

The Supervisory Board of MagForce AG decided in its last meeting unanonimously to extend the contract of all members of the Management Board, i.e. Dr. Ben J. Lipps, Chief Executive Officer, Prof. Dr. Hoda Tawfik, Chief Medical Officer and Christian von Volkmann, Chief Financial Officer, ahead of schedule for a further 2-year term until end of 2020. I am proud to be part of this exceptional management team and convinced that with this decision we underline our commitment to the set goals and strategy we implemented at MagForce and ensure continuity and stability in the Company’s leadership in order to create further shareholder value.

 

Dear Shareholders, after this good and productive start into 2018 we are very grateful for your continuous support of our efforts.

 

Sincerely,

 

Dr. Ben Lipps  

Chief Executive Officer &

Chairman of the Management Board”

 

About MagForce AG and MagForce USA, Inc.

MagForce AG, listed in the Scale segment of the Frankfurt Stock Exchange (MF6, ISIN: DE000A0HGQF5), together with its subsidiary MagForce USA, Inc. is a leading medical device company in the field of nanomedicine focused on oncology. The Group's proprietary NanoTherm® therapy enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles.

NanoTherm®, NanoPlan®, and NanoActivator® are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of brain tumors. MagForce, NanoTherm, NanoPlan, and NanoActivator are trademarks of MagForce AG in selected countries. www.magforce.com

 

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Disclaimer      

This release may contain forward-looking statements and information which may be identified by formulations using terms such as "expects", "aims", "anticipates", "intends", "plans", "believes", "seeks", "estimates" or "will". Such forward-looking statements are based on our current expectations and certain assumptions, which may be subject to a variety of risks and uncertainties. The results actually achieved by MagForce AG may substantially differ from these forward-looking statements. MagForce AG assumes no obligation to update these forward-looking statements or to correct them in case of developments, which differ from those, anticipated.

 

10.02.2018

MagForce USA receives FDA Investigational Device Exemption approval to conduct a clinical trial with NanoTherm® Therapy as Focal Ablation Treatment for Intermediate Risk Prostate Cancer

Berlin, Germany and Nevada, USA, February 10, 2018 - MagForce AG (Frankfurt, Scale, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, together with its subsidiary MagForce USA, Inc. today announced that it has received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to conduct a clinical trial with NanoTherm® therapy as focal ablation treatment for intermediate risk prostate cancer. The approval of this IDE now allows MagForce to conduct a pivotal clinical evaluation with the Company’s innovative NanoTherm® therapy at selected medical centers in the US. MagForce anticipates to initiate patient enrollment in this study in the coming months.

 

The purpose of this focal thermal ablation registration study that will enroll up to 120 men in a single arm study is to demonstrate that NanoTherm® can focally ablate cancer lesions for patients who have advanced to intermediate risk Prostate Cancer stage and are under active surveillance. By focally ablating these cancer lesions, it is anticipated that patients will be able to be maintained in Active Surveillance Programs and to avoid definitive therapies such as surgery or whole gland radiation with their well-known side effects.

 

In order to conduct the study, MagForce has already installed two NanoActivator® devices, magnetic field applicators in which the NanoTherm® therapy is performed, at University of Washington Medical Center in Seattle and at CHRISTUS Santa Rosa Hospital - Medical Center in San Antonio.

 

Dr. Ian M. Thompson, Jr., President of CHRISTUS Santa Rosa Hospital - Medical Center and Director, Cancer Therapy and Research Center, a National Cancer Institute-designated Cancer Center at the University of Texas Health Science Center at San Antonio, and Dr. Dan W. Lin, Chief of Urologic Oncology and Professor in the Department of Urology at the University of Washington School of Medicine in Seattle, have agreed to be co-principal investigators in the Focal Thermal Ablation Registration study.

 

 “We are delighted to announce that NanoTherm® therapy has been granted FDA IDE approval. This is a significant milestone in the development of NanoTherm® therapy for the treatment of prostate cancer patients in the USA and a significant step towards our goal - to supplement the current standard therapy with a less invasive, effective, and well-tolerated form of treatment. Potentially 50,000 to 100,000 men in active surveillance programs in the US could benefit from this focal therapy after registration,“ said Ben Lipps, Chief Executive Officer of MagForce AG and MagForce USA, Inc. “We are very excited to work with the teams of Ian M. Thompson Jr., MD and Dr. Dan W. Lin, with their exceptional experience and knowledge and I believe the registration trial will prove that NanoTherm® therapy can fulfill the desired outcome.”

 

MagForce’s NanoTherm® therapy has obtained a CE mark (European Certification) in the European Union to treat brain tumors and is already commercially available to brain tumor patients at renowned treatment centers in Germany.

 

 

Potential advantage of NanoTherm® focal ablation therapy for patients enrolled in Prostate Cancer Active Surveillance Programs

 

Prostate Cancer, although one of the most frequently diagnosed forms of cancer in men, worldwide, is treatable, if detected early. According to estimates of the National Cancer Institute, around 230,000 new cases of Prostate Cancer have been diagnosed per year in the USA.

 

Within the past two decades, Active Surveillance Programs have been developed in the USA to follow the slow growth of Prostate Cancer in order to avoid the side effects of definitive therapy (radiation or surgery), for as long as possible. Currently, there are over 250 Active Surveillance Programs in the USA. Active Surveillance is the merging of watchful waiting and active management into a program that is interactive for the patient, ultimately allowing a man diagnosed with Prostate Cancer to monitor his disease and have the highest quality of life possible while delaying or even completely avoiding invasive treatments.

 

For the past decade, these Active Surveillance Programs have been seeking a focal therapy which would ablate the small tumors that have progressed to the intermediate risk stage because approximately 60% of the patients in Active Surveillance Programs who have participated in these programs for an extended period of time require definitive therapy such as whole gland surgery or radiation.

 

NanoTherm® therapy represents a new concept for interstitial hyperthermia of the prostate. This method is based on the controlled transfer of energy from an alternating magnetic field to biocompatible, superparamagnetic nanoparticles injected into the tumor. The resulting amount of heat generated is suitable to directly destroy cancer cells.

 

Consequently, MagForce expects to ablate these small lesions of cancer with focal NanoTherm® therapy with minimal adverse effects. With successful NanoTherm® treatment, it is anticipated that the patients can return to Active Surveillance and keep their quality of life. Clearly, there is a major medical need for a focal therapy with decreased side effects in the USA.

 

 

About MagForce AG and MagForce USA, Inc.

MagForce AG, listed in the Scale segment of the Frankfurt Stock Exchange (MF6, ISIN: DE000A0HGQF5), together with its subsidiary MagForce USA, Inc. is a leading medical device company in the field of nanomedicine focused on oncology. The Group's proprietary NanoTherm® therapy enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles.

 

NanoTherm®, NanoPlan®, and NanoActivator® are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of brain tumors. MagForce, NanoTherm, NanoPlan, and NanoActivator are trademarks of MagForce AG in selected countries.

 

 

For more information, please visit: www.magforce.com.      

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Disclaimer      

This release may contain forward-looking statements and information which may be identified by formulations using terms such as "expects", "aims", "anticipates", "intends", "plans", "believes", "seeks", "estimates" or "will". Such forward-looking statements are based on our current expectations and certain assumptions, which may be subject to a variety of risks and uncertainties. The results actually achieved by MagForce AG may substantially differ from these forward-looking statements. MagForce AG assumes no obligation to update these forward-looking statements or to correct them in case of developments, which differ from those, anticipated.

 

14.11.2017

MagForce AG to participate at SNO 2017 Annual Meeting from November 16-19 in San Francisco, USA

Berlin, Germany, and Nevada, USA, November 14, 2017 - MagForce AG (Frankfurt, Scale, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, today announced its participation in the 22nd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology, SNO 2017, held from November 16-19, 2017, in San Francisco, California, USA.

Reporting on their experiences with NanoTherm® therapy, PD Dr Dr Oliver Grauer, Head of Neuro-Oncology at the Department of Neurology (Director: Prof. Dr. Heinz Wiendl) and part of the team of Prof Dr Walter Stummer, Director of the Department of Neurosurgery at the University Hospital Münster, Germany, that are treating patients with NanoTherm® therapy, will  give an oral presentation on the Münster Team’s experience with intracavitary thermotherapy with iron-oxide nanoparticles in combination with radiotherapy as a promising treatment modality in recurrent glioblastoma. The oral presentation will be held on Friday, November 17, 2017, 13:45 PDT as part of the session on 'Experimental Therapeutics and Tumor Models'.

"We are looking forward to presenting results from our research at this outstanding conference and discussing those with experts in the field”, said PD Dr. Dr. med. Oliver Grauer. "Even today, the prognosis for glioblastoma is extremely poor, since recurrence is very likely (>90%) and treatment options for patients at the time of recurrence are still limited. Most glioma recurrences are observed in the direct vicinity of the original resection cavity after the tumor has been removed. To address this, tumor cavities were, after resection, covered with superparamagnetic iron-oxide nanoparticles to create high local particle concentrations for subsequent heating in an alternating magnetic field. Patients underwent six 1-hour hyperthermia sessions and received concomitant or sequential radiotherapy. In our work we were able to demonstrate that local NanoTherm® treatment combined with radiotherapy can induce a persistent inflammatory reaction at the resection cavity which might lead to long-term stabilization of recurrent GBM patients. These results warrant further investigations and we are aiming to continue investigating this interesting effect during the treatment of further patients.”

MagForce will be presenting its NanoTherm® therapy for the treatment of glioblastoma and other brain tumors at booth #204 in the Golden Gate foyer, Level B1 of the Marriott Marquis Hotel in San Francisco, California, USA.

Presentation Details:

Speaker:

PD Dr. Dr. med. Oliver Grauer, Head of Neuro-Oncology, University Hospital Münster

Authors:

Grauer O, Jaber M, Hess K, Weckesser M, Maring S, Schwindt W, Stummer W, Wölfer J

Dpts. of Neurology, Neurosurgery, Neuropathology, Nuclear Medicine, Radiooncology, and Radiology, University Hospital Münster, Germany

Presentation (oral):

EXPERIMENTAL THERAPEUTICS AND TUMOR MODELS:
"Combined intracavitary thermotherapy with iron-oxide nanoparticles and radiotherapy as a promising treatment modality in recurrent GBM" (SURG-32)

Date of presentation:

Friday, November 17, 2017, 13:45 PDT, Session 2C

Location:

Marriott Marquis, San Francisco, California, USA

MagForce booth:

No. 204, Golden Gate foyer, Level B1

About SNO 2017

The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education. This year’s Scientific Meeting will highlight a number of the 10 Blue Ribbon Panel recommendations related to the Cancer Moonshot program. Building on the success of past SNO meetings, sunrise sessions, plenary and concurrent sessions will be featured with oral abstract presentations, enhanced oral eTalk electronic poster presentations, and poster presentations. Special lunch tutorials and industry-sponsored symposia will provide in-depth information on evolving technologies and therapeutics. Circulated for viewing throughout the meeting will be webcasts with “Meet the Expert” recordings of esteemed scientists and clinicians on topics such as mouse models, The Cancer Genome Atlas, telomeres, genetics and epigenetics of pediatric brain tumors, and immunology checkpoint inhibitors.

In keeping with the main meeting theme, the Education Day will focus on two of the Cancer Moonshot Blue Ribbon Panel recommendations: “Developing Ways to Overcome Resistance” and “Minimizing Cancer Treatments Debilitating Side Effects.” Concurrent tracks in both basic science and applied neuro-oncology will offer a comprehensive look at these two recommendations.

 

27.10.2017

MagForce AG publishes Directors' Dealings

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