MagForce AG Publishes Shareholder Letter
- Europe: Continued significantly increased numbers of brain tumor treatments
- USA: Treatments of patients in current stage of the prostate cancer trial with streamlined protocol so far show only minimal treatment-related side effects
Berlin, Germany, and Nevada, USA, September 21, 2020 - MagForce AG (Frankfurt, Scale, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, today published a Shareholder Letter:
"Dear MagForce Shareholders,
I am very pleased to update you on the progress we have made with our transformative NanoTherm therapy system as a treatment option for solid tumors. Although the COVID-19 pandemic has developed into a very serious global healthcare challenge with extreme economic and personal restricitons, MagForce is coping with the evolving situation and we continue to have very good prospects for 2020. Our utmost priority in this pandemic remains the safety of our employees, patients and physicians in the clinics as well as partners. We are still happy to say that MagForce's production has barely been affected. Our expert team is diligently working to bring our therapeutic system to cancer patients worldwide.
MagForce AG - Europe - Brain Cancer Treatment:
Despite the challenging COVID-19 situation, our commercial team was able to turn the corner on commercial revenues and I am very proud to inform you that this has now been impressively reflected in treatment figures. We have won partner clinics that are convinced of our technology and use it with great commitment. We see that this trend is so far sustainable and more and more patients, who often do not have time to spare, have access to our innovative brain tumor treatment option.
Last year, we entered into a cooperation agreement with the Paracelsus Clinic Zwickau. Prof. Dr. med. Habil. Jan-Peter Warnke, Head of Department in the Neurosurgical Clinic at Paracelsus Clinic, and his team have treated brain tumor patients in our new mobile therapy center since December 2019 and offer our potential life-prolonging therapy in the acute interest of patients in Eastern Germany with increasing treatment numbers reported eversince. At the end of September, Paracelsus Clinic Zwickau, with support from the German Brain Tumor Association and the Cancer Society Saxony, will host a patient event which offers the chance to visit the mobile treatment center, as well as provide information on glioblastoma and potential treatment options for patients in Zwickau and the surrounding region.
We already announced that the Hufeland Clinic at the Mühlhausen site in Thuringia will be the next clinic in Europe to offer MagForce's NanoTherm therapy system for the commercial treatment of brain tumors. Currently construction is ongoing on the station that will be integrated into the neurosurgical department. Most importantly, the center will have its own entrance, which is crucial as brain tumor patients require facilities that are easily accessible. Furthermore, this integrated treatment center provides even more protection in the current pandemic as it will help limit unnecessary contact to persons not directly involved in the treatment process. Final inspections are planned to take place in October with the center opening for patients immediately thereafter. The new treatment center is managed by Privatdozent (PD) Dr. Johannes Wölfer, head physician of the Department of Neurosurgery and Spinal Surgery.
As a long-standing expert in the use of MagForce's NanoTherm therapy system, PD Dr. Wölfer was also involved in the development of the training concept for the "NanoTherm Therapy School," together with two further renowned medical opinion leaders: Prof. Dr. Walter Stummer and PD Dr. Dr. Oliver Grauer both at the University Hospital Münster. At the "NanoTherm Therapy School," surgeons are certified in the use of the innovative technology by participating in a comprehensive series of application training courses. Two sessions have already taken place and on October 9th the next module will be hosted to acquaint surgeons from various clinics in Germany with this new treatment method in a stress-free yet largely realistic setting. This is key to ensuring that patients receive the highest quality of treatment.
However, our expansion activities, including NanoActivator installations in Spain and Italy with partner hospitals, which were planned for the second half of 2020, are delayed due to the enormous challenges in these countries caused by COVID-19 and the travel restrictions. We continue to see interest from other European countries and will proceed with on our European roll-out path in the months to come. With that said, we plan to open at least one additional NanoTherm treatment center in Germany, which should help us reach our treatment goals for 2021 - tripling the number of commercial treatments compared to 2020.
MagForce continues to work tirelessly to establish the NanoTherm Therapy System for the benefit of brain tumors patients throughout Europe.
MagForce USA, Inc. - USA - Prostate Cancer Treatment:
In the USA it was estimated in 2019 that there were 174,000 new cases of prostate cancer and inspite of advances in diagnosis and treatment an estimated 31,000 deaths occured according to the American Society of Clinical Oncology. MagForce's focal ablation approach targets patients who have progressed to intermediate prostate cancer stages and are under active surveillance. By destroying smaller cancer lesions, it is anticipated that patients will be able to remain in Active Surveillance programs and avoid, for as long as possible, definitive therapies such as surgery or whole gland radiation with their well-know side effects.
Late April, we were pleased to announce that MagForce USA, Inc. received FDA approval for a streamlined trial protocol for the next stage of our pivotal US study with the NanoTherm therapy system for the focal ablation of intermediate risk prostate cancer. During Stage 1, MagForce USA successfully developed and validated a new standardized clinical procedure. With a streamlined protocol we are able to treat patients much faster than in Stage 1, where each step, instillation and activation, took much longer. Now, both steps will be completed on the very same day, which should favorably affect the duration of the trial. Clearly, the streamlined trial protocol benefits the patients by completing the whole treatment within one day, thus minimizing the burden of repeated visits at the physicians office.
Initial findings during Stage 1 showed only minimal treatment-related side effects, which were tolerable and similar to those commonly associated with biopsies. The ablation analysis showed very well-defined ablation and cell death in the region of the nanoparticle deposit, as was observed in the previous pre-clinical studies.
The current stage of our study is conducted in phases to ensure early on that the minimal side effects observed in Stage 1, with a drawn out procedure, are maintained in the streamlined one-day procedure. Treatment of the first ten subjects should be sufficient to affirm expected minimal side effects. By the fourth quarter of 2020, we believe we will have sufficient data to reinforce the initial finding that our streamlined procedure continues to show minimal patient side effects and achieve the required 80 percent confidence that the clinical objectives can be met.
After ethics committee clearance in June 2020, first patients were enrolled into the next stage and patient treatments have started. MagForce initially began treating patient in one treatment center, making continuous treatments more efficient given clinic and travel resitrictions due to COVID-19. Nothwithstanding further pandemic restrictions, the additional two treatment centers will initiate treatments by the beginning of December.
While finishing the trial, we will start with our activities to prepare for commercialization, which we expect will commence during the second half of 2021. All three participating clinical trial sites are already fully equipped with the NanoActivator devices and would be in a position to start commercial treatments immediately following approval by the FDA. Once the study is completed, we anticipate that two additional MagForce owned treatment centers will have been added. Further sites will then be opened in strategic locations across the USA to allow patients to be treated locally. MagForce is already in contact with the most significant Active Surveillance Programs across the country to allow for a consistent stream of potential patients once the therapy is launched.
We must acknowledge that COVID-19 has created worldwide disruptions. With this in mind, we will surely experience some delays, even though the structure we have implemented in the USA permits MagForce to continue its clinical registration trial.
Increased commercial revenues, flexibility in fincancing tools and a committed management team
MagForce is sufficiently funded and we have several options available to secure further financing in the current market environment if needed. To ensure we remain in contact with investors, we have participated in several virtual roadshows and conferences since the start of the pandemic.
Encouragingly, we see that our commercial strategy in Europe is progressing well; we receive a constant flow of income resulting directly from increased commercial treatments, as described above - these revenues cover our expenses to an increasing extent.
The Company has extended the executive board contracts of Christian von Volkmann as Chief Financial Officer and myself, Ben Lipps, as Chief Executive Officer of MagForce AG for another two years to ensure timely execution of the Company's strategy as outlined above. Prof. Hoda Tawfik will not extend her contract and depart the Company upon the end of her appointment to the Management Board. I would like to use this opportunity to thank Hoda for her long-time contribution to MagForce, especially with regards to the post-marketing study in Europe and introducing our technology to key opinion leaders and neurosurgeons across Europe. We wish Hoda all the best in her future endeavours. At the same, time I am proud that we have built a successful commercial team under the leadership of Dr. Andreas Jordan, Executive Vice President, Managing Director Europe and Chief Scientific Officer, which has made important milestones in our European roll-out strategy that have reflected in increasing glioblastoma treatment numbers.
In summary, MagForce has passed several major milestones and made significant progress with the NanoTherm therapy system both in the EU, with our brain cancer treatment expansion strategy, and the USA where we aim to bring our innovative approach to develop a minimum risk focal ablation therapy for Active Surveillance to prostate cancer patients. For the future MagForce envisions that NanoThern technology can be applied to any solid tumor with no metastization that is confirmed by targeted biopsy.
I would like to express my thanks to our employees for their tireless efforts and achievements and you, our shareholders, for placing your trust in our mission.
Dr. Ben Lipps
Chief Executive Officer &
Chairman of the Management Board MagForce AG
Chief Executive Officer MagForce USA, Inc."
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(R) therapy system enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles.
NanoTherm(R), NanoPlan(R), and NanoActivator(R) are components of the therapy and have received EU-wide regulatory approval as medical devices for the treatment of glioblastoma. MagForce, NanoTherm, NanoPlan, and NanoActivator are trademarks of MagForce AG in selected countries.
Barbara von Frankenberg
VP Communications & Investor Relations
M [email protected]
For more information, please visit: www.magforce.com
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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.
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