23.11.2015

MagForce USA Installs the First Clinical NanoActivator® in the USA

Berlin, Germany, and Nevada, USA, November 23, 2015 - MagForce AG (Frankfurt, Entry Standard, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, announced today that MagForce USA, Inc., MagForce AG’s US subsidiary, has successfully installed the first clinical NanoActivator® in the USA. This NanoActivator® is similar in design to the five NanoActivator® devices operating at University Hospitals in Germany applying NanoTherm™ Therapy for the treatment of Brain Tumors. However, the USA NanoActivator® has been modified to apply NanoTherm™ Therapy for the treatment of Prostate Cancer in addition to the treatment of Brain Tumors.

 

The USA NanoActivator® is located in Seattle, Washington, near the University of Washington Medical Center, and will be utilized in the Focal Thermal Ablation Registriation Study for Prostate Cancer for which the Company has filed an Investigational Device Exemption (IDE) with The US Food and Drug Administration (FDA) in May 2015.


About MagForce AG and MagForce USA, Inc.


MagForce AG, listed in the entry standard 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. Mithril Capital Management, a growth-stage technology fund founded by Ajay Royan and Peter Thiel, along with MagForce AG, are investors and strategic partners in MagForce USA, Inc.

 

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.

 

30.09.2015

MagForce AG Publishes Financial Results for the First Half of 2015 and Operative Highlights

Full Report (180 KB)

  • Installation of further NanoActivator devices at University hospitals in Cologne and Frankfurt
  • Start of commercial treatments at three renowned clinics in Germany and expansion of commercial brain therapy recruitment
  • Pre-Submission meeting with the US FDA for MagForce's NanoTherm focal therapy for Intermediate Risk Prostate Cancer and filing of Investigational Device Exemption (IDE)
  • Extension of outlicensing NanoTherm therapy in the territories Mexico and Canada leads to proceeds of EUR 3.0 million
  • Outlook for 2015 confirmed


Berlin, Germany, and Nevada, USA, September 30, 2015 - MagForce AG (Frankfurt, Entry Standard, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, published today financial results for the first half of 2015, ending on June 30, 2015, and operative highlights.

 

"I am pleased to report that we continue to make progress toward achieving our 2015 targets and setting the stage for a successful year 2016. At the end of this year we will have six NanoActivator devices operational in Germany and additional centers trained to perform the instillation of the nanoparticles, giving us sufficient capacity to complete enrollment in our Post-Marketing Glioblastoma Study and as well as to accomplish our commercial treatment targets through 2017. Although we expect to meet our 2015 financial target as forecasted to date, we have achieved less revenue from commercial patients than planned. Clearly this is below my target, but we have taken measures to accelerate this pace to achieve our 2016 objectives. We are in the process of expanding our commercial brain therapy recruitment. In addition, we have expanded the opportunity for NanoTherm therapy to treat primary Glioblastoma Brain Tumors in combination with surgery and radiation. These and other measures will enable an increasing number of patients to benefit from NanoTherm therapy," commented Dr. Ben J. Lipps, CEO of MagForce AG and MagForce USA, Inc. "Regarding the application of our NanoTherm therapy for the focal treatment of Prostate Cancer, MagForce USA, Inc. has filed an IDE with the USA Food and Drug Administration (FDA) in May. This is a significant milestone for MagForce USA, Inc. and MagForce AG. The study treatment uses MagForce's proprietary NanoTherm technology to completely ablate Prostate Cancer lesions. We believe the registration clinical trial will prove that NanoTherm therapy can fulfill the desired outcome and we are now working with the FDA to advance the registration approval in the USA."


Results of operations, net assets and financial position

In the first half of 2015, MagForce has started commercialization and reached further important milestones. This led to revenues of EUR 1.3 million from the sale of the NanoTherm therapy to commercial patients and the sale of two NanoActivator devices to MagForce USA, Inc. Net profit was EUR 0.5 million (previous year: EUR 3.8 million), mainly due to the extension of the outlicensing of NanoTherm therapy in the territories of Mexico and Canada which led to proceeds amounting to EUR 3.0 million. The previous year's net profit was mainly due to the outlicensing of NanoTherm therapy in the US territory for the treatment of Prostate Cancer which led to proceeds of EUR 6.9 million. Adjusting for these outlicensing effects, net loss for the period was reduced by EUR 0.6 million compared to the previous year's loss. Other operating expenses decreased by EUR 0.6 million primarily due to lower legal and consulting costs and the reduction of patent costs. Other operating income amounted to EUR 3.6 million (previous year: EUR 7.1 million) and is mainly due to the outlicensing of the US rights to MagForce Ventures GmbH.
Cash outflows from operating activities amounted to EUR -3.8 million (previous year:
EUR -3.5 million), mainly as a result of accelerating the operating business. The available liquidity at the end of the period was EUR 5.5 million (December 31, 2014: EUR 9.1 million).


Financial outlook 2015

The financial outlook for the year 2015, as reported in the 2014 annual report published on June 30, 2015, was reaffirmed by management. Those forecasts and statements therefore continue to apply.

 

Given the rollout plan and the ongoing clinical study, the Company expects the net loss for the fiscal year 2015 to be higher than in 2014. This increase in net loss is due to the reduction of special measures taken in 2014 from the out-licensing of distribution rights and to increased commercialization efforts, which can be seen in the context of the corresponding focus of the Company on key strategic value drivers. However, management expects revenues from commercial patients to start in 2015. For the fiscal year 2015, MagForce AG is forecasting a lower negative operating cash flow, which is partly due to increased cash revenue from product sales.


Investor Relations

Shareholders have been informed about current developments via a quarterly letter to shareholders, and four analysts are now covering MagForce AG. Additionally, research updates were presented by Berenberg (EUR 8.65) and Hauck & Aufhäuser (EUR 12.40). Futhermore, GBC AG initiated research coverage and presented an update. The target price in the update was increased from EUR 13.20 to EUR 14.30. All reports are listed on the Company's website www.magforce.com.

 

For a detailed overview of our Investor Relations activities, conferences and roadshows, please see the chapter "Shares and Investor Relations" of the full half year report.


About MagForce AG and MagForce USA, Inc.

MagForce AG, listed in the entry standard 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. Mithril Capital Management, a growth-stage technology fund founded by Ajay Royan and Peter Thiel, along with MagForce AG, are investors and strategic partners in MagForce USA, Inc.

 

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(TM), NanoPlan(R), and NanoActivator(R) 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.

 

Contact:
Anne Hennecke
MC Services AG

T +49 211 529252-22
F +49 211 529252-29

Email:

 

18.08.2015

MagForce AG announces positive results of 2015 Annual General Meeting

  • The Annual General Meeting approves all agenda items with a clear majority
  • Executive Board and Supervisory Board have been discharged

Berlin, Germany, August 18, 2015 - MagForce AG (Frankfurt, Entry Standard, Xetra: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, held its Annual General Meeting in Berlin today. The Annual General Meeting approved all resolution items with a clear majority.

 

The CEO and Chairman of the Management Board, Dr. Ben J. Lipps, explained the current operational developments in detail and provided an overview of the 2014 fiscal year, as well as an outlook for the current year. Subsequently, he updated the status of his strategic five-year plan.

 

The Management Board and Supervisory Board were pleased by the positive election results.


The Management Board presentation is available on the Company's website at www.magforce.de/en/presse-investoren/hauptversammlung.


About MagForce AG and MagForce USA, Inc.

MagForce AG, listed in the entry standard 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(TM) therapy enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles. Mithril Capital Management, a growth-stage technology fund founded by Ajay Royan and Peter Thiel, along with MagForce AG, are investors and strategic partners in MagForce USA, Inc.

NanoTherm(TM), NanoPlan(R), and NanoActivator(R) 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
Get to know our Technology: video (You Tube)
Stay informed and subscribe to our mailing list.

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.

Contact: Anne Hennecke MC Services AG T +49 211 529252-22 F +49 211 529252-29 Email: anne.hennecke@mc-services.eu

 

30.06.2015

MagForce AG Publishes Financial Year Results 2014 and Operative Highlights

  • Start of clinical post-marketing study with glioblastoma (GBM) patients
  •  Installation of further NanoActivator(R) devices at University hospitals in Cologne and Frankfurt and start of commercial treatments at three renowned clinics in Germany (after period-end)
  • Incorporation of subsidiary MagForce USA, Inc. and successful closing of a growth financing round under the lead of Mithril Capital Management
  • Pre-Submission with the US FDA for MagForce's NanoTherm(TM) Focal Therapy for Intermediate Risk Prostate Cancer and filing of Investigational Device Exemption (IDE, after period-end)
  • Successful capital increase for MagForce AG

 

Berlin, Germany, and Nevada, USA, June 30, 2015 - MagForce AG (Frankfurt, Entry Standard, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, published today its financial results for the fiscal year ending on December 31, 2014 and operative highlights.

 

Operative Highlights:

 

Brain Cancer NanoTherm(TM) Therapy at MagForce AG

After establishing two further NanoActivator(R) devices at the University Hospitals in Münster and Kiel, in addition to the one at University Medical Center Charité in Berlin at the end of 2013, MagForce treated the first patient in its resumed Post Marketing Study MF 1001 in the first quarter of 2014. Additional NanoActivator(R) devices became operational in the world class hospitals in Frankfurt and Cologne during the first half of 2015, and the installation of the sixth NanoActivator(R) at the University Hospital at Göttingen is on schedule. This gives MagForce sufficient capacity to complete enrollment in its Post Marketing Glioblastoma Study as well as to accomplish its commercial treatment targets through 2017.

 

Commercial NanoTherm(TM) treatments have restarted in early 2015 and can now be more broadly performed, as NanoTherm(TM) therapy has CE certifications for the treatment of all Brain Cancers while the application of NanoTherm(TM) therapy in the Post Marketing Study is limited to recurrent Glioblastoma.

 

Prostate Cancer Therapy at MagForce USA, Inc.

Regarding the application of NanoTherm(TM) therapy for the focal treatment of Prostate Cancer, MagForce's unique technology is viewed as a very promising complement to current treatment approaches. In November 2014, the Company filed a Pre-Submission for NanoTherm(TM) therapy in intermediate risk Prostate Cancer with the FDA's Center for Devices and Radiological Health. Subsequently, in January 2015, an in-person meeting was held to discuss the agency's response. During this meeting MagForce received very constructive feedback on its submission and gained an understanding of the pathway to market in the USA. Based on this, MagForce USA, Inc. has recently filed an IDE with the FDA, and is now preparing itself to start the registration trial, once approved. The study, which is expected to enroll 120 patients, uses MagForce's NanoTherm(TM) technology to completely ablate Prostate Cancer lesions. By ablating the lesions, patients should be able to maintain active surveillance and avoid surgery and other treatments, with all the well-known side effects like impairment of urinary and sexual functions.

 

Corporate Update

On March 10, 2014, MagForce AG incorporated MagForce USA, Inc., based in Nevada, USA, as a wholly owned subsidiary. This company will be responsible for opening up the North American market (USA, Puerto Rico, Mexico, Canada) for the Company's technologies and products. To strengthen the strategic focus of MagForce USA, Inc., all shares of MagForce Ventures GmbH were transferred to MagForce USA, Inc. against the issuance of 5,000,000 shares on May 15, 2014. In addition, a growth financing round was closed in the further course of 2014, with total proceeds of USD 15 million and an option to increase the size of the round to USD 30 million. Mithril Capital Management, founded by Ajay Royan and Peter Thiel, and MagForce AG are investors and strategic partners of MagForce USA, Inc. Because of the previously transferred prostate indication rights to MagForce Ventures GmbH, the US company is now fully able to start the process of developing and marketing NanoTherm(TM) therapy in this indication by itself.

 

Financial Results and Outlook:

 

Results of operations, net assets and financial position

MagForce's financial development in the fiscal year 2014 was in line with the Company's expectations. MagForce came closer to commercialization of its NanoTherm(TM) therapy and reached additional important milestones. Net loss was at EUR 1.0 million, so that is EUR 0.6 million below the previous year. However, excluding in both years the effects of outlicensing NanoTherm(TM) therapy rights for prostate cancer and brain tumors for the North America region (2014: EUR 6.9 million; 2013: EUR 5.2 million), net loss increased by EUR 1.2 million. This was mainly due to higher personnel costs resulting from an increased average staff number, the enlargement of the Management Board, and bonus payments in connection with financing rounds. Other operating expenses were affected by the increase of Investor Relations activities relating to the financing rounds in 2014, and associated rises in travel, legal, and consulting costs. Accordingly, operating expenses developed as forecasted.

Cash outflow from operating activities amounted to EUR 8.7 million, compared to EUR 6.8 million in the previous year. This increase relates primarily to higher operating expenses.

Liquidity at the end of 2014 was EUR 9.2 million, so this figure was nearly unchanged from the previous year (EUR 9.3 million). Overall, our capital structure has improved significantly in the last few years.

 

Outlook 2015

Looking forward, MagForce will have completed its target of installing and operating six NanoActivators(R) in Germany during the third quarter of 2015. This accomplisment will provide an operational clinical NanoTherm(TM) therapy structure to demonstrate expected medical value of NanoTherm(TM) therapy for the treatment of brain tumors as well as to continue the Post Marketing Glioblastom Study in Germany. During the second half of 2015, MagForce AG will also expand its efforts to establish a reimbursement structure for commercial NanoTherm(TM) brain cancer therapy in addition to that of private pay.

With respect to the Company's expansion phase outside Germany, MagForce USA, Inc. plans to submit an IDE with the FDA for the treatment of brain cancer with NanoTherm(TM) therapy after the approval has been granted for its IDE for the NanoTherm(TM) treatment of Intermediate Risk Prostate Cancer.

Given the roll-out plan and the ongoing clinical study, the Company expects the net loss for the fiscal year 2015 to be higher than in 2014. This increase is due to the discontinuation of special measures taken in 2014 from the out-licensing of distribution rights and to increased commercialization efforts, which can be seen in the context of the corresponding focus of the Company on key strategic value drivers. However, management expects revenues from commercial patients to start in 2015. MagForce treated a limited number of patients during the first half of 2015 but the Company expect to accelerate this process as 2015 progresses. For the fiscal year 2015, MagForce AG is forecasting a lower negative operating cash flow, which is partly due to increased cash revenue from product sales.

With its liquidity the Company will be able to cover its expenses until 2017.

 


About MagForce AG and MagForce USA, Inc.

MagForce AG, listed in the entry standard 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(TM) therapy enables the targeted treatment of solid tumors through the intratumoral generation of heat via activation of superparamagnetic nanoparticles. Mithril Capital Management, a growth-stage technology fund founded by Ajay Royan and Peter Thiel, along with MagForce AG, are investors and strategic partners in MagForce USA, Inc.

 

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

 

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

Get to know our Technology: video (You Tube)

Stay informed and subscribe to our mailing list.

 

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.



Contact:
Anne Hennecke
MC Services AG

T +49 211 529252-22
F +49 211 529252-29

Email: