• Ben J. Lipps new Chairman of the Management Board and Chief Executive Officer of MagForce AG since September 1, 2013
• Installation of two additional NanoActivator(R) devices at university hospitals Münster and Kiel
• Start of clinical post-marketing study with glioblastoma (GBM) patients (after period-end)
• Incorporation of subsidiary MagForce USA, Inc. (after period-end)
• Pre-IDE-Meeting with U.S. Food and Drug Administration (FDA) discussing registration process for NanoTherm(TM) therapy in the USA (after period-end)
Berlin, Germany and Nevada, USA, June 30, 2014 - MagForce AG (Frankfurt, Entry Standard, XETRA: MF6), 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, 2013 and operative highlights.
Ben J. Lipps, CEO at MagForce, explained: “I am pleased to report that we achieved our 2013 targets and are progressing well toward achieving our objectives for the year 2014. Regarding our brain cancer therapy, our main objective for 2013 was to facilitate our post-marketing clinical study in recurrent glioblastoma (GBM) patients in Germany. Together with our clinical investigators, we have reached a very significant milestone in the first quarter of 2014, with the enrollment of the first patient into the study at Münster University Hospital. We also expect to treat patients commercially at the end of 2014. With respect to our expansion phase outside Germany, we continue preparing our registration path for the USA. In an in-person meeting with the U.S. Food and Drug Administration (FDA) we discussed MagForce’s NanoTherm(TM) therapy presubmission. We received very constructive feedback on our request and have now a better understanding of the issues and process for the registration of NanoTherm(TM) therapy in the USA. Regarding the application of our NanoTherm(TM) therapy for the treatment of prostate cancer, NanoTherm(TM) is viewed as a very promising complement to current treatment approaches.”
With the incorporation of MagForce Ventures GmbH in 2013 and subsequently of MagForce USA, Inc. in spring 2014 together with the grant of a license for the development and commercialization of NanoTherm(TM) therapy in the field of brain tumors the USA, MagForce established the basis to tap the US market and attract new groups of investors as well as new clients. In order to keep pace with the fast progress, MagForce wants to increase the awareness for the Company in the financial community and presented at various capital market conferences in the first half of 2014.
Results of operations, net assets and financial position
The key financials for the fiscal year 2013 developed according to plan. The loss from operations increased to EUR 7.0 million compared to 2012 (EUR 5.8 million), largely due to the start of the post-marketing clinical glioblastoma study and to preparations for market entry through the Management’s increased efforts to bring more devices to the market. Other operating expenses increased from EUR 3.2 million in 2012 to EUR 4.2 million in 2013, also attributable to the capital increase in the beginning of the fiscal year, increased capital market activities in general and corresponding consulting fees. On the other hand results of the restructuring measures taken in 2012 materialized for the first time in full 2013 resulting in a reduction of administrative expenses. The net loss of EUR 1.6 million was significantly lower than in 2012 (EUR 5.7 million) due to an accounting gain in connection with the contribution to equity of a license to develop and commercialize the NanoTherm (TM) therapy for the treatment of brain tumors in the USA to our newly established subsidiary MagForce Ventures GmbH. These shareholdings were subsequently contributed to MagForce USA, Inc. against issuance of shares in 2014.
Cash outflows from operating activities were EUR -6.8 million (2012: EUR -5.5 million). Cash outflows from investing activities amounted to EUR -0.9 million (2012: EUR 0 million), and cash flows from financing activities to EUR 16.3 million (2012: EUR 6.2 million).
The available liquidity at the end of 2013 amounted to EUR 9.3 million (2012: EUR 0.7 million). During the reporting period, the Company received cash funds of EUR 17.6 million from capital increases.
As a result of the capital increase, MagForce has no debt as of Decemer 31, 2013.
Outlook 2014
In the year 2014, the Company will focus on continuing to establish additional NanoTherm(TM) therapy centers throughout Germany as well as on developing the US market by initiating the registration process with the FDA through its newly founded subsidiary MagForce USA, Inc. Given the roll-out plan and the ongoing clinical study, the Company expects operating expenses and negative operating cash flow to be higher in 2014 than in the previous year. This increase is in line with the measures taken in 2013 and the corresponding focus of the Company on key strategic value drivers. However, management expects first revenues from the commercial treatment of patients starting at the end of 2014.
About MagForce AG
MagForce AG, listed in the entry standard (MF6), together with its subsidiary MagForce USA, Inc. is a leading medical device company in the field of nanomedicine in 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. 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.
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
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