Nanostart subsidiary MagForce Nanotechnologies AG, has reported financial results and company highlights for the fiscal year ended December 31, 2010. In 2010, the company laid the groundwork to bring its novel NanoTherm therapy to the market.
In June of last year, MagForce received EU approval for its medical products, NanoTherm® and NanoActivator™, for the treatment of brain tumors. Through two capital measures, the company secured access to EUR 23.4 million to restructure the company from its former research focus and build development and commercial expertise.
“In the last year, we made significant progress in strengthening our financial basis, hiring key individuals with industry expertise, and establishing the commercial structures necessary for product launch. Due to the extensive technical processes associated with the construction and certification of the first commercial NanoActivator for the first NanoTherm therapy center in Berlin, the preparation time for commercial patient treatment has taken longer than anticipated,” said Dr. Peter Heinrich, CEO of MagForce.
Heinrich continued, “We are pleased that our first treatment center has now been established at the Charité University Hospital Berlin, and we expect to begin patient treatments soon. Bringing a novel medical technology to the market presents many challenges, and we will continue to work with leading medical centers and neurooncology experts to make NanoTherm therapy available to brain tumor patients who are in need of new therapeutic options.”
Gradual European Product Launch
MagForce’s European sales and marketing activities are currently focusing on Germany as the first market. In order to reach as many patients as possible, the company is targeting regional centers specialized in the treatment of glioblastoma, the most common and aggressive type of brain tumor.
In preparation for product launch, MagForce already began in 2010 with the restructuring of the company and expanding its expertise from a research only focus to include the individuals and capabilities needed to bring a novel technology to the market. The hiring of the sales and marketing team was completed in March of 2011, and through their activities at international conferences and meetings with treating physicians, the first steps for introducing NanoTherm therapy to the market have been initiated.
Over the next two years, European market introduction will be expanded to other key countries (UK, France, Italy, and Spain). In addition, MagForce is pursuing business collaborations in Asia, Russia, and North American with local partners as part of the international rollout.
In 2010, the company successfully carried out two equity measures to secure access to EUR 23.4 million and ensure the initiation of its European market launch. At the beginning of May 2010, MagForce signed a Standby Equity Distribution Agreement (SEDA) with YA Global Master SPV Ltd. (YA Global), in which, for a three year period, YA Global commits to subscribe and purchase up to EUR 20 million of newly issued MagForce shares. In addition, the company raised an additional EUR 3.4 million through a capital increase in June of 2010. The shares were placed with German and international institutional shareholders.
With a secure financial basis in place, the company was able to expand its management team and hire experienced individuals to build sales and marketing and support product commercialization. Due to these expenditures, net loss for 2010 increased as expected to EUR 7.4 million from EUR 4.1 million in 2009.
The net loss relates directly to the increase in other operating expenses from EUR 1.0 million in 2009 to EUR 3.7 million in 2010. The increase can be mainly attributed to costs associated with financing activities and projects relating to market access strategy, reimbursement for the key European markets, medical software development, and corporate finance. Headcount increased from 24 in 2009 to 28 in 2010.
Clinical studies to expand therapeutic indications
NanoTherm therapy has great therapeutic potential to treat a variety of solid tumor indications. MagForce is aiming to initiate new clinical trials and explore the use of its technology in different oncological indications. The focus of the upcoming clinical development will be on pancreas and prostate carcinomas and trial designs are currently under discussion with national and international key opinion leaders along with medical experts in these fields.
Feasibility studies in pancreatic and prostate carcinoma are still ongoing and have already shown promising results. In addition, MagForce plans to initiate international multicenter trials in these indications for defined patient populations.
The prostate carcinoma trial will focus on early stage treatment to prolong the active surveillance period and support organ preservation for enhanced quality of life. Pancreas carcinoma is a disease with limited treatment options where NanoTherm therapy has the potential to prolong patient survival.
MagForce is also planning a further clinical trial in glioblastoma to generate additional data and support the expanded use of NanoTherm therapy in brain tumors in combination with other therapeutic options.