MagForce AG

  • ISIN: DE000A0HGQF5
  • Land: Deutschland

Nachricht vom 24.10.2018 | 08:30

MagForce AG Publishes Financial Results for the First Half of 2018 and Operative Highlights

DGAP-News: MagForce AG / Key word(s): Half Year Results

24.10.2018 / 08:30
The issuer is solely responsible for the content of this announcement.

MagForce AG Publishes Financial Results for the First Half of 2018 and Operative Highlights

  • Start of pivotal US prostate cancer study and treatment of first patients with NanoTherm therapy following U.S. FDA IDE approval in February and IRB approvals in April of this year
  • First ten patients expected to be treated until year-end 2018, results to be announced beginning of 2019
  • First collaboration agreement for NanoTherm therapy outside of Germany with one of the most prestigious brain cancer treatment centers in Poland
  • Successful capital increase of MagForce USA, Inc, with gross proceeds of USD 9.0 million (after period-end)

Berlin, Germany and Nevada, USA, October 24, 2018 - MagForce AG (Frankfurt, Scale, XETRA: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, published today its financial results for the first half of 2018, ending on June 30, 2018, and operative highlights.

"Whereas 2017 was a year in which we laid important cornerstones for our two-pillar strategy, 2018 has shaped up to be a year of delivering results," commented Ben Lipps, CEO of MagForce AG and MagForce USA, Inc. "Today, we are more confident than ever, that our strategy will pay off. We are excited to report the initial results of our prostate cancer study very soon and remain on target to start commercialization towards the end of 2019. We continue to see a huge market potential for our NanoTherm therapy in the US, which has the potential to tap into the prostate cancer market, worth an estimated 300 million USD, as a unique focal treatment option. In Europe, we will focus on establishing further treatment centers in selected European countries, obtaining domestic reimbursement and streamlining the cross-border reimbursement process. We look forward to a successful remaining 2018 and an exciting 2019 with many inflection points ahead."

Operative Highlights:

US pivotal study for unique focal treatment option of prostate cancer progressing well

In February 2018, the U.S. FDA granted approval for MagForce's IDE application. An important milestone and significant step towards the approval of MagForce's therapy for the treatment of prostate cancer patients in the US that allowed the Company to commence with a pivotal clinical evaluation of NanoTherm therapy as focal ablation treatment for intermediate risk prostate cancer at selected medical centers in the US with the objective to demonstrate that this approach can ablate prostate cancer lesions.

After receiving Institutional Review Board (IRB) approval from the two clinical US sites, the CHRISTUS Santa Rosa Hospital - Medical Center and the University of Washington, MagForce USA, Inc. started enrolling the first patients in this pivotal, staged, single arm study in July 2018 with results of the first ten patients treated with NanoTherm therapy expected to be published beginning of 2019. The Company still expects that this initial assessment will demonstrate ablation effectiveness with minimal side effects, and that the registration trial will prove that NanoTherm therapy will allow men diagnosed with prostate cancer to have a higher quality of life, while delaying or even avoiding invasive treatments. Subject to a successful completion of the trial, MagForce targets initial commercialization towards the end of 2019. Management continues to see a huge market potential for the Company's NanoTherm therapy in the US, which has the potential to tap into the prostate cancer market, worth an estimated 300 million USD, as a unique focal treatment option.

Refined strategy accelerates European roll-out to provide brain cancer patients fast access to therapy

In Europe, the Company's refined commercial strategy is starting to bear first fruits. To provide accelerated treatment options, speed up the European roll-out and drive uptake, MagForce has, for one, developed a mobile solution for the placement of NanoActivator devices enabling the Company to place the devices sooner and more cost-effectively in further European countries. The response to this strategic revision was well received and MagForce signed the first collaboration agreement with one of the most prestigious brain treatment centers in Poland, the Independent Public Clinical Hospital No. 4 in Lublin, in June of this year. Prof. Dr. hab. n. med. Tomasz Trojanowski, Head and Chairman of the Department of Neurosurgery and Paediatric Neurosurgery, with the support of his renowned medical team of qualified and experienced doctors and nurses will introduce and provide access for brain cancer patients to be treated with NanoTherm therapy in the country. For that purpose, preparations for the installation of a mobile container containing a NanoActivator device towards the end of the year are currently underway. With a majority of all patient inquiries who could qualify for NanoTherm therapy coming from this country, Poland, together with Germany and Italy, makes up one of the key markets for MagForce's NanoTherm therapy within Europe.

MagForce's market development team continues to diligently work on identifying and building relationships with further possible partner hospitals throughout Europe and management is confident, that the Company will soon be able to announce additional collaboration agreements.

Results of operations, net assets and financial position

Revenue and other operating income amounted to EUR 9,222 thousand (previous year: EUR 1,289 thousand). The increase mainly stems from the the transfer of shares in MagForce USA, Inc. to MagForce USA Holding GmbH and the resulting disclosure of hidden reserves in the amount of EUR 8,769 thousand.

Personnel expenses remained on last year's level with EUR 1,729 thousand (previous year: EUR 1,707 thousand). Other operating expenses decreased to EUR 1,527 thousand (previous year: EUR 1,876 thousand) mainly due to the absence of financing costs in connection with the borrowing transactions of the previous year.

In total, the Company generated a net profit for the period of EUR 4,106 thousand compared to a net loss of EUR 3,023 thousand in the previous year.

The cash outflows from operating activities amounted to EUR -4,009 thousand (previous year: EUR -3,154 thousand). The cash outflow from operating activities was derived indirectly from the net profit for the half-year. The cash outflows mainly relate to the financing of operating activities.

The cash outflows from investing activities amounted to EUR -516 thousand (previous year: TEUR -3 thousand).

The cash flows from financing activities amounted to EUR 9,189 thousand (previous year: EUR 10,285 thousand) and is in the reporting period mainly attributable to the call of the first tranche of the EIB loan, in the previous year to the issue of the convertible bond and the capital increase.

Cash and cash equivalents increased by EUR 4,664 thousand to EUR 5,330 thousand (December 31, 2017: EUR 666 thousand).

Financing transactions of the Company

To improve liquidity and to accelerate the on-going international expansion, the Company executed the following financing measures during the first half of the year.

On January 8, 2018, the first tranche of EUR 10.0 million of the financing agreement with the European Investment Bank (EIB) signed in the third quarter of 2017, was disbursed. The first tranche has a maturity of 5 years.

To finance the initiated pivotal clinical trial in the USA with NanoTherm therapy for focal tumor ablation in intermediate risk prostate cancer and associated business operations, MagForce subsidiary MagForce USA, Inc. carried out a successful capital increase by exercising 700,000 subscription rights of MagForce USA, Inc. and by issuing 166,666 new shares in MagForce USA, Inc. The subscription rights were issued to US investors as part of a growth financing round in 2014 and had a term limit of four years. There are no outstanding subscription rights remaining after the exercise. The new MagForce USA, Inc. shares were subscribed by a new US investor. The issuance of a total of 866,666 new shares generated gross proceeds of approximately USD 9.0 million for MagForce USA, Inc.

Following the issue of the new shares, MagForce AG holds 67.9 percent of the shares in MagForce USA, Inc. and will continue to retain a majority ownership position in the US subsidiary. Post transaction ownership structure MagForce USA, Inc.: MagForce AG 67.9 percent, Lipps & Associates 17.0 percent, other US investors 15.1 percent.

Outlook and financial prognosis 2018 and beyond

The outlook for the year 2018, as reported in the 2017 annual report, published on May 3, 2018 was reaffirmed by the management:

For the remainder of the financial year 2018, MagForce will continue to focus on executing its two-prongued approach in its key markets the US and Europe.

In the US, MagForce plans to conduct its pivotal prostate cancer study as quickly as possible targeting to start commercialization towards the end of 2019. In Europe the Company anticipates to enter into additional collaboration agreements and establish further treatment centers in selected European countries, obtain domestic reimbursement and streamline the cross-border reimbursement process.

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 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 brain tumors. MagForce, NanoTherm, NanoPlan, and NanoActivator are trademarks of MagForce AG in selected countries.

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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.

Barbara von Frankenberg
Vice President
Communications & Investor Relations

T +49-30-308380-77

24.10.2018 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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