MagForce AG announces successful capital increase of the subsidiary MagForce USA, Inc.

DGAP-News: MagForce AG / Key word(s): Capital Increase
31.12.2019 / 11:42
The issuer is solely responsible for the content of this announcement.

MagForce AG announces successful capital increase of the subsidiary MagForce USA, Inc.

Berlin, Germany, and Nevada, USA, December 31, 2019 - MagForce AG (Frankfurt, Scale, Xetra: MF6, ISIN: DE000A0HGQF5), a leading medical device company in the field of nanomedicine focused on oncology, today announced the successful completion of a capital increase of its subsidiary MagForce USA, Inc. The issuance of a total of 292,200 new shares will generate gross proceeds of approximately USD 4.5 million for MagForce USA, Inc. The new MagForce USA, Inc. shares were subscribed by Lipps & Associates LLC, of which Ben Lipps, CEO of MagForce AG and MagForce USA, Inc., is the principal owner.

Following the issue of the new shares, MagForce AG holds 65.3 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 65.3 percent, Lipps & Associates 24.5 percent, other US investors 10.2 percent.

The proceeds from the capital increase will mainly be used to fund operational spending, Stage 2 of MagForce's pivotal clinical trial for the focal treatment of prostate cancer, and to prepare for commercialization.

MagForce USA, Inc. has completed enrollment and treatment for Stage 1 and now prepares for Stage 2 of its pivotal, single-arm study for the focal ablation of intermediate risk prostate cancer with NanoTherm therapy. With Stage 1 MagForce achieved the successful validation of a standardized clinical procedure for the instillation of MagForce's NanoTherm nanoparticles in the first patient cohort. Initial findings in this cohort showed only minimal treatment-related side effects which were tolerable and similar to those commonly associated with biopsies. The next Stage of the clinical trial is being initiated with three well-respected urological centers in the US who actively enrolled patients in Stage 1.

About Active Surveillance Progams in the USA

Within the past two decades, Active Surveillance Programs have been developed in the USA to follow the slow growth of Prostate Cancer in order to avoid the side effects of definitive therapy (radiation or surgery), for as long as possible. Currently, there are over 250 Active Surveillance Programs in the USA. Active Surveillance is the merging of watchful waiting and active management into a program that is interactive for the patient, ultimately allowing a man diagnosed with Prostate Cancer to monitor his disease and have the highest quality of life possible while delaying or even completely avoiding invasive treatments.

For the past decade, these Active Surveillance Programs have been seeking a focal therapy which would ablate the small tumors that have progressed to the intermediate risk stage because approximately 60% of the patients in Active Surveillance Programs who have participated in these programs for an extended period of time require definitive therapy such as whole gland surgery or radiation.

High medical need for a new less invasive, effective and well-tolerated treatment option

The purpose of this focal ablation registration study, which will enroll up to 120 men in a single arm study, is to demonstrate that NanoTherm therapy can focally ablate cancer lesions with minimal side effects for patients who have progressed to intermediate risk prostate cancer stage and are under active surveillance. By destroying these cancer lesions, it is anticipated that patients will be able to remain in Active Surveillance Programs and avoid definitive therapies such as surgery or whole gland radiation with their well-known side effects as long as possible.

"Even as the treatment landscape for prostate cancer has evolved, there remains an important unmet need for patients who have progressed to the medium-risk stage and for whom the benefits of treatment with current methods come with a significant risk of related side effects. NanoTherm therapy has the potential to significantly change the way we treat prostate cancer, because it allows for a less invasive, less aggressive treatment modality that could cure the cancer or, at a minimum, reduce a patient's chances of needing a more aggressive treatment in the future," Dr. Thompson III of the Texas Urology Group said. "About 30,000 men die of prostate cancer every year in the US. With NanoTherm therapy, we hope we can continue to reduce those numbers while avoiding the cost of surgery or radiation for some of those men."

Based on the positive findings from Stage 1, MagForce will now proceed with the next Stage of the study with urological specialist centers - Texas Urology Group, University of Texas, San Antonio, and University of Washington, Seattle. To further bolster recruitment and ensure broader geographic coverage as well as allow for more patients to be treated simultaneously, MagForce has added a third study site in the Eastern region of the United States in Sarasota, Florida at the Sarasota Inverventional Radiology Center lead by Dr. Gerald Grubbs.

To minimize the time needed for patient treatment, MagForce USA will streamline the focal procedure and with FDA approval, MagForce will offer the streamlined focal therapy to the patients who enroll in the next Stage of MagForce's pivotal study.

"This capital increase again shows my trust in MagForce's NanoTherm therapy. I am still very optimistic regarding the US market, which offers great market potential for the treatment of prostate cancer. This additional funding will be helpful to achieve our commercilization target of late 2020," commented Ben J. Lipps, CEO of MagForce AG and MagForce USA, Inc.

Contact:
Barbara von Frankenberg
Vice President Communications & Investor Relations
T +49-30-308380-77
E-Mail: bfrankenberg@magforce.com

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 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)

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.

31.12.2019 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.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at www.dgap.de