Original-Research: MagForce AG - von GBC AG
Einstufung von GBC AG zu MagForce AG
Unternehmen: MagForce AG
Anlass der Studie: GBC Management Interview
Empfehlung: Management Interview
Analyst: Cosmin Filker
MagForce AG, which is specialized in the field of nanomedicine with a focus
on the treatment of malignant brain tumors (glioblastoma) and prostate
cancer, has made further progress in recent months. The Company currently
has EU-wide certification for glioblastoma treatment and is also seeking
approval in the US for the treatment of prostate cancer. MagForce CEO Dr.
Ben Lipps spoke to GBC analyst Cosmin Filker about the latest company
Cosmin Filker: In early 2018 the FDA approved a clinical trial for the
treatment of prostate cancer and in July 2018 the first patient was already
recruited. What is your assessment regarding the current clinical trial
Dr. Ben Lipps: The trial you are referring to is our pivotal, staged,
single-arm study that will enroll up to 120 men. We want to demonstrate
that NanoTherm therapy can focally ablate prostate cancer lesions with
minimal side effects.
As background, this is the very first time that MagForce is applying
NanoTherm therapy as a focal treatment. Although the NanoTherm therapy is
recognized and approved as a device, the FDA considered our nanoparticles
as a drug in 2015. During 2016 and 2017, MagForce re-conducted the ten-
year-old studies to the latest FDA preclinical standards. MagForce
demonstrated to the FDA, that the nanoparticles remain at the injection
site and do not wander in the patient's body, and thus can be classified as
medical device rather than as drug, as opposed to a classification as a
drug, which would have required years of very expensive clinical testing to
After having reviewed all the safety data and new preclinical data that
MagForce provided in 2016 and 2017, the FDA granted us Investigative Device
Exemption (IDE), which allowed us to start patient recruiting at the first
clinic in July 2018. This was a major achievement for MagForce in bringing
our innovative prostate cancer treatment to the patients.
As part of Stage I of this clinical trial, we took the required time and
focused our work during the past months on precisely injecting our
NanoTherm particles into the targeted human prostate Region of Interest
In this context, MagForce diligently worked to quantify the effect of
prostate perfusion and optimized the nanoparticle infusion process with the
latest, cutting-edge biopsy technology that is available for surgeons. We
introduced a standardized process for the instillation of the particles, to
ensure that it is equal across all study physicians. Based on our
experience so far, we anticipate to show with successful completion of
Stage 1 that there are only minimal treatment-related side effects which
are tolerable and similar to those commonly associated with biopsies.
Cosmin Filker: You previously mentioned, that you had to show to the
regulators that you can precisely instill the nanoparticles into the
lesions. Could you explain this in more detail?
Dr. Ben Lipps: Of course. 10 years ago, the technology to conduct targeted
biopsies did not exist. Today, we are using this cutting-edge technology
(MRI-ultrasound fusion biopsies technology) to instill the NanoTherm
particles but we are utilizing a different injection needle. However,
contrary to the isolated whole prostate gland studies that were conducted
10 years ago, our objective is to contain the nanoparticles in the 2-4 cc
of the suspected cancerous region - the lesion. This focal application
required an injection speed of about 1/5 of the speed used in the old whole
gland study to allow for the NanoTherm particles to conjugate in the region
of interest, which ensures they will remain in that region. During the
treatments so far, we have shown that NanoTherm particles can be accurately
instilled in the targeted treatment area in the minimally invasive
Cosmin Filker: This means that the original timetable for the planned
marketing authorization as of late 2019 is not valid anymore? What could an
updated possible schedule look like?
Dr. Ben Lipps: After the extensive work over the past months, I do not
think it is realistic for us to commercially launch NanoTherm therapy in
the US in 2019. Please keep in mind that this is the very first time that
such an innovative focal treatment approach to ablate prostate cancer
lesions has been tested on patients in the US. In Stage I, Mag-Force has to
proceed diligently with the first 10 patients, as we define the therapy to
be used in the next 100-patient stage. This process cannot and should not
be rushed in the very best interest of the physicians but most importantly
However, in 2019 we will proceed with introducing the ambulatory
NanoActivator chair to select urology programs, so called Active
Surveillance Programs, to allow gaining experience with training phantoms,
which are commonly used for new urological procedures. My new target for
commercialization is 2020. The delay is due primarily to the extra effort
MagForce USA had to perform to achieve device status for our nanoparticles
- like I said before: as opposed to a classification as a drug, which would
have required years of very expensive clinical testing to obtain approval.
However, our nanoparticles are the only nanoparticles with a device status.
Cosmin Filker: So, patient recruitment is key. Are you confident to be able
to successfully enroll the requested amount of prostate cancer patients?
Dr. Ben Lipps: Yes, absolutely. As mentioned before, we have now extended
patient enrollment to three urological centers - Texas Urology Group,
University of Texas, San Antonio and University of Washington, Seattle. All
three of them are currently continuing to actively enroll male patients
aged 40-85 that are diagnosed with intermediate risk prostate cancer to be
treated at one of the two US study sites, the University of Washington
Medical Center in Seattle and the CHRISTUS Santa Rosa Hospital - Medical
Center in San Antonio. We are very fortunate to be working together with
such well-respected partners for the recruitment with their extensive
Within the near future, we will be setting up a third site in the Eastern
region of the United States.
The University of Washington (UW) Medicine group consists of a network of
hospitals and clinics that reach from Olympia to Bellingham, Washington, a
catchment area housing of as well nearly six million people. Through their
extended network, e.g. partnerships with the Seattle Cancer Care Alliance/
Fred Hutchinson Cancer Research Center, one of the top ten cancer research
facilities in the country, and the willingness of patients to travel for
cancer care, this number is even significantly higher. An initial
evaluation of the electronic health records system at UW Medicine shows
30,000 patients with prostate cancer diagnoses currently being cared for by
UW. The San Antonio/Austin and South Texas region alone has a similar
catchment area housing nearly six million people.
The therapy procedure in the next stage is projected to require a one-day
stay at one of MagForce's NanoActivator facilities. Therefore, patients can
be recruited from across the USA in addition to the catchment areas
surrounding the MagForce facilities.
Cosmin Filker: The MagForce technology is already certified in Europe for
the treatment of glioblastoma. Recently, you announced the installation of
the first mobile treatment center in Poland. How is the response so far?
Dr. Ben Lipps: Immediately when we began treating patients commercially in
Germany in late 2015 and early 2016, we saw an elevated interest for the
therapy in patients from Poland. In 2018, MagForce had over 700 inquiries
and about 40% of these inquiries were from Poland. With our NanoActivator
in Poland, these patients have a significantly reduced economic burden to
receive treatment since non-NanoTherm therapy procedures are all reimbursed
in Poland and they receive the treatment in their home country.
Consequently, only the NanoTherm therapy must be funded by private pay or
crowd-funding until MagForce can get reimbursement for the NanoTherm
Cosmin Filker: What is the rollout strategy for Europe and Germany?
Dr. Ben Lipps: Due to the aggressive nature of glioblastoma, there is a
narrow window for patients to receive treatment. In order for patients to
benefit from our NanoTherm therapy, access has to be fast. To this end, the
goal of our European roll-out plan is to establish treatment centers in
selected European countries to allow patients to be treated in their
homeland. Mobile treatment center enable us to place the devices more
quickly and cost-effectively by avoiding protracted construction and
allowing for easy integration into existing hospital infrastructure.
Although the highest interest in our therapy stems from patients from
Poland we also register high numbers of patient inquiries from Italy and
Spain and are currently in negotiations with an Italian and a Spanish
clinic. In addition, we are delighted to report, that additional hospitals
in Germany have displayed strong interest in our therapy and we expect to
open another treatment center in Germany, too.
Cosmin Filker: To what extent is achieving reimbursement by health
insurances in Europe and in the USA decisive for the use of the MagForce
Dr. Ben Lipps: Achieving reimbursement is of course an important factor
when it comes to selecting a treatment plan. The reimbursement in Germany
so far was achieved in a rather lengthy process for each individual
patient/case. As previously communicated, we now have the number of cases
necessary for the NanoTherm treatment centers to be able to negotiate their
budgets with the health insurance providers. These negotiations are
currently ongoing and we support the clinics in every way we can in order
to achieve the best possible result and facilitate the reimbursement
Cosmin Filker: MagForce AG entered into a financing agreement with the
European Investment Bank (EIB) totaling EUR 35 million. Will the EIB
financing ensure sufficient funding until the comprehensive market entry in
the USA and Europe?
Dr. Ben Lipps: Over the past two years, we have secured the necessary
funding to drive MagForce through our next inflection points and execute
our strategy. Moreover, the EIB loan offers us financial flexibility to
pursue our goals. With that said, I would still never rigorously exclude
any financial transaction as we need to remain flexible to operate
successfully and continue to evaluate all options open to us.
Cosmin Filker: Finally, another question for investors with a long-term
investment horizon: Where do you see MagForce AG in five years?
Dr. Ben Lipps: With the encouraging results we have seen so far from our
pivotal study, our confidence in our NanoTherm technology and unique
therapy feature remains high. I am positive that, after approval in the US,
MagForce will generate revenues north of 200 million Euro in five years
from now with a very favorable profit margin.
Cosmin Filker: Dr. Lipps, thank you for your time.
Die vollständige Analyse können Sie hier downloaden:
Kontakt für Rückfragen
0821 / 241133 0
Offenlegung möglicher Interessenskonflikte nach § 85 WpHG und Art. 20 MAR. Beim oben analysierten Unternehmen ist folgender möglicher Interessenkonflikt gegeben: (5a,5b,11); Einen Katalog möglicher Interessenkonflikte finden Sie unter:
Datum (Zeitpunkt) Fertigstellung: 06/05/19(09:33 am)
Datum (Zeitpunkt) erste Weitergabe: 06/05/19 (11:00 am)
-------------------übermittelt durch die EQS Group AG.-------------------
Für den Inhalt der Mitteilung bzw. Research ist alleine der Herausgeber bzw.
Ersteller der Studie verantwortlich. Diese Meldung ist keine Anlageberatung
oder Aufforderung zum Abschluss bestimmter Börsengeschäfte.