Original-Research: MagForce AG (von GBC AG)

Original-Research: MagForce AG - von GBC AG

Einstufung von GBC AG zu MagForce AG

Unternehmen: MagForce AG
ISIN: DE000A0HGQF5

Anlass der Studie: GBC Management Interview
Empfehlung: Management Interview
Letzte Ratingänderung: 
Analyst: Cosmin Filker

At the end of April 2020, MagForce received FDA approval to start the next
stage of the clinical trial for the treatment of patients with prostate
cancer. Until the end of 2020, the promising results achieved so far,
should be confirmed within the treatment of additional 100 patients. In the
recently published letter to shareholders, the company also reported on the
successful development in the treatment of brain tumors in Europe. GBC
analyst Cosmin Filker spoke with MagForce CEO Dr. Ben Lipps about recent
developments and future prospects:
 
Cosmin Filker: Now that FDA approval has been received for the next stage
of the clinical trial in prostate patients in the USA, the next step
towards approval in the USA can now be taken. What is the timetable for
this?
 
Dr. Ben Lipps: We are very pleased to have received FDA approval for the
next stage of our pivotal U.S. prostate cancer study; we are now initiating
the treatments with three well-respected urological centers in Texas,
Washington and Florida who actively enrolled patients in Stage 1. Initial
findings shown in Stage 1 were encouraging demonstrating a favorable safety
and tolerability profile as well as well-defined ablation and cell death in
the region of the nanoparticle deposit. Our positive experience from this
initial phase resulted in a streamlined trial protocol for the next stage
of our trial.
 
The approved next stage of our study will be conducted in phases to ensure
early on that the minimal side effects observed in Stage 1, with a drawn-
out procedure, are maintained in the streamlined one-day procedure.
Treatment of the first 5 to10 subjects should be sufficient to affirm the
minimal side effects as expected. This streamlined procedure will allow
patient treatment to be completed within one day at one of MagForce's three
out-patient treatment facilities. Which further means, that we can treat
patients much faster than in Stage 1. During Stage 1, each step,
instillation and activation took several weeks. Now, both steps will be
completed on the very same day, which should favorably affect the duration
of the trial. I therefore see a good chance of completing the patient
treatments still this year, as originally planned.
 
Cosmin Filker: What is the study objective that needs to be achieved to
meet this timetable?
 
Dr. Ben Lipps: The purpose of the focal ablation registration study, which
will enroll up to 120 men in a single arm study, is to demonstrate that
NanoTherm therapy system 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.
 
The American Society of Clinical Oncology reports that in 2019, it was
estimated that there were 174,000 new cases of prostate cancer in the
United States and in spite of advances in diagnosis and treatment an
estimated 31,000 deaths occurred. Clearly, early diagnosis and MagForce's
Focal Therapy has a strong chance to reduce the death rate for prostate
cancer.
 
Cosmin Filker: Do you see any restrictions from the current Covid-19
situation on the approval process in the USA?
 
Dr. Ben Lipps: While there are many restrictions that have been applied
such as 'Shelter at Home' and eliminating state to state travel via car or
via plane; however, MagForce is still working diligently with its physician
investigators. Exemptions exist for healthcare workers, such as MagForce's
USA staff at MagForce USA clinical facilities. Clearly MagForce USA can
conduct the trial in its out-patient facilities and has developed COVID-19
infection control procedures for staff and study subjects. All this effort
has caused a certain delay but MaForce is confident the next stage of the
clinical trial will not be unduly delayed since MagForce USA will conduct
the trial from its own facilities.
 
We are still hopeful that the COVID-19 pandemic will not cause significant
delay beyond 2020 to complete this single-arm clinical trial.
 
Cosmin Filker: MagForce AG's NanoTherm technology has already been approved
in Europe for the treatment of malignant brain tumors. In the current
letter to shareholders, you reported a strong increase of 700% in treatment
numbers. How do you explain this dynamic development?
 
Dr. Ben Lipps: Over the last 20 years, there was no significant progress in
survival of glioblastoma patients - which is also evidenced by various
publications. After years of development, MagForce has a significantly
improved clinical procedure. Our dedicated staff, especially the whole
commercial team, has turned the 'Commercial Glioblastoma Corner'. Of
course, it is clear that this growth rate is based on a comparatively low
level, but we now have partner hospitals that are convinced of NanoTherm
therapy and use it with great commitment for the benefit of their patients
in treatment. We therefore expect the number of treatments will continue to
increase sustainably.
 
Cosmin Filker: The treatment of malignant brain tumors must generally begin
without delay, so Covid-19 should not have any influence on the therapy.
Are there any possible restrictions in Europe due to the current pandemic?
 
Dr. Ben Lipps: That's right, brain tumor treatments must be carried out as
quickly as possible, even in times of COVID-19. The corresponding safety
regulations exist in the hospitals. Fortunately, the course of the
pandemic, especially in Germany, has so far been such that patient care in
hospitals is always possible and our partner hospitals in Zwickau, Munster
and Lublin are continuing to offering NanoTherm therapy to treat brain
tumor patients, also during the COVID-19 crisis.
 
Our expansion activities, including NanoActivator installations in Spain
and Italy with partner hospitals, which were planned for H2 of 2020, will
be delayed by six to nine months; however, we plan to install two more
activators in Germany, which has about 3,000 new glioblastoma cases per
year.
 
Cosmin Filker: Is there a current development regarding the reimbursement
of treatment in Europe?
 
Dr. Ben Lipps: In Poland, the financing of NanoTherm Therapy treatment is
still well covered by private payers and crowd funding. In addition, a
'Health Technology Assessment' (HTA) is currently being carried out, which
should lead to reimbursement by the health care system. In Germany, in
addition to reimbursement by private health insurers, costs are currently
reimbursed from the budgets of the hospitals themselves. The hospitals will
continue to submit applications for reimbursement this year, which will be
negotiated and decided on at the turn of the year. This support from the
hospitals is very helpful for MagForce, as it clearly shows the hospitals'
interest in NanoTherm therapy.
 
Cosmin Filker: Dr. Lipps, thank you for the interview.

Die vollständige Analyse können Sie hier downloaden:
http://www.more-ir.de/d/20899.pdf

Kontakt für Rückfragen
Jörg Grunwald
Vorstand
GBC AG
Halderstraße 27
86150 Augsburg
0821 / 241133 0
research@gbc-ag.de
++++++++++++++++
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: 
http://www.gbc-ag.de/de/Offenlegung
+++++++++++++++
Date (time) of completion: 27/05/2020 (08:20 am)
Date (time) of first distribution: 27/05/2020 (10:30 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.