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MAGFORCE NANOTECHNOLOGIES AG, DE000A0HGQF5

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18.10.2021 - 10:05:29

Original-Research: MagForce AG : Buy

Original-Research: MagForce AG - von GBC AG

Einstufung von GBC AG zu MagForce AG

Unternehmen: MagForce AG

ISIN: DE000A0HGQF5

Anlass der Studie: Research Comment

Empfehlung: Buy

Kursziel: 11.00 EUR

Kursziel auf Sicht von: 31.12.2021

Letzte Ratingänderung:

Analyst: Cosmin Filker, Marcel Goldmann

FDA announces conditions for the final pivotal study; study

expected to start in 2021 and to be completed in mid-2022; timeframe

largely in line with our expectations; forecasts, price target and BUY

rating confirmed

According to corporate news of 13.10.2021, MagForce AG has made significant

progress in obtaining approval for the treatment of prostate cancer. The US

regulatory authority FDA has notified MagForce AG of the conditions for

approval of the final clinical protocol. Finally, the company has received

the conditions for final approval in the USA. After timely submission of

the required documentation to the FDA, the company expects to receive final

approval to begin Phase 2b in November 2021.

Until the start of Phase 2b, recruitment of the required 100 patients will

continue. These patients will be used to confirm the promising results and

the very good safety and tolerability profile of Phase 2a, which has

already been conducted. The aim of the study is to enable prostate cancer

patients to remain stable for a longer period of time without external

radiation or surgery. Patients with moderate dysfunction (lesions) could

thus return to the so-called 'active surveillance' programme, in which only

close observation takes place.

Assuming prompt FDA approval, MagForce's management board expects the trial

to be completed in the summer of 2022. In the course of the trial, the

company will submit interim results to the FDA after treating 15 to 30

patients, so that market approval can also be obtained quickly upon

completion of the trial. Should this take place in the second half of 2022,

MagForce AG would be in a position to quickly enter the commercialisation

phase. This is possible primarily because the treatment centres and

personnel required for commercialisation are already in place to carry out

the approval study. Accordingly, there is no need to build up the

infrastructure. However, it is likely that the current MagForce treatment

centres in Texas, Washington and Florida will be joined by additional

centres as early as the 2022 financial year, enabling broader regional

coverage.

Compared to our previous expectation, this results in a slight delay of two

to three months. Previously (see research study dated 20 July 2021), we had

expected commercialisation to begin in mid-2022, so the current approval

schedule is largely in line with our expectations. Since we had assumed

only low sales revenues in the prostate segment for the coming 2022

financial year anyway, we currently see no reason to adjust our forecast.

With an unchanged price target of EUR11.00, we continue to assign a BUY

rating.

Die vollständige Analyse können Sie hier downloaden:

http://www.more-ir.de/d/22983.pdf

Kontakt für Rückfragen

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,6a,11); Einen Katalog möglicher Interessenkonflikte finden Sie unter:

http://www.gbc-ag.de/de/Offenlegung

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Date (time) of completion: 15/10/2021 (3:04 pm)

Date (Time) first distribution: 18/10/2021 (10:00 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.

°

@ dpa.de