Original-Research: MagForce AG (von GBC AG)

Original-Research: MagForce AG - von GBC AG

Einstufung von GBC AG zu MagForce AG

Unternehmen: MagForce AG

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
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

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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.-------------------

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