Back in March 2020 - AIPAC data released from primary endpoint -...

Back in March 2020 - AIPAC data released from primary endpoint - PFS.

Quote from: AIPAC Principal Investigator, Hans Wildiers of University Hospitals Leuven, Leuven, Belgium, said: “I am
pleased to see this innovative chemo-immunotherapy approach in AIPAC is well tolerated by patients, while
showing a numerically (non-significant) higher progression free survival rate compared to chemotherapy
alone.
Prior to PFS results, January 2020 Marc said:
'In light of the upcoming AIPAC readout, Immutep is undertaking regulatory steps to expedite the possible
use of efti for metastatic breast cancer (MBC) patients in the US, pending the AIPAC results. This includes a
small bridging trial evaluating the combination efti with paclitaxel in 24 patients in the US and the EU which
will take place pending the first AIPAC results. For that purpose, Immutep plans to file an IND in MBC which
would enable Immutep to discuss regulatory strategies based on AIPAC results also in the US.'

Obviously and sadly bridging trial did not happen due to PFS results not being good enough.

Clearly, sub-groups have gained significant benefits in final OS, however, my view is a full phase 3 registrational trial may be necessary to convince FDA/EMA to approve - assuming results are consistent or better than P2b.

That being the case and reading between the lines of recent announcement and in full year report, I believe it is unlikely that Immutep will move on AIPAC - 003 and look to bigger potential bang for buck with TACTI-003 and others in various combination settings.

The dilemma (for me) is that the more we get in to bed with Merck without other BP in the P2 mix the more reliant we are on them, which gives us less bargaining power if/when it comes to licensing/buy-out.

Also, our cash position whilst very healthy now, will gradually (and more quickly in a P3 trial) be depleted leaving us further exposed. Dont want to start the cap raising issue here, but we've seen it before, when SP is beaten down.

An eternal optimist but realist hoping that Marc and the board make the right decisions that create value for long suffering shareholders.....