Mologen's (DE:MGNG) Phase III pivotal trial (IMPALA) in metastatic colorectal cancer (mCRC) is now the focus for investors as both the Phase II trial (IMPULSE) in small cell lung cancer (SCLC) and Phase I trial in HIV (TEACH) are now complete. The company recently announced the results of a statistical forecast that has predicted the primary analysis of the data will most likely occur in April 2020 (95% CI: +/- five months). Cash reach has been prolonged to the end of 2018 by recent financing arrangements, and the signing of a licence and co-development agreement with Oncologie, in addition to R&D cost reductions. A new study with lefitolimod in HIV (TITAN) is expected to be initiated by Aarhus University Hospital in 2018. We value Mologen at €243m (€6.5/share).
IMPULSE data interesting, focus now on IMPALA
Mologen has confirmed the initial top-line results for its 103-patient Phase II IMPULSE trial in SCLC. While it missed its primary end point, two predefined subgroups demonstrated improvements in overall survival hazard ratios. The company is currently assessing its future development options. Focus has now predominately switched to IMPALA, a 549-patient (enrolled), two-arm, randomised pivotal Phase III trial for the maintenance treatment of mCRC patients.
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