In the last six months, mixed readouts in the Phase II SCLC trial (IMPULSE) and the Phase Ib/IIa HIV trial (TEACH) weighed on the stock. Full data packages presented in the next 12 months may yet highlight potential in these indications. Our valuation is adjusted to take into account both the current trial data and visibility of the long-term strategy in certain geographical regions. While long-term potential lies in the lefitolimod Phase III mCRC trial (IMPALA, readout expected in 2019), Mologen AG (DE:MGNG) has additionally signed a binding term sheet with Chinese iPharma, which could provide €100m+ in revenues over several years and boost the cash position. We value Mologen at €253m.
Top-line TEACH and IMPULSE data read out
Top-line data from TEACH, an exploratory, non-randomised Phase Ib/IIa trial testing lefitolimod in HIV-positive patients, failed the primary endpoint of reduction in viral reservoir in 12 patients receiving both antiretroviral therapy and lefitolimod. However, an increased duration of viral control above what is typically expected was observed in one patient out of nine after stopping ART (further analysis ongoing). Full data will likely be presented next March at the Conference on Retroviruses and Opportunistic Infections (CROI). Data were presented at ESMO from the exploratory Phase II IMPULSE trial in small cell lung cancer (SCLC), which demonstrated that it did not meet the primary endpoint of overall survival. However, it showed potential, non-statistically significant advantage in two subgroups. SCLC is a difficult disease to treat and any benefit hints at potential for lefitolimod.