Hi all
Extrapolate out MSB's quarter cash burn, taking into account when the drawdowns are made available and adding the TiGenix licensing revenue due this year... and MSB's new US$75m Hercules Capital facility has MSB funded out to June 2019.
To be conservative, this ignores the fact that cash burn should decrease given:
i) aGVHD trial has completed;
ii) Class II/III CHF trial should complete enrollment in 2H18; and
iii) CLBP has completed enrollment in Mar18.
That gives Mesoblast at least 15 months from today to find a partner who will provide additional funding.
The following programs are up for partnership + status:
1. Adult aGVHD; fast track designated pediatric phase 3 FDA trial meets primary endpoint, final read-out in Q3 2018 after which NDA submission can be made. IMO likely to be first cab off the rank, this is ripe for partnership right now.
2. Class II/III CHF; phase 3 trial due to complete enrollment 2H18. Aug17 Futility analysis recommended trial proceed as planned. Once fully enrolled in 2H18, majority of costs have been incurred for this trial. 12 month primary endpoint.
3. Class IV CHF(LVAD); RMAT designated phase 2b trial funded by NIH, due to release final trial results in Sept (determined by NIH). A successful phase 2b trial would allow MSB to file for accelerated market entry through the RMAT designation. Partner likely to be found if read-out is positive in Sept, and definitely if advanced entry is granted by the FDA (purpose of RMAT designation).
4. CLBP; Phase 3 trial completed enrollment in Mar18 i.e. majority of costs have been incurred for this trial. 12 & 24 month primary endpoints. Partner could present itself at any time.
5. RA; phase 2 completed. Seeking partner for phase 2b, to evaluate optimum dosage before proceeding to phase 3 trial. Program will not proceed without a partner, so this is 100% up for partnership in its current state.
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