2022.. Baba...Bababa..BOOM, page-3

Good points... it got me thinking...

SI : For Back Pain - Terrific interaction with the FDA on our confirmatory trial requirements. We own all the rights, and we will be taking this forward ourselves and retaining the full market opportunity in the USA.( Not going to get any USA partners)

The trial timelines have not only halved in time frame, but will now be eligible for both US and EU approval process. This alone is a significant milestone, no wonder SI saw it as Terrific.

Going back in reviewing the original Grunenthal agreement:

10/09/2019
Mesoblast will receive up to US$150 million in upfront and milestone payments prior to product launch, as well as further commercialisation milestone payments. These payments include commitments up to US$45 million within the first year comprising US$15 million on signing, US$20 million on receiving regulatory approval to begin a confirmatory Phase III trial in Europe, and US$10 million on certain clinical and manufacturing outcomes. Cumulative milestone payments could exceed US$1 billion depending on the final outcome of Phase III studies and patient adoption. Mesoblast will also receive tiered double digit royalties on product sales.

The agreement was subsequently amended in 2021:

30/06/2021
Mesoblast plans to leverage the results from a planned US trial to support potential product approvals in both US and EU by including 20% EU patients in order to provide regulatory harmonization, cost efficiencies and streamlined timelines, without initiating an EU trial. In line with this strategy, Mesoblast and its partner in Europe and Latin America, Grünenthal, have amended their collaboration agreement, with Mesoblast being eligible to receive payments up to US$112.5 million prior to product launch in the EU, inclusive of US$17.5 million already received, if certain clinical and regulatory milestones are satisfied and reimbursement targets are achieved. Cumulative milestone payments could reach US$1 billion depending on the final outcome of Phase 3 studies and patient adoption. Mesoblast will also receive tiered double-digit royalties on product sales as per the original agreement.

I may have missed this, but it kinda points to me that the CLBP upcoming trial is already fully funded.

SI: Heart Failure - We will be working with our potential strategic partners to bring this to market in the coming years. We are in exciting discussion with the FDA at present.(No partnership deal yet)I think they are keeping this one low key, definitely sounds like something is brewing here.

SI: Covid ARDS - We are working with our partner to prepare a pivotal trial( I assume that this is the NIH who were partners in the first trial? )

I suspect some more data will soon come out - I believe this is still pending:

1. Number of participants alive at 12 Months [ Time Frame: 12 Months ]
2. Length of stay [ Time Frame: 12 months ] Hospital length of stay
3. Readmissions [ Time Frame: 12 months ] Number of readmission
4. Length of Stay in Intensive Care Unit [ Time Frame: 12 months ]
5. Pulmonary symptoms [ Time Frame: 12 months ] including the presence of emphysema, COPD, asthma, pulmonary fibrosis, other pulmonary disease, and the need for respiratory support will be reported by randomization