RE: Juho on the bio report podcast31 Jul 2025 06:39
1)
No problem gents, wrt reaching out to capital markets and doing the phase 3 ourselves, I believe we have to work toward this position regardless, as putting up the for sale sign instantly lowers the price Big Pharma will be willing to pay, it may be that we need to take it all the way to raising more capital for the P3 if we cannot commence the phase 3 without having a larger cash runway, I believe the ‘rules’ on this are ambiguous wrt the FDA’s position, and we have already reached out for capital beyond Finland, even in the recent HCM bond facility.
There are numerous examples where the phase 3 was planned and that being the apparent trigger for the takeover, just the threat was enough to flush out a bid, eg Mercks takeover of Prometheus for $10.8 Bn.
Do I think we are worth that much? Potentially, a little further on, but I’m not sure we will get that in the near term, unless there are multiple suitors and the potential here is realised by being able to commence the phase 3 with 2 AA pathways (r/r & FL) and BTD designation ; whilst simultaneously working towards a companion diagnostic which demonstrates that clever - 1 (high expression) targeting = enhanced efficacy, which then spells out the mega TAM we are really looking at here.
Commencing and seeing early efficacy in solid tumours in combination with PD-1 / PD-L1’s in high unmet need orphan indications, I believe, is the approach we should be working towards immediately, & that is the strategy we should follow to maximise pricing of Bexmarilimab, something I believe big pharma will be envisioning for the development of Bex, especially in light of the recent Bill in the USA which allows multiple Orphan Drugs to be developed with the same asset, whilst retaining Orphan Drug pricing for each.
I don’t know how much it costs to develop said companion diagnostic, but I feel the reward would be worth it, even just commencing the process; however the likes of Roche who are pioneers in this field and big players in IO / Hemo therapies, and others such as Merck who have successfully used this approach to maximise Keytruda revenues will be only too aware of the implications of the bill, and the potential Bexmarilimab holds by taking this approach in the earlier Orphan Drug Pricing years, thus may want to get the asset before it is tarnished by going into bigger indications too early, and nullifying the 7 years / 10 years ODD market exclusivity and the biological and patent exclusivity which can extend this further to 12-15 years, a very long time for bumper revenues and one which needs careful and multiple development exploitation eg AML / MDS / solid tumour trials all developed in concert.
The thing is the major players will all know this, so early efficacy in Solid tumour combos could lead to a bumper takeover by a major with a proprietary PD-1 / PD-L1 eg Merck, BMS, GSK, AstraZeneca, Roche, Regeneron etc to maximise combination revenues.
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