CYP 2021 - The year ahead, page-93

"These agreements must be somewhat new and novel given there has never been a Cymerus process before, seems to me. Seems they are what Ross can make them be.."

I'm referring to the majority of pharmaceutical licence agreements. The company that acquires the licence to a particular drug usually vertically integrates it to maintain control over the process and maximise operating profit margins. For the Cymerus process, contract manufacturing would be a process borne by the acquirer. This is not necessarily a bad thing, as it is likely different companies will have slightly different approaches and preferences towards the manufacturing process.

"Actually I agree with you about large up front costs making potential partners cautious about committing prior to getting proofs of scalability, but not that a mere 440 person trial with around a thousand doses results to be known in over two years time is likely to be enough proof.

I think CYP needs faster trial results on some other indication but also to demonstrate a proof in principle that many thousands of doses can be made in commercially relevant clincial timeframes (before the OA resuts come in). This could be done with a demonstration that CYP cells work (in an animal model say) after coming though a 3D manufacturing process. It need not be done at huge scale (not a Fujifilm 20,000 litre bioreactor) but I think it needs to be done in a scaled down prototype (maybe 5litres or 50 litres) with the proper media and microcarriers to demonstrate it can be done sooner rather than later."

I think you are fundamentally missing the strategic objective of Cynata. The goal of the company is to licence out the rights to use iPSC derived MSC's, not be a contract manufacturer.

To get a licence partner, the company needs to provide pre-clinical and clinical data demonstrating efficacy across a range of indications. So far, the company has generated pre-clinical data across a swathe of conditions and has initiated human Phase 2 & 3 trials in 7 indications.

I think it is extremely unlikely we will see Cynata invest shareholder funds in a 'proof of concept' around manufacturing at a commercial scale. To do this before demonstrating the efficacy of the product across a broader range of indications would be a bizarre use of shareholder funds. What is the point of showing you can manufacture a lot of a product if the product turns out to be useless?

In my opinion, if the results from the 7 (6 available) trials demonstrate strong results, it would be exceedingly unlikely that we won't get at least one licence arrangement. If I'm wrong and the trials demonstrate the efficacy of the Cymerus process but we don't receive any commercialisation offers, then I would 100% agree with you that Cynata would need to demonstrate the scalability and manufacturing capacity of the technology.