I watched the webinar live and I have to give Nina credit, the presentation she gave was extremely informative, she really is across everything (as one would expect) and presented very, very well. This was by far the best presentation to date. (The last one I saw her do recently, she was restricted to 8 minutes and really had to condense everything. This one lasted about 20-25mins uninterrupted).
Key takeouts:
- Nina spoke about the Sparsentan Phase 3 failure and re-assured listeners that, despite being a blow to Sparsentan and the patients on the trial, this was good news for Dimerix, in more ways than one. DMX-200 works by a completely different mechanism. DMX-200 is being trialled vs a placebo, whereas Sparsentan was being trialled vs another drug (Irbesartan). Also, as DMX-200 is the only Phase 3 FSGS trial worldwide, patients from the Sparsentan trial can participate in the DMX-200 trial and obviously the addressable end-market is greatly increased.
- Multiple licensing partners have shown an interest and submitted term sheets to Dimerix since commencement of the Phase 3 trial. They are currently doing their own due diligence. Term sheets are non-binding and Nina will update the market once these discussions progress and binding term sheets arrive. Nina stressed that having money in the bank will put us in a stronger negotiating position with any potential partners
- She also explained why the CR was needed now. Basically the regulator has made adjustments to the trial design, adjustments which would cost Dimerix money now, but save Dimerix money in the long term. The adjustments are:
• Increasing the trial duration from 26 weeks to 35 weeks. Dimerix would need to fund a longer trial if a deal hasn't been struck by that point
• The 2nd part of the trial is to start immediately after the 1st part (pending analysis and DSMB recommendation) As approvals to start the 2nd part can take anywhere from 9months-18months, Dimerix need to swiftly start preparing for the 2nd part of the trial, so it continuously flows on from the 1st part. Dimerix needs money for this. I suspect the longer term financial benefit here would be that it is cheaper to do it this way rather than pausing after part 1, having a lag, and then having to fire up all the trial sites again after having some downtime
• The CR. $3.5m in the short term will be issued by the US based institution by way of convertible note, with the option for more later. Most pleasingly about this, is that it can be repaid in cash rather than issuance of shares (more dilution). This was comforting. My thoughts are that any potential future licensing partners could easily clear this liability as part of any licensing agreement.
• Nina also answered questions at the end, including 2 of my own. She stressed that, while DMX-200 Phase 2 trial did miss primary endpoint in the DKD indication, it did achieve primary endpoints in the FSGS and was statistically and clinically meaningful.
• One question put to Nina by a listener was "what is our likelihood of success?". Obviously Nina can not answer that question. Only a fool would set themselves up for a fall like that. However I do believe, with the data that the company has to date, there is a quiet confidence inside.
I do still believe we are on the right track. Shame the CRs have been messy the past few years. But I still believe in, and support the drug, the company, and the management team. BRING IT HOME NINA!!!
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