The two main questions are: When can we expect commercialization...

The two main questions are: When can we expect commercialization and how much will it cost to get there.

Wayne has said in the past that the pivotal trial will implant 900 - 1100 patients and with him mentioning in the recent video interview that it won't need the 5,000 - 6,000 patients compared with trials he's run in the past, my Wayne-speak decoding skills tells me that he's saying the trial will be large, but not 5 to 6 thousand large, so that fits with his past comments. Steviebuoy guessed 800 patients, which is probably a good guess but I'll figure 900 to be a little conservative, with 450 of those being implanted with DurAVR's.

My timeline has been one and a half to two years for enrollment, then another year to complete the trial as patients will probably be followed for a year after implantation. So the trial should take two and a half to 3 years to complete. A smaller ViV trial should run concurrently and could be completed sooner but my guess is that the FDA will want both trials to finish before the PMA can be submitted, otherwise why run such a large pivotal trial. The FDA will likely want as much safety data as possible.

That's two and a half to three years to complete the trial. If the first pivotal implantation happens in November, which still could be optimistic given how slow everything with the FDA is, that would mean the earliest it would be completed by my estimation would be May of 2027. Then it should take maybe 3-4 months to complete the PMA application and get it filed, and after that the FDA has 180 days to make the determination about approval. By my estimation, the earliest approval could happen would be in Q1 of 2028. That's just my estimation though.

Q1 2028 is 14 quarters from now. With cash needs of $20 million per quarter, that obviously means $280 million will be needed. I'll use 550 DurAVR's sold through trials, 100 for ViV plus 450 for the pivotal, which will bring in around $21 million at the current exchange rate. Then there are maybe another $18 million in options currently in the money that will expire before 2028 (and maybe more because a million AVRAC are only listed as various dates and prices). And of course the company probably has around $32 million in cash on hand currently. So $209 million will need to be raised to get to the earliest commercialization date. There are also more than $80 million in options currently out of the money. If the share price cooperates, that could be rich source of cash but most have an exercise price of $24 or $29.

$209 million at $15 per raise is 14 million shares and with around 27 million fully diluted, I think 40 million shares fully diluted is reasonable at commercialization. Obviously cash needs will be less if higher priced options are exercised and the current fully diluted amount would be smaller if options eventually expire worthless so 40 million seems very reasonable. That's fully diluted not fully paid. I think 40 million was my projections at commercialization a few years ago when I first invested, not saying that I'm a prognosticating genius but I have been down this path more than a few times before with clinical-stage companies.

What I like to do is project the eventual fully diluted share count, then see what the market cap would be at the current share price with that many shares. 40 million shares would make the effective fully diluted market cap $540 million at a share price of $13.50. That's what the market cap would be using the current share price with the amount of fully diluted shares I project the company to have in 2028.

With DurAVR's likely selling for around $54,000 in 2028 and at a price to sales multiple of 10, that means only around 1000 DurAVR sales after commercialization are currently factored into the share price. I've made a lot of assumptions here but I think they all can be justified and the bottom line is that even if my calculations are off and it costs 50% more to get to commercialization, and it will take time start generating revenue after approval, the sale of only 1500 DurAVR's are currently baked into the share price. So if you are willing to wait a few years and think that more than 1500 DurAVR's, to be conservative, will eventually be sold, the company is still probably cheap.