No, he is not going to need anywhere near $300m. That is not being conservative that is being unrealistic (not trying to be a jerk in saying this so I hope it doesn't come across that way.) To progress the whole pipeline across AD, PD, and Schizo over the next 4 years and operate the company? Yes, $300m. But not for AD alone.
Here is my estimate of need (I have reviewed and/or negotiated about 20 budgets for my trials at my site and have had conversations with companies about CRO fees): 800 patient P3 over 72 weeks with visits, MRI, labs, CRO fees, screen failures, etc about $75,000 per completed patient (25% dropout at some time, but there are also 25% screen failures) so +/- 60 MM. Site activation and start up fees could be 5 MM more Per sources, US is most expensive but EU is 80-100% US; Eastern Europe and Australia would be a little less. So bargain rate is 60 MM, could easily be 70 MM. Adjust up if PET scan needed, take away a bit if serum AB 42.40 and pTau 217 sufficient for diagnosis at screen. A273 is cheaper than Amyloid drugs as they had 3 PET scans and more MRI visits (adding 25-30,000)
Rett is much simpler: 200 patients, no imaging, all in 40-45000/patient 8-10MM
PDD ain't happening
Schizo: Company needs to decide if they do a dose finding 2b with 120 or so patients followed by 2 P3 with 250 patients each (as Karuna did) or do serial P3. Although no imaging, these patients need to be inpatient at special facilities so cost is easily 100,000 per patient all in ----- 60 MM
Operations: Last year Anavex spent 10 MM a quarter. TImeline for A273 AD assuming a start in mid 2026, +1 year recruiting, +1.5 years last patient completes, plus 3-4 months analysis means Topline would be 2Q2029 but Anavex history is not efficiency so more likely be 4Q2029. 4 years of operations is 160 MM
So, 70 MM AD P3 10 MM Rett 60 MM Schizo 160 MM operations so your 300 MM is realistic to get the company to topline data plus continue other efforts.
The company had about 100 MM at August CC. I hope that Missling sold 18MM shares to raise 150 MM. That would not leave much more to raise. Missling knew how the LOI went and could easily have predicted the negative vote (apparently called a trend now). The ATM is in place and active. He also sold vested options that had not yet expired in Sept/Oct which he would not have done if he had great confidence in a much higher SP. Hopefully he took this opportunity to raise.
I'd love to see Dr. Gabellle or Dr. Sabbagh.
I have wanted Missling (and Donhauser and Thomas) out x many years. But, lets not replace incompetence with inexperience --- they could be CMO but not CEO. Some MDs are amazing CEOs like Steve Paul of Karuna (P2 start to Market and buyout in 5 years) or Dr. Levenson (Genentech), but most KOLs do not have broad enough knowledge to get to the finish line
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