RE:Year end highlights or lowlights I don't think their strategy was a mistake. I think there was an opportunity to unlock value by getting the regulators on their side. What has happened is belief in NASH as an investable indication has tanked and that has made ALL NASH investments look worse. I do think they need people to think NASH is worth risky bets because of their weaknesses and unfortunately things have moved in the opposite direction to that. If NASH had some wins and people were looking for late-stage assets to rush to clinic then their strategy might have paid off. If they'd spent big on an exploratory trial they'd still have the problem of NASH being unloved.
I don't think we can criticize them for having faulty crystal balls. As the process continued and as NASH became less and less appealing it probably became more and more clear that this approach was not going to succeed. At that point it was probably still correct to complete the process and at least have something in the bank for any future upturn.
I think Paul is generally right. They need the sector to turn around. I think he's stretching when he says what happened to MDGL recently has started that process, I think it needs more than that. With hindsight they were probably right not to invest a pile of cash in this program up to now. That doesn't help us get any return from this investment. I guess what I'm saying is the situation could be worse.
jeffm34 wrote: Cash on hand $40M
More delays for the NASH program
Trogarzo sales in the US were down $5M (17%) on the year
Hiring spree added about $1.5M/quarter in added operating expense
Cash needed over the next year ~ 120M
56M operating expense (14M x 4)
64M due from senior notes
Shortfall of $80M this next year
I would expect a financing sometime in the next couple of months based on their immediate cash needs. Unfortunately the company will not be able to rely on any positive efficacy data from the phase 1 cancer trial to boost the share price before they do another offering. The trial delays will push any significant efficacy data well into the 2nd half of 2022 and possibly early 2023. The only question is if there will be a share consolidation to go along with this next offering.
The only short term catalysts before an offering are possibly a Chinese partnership and the release of more pre clinical data.
The NASH program has been a disaster for the company. They wasted 2+ years going after a phase 3 trial for NASH in the general population. Now they are going back to the FDA to get a phase 2b trial approved. We had someone here screaming at the top of their lungs that it was a mistake to go that route. Surely the company had others telling them the same thing. Instead they push forward with their own plan because they think they know better than everyone else.
It's hard to find any positives from the update today