RE:RE:RE:RE:Cash position I have to disagree with you about #2. Just being on the trial for x months is not proof of anything. I recently read that PFS in late-stage ovarian cancer is about 5-6 months without treatment. That's to say it can naturallly take that length of time for tumours to grow by 30%. Just hanging on for that length of time is no proof a drug is working, not even a hint. If one patient stretch's to >12 months I might concede that's a hint but not a very strong one and not one you can comfortably see signposts the path forward.
I think you're over-egging the distinction between a hint and a hard confirmed data point. The hint has to be foretelling the coming of those hard facts. What we know about patient#2 isn't doing that in my book.
SPCEO1 wrote: TH has already hinted about hints of efficacy with patient #2. I think what they are saying is there might not be the scientifically defined preliminary signs of efficacy until phase 1b. I do not think they are saying they have no reason to believe the drug actuallty works in humans as a result of the phase 1a trial. Basically, everything I have heard or seen from the company and others about TH-1902 is very positive and it would seem very strange for the company to keep saying these positive things if they did not already have a very good idea that TH-1902 is safe (which they did outright confirm today) and effective. I know you will know be willing to accept efficacy until you see it, but I think we heard it today, if only between the lines.
qwerty22 wrote: I think more clearly than ever they've pushed efficacy to 1b. That tends to suggest to me they haven't yet seen the hints of efficacy that they might hope will turn into a solid reportable data point in the short term. If it's going to appear then it can happen with any enrolled patients so we still can't rule out 1 of these last 6 patients will be responders but it doesn't seem to me like they have anything yet.
On the up side. The lack of DLTs in the first 3 patients has increased the chances that 300 will be the RP2D. They seem comfortable around that outcome.
SPCEO1 wrote: There is lots to unpack in your post - I will give it a try and hope that proves helpful to your understanding. See my comments in
red below:
jeffm34 wrote: Now down to 12 month cash runway. Cash required in next financing will be at least $100M to look after the convert and finance the phase 1b/2 cancer trials. (Any licensing deals could be a potential source of up front cash as well) I think that your $100 million guess for an amount is a good one. It might be more though. They left the strong impression on the call that it would be all debt and they did not tallk about timing but they likely will not wit too much longer. I ahve to think they want to use the ATM too just to get Cantor to pick up coverage of the stock, if nothing else. We will have to see how it all shakes out but something is going to happen on the financing front. The fact they are considering debt financing is another signal of how confident they are on cancer. You don't take down $100 million in likely five year term debt financing unless you are pretty confident about cancer's future. The race now is can they can get any meaningful trial data before the next offering? That is not a big issue if they use debt financing. Also, they spoke about seeing preliminary indications of efficacy in the phase 1b. I think they have seen something in the phase 1a but there are medical definitions that need to be adhered to in reporting trial results and that might technically keep them from claiming preliminary signs of efficacy in phase 1a even though they functionally have it. The whole presentation today reeked of them being very confident about their prospects in cancer. Someone mentioned on the call that efficacy data could be available towards the end of the year. That was a mention of preliminary signs of efficacy in phase 1b. My guess is due to the limitations of the phase 1a trial, they may not be able to proclaim they have seen the scientifically required data to declare they have seen preliminary signs of efficacy in the phase 1a. So, that will be confirmed in phase 1b when the trial is set up to identify that better from a scientific point of view. Actual efficacy will come in phase 2 when there are enough patients in the trial to declare statistically significant results. But they all but told us they have either already seen signs of efficacy or have enough data to know they almost certainly will. If that is the case as opposed to what Paul said, then we are in trouble. Remember last year at this time and you all were saying we'd see efficacy data by the summer of 2021. I actually do not remember that. I think the earliest hopes were for the Fall of 2021. Either way, your overall point is correct that these result shave been delayed significantly. Again, that is not uncommon in drug trials as they always seem to take longer than seems reasonable and drug company mamangement teams never seem to take that reality into account. I think it's safe to say your predictions on how fast this company moves are wildly optimistic. I'm hoping we might see something by Q3 but that might be too optimistic as well. With the phase 1b starting by the end of May and given that some, if not all, of the last six patients will roll over into the phase 1b, TH will have a head start on seeing signs of preliminary efficacy in those patients. We could see an announcent this summer that one or more patients has displayed signs of efficay and that a phase 2 trial for that cancer type is starting soon. Regardless, who is going to buy any significant amount of TH stock knowing a major dilutive financing is coming at any moment ? TH effectively told us they have a very interesting future in cancer today. While no one is listening to them right now, that will change as TH-1902 has to get some attention - you cannot hide what it apparently can do even if you were trying. On the issue of a dilutive financing, as I said, they pretty much told us they are doing a debtfinancing, which is non-dilutive and reflects their confidence about TH-1902's prospects. The delays in the phase 1a trial will likely mean the offering is done near todays prices and not $5+
As I said, I would be surprised if there is not an equity component but that might come much later after more data is available and the stock price is higher. I also wonder if they might negotiate with the convertible holders to restructure it.