RE:RE:RE:RE:RE:RE:RE:A concern?Interesting. I guess we should go with the CMO over the CEO and hope it wasn't a language thing. But I think we're basically on the same page there and so are they.
One thing that's out there is the second tranche of debt in order to redeem the remaining bond due. That is within the period we're looking at. If I recall, SPCEO seemed to think they could hit the hurdles for that tranche so let's assume we can ignore the need to redeem the debt. If not, just assume they'd need $20mil sooner.
To be fair to them, they've been saying they will be "fully enrolled" by 1Q and not "completed". If your last patient comes in the last day of the quarter, you've still got a few cycles to get through. The optimistic take would be they see something in one cancer before that so while they're finishing the full basket cohort, they're also moving on with FDA and the lead cancer designation. They seem to emphasize they are talking with FDA a lot, so we'd have to hope as they see 2-3 signs of efficacy they are recording that with FDA so they can move quickly.
But to directly answer your questions: I think they can swing one 25 person 1b extension - that would be $5mil. As an extension, I think it would just start right up in recruiting. It's hard to put a timeline because I would assume they'd be really pushing to move. So depending on whether all centers are recruiting, there's new centers recruiting, they suspend the other cancers, it could be anywhere from 10 weeks to enroll (around 2 a week), to the pace they're at now which appears to be only a few a month (so maybe assume 6 months for 25). Then you need to get the scans and cycles in.
As you've always pointed out, a lot just depends on the numbers they wee and it's complete guesswork for us. If they get the 2-3 out of 10 and see the same percentage in the extra 25, then you'd have around 10-12 responses in the bigger pool. If in that time they get another 2-3 from the initial 10, you'd have a pretty full set of activity responses and then you're off to the P2/3 pivotal. But that would put a P2/3 pivotal in 2024 pretty easily I think.
To summarize -- they shoudl be able to do 1 extra 25 patients for $5mil. Likely not another without a raise. The extra 25 would see enrollment and results in 6-12 months depending on "ramping" pace, exclusion of other patients, etc... P2/3 most optimistic would be 2024 and 100 ($20mil) - 200 ($40mil).
One has to assume the market will react positively to decent efficacy signs and they'll raise $100mil if they can get the stock to $5-$7 sometime in the next 6 months. The alternative is no efficacy and no need for raise. We haven't seen any definitive signs for either case, but the evidence has been leaning toward seeing the drug work at some level; hence, the outreach, conferences, insider buying, language used, etc....
qwerty22 wrote: On point 1 I thought the same as you for a long time but Christian said this in the Q CC
"once we see signs of efficacy that could be two responses or more in one tumor type, we would be ready to do an amendment and discuss with the FDA to increase the number of patients and to initiate assignment design Phase II assignment design with an additional 25 patient as an example and after that to move into the pivotal trial."
Which had me thinking it's 10+25 for each cancer with the 'go-signal" not 10+15.
But he seems to be calling that PhII which is not how I see it but that's no matter (other than I'm confusing people). What matters is the intention of the trial more than it's name. Then he says they move to pivotal (which I called registration and I also like to call confirmatory. Maybe I should stick to their words).
Anyway that aside I'm concerned about timing and cost.
So the timing of the 70 patient trial (10/cancer) is finishing Q1 23 and is financed.
How long for the +25 (or 15) and is that funded because if we say two cancers and max 25 each that's only 50 patients so less expensive than the present 1b. There's cash in the bank is what you seem to be saying (@$200,000 per patient). When do you think that trial runs to? You left that out. I'm thinking well into 2024 as an optimistic guess.
Isnt a cash rise, just to cover a successful cancer program, not something they need before mid-2024? It's something for the bigger pivotal phase and that is likely 2024/2025 commencement (assuming things are going well).
It just seemed in the earlier discussion the +25 (or +15) was being left out of the reckoning.
Wino115 wrote: A couple points, according to the Cannacord conf from a few months ago where Paul spoke.
1. He said they'd fully recruit the 70 by 1Q23. If they saw signs of efficacy in one, they would "enlarge it to 25" -- my interpretation is they would add 15 to get the full 1b sample in that cancer to 25, not add 25 to the existing 10. He said this wording twice ("increase to 25,....enlarge to 25").
2. This also means that if they see the efficacy and increase it towards the end of the 1Qtr, the additional 15 enrolled would occur after that date. Of course, it also means we would have some very positive numbers behind the increase so I think the solid data would help the share immensely versus the new addition of time for the next 15 patients.
3. He said the next trial step depends on the type of cancer and data. The stronger the data, the more you can likely move right in to a pivotal trial from the 1b data. That was his words. He threw out that the pivotal would be something between 100 and 200 patients depending on the standard requirements in those kind of cancers. The price he put it at was $20mil to $40mil.
To answer your question, I think the two paths would be:
1. Mixed efficacy data in a cancer would lead to fuller P2, maybe not pivotal. 100 patients $20mil.
2. Good to very good data in a cancer would lead right into a pivotal trial and depending on the type of cancer (pop size, etc...) it would be 100 pateints/$20mil or 200 patients/$40mil.
They'd likely need money regardless to pursue the next step but seem to be fine for getting through the 1b and an increase of one cancer by 15 patients. The above leads you to believe a trial is roughly $200,000 per patient. So the increase in 15 would only be $3mil which they can easily handle at this point. In fact, they could probably even start a Phase 2, although the Board would undoubtedly want to have a concrete capital raising in the works.
So my conclusion is they are fine through this 1b and the additional 15 down the road. Even an additional 15 in 1-2 more could probably be swung. But adding 15 means the news is positive so the share should react and give them a means to use with the ATM or do a full offer of $150mil at a far higher share level. At that point, moving to a pivotal in a trial costing $20-$40mil when you're looking at a possible revenue line of $300mil to $1bil would be very easy to do.
qwerty22 wrote: IDK what people are calling Ph1 and Ph2 but I see the path forward as 10 patients (1b), +25 patients(expanded 1b), then Ph2/3. No matter what you call it don't you think they have the cash to cover the +25 step? If 10 patients finishes end of Q1 2023 then +25 probably runs for another 12 months. The step into Ph2 (with this being the beginning of the registrational phase) won't happen until late in 2024 at the earliest.
We forgetting the +25 patient step here? Do you think the +25 patients in one or two cancers is already covered by cash on hand? Are we foreshortening the period before they go into a much larger trial with this discussion? Just seems worth getting it clarified what people are talking about here.
PWIB123 wrote: Makes sense. I assumed when they said they had enough money for the foreseable future that would be for business as usual today. No doubt they'll need to raise money for Ph.2, but that would feel a whole lot better if they get good results, the stock price rises, and then they raise money at a better value to shareholders. The only thing that comes to mind if they were to raise money now is an anticipated DELAY in results. They would need to be very clear about what that means and what has changed just a few weeks after the earnings call where they indicated timelines were on track.
I fully understand it takes time to do a share offering, but they do have the ATM, so maybe they are simply beginning conversations in preparation and well ahead of the inevitable need for capital to pay for the Ph. 2.
SPCEO1 wrote: On its face, it would be a terrible idea but we would need to hear what their justification for it would be before drawing a final conclusion. But it would need to be a solid justification where the benefits of rewarding a large shareholder with bargain basement stock has a near immediate and tabgible payoff to other shareholders.
When companies say they have enough cash for the next year, that is just satisfying a regulatory requirement and assumes nothing changes with their business, which is often not a good assumption, particularly for a biotech like TH. You should take very little away from that statement and you can be sure they will raise money if they go on to do a phase II TH-1902 trial.
The loan does not help them at all with the money they need for a phase II TH-1902 trial as the unmarked funds later in the loan's life do not get released until after that trial would likely be started. The next tranche is meant to pay off the rest of the convert.
Raising cash through partnerring at least would be viewed as a knowledgable third party endorsing TH-1902. Acquiring cash through the ATM is just dilution in the eyes of investors.
TH does run with less cash than other biotechs but that is aprtly because theyhave the two legacy drugs generating cash to cover a lot of the expenses most other biotechs have to raise capital for.
PWIB123 wrote: SPCEO1, this would make no sense and would be a terrible idea. THTX just told us on the conference call a few weeks ago that they had enough cash for a year. Plus, they have a pathway via the loan to unlock more cash. Furthermore, it was stated that they expect to see efficacy from at least one cancer type soon. Selling more shares at this price would be a flip flop of what we heard on the conference call and would definitely send a negative signal.
I'm not sure what's worse, partnering too early and not getting paid the highest premium or diluting the company now in order to gain a larger cash reserve. I can imagine institutional investors would like to see more cash on hand with future clinical trials likely, but THTX has communicated they have the cash they need for the foreseable future.
SPCEO1 wrote: I have heard THTX had good meetings with major shareholders post their third quarter results. Should any of those shareholders want to pickup additional shares of THTX, they would likely only do so through an offering. Could THTX sell shares to them via the ATM facility at these low prices. We know companies always find it pretty difficult to turn down alluring new money like this. I would be interested to know how people here feel about such a development should it occur. It would be good to let the company know before they pull the switch on such a deal if they are indeed considering it. We should have a voice in such a decision and we should let them hear it. Now, I am just speculating based on rather narrow info, but I suspect this is a risk. So, let's just assume a deal at $2 per share for 5 million new shares raising the company a new $10 million in equity capital just for argument's sake.
To me, doing such a deal would be quite worrisome as it would seem to indicate the data on TH-1902 is not looking good enough to hold off and do a deal once that data is available. Or, perhaps it indicates the phase 1b is going to take a lot longer than they are currently intimating and they need to boost the cash coffers to bridge until they get there.
On the positive side, we would likely get a new analyst report from Cantor if the ATM was used. But what can a new analyst say before we get phase 1b info.