I think you hit the nail on the head. Selicks team, by visiting all the sites where the patients have been tested, cannot help but have a general idea of how the overall survival rates are trending and the issuance of a definitive co promotion agreement indicates a high level of confidence that the data will be good. This is beginning to look very encouraging!
The latest presentation just concluded. The major takeaway for me was that both Phase III trial event completions have occurred and Threshold has been traveling to all the various sites to verify the data is clean and acceptable. This is a normal occurance prior to evaluating the final data readouts. Once they are satisfied that all the data sites have yielded clean data it will only take THLD a few minutes to compile it and reach their publishable results. Still forecast for both sets of Phase III data to be released by the end of the year.
Under the terms of the agreement, Merck will receive co-development rights, exclusive global commercialization rights and will provide Threshold an option to co-commercialize the therapeutic in the United States. In exchange, Threshold will receive an upfront payment of $25 million and could receive up to $35 million in additional development milestones during 2012. Threshold is also eligible to receive a $20 million milestone payment based on positive results from its randomized Phase 2 trial in pancreatic cancer. Total potential milestone payments are $525 million, comprised of $280 million in regulatory and development milestones and $245 million in sales-based milestones.
In the United States, Threshold will have primary responsibility for development of TH-302 in the soft tissue sarcoma indication. Threshold and Merck KGaA will jointly develop TH-302 in all other cancer indications being pursued. Merck KGaA will pay 70% of worldwide development costs for TH-302.
Subject to FDA approval in the United States, Merck KGaA will initially be responsible for commercialization of TH-302 with Threshold receiving a tiered, double-digit royalty on sales. Under the royalty-bearing portion of the agreement, Threshold retains the option to co-promote TH-302 in the United States. Additionally, Threshold retains the option to co-commercialize TH-302 allowing the company to participate in up to 50% of the profits in the United States based on certain revenue tiers. Outside of the United States, Merck KGaA will be solely responsible for the commercialization of TH-302 with Threshold receiving a tiered, double-digit royalty on sales in these territories.
From the March 2015 Edison Research Report:
STS 18,000 patients times $80,000 per patient equals $1.44 billion in SALES (not market cap)
Pancreatic Cancer Evo's share of patients is 78,000 times 50% or 39,000
times $80,000 per patient equals $ 3.5 billion in SALES
Total SALES equals $4.94 billion
Assuming 80 million outstanding shares after all warrants are exercised yields a price per share of $370 based on a price to sales ratio of 6.
All this assumes both Phase III tests are approved and does not include any other indications.
Google Edison Research Report for Threshold Pharmaceutical. Then click appropriate location to download full report. Very interesting reading.
You have become too tedious to listen to any more. If you think the board is obsessive, as you put it, then leave. You are now on ignore.
You have your philosophy for making money with this stock and more power to you. You have expounded on your trading abilities many times and use it to denigrate those of us that buy the stock and hold it for the trial results.
You say that I may as well be reading tea leaves or flipping a coin as much good as rational thinking will do. You are so wrong in your ridicule and you fail to see others point of view. The decisions I make in investing are mine and mine alone and are not based on the unintelligent flip of a coin. I research a company and their chances for success before I invest a dime; no ouija board involved.
I feel good about THLD's chances and I certainly have a much better than 50/50 chance of being right. So trade away my friend.
1. They just reported that they had $56 million in cash and are burning it at a rate of $7 million a quarter which means they have only 2 years of cash left. This would not be enough for the additional testing for other indications. If they needed more cash they could either float a secondary share offering or use any milestone payments they might receive from Merck. Since they haven't announced a secondary offering the milestone payments must be forthcoming. They would only be awarded if the Phase III trials were successful.
2.They have hired key personnel to oversee bringing the drugs to market.
3. If the Evo didn't work then they would not have started Phase II trials for other indications.
I think the anecdotal evidence points to a winner for us longs.
"This is an exciting time for Threshold as we anticipate announcing top-line results from the two pivotal Phase 3 clinical trials of evofosfamide in patients with advanced soft tissue sarcoma (TH-CR-406) and in patients with advanced pancreatic cancer (MAESTRO) around the end of this year," said Barry Selick, Ph.D., Chief Executive Officer at Threshold. "In the third quarter, we also made significant progress with tarloxotinib, our exclusively-licensed hypoxia-activated EGFR tyrosine kinase inhibitor, with the initiation of two proof-of-concept Phase 2 clinical trials. We expect to have preliminary data from those trials in the first half of 2016."
In other words they have seen the blinded data trending towards successful Phase III data for both trials?
This looks promising. The TH302 Phase II test for STS yielded 21 months Overall Survival. This shows the likelihood of a significant improvement over the previous drug tests, as you point out. I'm encouraged.
I agree with you; it is bad but it is very explainable.This is not random movement in the stock price. It is the concerted effort of those with large amounts of cash to drive the price down so that they can acquire more shares at a much cheaper price. What I don't understand is why don't they drive it lower to, say, $1 because they certainly have the where with all to accomplish that.
This is a little known stock and shouldn't be getting the selling attention it's beeen getting for many months. I think that this group expects the data to be good, otherwise why bother to manipulate the stock price to acquire more shares.
My take is that the Biotech ETF's are being sold in a panic and causing companies like THLD with Trial dates looming to be dumped as part of the selloff. THLD is not being sold on its merit of two Phase III sets of data coming out shortly. Every biotech is receiving the same treatment. Also margin calls are undoubtedly contributing to the rout.
You make a good point. The side effects determine the quality of life and this is very important to the cancer patient and to his/her family members. Safety is so important!
Tredleon, I can't help but think that Threshold knows a lot more about the data as it comes in from the two Phase III trials than we do. Whatever they are seeing, that we aren't privy to, has encouraged them to hire three key individuals to oversee the transition to marketing TH 302 once it has been approved. I do not think that they made this decision in a vacuum. This decision was, in my opinion, influenced by the results they are seeing.
Bottom line; I put the chances greater than 70% for both trials because the anecdotal evidence points that way and because they are partnered with another pharmaceutical company that probably had a say in the decision as well.
The appointment of Dr. Hopkins, who was outside legal counsel, to lead the protection of intellectual property is, in my view, a very positive development. Thld sees the next step in the Phase III trials as almost a given and are, and have been, taking steps to allow for a seamless transition to bring the drugs to market.
Thld also, in their press release, reiterated that top line data will be released around the end of the year.
I think you folks are reading too much into the price action of this stock. The price has been moving up and down, in my view, as much as 15 to 20 percent in very short time frames on no news. Since the stock is thinly traded the traders are having a field day moving it up and down, irrespective of the fundamentals of Phase III approvals. This is just a cash machine for the hedge funds. Also the only time the stock moved down significantly was when accelerated approval was denied, which if memory serves was in the Fall of 2012 and the Fall of 2014. This was based on an event not taking place.
Also the hiring of the two individuals by Merck kga showed strong support for the ultimate approval of at least one of the Phase III tests. To me this is very significant! Nothing I have seen points to any leaks of the data. The trading pattern remains unchanged.