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Nice news today on the Nevada pilot program. Still, I think they are offering a share and a unit to purchase a share for $0.75 each to raise $15 million...so $15 million (another year) and 30 million (150%) dilution.
I wondered who Dr. Varney was in the PR, and I googled. It's Beebe. Looks like she's not putting all her eggs in Titan's basket.
https://www.drkatedevarney.com/
Turks, love your confidence. I really hope they turn the ship around. They've got to raise some money to keep the lights on. Once they do that, I'm back in...I don't think they will be outlicensing probuphine....I like the 100% of less sales strategy
I seem to recall more than a few delays, rejected IND applications and the like, but I didn't mean to make it personal against Beebe, so you're right that was unfair of me. Just saying if they aren't developing new applications, the need for a development staff goes away.
Turks,
Agree it makes sense, but only halfway. Why continue to pay Beebe and her staff, when they've done nothing but mess things up. If Titan is only about probuphine, then reduce overhead and hire some sales people to replace the scientists...
I love it...first one is free, and pay for second.
Would be good PR as well.
I think it has more to do with stupidity and greed.
First off, this is priced way out of whack. Should be half of the $5,000 price. Insurance companies would be lining up to pay for it rather than $1,400 a month sublocade.
Second, Braeburn paid $600 per treatment for the implant, but was unwilling to float doctors the $5,000 price pending insurance approval. So, they required the doctor (literally the "the middleman") to assume ALL the risk of nonpayment by the insurance company.
How about have the doctor/patient deposit the $600 cost of the rods, and then wait and see about insurance. If insurance doesn't pay, you haven't lost money, and you don't provide a second treatment.
That seems to be the strategy Indivior is utilizing. Much smarter.
Go to minute 1:55...."it's been a nightmare trying to get a new probuphine implant."
Still watching from the sidelines until there is a little more clarity. Probably will miss out on a bump up on parkinson's data.
Hey Turks, it's stuff from the termination agreement with Braeburn.
Yeah, ALKS is another potential acquirer. Be interesting to see if anything has come of the vivitrol implant work. I know Indivior couldn't shelve it, but they could price it the same as sublocade which effectively kills it.
Hey Turks, if I were Titan, I would be a lot more aggressive on pricing. Rods cost Titan $600 for the six month treatment. Sublocade is selling at $1,580 per month ($9,480 for six months).
Price it at a third of sublocade: $3,000 or so. Literally force insurance companies to prefer probuphine over sublocade. At $3,000 vs $9,480, I think you'd see a lot of insurance companies requiring tapering down to 8mg per day on sublingual before approving subcutaneous, and then pushing towards probuphine.
The people pushing sublocade are treatment centers that aren't equipped to do the probuphine procedure, but insurers have the final say (as we have learned).
Given all that, I don't see why Indivior doesn't just buy Titan and shelve probuphine to eliminate the problem.
Agreed, but it was a failure at an artificially high price that was kept high so as to not erode profit margin on what Braeburn believed would be their cash cow (injectables). A distributor/licensee with no other fish in the fire in the buprenorphine market will hopefully be motivated to sell, and lower the price accordingly. If not, Titan may be capable of coming to deals with the VA, prison systems, state medicare plans, etc. that don't require a sales force.
Things look a lot better, and I'm just about ready to pull the trigger and buy back in.
First, I want to see what kind of deal they get to raise some cash. They have an ATM registration statement on file, so maybe the best alternative for them is to wait until ropinirole Phase I results are announced to get a rise in the stock price, and then sell into the ATM offering to raise $.
I also really can't wait to see sublocade sales numbers which are supposed to come out relatively soon. If sublocade is selling, then there is a market for probuphine.
Some insider buys wouldn't hurt at this point as well.
But a typically anemic reaction by the market.
15 cents a share pre-split valuation, 15% royalty just became 100% plus a free $1 million, and....Titan is up a couple of cents.
That's great news!
Apologies to anyone who read my post yesterday; I made some rookie errors, but I think I understand this a little better now. It helps my simple brain to just exclude Sorafenib. In the Dovitinib vs Sorafenib study, only 2 of 282 Sorafenib patients were progression free after 12 months. And so for purposes of TIVO-3 (which fully enrolled in June 2017), it is safe to assume that Sorafenib has done its thing and is no longer a factor (i.e., all 161 sorafenib participants have had disease progression events).
So really, what we have now is a one drug trial of 161 TIVO participants with data readout triggered at reaching 94 PFS events (the 255 PFS events required including sorafenib participants, minus the 161 sorafenib participants).
The mPFS will be determined based on where the 80th patient falls (the 50% mark), but we don’t get the data until we hit the 94th PFS event. So, for all we know, the 80th patient has already had a PFS event but we are waiting out the 94th PFS event for data.
The only thing we can say with certainty is that at least 93 participants have not had a PFS event yet. So, at a minimum 93 of 161 participants (57.7%) remain disease free for at least 8 months (assuming worst case scenario of dosing in August 2017 and a two month data lag). That allows us to predict with absolute certainty that the trial’s goal (mPFS of six months) has been met and exceeded by two months.
Assumptions:
1. 50% of patients in TIVO-3 (161 patients) had received first dose of treatment by January 31, 2017. I think this is reasonable in light of (1) safety monitor review was conducted in January, 2017, (2) AVEO announced it was enrolling two months ahead of schedule in January 2017, and (3) futility study press release disclosed that 128 PFS events occurred on May 29, 2017.
Accordingly, I’m also assuming 50% of the patients would have been dosed after January 30, 2017.
2. At least 33% of patients taking TIVO will have a PFS event within the first nine months of treatment. For TIVO-1 in 1L RCC, it was about 40% by month nine, and so I think that assumption is safe.
3. Sorafenib’s performance will track the Dovitivinib study, with mPFS of 4 months and 5% PFS at 9 months.
4. There is a two month data reporting lag (demonstrated by the fact Aveo was alerted to the 128 PFS events for the futility study in early August 2017, but subsequent analysis showed the data cut off date was May 29, 2017 (nine week lag).
5. Final dosing occurred no later than July, 2017 (supported by June 2017 announcement of full trial enrollment). Accordingly, there would be at least 9 months of data for any patient dosed in July, 2017 (11 months to May 2018, minus the two month data lag discussed above).
Sorafenib Performance
Of the 80 patients dosed on or before January 30, 2017, the Dovitinib study tells me all 80 would have had PFS events by now.
Of the 81 patients dosed after January 30, 2017, I have assumed a PFS rate of 5%, meaning 77 have had PFS events.
So, with sorafenib, the PFS event total is 157.
Tivozanib Performance
I am assuming a 33% PFS response rate before month 9, which means of the 80 patients dosed on or before January 30, 2017, at least 27 would be PFS responders, and of the 81 dosed after January 30, 2017 but before July 30, 2017, at least 27 would be PFS responders.
That gives us a total of 54 PFS responders to add to the sorafenib total (157), for an aggregate amount of 211.
Analysis
Remember that we know 255 events have not occurred as of April 2018 (2 month lag), and it is 14 months from January 31, 2017 to April 30 2018.
If we assume none of the remaining 54 post-January 2017 dosers have not had a PFS event (the least favorable assumption to AVEO), that would mean at least 43 of the pre-January 2017 dosers have not had a PFS event, because 44 PFS events in that group would equal 255 (211 plus 44).
That would mean 43 of the original 80 pre-February 2017 dosers (53.75%) have mPFS of greater than 14 months, which means, for that 80 person group, mPFS is 14 mths or more. For every PFS event in the post-January 2017 dosers, the total of pre-February 2017 dosers must rise, further increasing the percentage of that group that have mPFS of 14 months.
If we assume two 80 person trials would have similar results, then over 50% of the TIVO arm has mPFS of 14 months.
FDA says no to bupe spray for pain
https://finance.yahoo.com/news/insys-gets-negative-fda-recommendation-142202527.html
Well said, although I'd say TTNP is on life support and not ready for the wake quite yet. I agree with everything you wrote. My two cents:
-Gotta love Zacks. Just reiterated the $8.50 price target. Curious whether that has any basis in reality in terms of an enterprise value for the technology. Personally, I'd say its worth a $4 buck a share bet (or at least that much for Indivior to buy TTNP to put probuphine on the shelf forever and clear the path for their injectables).
-Sunil was a little testy on the CC. Everything was "we'll get back to you." Maybe he is finally feeling a little job pressure.
-Rubin was in a good mood on the CC, praising Molteni and the new board member, and saying how useful the new guy from Molteni had been. Which is kinda like saying how not useful Sunil has been. Just have a hunch here, but Sunil's days may be numbered.
-Even Zacks admits dilution is coming. Will probably be big, but they will be delisted from Nasdaq anyway so that's not an issue.
-Really liked Sunil's comments about TTNP selling directly to niche markets. Probuphine is not going to be a home run for any licensee, so they probably won't dedicate that many resources to it. But selling probuphine directly to niche (compliance challenged) markets...prisons, etc.... holds potential.
4 Rods cost $600. Sell for $2,400 (one third the price of competition). $600 cost, and $240 (10%) commission to specialty pharmacy. $1,560 profit per sale. A thousand users x 2 kits a year = $3.0 million in profit. 10,000 users and you are over a buck a share in earnings.
There I go again!!! I will probably buy back in once the dilution occurs and probuphine returns.
Actually 25k. 40k was last year.
Key to valuation is return of probupine to Titan, which Braeburn controls to a certain extent (Titan can't afford to sue them).
But I agree, with probuphine returned, its worth $100 million to Indivior to just buy it and put it on a shelf to prevent competition with sublocade (if they offer implants at 1/4 the price of injections, they could make some headway against them and still make a profit).
Braeburn stalls negotiations, and then look for them to come in as save the day as a white knight for a buck a share.
SMH.
I think the first thing a new partner will do is go back to the FDA and get the REMS changed so it can be used front line in combo with sublingual.
With that change, and pricing it at half of sublocade, it could be a big success.
I agree about the PR. Hard to get upset though...it's Titan, what do you expect. Maybe they are saving it for their earnings call. I have a feeling they will be announcing some more dilution at that time.
I tend to think the transfer from Braeburn won't be done until the third quarter, just based on how long it takes Titan to get things done.
I will be real interested to see how Sublocade is selling. If Indivior can sell a more expensive treatment, but Braeburn couldn't sell probuphine, that will be really telling.
Maybe things will start happening with Braeburn now. I had a feeling they were holding out to get the milestone payment from Knight upon Canadian approval....probably a couple of million. Wonder if Titan will get 15% or so of milestone.
A whole lot lately about Notch3 and cancer..."more recent findings suggest that Notch3 signaling may play an important role in oncogenesis, tumor maintenance, and resistance to chemotherapy."
https://www.ncbi.nlm.nih.gov/pubmed/29622701
AVEO patent for its Notch3 antibody is a composition of matter patent. In other words, for the exact chemical make-up of the antibody (does not address use of the antibody). Very wide patent grant.
AVEO states they are looking for a partner for Av-353 for PAH...I bet part of the hold up is licensees want the rights to the patent for ALL applications, not just PAH.
AV-353: A lot of publications regarding Notch3 signaling and cancer lately.
Description of Notch3: https://ghr.nlm.nih.gov/gene/NOTCH3#conditions
Notch and Cancer: https://www.nature.com/articles/s41585-018-0005-1/tables/1
Titan director out at Celgene...
https://www.investors.com/news/technology/celgene-scott-smith-unexpected-exit/?src=A00220&yptr=yahoo
So, good news is the immediate pressure of paying off the Horizon loan is over.
Bad news is another 2.5 million in dilution in warrants at pretty low exercise price ($1.20 per share), and Titan doesn't get the $3.0 million prepayment to Horizon back...so they are left with $3-$4 million right now. It would seem they still need to raise money.
In sum...
Molteni bought $2.4 million of Horizon's loan.
Loan was extended to December 19, 2019
Titan now owes $1.4 million to Horizon and $2.4 million to Molteni.
Molteni's $2.4 million is convertible into 2 million shares of Titan stock.
Molteni and Horizon got another 580,000 warrants to purchase at $1.20.
Movement on...I have no clue. Maybe Titan should just never announce anything and it would rise to $50.
Yeah, I think they need their money for the injectables launch, but on cafe pharma it looked like they were hiring for probuphine. Who knows. I think TTNP would be crazy to trust Braeburn after the CEO didn't even mention probuphine at the opioid summit. I mean, you have an approved MAT product, and you don't even mention it? Yeah, but he's gonna really try to sell probuphine.
Not sure, but I noticed on cafe pharma that Braeburn is now hiring sales reps (!) so maybe it is staying with Braeburn and they are paying Titan something for that. Not sure how I feel about that. But it better be just a cash payment and not Braeburn "investing" in Titan again and diluting stockholders.
Yes, benefit TTNP long-term (because they can go back to the FDA for supplemental labeling getting rid of the 6 month requirement), but maybe hurt TTNP short-term because Braeburn sees the same thing and that may make them less likely to return probuphine without a fight.
Deadline for 10-K is today, and they did not file pre-market.
These guys make it hard to root for them.
So the FDA is saying: You can have opioid addiction medication even if you aren't 100% clean, but.....you need to be 100% clean for 6 months before you get probuphine.
Why?
Can somebody explain the probuphine REMS in light of this statement by the FDA:
A senior FDA official said "we will permit an endpoint that shows substantial reductions but does not require the patient to be totally clean at every visit if the measurements are fairly frequent."
Seriously, Titan has plenty of its own issues, but the FDA has screwed it royally.
https://www.firstwordpharma.com/node/1544823?tsid=28®ion_id=4