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TGTX/Brean(3 New Combos)
3 previously unmentioned combos(noted at the bottom of the Brean update)suggest to me that TGTX is an aggressive, confident company that thinks they can create competitive, low cost alternatives to the combos of the majors and steal even more market share(than they would be able to do with the TGR-1202 & TG-1101 combos already in process), as well as make themselves a must-buy company(which is, btw, ultimately what I think they have in mind)in the process!
Very bullish...
TGTX>>>
"Just a matter of time"
i.e.about 6 months...
TGTX:TG-1101/Ibrutinib EHA Combo Data
Hi GD,
Just noticed that a preliminary peek at first combo data this Wed.(May 21,2014)via abstract, will likely only be for the above combo,(TGTXs anti CD-20 & Ibrutinib), and will probably not include combo data on TGTXs TGR-1202/TG-1101 combo.
According to guidance from the last presentation slides(May 7,2014, see below), we'll have to wait till the Pan Pacific Lymphoma conference(in July) for the latter. Not sure if they release early abstracts for this one.
However, looking forward to this Ibrutinib combo data-I believe it will be first such anti CD-20 combo since the Ofatumumab/Ibrutinib data at ASCO.
2014 Milestones (see pg23 of PDF linked below)
1H 2014 Determine optimal dosing for TGR-1202 as single agent
Enroll Ph. 2 TG-1101 + Ibrutinib in CLL and MCL
Enroll Ph. 2 TG-1101 + TGR-1202 in B-cell Malignancies
Q2 2014 ASCO - Present updated single agent data for TG-1101 & TGR1202
EHA - Present prelim combo data for TG-1101 + Ibrutinib (June, 2014)
Q3 2014 Pan-Pacific - Present prelim combo data for TG-1101 + TGR-1202 (July, 2014)
2H 2014 Commence combination registration trial(s)
Q4 2014 Present updated combo data and single agent TGR-1202 data
http://files.shareholder.com/downloads/MHA/3008734518x0x753325/1106d1c2-a7ec-49cd-bb0a-dc8471e1f2b3/TG_Therapeutics_Corporate_Presentaton_May_2014_DB_Conference.pdf
Regards,
bw
Thanks-I wasn't thinking of that- great-early first peak!
Thanks for posting that GD-
I had seen & listened to this, but forgot some of the particulars-shows what they believe they have and are going after.
Really like how focused this company is.
So far(last 2 years)they've done everything they said they would.
Now, it seems pretty much like a matter of execution.
Should be an interesting back half of the year...
Ok, now I see what you're referring to with ORR(a lot easier going thru slides while you listen to the presentation(which I didn't)).
I assume you mean ORR as referring to the sum of PRs and CRs that includes both peripheral and nodal responses.
In that case I'm not sure TGs delta will reach 85% as mono-therapy. But since it's primary indication is intended to be as part of a combo-preferably with meds that are more effective in eliminating peripheral lymphocytes(like TG-1101, TGs anti CD-20), I don't think that really matters. What will is nodal efficacy plus a durable low tox profile.
And in that department, I think it's got a great shot. In other words, it really just has to perform as well or better than the competition(in nodal efficacy) minus the toxicity to be BIC(from a combo POV), and that's what I expect.
Since it will be part of a combo, the other drug should take care of the peripheral clearance(which appears, in general, to be no problem for TG-1101).
So So True...
Why can't I learn to say such in a few words(lol)?
Should be a double or triple with any luck at all...
TGTX(Post Ibrutinib/Idelalisib Combos in CLL)
Hi jaybe,
I think we have an ORR for TGTXs TGR-1202(PI3Kdelta)in R/R CLL-It's just for a relatively small number of pts(also for a relatively low avg dose(greater/equal to 800mgs) and only approx 2-3month avg duration of tx. The ORR was 67%(4/6)).
Obviously we need to see more pts, but when I factor in no signs of liver tox for approx 8 months tx(ceo report at Qtrly), and every reason to believe the ORR should improve in this drug class with increased exposure duration and higher doses, it's extremely compelling.
Comparing that to the IPI-145 data provided, in which they had identified a MTD, experienced 2 deaths, approx 7%liver tox., and overall AEs(greater/equal to 3), as best I could tell, in the 15-20% range, and an ORR of only 47%, I can see why IPI-145 is past tense post ibrutinib/idelalisib, but I don't think that tells us much if anything about TGR-1202, because, even at this early read, all the numbers are better, including the most important one it was designed for(low tox), and combo compatibility.
So I agree that we do need to see more numbers, but the comparison with IPI-145 still leaves me very encouraged.
I can also understand being cautious in a drug class where you've been burnt before-I(I think like yourself)was in ARIA in a very big way, so I do know about getting burnt. Nevertheless, I guess I'm hoping(on the basis of what looks to me like a very good value prospect(TGTX))to get on with my investment life.
Appreciate the feedback,
Thanks,
bw
TGTX/BIC/Proof-of-Concept,Etc.
Well jaybe,
You raise a lot of issues, but I'll do my best to respond in terms of what I believe are the top priorities(for a stockholder):
1) I didn’t say it(TGR-1202) would be BIC, only that I believe this data(combined with the favorable tox profile) suggests it has an excellent shot-yet to be proven one way or the other.
2) I would disagree with you that a BIC PI3K drug(with a favorable tox profile) may not have a market. I don’t think there are many people in the B-cell therapy sector that would deny the value of such in a variety of combos.
3) Although TGTXs combo final results may be a few years off, I think more importantly, we should be in possession of proof of concept information for both drugs in 2 combo therapies, in addition to longer term(convincing) mono therapy data for both, by the end of this year(see timelines listed in latest slide presentation below):
2014 Milestones (see pg23 of PDF linked below)
1H 2014 Determine optimal dosing for TGR-1202 as single agent
Enroll Ph. 2 TG-1101 + Ibrutinib in CLL and MCL
Enroll Ph. 2 TG-1101 + TGR-1202 in B-cell Malignancies
Q2 2014 ASCO - Present updated single agent data for TG-1101 & TGR1202
EHA - Present prelim combo data for TG-1101 + Ibrutinib (June, 2014)
Q3 2014 Pan-Pacific - Present prelim combo data for TG-1101 + TGR-1202 (July, 2014)
2H 2014 Commence combination registration trial(s)
Q4 2014 Present updated combo data and single agent TGR-1202 data
http://files.shareholder.com/downloads/MHA/3008734518x0x753325/1106d1c2-a7ec-49cd-bb0a-dc8471e1f2b3/TG_Therapeutics_Corporate_Presentaton_May_2014_DB_Conference.pdf
At that point, assuming the data holds up and progresses as I think it will(if not well before>>>like now!) relative value issues will certainly come into play, and a company with a measly Ent. Value of approx 120ml with 2 very active drugs that it can use in combo, either by itself, or with those of other companies, will come into bold relief and a very significant revaluation should occur.
Remember, the first 2 combo preliminary results are due within the next 2 months...
Best regards,
bw
Re:TGTXs TGR-1202(PI3Kdelta) vs Ibrutinib Monotherapy(in CLL)
jaybe,
I know you're new to TGTX, but if you're going to compare these two montherapies, in fairness, I think you have to consider the following:
1)the 800mg dose escalation cohort for TGR-1202 couldn't have started before Sept 1,2013(see Sept 27th slide show, pg 18. It confirms they were on the 800mg cohort at the time): http://files.shareholder.com/downloads/MHA/2844438963x0x694000/fdce5f29-e29e-4e0e-9dbc-1c4feedbe843/TG_Therapeutics_Corporate_Presentaton_September_2013_-_Newsmakers.pdf)
Therefore, since the ASCO abstract only covered data till the end of Jan 2014, max tx was only 5 months and probably about 3 months avg. Plus, at least half of the pts were probably treated at a suboptimal dose, since this delta only starts to show significant nodal responses at about 800mg(with original dosing parameters).
2)Since we know no MTD has been identified, I think we can assume the optimal dose will be at least 1800mg(or the new regimen equivalent), and probably higher(due to the absence of significant toxicities). When you put that together with the fact that efficacy tends to increase with successive cycles of tx with this category of med., I can only assume that better(possibly much better)performance is likely with TGR-1202 with additional time and more ideal dosing, and that the 67% PR rate was extremely good efficacy in this context.
3)Therefore, comparing these results unfavorably with an Ibrutinib tx group that presumably got the optimal dose for at least a full 6 months in generating 100% nodal PRs in CLL doesn't seem appropriate, and it may be that TGR-1202 could, particularly with the new dosing regimen, get very close to that, or even match it in time.
4)At the least, however,(and particularly if the tox advantages hold up at higher levels of exposure), these results suggest to me that TGR-1202 may very well eclipse Idelalisib as the best in class PI3K in the tx of B-Cell malignancies.
Regards,
bw
I know its early and 6 CLL patients is too few to judge
Hi jaybe,
I don't want to speak for Doug, but it's my understanding that it's often takes several cycles(unlike some anti CD-20s) to show efficacy with PI3K inhibitors, so 67% for a Jan readout seems fine for the moment, because I think we can assume that the efficacy will only improve with time.
In addition, since PI3Ks are all likely to have their major value in combos, when the ceo recently confirmed that efficacy continues to improve with time, but more importantly, that TGR-1202, (as of the recent Qtr call), continues to show no signs of liver or any other unmanageable toxicity, I think that's a lot more important. This is after all a dose escalation study, so max efficacy doesn't usually materialize at the outset.
In other words, if TG-1202 does what it was presumably designed to do(to avoid liver toxicity by eliminating certain aspects of previous PI3K chemical structures associated with toxicity), then it's efficacy should increase nicely with the 3-4 fold formulation and administration advantages recently identified, and the lack of toxicity issue will be a critical advantage.
Although I agree that this is yet to be demonstrated, I think the absence of any liver tox to date is very encouraging in this class of drugs.
But I agree with Doug-I appreciate you looking into tgtx and please advise us of any reservations you may have.
Best,
bw
Re:The TGTX Story
Hi,
TGTX Pop Etc...
Hi Dew,
That's what I presume-apparently, the data forced at least some cadre of informed reviewers to connect the dots...
And, after the effective demise of GILDs syk/idelalisib combo in B-Cell therapy, as well as the ABT-199/Rituxin recurrence of severe side effects and a death(again from Tumor Lysis Syndrome)in the same tx sphere,
I think a number of people recognized that TGTXs combos potential, if only by exclusion, had just took a major leap forward.
Seeing as INFIs PI3K delta/gamma has already shown some serious problems with toxicity, I would think the GILD and ABT combo problems have cast a shadow regarding future combinations of that drug in B-Cell therapies(which probably explains much of their drop today:-5.10%).
Therefore, of the PI3ks, its starting to look(particularly in view of its safety profile), like TGR-1202 may be the prime combo candidate in this space, both for combinations with it's own anti CD-20(TG-1101), as well as other meds.
This, of course, increases the perceived value of TGTX(the company) considerably, thus today's pop.
Needless to say, if this isn't just a fantasy rxn(and the combos are as safe and effective as I expect),in a multi-billion dollar market, the approx. 120ml enterprise value of this company is absurdly low, and we're just getting started here.
Finally, such a discrepancy between potential and current market value is also likely to ultimately put this company in play(particularly since the ceo signaled early on that he was open to such a possibility, or any possibility, if the price was right!).
BTW, Congrats on the nice partial recovery of MNTA today!
Best regards,
bw
TGTX/TGR-1202
Tony,
See I forgot to mention that the TGR-1202 formulation and tx regimen has been tweaked so that administering this PI3Kdelta while taking food and reducing particle size was shown to increase exposure level 3-4fold(as previously mentioned by BTH)-and this is on top of their already very competitive and safe performance(based on the previous regimen)reported last night-
This suggests TGR-1202 has great best in class potential, which by itself more than justifies a much higher valuation than tgtx currently has.
However, the real icing on the cake should come when tgtx report it's own proprietary first combo data(TGR-1202 & TG-1101) in B Cell Malignancies next month. I'm willing to bet you'll see great efficacy w/o serious side effects, which will be a big improvement over the Gilead Syk/Idelalisib combo data from last night(trial stoppage due to 5 deaths and excessive AEs)...
Best Regards,
bw
TGTX Earnings Call...
Even a casual reading of this call suggests that the development and potential of both of tgtx's drugs(TG-1101(the anti-CD-20), and TGR-1202(the PIK3delta)), particularly in combination TXs, only continues to improve.
The 3-4fold exposure improvements via formulation tweaks of the delta would seem to provide another serious advantage, seeing as (despite competitive efficacy) they've (unlike the competition) seen no significant AEs to date, and therefore intend to continue the dose escalation. As such, tgtx's the only player in a position to increase exposure levels(and potential efficacy), which could confirm their delta as best in class(not to mention the CD-20).
Therefore, I continue to think people will eventually come to recognize tgtx as a major relative value(as well as growth)play at these market cap levels. IMO, worth a close read/listen:
http://seekingalpha.com/article/2214793-tg-therapeutics-tgtx-ceo-michael-weiss-on-q1-2014-results-earnings-call-transcript?uprof=44
Regards,
bw
TGTX(R/R post Rituxin in CLL)
I think what they were trying to demonstrate is that if you're going to use a CD20 as a single agent, their class of CD20(like gazyva)exhibits superior performance(and would be of value in rituxin failures).
However, since they've been suggesting all along that combos will likely become the standard of care in the treatment of B cell malignancies, I don't think they expect anyone to be using any single agent(CD20 or otherwise)in R/R in the near future.
Therefore, their combo studies(which I believe will be successful) are intended to demonstrate that combos will become best practice(due to superior response rate and durability)going forward.
TGTX-
TG-1101 doesn't appear to be that similar to Rituxin-same class, but unique epitope on CD20.
Also, like Gazyva, glycoengineered(meaning sugar residues that limited signal potentcy in earlier generation CD20s are minimized)-result:50-100X the ADCC of Rituxin.
The results of this, in a small study in R/R Clls Pts(pg11 of slides below) was 100% peripheral(blood) response, and 63.6% (nodal) partial responses at 4 months, vs a 13% response rate in comparable pts on Rituxin. Quit different.
http://files.shareholder.com/downloads/MHA/3008734518x0x719982/c0400996-8b4b-45bb-9149-4ba72fab36f3/TG_Therapeutics_Corporate_Presentaton_JPM_2014_jb.pdf
I know-somebody (besides you & I, Dew), must think they "know something";)
Somebody with a big chunk of cash who wanted in, but didn't want to run up the stock...
TGTX-Private Institutional Investment at today's closing price-
a good omen!
https://snt151.mail.live.com/default.aspx?id=64855#n=1560686919&fid=1&mid=6a274655-a962-11e3-acb4-00237de4aeb2&fv=1
Any life here???
I have a large position in this one, and, with an avg. PT of 23.67 I believe is well justified(no debt, multiple partnerships, new, broad-based MOA, high quality, experienced staff), I have to believe this one continues to function under the radar.
The obvious reason seems to be that their first product involves improved targeting and maximized efficacy for chemo(docetoxil)-therefore, a lot of people must be missing the fact that this technology(acccurins)can be used for all sorts of payloads-this initial chemo product is only a convenient proof of concept.
Wonder when the herd will finally start to take notice and we'll see some volume here(in the stock, as well as on this board-lol!).
Should, as usual, happen quickly...
Regards all,
bw
Re:CEMP Reports 4th Quarter Results
Blade,
I like the products and the management here too(although I wish the CEO's accent wasn't so thick),
but delays in anticipated trial completion dates(regardless of likely positive outcomes), do have consequences,
which is why cemp is taking it on the chin today.
However, I think(hope, lol)this 10%+ haircut is about it.
Regards,
bw
Well, I know what you mean(a charisma-gap of sorts?), but I actually found his just-the-facts(as he sees them)approach rather refreshing.
And, since I concur with these, it worked for me
TGTX, IMO, has been, and continues to be, an excellent relative value play...
Hi Dew,
In the short term, this pop was probably based on a cup and handle break out, that formed due to apparently increased appreciation of the fundamental value here(e.g.large Baker Bros purchases,updates that have only confirmed the continuation of favorable results, Michael Weiss's recent no charisma, just the facts, "the street.com" interview).
In other words, I think you know the story by now, but it seems like a lot of other people are finally starting to notice.
I'd be very surprised(short of some clinical reversal(which I don't expect)), if this stock isn't in the $10+ range in the next few months.
Full disclosure, I'm very long this one.
Best,
bw
TGTX/at BIO CEO Investor Conference
Another "flawless" presentation by Micheal Weiss(lol)...
Seriously, continued absence of any serious toxicities(no MTD)with continued dose escalation into therapeutic ranges of his PIK3delta(TGR-1202)-
emphasized advantages of pricing and therapeutic flexibility with "potential" best in class Anti-CD20 and PI3Kdelta both in house.
Bottom line:continuation of stated plans for pivotal combo trials in 2H 2014...
Worth a listen:
http://www.veracast.com/webcasts/bio/ceoinvestor2014/85138293747.cfm
Best,
bw
TGTX(JPM)
I know-he wouldn't be my first choice as a pitch man-He gave a much better presentation the last time I heard him.
He seems to get nervous(or overly excited) at times and things get a little jumbled.
However, I'm still "very(x3,x6,whatever)excited" about the compounds and the program. Like the way he's intent at going right at it in terms of the combos and registration strategy. In other words, I think your SI pick here is still secure.
Btw, thanks for the slides!
Best,
bw
Makes sense to me-
kind of the "problem/issue" I've had, in that I haven't wanted to(or have been too busy with other things to)follow an infinite number of small positions.
But, this year(again, after my ariad debacle) I am trying to subscribe to the diversification mantra, and forcing myself to do all the work I should have been doing all along.
Hopefully that way I'll know enough about a lot of positions to be able to take smaller ones proportional to the risk each warrants, and reduce my overall risk profile.
Sadly, there is no "free lunch" is there(lol)!
Regards,
bw
Even after my(all too recent)experience with Ariad, I would think that if you were willing to allocate such a high virtual % bet for the contest,
that you'd put on at least a small real-time wager.
Have you, and if not, why not?
I would think ceo reputation(though very important)is just one of many variables that needs to be discounted against the entire picture.
TGTX
-thanks for the background, and I noticed(and was a little surprised) you picked tgtx in the SI contest. I guess I thought the ceo's controversial past would(like Harvey Berger's) rub you the wrong way. But, as you noted, it was a contest, not a real money pick for you.
However, it does and continues to seem like a logical choice to me because, although it may be a "me too" stock, when you have 2 active compounds that are attractive as combos either together or with other approved drugs,
and the valuation, even after today's runup, is still rather modest(EV under 100ml, 50ml cash,3.5ml burn rate/qtr.)with heavy(50+%)insider ownership, and an expressed willingness to be sold if the price is right,
well, "me too" seems ok- in fact a lot more than ok in this case.
Bottom line, I assume you picked it as a good risk/reward, relative valuation call, with which I completely agree.
And I'm hoping you're right b/c in my case it's a real money pick...
And how bad can the news be with a last minute appearance decision?
Best,
bw
TGTX-Some nice ASH data(albeit limited due to dose escalation context)for their PI3Kdelta(important positive signal for it's Ibrutinib and other combos):
https://bay170.mail.live.com/default.aspx?id=64855#n=1326744096&fid=1&mid=9a9db76f-60ea-11e3-9c5a-00215ad8199e&fv=1
Hi 2da,
Looks like you're moving the stock;)...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=93593808
Nothing has changed, and not saying this won't recover to some degree in the future; just would rather take my chances elsewhere...
Of course, if we do have another "beheading", I would probably play the bounce...
Yes.
Bounced in and out several times, but, at this point, the lack of confidence in Ariad, the company, plus all the fundamental liabilities piling up, just doesn't, in my humbled opinion, present a good risk/reward along any dimension.
In other words, this co has become little more than a trade-sad to say and to see...
I guess those who have stayed in will have to hope that 113 is as good as they are suggesting in ALK+ NSCLC- but who knows what the case will turn out to be there as well. I certainly don't.
So, on balance, it's the no confidence vote that takes the day as far as I'm concerned.
Best of luck to everyone either way!
bw
Extremely-
Short of another slew of bad messages, I would expect some sort of short-lived attempt at a bounce, quickly followed by an even greater sell-off.
But, like yourself, I'm no world class trader, so I'm just leaving this one alone.
Iandy,
That 16.1 ml short interest figure is of 10-15-13.
It's likely to be a lot less by now when you consider what has happened since then(probably a lot of covering)...
Also, the high SI should cushion any further declines.
I apologize-
but I couldn't resist recycling an old classic, at a time when all of us appeared to be transfixed with the ascent,
and "a cat" seemed to be in possession of our collective tongue(lol)!
T-I-M-M-M-B-E-R-R R R R!!!!!! lol...