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TGTX/TGR-1202/PT$22(from $19)/Too Conservative?
What's particularly encouraging about this PT upgrade(re: TGR-1202, TGTXs PI3Kdelta inhibitor), is that it's predicated on projected CLL revs only,
while we know there's a whole range of other potential B-cell applications(eg. MCL), not to mention a much wider range of potential applications for this high dose, very low tox PI3K in other cancer sectors, as well(where the toxicity of previous PI3Ks limited the use of this class)...
Once it's approved for any use, these other potential applications should receive rapid attention,
and the obvious result should be a proportional(and likely rapid) increase in TGTXs overall market cap.
Therefore, when you bear in mind the above, plus all the other synergies(plus buyout potential)of TGTXs programs, this PT(despite the raise) appears to me to be a little conservative.
Regards,
bw
TGTX/Roth Update/Oversights
I'm already too busy. But since you posted this, I think Roth may have forgotten to mention the updated TGR-1202/TG-1101 combo data also to be expected at ASH.
This should, in addition, be supplemented by a cohort of triple play(1202/1101/Imbruvica) data.
As I think I already mentioned, I'd be very surprised if they didn't also announce a pivotal 1202/1101 trial, since the results have been so good, and it's all in-house.
Really interested to see if the triple play makes any appreciable difference durability wise(because I don't expect that the initial responses, except in very select cases, can get much better). But I believe it will take a long time for such advantages, if any, to show.
Of course, the irony of it would be, that, for the most part, none do. And, should that turn out to be the case, that would put the 1202/1101 combo in a very strong position(probably what TGTX had in mind)-
And we haven't even mentioned the IRAK4 program...
So yes, plenty to look forward to...
Regards,
bw
Just saw this-extra 65ml apparently the result of Rhizen's speculation about a combo product that's not even anticipated at this point...
So, I guess this deal looks even better, again...
What looked better yet was the particular wording of this section:
"...approval and sales based milestones in the aggregate of approximately $1751 million, a small portion of which will be payable on the first New Drug Application (NDA) filing and the remainder on approval in multiple jurisdictions for up to two oncology indications and one non-oncology indication and sales milestones, the largest of which will be upon $2 billion in net annual sales."
TGTX/Rhizen/TGR-1202
How about that Dew...
Though it's been noted that aggregate payments, and milestones have been increased from the original 10K statement(240ml vs 182.5ml),
the critical metric, from my POV, is that TGTX gets what is clearly the BIC PI3K(in terms of safety, efficacy, and administration characteristics(1 vs 2/day dosing)), for 240ml,
while ABBV pays INFI $800+ml for the runner-up...
In view of the value of the overall deal, and the solo and combo potential of this premier PI3K,(which, due to such low tox & and formulation expanding exposure, should actually be able to broaden the range of applications of the PI3K class as a whole), I'd suggest this 60ml differential isn't material.
Another day, another positive step forward...
BTW, are you in yet;)?
Best,
bw
$TGTX Seeking Alpha Article/My Comment...
I'm posting my comment here because it's either not posted(or virtually inaccessible) at Seeking Alpha.
Seeking Alpha article:http://seekingalpha.com/article/2507195-tg-therapeutics-reaches-phase-3-special-protocol-assessment-faster-than-expected#comment-40433445
MY Comment:
Mrs. BullBear,
I guess your TGTX article is fair, as far as it goes(although I don't think you really need to tell us that clinical trial failure is a risk, do you?). But I'm afraid the biggest problem IMO, is that your article is so superficial in it's appreciation and value assessment of TGTX, that I have trouble understanding why you even wrote it.
For example, most observers would note that TGR-1202(TGTXs PI3K inhibitor) is
very likely to be a superior drug(due to it's much better toxicity and administration profile) compared to duvelisib, which ABBY just paid INFI approx. 800ml for(and that's not even including hefty future royalties).
This fact alone clearly suggests, TGTX, at its current Mkt cap of about 450ml, is seriously undervalued, seeing as the company, as you note, also has another likely best-in-class drug (TG-1101) on a fast track to approval in combination trials with one of the most important drugs in B-cell therapy(Imbruvica).
Just as importantly, however, also overlooked is that fact that if TGR-1202 and TG-1101(an anti CD20) both prove to be best-in-class (as is likely), they will become part of a wide range of combination therapies which would dramatically outstrip their utility and profitability as single drug therapies.
This of course, further suggests that the company is seriously undervalued and(as has been pointed out frequently), an obvious takeover target for a number of larger companies looking to bolster their B-cell combo assets as competition heats up in the sector.
Therefore, in summary, I was disappointed in your article because it missed the larger points(as has most of the market till very recently),that 1)TGTXs vision to produce the best drugs for B-cell combination therapy is the correct one, and, 2) it's ability to execute on that vision (with 2 seemingly best-in-class drugs), makes it a steal(at the current market cap).
Apparently, they only print favorable comments(lol)?
Regards,
bw
TGTX Seeking Alpha Article/My Comment...
I'm posting my comment here because it's either not posted(or virtually inaccessible) at Seeking Alpha.
Seeking Alpha article:http://seekingalpha.com/article/2507195-tg-therapeutics-reaches-phase-3-special-protocol-assessment-faster-than-expected#comment-40433445
MY Comment:
Mrs. BullBear,
I guess your TGTX article is fair, as far as it goes(although I don't think you really need to tell us that clinical trial failure is a risk, do you?). But I'm afraid the biggest problem IMO, is that your article is so superficial in it's appreciation and value assessment of TGTX, that I have trouble understanding why you even wrote it.
For example, most observers would note that TGR-1202(TGTXs PI3K inhibitor) is
very likely to be a superior drug(due to it's much better toxicity and administration profile) compared to duvelisib, which ABBY just paid INFI approx. 800ml for(and that's not even including hefty future royalties).
This fact alone clearly suggests, TGTX, at its current Mkt cap of about 450ml, is seriously undervalued, seeing as the company, as you note, also has another likely best-in-class drug (TG-1101) on a fast track to approval in combination trials with one of the most important drugs in B-cell therapy(Imbruvica).
Just as importantly, however, also overlooked is that fact that if TGR-1202 and TG-1101(an anti CD20) both prove to be best-in-class (as is likely), they will become part of a wide range of combination therapies which would dramatically outstrip their utility and profitability as single drug therapies.
This of course, further suggests that the company is seriously undervalued and(as has been pointed out frequently), an obvious takeover target for a number of larger companies looking to bolster their B-cell combo assets as competition heats up in the sector.
Therefore, in summary, I was disappointed in your article because it missed the larger points(as has most of the market till very recently),that 1)TGTXs vision to produce the best drugs for B-cell combination therapy is the correct one, and, 2) it's ability to execute on that vision (with 2 seemingly best-in-class drugs), makes it a steal(at the current market cap).
Apparently, they only print favorable comments(lol)?
Regards,
bw
Today's TGTX Run/Thoughts/Prediction
Thanks $heff...
Here's the general value case:
I think we're in a value recognition/digestion mode.
Therefore, even with the seemingly large run TGTXs seen the last few days, what should both sustain and drive it(perhaps much) further, is recognition of the fact that, at the current market cap of approx. 430 ml,
the company is still relatively very cheap...
All one needs do is look at the recent INFI/ABBV duvelisib deal, with upfront & milestones over 800ml, plus hefty additional royalties, for a single drug which has real tox (& therefore combo)questions,
and it becomes obvious that TGTX, with
1)a comparable drug(TGR-1202, with the advantages of no tox to date(approx. 2 yrs data), high efficacy, and once vs twice a day dosing),and
2)another likely BIC anti CD20(TG-1101,in combo with Ibrutinib prog, plus inhouse with TGR-1202), plus
3)a new IRAK4 program, not to mention all the PCYC/JNJ buyout speculation,
is still extremely undervalued, period!
Best regards,
bw
Today's TGTX Run/Thoughts/Prediction
Yes Doug, I think we are definitely in a relative value realization/digestion mode.
But, even with the seemingly large run we've seen the last few days, what should both sustain it and drive it(perhaps much) further, is recognition of the fact that, at the current market cap of approx. 430 ml,
the company is still relatively very cheap...
all one needs to do is look at the recent INFI/ABBV duvelisib deal, with upfront & milestones over 800ml, plus hefty additional royalties, for a single drug which has real tox (& therefore combo)questions,
and it becomes obvious that TGTX, with a comparable drug(TGR-1202, with the advantages of no tox to date(approx. 2 yrs data), high efficacy, and once vs twice a day dosing), not to mention another likely BIC anti CD20(TG-1101,in combo with Ibrutinib prog, plus inhouse with TGR-1202), plus a new IRAK4 program...
and, I repeat, it becomes obvious that TGTX is still extremely undervalued, period!
Best regards,
bw
Todays TGTX Move
Yes, seems you did $heff...
You appear to be a victim of a triumph of fundamental realization(re: TGTXs package value), over the pure short-term technical play...
I'm looking for a possible true breakout run into the 13s before we really see a stall here...
Best regards,
bw
TGTX/TGR-1202/Gazyva/Ibrutinib,etc.
No one seems to have noticed, in all the hubbub concerning the TG-1101/Ibrutinib combo trial(me included till now), that TGTX has initiated a TGR-1202(PI3K delta)/Gazyva(anti-CD20)trial.
Now why would they do this(lol):
Could it be b/c, at the least, they expect to show strong efficacy which would create another indication for 1202?
Well yes, but I think it's also obvious that they they wouldn't have run this combo unless they also, at the least, expected that it's efficacy and safety wouldn't be significantly different from their own in house(and ultimately less expensive)PI3K delta/anti CD20 combo-> namely, TGR-1202/TG-1101.
However, in all probability, they also expect, as do I, that the results of Gazyva/1202 may be inferior in certain respects due to TG-1101s apparently better administration characteristics, not to mention pricing & possible efficacy advantages.
So, before we get lost in all the uproar over the potential of the TG-1101/Ibrutinib combo, I think it's worth noting that TGTX is apparently moving ahead simultaneously, and at an impressive rate, on multiple B-cell therapy fronts.
Best regards,
bw
TGTX/Buyout...
Hi Kris,
I think the majority owner issue is effectively a poison pill-
no buyout will occur without M Weiss's approval.
Nevertheless, he's indicated on several occasions that he's always interested in the "right deal"
And I think it's clear that he's on a mission to make TGTX what is essentially an indispensable addition to one of a number of major players.
Of course, as has already been alluded to here, the only likely risk to my mind is an inside deal that disfavors the shareholders.
But, since I don't think that will be necessary to effect the desired result, I don't think we'll see it(or not in any major form anyway).
Best,
bw
TGTX/R&R/ASH
Hi $heff,
From my previous posts(e.g. http://investorshub.advfn.com/boards/read_msg.aspx?message_id=105904765&txt2find=tgtx),
you can see that I agree this is a great pick, both for ASH, but also in general...
Been accumulating for over a year since the 3's(by far my largest position at about 5).
Great long term take over play(or not, lol;)
Just beginning to be discovered, and coming out from underneath the cloud of all those B-cell therapy giants(PCYC, ROCHE, ABBV, etc.).
Like so many emperors before them, these too may soon be shown to have "no cloths"(or, at the least, to be in need of wardrobe additions)
Target->$25-35 in a year or two...
Best,
bw
TGTX/R&R Notes
In terms of efficacy and safety, everything still on track for TG-1101(think Gazyva) and TGR-1202(think Idelalisib/Zydelig) to achieve strongly arguable BIC status, if current trends continue.
TGTX planning direct comparative studies of TG-1101 and Gazyva.
TG-1202 seemingly hasn't reached a MTD for the enviable reason that despite very strong efficacy at a number of dose/exposure levels(due to the combination of new micronized formulation, and fed protocol), no significant toxicities have been noted. Suggestion was that since efficacy appears to be very strong, a point of diminishing returns may shortly be reached, and they may just settle on a dose and discontinue dose escalation efforts...
Various combo pathways to FDA approval were discussed.
IRAK4 was mentioned in passing as an efficacious B-cell target which should be synergistic with TGTXs other drugs.
All and all a very positive and informative presentation that gave me the impression TGTXs game plan, though affording multiple options, was clear, straightforward, and so far, right on schedule...
So rare in a biotech!
http://wsw.com/webcast/rrshq24/register.aspx?conf=rrshq24&page=tgtx&url=http%3A//wsw.com/webcast/rrshq24/tgtx/
Best regards,
bw
TGTX/R&R Webcast tomorrow PM->
https://snt151.mail.live.com/default.aspx?id=64855#tid=cmZpoH7ls35BGRPtidZ1yJbg2&fid=flinbox
TGTX at Rodman/Renshaw(Next Week)
Hey $heff-everyone seems so focused on the end of the year ASH catalysts, that it appears they're missing the potential ones we may see in just 1 week->
TGTX at R&R AHCC (Sept 8-10, 2014)
The irony is that we just saw ABBY paying approximately $800 ml in upfront/milestones for what appears to be an arguably inferior(PI3K)combo drug(in terms of liver tox/safety & dosing profile),
while, in addition to TGR-1202(PI3Kdelta), TGTX has an arguably BIC anti CD20(think GAZYVA), an IRAK4 inhibitor, and numerous cutting edge combos underway, all integrated to address B-cell therapies,
and the entire market cap of the co is only about $350ml...
Laughable really!
I think if investors we're a little more "enlightened", they'd be trading up TGTX at least as much(50-60%) on this news, because it only confirms the value of TGTX's asset class, which is obviously very undervalued in view of ABBY's action.
Of course, JMO...
Best regards,
bw
TGTX/Rodman/Renshaw
More like 20 days, $heff, so the emergent catalysts are really imminent!
Confirmation of the individual trials for TGR-1202, TG-1101, the TGR-1202/TG-1101, and TGR-1101/Imbruvica combos, and more color on the new TG-1101/TGR-1202/Imbruvica triple play combo...
Result-> Things here could/should really move into ASH!
Best regards,
bw
TGTX/Double vs Triple-Play
I think what they intend to do is show both. Although the investigators may suspect that the addition of imbruvica will have significant efficacy consequences in some disease cohorts but not others, the only way to demonstrate this is empirically.
In the process, I assume TGTX intends to show that the addition of it’s med’s to Imbruvica provides a significant advantage over mono therapy in some cases, while also demonstrating that, in others, there is no significant difference-thus establishing it’s double (PI3Kdelta/anti-CD20)combo as a viable alternative to most likely combinations of BTKs in such instances.
Since the only way to demonstrate such is empirically, I don’t see this as ethically challenged(particularly if there is a need for more efficacy, and the addition of the other meds doesn't lead to unacceptable side effects).
How, for example, would one know if the addition of a BTK was going to be advantageous in such instances without testing it.
At the same time, if TGTX is successful in demonstrating the above(unique value as combo with imbruvica in some cases, and competitive alternative in others), it will, IMO, have increased it’s acquisition value considerably.
TGTX/Triple-Play
With the expanded exposure potential of TG-1202(TGTX's PI3K delta)due to low tox and micronized formulation, I'm wondering, in addition to the opportunity to explore the advantages of triple therapy, if this isn't also a chance for TGTX to demonstrate, within a single study, that the efficacy advantages of adding Imbruvica may not be that significant.
If that is(or looks likes it's likely to be)one of the results, I would guess any motivation on their part to purchase TGTX would be dramatically increased.
If nothing else, you have to give TGTX a lot of credit for keeping things interesting in B-cell therapy...
Regards,
bw
TGTX/Deutsche Bank...
btw, Deutsche Bank is, by far, the largest international investment bank providing IB services and analyst coverage to Pharmacyclics Inc.
Since it has been frequently suggested by a variety of people(including myself) that PCYC is the most obvious suitor for TGTX, a company which has frequently made it clear it's open to an acquisition at the right price, I'm wondering how purely coincidental this meeting was.
Staying tuned!
Best regards,
bw
Thanks...eom
Thanks, so how did you hear about it(if that's not a proprietary issue)?...
any link?
So what do you imagine are the implications of this event?
TIA,
bw
Its a Bcl-2 antagonist that seems to have had a little more trouble in terms of toxicity than TGR-1202(Tumor lysis syndrome, a few deaths), however the efficacy appear to be very strong.
Although they claim the problem was largely rectified by altering initial therapy regimen, it's still seems to be somewhat controversial.
http://meetinglibrary.asco.org/content/132375-144
http://meetinglibrary.asco.org/content/134145-144
Well, depending on clinical need, I think you may be being a little extreme in terms of the time lines,
but, what I was referring to was that, in about a year, I believe the proof of principal(both in terms of a superior toxicity & efficacy profile) will be well established, even if the drug isn't yet available.
Therefore, maybe it would have been more accurate to suggest that Zydelig will be a lame duck by then.
Sorry for that inaccuracy.
TGTX/TG-1101(anti CD-20)
Another indirect read thru for TGTX, since they have the only glyco-engineered CD-20 in combo trials with Ibrutinib.
(Since, if I remember correctly)I don't believe Gazyva has gone there yet.
Therefore since combo treatment will likely predominate in B-cell therapy, and Ibrutinib is now likely to dominate CLL, TG-1101(like TGR-1202)should also be in great demand.
Although I obviously missed the trade, I wouldn't mind that as much as what seems to be this purely technical selloff-
In the other case, the company would end up stronger ultimately.
But, I don't believe that's it. But I hope you're right.
We'll see soon enough...
TGTX Earnings Call Transcript
http://seekingalpha.com/article/2330295-tg-therapeutics-tgtx-ceo-mike-weiss-on-q2-2014-results-earnings-call-transcript?uprof=44
Results couldn't have been any better, not that it's made any difference, in this totally trade-centric market...
TGTX(Stockholder Rights Plan)
Things are heating up here. Need to study this document:
http://biz.yahoo.com/e/140721/tgtx8-k.html
Anybody have any insights or comments on it's structure?
Much appreciated!
bw
Ok, I'm sitting upstairs in my underwear right now(lol)...
Can you provide a link to this info and what is the source?
Thanks,
bw
This does look like a possible avenue to accelerated approval.
Thanks. Where did you get this info?
Were you at the Pan Pacific Lymphoma conference, or did you access this information from there remotely?
Link?
Regards,
bw
So, what's your point(lol)?
TGTX(TGR-1202)
Right-That's why I said "preliminary"->
These are excellent first pass data in a drug class that is(barring toxicities,) known to improve with continued exposure.
And since there is considerable reason to believe that significant toxicities will be contained at higher doses, the potential here is yet to be determined.
Re: TGTX(TG-1101/TGR-1202)
Yes, (I should have said), "very exciting!" for large shareholders such as myself(lol), not to mention all the patients that stand to benefit!
And did you notice that Pharmacyclics was one of the major sponsors of this conference(Pan Pacific Lymphoma)? The significance of these data won't be lost on them...
TGTX(TG-1101/TGR-1202)
Results, look, for all practical purposes, essentially comparable to the TG-1101/Ibrut. preliminary combo results.
It would seem that the reduced liver tox of TG-1202 coupled with it's potential for substantially increased exposure (via the micronized particle size/fed protocol)may open up a whole new range of oncology applications for PI3K inhibitors(previously limited by toxicity issues).
These preliminary results also suggest that this TG-1101/TGR-1202 combo may ultimately turn out to be a preferred treatment choice for a variety of B-cell malignancies(exciting!).
Best regards all,
bw
TGTX/Mark Schoenebaum
Mark Schoenebaum, the much heralded, and long-standing #1 biotech Analyst from ISI, and author of the recent open letter to Janet Yellen questioning her indictment of small cap biotech as too frothy,(who was also just interviewed on CNBC regarding such),
happens to be a member of TGTX's BOD.
I see this as a major vote of confidence in both the viability and potential of TGTX's programs, because, as a top flight analyst, if he had any questions about either of these, he wouldn't have associated himself with the company.
It's just a shame that, as a board member, he's precluded from commenting on TGTX directly!
http://www.forbes.com/sites/matthewherper/2014/07/18/an-open-letter-to-janet-yellen-is-there-a-biotech-bubble/
Best regards,
bw
TGTX Buyout/TG-1101/etc.
I'm not sure I agree that it will have to be superior to gazyva, assuming tgtx's cd-20/Ibrut combo is the first to show superior efficacy over ibrut mono and it's combination with any other CD-20s.
If it's efficacy is as good, but it's administration characteristics are superior, as has been reported(much shorter infusion time), and it's the first to demonstrate best combo results(as above), that may/should be enough to get a market foothold.
I haven't researched zevalin and bexar, but I think the marketing advantage for tgtx's CD-20 would be that it's the glycoengineered CD-20(comparable to gazyva) that's more convenient(to administer).
I agree too-companies like TGTX will need to do combo trials to get approved-but I don't see that as a big impediment-
In almost all cases, docs providing tx with Ibrutinib or another CD-20 would be happy to have a free CD-20(TG-1101) or a free delta(TGR-1202) to supplement mono therapy(so the costs of a trial are largely administrative plus the cost of the drug provided), and trial participants should be fairly easy to find -not insurmountable/part of their overall game-plan.