watching biotechs, gold & silver
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No one truly knows how many have SLE and LN.
Cantor is using a 278K number for SLE.
Aurinia is using 500K for SLE here: https://ir.auriniapharma.com/press-releases/detail/107
In their April 2018 Corporate Presentation, Aurinia states (Page 5) that the number is greater than 445K. Everyone seems to accept the current thinking that 60% of SLE sufferers will develop LN.
For a host of reasons (hard to diagnose, fairly widespread ignorance within the medical field, etc.), there is a fairly wide range of estimates of the true size of the population of sufferers of LN and SLE.
In general, the current consensus (if it can even be called that) is that Aurinia's numbers are conservative.
Cantor's numbers are even more conservative.
Bottom line is the market for Aurinia's drug could be substantially greater than is currently estimated.
"....they claim 278 million individuals have SLE."
Obvious misprint- they meant to say 278 thousand. 60% of that number gives an approximation of the number of LN sufferers- about 167 thousand.
If you take that number and figure 20% will take Voclosporin at an annual cost of 35K you get a number over $1B.
Seems realistic to me.
Fooling around with the numbers, if VCS works for SLE, all 278 thousand could take the drug for $7000 annually (doesn't include the cost of the drug to manufacture, market, distribute, etc.) and get to a $2B annual sales number.
Re Cantor report- I like the fact that they are valuing DES, MCD, FSGS, SLE potentials all at zero. They are leaving a ton of room to jack up their estimates later.
Still somewhat surprised such a high quality company (great science, great management) is still flying under the radar.
Notice short interest recently dropped- looks like they're being allowed to escape unscathed.
Here's how Cantor gets their $16 AUPH target:
From 1 month ago:
https://cantor2.bluematrix.com/sellside/EmailDocViewer?encrypt=92ec526a-674d-4b61-9ff6-ac87a2c69ebf&mime=pdf&co=cantor2&id=equities_global@cantor.com&source=mail
(Saw it tweeted)
You're hearing "Let it ride" but can't you also hear the inner voice saying "Press it up, press it up!"
The dice tables beckon
Or maybe the SLE carrot is a shrewd preemptive negotiating ploy to entice an early BO; ie., suggesting to BP that they not get LN but SLE in addition to DES, MCD, FSGS, and potentially a bunch of other indications.
Admittedly far fetched, but it's fun to dream what the future valuation could possibly be here.
"The SLEDAI score calculator consists of a list of 24 items, 16 clinical and 8 laboratory results."
Here's the calculator:
https://www.thecalculator.co/health/SLE-Disease-Activity-Index-(SLEDAI)-Calculator-1119.html
The advantage LN tests have is they are all objective (measurable lab tests) vs. the SLEDAI which has some subjective components.
It's a puzzlement, definitely. Hard to believe that across the pond they are unaware of Aurinia's drug. Guess they didn't see the Monte Carlo webcast.
It also might simply be confirmation bias- if the only tool you have is a hammer, everything looks like a nail.
They're planning on shopping it to BP, so it will be interesting to see how that goes.
ImmuPharma not giving up on Lupuzor
https://www.directorstalkinterviews.com/interview-immupharma-will-continue-push-lupuzor-forward/412749478
Thanks Jess- good to hear. Looking forward to that. Does the countdown clock start after full enrollment or ???
TIA
Thanks Jess- much appreciated. You are correct re my lack of awareness re passive investors and DD. Guessing you know that from your experience/observations over time on ihub and role as moderator.
Thanks again- have a good one.
Forgot to add- missing Vid's excellent contributions. Hope he's doing fine.
Thanks. I give Luna A+++ and myself a B. Luna's grade goes off the charts if his insight/premonition re rumblings re possible EMA meeting re Voclosporin and SLE potential bears fruit.
AUPH may have been waiting for this Lupuzor result to make an announcement re same.
Admittedly wishful speculation, but the recent signs point to the possibility.
We shall see.
* LUPUZOR DEMONSTRATED SUPERIOR RESPONSE RATE OVER PLACEBO IN PRIMARY ANALYSIS ON FULL ANALYSIS SET OF ALL 202 PATIENTS
* SUPERIOR RESPONSE DID NOT ALLOW STATISTICAL SIGNIFICANCE TO BE REACHED (P = 0.2631) AND TRIAL’S PRIMARY END POINT WAS NOT MET
* IN PATIENTS WHO HAD ANTI-DSDNA AUTOANTIBODIES LUPUZOR DEMONSTRATED A SUPERIOR RESPONSE RATE OVER PLACEBO
* STUDY CONFIRMED SAFETY PROFILE OF LUPUZOR WITH ZERO SERIOUS ADVERSE EVENTS REPORTED
Stock down 84%
https://uk.reuters.com/article/brief-immupharma-announces-topline-resul/brief-immupharma-announces-topline-results-of-lupuzor-pivotal-phase-iii-trial-idUKFWN1RU01E
mdro- thanks for the video link to Professor Muller's presentation in mice models re Lupuzor (P140)
I'm not qualified to comment on the science, but I found it very interesting, particularly the peptide vs. MAB approach and strategy.
It sounds like the drug is very easy and cheap to manufacture, which is always good.
I did some additional reading and consider the following items red flags:
Cephalon/Teva bailed on the drug and thus the rights reverted to ImmuPharma who really have been operating on a shoestring budget to push it through the P3 trial.
The Phase IIb couldn't enroll the 204 pts planned, and went with 150 pts, of which 147 completed the study.
They used a subgroup analysis to find what I think were modestly favorable results.
I note that the stock price has tripled since last fall, so I'm hoping that you're in this at a very favorable price and have protected yourself by selling enough at the recent highs so that you have either free or very low cost shares riding on the outcome because you don't need any more stress in your life.
Best of luck to you and thanks again.
Luna, thanks for your observations- somehow I knew in advance that would be your take on the whole elitist show. Haven't been there but I'm sure it would be a laugh seeing so many "beautiful people" firsthand.
But the best part would be the cars, yachts, scenery and maybe taking a road trip through Provence.
Maybe after the BO. There are also lots of casinos in Vancouver. Guessing Richard wouldn't be found at the VIP craps tables so may get the chance to throw the bones with him yet.
He might be even throwing us one now re the SLE potential he alludes to.
cheers
north, question for you- just looked at your profile and see you are a patent attorney.
Have to ask if you have a view re Aurinia's position re their patents. As I'm sure you're aware, some time ago there were some negative things expressed re same but as far as I can tell their IP is in good shape.
Just wondered what you thought about it?
TIA for any response
"The scores of very expensive cars and limos parked outside were a more interesting sight to behold."
A friend of mine used to work for Chrysler in Europe and his job found him travelling to different countries where the various plants were. He told me one night he and his buddies were in Monte Carlo so they drove up to the casino in their Chrysler Minivan (company car), and were just blown away by the assortment of Lamborghini's, Ferrari's, Bentley's, etc.
While they're sitting there and collectively drooling over these fantastic machines they were approached by one of the guys you're talking about and were greeted with something like "Just what do you think you're doing?" and were basically told "Get this POS out of here". Funny stuff.
All in a world gone mad
Thanks- will check it out.
"Glickman is a huge Craps player,..."
Have to say I love that game- it's the American Dream in 30 minutes.
Heard you have to wear a suit jacket and tie in Casino de Monte-Carlo, so I will never get to experience it there.
Can't help but wonder if AUPH IR would respond if asked? Is that "inside information" so they're not allowed to comment?
Sounds possible since Richard Glickman is on already on record saying he believes there is an SLE benefit.
Also makes sense to me since why go to Monte Carlo only to present to 3 people?
Killing 2 birds with one stone?
Thanks for the bulletin on this.
I'm aware of them and am watching for their P3 results, but confess they're a mystery to me as I wonder why the market cap is so low, why they only have $4M in cash and why they only have 10 employees (according to yahoo finance).
As Luna said, they're targeting SLE, so they're not an AUPH competitor.
What can you tell us about IMMPF?
Luna- Thanks for running that down. I'm guessing Benlysta (Belimumab) might be one of those drugs Dr. Glickman referred to that might possibly help in LN if they did a steroid taper.
The main problem with it may simply be that it's only marginally effective.
GSK makes it clear they don't want it used for LN as their label states: "The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, and has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is therefore not recommended in these situations."
More speculation: Maybe GSK looked at Voclosporin and thought it superior to their drug so decided not to pursue it for LN.
Anyway, as you've previously stated, there is no immediate competitive threat to Aurinia's drug at this point.
Hilarious exchange! This board is awesome!
Good point. One more question- I was surprised when Dr. Glickman said during the Q&A that the next upcoming milestone for investors would be the notice of full enrollment in the P3.
Maybe I'm misinterpreting that remark, but I take it to mean he's saying that's somehow a big deal that will stimulate activity in the stock.
I'm thinking that everyone knows it's a foregone conclusion (done deal) so why would that somehow be a trigger to buy?
TIA
Thanks Luna for responding to my paranoia :)
"Also, at the conference Glickman mentioned VOC can be used in combination with current treatments as well as potential competitors."
Seems like a beautiful drug: super safe, works really fast, very potent, etc.
Glickman also mentioned he believed there were so many LN trial failures because those drugs potential activity were masked by steroids, so it seems like as long as there is either an absence of them or a rapid taper, VCS can be layered with almost anything else, as you stated.
Still can't believe this was on fire 14 months ago and now is semi-comatose.
The market is bizarre beyond words- a temporary gift opportunity to either get in or add.
Thanks again for your thoughts.
That's why they're called "Black Swans". You never see it coming. The world could also end tomorrow.
Given all that, this is looking better and better every week.
Eventually there will be fireworks here.
"Patience is the key." Amen. Not always easy but essential here- this looks almost too good to be true but can't find anything credible to counter that belief.
It continues to astound me why we're at this PPS when I look at the exceptional science and management.
When it launches up, it could be so quick many miss it.
I agree with you they could be gobbled up before results.
Because of that, the greater risk here is being out and missing it.
didn't even get the correction right- spelled the error wrong as well- back to proof reading school :)
Thanks Jess. Still looking high and low for that elusive bear case here and still coming up empty (thankfully).
I'm hoping that P3 is not recruiting because of AUPH's VCS, since Benlysta is not a stellar drug. I think they failed a P2 and I think their successful P3 didn't show very impressive results.
I think they got approval with mediocre results because nothing else had for 50 years (in the USA) and the advocates/sufferers really need some help.
It would be really awesome if VCS could help the SLE folks also.
Spelling correction: Benlysta (Belimumab)- not "Belystra"
It's hammer Luna time- the downside of being the go-to guy :)
You may have already addressed this previously but I can't recall it:
Wondering about the P3 for LN with Benlysta???
Status is "active not recruiting"
https://clinicaltrials.gov/ct2/show/NCT01639339?term=Benlysta&cond=Lupus+Nephritis&rank=1
A. Wondering whats up with that?
B. Wondering what your opinion is re Benlystra as a competitive threat?
Any feedback appreciated - TIA
"Biotech M&A is ripping along now as IPOs surge and venture cash flows. Who’s the next big target?"
Good time to be for sale.
https://endpts.com/biotech-ma-is-ripping-along-now-as-ipos-surge-and-venture-cash-flows-whos-the-next-big-target/?utm_medium=email&utm_campaign=445%20Wednesday%20041118%20Biotech%20MA%20is%20red%20hot%20as%20Alexion%20gets%20into%20the%20game%20whos%20next%20Roche%20suspends%20Tecentriq%20combo%20study%20in%20wake%20of%20patient%20deaths&utm_content=445%20Wednesday%20041118%20Biotech%20MA%20is%20red%20hot%20as%20Alexion%20gets%20into%20the%20game%20whos%20next%20Roche%20suspends%20Tecentriq%20combo%20study%20in%20wake%20of%20patient%20deaths+CID_2215e496dc8ec7bfa88859019dbbfdaf&utm_source=ENDPOINTS%20emails&utm_term=Biotech%20MA%20is%20ripping%20along%20now%20as%20IPOs%20surge%20and%20venture%20cash%20flows%20Whos%20the%20next%20big%20target
Luna, thanks for that very succinct explanation. Very helpful
Thanks for that Luna. Any idea why this P3 study was withdrawn?
"Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation (INSPIRE)"
https://clinicaltrials.gov/ct2/show/NCT01586845
Dr. Glickman said at one point yesterday that Voclosporin had significant advantages/superiority vs. Tacrolimus.
Potential monster stock. At 2 minutes 50 seconds in, Dr. Glickman says:
"We focus on Lupus Nephritis rather than SLE, but it's likely that our drug has potential to be used in both."
If that becomes a reality, the probable valuation boggles the mind.
What is Dr. Glickman referring to?
At the 1 minute 50 second mark of yesterday's webcast, he says:
"Voclosporin is a next generation calcineurin inhibitor; very, very differentianted,....... and the potential to be used in many, many different indications"
Any ideas/info on what might be the "many, many different indications" that he's calling attention to?
It sounds like there's more to come after DES, MCD and FSGS as they alone don't seem to qualify as "many, many different indications".
Thanks in advance for any info/clarity on this.
I'm wondering how big could this possibly become?
Awesome! I get the feel he's more and more confident as this unfolds.
"He even said his gut tells him they will be acquired before commercialization."
I'm thinking he's not prone to a lot of bluster (so common in bio-land) and therefore currently believe that's an understatement; as in he's likely to have already been approached by one or more interested parties.
This could be a really fun and wild ride!
cheers
Thanks Luna- Excellent Monte Carlo webcast (their first presentation in Europe)
My favorite (almost inaudible) soundbite from Dr. Glickman was at the 26 minute plus mark when he said ""We are going to build the infrastructure so that we can launch it ourselves, on a gated basis, but we're very likely to get acquired at some point."
Very bullish presentation!
His last AUPH post before today was historic- that day AUPH closed at $2.15 and then went almost straight up to $10+.
Maybe he caught it perfect and wants to do it again, or maybe he missed it and wants it to repeat.
Either way, I hope lightning has struck again and he picked the low point to post here.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=127355333