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Iovance Biotherapeutics Inc

Iovance Biotherapeutics Inc (IOVA)

11.3415
0.1515
( 1.35% )
Updated: 15:38:13

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IOVA News

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IOVA Discussion

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Monksdream Monksdream 2 minutes ago
IOVA, 10Q 11/7
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surfkast surfkast 3 days ago
Thanks for posting!
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WhirlwindAstrologer92 WhirlwindAstrologer92 3 days ago
Q3 2024 Financial Results Conference Call
Management will host a conference call and live audio webcast to discuss these results and provide a corporate update on November 7, 2024 at 4:30 p.m. EST. To listen to the live or archived audio webcast, please register at https://edge.media-server.com/mmc/p/vxykqwaf. The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com. The archived webcast will be available for one year.

Upcoming Conference Participation

Society for Immunotherapy of Cancer (SITC) 2024, November 6-10, 2024, Houston, TX
Friday, November 8, 2024, Rapid Oral, 12:30 p.m. CST

Abstract #409: Multimodal single-cell sequencing analysis reveals putative tumor reactive population in lifileucel TIL products
Saturday, November 9, 2024, Poster Session 9:00 a.m.–8:30 p.m. CST

Abstract #1488 (Late-Breaking): A multicenter phase 2 trial of lifileucel plus pembrolizumab in patients with checkpoint inhibitor-naive metastatic NSCLC: updated results
Abstract #416: Superior anti-tumor activity of IL12-engineered TIL IOV-5001 in simulated tumor microenvironment
The full abstracts will be available on November 5, 2024 at 8 a.m. CST as a supplement published in the Journal for ImmunoTherapy of Cancer (JITC).
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surfkast surfkast 4 days ago
Are the big boys colluding and manipulating the PPS here? Do they want the so called cheap shares as they know something?
Yes it sounds like a typical OTCM statement which 99.9% of the time is BS.
But this is a Nasdaq company with huge intuitional holders. Waiting for the update FINRA short numbers.
Make one think.
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surfkast surfkast 5 days ago
Thanks. This way anyone, including me, knows what is going on.
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jondoeuk jondoeuk 5 days ago
The titles can be found here https://www.sitcancer.org/2024/abstracts/titles-and-publications

The abstracts aren't out yet.
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surfkast surfkast 5 days ago
Please post or link. Thanks.
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jondoeuk jondoeuk 5 days ago
LBA - Abstract Number 1488: A multicenter phase 2 trial of lifileucel plus pembrolizumab in patients with checkpoint inhibitor-naive metastatic NSCLC: updated results
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surfkast surfkast 7 days ago
At ties I agree they hold 100%. Will they pick a price point after the financials watch it run then short again?
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Structural_Biologist Structural_Biologist 7 days ago
82% ? I think those institutions are also responsible for essentially all of the short interest as well
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Monksdream Monksdream 1 week ago
1-yr chart
It is similar to hundreds of issues regardless of sector or industry
In the way the pps bottomed in the fall of 2023
That graph of the sector in a previous message from Barchart shows how stocks rallied in 2024 but peaked in the spring and summer
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badgerkid badgerkid 1 week ago
FWIW, some good news with a little insight into OOS product and the attempt to still use whenever possible for cancer patients. Multiple potential benefits: cancer patient improves, OOS product may prove to be acceptable such that a lower threshold could be approved and billed, additional data collection leading to future mfg improvement, other. https://ctv.veeva.com/study/expanded-access-program-of-lifileucel-ln-144-in-patients-with-unresectable-or-metastatic-melanoma

So much depends on a good sample from the patient from which Amtagvi is manufactured. As the quality of samples and the health of the patients improve as a result of earlier line treatment, OOS numbers will likely drop, but the hope remains that a lower threshold for specs proves to still be more than acceptable not only for the benefit of the patients, but since we'll be doing this all over again as foreign markets open up to Amtagvi (Lifileucel).
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surfkast surfkast 1 week ago
Hopefully the news outstrips their desire to take profits and then short. Enjoy!
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Monksdream Monksdream 1 week ago
Institutions drive the share
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surfkast surfkast 1 week ago
I have seen other who feel that institutions holding around 32% is an issue. We shall see.
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Monksdream Monksdream 1 week ago
The major drawback is the OS count
That is a lot of shares
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surfkast surfkast 1 week ago
Thanks for the reply. Looks like you are into several high quality stocks. This one had a great run early this year. Dropped way down and is slowly climbing. Actually beating many projections. How this goes based on Amtagvi and a pipeline full of other programs looks good to me I see that the projections are for between $114 and $121 million in sales this year which is anticipated to grow to $475 or more in 2025. I have also seen projections for as high as $35 in 2025. I would to see this run sooner than later as I am not getting any younger. I already took a gamble and sold and brought back in.

The institutional holding really look great.

Iovance Biotherapeutics, Inc. (US:IOVA) has 524 institutional owners and shareholders that have filed 13D/G or 13F forms with the Securities Exchange Commission (SEC). These institutions hold a total of 249,134,762 shares. Largest shareholders include Vanguard Group Inc, Perceptive Advisors Llc, Mhr Fund Management Llc, BlackRock Inc., State Street Corp, Avoro Capital Advisors LLC, VTSMX - Vanguard Total Stock Market Index Fund Investor Shares, Soleus Capital Management, L.P., XBI - SPDR(R) S&P(R) Biotech ETF, and NAESX - Vanguard Small-Cap Index Fund Investor Shares .

UBS just jumped in with a goal of $17 short term.

Nice to see you here as it has been years! Good luck.
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Monksdream Monksdream 1 week ago
I got it from this list from a Barchart sector
https://www.barchart.com/stocks/quotes/TECH/competitors?quoteSectors=-283G&viewName=main&orderBy=weightedAlpha&orderDir=desc
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surfkast surfkast 1 week ago
Welcome. What brings you here if I may ask?
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Monksdream Monksdream 1 week ago
IOVA under $15
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badgerkid badgerkid 2 weeks ago
Iovance is a strong leader, so another company is leaving the TIL space: "Lyell has prioritized its pipeline to focus on next-generation CAR T-cell therapies, including IMPT-314 and LYL119, and is discontinuing development of LYL797, LYL845 and earlier-stage TIL programs."

https://finance.yahoo.com/news/lyell-immunopharma-acquire-immpact-bio-200000548.html
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badgerkid badgerkid 2 weeks ago
Short interest still high. Low volume down days, higher volume up days, and new analysts initiating IOVA as a buy. Yeah, shorts have their work cut out for themselves:

Shorts remain in trouble, not much movement:
10/15/2024 60,338,267
09/30/2024 59,945,282
09/13/2024 60,293,439
08/30/2024 57,686,674
08/15/2024 59,334,386
07/31/2024 61,318,556
07/15/2024 58,941,197
06/28/2024 56,421,027
06/14/2024 54,631,791
05/31/2024 49,964,621
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eastcoastguy eastcoastguy 2 weeks ago
Thanks, badger, for the SITC info and the put option selling strategy. I've got a healthy core position but would add on weakness. I expect good earnings and hopefully some more info on clinical trials.
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badgerkid badgerkid 2 weeks ago
SITC in early November, Iovance currently lists 2 abstracts, one of which will be an oral presentation. https://www.sitcancer.org/2024/abstracts/titles-and-publications

Abstract Number 409 (Top 100) - Multimodal single-cell sequencing analysis reveals putative tumor reactive population in lifileucel TIL products (oral presentation)

Abstract Number 416 - Superior Anti-Tumor Activity of IL12-engineered TIL IOV-5001 in Simulated Tumor Microenvironment (poster presentation)
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badgerkid badgerkid 2 weeks ago
New coverage, UBS initiated IOVA with a Buy and a $17 price target.

"UBS analyst David Dai initiated coverage of Iovance Biotherapeutics (IOVA) with a Buy rating and $17 price target The firm launched coverage of SMID cap biotech sector with a focus in oncology and autoimmune diseases. Its top pick is Syndax. Iovance is “laser-focused” on manufacturing execution to drive near-term launch success for the first cell therapy in solid tumor, the analyst tells investors in a research note." Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news.
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GMH* GMH* 2 weeks ago
My estimate would put the MC at close to 30B which would be about the size of Seagen when they were taken over. The premium paid would be less (40% in that case) and would likely be a stock+cash deal if it were to happen. A BO is always possible but I think it would depend on how NSCLC and IOV-5001 were to be coming along (as well as any competition in the space).

The problem I have with the BO scenario is that you cannot model that. It is purely guess work on something someone said. Fred said "Iovance would be a good bolt-on" but that was 8 months ago, Everyone say "WR sells companies", but he has sold more stakes in companies than he has sold companies.

With modeling out fair value, I can make a judgement on the stock regardless. If the SP runs past where I think fair value is (given the facts at the time), I will liquidate, but if I had a BO thesis, I am kind of forced to hold until a BO happens.
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badgerkid badgerkid 2 weeks ago
GMH, regarding your unsolicited long term thesis: first and foremost, thanks for the work and food for thought.

I know we've kicked some of this around before, but assuming your projections are in the ball park and given WR's history of letting a big one get away, does the company try to go it alone with those kind of projections, or do you see a number that Big Pharma can pay that would satisfy both sides in what could be viewed as a "fair" buyout number?

My thesis remains the same, Iovance is building a turn key operation which will then be sold to the highest bidder and the mfg process is being designed to be replicatable (and almost modular). But to your point, revenue numbers keep edging up and Iovance is creating a working model. Will they have access to the necessary capital to take it to that next level? Do they have the team that can do that? Does Iovance go out and acquire the right people to build a team for a high growth company, or is the writing on the walls (my view) that a sale is far more likely.

I contend that the evidence currently suggests that a sale of the company is more likely and possible over the next 6-15 months. I think a few more pieces still need to be put in place before that ultimate deal, but all signs point to success regardless the final decision by Iovance.

I look forward to any additional thoughts you care to throw at my ramblings.

Good luck to the longs.
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GMH* GMH* 2 weeks ago
"I'll be curious to see if the specs loosen up at all as more data comes in on using the OOS product and the results of those patients." - I think this is really what they are looking for and having them in an EAP allows them follow-up.
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badgerkid badgerkid 2 weeks ago
Hicham, you're not alone. Many of the longs who have been around for a good while (me included) have started trading some portion of their holdings to capture a little extra money while we wait for what we see as an inevitable rise in share price.

I've been selling near term puts at or below $10 strikes. It's quite satisfying getting paid to take the risk of having to buy a stock I'm willing to buy anyway. Last Friday, those $9.50 puts I sold two days prior to expiration all expired worthless and the money paid to me was now all mine to keep. It may be small amounts week in and week out, but it's been adding up.

I'm still sitting long on a core position that is going nowhere for the time being and I'm collecting some additional put money that can now be rolled into more shares should I choose.

Keep making money while they keep holding us down. Good luck to you.

FWIW, recent option action suggests that the price will be slowly moving up over the next few weeks. That $10 strike price which has been the usual max pain number may be moving higher.
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badgerkid badgerkid 2 weeks ago
GMH, thanks. We'll have to look at the Q3 rev numbers to see if we can deduce how it's applied to the bottom line. I would figure that certainly worst case it's fully deductible as an expense if it's supplied at no cost to the patient (but that is likely a much smaller number based on production cost). If it's not technically a trial, then hopefully Iovance can recapture some of the cost or some partial payment. Regardless, I would assume as the patient population improves, so does the quality of the tissue samples thereby producing higher quality TILs that are more likely in spec. I've mentioned this before, but I'll be curious to see if the specs loosen up at all as more data comes in on using the OOS product and the results of those patients. Hopefully it proves to be a win-win.
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Hicham007 Hicham007 2 weeks ago
I am in fact using this volatility to be my benefit trading around 20k shares between 9 and 11. Not only it helps me to make a decent amount of money (around 10k$ per month) but also to manage the stress when the SP drops from 11 to 9 lol.


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GMH* GMH* 2 weeks ago
In looking at the Front Line MM trail, I saw this under the EAP section which answers our question. Because of this, I am not sure if they do get revenue for the IL2 in these cases, but do follow for safety and efficacy.

Brief Summary
The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.
Detailed Description
This program provides access to OOS AMTAGVI (lifileucel) that does not meet commercial release criteria but does meet Iovance clinical trial release criteria. Patients will be followed for safety and efficacy.
Official Title
Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release
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GMH* GMH* 2 weeks ago
Posted my short term Q3 thesis, so here is my long term (2029-30) thesis (not that anybody asked):

Peak L2+ MM patients/slots (US): 1,900/yr (largely due to screening vs label)
Peak L2+ MM patients/slots (RoW): 2.800/yr - approval very likely in 2025
Peak L1 MM patients/slots (US): 3,000/yr - likely approval given interim top line - expected in 2027
Improved manufacturing/infusion success rate from est 55% to 80% - feasible given addressable items in label.
Gross Margins to 70% - management guidance and should follow success rate improvement
SGA/R&D spend increases 5%/yr: $404M to $515M
Dilution of 20%
Using IBB PE of 18.8 and PEG of 1.50 given growth/pipeline
Without showing the math, SP would be in the $100-$110 range.
Additional patients from NSCLC would simply add (5,000 patient/slots per year) but need more data before incorporating
IOV-5001 would open up eligible patients significantly due to elimination of IL2 - but still pre-clinical so will wait and see

Regarding a Buyout, was reminded that WR invested in Pharmacyclics. He got in sub $2 and sold his stake for $7 for a nice return, but Pharmacyclics eventually was sold for $261/share. I am guessing his current cost basis is around $10 and I do not think he wants to make the same mistake as he did with Pharmacyclics.

Just my opinion. As always, do your own DD.
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badgerkid badgerkid 2 weeks ago
Getting ready for Europe to open: https://iovance.bamboohr.com/careers/1497

Job openings at Iovance - obvious growth: https://www.iovance.com/current-opportunities/
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Structural_Biologist Structural_Biologist 2 weeks ago
Nice to see you 😄 and have a lovely weekend all !
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badgerkid badgerkid 2 weeks ago
Surfkast, as always, it's your money so it's your rules. As for me, I'm holding as I don't think we're even close to a realistic value yet. I am anxious to see the Q3 numbers and to hear any updated guidance that they may offer. Good luck.
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badgerkid badgerkid 2 weeks ago
Hicham, glad to see you're still around. I was worried we lost you. The reasons to be long and strong remain and have actually increased over these past several months. We can't completely predict the timing of upcoming events, but we can certainly jump on the winning horse early in the race. The finish line may be closer than we think, and the run to profitability continues. Good luck to the longs.
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surfkast surfkast 2 weeks ago
I have a nice core position which I picked up @ $7.44 as when missed the big run I sold and bought back in. My dilemma is when to take some profits or hold on tight to everything. (Not getting any younger.)
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Hicham007 Hicham007 2 weeks ago
All, I am still around and still holding firmly to my 100k shares +-10k shares and my confidence to keep holding the shares comes form this board. 

Thank you all and it does feel good when we have 2 good days like this. 
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GMH* GMH* 2 weeks ago
Feels to me like this is short covering going into earnings. To much of a potential catalyst upside risk to carry a big short position into that event.
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MN Gopher MN Gopher 2 weeks ago
https://finance.yahoo.com/news/iovance-biotherapeutics-inc-iova-most-231558542.html

We are seeing alot of “chatter” to me this means some news drop is on it’s way & we are moving up & up into Q3 Earnings.

#CureCancer
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badgerkid badgerkid 3 weeks ago
Surfkast, we'll see soon enough. Was today's action tied to options, or is there some additional reason. It could be as simple as a new buyer or fund just decided that it was time to take a position. With the XBI a bit soft today, it was a good day to buy when nothing else is pushing it up or creating competition. Good luck to the longs.
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badgerkid badgerkid 3 weeks ago
GMH, good points, and if Iovance is still getting paid for IL2 despite administering the OOS TILs that don't produce revenue, then purchasing the worldwide rights to Proleukin will have proven to be a very shrewd decision indeed guaranteeing some income even on OOS TILs when administered. I wonder if this was actually thought of at the time of purchase, or just a lucky bonus.
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surfkast surfkast 3 weeks ago
Nice move up so far today. Will it keep moving up?
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GMH* GMH* 3 weeks ago
I was wondering if they would track the OOS patients as part of an OLE type program for that purpose. When this was approved, I know they made a big deal about the FDA changing the volume requirements which improved ORR but what they didn't say (but we should have known) that it would also add to the OOS product for which they would not get revenue. Pay attention to what management says, but even more so to what they don't say.
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badgerkid badgerkid 3 weeks ago
GMH, thanks. I do recall some of that discussion now that you mention it. Hopefully some or all of the IL2 does get covered by insurance which would make sense since it's not out of spec and would be required as part of the process should they elect to administer the TILs. The company would have no reason to comp that even if the TIL gets charged to R&D. Depending on the success with out of spec product, I'll be curious to see if the specifications eventually change. It would follow that if the product still proves effective at some level, it could change the parameters of what is and what is not considered in spec.
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GMH* GMH* 3 weeks ago
In the Q2 earnings call, JMB (CFO) said that, when the product was OOS, the doctor had the decision to use or not. If the doctor used, those expenses were moved over to the R&D line and out of COGS. I suspect the doctor/patient would make that decision depending on how far out of spec the product was and whether the chemo/IL2 treatment would be worth the risk. On Stocktwits, someone confirmed this was how CAR-T was handled. Only question I have is if they would also give away IL2, but I suspect that this would still be covered by insurance so probably would add to revenue.
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badgerkid badgerkid 3 weeks ago
GMH, what we don't fully know is if and how the out of spec product is used. Can they still administer? The prevailing thought is yes but it may not be chargeable as such. It may drop in as a trial or written off as charitable. I'm curious to hear from the company on this and hopeful our analysts ask such questions. Out of spec does not necessarily mean toss it in the trash. It's far more involved than that. Keep trading to make a few bucks, and build your core for the eventual run as revs continue to grow. Good luck to the longs.
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badgerkid badgerkid 3 weeks ago
TIL Therapies Summit 2024 is next week. Iovance is speaking:

https://til-therapies.com/
https://til-therapies.com/about/about-event/
https://til-therapies.com/speaker/friedrich-finckenstein/
https://til-therapies.com/speaker/sean-hall/
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GMH* GMH* 3 weeks ago
An update on my assessment, it was pointed out to me that there could be some additional IL2 sales on the OOS TIL product. Assuming 2/3 of OOS product still gets infused, this would be about 32 patients adding $3.2M to the IL2 sales. Updated total revenue is $66.8M with a $52.4M/$14.4M TIL/IL2 split. Numbers are updated, but my trading thesis has not changed.
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