Iovance Biotherapeutics Inc (IOVA) News

Merry Christmas and Happy Holidays. I wish you all good things this holiday season. Celebrate in whatever manner suits you, hopefully surrounded by the people you love. I look forward to a great year in 2025.

Check out Dr. Meredith McKean's answer: https://www.foxnews.com/health/year-cancer-advances-made-2024-predictions-2025

Q: What do you see as the most important cancer advances in 2024?
A: The first cellular therapy, Lifileucel, was approved in melanoma after decades of research in academia and industry. "We are in a unique time when treatments can be tailored specifically to each person, and many of these are available through clinical trials." This is a significant step forward for both patients with melanoma, but also the field of oncology at large.

Recent article fwiw: 'It’s saving lives': New melanoma drug debuts at Pittsburgh hospitals

https://www.post-gazette.com/news/health/2024/12/21/new-melanoma-drug-lifileucel-pittsburgh/stories/202412220025#:~:text=In%20February%2C%20decades%20of%20research,exhausted%20all%20other%20treatment%20options

IOVA, under $8

Merck has spent a lot of money trying to protect exclusivity of Keytruda. More of their attempts have been tossed onto the scrap heap. Their combo with Iovance's Amtagvi is still one of their best hopes for continuing with their cash cow Keytruda. Here's some of the latest victims and failures: https://www.biopharmadive.com/news/merck-discontinue-vibostolimab-favezelimab-TIGIT-LAG3/735714/?utm_source=Sailthru&utm_medium=email&utm_campaign=Newsletter%20Weekly%20Roundup:%20BioPharma%20Dive:%20Daily%20Dive%2012-21-2024&utm_term=BioPharma%20Dive%20Weekender

"Merck calls quits on two immunotherapies for cancer:

Published Dec.16, 2024, Jonathan Gardner, Senior Reporter

The company is scrapping two drugs aimed at targets called TIGIT and LAG-3, both of which were in the middle of Phase 3 testing.

Merck & Co. has long been dominant in cancer immunotherapy, with its drug Keytruda earning 40 approvals en route to becoming the world’s best-selling medicine. But the New Jersey-based drugmaker has had difficulty finding a successor, and a Monday announcement is the latest evidence..."

Amtagvi with Keytruda is at least one very good option for Merck in giving some hope to avoiding the patent cliff that is just in front of them for Keytruda.

Good luck to the longs.

FWIW, today's triple witching will be behind us at the end of the day. I do see calmer waters ahead with some definite upside coming.

This year did not close out as hoped nor as expected. IOVA isn't even close to what I had anticipated. But to your point, I wasn't planning on selling a single share anyway, so waiting was already part of my plan. All still remains on track for success, so no reason to go anywhere and I continue to add a few shares as funds allow at this bargain prices.

The election gave us that initial excitement, but there's a lot of moving parts which the markets are still trying to figure out. Good luck.

https://finance.yahoo.com/news/wall-street-next-test-fed-190145704.html

🙄 I’ll keep adding and holding here for a long time in the future thanks but you can continue to contribute to this board

Lol stuckholders want to know..

"If I Could Only Buy 3 Stocks in the Last Month of 2024, I'd Pick These"

FWIW, Iovance made the MFer's list: https://www.fool.com/investing/2024/12/19/if-i-could-only-buy-3-stocks-in-the-last-month-of/

"3. Iovance Biotherapeutics

Finally, add Iovance Biotherapeutics (IOVA) to your list of stocks to buy in the last month of 2024. It's not a household name -- at least, not yet. But 2025 could be the year this company moves into the spotlight, pushing its stock higher as a result.

Just as its name suggests, Iovance is a biopharma company. Its flagship drug is a skin cancer treatment called Amtagvi. Like many other biopharma stocks of its ilk, this one's been ebbing and flowing ever since the therapy first started showing promise years ago, well before it won its first FDA approval in February of this year.

The problem? By the time that long-anticipated approval materialized, investors had lost interest. Shares are down more than 50% from that news-driven February peak, and knocking on the door of a new 52-week low.

You can use this unlikely disconnect between the drug's developmental progress and Iovance stock by stepping into a new position when the company's growth prospects have never been more promising.

Iovance's expected revenue of between $160 million and $165 million for the fiscal year ending this month is expected to roll in at somewhere between $450 million and $475 million in the coming year. Most of that growth will come from Amtagvi, one of only two drugs the company makes and markets. While this still won't drag Iovance Biotherapeutics out of the red and into the black, it does put the company on pace to swing to a profit in 2027. And as veteran investors can attest, sometimes progress toward profitability is enough in and of itself in the meantime.

There's still above-average risk here, to be sure. But cancer-fighting Amtagvi is the real deal with real potential. Although it's only approved for one use right now, it's currently being tested in 12 other drug trials. Investment research outfit GlobalData says enough of these trials will pan out to potentially produce annual revenue in excess of $1 billion by 2030. A bunch of other investors could finally start to see and believe in this possibility beginning in the coming year, as Iovance reports a few more quarters of strong growth."

This is a comfortably conservative estimate for what's to come. Many here believe these numbers will likely be significantly beat with Q4 of 2025 possibly being the first Q in the black, well ahead of these estimates above.

IOVA lost its momentum going into the end of the year with the entire biotech sector. This has provided a great entry point or add point for those who wish to take a position or to add on. I've increased my position significantly due to this extreme pullback.

Investing in biotechs is not for the faint of heart. Good luck to the longs.

$7.25 around Xmas. Says it all. What a shame! My worst holding to date.

WTF is going on here? Where is the bottom?

Happy Hours for the Holidays - click on the link above.

SB, thank you. Incredibly well done podcast and absolutely worth a listen if thinking about investing or already having invested in IOVA. I had not listened to this podcast previously.

For me, the entire podcast is valuable, and I picked up some additional insights from "22:06-27:25: Clinical trials" and from
"27:25-29:25: How do you address cost?" There was a little teaser in the "34:21-35:30: Can TILs be improved?" where future/current partnerships were mentioned but not expanded on due to being non-public info at the time for improving TILs.

Though this podcast was from Sep of this year, all of the information remains relevant to how Iovance is growing and increasing its market share. Keep up the great work of finding these gems that may have been overlooked previously and sharing or re-sharing here on iHub while Iovance continues on its journey.

00:47-04:44: About Iovance Biotherapeutics
04:44-07:57: What is polyclonal tumor infiltrating lymphocyte treatment?
07:57-14:55: What is the production process for TILs?
14:55-18:32: Are there any limiting factors for TIL treatment?
18:32-20:59: Is early intervention important?
20:59-21:22: Does better psychology help?
21:22-22:06: Are other companies working on TILs?
22:06-27:25: Clinical trials
27:25-29:25: How do you address cost?
29:25-34:21: Iovance’s pipeline
34:21-35:30: Can TILs be improved?
35:30-37:21: Where does the TIL space go from here?

I shared this message on ST but wanted to share here too. I would love for you all to listen and share your thoughts!

Below is a 30 minute podcast from September with Dr Brian Gastman (EVP Medical Affairs).

My favourite takeaways:
- Iovance’s ability to manufacture at scale is a feat. Dr Gastman made it clear that it’s easy for “mom and pop shops” to treat a few patients a year but the ability to manufacture TILs at scale does not exist anywhere else. This made me smile because he was referring to Obsidian. Even CDMOs are reliant upon Iovance providing all necessary patented workflows and training.
- management is aware that the goal is to get TILs approved in an earlier line. They know how compelling their data is. Also, that 31% average ORR ? It’s the result of Lifileucel monotherapy in patients ranging from SECOND to SEVENTH line! They were on deaths door!
- they’re working hard to educate all doctors on TILs. They don’t want it to be only known by some oncologists who decide to use TILs in a 3rd or 4th line setting after the patient has been tossed to them after seeing several other doctors.
- a lot of excitement for IOV-4001 and IOV-5001, they know how important it is to get 5001 to trials and bring down the toxicity
- they’re playing around with minimum dosing of IL-2 and TILs for viable (and payable) treatments
- lastly ! there are some trials that Iovance is involved in with partners that can’t be publicly disclosed.

https://podcasts.apple.com/ca/podcast/beyond-biotech-the-podcast-from-labiotech/id1629447269?i=1000668579420

https://open.spotify.com/episode/7vU8tgV6rV39Zbej3oYqmA?si=zpM7gOHyStC3T_DzlYljdQ

Sunman, $8 is max pain for options this Friday, 12/20/2024 and it's in play in a big way. It would seem that the goal to keep IOVA below $8 for this Friday will be a huge win for the sellers of all of those calls for 12/20. There is absolutely millions of dollars in play and a desire to not have to deliver millions of shares.

In reviewing the call options, we can see that someone or some fund rec'd nearly $2.15 million back on June 17th for the 10,100 $8 calls that were sold. If they don't have to deliver those shares because IOVA is at or below $8 on Friday 12/20, they walk away a winner on multiple levels, not to mention all of the other calls that were sold at higher strikes expire worthless. If I'm reading things correctly, a lot of pressure to keep IOVA down below $8 disappears as soon as Friday's option expiration passes.

I'm betting that derivatives are at the heart of the battles being waged over the IOVA share price, not some secret leak of news that only the shorts know.

Once again, just look at the major share holders of IOVA. Maybe they're playing the game from both sides of the aisle. We're just pawns in this game for the time being. No worries, Iovance has an incredibly bright future with substantial profits that will become obvious not too far down the road.

https://ir.iovance.com/stock-information/ownership-summary

Good luck to the longs.

BK (aka cheerleader)

According to the licensing request, it is open for public comment until 12/17 (tomorrow) at which time, if there are no objections, license would be granted. NIH does get royalties under the license and license is said to be exclusive but limited to the TIL area (so would exclude extension to CAR-T). I think the NIH does a lot of these for research funded by the government but allows further development and commercialization by the private sector (which the NIH would not be able to do).

Share price sub-8 may signal they miss Q4 earnings. Raising cask in a sneaky manner at the ATM around this time would be adding salt to injury. More pain ahead? A huge short position is betting on it .

I’m also unsure if this license was granted and if it is, how it impacts Iovance’s application. It cites the February Marble Therapeutics application as supplementary material so clearly they’re aware of the status of that license.

Marble Therapeutics appears to a tiny Stanford startup that seems to focus on skin care and anti aging as well as cancer.

So, are we looking at direct licensing, cross licensing, an actual patent, or a limited patent specific to each company wanting to employ this tech in their specific treatments? Honestly, I haven't dug that deep just yet, but it's intriguing to see possibilities that will further improve TIL therapy's success and the overall response rates. Please continue to share more if you have a handle on this issue specifically. Thanks.

Dr Restifo is Co-founder and Chief Scientist at Marble Therapeutics. From this: ''At Marble Therapeutics, he is working to figure out how to rewind the epigenetic clock on these cells, using any means possible. The company started out with a focus on skin rejuvenation, adds CEO Denitsa Milanova, but expanded to also work on adoptive cell therapy to prove their platform works.'' https://web.archive.org/web/20231218233715/https://www.nature.com/articles/d41573-023-00206-6

They have a license for TIL plus a neoantigen vaccine https://www.federalregister.gov/documents/2024/02/07/2024-02491/prospective-grant-of-an-exclusive-patent-license-vaccine-augmented-adoptive-cell-therapy-for-the

Preclinical data on the vaccine https://jitc.bmj.com/content/11/Suppl_1/A418

FWIW, possible patent portfolio addition: https://www.federalregister.gov/documents/2024/12/02/2024-28081/prospective-grant-of-an-exclusive-patent-license-vaccine-augmented-tumor-infiltrating-lymphocytes

This was another painful day for all of us but then I remind myself of the following: this is not a meme stock, it is also not a clinical stage company, this is a commercial stage with an  unique technology.

Sooner or later (1 to 3 years), IOVA will reach the 1 billion $ revenue, break even in terms of.profit and cash which will result in 16 to 25 $ EV per share in the market or.in BO deal

So unless you are highly leveraged (which  is never a good idea in volatile stocks), all you have to do is hold and make 100 to 200% return in 1 to 3 years which is an excellent investment  by all standards.

No short term pain and background noise linked to inflation, interest rate or HFs market manipulation can change this great mid term outcome and therefore I will not give up and will HOLD MY SHARES.

Company really needs to focus on the path to profitability (or at least cashflow breakeven). As the sector gets pummeled, it requires more dilution to raise the same amount of cash. Debt markets are not really open in this sector and big money knows it. Putting that risk behind it is the only way IOVA can separate it from other clinical biotechs.

Compare IOVA with LABU and XBI, and the picture becomes far more clear. The entire sector is getting slammed right now. Opportunities are there to build a long position in IOVA and other decent names, but many of us have already done that. Plenty of positive news right around the corner, but as Tom P would say, the waiting is the hardest part.

The waiting is the hardest part
Every day you see one more card
You take it on faith, you take it to the heart
The waiting is the hardest part

Lol ya right.. it can barely hold $8.. brace yourself...

But on Level 2 I see no really support volume at 8.

Holy Cow. Would like to reenter. oversold on the long time frames.

GMH, SB, there was also some quiet rumors rolling around that lung data may have been updated prior to year end along with EMA approving before year end. Those have been pushed into next year as well per the company's comments, so that likely also had some effect on IOVA momentum.

All still looks very solid for 2025 with lots of good news likely which will help the share price in the coming months, but 2024 is kind of going out with a whimper instead of a bang that could have occurred had either or both of those items transpired. I've added to my position and I have a few extra for trading as situations allow.

I will continue to be a cheerleader regardless of who it may upset. Curing cancer will not go out of style.

Good luck to the longs.

I completely agree with this. We all expect the holidays to disrupt treatments. I don’t think we’ll see that $4.6M beat.

Fully agree with your assessment. The one (short term) concern I have is with Q4 revenue. The beat Q3 by $4.6M ($58.6M vs $54.0M) but they only affirmed full year guidance. This means that originally, Q4 discrete guidance was originally $76.7M ($162.5M-$54$-$31.1-$0.7M) but now is $4.6M less at $72.1M in that they are giving up the Q3 beat. I think this may be driving some of the SP pressure now and I think they need to beat full year by at least the $4.6M, if not an additional $4.6M before the "demand slowing" narrative subsides. I think that will be hard to achieve because of the holidays. It may be overcome if the report a very large number of infusions already taken place in Q1 which could happen if patients push off infusion until 1st week of January. Reporting will be 8 weeks after year end rather than the 5 weeks after quarters' end normally so this will muddy those numbers a bit. Plan on lightening up some of my trading positions if we run-up into year-end reporting.

Thank you for taking the time to summarize potential positive and negative developments that can occur in 2025. I remain invested with my core position. Did dump some at $11.50. Will buy back now.

Thanks. That is a good summary of what we can expect in 2025. If the drivers go as planned SP should 3X. If the XBI finally has a good year it should be a tailwind to help push IOVA to new highs.

SB, excellent post and summation. I truly appreciate your efforts and your posts on this board.

That is such a general question.

Potential drivers:
- data readouts next year including TILVANCE-301, LUN-202, and GM1-201.
- every ER supporting their guidance
- ASCO in June and WCLC in September
- approval for UK, Canada, and EU (will not realize ex-US revenue until 2026)
- guidance of no further dilutions needed

Potential barriers:
- data not as good as expected
- revenue not as good as expected
- rejection of ex-US applications
- more dilution without near term profitability

Based on all data we’ve seen so far, it is very unlikely we will be surprised with poor data. We’re expecting around 25-30% ORR with lung.

They guided so far ahead and so specifically it would be shocking if they fell substantially below that. I also think revenue will continue to ramp throughout 2025 as more ATCs come on online and existing ATCs treat patients more efficiently.

I am confident in their ex-US approvals but revenue will not be realized until 2026 and it will ramp slowly and continuously with leading proleukin sales just like the US launch.

Igor explicitly stated there wouldn’t be substantial dilution needed to reach breakeven and they have been conservative with their guidance and transparent for several quarters that general efficiency improvements have been improving margins.

Sunman, "What (are) the major drivers to get SP higher? What are the major barriers to prevent this from happening?"

I'd like to hear your answers.

As a "cheerleader", I'm still able to see the score of the game and understand that some things will not play out as predicted or expected. I could post on these boards all of my complaints, but that also serves no purpose. Reasons to be higher do not always lead to the logical conclusion. Elections don't always end the way the media predicts they will either.

I can live with my predictions being wrong or mistimed because I always accept that many factors are outside the control of the person making the prediction, a lot of information is not available so we work with what we've got and strive to see where it will lead. I also believe in personal responsibility for any decisions we make in life. Due diligence is every investor's personal responsibility.

I'll kick the ball back to you and await the answers to your questions. The game isn't over, it's just running longer than expected. TIA for your answers.

Nope

We are NOT going to see higher highs at the end of this year like some cheerleaders were touting on this board all year along. Frankly, it is pathetic to see SP below $9 in a sustained manner, a level at which Amtagvi received accelerated approval in Feb 2024 and reached a yearly high of $18.
So much talk to explain why we remain below $9. I guess we will slowly walk to $18 in 2025 or 2026? What the major drivers to get SP higher? What are the major barriers to prevent this from happening?

Was just thinking that I should check EMA schedule this morning when I woke up... now I don't have to. Thanks.

Here is the EMA timeline:

https://somerville-partners.com/marketing-authorisation-application-ema-vs-new-drug-application-fda/

I think we are at clock stop 1, so how long this takes will depend on how quickly IOVA responds to the questions raised.
I guess we will now see if Raj is really worth that $1M he just got in RSUs.

FWIW, European Medicines Agency update, Iovance on the agenda today (see 3.3.2.): https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-9-12-december-2024_en.pdf

I agree with you that the short interest is mostly large institutional players and that they are putting on that position with the hopes that the price goes down (or at least not up as much as the overall market). The one thing I disagree with is your statement that large HFs "take control". There are currently 54M shares short but also 360M shares long (Outstanding + Shares short). Why do you give them more pricing power than the longs. The stock price at any given point is determined by buyers and sellers, not shorts or longs. If shorts were impacting the price, they would need to be selling additional shares, but the SI has been very consistent since approval 9 months ago (increasing slightly from 48M to 60M). If they were profiting from these swings, I would expect much more gyrations in the SI postings (or they are not taking advantage of the drops, only the increases to add to the SI - but that makes no sense if they control the price).

After having contemplated this the last few days, I believe that the SI is simply a carry trade/source of funds. Very little risk in the sector that is out of favor and can simply short any biotech stock that pops (usually see SI increase after a catalyst). Using a long/short strategy allows the HFs to leverage funds only paying the borrowing fee (0.25%) vs a margin loan at 3%-5%. I remember an article analyzing the strategy. They ended up losing 2-3% on the short position, but because they went long the S&P, which was up 10%+ that year, their overall return was 30%+ (don't remember the exact numbers but these are close). I do pay attention to the Yen carry trade in regards to the overall market for this very reason. Japan raises interest rates and our market will have a significant sell-off.

Anyway, that is my take. Just refuse to believe we are puppets on a string to the HFs... maybe I am naive.

Totally agree.

Based on fundamentals this should be at $12 or higher.

Because the level of short interest indicates that big players are in the trade for the price to go down. Now. I know that it sounds obvious, but i take the short interest quite seriously. We can see with IOVA that the powers that have accumulated a large short interest have some control. How many times have you questioned - why did we get to 12 and then there was a sudden sell off without news? I am sure that the powers that are short have quite a lot of control of the direction. I have seen it time and time again with IOVA. Frankly, that is why i trade it and do not hold a position. Yes. We can say that we have a long horizon of 2 to 3 years, but that does not eliminate the idea of a good entry. For me, IOVA is textbook for the control that these hedgefunds that are short have over a stock. Should this stock be in the 8s with their strong guidance? IMO. No. I have been in and out of this stock for over a year and I was always amazed at how they could constantly load the ASK on every tick to drive the price down without any real change in large fund ownership. I am sure that as we all look at this stock, we do not think that it trades rationally. Short interest matters greatly. It's not a bunch of idiots that go short. It is large HFs that take control. One day they will exit, but over years of trading, I have seen it occur orderly as we are now seeing. Yes - sometimes they get burned, but I am sure that their overall win rate is very high.
For me, I never fall in love with a stock that is highly shorted. I look for entries and exits to play along. Will I miss a BO? Maybe. But i actually may be in it with a nice entry. I have much more patience with highly shorted stock to get a good entry.

I have the exact same opinion. It doesn’t impact my investment thesis and I’m looking ahead many years. I have no idea why the short interest got so high and my interest in it is purely curiosity.

I am grateful for the high short interest because it previously lead me to read heavily about Obsidian and TCR-T therapies. I am convinced that 10 years from now Iovance will be treating ten thousand patients a year or more.

Serious question to everyone: Why are you concerned about the high short interest?

For me, it does not change my investing thesis one bit since I do not know why they put on the short position. Not sure my thesis would change if the SI increased 20M or dropped 20M. I guess the higher the short interest, maybe the more I should question the facts around my thesis (sometimes I have too much conviction( or maybe assess the current SP against current facts (I do tend to forward look 2-3 years on investments).

I simply see the short interest as a trading opportunity, but from that standpoint, I would rather have a high short interest since, on any surprise upside event, I would rather have 60M shares rush to the exit vs 10M.

Just curious as to how the SI impacts everyone's investing philosophy. Thanks.

Apparently the short interest report is filed based on settlement which takes 2-3 days after covering. And there has been a lot of weird heavy after hours activity on many days after that settlement date. I’m curious to see the next report!

Whirlwind, thanks for the update on the short interest. A healthy drop indeed and I take the drop as a good sign. I haven't checked the sector to see if this was across the board or specific to Iovance. I suspect that the drop in SI is bigger still and we'll likely see that in the next report.

I always thought there was a high probability of approval in the EU since EMA often follows the FDA. Bigger issue will be country coverage and reimbursement. I think most countries will cover, but I am sure there will be a couple that push back on the cost/benefit (UK is usually quite difficult so I am rather surprised that they are targeting there early on).

Because there are more MM patients ex-US, I have that number at a little over 2k in my modeling. I think reimbursement will be about 80% of the US rate (similar to CAR-T).

Without question, the data is so compelling and exciting for Lifileucel + pembro for both frontline melanoma and NSCLC!

Next year I’m most excited for continued improvement in ATCs/patients treated/ex-US expansion, as well as the start of the phase 1/2 for IOV-5001 for multiple tumour types. IL-2 treatment will be dramatically reduced and dramatically open up TAM.

I’ll continue to add to my core position. As a postdoc I have a tiny position compared to everyone but I am very excited to see where it ends up several years from now 😄