Iovance Biotherapeutics Inc (IOVA) Options

You dismantled my argument 😅

I was trying to be charitable about something I briefly looked up. To be clear I’m heavily invested in Iovance and don’t own any Northwest Bio.

I absolutely do think these dendritic cells will be used to treat several solid tumours

These vaccines have been an abysmal failure since the 1990s.

I like the idea of arming with them tumour associated antigens that’s going to offer defence against tumour heterogeneity.

Many TAAs are self-antigens. As a result of negative selection, to prevent autoimmunity, any T-cell that is able to target a TAA will express a TCR with a low affinity. But TCRs with high affinity (for TAAs) are required for efficient antitumour immunity https://academic.oup.com/cei/article/180/2/255/6422173

This is why ADAP (and other companies) do what they do.

Lastly, DCVAX-L will be approved for glioblastoma.

The trial was negative. While the original primary endpoint of PFS was no different between the groups, it was numerically longer in the placebo group (mPFS was 7.6 months in the placebo group and 6.2 months in the -L group, with an HR of 1.1 for the latter (a 10% increased risk of tumour progression))

The original secondary endpoint was OS, but it couldn't be analysed due to the crossover (talk about badly designed!). However, a number of the placebo control group patients did not crossover. If -L works, there should have been a (strong) trend towards benefit. But based on the company hiding the data, it is almost certain there was no such trend. I think the opposite is true. There is no reason they could not report the data, other than they know people would not like it. Instead, they switched (post-hoc) to cherry-picked ''controls.''

There’s also an ongoing Phase 1/2 basket trial for DCVAX-Direct for multiple solid tumours.

It finished years and years ago. Not a single patient responded (see Table 3) https://aacrjournals.org/clincancerres/article/24/16/3845/277824/Cytokines-Produced-by-Dendritic-Cells-Administered

Also, read this https://www.thestreet.com/investing/stocks/biotech-school-how-to-spot-hidden-danger-signs-in-clinical-trial-data-13748701

Finally, NWBO is a shitco scam!

dstock, it's time to take this conversation back to your other board at NWBO. IMO, this has gotten too far off topic for this board which is for the discussion of Iovance.

Good luck to you.

Lots of apples and oranges being compared here, but SB makes the obvious point, there's room for all kinds of treatments when it comes to solid tumor cancers.

My concern in what you're saying dstock, is that you confuse a treatment option with a treatment choice. As we continue to refine our understanding of genetics, we will continue to draw closer to matching the best option for any given patient. But all patients bring a different set of variables to the table, and sometimes a single variable can alter the expected outcome of a certain treatment option.

Harnessing our own natural responses is often proven to be the best choice for treatment, but sometimes our bodies can't keep up with the invaders, so we seek additional help. But those invaders are also skilled at hiding from the medicines we may introduce, so we have to try other options. The battle will never be completely won because we have yet to fully understand all of the possible variables and the interactions that result. But we continue to find better and more successful options that improve our chances at survival and quality of life.

That said, TIL therapy has an enormous amount of untapped uses that have yet to be explored, but that will also take years and decades to fully understand and the money needed to research it will be limited to those areas that have the best chance of financial reward early on.

Forgive my layman's approach to this discussion. I may understand a lot of what I read, but I lack the skill to talk the talk.

Good luck.

They need to hammer it on next earnings or another leg down is coming. The lows have been tested twice within a week. If earnings fall short, market cap is going down to $1.2B. Added to my position yesterday. I'm prepared for another leg down, then a long hold from there. Good luck guys.

Bro,

No phase 3 trial for DCVax-L. That's the beauty of this treatment. Phase definition doesn't apply for DCVax-L. What matters is its efficacy.

Take a look at the outcome measures of the combo trial. Can you find another trial listed on the website that chose the similar measures? I cannot find another one.

Only treatment that can trigger massive and sustainable t cell infiltration into tumor sites (both hot and cold) can be qualified for those outcome measures.

https://clinicaltrials.gov/study/NCT04201873

NADINA does indeed show less patients may have to go to second line but let’s be honest - it’s unlikely it’ll be so durable that an additional 30% of patients no longer progress. Even so, let’s say there’s a 30% reduction in secondline melanoma patients. Because of the very small amount of patients required for Iovance to become profitable in the US, that 30% cut is not consequential. And that’s excluding the strong likelihood lifileucel will get frontline melanoma approval.

Back to DCVAX - currently pending approval for doesn’t reduce the patient population but you are glioblastoma. And again, a very hopeful Phase 1/2 basket trial for multiple indications.

You also insulted me. I already read into DCAX and told you that I understood how it worked and that these dendritic cells were able to recognize tumour associated antigens and be effective against heterogeneous tumours from all sorts of solid tumours.

The reality is that DCVAX will need to undergo phase 3 trials for approval into each of these indications. And I have no doubt that it will and it will be approved.

In addition to that, lifileucel is in a registrational trial for secondline NSCLC with a partial readout this year and a full patient readout next year.

And TILVANCE-301 will likely read out next year with approval sometime in 2027 for frontline.

Also there’s a trial for endometrial cancer currently enrolling and likely the start of a phase 1/2 basket trial for IOV-5001 (IL12-tethered) for multiple tumour types. This would negate the need for IL-2 treatment.

Melanoma is not the end goal for TIL therapy it will be used in multiple tumour types. It will never be the frontline standard of care but it will be an important part of the therapy landscape for decades. This is because, once again, the TAM for solid tumours is too great and the incredibly durable responses of TILs cannot be ignored.

There is a need for many new cancer therapies.

Full Disclosure - I do not have a ton of skin in the game anymore. I sold out in the double digits and recently bought back in at 6.30.
I worked in medical for 32 years as a clinician and then on the sales side.
We can definitely and without bias - not be happy with the price action of this stock.
As I have mentioned in previous posts - A huge short interest exerts pressure on a stock.

Now, with respect to dstock07734 and his posts concerning a "better" option for melanoma patients.
He appears to be quite knowledgeable.
Still, In my sales career that spanned 25 years - It is amazing how many times that we heard that there was going to be a "better" option than the current device/drug that we were selling.
Do you know how many times that it caused a huge decrease in sales of what we were selling? - never.
First mover is a huge advantage and the idea that some unapproved - new treatment option is going to cause a cutting edge therapy like Amtagvi to get crushed is not a high probability.
There is always room for more than one rx and frankly - an unapproved therapy that has yet to go through commercialization is no near term risk. JMHO.
On the flip side, I am not a fan of people that just continue to spout of positive on Iovance.
Price action is price action in the market and we can come up with all of our justifications, but until we get an indication that this downward cycle is reversed - people are guessing.
I used to have an oversized position in Iovance, but I always take profits.
So now I have my small position 4000 shares at 6.30. If we get good earnings then I will add.
The beauty of a highly shorted stock is that the MMs rarely let it fly to allow for short exit.
An epic short squeeze is quite rare and you can always find entry points on pullbacks.
I am sure that many people have hedged their long position which is great.
But at the EOD, unapproved therapies are no threat. As we have seen with Iovance, unapproved to approved to commericialization is a very very long road.

NADINA trial indicates that the number of melanoma patients coming to TIL therapy as the 2nd line treatment will be reduced by 30%.

It should be noted that NWBO technology makes dendritic cell not picky meaning the technology can make dendritic cells swallow lysate from various types of solid tumors, digest lysate into peptides, bind those peptides with MHC Class I&II molecules on the surface of DCs, and present them to immune system.

Here is the trial on three tough targets with DC vaccine in combination with CYT107 which can increase CD4&8 t cells by three or four folds. Note that I have no doubt the pulsing technology adopted in the trial is the same as DCVax-L.

Therapy to Treat Ewing's Sarcoma, Rhabdomyosarcoma or Neuroblastoma
https://clinicaltrials.gov/study/NCT00923351

Adjuvant Immunotherapy to Improve Outcome in High-Risk Pediatric Sarcomas
https://aacrjournals.org/clincancerres/article/22/13/3182/79179/Adjuvant-Immunotherapy-to-Improve-Outcome-in-High

Autologous tumor lysate, cell therapy, and CYT107
Tissue was obtained via percutaneous core needle biopsy and/or fine needle aspiration (n = 26) or surgical resection (n = 3).

Results: Forty-three patients enrolled and 29 received immunotherapy. The regimen was well tolerated. Intent-to-treat analysis demonstrated 5-year OS of 51% with significant differences based upon histologic group (63% vs. 0% for Ewing/rhabdomyosarcoma vs. other sarcomas) and response to standard therapy (74% no residual disease vs. 0% residual disease). Five-year intent-to-treat OS of patients with newly diagnosed metastatic Ewing/rhabdomyosarcoma was 77%, higher than previously reported in this population and higher than observed in a similar group treated with an earlier adjuvant immunotherapy regimen (25% 5-year OS). T-cell responses to autologous tumor lysate were identified in 62% of immunotherapy recipients, and survival was higher in those patients (73% 5-year OS with vs. 37% without immune response, P = 0.017). Immune reconstitution, measured by CD4 count recovery, was significantly enhanced in subjects treated with recombinant human IL7.

Right so I read about them a bit. I absolutely do think these dendritic cells will be used to treat several solid tumours. I like the idea of arming with them tumour associated antigens that’s going to offer defence against tumour heterogeneity. Perhaps even it becomes the new standard of care for many indications!

But let me be clear: there are hundreds of thousands of patients each year in the US alone with solid tumours. What happens when patients progress from their current treatment or simply don’t regress? They try another treatment. There is room for dendritic cells, vaccines, TCR-T, next gen immune checkpoint inhibitors, and TILs.

Lastly, DCVAX-L will be approved for glioblastoma.

There’s also an ongoing Phase 1/2 basket trial for DCVAX-Direct for multiple solid tumours. After that there will be Phase 3 trials for specific indications for approval. And then we can talk overall responses and partial responses and complete responses and duration of response and how all of these compare to lifileucel.

When combined with an immune checkpoint inhibitor in ICI naive melanoma patients, they’re seeing a 30% complete response and duration of response not met. And 55% ORR and ~10% CR for ICI naive NSCLC PD-L1 negative EGFR-wt. there’s 50,000+ such cases in the US alone. That is an unmet need that requires everything available - TILs + ICIs, TCR-T, vaccines, DCVAX, etc etc.

Cancer patients want the best available treatment.

My understanding about lifileucel is that there can be tumor infiltrating lymphocytes (TILs) in tumors that can kill cancer cells. But there are too few. lifileucel involves harvesting TILs first, multiplying billions of them, formatting patient's immune system by lymphodepletion regimen which can be highly toxic, and infusing billions of TILs back into patient. Will this treatment trigger significant immune memory? Probably not. Since billions of t-cells are CD8 type.

You can check how DCVax-L works to see the its huge advantages over lifileucel.

https://nwbio.com/wp-content/uploads/NWBT_ASCO_slides_06032023_FINAL.pdf

I will never understand why people think there is no room for multiple treatments. We’re all aware there’s hundreds of thousands of patients with solid tumours in the US alone.

If/when these vaccines approved for frontline treatment of multiple indications, it’s not going to mean there won’t be room for many 2L+ treatment options.

Especially cell therapies like TILs where responses are durable and complete responses are quite high.

You think so?

Keep in mind DCVax-L has approval pending.

This may be a risk longer term, but is certainly NOT the reason IOVA is down this quarter.

I doubt the dude understands what he is talking about. Cannot you see he likes copy and paste stuff. If he has a good understanding, he should be able to explain things that lay person cannot understand.

Again be careful about $IOVA. I reminded those people when the sp price was $18. When the paper on NADINA trial was out, I pointed out the potential risk again when the sp was around $9.

How many tumor antigens can Provenge developed by the Nobel Prize Winner Ralph Steinman present to immune system? Provenge is DC vaccine for prostate cancer. Only one tumor-specific antigen.

How many tumor-associated antigens can DCVax-L present to immune system? Hundreds of them. See the difference?

See the following figure? Blue dots are cancer cells. Can you see the blue dots were significantly reduced two weeks after the treatment? Red dots are t-cells (CD4 and CD8). For a normal person without tumor, the base line for t-cells is around 20. How many red dots are there? The anti-tumor immune response was so intense that the patient had to take RA drugs to suppress immune response. The occurrence rate of this magnitude of immune response is between 20% to 30% among the patients.

For those of us (me in particular) who do not have a deep background in biology, could you expand on your premise on this? Thanks.

Still no data from IOV-COM-202, Cohort 1B or C-145-03, Cohort 4 using PD-1+ TIL https://www.jci.org/articles/view/73639

One wonders why? Since that paper, it has been shown that CD39, rather than PD-1, accurately distinguish between neoantigen-reactive (CD39+) and unrelated (CD39-) CD8+ T-cell populations https://www.nature.com/articles/s41586-018-0130-2

In line with it, another showed that co-expression of both CD39 and CD103 favoured the identification of tumour-reactive CD8+ T-cell populations https://www.nature.com/articles/s41467-018-05072-0

Iovance has put everyone on notice, this company is ramping up and expects to do so in a faster manner. Mr. Kirby has accepted the challenge and is expected to produce if he wishes to reap the rewards of the stock options. This is a very well structured deal for both Mr. Kirby and Iovance. I wish him well.

https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-reports-inducement-grants-under-24

https://ir.iovance.com/financial-information/sec-filings

Thanks, GMH, very worthwhile. It was great to hear Dan Kirby's own words. I believe Iovance made a great hiring decision and Mr. Kirby sounds like a man who will enjoy this challenge and bring a wealth of successful experience.

Can we take the NWBO discussion to the NWBO board please.

This was posted on ST and thought I would re-post here. If you were wondering if Dan Kirby was a good hire, give a listen and will answer those questions.

https://www.lifescienceleader.com/doc/commercial-readiness-with-orca-bio-s-dan-kirby-0001

FWIW: Increased institutional IOVA positions.


Swiss National Bank reports 9.28% increase in ownership of IOVA / Iovance Biotherapeutics, Inc.
On February 10, 2025 - Swiss National Bank filed a 13F-HR form disclosing ownership of 417,856 shares of Iovance Biotherapeutics, Inc. (US:IOVA) valued at $3,092,134 USD as of December 31, 2024. The entity filed a previous 13F-HR on November 7, 2024 disclosing 382,356 shares of Iovance Biotherapeutics, Inc.. This represents a change in shares of 9.28% during the quarter. The current value of the position is $2,377,601 USD.



Skandinaviska Enskilda Banken AB (publ) reports 36.62% increase in ownership of IOVA / Iovance Biotherapeutics, Inc.
On February 10, 2025 - Skandinaviska Enskilda Banken AB (publ) filed a 13F-HR form disclosing ownership of 155,684 shares of Iovance Biotherapeutics, Inc. (US:IOVA) valued at $1,152,062 USD as of December 31, 2024. The entity filed a previous 13F-HR on November 7, 2024 disclosing 113,952 shares of Iovance Biotherapeutics, Inc.. This represents a change in shares of 36.62% during the quarter. The current value of the position is $885,842 USD.

Iovance Biotherapeutics Appoints Dan Kirby as Chief Commercial Officer



SAN CARLOS, Calif., February 10, 2025 -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that Dan Kirby will join the Company’s executive leadership team in the newly created role of Chief Commercial Officer, effective today.

LOL - You lie for a buck paid pumpy!!

2025-02-07 13F BlackRock, Inc. 23,476,035 shares.

Looks like an increase of 3.3 million shares.

I'll take this as a positive sign.

Good luck to the longs.

Looking to add huge very very soon to my already large position. Looking for that false breakdown.

Don't worry about their downgrade or any of these analysts. A lot of times they have other interests at heart when they put these out. Don't overthink it. This is purely a move by the those that control this stock. This of this as a buying oppty. Execution in terms of commercial launch (sales, ATCs) are hitting all expections. Ignore the noise.

Crfawling back up?

SG Americas Securities LLC Buys Shares of 69,625 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA)

You forgot to mention that after the publication of the paper on Nature Communications those naysayers from medical field stopped publishing attacking pieces. Do you know why? Let me tell you why. Those people know very well that DCVax-L indeed can trigger intense and sustainable t-cell infiltration into tumor sites which matters the most in immunotherapy. They should be amazed that UCLA team can use GSVA score of a certain gene set after the vaccination to predict OS, which has never been achieved by any one else. See the following figure? The percentage of CD4 t-cells activated by DC vaccine which is essential to trigger immune memory outnumbers that of CD8 t-cells. CD14 monocytes which will differentiate into tumor-associated macrophages once seeping into tumor tissue is also significant, which clearly shows the tumor-associated macrophage immunosuppression that can be dealt with CSF1R inhibitor.

See those targets (highly overexpressed mutated genes) Genentech chose for their precision medicines for different types of cancers. If these targets happen to exist in three types of brain tumors, DCVax-L + Poly-iclc can fix the mutated genes.

This company has the biggest breakthrough in medicine ever. Once investors realize the true value of this company, the management will become one of the richest in the country. They have no interest in the small drop in a bucket. How's your prediciton on NVCR?

https://www.nature.com/articles/s41467-024-48073-y

NWBO's management is both morally and ethically corrupt. After many years of looking at this company, I have concluded the purpose of it is to transfer wealth from the public company into the pockets of private entities. They have been very successful at that!

The DCVax-L trial was negative [1-3] and not a single patient responded to DCVax-Direct [4].

When they went OTC were required to disclose "Third Party Advisors" providing "Promotion of the company" (paid pumpers) [5]. They do have a long history of paying third parties [6].

Refs:
1 https://academic.oup.com/neuro-oncology/article/25/4/631/6958519
2 https://www.sciencedirect.com/science/article/pii/S0035378723009190
3 https://www.practiceupdate.com/content/2022-top-story-in-oncology-dcvax-in-patients-with-newly-diagnosed-and-recurrent-glioblastoma/143631
4 https://aacrjournals.org/clincancerres/article/24/16/3845/277824/Cytokines-Produced-by-Dendritic-Cells-Administered
5 https://www.otcmarkets.com/stock/NWBO/disclosure
6 https://www.nasdaq.com/articles/behind-promotion-northwest-bio-2014-07-07

Thanks for the reply.

Had a longer response but iHub timed out the post. Short version:

1) The finances are critical. NWBO has cash runway of less than 1 quarter.
2) UK approval may provide milestones but this was licensed out so they will only get royalties and only after approval and reimbursement agreement.
3) US trial is P1 so it is years off.
4) Licensing deal pretty much takes any BO off the table.

I have learned that both the science AND the finances are critical in biotech. Many companies "survive" but generally the SP doesn't do well. Just my approach... as Badger says, its your money and your DD. Hope you do well, but not a company I would invest in.

The UK approval is pending. The science is truly amazing. Here is the figure from one patient in the combination of trial with Merck as one of the collaborators and the technology adopted in the trial was licensed from NWBO. The blue dots are cancer cells. Can you see the blue dots were significantly reduced after the second shot of the vaccine? The green dots are tumor-associated macrophages which suppress anti-tumor immune response. Those green dots can be depleted by an inhibitor called CSF1R inhibitor.

BTW, have you seen a company that can survive on OTC for nine years and be able to file for RA approval for the revolutionary technology? I assume you know Provenge developed by the Noble Prize winner Ralph Steinman. Do you know how many antigen his technology can make dendritic cell present to immune system? Only one tumor-specific antigen related to prostate cancer. Guess how many tumor antigens NWBO can make dendritic cells present to immune system. Hundreds of them. That's why for the most difficult cancer--glioblastoma, the trial has amazing data.

It is worth taking a closer look.


https://clinicaltrials.gov/study/NCT04201873

Regarding $NWBO, the finances are not good here and there are no near term catalysts that I can see.

Thanks.

Wow, 140k shares! That's a lot.
Take a look at $NWBO and use the rest capital of 60k to load $NWBO as a way to hedge your current investment.

I have been thinking about the Piper downgrade this weekend, trying to see how much merit there is to the assessment. Most people are dismissing the report, but given that this analyst was the only one who called Q2 correctly, I am wary to do so. The original analysis stated that ramp-up was slow because "The slow uptake is attributed to extended waits for manufacturing slots, which delay infusion times and may restrict patient eligibility." (link: https://www.investing.com/news/company-news/piper-sandler-sees-manufacturing-delays-impacting-iovance-stock-potential-93CH-3540561). This was also confirmed by U of Kansas docs as well as Boston General. The Piper projected 24 infusions which was very close to the 25 actual. However, I think the issues were more than simply slot availability (which I think has been fixed with additional hiring ). I think the issues also included:
1) initial (bolus) patient health with high drop rate early on - note 100+ patients "enrolled" at Q2 ER but only 55 infused at Q3 ER. Now resolved via patient selection
2) Extended initial cycle-time of +/-90 days. to +/-75 days at Q3 and reduced to +/-63 days.
3) At JPM, GS reported Fred saying "management had previously suggested that out-of-spec product was occurring primarily due to poor tumor resection quality, arising in part due to the large number of surgeons resecting samples and where the level of training had been variable. Accordingly, efforts to retrain surgeons on appropriate harvesting techniques focusing on quality and size have been implemented. Management noting that on average, outcomes improve after 2-3 patients but additional efforts are underway, particularly with new ATCs ... to ensure correct tumor resections are occurring with the first patient". (confirmed by U of Kansas docs and also supported by the enrolled to infused number reported in Q2/Q3.

So, the current Piper theory is that, based on the 6 ATCs they surveyed, they have reached a "steady state" of patients. Here is my take on that thesis:
1) I assume that these are the same 6 ATCs that responded to the first survey. As such, they would have been part of the initial 30 ATCs, which are much more likely to be at "steady state" than any subsequently onboarded ATC. Therefore, extrapolation to other ATCs would be inappropriate.
2) IOVA hired most of the regional marketing staff in the last 3 months so community out-reach has really just started.
3) OOS rates should drop (based on above) so even at steady state of patient beds, infusion rates should increase.
4) IOVA has increased staff by 50+ in the 2 months from Nov 7th ER to Jan 13th JPM, so unless these are all marketing/RoW rollout hires, seems like there is still manufacturing growth.
5) Looking at the balance sheet, starting in Q2 2023 (after Proleukin purchase), IOVA started reporting inventory numbers. This was all under WIP and Finished Goods and this was steady at about $10M total until Q1 2024 and has increased $2M/quarter since then. From this, I assume the initial $10M was for planned stocking (very small sales until Q2 2024) and the $2M quarterly increase was being driven by Amtagvi and Proleukin usage. The bigger thing is that raw materials jumped from $0 to $5.6M in Q1 to $13M in Q2 to $23.9M in Q3. This obviously was all driven by Amtagvi manufacturing and the only reason for that build up would be for increased manufacturing.

Bottom line, while Piper got the Q2 call correct, I think they are missing the boat with this call.

They have less than 1 quarter cash runway... always monitor the cash position in biotechs in relationship to any catalyst. Unless there is a clear path to profitability, you will be diluted endlessly... I have learned those companies are trades only.

It seems the sector is crazy lately. Here is another one that is crashing. RNAZ!

https://ih.advfn.com/stock-market/NASDAQ/transcode-therapeutics-RNAZ/stock-news/95244508/transcode-therapeutics-announces-first-patient-dos

Well said Hicham & Badger 🫡 very much agreed

Hicham, you're in good company. I've also increased my position, reduced my average cost, and I'm willing to add more shares in the coming months as my funds become available. I see more reasons now to be long IOVA than I did when the share price was $18. I'm also far more willing to wait for the multitudes of good news expected this year which most certainly should move the share price higher.

The sector has been a bear, but the low multiples that the biotechs are currently trading at should start returning to more realistic levels over the coming months and years. Lots of bargains out there right now including IOVA (or so I believe), but making good choices on what to buy and hold going forward is still the challenge. All of our due diligence on Iovance leading to our share purchases will likely result in very good returns.

Here's a little something I shared on another site: "These guys did okay. Catch Charlie's comment at 1:52:"



Good luck with your investing in 2025.

Painful but nothing new...

I have averaged down my portfolio to 6.6$ down from 9.8 and I have now 140k shares and i am ready to increase it to 200k if the SP continues on  dropping.  By now Iova is my only stock market investment so we can say all In...

I am ready financially to accept a SP drop to 3 because I know sooner or later we will be >20.

Just need to be patient...

As long as the small cohort we saw from LUN-202 scales there’s no issue. And every reason to think things will actually improve because of 2L patient requirement (2L-4L in COM-202) and also increased partial responses over time. I think more like ORR ~30% and mDOR >9 months. We’ll see by September during WCLC 😄

FUD or confusion? I'm seeing some comments being posted about Lung data with the usual what if comments on multiple message boards. Here's my view FWIW (and you're paying nothing for it, so that should establish its value).

TIL therapy works. That much you should know before spending your investment dollars on IOVA. 40 years of research has already proven that case. Where the challenge lies is in the commercialization of TIL therapy and creating a system that can succeed for both the patient and the profitability of the company - Iovance.

I'm investing in the ability of Iovance to succeed with its manufacturing capability and being organized in such a way as to meet the increasing demands of qualified patients while still turning a profit. For my purposes, TIL is already a given and will be approved for multiple cancers.

There were several bumps at the start last February and for several months due to logistics of managing multiple ATCs, docs, hospitals, surgical suites, and so on. Insurance was a minor concern, but that is also now almost fully resolved.

At the start, Amtagvi manufacturing capability at the iCTC wasn't fully ironed out. With lots of new hires, some initial staffing shortages, the usual when starting up what has never been done before, it was logical to assume some glitches. It's easy to criticize the launch, but you don't know what you don't know. Iovance did learn quickly and made all necessary corrections and adjustments.

There are now several reports and comments by the docs themselves that the process to treat patients with Amtagvi has been successfully organized and the operation from beginning to end is much smoother.

Do your due diligence, understand the facts of TIL therapy, the trial process, and what Iovance is doing to become the first and only successful TIL therapy company for years and possibly decades to come.

Iovance may be under a different name (acquired by BP) in the not too distant future, but TIL therapy is here to stay.

Good luck to the longs.

And wishes for good health to all that have to get treatment for cancer.

Iovance Biotherapeutics (IOVA) Forecasts Strong Growth Due to Flagship Treatment
Casey Dylan, CIMA
Jan 28, 2025, 02:24 AM

Tipranks: https://www.tipranks.com/news/iovance-biotherapeutics-iova-forecasts-strong-growth-due-to-flagship-treatment

The two largest failures have been inopportune raises and lack of preparedness for the launch and demand.

Thank you for this. This is something that no matter how much you research a company this will not come up.

I hope this makes you a ton of $$!! I'll cheer with you as a build a position

Iovance is significantly undervalued at this time for any number of reasons that have been discussed to death on this board and on numerous other boards. Do your due diligence. Your multiples are not correct, they should be much higher by simple comparisons to similar companies.

Here's just one of any number of discussions regarding valuations. https://finerva.com/report/biotech-genomics-2024-valuation-multiples/ Here's an excerpt:

"Revenue multiples for BioTech & Genomics companies grew throughout all of 2020, peaking at 17.5x in Q4 2021. After a continued fall throughout all of 2021, revenue multiples stabilised between the 5.5x and 7x mark for the past two years. In Q4 2023 the median EV/Revenue Multiple for BioTech & Genomics companies was 5.7x, after hitting a 5x low in Q3."

The point is that Iovance's TAM is significant, the company continues to build out manufacturing to meet the increasing demand, but Iovance is also notorious for limiting their PRs and updates, which makes it hard for an investor to get a handle on how the company is doing. The next few months should prove very telling with all the expected news that's right in front of us including the Q4 report, annual report, and a 2025 forward guidance update is also expected.

If you dig deep, you'll find plenty to support a much higher share price, but right now biotechs have been beaten down, and some like Iovance have been beaten down even more than the average. When the reversal happens, those are the companies that will likely have the bigger bounce.

Lots of investors want to be spoon fed reasons to buy - Iovance just doesn't do that. That's also why so many investors just follow the crowd and wonder why they never quite get those great returns.

It's your money, it's your rules, do your due diligence, make your choices.

Iovance Biotherapeutics (IOVA) Among Billionaire Joseph Edelman’s Long-Term Stock Picks

https://finance.yahoo.com/news/iovance-biotherapeutics-iova-among-billionaire-201009995.html

I’ll start by telling you I’m heavily long here, this is the vast majority of my portfolio. My outlook is several years from now.

Read the last few ERs and their updated corporate deck for most of the answers to your questions.

Management performance over the last year has been ok. The two largest failures have been inopportune raises and lack of preparedness for the launch and demand.

Fundamentally thankfully nothing has changed. Profitability expected in 2026. Frontline melanoma (combo) and secondline NSCLC (mono) approvals likely in 2027. Phase 1/2 for IOV-5001 starting this year.