Iovance Biotherapeutics Inc (IOVA) Options

Patient drop off / Manufacturing OOS was $9.1M so this was not the reason for the drop in revenue. I do question if they get revenue for IL2 and then charge R&D the same for IL2, but that is just and accounting thing. You say stock is really cheap, but I am now thinking that is for a reason. Only hope is that WIP/Finished Products is an indication of Q1 infusions. Just wish they had an answer for why the low revenue rate, but being circumspect, just leads to doubt.

Hicham, there's several catalysts yet to come this year, and one additional thing that could easily help is a change in the biotech sector sentiment. Currently out of favor and any reversal in that sentiment will work wonders for the better dogs in the fight - Iovance.

Good luck and stay well. We'll be here for a while longer.

This is disappointing. While nothing has changed as far as the company is concerned, the qualification of  "being long" did. Patience is measured as far as IOVA is concerned in years and not months, I fear that there will be no significant change in SP before 2026.

SB, with a deeper dive, I think Q1 is actually going to be just fine and based on cash burn and expected revs for 2025, Q4 of this year is still in the running to be our first profitable quarter. It may only be a cent or two, but the numbers work based on the expected growth of sales Q over Q for all of 2025.

This beat down on the stock price stinks of being orchestrated and preplanned. Everyone knew what the numbers were going to be, or at least the total revs number, so it would have taken a big surprise beat or some unexpected data release to sway the powers that be from crushing the stock price given the overall negative sentiment at this time in this sector. IMHO of course.

Good luck to the longs. The ride took a dramatic turn today from a stock price perspective, but I'm still on board knowing where this ride we call Iovance is headed.

Looking at 2025, it’s clear that data readouts and ex-US expansion are the most important catalysts.

It’s indisputable Q4 was and Q1 will be quite pathetic for growth but there were several factors at play:

- they’re running a lot of trials and dedicating resources to them as well as towards commercialization of amtagvi
- holiday clearly affected ATC operations
- majority of ATCs recently part of network are not yet running and many more ATCs still ramping up
- some amount of ICTC downtime late last year or during Q1

I think these will all improve quarter after quarter and year over year.

Their manufacturing capacity is increasing, already at 1200/yr. There will be enough demand and manufacturing next year to bring this very close to break even. Sometime in 2027 at the latest.

And when frontline is approved, that demand in melanoma alone will not be going anywhere for many years.

But lastly I think it’s going to be a long year. I’m not bothered because I was always looking at ~2028 and a reasonable valuation. Nothing I saw today made me question that.

I would not take that as a bad sign as they stated that they were moving away from giving infusions numbers so it make sense to not give numbers to date this quarter.

Here is the start of this breakdown....could see this coming from a mile away. going to start nibbling.

GMH, the total billable infusions was a stumble, but do we know what the OOS percentage was? There was a reference to still getting paid for Proleukin even when the OOS product couldn't be billed even though it does get used for an infusion. I would appreciate it if Iovance management would offer more detail so that we can understand just what is going on in total and what the future looks like as more of these process improvements take place.

Proleukin sales imply growth and a likely increase in guidance is coming if the % of OOS product continues to drop (improved manufacturing success). My guess is we'll get that guidance update after the Q1 for any number of reasons including improved community outreach and patient totals (sales).

Stock price is ridiculously cheap regardless. Cash runway is healthy, more dilution occurred, but not enough to justify this drop in price.

Did you get the impression that they were trying to not disclose that 95 infusion number?
The first question from GS asked about the number of patients infused so far this quarter and they said they would not be disclosing this metric. However near the end of the call when they were asked about patients infused in Q4 they were forthcoming with the number.

And the fact that they did not give the Q1 infusions to date is also a bad sign. I just do not buy the "we didn't think people found that metric useful" BS line,
The (after hours) market seems to agree with that.

And the fact that they did not give the Q1 infusions to date is also a bad sign. I just do not buy the "we didn't think people found that metric useful" BS line,

I see. Ok that is what is causing the sell off. Market does not care about proleukin sales. Al they want to see is growth of patients infused. So they only added 13 patients Q/Q. I will be interested to see how this opens tomorrow, but of course we are in a macro sell off currently which always weighs on speculative small caps. IMO - the market agrees that this therapy is life changing, they are questioning its commercial viability. The shorts have been right on this one. They have been huge in numbers and convicted to their positions. Oh and IMO, They really need to move on from an interim CEO.

Questions- Did perceptive reduce their position in IOVA?
Did you get the impression that they were trying to not disclose that 95 infusion number?

I think consensus was 107-118 from the analyst community.

Share price dump says it all. It’s a sad day for IOVA believers and long shareholders.
$4 stock with an innovative therapy. $8 would be 100% gain. Will it happen in 2025?

Wow. This is straight up rough. So what was the number of infusions that would have been satisfactory growth?
It sounded like they did 95 which was an increase from 82?

Sorry longs... 🫠 I feel your pain

Beat was due to Proleukin stocking, not patient infusions.

Report looks good. They did as well or better on the projections. So why is the PPS tanking?

Significant Demand for Amtagvi® (Lifileucel) Continues with Total Product Revenue of $73.7M in 4Q24 and $164.1M in FY24, Achieving Upper End of FY24 Guidance Range of $160M-$165M

Reaffirming FY25 Total Product Revenue Guidance of $450M-$475M

FY25 Cash Burn Anticipated to be Under $300M

2025 Regulatory Approvals for Amtagvi Expected in the UK, EU, and Canada

Enrollment Accelerating Across Global Registrational Trials in Frontline Advanced Melanoma and Previously Treated Advanced NSCLC

https://www.globenewswire.com/news-release/2025/02/27/3034267/0/en/Iovance-Biotherapeutics-Reports-Financial-Results-and-Corporate-Updates-for-Fourth-Quarter-and-Full-Year-2024.html

Hopefully we see numbers higher than what was anticipated and this moves back up.

FWIW, short interest saw a very small drop:

02/14/2025 63,597,563
01/31/2025 63,909,963
01/15/2025 61,984,016
12/31/2024 61,305,700
12/13/2024 59,327,307
11/29/2024 56,916,236
11/15/2024 53,988,814
10/31/2024 59,731,383

Hope to hear from all of our fellow longs tomorrow and Friday following the Q4 report.

I look forward to reading any of your thoughts and analyses of the numbers.

Good luck to the longs.

Nice information.

Anyone having concerns about the long-term potential of IOVA should really listen to this video.

Heating up for a big move to where it belongs?

FWIW, two more patents added to the patent portfolio:

https://patents.justia.com/patent/12226434

https://patents.justia.com/patent/12230379

Iovance Biotherapeutics to Report Fourth Quarter and Full Year 2024 Financial Results and Corporate Updates on February 27, 2025

https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-report-fourth-quarter-and-full-year-2024

Upcoming Conference Participation:

TD Cowen’s 45th Annual Health Care Conference
Fireside Chat: March 3, 2025 at 9:10 a.m. ET
Boston, MA

Barclays 27th Annual Global Healthcare Conference
Fireside Chat: March 13, 2025 at 9:30 a.m. ET
Miami, FL

FWIW: bullish options action.

https://www.tipranks.com/news/the-fly/iovance-biotherapeutics-call-volume-above-normal-and-directionally-bullish-18

Welcome to the Iovance iHub page. Mizuho Senior Biotech Analyst Salim Syed shares his take on 2025 and key catalysts from companies he covers.

He discusses BridgeBio, Cytokinetics, Wave, Vaxcyte, Iovance, Unity, and Enliven

https://www.biotechtv.com/post/salim-syed-february-11-2025

I recommend listening to the entire interview, but for those in a hurry, at least listen to the Vaxcyte and Iovance discussions. The details in both discussions are applicable to an investment in IOVA.

Time stamps:
Opens with intro and BridgeBio
Cytokinetics 6:00
Wave 11:24
Vaxcyte 15:23
Iovance 18:05
Summary and final two 20:25 to the end.

Good luck to the longs.

Same BS, different day.

When are going to learn? Let me ask a simple question. Can you find another DC vaccine that can present hundreds of tumor-associated antigens bonded with MHC Class I&II molecules on the surface of dendritic cells? How many tumor antigens can Provenge present to immune system?

Why did you not mention the following figure in the paper? See how many treatments the patients received before they received the Direct? You cannot show some fundamental respect for the amazing science. That's why you are losing. Maybe you need to get a Ph.D. first.

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.