Iovance Biotherapeutics Inc (IOVA) Quote

Higher average daily shares traded, higher volatily, higher shorting ratio...

I fear the pressure on SP is not going to ease anytime soon and I just hope we have reached a SP floor of 7.5 and it holds.

FWIW, short interest is higher for the 6/14/24 report. 54.63 million shares short, up from 49.96 million. Days to cover has gone down on higher average daily volume from 8.96 days to 6.84 days.

I have never gotten a response from IR either so have stopped trying after half a dozen attempts. Their IR department is the worst I have ever come across. Fred should stop by the IR department to make sure those people are still alive.

These guidelines should help new ATCs ramp up more quickly and provide better overall outcomes for patients although they may also create a bit of a higher dropout rate from the "patient selection considerations", but overall better for the patients and should also speed up the treatment process a bit.

GMH, I'd encourage you to ask Iovance that question, but I've never received a single response to any calls or emails to IR that I've made That actually surprises me and concerns me a bit as that is the point of IR after all. Another thought why some ATCs may choose not to be listed on the site is that they only provide service to their specific insured groups and may not want to reach out for other patients from outside providers. Just guessing at this point.

(article) "Lifileucel Recommendations in Solid Tumors Deliver Comprehensive Guidance" June 21, 2024 Morgan Bayer

https://www.targetedonc.com/view/lifileucel-recommendations-in-solid-tumors-deliver-comprehensive-guidance

Amtagvi list was just updated to include University of Miami Hospitals. It is good to have an ATC in South Florida, where I am sure there are a lot of potential patients.

The one thing I am trying to figure out is why they do not just list all approved ATCs. The only thing I can think of is that they do not want new ATCs to be inundated so by having patients go thru IovanceCares, they can direct to sites where there is capacity and an efficient process already in place and allow new ATCs to maintain a more manageable ramp.

https://news.med.miami.edu/cell-therapy-on-the-table-for-metastatic-melanoma/

Buying is quietly picking up. Short interest report for June 14th will be out tomorrow. I suspect a little more drop in the total but I don't see a rush for the exits just yet given that the Q2 report won't be out until Aug 6th or so. Of course, this also assumes we'll get a reasonable revenue total and some forward guidance. I don't expect the guidance to be all telling, but I do hope we get some read on patient totals, how the ramp-up is going, and how well the ATCs are adapting to the patient slot scheduling.

Good luck to the longs.

Stocktwits is usually filled with A Holes. But lets see what turns up.
Hey if it brings in buyers.......................

I don't have a link was just going by what was reported by multiple people on Stocktwits.

Could you provide a link. Nothing showing on the website so not sure if this is another source.
Thanks

That is exactly what we need. Dr, Chesney reporting. Right from the horses mouth and it was very positive.

Just tossing this out there. I am by far no expert in this field. If someone or several feel that there is a great post to sticky let me know. Along the same train of thought, if there is something to update in the IBOX let me knowm

June 20, 2024 Inducement Grants for 43 new employees: "Iovance...announced that on June 20, 2024 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 187,650 shares of Iovance’s common stock to forty-three new, non-executive employees."

https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-reports-inducement-grants-under-19

Lots of new employees. It almost seems like the company might be growing. I wonder why?

Good luck to the longs and have a wonderful weekend.

OT, but very interesting info regarding record level options expiration today: https://www.marketwatch.com/livecoverage/stock-market-today-stocks-dow-futures-ease-as-nvidia-shares-dip/card/nearly-6-trillion-in-options-due-to-expire-during-friday-s-record-breaking-triple-witching--kymTZiLQvPk2lKfg8co6?mod=home-page

FWIW and not particularly of value, but today's max pain # for options is actually $8.50. I wouldn't be surprised if the game gets played to close IOVA exactly on $8.00 today, but nothing seems to be driving the price today so we'll just have to wait and see how it gets played at the end of the day. Call options for September and beyond still look pricey, but that makes sense given that we're all waiting to get our first glimpse of Amtagvi revenue numbers for Q2 in early August. August 16 options just opened so I suspect those options will start getting attention. Revenue guesses are all over the place and they've been changing recently as well, getting a bit more conservative. A slow and steady ramp-up is fine so long as we're avoiding any missteps. So far, that's what the company has indicated.

Good luck to the longs.

A while back, I did a bit of retrospective analysis by pulling up the Top 10 Biotech Buyout targets for 2018 (figured 5 years was enough time to let it play out). Results were: 2 buyouts in 2018, 1 buyout in 2019, 1 buyout in 2022, 4 companies still public and 2 bankruptcies. Results were much better than I thought going in, but still would monitor closely any investment in the biotech space.

Was going to look at other years, but many companies were on the list for multiple years so there would be a lot of correlation in the results.

Not sure how you can be certain there will be 1000+ patients per year. Every place I look, there seems to be some criteria where the TAM gets cut. Adjustments to just a few assumptions and I could see the run-rate be well below 1000.

Regarding insider buys, I would also just remind you of Eddie Lampert and Sears... insiders are not always right and sometimes they get caught up in thinking they are right when they aren't.

While I am not one to buy into conspiracy theories, the one area where I think there is the potential for some suspicious actions is with sell-side analysts and their underwriters. There is supposed to be a firewall between these 2 groups but I am sure discussions happen. Fortunately, only a couple of the analysts firms are involved in the underwriting for IOVA, but doesn't mean the others aren't looking for a piece of the next secondary.

Regardless of me being Debbie Downer today, I am still holding, but I really hope that the Q2 revenue is way above expectations, otherwise, I am afraid we are in for a world of hurt. There just seems to be something that the market knows that we are missing.

Good article Badger & One would think we are on BP radar with our Novel Therapy
Amtagvi.
A top candidate for buyout in 2025/2026 is our Iovance.
Time will tell as wealth once again transfers from the impatient to the patient.
Iovance “Longs” will cash in big time
In my opinion.
Keep adding cheap shares as our $8 SP range is where the MM’S are holding us so big time investors can hoard shares in this range.

#CureCancer

13 analysts have done their homework and came back with a 25 $ target price and this is definitely more than 1000 patient per year.

Moreover more approval are on the way for other indications and geographies so the target market cannot be the issue.

And institutional investors and directors are still adding shares >9...

As BK puts it well, time is what we are missing. We need to be patient and it is painful.

OT, M&A article: https://www.fiercebiotech.com/biotech/biopharma-dealmaking-continues-rise-ma-values-hold-steady-pwc

GMH, valid points. What are we missing? The only answer that I've been able to come up with is "time".

I assumed too much too quick, the market is saying not enough not yet. I assumed stock price support based on potential market growth, the market is saying "prove it!" I've looked for reasons to sell some or all of my position. I've searched for hidden problems that we may have missed. I come back to the only thing that I can offer - time. We need to see actual revenues. It will likely take a couple quarters or more for the market to buy into what we already believe is the future of Iovance.

TIL therapy has been proven. Manufacturing capability is still proving itself along with market demand which is also assumed but not yet proven. We have plenty of evidence that demand exists, we need hard numbers. Time. How much time? One more quarter? Two? Three? The company has not backed down from their statements, they've continued to deliver more than implied or stated, and the major investors have increased share positions along the way. The analysts who have had more of an inside look at the manufacturing facility and capability are still indicating a buy. They've maintained their target prices which are well above the current share price indicating that they fully expect success ramping up Amtagvi and continued success with future indications for Iovance.

As far as getting out or staying in, I've chosen to stay in because the current price is worth the risk in my estimation of what this company is on the verge of doing. It's completely new, it's a whole new way of creating and selling a drug/therapy. Amtagvi is completely individualized which has not been done to date at this level for this type of cancer treatment as far as I know.

Confusion has been filled in with misinformation leading to lack of stock price support. I've had to adjust my investment horizon. The confusion will dissipate when the company shares more details regarding production and revenues. I have no concerns about the success and efficacy of TIL therapy. What I want to know is can it be profitable. I believe the answer is yes. I will add more shares as each new milestone is achieved or until my shares are sold to another company.

Semper Vigilans

Badger - yes, we have all done our DD and think that there is great potential here. My concern is if we are creating a confirmation bias loop and that we, as a whole, are missing something that the market is not (as I say, stock price is reality). The only think I can think of is that the TAM is much smaller than has been presented until now. If the run-rate annual enrolled patient population is only 1,200, we get to break-even, but that barely supports the current SP. We are moving from an XBI company where the PE is "NA" to an IBB company where the PE is about 17.5. That means we need to hit a profit of 125M per annum just to justify the current Market Cap. That leverage ups quickly with just a few additional patients, but also leverages down if the run-rate is short of that.

I agree that we won't really know until Q2 and Q3 earnings, but if those come in short, I am thinking we could be dropping back to the 3s. I do not think this will be the case, but if revenue comes in light, it will already be too late to get out. Just listened to Brian Gastman's comment at GS chat and he addresses demand and patient qualification which sounds encouraging. He also stated that "confusion can be filled in with misinformation" which is where I think we are now, but that is a pretty tentative statement as an investing thesis.

Grab some more today at 7.83. My gut feeling this might be the bottom today.

Badgerkid, thank you very much!

Corsair, the news on May 31 was the ASCO presentations which had to do with the combo of Pembro and Lifileucel:

https://ir.iovance.com/static-files/6e77db81-ba69-4c07-a092-797d83ac5bcb

https://ir.iovance.com/events/event-details/iovance-asco-investor-event

Check out the company's website for other information and updates regarding ongoing trials. I'm unaware of any exact dates given for NSCLC data to be released. If others on this board have more current info, please share it at your convenience.

https://www.iovance.com/

If you have a link of what you're referring to, please provide it.

Dear IOVA board members, I am wondering if anyone of you knows when the data for NSCLC is expected to announce? Apparently it is not true that on BiopharmCatalyst, it was expected on May 31, 2024.

Sure it appears contradictory but it pays to be diversified with your nest egg. I bought fixed annuities worth $3M and have a bigger amount in individual stocks and index based mutual funds. Around Feb 2024, I moved majority of my profits from IMGN to IOVA and IBRX. I sold 1/2 of my IOVA core position at $15-16 range and now my core position avg. price is $8.5. I bought puts at $12 to insure against downside for the rest of my IOVA position. I am slowly adding back. Just disappointed to see it slide under $9. It tells me many are betting IOVA will not impress with sales and revenue numbers .
My wife and I are both medical doctors and are well connected with several medical oncologists in our community. I’ve been cautioned about a slow start with Amtagvi due to significant logistical concerns. This places a big strain on finances for this small biotech which is firing on all 10 cylinders. Proof is always in the pudding. We need to see over 200 patients treated by end of Q3 with at least 150 primed for treatment in Q4. If they fall short in a big way, look for further downside pressure. We may have differing perspectives but that’s Okay. Diversity enriches us.

Currently have 50 Atc sites. Just achieving 2 patients per site per month should get them to profitability using $450k/ patient.

GMH, your points are well taken and such a lesson recently happened with Aerovate Therapeutics (AVTE). Friday it was $24.50, today it's $1.50. They have only one asset and it failed a Phase 2 trial.

Such a risk doesn't exist for Iovance. Iovance has two revenue producing approved drugs that are now commercial, has a pipeline of additional candidates with a proven concept and they're well funded for the commercial launch of Amtagvi. They have a ready market for their products, and they were fully prepared for the launch with 30 ATCs ready to go. Iovance has solid financial backing, good access to the capital markets, and they're now generating revenue. Many risks no longer exist. Even though the risks associated with commercialization are now on the table, those types of risks are far easier to assess and plan for with an investment.

We've all done substantial due diligence which is why many of us own the positions that we do in IOVA. I may not like the current share price, but I'm willing to see it through for at least 3 quarters of Amtagvi revenues (operating from the belief that no competitor will suddenly pop up). After the Q4 with full 2025 guidance, there will be substantially more clarity on just how soon Iovance will achieve profitability and I assume that the share price will fully reflect that information at that time.

A potential buyout is always on the table, but I do believe the company has far more to gain by not rushing that scenario just yet.

Good luck and keep up the great analyses. Much appreciated.

BK - for me, any biotech that is in the clinical stage is purely a trade (I have learned my lesson). The only reason I think IOVA is a longer-term hold is the fact that they are now in the commercial stage and, from that standpoint, the profitability matter. It is for that reason that I do model out the financials to assess how profitable and how quickly that can occur. From a commercial standpoint (approved products only):
1) Total Addressable Market: 11,100 patients per year (L2+ from the slide).
2) Eligible patients (due to heart/liver/lung/brain issues): The slide indicates 60% (13k/21k) but I included at 50% for L2+ patients
3) Intent-to-Treat: Depends on age and proximity to ATCs
4) Failure rate (due to lack of TIL in tumor or patient cancer progression):10%

Through all these calculations, you can start at 200k (or 21k) but I assess the run-rate at between 1,800 and 2,400 patients per year (2027). Any worsening of these assumptions could decrease the overall profitability substantially, so I am concerned about the overall number of treating patients. You can have a really good product, but not a big enough treating patient population can doom a stock. I do not think that is the case here, but it is something I am watching closely.

1) Most of the docs, when discussing the therapy, say that the IL-2 is manageable since it is "only" 5-6 doses and it is effective even with 1-2. (Dr Lawrence said he hasn't had a patient where he was not able to get to the 5-6 dose level). I think that the big issue is the toxicity from chemo/IL-2 eliminates patients with underlying heart / pulmonary / liver co-morbidities (so the patients who cannot be treated).
3) I agree that untreated brain mets (along with the other health issues) would be identified quickly (Dr Lawrence said screening process was just a few days already). Again, not so much the screening process but a question of how many patients does this exclude, since 60% of MM patients have brain mets, but how many are untreated/refuse treatment because of same.
4) I think you can ascertain some of that by looking at the timeline of the deaths, but as they noted, the trial was different than the commercial setting because you now have, in some cases and extra 4-8 weeks for insurance approval and there is an additional 12 days for the QA against the assay protocol. I think they originally reported a 5% drop rate, but that moved to 10%. I am guessing it will be about 20% for the bolus patients who are later line (which also impacts TIL production since ICIs also reduce the TILs in the tumor), but will move back to 10% or lower when they get to run-rate.

2) For statistical analysis, you make a hypothesis and the a trial to determine if the hypothesis is correct. It is statistically inappropriate to run a trial and then sub-group the patients after-the-fact (post hoc) and draw conclusions from that. That is why there is an agreement with the FDA on the appropriate end-points prior to the start of a trial. For Replimune (slide 10), they subsequently ( i.e. Investigator assessed) a split between Stage III/early Stage IV and Late Stage IV patients showing the former with much better CR and ORR. The FDA will generally not accept unless that was part of the original trial design, especially if they think the data is only good enough for approval for the Stage III. The FDA would require them to run another trial with that as the specific end point. IOVA ran into this issue with Cohort 2 and the confirmatory Cohort 4 stating that the disease burden in Cohort 4 was much higher. FDA would only approve based on Cohort 4 alone, but did allow the combined data to be included on the label (makes a difference on DOR, which is important in the space). Going forward, IOVA will always include a Sum of Diameter segmentation on future trials for this reason.

Thanks for the insight. I have rebuilt my 100 k shares position and do not intend to add for the time being unless it does drop seriously below my 7.5 limit... I really hope it does not !

So you bought a fixed annuity with your retirement and are fretting about a small cap biotech. Nothing contradictory there.

Over 200,000 cases of Melanoma will be diagnosed this year in the U.S.: https://www.aimatmelanoma.org/facts-statistics/

Iovance is going after that portion of this market that was the unmet need, that form of melanoma that just wouldn't respond to other treatments, a form of melanoma that until recently was a death sentence. Understand, there's a lot of melanoma and there's going to be a lot of drugs that target portions of that market. But Iovance is doing what none of these other drugs and therapies can do (see page 8): https://ir.iovance.com/static-files/1d6a7a28-9af3-4d25-b133-4bb9f33d64f2

There is no competitor for Iovance's Amtagvi at this time nor is there any currently on the horizon for many years to come. Know your investment and know your company.

IMO

Nice post. Thank you.

1. IL2 - it is interesting as this treatment is really the necessary evil. But, I just watched a pretty recent video of Dr. Betof - Warner on YouTube. She was speaking presenting to a group of patients/lay people concerning TIL as a nice new option. She stated that IL2 was the most difficult aspect for the patient, but stated that they have utilized for many years and are good at managing the symptoms. She also was more positive than she was at ASCO as she related that the difficult time for the patient was very finite and contained to about 2 weeks. Then she went on about how wonderful that this is just a 1 time treatment (unlike the others that required continuous RX). It was interesting her tone here vs ASCO.
2. I would love to hear more of your insights on Replimune concerning “post hoc assessment”.
3. Concerning dropout rates. I have a strong feeling that there is referral procedure in place that would immediately eliminate MD referrals for patient with untreated brain Mets. So, and this is just my opinion, I doubt that the referral would even be included in the screening number.
4. Concerning the study that allowed for approval. Do they identify, the number of patients that entered the study and then dropped out due to waiting for the TIL? I would think that that would be included. What do you think?

Thanks and enjoying th engagement to get a better understanding on projected # of patients receiving TIL

Dennboy, thanks for sharing the "Impact Melanoma" video. I had a chance to watch it in its entirety and found it very worthwhile. Dr. Lawrence was also part of the KOL panel at ASCO 2024 for Iovance and he has a nice way about him in how he explains the medical science surrounding TIL as well as offering a brief history lesson about advances in cancer treatment. He makes a great teacher.

Much appreciated.

A takeaway that I've been sharing as well is that Iovance is the Henry Ford for TIL in a manner of speaking. They're making TIL therapy possible for the masses through innovations and improvements in manufacturing. That was no small feat and will have significant ramifications for Iovance's ability to deliver on a global scale.

Thanks.

IMO

GMH, as you noted, the brain metastases were discussed in several places and yes, the brain mets need to be treated first prior to the therapy. Another reason why they want to get TIL as close to frontline as possible to avoid just such problems that occur with metastatic melanoma. The desire to address it before it spreads is paramount for so many reasons, not the least of which is treating healthier patients sooner with likely better outcomes as a result. I'm not concerned about the company having more than enough patients to treat, but I am concerned for those patients that dropout during that waiting period. The good news is we're only at the beginning of TIL and all of the advancements that will come in time that improves the process and speeds it up as well (at least that's the goal and evidence does suggest it will only get better and quicker).

IMO

At minute 17:50 of the ASCO KOL call, it is untreated brain mets would need to be treated with radiation therapy prior to TIL. Another delay, but not a serious limiting factor for those otherwise qualified for TIL.

One additional item that I noted was there was mention that this was not indicated for patients with brain mets (not sure if that is absolute or just uncontrolled - mentioned at ASCO KOL too). Did a quick search and 60% of MM patients also have brain mets. This could be a severe limiting factor on the screening process. Trying to look a bit more into this issue.

Thanks for sharing this video; it was a good watch. I would just add/clarify a couple of items.

- since hospitalization primarily occurs after chemo/infusion for immune system recovery, this is where the patient bed limitation will be occurring.
- In the video, the Dr does make a point of IL-2 toxicity, but on the ASCO KOL call, someone (think it may have been the Dr.) said that IL-2 was not an issue and that most patients got the full 5-6 doses of IL-2, but TIL has been shown to be effective even after only 1-2 doses.
- Not sure of your mention of the grade 4 SAE. He does mention the treatment mortality rate was 7% (this is on the label) and he thought that should be closer to 0%. I wonder if the FDA, when in doubt, classifies a death as "treatment related" if no other specific cause can be identified.
- The mRNA vaccine is really targeted at grade 3 or lower cancer treatments where the cancer can be resected so the tumor burden is much lower. Replimune is also more effective in that space (and I do not think they will get accelerated approval because that was a post hoc assessment)
- I share the concerns on the time it takes for treatment because patients will deteriorate quickly. The drop out rate for various different causes is my biggest concern:
1) Not within label: How many patients move from screening to enrolled? 70%?
2) Insurance approval - I think this will be close to 100%, but may take time for approval
3) Health deterioration waiting for treatment (including waiting for insurance approval) - I took a look at the Kaplan-Meier curves for Stage IV MM and mortality is about 12% within 3 months of diagnosis and 18% within 6 months. Assuming that, not only death, but also health deterioration would keep a patient from getting TIL, I think we are looking at a dropout rate from waiting at around 20%. Therefore, for every 100 patients that are screened, we probably will only have about 50 infusions... just a guess on my part,

After carefully listening to the presentation by Dr. Lawrence and processing the thoughts so nicely articulated by Denniboy, I believe the journey to SP recovery will
largely be possible with actual patients treated and revenue recognized in Q2 and Q3. Meantime. macro conditions will drive the price lower. Hope the floor of $7.75 holds. Schwab keeps sending me feelers to lend my shares for shorting and are offering me attractive interest rate. This confirms my theory of downward pressure.

The whole process of getting a patient from identification to treatment is complicated and there is a learning curve. If they can show success with the first 100 patients treated and project more than 300 for 2024, I will be reassured. This will confirm the trajectory to breakeven with possibility of or more dilution. Definitely a lot of risk but I believe the potential reward makes is worth it.

Truly remarkable analyzing the Pros & Cons of Iovance, today, tomorrow & into the future.

Love this post Dennboy, the Dr opinions to me address our main issues with our treatment today.

In the future as we grow, learn, experiment & use genetics moving forward, mabye we can learn to do great things without IL-2
Or much less IL-2 pr treatment.

Time will tell & yes it took nearly 40 years to bring this treatment to the general population & its well deserved.

Shorts are short sighted focused on the here & now.

They have been sadly correct in our SP plummeting from $18’s to now 8’s.

Until we drop our upcoming information bombs on the market, nothing but downward pressure on our SP will continue unabated.

7’s, 6’s who knows where… just in my opinion keep buying cheaper shares & our day will come just like it did for Apple & Microsoft & NVIDIA.

My buddy bought a struggling NVIDIA at $2.75 many moons ago.

Its the ONLY stock he bought at the time. He believed in what they were doing & saw in his minds eye, where it was headed…one day & that day arrived big time.

Our Day is Coming, Never Ever Lose Faith.
In Wayne We Trust.

Happy Fathers Day to all of our Dads on Ihub.

#CureCancer

Thanks for sharing your thoughts and pointing me to TLT ETF.

Thank you. This is an excellent and insightful post.

I think the best buy in the market right now if TLT, a ETF for 20 year Bonds. It moves up as rates move down. The consensus is for lower rates by the end of the year. It may only be 1 or 2 rate cuts but most people think they are coming. If you look at a 10 year chart it is remarkable how close the TLT tracks biotech through XBI, and LABU. You can overlap the three charts and see that they look the same over a 10 year period. In general small bio is starved for cash and lower rates are seen as relief this is the reason they move together. As the market has climbed in the past few years Biotech has been left behind and shunned for three years since its high in 2021. If TLT moves higher through the end of the year I expect Bio to also go up. Its turn is now regardless of bearish general market move. It is possible for Bio to go up and the NASDAQ to drop. They have moved opposite in the past since Bio hits it peak in 2012. IMHO the bottom for IOVA is somewhere where it sits now.

Ok. This is the best presentation that I have seen concerning the science of TIL and preceding tx regimen. It is presented to patients by Dr. Donald Lawrence who is one of the Top KOLs on Melanoma. It is long but the gist begins around the minute 28. What is really nice about this is that there is no "rose colored glasses" concerning this therapy. Dr. Lawrence gives a very balanced presentation. I am very interested in hearing your thoughts. I have listed my thoughts at the bottom of this post. I suggest that you watch the video first prior to reading my thoughts so that your ideas are unbiased.






Thoughts:

Overall - Dr. Lawrence is excited to have this treatment option as he really had no effective treatments for those that failed PD-1. Frankly, it is obvious that he is excited as they put together a presentation that's main topic was TIL.

Key points
1. Iovance did not produce the science behind this treatment, but have provided the opportunity to mass produce this treatment so that it can be provided throughout the world. They provided the infrastructure and the finance to produce the therapy and get it approved.
2. Dr. Lawrence does describe the therapy as antiquated as it was developed 40 years ago.
3. Infiltrating Lymphocytes do nothing without "high doses of chemotherapy" and IL-2.
4. He calls IL-2 as "notorious" and produces a "TON of side effects"
5. He feels that a very limiting factor is the amount of time it takes to provide the therapy as from the time of tumor resection it takes 5 weeks to produce the product. This is a big issue for him.
6. Interestingly the surgery occurs and then the patient returns home to wait for the TIL product
7. He reports that once the therapy begins that patients get very sick and feel horrible. He relates that it has nothing to do with the TILs but is related to chemo and IL-2
8. It is quite apparent that for him the utilizing of IL-2 is a necessary evil and if there was an option with the same efficacy that did not require IL-2 that he would like that.
9. He presents a CR case of his that occurs because of TIL therapy.
10. He feels that the one grade 4 AE in the IOV-COM 202 Study was not a result of the therapy but was most likely related to the facility providing. He thinks that it should be zero for ATC that are specialized and that have great knowledge in treating this patient population.
11. He is concerned with the idea of 70 ATCs as he does not think that this therapy should be provided by hospitals that do not have the expertise with this therapy and patient population.
12. He noted that he receives no compensation from any company.
13. He made it a point to talk about his excitement of next gen TIL
14. He is excited about the mRNA product but not because it will replace the other therapies including TIL but that it may allow them to be more effective.

My impression -
Dr. Lawrence most likely is representative of many of the oncologists that provide treatment for advanced melanoma. He is very excited to have this new option that can be quite effective for his patients that do not respond to Checkpoint inhibitors. It is like - ok - we had nothing and now we have something. Still, he is not thrilled that the treatment has to utilize IL-2 and feels that the time frame to get to treatment is too long. This is what was echoed by physicians at ASCO. As investors in this company, I am sure that we would like to hear the MDs giving glowing praise to Amtagvi. It is a wonderful therapy that provides patients with hope when there used to be none, but it is not without issues which appear to be IL-2 and time to treatment. Frankly. he doesn't say it out loud but infers that if he has some treatment that he can provide with the same efficacy that he would use it.
So what does all of this mean for the company, the treatment and the share price.
Well, it becomes more apparent why the shorts are embolden. There thesis is that doctors will utilize the therapy, but begrudgingly due to the side effects of IL2. They will anticipate that there will be many dropouts due to the time to receive the therapy. They will look at any study that comes out with similar efficacy that does not utilize IL-2 and heavy chemo as a real threat to Iovance. I believe that we recently saw that with the study released by Replimune.

So with all of that, why invest in Iovance. Well having worked in medical as a clinician and then moving to medical sales, I feel that being first to market is a HUGE advantage. I also noted in the video that Dr. Lawrence spoke to next generation TIL with great excitement. He particularly has interest in "lower dose or no IL-2", "Lower dose chemo" and "more rapid growth techniques. Looking at Iovance pipeline - they basically have allow of those currently in some form of study. Iovance also has the infrastructure to CURRENTLY provide TIL therapy with their facility and employee expertise. (Dr. Lawrence related exactly that point). Yes, we will hear about other studies like the triple combo and shorts will tout it as an iovance killer, but will not relate the "50% discontinuation due to toxicity". We will hear about mRNA as an Iovance killer but the shorts do not relate that this not for the same type of patient and may be utilized as an adjunctive therapy. You will hear about replimune and how it is an iovance killer as they don't use IL2. They have not even submitted yet. They have so many hurdles to jump and their efficacy is the similar to non-combo lifileucel. And Iovance has a combo therapy that although the N is small, is demonstrating efficacy that is almost DOUBLE - Replimune. By the time, Replimune comes to market if they do at all. They will be considered "old" therapy as Iovance will have already moved ahead or have been BO due to their infrastructure and pipeline. All in all, I can see how the shorts or those with a vested interest in Iovance struggling can "spin" a negative narrative. But, Iovance is here and now. They are demonstrating that they could get a therapy approved and have the infrastructure to provide. They are demonstrating that they are not static but very dynamic in their next gen TIL development. They are demonstrating that they are taking their first mover status to europe and beyond. It is very very important to be the first to market. In my mind, they will not be the Palm Pilot but the Microsoft of TIL therapy. Remember when Microsoft was dead to everyone because of Apple. Well, Microsoft was dynamic and for a moment in time last couple weeks was the most valuable company in the world (prior to Apple surges 15 points). Iovance in my mind will be the same. So. IMO - this is why I invest in Iovance. I have seen this before when I was part of a launch of a new product. I will end with an example - One product that I was part of the launch was a device that controlled blood loss in surgery utilizing Radiofrequency cauterization without burning the tissue. Well, we hear about all these other products that were "better" than ours and that our product would be eliminated. Everything your mind could imagine and how we would fail. But we kept our head down and just kept selling our first to market innovative product that we kept on enhancing. At the EOD the day, we were bought by medtronic and that devices is still utilized today by many surgeons. We were dynamic and first to market with and innovative product. Sound familiar? So, I will just continue to do my diligence on Iovance and keep my head down.

Dear IOVA board members, I met my retirement specialist who sold me a fixed rate Allianz annuity. During his presentation he stated the biggest concern every retirement specialist has on their minds is that the major indices are at all time highs and are due for a major correction. Even he has moved his retirement money from variable rate to fixed rate. The recent market highs have been driven by large cap stocks. Mid and small cap stocks have tanked. All this has happened in a very coordinated manner. The lobster (small. caps) is cooked without any drama of boiling water. IOVA is a small cap and so are other unprofitable biotechs with great news cooking. There was a time when the odors of great news cooking were amply appreciated in stock price. Not anymore. It’s like the cabal planned and executed this to perfection and their reward will be to buy small caps on the cheap. My biggest concern is what will happen to small caps if DOW and NASDAQ dip 30%? Can IOVA go to $5 if this were to happen? Or will money magically flow to small caps when large caps undergo a major correction?

Market is blindly shorting with the macro trends They are assuming the worst from every company. Guilty until you prove your innocence. IOVA will have to prove revenue is on target or better than expected for shorts to cover in a meaningful manner. Overall market trend for this summer is down: Future promise is being ignored. Let’s be patient and weather this. Once the trend reverses, it will rebound quick. Meantime, I am choosing to hold my long position with insurance and will keeping adding under $7.75. I also think the cabal may take it down below $7 once the bigger markets trend lower on softening sales.

GMH, you're not missing anything. There's no retail to speak of buying this stock. The shorts did their worst and brought it way down. Some shorts have started to cover and the price does spike quickly with any real buying volume. Funds own this company and there's no evidence that they're selling, so it's this painful game of waiting for evidence that the company is making money. All signs point to growth and profit, but all signs also point to the need to get through a few quarters of earnings before predictions can be made and guidance can be accurately provided. In that interim of time between what we think is happening and what will be revealed as actually happening, the door was opened for all of this nonsense that's occurred over the past several weeks (even though it feels like months).

The funds have shown considerable patience which implies to me that they like the future that they see so I'll just wait as well. The company is starting to improve their messaging, but they also explained why they choose not to give guidance at this time. I get it, I don't have to like it, but I'm in for the long haul as the future still looks great - incredibly great if I'm being honest.

We saw the future sooner than some, but others will start buying up shares in the not too distant future.

IMO

Have a great weekend.