Iovance Biotherapeutics Inc (IOVA)

[badgerkid]

Dennboy66, thanks for sharing. The battle has begun as Iovance cuts into the CAR-T market and other earlier line options for cancer treatment.

Now that Amtagvi is recommended as a second line therapy and could soon be considered for frontline, other Pharma companies aren't going to quietly step aside. As Amtagvi continues to demonstrate that it's a better therapy with less side effects and provides a better match to the specific cancers treated, it will increasingly be requested by docs who see the benefits of this bespoke therapy. This is why Iovance is a buyout target. Even if the current team and primary investors at Iovance choose to remain unavailable for sale for the time being, the pressure from big pharma to accept a buyout offer will grow.

If we're correct in our understanding of the value of Iovance and TIL therapy, bigger players are going to want a bigger piece of the pie before much longer and before the real revenues start hitting the bottom line. I still believe that Iovance could be in the black by the end of 2025.

Best of luck to you.

[Dennboy66]

From DrLen in comments section of recent SA article.

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I was at NIH in the early 1970s studying immunology with Nobel Laureate Baruj Benaceraff who was a fan of Dr. Steve Rosenberg , who did the pioneering research on TIL. It has certainly been a long haul to commercialization. I think the fact that TIL has produced significant and durable remissions(? cures) in VERY advanced melanoma patients is quite remarkable and testifies to the liklihood that TIL will be more efficacious when used in earlier stage disease alone or in conjunction with Keytruda. CAR-T cells have been a major commercial success with sales already in the billions. My hunch is that TIL will follow this course. When used in earlier stage cancers the lymphodepletion protocol will be much better tolerated and the chances of efficacy in my opinion will be much greater. Another encouraging fact is that the most recent NCCN cancer therapy guidelines now recommend TIL as SECOND line therapy for melanoma, not third or fourth line; this is very likely to stimulate rapid uptake. I share the enthusiasm of the corporate insiders who have been consistent buyers of the stock despite their large stock options. I can understand the analysts drilling down on initial uptake, uptake, but I think they are missing the forest for the trees. It may take a little more time, to get established, but TIL has a very good chance of being a revolutionary product and I regard it as an outstanding speculation.

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[Sunman88]

https://www.marketwatch.com/story/no-return-left-for-u-s-stock-market-in-2024-says-goldmans-david-kostin-1da2d4ac

[Sunman88]

Good morning and greetings from the beautiful Pacific Northwest.
Upon reflection, over last few weeks the market Gods had decided to look at every news as the “glass is half empty”. No matter what anyone had to say, the market makers refused to see the glass as half full. This was done by design. They placed pressure on all stocks which are burning cash and may need cash again before they turn profitable. The beatings were overdone like they usually are. They elected to forget some these stocks are also on an exponential growth curve and some like IOVA have additional turbo boosters in the wings (Phase 3 trial with Keytruda and Phase 2 trial for NSCLC) which can do a boom-boom.
Sensibilities will eventually prevail like they always do, may take a bit more time. Stocks are still the best bet for great ROI for future generations.
Feds are watching and will relax interest rates in the second half of 2024. Hopefully, this may drive a rally prior to elections. Irrationality will return😅 Best thing to do when market behaves the way it has over the past few days is to walk away and take time to smell the roses . and enjoy the beauty around us. The best things of life are free. Enjoy Mothers Day and be sure to recognize all the wonderful mothers in a very special way.
Wishing you all lots of sunshine and better days ahead.
Sunman

[52172]

Monday we bounceback

[badgerkid]

GMH, regarding May 17 options. I had noticed before the earnings call that max pain was still sitting at $12 for next Friday. I had hoped that the news would be more than enough to keep the sellers from the move we saw on Friday. With that said, I do use options max pain as an indicator of where a stock price may trend towards on options expiration dates. It has its limitations but it does seem to be a good indicator with some regularity when options volume is high. If those sellers can close IOVA exactly on $12 or slightly below next Friday, they win big on all those contracts that will expire worthless (some of the $12 calls are mine which should have been a clue that they might be worthless next Friday). I'll add more shares, but I won't be buying any calls for the time being as the big boys continue to win that game.

I've gotten back to my original plan of selling puts and accumulating shares. I sold some $11 puts for Jun and Sep on Friday. I have a core position of shares and a few trading shares that I'll sell calls on from time to time, but the future still looks great so I see no reason to worry even though that's my habit.

I agree that the sell off looks overcooked a bit, but such is the nature of markets when news is good and incredibly supportive of the future but not earth shattering at the moment. I feel more confident in what this company is doing, but stock price movements like we saw on Friday will test your mettle.

Best of luck to you and thanks for your willingness to share your thoughts and research on this board.

Good luck to the longs.

[surfkast]

It looks like the expectation of $2.03 million with revenue of just $715,000 caused the major adjustment. Doing a little DD and seeing what the analysists say I believe this will rebound quickly as everything else appears either on track or ahead.

Reiterates HC Wainwright & Co.: Buy to Buy 5/10/2024

Iovance Biotherapeutics Poised for Growth: Analyst Reiterates Buy Rating Amid Strong Q1 Performance and Promising Clinical Advancements

In a report released today, Joseph Pantginis from H.C. Wainwright reiterated a Buy rating on Iovance Biotherapeutics (IOVA – Research Report), with a price target of $32.00.

Joseph Pantginis has given his Buy rating due to a combination of factors that suggest a strong potential for Iovance Biotherapeutics’ growth and profitability. The company’s recent earnings report for the first quarter of 2024 surpassed expectations with a lower-than-anticipated loss per share and showed a promising cash position. Pantginis notes the importance of Proleukin sales, which are now projected to substantially contribute to Iovance’s revenue throughout the year. Additionally, the analyst sees the enrollment progress of AMTAGVI therapy, with over 100 patients already enrolled and 60 more in the pipeline, as a sign of strong launch momentum that is expected to carry forward, particularly as the company aims to expand into global markets

https://markets.businessinsider.com/news/stocks/iovance-biotherapeutics-poised-for-growth-analyst-reiterates-buy-rating-amid-strong-q1-performance-and-promising-clinical-advancements-1033363090

The first quarter of 2024 was transformative for Iovance. It included:

Commercialization: Following FDA approval, Amtagvi's launch progressed rapidly, with over 100 patients enrolled via more than 40 authorized treatment centers.
Global strategy: Plans for regulatory submissions in Europe, Canada, and Australia reflect Iovance's ambition for global reach.
R&D drive: The ongoing Phase 3 TILVANCE-301 trial and other studies fortify the pipeline, emphasizing the strategic focus on TIL cell therapies.
Financial performance: Despite lower-than-expected revenue, strategic investments in R&D and commercialization are shaping long-term prospects.
Iovance also produces a melanoma cancer drug aldesleukin (originally approved for use back in the late 1990s) under the brand name Proleukin. Iovance is now recognizing all Proleukin revenues for commercial and clinical use and recently began significant sales to distributors. Iovance completed the transfer of marketing authorizations in Q1 and began distribution of Proleukin. Beginning in Q2, Iovance expects to recognize significant incremental revenues for Proleukin as part of the Amtagvi treatment regimen.

https://www.fool.com/data-news/2024/05/10/iovance-biotherapeutics-q1-revenue-falls-short/

[badgerkid]

Sunman, per the transcript: Jean-Marc Bellemin: "Thanks Igor. Today, I will review our current cash position as well as our results for the quarter ended on March 31, 2024. I will also highlight our 2024 outlook. As of March 31, 2024, Iovance had cash, cash equivalents, investments and restricted cash of approximately $362.6 million. The current cash position and anticipated revenue from Amtagvi and Proleukin are expected to be sufficient to fund current and planned operation well into the second half of 2025..."

The company has consistently under promised and overdelivered. An additional offering is always on the table, and if it looks needed, that would be in line with your 2025 Q2 timeline. But with the above statement, I think the patient numbers that Iovance is projecting (albeit internally) will be a bit higher and maybe significantly so compared to your estimates. If revenue is steady and growing, additional funding may take the path of non-dilutive means such as standard business loans or other such financing. If the company is close to a buyout consideration, I would assume the majors will not want to dilute their positions.

Just thinking out loud a bit here. I haven't done a deep dive on this angle as of yet. Have a great weekend.

[Sunman88]

Hopefully they achieve 250 patients in 2024 and point to 500 in 2025 and 800 in 2026 to break even: They will need to refinance by 2025 Q2.. This is an overhang. Hopefully, they dilute 20M shares above $15 after they announce positive Phase 3 results or positive Phase 2 for NSCLC. After that there is no looking back. A buyout at that time would sweeten everything.

[badgerkid]

Iovance Q1 call transcript: https://uk.finance.yahoo.com/news/iovance-biotherapeutics-inc-nasdaq-iova-163350605.html

Here's a snippet - enjoy:

Dr. Fred Vogt:"... Demand has increased month over month since approval and expected to grow further throughout the year. As of today, more than 100 patients are already enrolled for Amtagvi therapy and most are expected to be ready for infusion across the second and early third quarters of 2024.

In addition, more than 60 additional patients have been identified at ATCs and are expected to enroll soon. As existing and new ATCs continue to build experience, we expect patient enrollments to steadily increase throughout the year, supporting our expectations for sustained growth. As we anticipated, interest is very high on ATCs and they are demonstrating that they have the training, infrastructure and capabilities to treat patients with the Amtagvi, which Jim will further highlight. We remain on track to have 50 total ATCs by the end of this month. We also set a new goal of at least 70 ATCs by the end of this year, representing the largest ever number of ATCs for a cell therapy launch. We are pleased to see positive reimbursement trends, which is a key indicator for success and adoption..."

[badgerkid]

Upcoming event on Monday, May 13th, 2024 at 2:00 pm EDT: The Citizens JMP Life Sciences Conference

https://ir.iovance.com/events/event-details/citizens-jmp-life-sciences-conference

[badgerkid]

Amtagvi Launch Minimizing Attrition, Truist Securities Says
1:35 PM ET 5/10/24 | MT Newswires

Iovance Biotherapeutics' Patient Selection for Amtagvi Launch Minimizing Attrition, Truist Securities Says
01:35 PM EDT, 05/10/2024 (MT Newswires) -- Iovance Biotherapeutics' (IOVA) "disciplined" patient selection for treatment with Amtagvi, an intravenous infusion suspension for treating adults with unresectable or metastatic melanoma, is helping minimize patient attrition, Truist Securities said in a note Friday.

The company reported having enrolled over 100 patients for treatment, which Truist described as solid.

"Based on our analysis, time from enrollment to receiving therapy (which is the billable, revenue-generating event) is taking longer than what was anticipated, but this is likely to improve as treatment centers and payors become more familiar," Truist Securities said, adding it expects more than 60 patients treated would contribute to the company's Q2 revenue.

Enrollment to infusion currently takes around three months, but this could be shortened to six to eight weeks as each authorized treatment center gains more experience in handling patients, the note said. Truist said the number of treatment centers is on track to reach about 50 by end of this month and 70 by year-end.

Truist maintained its buy rating on Iovance Biotherapeutics with a price target of $26.

[badgerkid]

Jim Simmons passed away, the reason we're all dinosaurs in the stock market and the reason days like today for IOVA happen:

https://www.cnbc.com/2024/05/10/jim-simons-billionaire-quantitative-investing-pioneer-who-generated-eye-popping-returns-dies-at-86.html

[Sunman88]

With about $365m left and burn rate of over $110m per qtr, Share price action suggests some big sellers are focused on the burn rate and the possible need to dilute by late 2024 or early 2025. Also, they may have been expecting demand projections to be in several hundreds and may have misunderstood the context of “100 patients are being screened and some are not making the cut”. TIL is a process with a lot of logistics involved and cost is high. Ramp up will be gradual pace and not rapid. Some are using this to create FUD and shock the longs. It boils down to having faith in the technology and execution over time versus killing the hen that lays one golden egg daily in hopes of getting several hundred today.

[surfkast]

Stopped raining. Going fishing!

[MN Gopher]

Shocking meltdown today. The report was very good & The Shorts are covering & a general overall sell-off is in full swing.
Great opportunity to add shares on a much lower level today.

In time, we will have our day(s)
Today is not one of them.

Stay Strong Longs
#CureCancer

[surfkast]

WTF???????????????????????????

[Rubraquercus]

sell the news is classic, not any more complicated than that, I added

[retired early]

Fantastic dip. Load mode.:)

[badgerkid]

GMH, most of our analysts have reiterated. There's nothing in the 10-Q that looks negative. It looks like a well orchestrated short attack or MMs going after all of the stop losses that were just sitting there for the taking. From our low a few weeks back, you have a lot of new investors that were likely buying into the Q1 call and may have added to all those open stop loss orders or got sucked in on the morning panic sell. Surprised that it got so low, but we've seen this too many times to be shocked: good quarterly call, positive results, allow a few buyers to pay higher prices, then attack the stock.

My reasons to hold haven't changed. I tried to sell some puts this morning, but the premiums didn't excite me, so nothing added as my sell offers weren't hit. I'll be adding some shares next week with a few more deep in the money calls, but I was tempted to add a few more shares this morning as well. I'm sticking to my plan (as tough as that is after such a good call and a ridiculous sell off).

Nothing for me to do but wait. I can't find any news or reasons to change my plan. If anything, I'm even more confident in the future of Iovance after yesterday's call. Unfortunatley, we're right back to the initial premium price after the approval and the secondary. Time may be the only issue to those looking for fast money.

The only item of note was the S-8 this morning, but that's not news worthy (or it shouldn't be).
https://ir.iovance.com/sec-filings/sec-filing/s-8/0001104659-24-059473

[surfkast]

I am shocked by today's trading.

[GMH*]

I really do not know what more people were wanting from that call. I have been on a lot of biotech product launches and almost always, the ramp disappoints as people expect a higher on-boarding. This is one of the first times where I think the on-boarding significantly exceeded expectations. Discussions of other developments and EU/UK/Canada/Australia rollouts and new INDs were all quite positive. Only thing I can think of is the revenue miss of $0.7M vs expectation of $2.1M... simply HF algo trading. Really do not get this sell off. I will bet that Wayne adds to his holdings today... just a guess.

[GMH*]

I generally do not like to buy stocks and increase my cost basis, but bought another 1,000 shares at $11.50... the sell off is crazy relative to the news. Not sure what the item is that people are concerned about..

[GMH*]

I had noted that comment on why people were disqualified from treatment and discussion around not within label including "not having melanoma". I really do not think there will be off-label use just because payers have to authorize so the price tag will probably eliminate off-label unless someone pays cash or if NCCN recommends off-label (which I would doubt will happen). I would think that these individuals would look for a TIL clinical trial as an alternative.

[surfkast]

Analyst Peter Lawson from Barclays maintained a Buy rating on Iovance Biotherapeutics (IOVA), with a $22 price target.

[badgerkid]

GMH, one additional comment that I picked up on in today's call implied that attempts may have been made to go off-label with some patients. Again, I'll need to revisit that part of today's call. I don't think it was specifically stated as much as it was implied or it could be inferred by the comment.

Curious - and why not try since proof of concept exists for solid tumors. As a doc, I would try for my patient if I perceived the value. I do believe this will eventually happen if and when an insurance company decides the risk is worth taking to avoid significant future costs. It's fun to speculate.

To your other point, it was a silly dance between the analysts and the management. Management wanted to say more but wisely didn't, analysts wanted more for modeling but knew they wouldn't get it. It was the Q1 taste with the request to come back for bigger helpings at the Q2 call.

Overall, not a bad call.

[GMH*]

We have all talked about the 100+ patients enrolled (passed the screening process vs label) but we should also consider the 60 patients currently in the screening process. Most of those will probably start treatment in May/early June.

[GMH*]

I just find the entire exchange hilarious. I have been invested in companies with about a dozen commercial launches and it is always the same thing. The company says it is too early and there is too much variability to give guidance (and rightly so). The first half dozen questions are all trying to elicit any tidbit of information to help ascertain a revenue estimate. It even gets to the point where the analysts themselves feel silly about the questions by saying "let me ask this another way" or "want to just ask another question about revenue". I just find it funny that it was so predictable.

Agree that by keeping it vague, if an individual investor can do better research (and I think that is possible in small cap biotechs), you can play the ER updates and other events as a catalyst. I put my first trade on way too early but put on another going into this one that should pay off nicely. Will see where we are and what the estimates are going into Q2 to see if there could be another upside pop.

[badgerkid]

GMH, I think the company offered all they could regarding revenue growth and projections and did so carefully so as to not get caught in a revenue trap for Q2. The anlaysts will likely stay conservative in their estimates as well, but one or two may surprise with high side estimates. As mentioned, revenue from Amtagvi is recorded when infused, but trying to pin down the exact timing is still challenging during this ramp up. Which side will it fall on for Q2 or Q3 is fluid right now, but I think by the end of Q3, we may see actual revenue guidance for Q4.

I for one am glad they kept it vague, it may allow me a chance to add a few more shares at bargain prices while I gather in a few more investing dollars.

Good luck to the longs.

[GMH*]

The vast majority of Q&A was trying to get a handle on how to model patient flow / flows to try and model out Q2 revenue. It will be interesting to see how the revenue projections are updated over the next weeks. Think analysts were caught off guard on the ramp since revenue estimates implied around 65 patients.

Just re-listening to the call. It is hilarious at how each analyst just tries to just re-frame the same patient question.

[badgerkid]

Congrats to Iovance. This team is on top of their game. There's a lot to digest in today's release, but GMH hit on several significant points. Earnings will still need to be verified for many to jump in more aggressively, but that too shall be revealed with Q2 and Q3 results. I can't say it enough, this team knows how to build this business. They are succeeding in ways we don't typically see, even in how they are working with the FDA. The cooperation is exciting.

I've said it before, it's one thing to have the goods, but you have to know what to do with it to make money.

We'll have plenty to talk about over the coming weeks from digesting today's report, to the upcoming chats and conferences.

Good luck to the longs.

[GMH*]

Biggest comments on the call for me:

1) Continued acceleration of patient enrollments
2) Expansion of approved ATCs to 70 by year-end because of interest from Cancer Centers - expected this but glad to hear it communicated
3) Progress made on NSCLC, especially when they said that P2 may be registrational.
4) Initiation of IOV-5001 using IL-12 rather than IL-2. IL-12 also seems to reinvigorate NK cells. - will need to read up a bit more on this and will share what I find later.

[surfkast]

I thought we had great news today. PPS seems to reflect that feeling. Tomorrow could be interesting.
I am thinking the analysists may raise their 2024 projections?

[GMH*]

Certainly does not seem to be a lot of hype going into the ER.

[surfkast]

that would be good. Lets see what the call does today.

[GMH*]

Options pricing is indicating a $2 move after earnings... just hoping for good patient start numbers so it is to the up-side.

[surfkast]

Hopefully today will see a resurgence in interest that will ignore outside influences and be based on IOVA facts!

[badgerkid]

Surfkast, the entire biotech sector was down today being spooked by the fed comments suggesting rates will remain unchanged a bit longer than some had hoped. I find it important to remind myself that Iovance does not trade in a vacuum, but is part of a much larger sector and many of the shares are held in funds. Unless there's significant news, IOVA does tend to trade in similar fashion to those sector funds.

The retail investors (us here) have little effect on the share price under most circumstances. The XBI can serve as a guide to the sector, but the XBI etf is heavily shorted which will also have an impact that can dampen a single stock's momentum at times. I believe today was one such example with regards to IOVA. I see nothing in today's action that is worrisome regarding the long term prospects of this stock. Unfortunately, it's easy to get caught up in the day to day action of a single stock and lose sight of the effects of the overall sector and market. It takes really good news to overcome a bad day in the overall market. News that's expected just doesn't do it.

I expect a good call tomorrow, but Iovance is still a quarter away from reporting revenues for Amtagvi. Revenues are currently being generated, but we won't see the bottom line impact until the Q2 report in early August.

I expect tomorrow's call to be very good. I anticipate more clarity on the ramp-up, guidance on patient starts, updates on trials and foreign markets, and maybe a few bonus comments about quality increases in production or patient results. But unless there's a big surprise, the news that's expected will only have so much of an impact. I just don't know what that expectation is and so it's hard to predict how the market will react.

With that said, I still expect higher highs throughout this year and into next. I have high confidence in the team at Iovance.

Good luck.

IMHO of course.

[surfkast]

Did not expect today's drop in price with the call tomorrow.

[GMH*]

I generally do not rely on analyst price targets. I have a biotech that I have had for years (probably too long) where the price targets have been consistently low of 1/2 of current price and high of 2x and the average is the current stock price. I bought it at $12 and it currently sits at $41.

I have found that analysts often send their juniors to the Q&A calls (listen for so and so sitting in for the lead analyst comments) in the smaller biotech space. I also do not know how often they update models. We still have at least one analyst with Q2 revenues below $6M. The 20 starts already reported will exceed that.

[GMH*]

You are correct. I only skimmed the Nov 22 deck and did not see the protocol.

[Sunman88]

Analysts base their targets on assumptions. Actual results from earnings call will help us gain better insight. For now, I like be conservative and settle for 22 as the target which values the company at $6B. This pants to 8x of $750m annual revenue run rate.

[Sunman88]

Thorough. I agree with all points you have listed. Another ask is an update about any significant adverse events during real world use and 30-60 day response rate. If both are better than expected, that’s a huge plus as it confirms safety and a better response than clinical trial data.

[jondoeuk]

They don't give any IL-2.

[surfkast]

If the CC reveals better than expected results, those estimates could be too low,
.

[badgerkid]

FWIW, on May 2nd, Peter Lawson with Barclays reaffirmed their buy rating for Iovance with a price target of $22.00.

The average price target from 12 analysts currently sits at $26.00 with a low target of $19.00 and a high target of $34.00.

[GMH*]

The expense guide was given during Q4 earnings call which was after Amtagvi approval so I would expect that those ramp-up costs would already have been incorporated. Similarly, the cash runway included Amtagvi revenue expectations so that is a risk... I do think there will be 1 more secondary offering at some point. CFO said that the revenue projections included were "conservative" during the Q&A session however.

Will be interesting to see what they say regarding foreign market filings. I really am not expecting much update. Heard from another biotech that the FDA filings can be up to 1 million pages of documents/forms and I expect CHMP requires their own forms so a lot of updates. I am thinking Q2 2025 approval for Europe as my best guess.

[badgerkid]

GMH, I wouldn't be surprised if expenses go up a bit with the ramp-up, but revenue growth should balance that and maybe prove to be more positive. Did you have thoughts on foreign market updates?

[GMH*]

As we head into the Earnings CC, here are my expectations and some of the things I will be looking for:

1) Number 1 is the number of patient starts. I think the Street is looking at around 65 based on Q2 Rev estimates. I think the "whisper number" is a bit higher based on recent price action so 80-90 starts. As I stated before, I am projecting about 115 based on commentary from oncologists postings/videos. My optimistic "hopium" number would be 150+ based on a favorable interpretation of managements comments, but that may be asking too much. I do not think they will give actual revenue guidance until YE for 2025 revenues.
2) Expansion of ATCs beyond the 50 by end of May due to interest from other Cancer Centers. Think this number could be pushed to 60-65 by end of Q3.
3) Any commentary regarding manufacturing success rate compared to the previously stated 90% number provided.
4) Expense burn for Q1 vs $80M-85M expectations (annual guide of $320M-$340M)
5) Any update/change regarding cash runway from H2 2026 which would give an indication of patient ramp relative to internal modeling/expectations. Don't think they will modify that until Q2 ER though.
6) Updates on any clinical trials/pace of enrollments, etc.

Any guidance or projections would certainly be welcome, but I just think it is too early in the launch for them to provide that with any certainty. Anything I missed?

[surfkast]

I reviewed the information and believe it is a win/win situation for everyone. By spreading out the "dilution" there will be no impact as I believe the companies numbers will be improving quarter over quarter.