Iovance Biotherapeutics Inc (IOVA) 시세

GMH, as for keeping the guidance unchanged with the Q4 call, I suspect some of that had to do with the Kirby contract which is incentivized based on exceeding that number. I do believe the company fully expects to beat guidance, but by how much is anyone's guess. Keeping guidance unchanged certainly seems prudent even if they're confident in a beat. It also allows for a small increase to 2025 guidance numbers once any of the foreign markets receive approval.

Based on the Q4 call and the recent fireside chats, I suspect Q1 will be mostly flat, Q2 slightly better, but the second half of 2025 will be very good indeed. I still think the OOS product was the drag on the total fully billable infusion numbers. That should improve with additional experience and helping the docs who harvest the tumors to make the best selections possible to increase the odds of successful manufacturing of Amtagvi.

I fully admit that this process is far more involved and nuanced than I had originally thought. My one big criticism is still the timing of their cash raises. I definitely now wish they would have been far more aggressive with their primary cash raise following the Amtagvi approval, knowing full well that it would hurt for awhile, but then less likely to have to raise additionally, especially when the stock price had gotten so abused.

Hindsight, I get it, most of us (the company included) didn't expect this low of a stock price ever again following that first approval. I sold plenty of higher priced puts that prove that point.

Someday we may hear the rest of that story, but for now, it's just business as usual. Grow the business, expand the markets, get additional approvals, improve the manufacturing, improve the margins, and thereby beat the revenue guidance.

GL

One additional positive is Kirby's Performance objective. He has a lot of incentive to hit/exceed the Corporate guide.. to extent of $500k at current SP and would be much higher value if they actually hit those numbers.

Nothing useful to add for the moment but I strongly agree with all of this.

Was waiting until after the ER and fireside chats to post my overall assessment, FWIW:

Negatives:
1) Disclosures: Management was not forthcoming on any negative aspect of quarter (low infusion rate, infusions done to date in Q1, reason why IL-2 sales "indicative" of future Amtagvi volume but inconsistent with low infusion rate, etc.)
2) Capital raise with dilution of 23.3M shares: Estimated raise of $143M ($422-$404+$25*5 qtrs) puts raise in low $6 range
3) What does new KPI tell investors? Over time, more and more ATCs will have treated more than 10 patients. Not sure if that really tells us anything. Kirby seemed to indicate they would use that as a 12 month rolling KPI rather than an ITD KPI, but is yet TBD.

Positives:
1) Cash burn reduced to below $300M, while still high, it does include CAPEX to build to 5k slots in 2025.
2) Capacity now at 1,200 so capacity should no longer be a constraint for either commercial or clinical trials
3) Work In Progress/Finished Products increased $9M from Q3. Most likely from Amtagvi since IL2 product sales were very high in Q4. Was this from Amtagvi shipped before Jan. 1, but not infused until 2025?
4) Employee growth to 950+ indicated increasing demand (but inconsistent with Q4 actual result, so which is correct?)
5) Europe has single payer system so no incentive not to refer and several countries will have single patient agreements in place upon EMA approval so should have early referrals.
6) Royalties for Proleukin is mid teens but NIH royalties generally 3% so blended royalty rate should be below 5% whereas current royalties (and COGS) several points higher simply because of current product mix.
7) Proleukin sales - JMB mentioned pre-acquisition sales were $20M (but think some of this was sales to IOVA - see transparency). Sales were about $0.5M for 5 quarters after acquisition so seems there is a disconnect, but 10-K indicated that they were letting existing inventory in non-SD dry up and now all stocking is thru SDs, which may explain the higher volume (but why not simply say that?).
8) Fred indicated some Proleukin sales were from single patient INDs (i.e. EAP) so they do actually get IL-2 revenue when patients get OOS in the EAP.

Outstanding questions:
1) How much of cash burn is CAPEX? My guess is between $30M-$40M, primarily from equipment purchases.
2) What is drop rate? My estimate, based on GMs and drop cost is that it is currently about 20%
3) Cash runway - how close is IOVA to a tipping point where revenue > cash burn?

Please feel free to comment/add any items you think are pros/cons/open issues.

Sunman, there are numerous things wrong in what you've said, but I'll pass the baton to other board members to explain where you're wrong in many of your statements.

I will say this one thing, based on comparisons to CAR-T, Iovance will likely have some exponential growth through the 2nd half of this year. Guidance for 2025 will prove to be conservative. See you in a year? Probably not as you'll have moved on by then.

Sad, really. When you joined us on this board, I had higher hopes for your ability to rationally analyze this company fairly.

Yeah, I'm the cheerleader, I get that. But in my view, you've become so negative that you no longer offer rational and thoughtful discussion on this very important company and cancer treatment therapy.

GL, but it's gotten very hard to take you serious anymore.

Seriously?? got major approval & SP dropping ever since because of finances???

OK - No wonder theory & jondouk giving your post thumbs up????

High burn, high outstanding, slowing uptake rate; not so lucrative margin, and more secondaries are now all facts. The real risk to this investment is now whether they will or will not meet their 25 guidance. Looking at q4 infusions, one may conclude that they will very likely miss the 25 guidance as they won’t be able to more than double infusions to meet guidance. WS won’t be kind to pps under such scenario, which will magnify the negative impact of the secondaries. Plan wisely and walk gently. That is my humble suggestion.

Please give it up with nwbo. They finished their only trial in gbm in 2018. And they still have no approvals in 2025. They are broke aka no cash, on the otc with 1 35B shares outstanding and their ceo has used nwbo to fund her own cdmo twice. That pipe dream will end soon in their pathetic MhRA rejection. You cant change endpoints on a pivotal trial because your primary endpoint failed. That is clinical trials 101. Nwbo dcvax is a threat to no one in ANY indication. Too many red flags to count for this company. Sinple.

And yes TIL has gone head to with ctlA4 ipi already and TIL won. But that is not say that ipi cant be used in conjunction with TIL and PD-1. So stop with your petty scare tactics. The sooner you realize nwbo is a scam, then you may be able to invest in legit companies. I have hope for you still.

Median overall survival among patients in the TIL group was 25.8 months (95% CI, 18.2 to not reached), as compared with 18.9 months (95% CI, 13.8 to 32.6) among those in the ipilimumab group (hazard ratio for death, 0.83; 95% CI, 0.54 to 1.27). The 2-year overall survival was 54.3% (95% CI, 43.9 to 67.2) in the TIL group and 44.1% (95% CI, 33.6 to 57.8) in the ipilimumab group (Fig. S8). Overall survival in key subgroups is shown in Figures S9 through S11.

As shown by NADINA trial, neoadjuvant therapy on melanoma will reduce the number of patients who have to seek lifeleucel as the 2nd line treatment by over 30%.

Likewise, the same could happen to lung cancer. Once the approval of DCVax-L is granted, institutional investors will immediately spot the big difference between lifeleucel and DCVax-L and they are going to exit fast.

You don't need to believe what I said. Read all the papers about lifeleucel and the papers on DCVax-L. People lie. Data don't lie.

Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer
https://www.nejm.org/doi/full/10.1056/NEJMoa2202170

Perioperative Pembrolizumab for Early-Stage Non–Small-Cell Lung Cancer
https://www.nejm.org/doi/full/10.1056/NEJMoa2302983

Largely my view too. Data from COM-202-3B and LUN-202 very compelling to date for 2L NSCLC. And as you’ve mentioned, lifeleucel + ICI in ICI naive patients is a game changer (COM-202 1A and 3A).

For amtagvi in 2L MM, it’s going to take ~3 years to hit peak sales globally due to staggered market expansions and increased push for getting more metastatic melanoma patients immediately post ICI (as per updated NCCN).

When I started my position here over a year ago, I knew there could be upwards of 500 M shares outstanding by the time the company was profitable. But on the other hand, I’m also confident there will be label expansions. And most importantly for the future here - next gen cytokine tethered TILs.

I’m not over-extended here and my forecast has always been 2027-2028. I sleep well at night and I’m optimistic about the future 😄

Come back to me in one year. Let's see who is right. 3.59$ mark this number. Mar 15 2026....better make sure you check back.


Can you explain how they fail in nsclc? Assay...nope that problem is solved. You know it is open label right. .and there isn't anything but chemo 2L. Give me evidence why it would fail? I'm listening

I get it you are bagholder/short or took a loss and are looking at share price and listening to social media.

What the downside risk here? First full year of sales is going be over 250m. 3x conservative multiple is 750m. They projected 2025 450m, 3x that is 1.35b. And that isn't taking into account for 1L. You seen those open pabel number too right? 65% 0RR 34% CR.. Sure cash burn is high, they are running trials and commercialization. Go invest in a index fund if you don't want risk.

Why should anyone trust you? You are still wearing rosy glasses and not pointing out the many risks with IOVA…. Cash burn is a disaster .and recurrent sneaky ATM cash raises has been a disgrace… shameless management will do it again at shareholder expense ….:.Chance of failure of with lung trial and combo trial (Keytruda and Amtagvi) for Melanoma exists. This has been a shareholders nightmare. Stay clear.

This is exactly it. Execution of the company is in company control. The company has laid out milestones and hit each and every one of them. Current sales supports this valuation. Growth in this current indication/Pipeline expansion isn't even factored in at these prices. I absolutely agree. You can't find bottom, but you can accumulate when it is undervalued.

Regulatory
-Approval in US
-Submissions accepted by EMA, UK, Canada
-2025 1H Submissions planned for Switzerland and Australia

Commercial launch:
-50 ATCs within first 6 months.
-70 ATCs by FY 2024 end.
-164M sales in 1st 3q of launch
-135k sq foot of their own wholly owned CDMO and secured contract with a backup CDMO that can support 2k patients.


Pipeline:
NSCLC pvotal and Endometrial POC readout due this year
Confirmatory 1L in Melonoma enrolling and possibly reading out in ORR this year.
Additional trials too much to even list.

Let's see the share price appreciation with a few more quarters of this type execution. I guarantee it won't be at this price. Check back in 2026. You will be glad you accumulated down here. That is financial advice. This is how you build a platform company. This is what you call the excellence of execution as the great nature boy would say. Watch and learn how it is done trolls.

I love the conviction from the longs here 👊

As a matter of fact, if the science is revolutionary, it is all about science.

Lol 😂 👍️

It is all about the Finances, not the science.

IOVA - Facts...
Dropped from about $16 SP after Melanoma therapy approval...
And now sitting @ $3.5, about 80% drop...
Why that would be????

Please leave this argument on NWBO board, not here. Appreciate it.

Adding while they bring it down. They hit everything they guided to:
- ATC launch 50/70 - Sales 164M (guided to 160-165M) in the first 3Q of launch (2024)
-Improved COGS Q over Q
- Executing in Pipeline (NSCLC and Endometrial readouts this year, and possibly Confirmatory reads out in ORR)

Everyone crying over price.....Take advantage and DCA and load up. Thank me later for the financial advice! I take tips! Yall knew when you invested you had a connected hedge fund cronie in charge, so of course there are games to be had with him and his friends. Declining price can affect the retail pysche, you can see it in all the social media posts.

FFS, they are on track to do over 250M in sales in the 1st 4Q of launch....you would think the sky is falling here listening to all the bagholders and weak retail moan.

Cosa, go back and read your last post on IOVA, management doesn't sit around thinking about the share price at this point in the company's growth. They will, but not just yet. As for some nefarious plot, that's Hollywood, not real world companies trying to achieve success.

This was unrelenting selling today. Is it the flush or are we due for all time lows? My guess is all time lows.

Do they get awarded yearly stock options? It would be really shady if they are fattening up their wallets by manufacturing a decline.

Barclays 27th Annual Global Healthcare Conference, tomorrow morning, 9:30 am EDT, Fireside chat with Iovance:

https://ir.iovance.com/events/event-details/barclays-27th-annual-global-healthcare-conference

KIPK, while you're shaking your head, what value have you brought to this board, the IOVA board? Why do you find it necessary to criticize a poster here about some other investment and their comments made on that board? Take your battle back to the NWBO board. Last I checked, this is the IOVA message board.

If you're bearish on IOVA, that's fine, but why not discuss that instead of criticizing one of this board's members and his/her statements made on a completely different board and a completely different investment?

Good luck KIPK in your investing, but here we try to discuss IOVA (for the most part).

thorysut - your constant dilutional posts against NWBO won't hep IOVA succeed.

If IOVA technology is as great as you think, why are you & few other IOVA investors are so afraid of NWBO success??

SMH

Theory, agreed. It would seem that the ability to buy large blocks of shares at these lower levels has diminished substantially. Mostly just day trading activity at this point imho. I don't see much reason for more shorting at this level, some covering certainly, but that too isn't in a hurry just yet to close out those short positions. It will, in time. GL

Sunman, I assume you no longer own any shares of IOVA, being a "smart one" amongst all of us fools?

Do you still own IOVA? I would assume you don't because you suggest that owners of the stock are foolish and ignorant, and you're certainly not foolish nor ignorant, are you?

Why waste your energy on the likes of IOVA investors by posting on this board? I would hope that you have far better things to do with your time than associate with the uneducated and witless rabble that make up this group, especially me who you've deemed to be a paid cheerleader with nefarious plans to somehow harm the retail investor by sharing my thoughts about this investment.

So there's no confusion, that's sarcasm.

Well, at least I'm amongst friends.

Good luck to the longs.

Yeah that is short interest as of 2/28. The volume appears to be drying up which is good. Would be interested to see the 3/15 Short interest. Want to see check out the Q1 fund holdings that will come out in mid April. I'm adding under $4. Looking strong in crappy macro tape.

Lid held tight under $4. Trust is low.
Share price is moving at the speed of trust. Raising $200M cash at the ATM twice already since Feb 2024 while revenue growth is anemic (after you tease out Proleukin stock up). This manipulative tactic to make things look better than they actually are does not fool the smart ones
This is dead money in 2025.

Just for fun, here's a little AI experiment when asked to analyze M&A potential for 2025. This is in part an AI generated response by Google.

"In 2025, the pharma and biotech sectors are expected to see increased M&A activity, driven by factors like patent cliffs and a push for pipeline replenishment through acquisitions, particularly in areas like oncology, immunology, and cardiometabolics.

Key Trends and Factors:

M&A Activity Anticipated: Industry analysts and experts anticipate a rebound in M&A activity in 2025, with larger deals expected after a period of "smaller, smarter" deals in 2024.

Patent Cliffs and Pipeline Needs: Major pharma companies are facing revenue losses due to patent expirations (patent cliffs) and are actively seeking to fill pipeline gaps through acquisitions, especially in areas like oncology.

Focus on Late-Stage Assets: There's a growing focus on acquiring companies with late-stage or market-ready assets to ensure quicker returns and to mitigate risk.

Specific Therapeutic Areas: Oncology, immunology, and cardiometabolics (specifically GLP-1 drugs) are expected to be prime targets for M&A activity.

Alternative Deal Structures: Expect to see more alternative deal structures and collaborations, such as joint ventures, licensing agreements, and partnerships, as companies seek access to pipeline assets and to mitigate risk.

J.P. Morgan Healthcare Conference: The J.P. Morgan Healthcare Conference in January 2025 saw several high-profile acquisitions, signaling a potential resurgence in deal-making confidence.

Factors Influencing M&A:

Falling Interest Rates: Lower interest rates are expected to encourage investment and make M&A deals more attractive.

Regulatory Uncertainty: Reduced M&A regulatory stringency due to the departure of FTC chair Lina Khan could also contribute to more deals.

Cash-Rich Big Pharma: Big pharma companies have substantial cash on hand, giving them the financial capacity for larger acquisitions.

Examples of M&A deals in early 2025:

Johnson & Johnson: Announced acquisition of neuroscience drugmaker Intra-Cellular Therapies for $14.6 billion.

GSK: Agreed to acquire cancer drug developer IDRx for up to $1.15 billion.

Eli Lilly: Made a $2.5 billion deal to acquire Scorpion Therapeutics.

AstraZeneca: acquired Fusion Pharmaceuticals in a deal worth up to $2.4 billion."


***For me, the one takeaway that aligns with my thinking regarding Iovance is the following: "Focus on Late-Stage Assets: There's a growing focus on acquiring companies with late-stage or market-ready assets to ensure quicker returns and to mitigate risk."

Iovance will have both in the very near future. Amtagvi is already commercial and revenue producing, trials for additional indications (nsclc, endo) are closer to data readouts that will (hopefully) confirm that they're tracking to FDA approval, and foreign markets will soon green light Amtagvi.

Good luck to the longs.

FWIW, short interest down a bit: https://www.nasdaq.com/market-activity/stocks/iova/short-interest

Well... one of the better performing stocks today 😁

added 9000 shares at 3.76

The excess amount of headwinds on the biotech sector is definitely more than I ever expected. I doubt I'm alone in being this surprised by the flight to safety.

That said, Iovance is still executing on their plan and they have the money necessary to grow all the way to profitability. I may still criticize the timing of their cash raises, but I'm sure glad they got it done before all this recent turmoil and prior to these even uglier current conditions.

GL

QQQ, SPY, IWM have all breached the 200 SMA on daily. The market is in distribution with people moving to cash. Nothing is safe. XBI is well below 200 SMA with a bear flag. There were multiple 300k shares sells on IOVA as of 8:30AM today.

Great $IOVA-like play...Im in $IOVA and $ESLA now too.....ESLA @ $1.00s: Low floater just got a one year price target of $16 from highly regarded bio/pharma Boral Capital...Volume precedes price...Looking great.
https://finance.yahoo.com/news/estrella-immunopharma-inc-nasdaq-esla-214600801.html

NOTE: Incredible news release from 9/27/24:
https://www.businesswire.com/news/home/20240927717371/en/

In my opinion: If you are running a company you concentrate on the operations, manufacturing, sales, and pipeline. The things you can control. They don't sit in a room talking about share price which is completely out of their control. I don't think they care what the share price is at, even if its underwater. They're longer than anyone..

As for me, I just got here. So my DD is really basic. I see stock that has taken a beating for 1 year. The revenue now matches what I believe is fair value for the market cap. They have an extensive pipeline, which R&D is very costly. But they have a fair amount of cash on hand to sustain for the rest of the year. With potential of revenue increasing, but this is not guaranteed. From what other longs have said, management is not the greatest. So transparency and what they say will not always be what they do.

Building a position here now has less down side risk. I would say at most the market cap can decrease by another 30% from bad news, which would put market cap at $0.85 Billion or the SP would be at about $2.65. This would not last long, maybe wick down and V shaped recovery. It would be complete flush of retail.
But it's impossible to always buy the bottom and sell the top. It just appears to me that now is the time to accumulate as the potential of the upside is 50% or much much higher with patience. And when I say patience, it could be years.

Good luck

Hicham, if you're really bored, here's just one of any number (100's if not 1,000's) of scholarly articles on Clinical Trials and Insider Trading:

https://journals.indianapolis.iu.edu/index.php/ihlr/article/view/27435/25007

This one is only 57 pages long, so it's at least a quicker read than some.

My guess would be that the company can neither share nor deny if any or all insiders are currently able or unable to buy shares in the open market. If anyone here has a definitive answer to that question, I'd appreciate your sharing.

And if you're an insider that knows the good news that's coming and are blocked from buying additional shares, well, sorry. Maybe just move the information release date up a notch. That could make all of us a bit happier.


GL

Hicham, the one reason that gets kicked around quite often is that they can't buy in the open market due to MNPI - material non-public information. There's plenty of possible bits of material information that could be considered a reason to limit insiders from buying or selling - the data from clinical trials is one that easily could be the blocker at this time and is the one that I find most likely.

The company continues to imply that the lung data is good, but the data has yet to be fully released, it should be therefore construed as insider information that is currently MNPI. Interestingly, nobody associated with the trials, even the doctors and patients if they have the data, can use that information to trade.

A lot of the cases that make the news are the ones where some trading took place prior to bad news being released, but trading ahead of good news being released is also an SEC violation. That's one likely reason why Iovance was recently looking to hire an attorney with this type of SEC background.

If there's any risk that an insider purchasing stock in the open market prior to good news being released, there's no reason to take that chance. There will be time after the data release to buy shares, albeit, at a higher price most likely. But again, so what. If Iovance achieves the level of success that many of us believe is possible, it will still prove to be a multi-bagger.

GL

GMH / Badger, Thanks for replies and info 🤙

I am going to ask a very stupid question that was asked 100 times:

 At <4$, why isn't Wayne and other at the board buying heavily ? Why wouldn't you do that if your average SP is around 7 to 9?

Jean Marc may find a reason or two to raise cash in the months to follow. His last comment does not put dilution concerns to bed for the rest of us. I estimate they will dilute the float to 370-400M if they achieve profitability in 1.5-2 years. Getting to $10 requires 150% increase in share price and is a big fat dream now. Too many risks abound. If all goes well, and that’s a big “if”, it may get to $12 in 2026 for a $5B valuation and get bought for $24 assuming pembro plus TIL trial is positive and leads to full
Approval.
A big trump card is lung data. If positive and they get accelerated approval, then chance of bas price going to $24 increases and buy out closer to $30-40. Not sure when the Lung trial wraps up.

GMH, correct, and it wasn't a significant raise, but due to poor timing, it was more shares than should have been needed. If 2026 is the year of profitability (which all indications are it will be), then the amount raised is sufficient. I'm not going to defend their timing on capital raises, but with regards to the growth of the company, it's fully in line with what they predicted relative to how CAR-T rolled out.

That said, yes, it's now all about execution. The company knows far more now than even 6 months ago, but they need to prove it to get the market buying back in and to get our investment back to $10, $15, and ultimately $20+ per share. I look forward to the results of what I believe was a very good hire in Mr. Kirby. The growth over the past year was not as fast as I had originally expected even though it was in line with the company's guidance. The market, the sector, and now the tariffs are all challenges for the share price at this time. That too will change.

For now, I see no reason whatsoever to walk away from this investment and I've even added to my core position. We are at an inflection point. A lot of what was necessary to prepare the ATCs, train up the staff, educate the providers, and encourage the docs to try the next best option in cancer treatment is in place with the potential for exponential growth over the coming months and years.

I've been on the max pain train before and know full well that sometimes it's right at that moment when you want to throw in the towel that the fight is almost won and profitability truly is in sight.

Good luck to all of us who are long this stock, but I'd be rooting for this company to succeed even if I wasn't invested. I've lost enough family and friends to cancer already, so I look forward to Iovance being phenomenally successful.

Also, when I listened to the call, Igor said there were ATCs treating 2-3 patients per week ... and in some cases 2 patients per day. At that rate, 1 ATC could have produced all the infusions they had in Q4. Sorry, but there is a lot of puffery with this management team. Still think they maybe able to pull this off, but I do not trust their statements, only execution from here on out.

At the Stifel fireside last Nov, Igor said they had "clear line of sight to profitability without having to raise significant amounts of additional capital", yet, here we are, 3 months later with 22M additional shares issued. Management comments need to be taken with a grain of salt. They have lost significant good will with me over these statements that, shortly after they are made, it becomes clear that they are simply false. Tired of management hiding behind these safe harbor statements.

Which is also why Jean-Marc Bellemin, Iovance's CFO, on the TD Cowan chat on Monday was able to state that Iovance has $422 million available as of 2/26/25 and a cash runway that will take the company through the second half of 2026.

The very last statement in that chat was that no additional financing was needed at this time, even with the additional expenses of bringing staffing up to the level of handling 2,000 infusions annually and with some of the additional buildout expenses accruing for the iCTC to progress toward that capacity of handling 5,000 patients annually.

This is a bigger deal than many are aware. The risk of further dilution is extremely low for the next two years regardless what the naysayers contend. The timing of such sales is still a concern that I have. Foresight may not be their strength on when to raise cash, but that's a discussion for another day.

Good luck to the longs.

They used the ATM after quarter close but before earnings call so they quoted cash runway "as of 2/26" but the share count increase not reflected year-end filing.

Did the OS just jump 20M shares? Was that from an ATM previously.