Iovance Biotherapeutics Inc (IOVA) 뉴스

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.

Took an initial small position end of last week....I think we have time to accumulate before the start north....some positives said on cc and feedback from Boston....

SB, other good takeaways from this morning's fireside chat: 2025 guidance is reiterated, 70 ATCs all ramping up, Jean-Marc even stated "very confident about our guidance" which are not words that get used if there's any thought/chance of missing the mark. To me they're signaling a beat is expected.

Q1 is likely going to be flat, the CDMO is going to do some maintenance during a short shut down during Q1, the iCTC can currently handle up to 2,000 patients per year but needs to add additional staffing for such an amount. They're currently staffed for handling up to 1,200 patients annually.

They are building out for up to 5,000 patients per year at the iCTC, which is currently underway and will probably take 2-3 years to complete the expansion.

$422 million currently in the vault providing a cash runway sufficient for the 2nd half of 2026. Jean-Marc at the very end of the call said he doesn't see any reason currently for additional financing. That should put much of the ongoing dilution concerns to bed.

https://ir.iovance.com/events/event-details/td-cowens-45th-annual-health-care-conference

Thanks for your thoughts. GL

Let's try to keep this board about Iovance. If you have information about other companies that are in combo trials with Iovance, great, but please don't use this board to promote other stocks and investments not directly related to Iovance. Some off-topic is fine from time to time, but we continue to see posts that have nothing to do with an investment in IOVA.

Thank you.

You are a biologist? Right. You must have a better understanding about immunotherapy on molecular level. There are over five hundred clinical trials related to the use of dendritic cells in treating cancer. But I am certain there is only one type of treatment that can make dendritic cells present hundreds of tumor-associated antigens to t-cells. You know that there are immune cells that can only be activated by antigen-presenting cells like dendritic cells.

If you have interest, watch the following presentation, go through the combination trial with Merck as one of collaborators, and read the paper.

But most importantly, download the data related to the paper and take a look at it yourself. The variations of over 36 thousand genes were measured pre- and post- treatments. All those highly overexpressed mutated genes went through significant changes resulted from the treatment. You could think of me as a liar. But data don't lie.

Here is the pipeline of precision medicine from Genetech for various types of cancers. You know how precision medicine works, don't you? All those targets (highly overexpressed mutated genes) which can also be founded in three types of brain tumors subjected to significant changes after the treatment of DCVax-L + poly-iclc.



https://clinicaltrials.gov/search?term=%22dendritic%20cell%22%20%2B%20tumor&aggFilters=status:act%20com



Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma
https://clinicaltrials.gov/study/NCT04201873

TLR agonists polarize interferon responses in conjunction with dendritic cell vaccination in malignant glioma: a randomized phase II Trial
https://www.nature.com/articles/s41467-024-48073-y

https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE237562

4 points from the TD Cowen fireside today:

- management very clear about strong demand!
- seasonality and ICTC maintenance throttled Q4 and Q1.
- ATCs are the bottleneck and IOVA is helping the ATCs get operational and ramp up, as well as focusing on community centre efforts.
- most excitingly, the company is working towards improving selection of TILs prior to expansion. This drastically improves treatment quality and reduces ex-vivo expansion time!

Fact is, since Approval of TIL therapy for Melanoma about a year ago, SP has dropped by about 80%..

What does it say?

Says, it need help & that help IOVA doesn't have!!!

You are out of Suit, theory... LOL

Quick.. post something.

This p is sinking.....

Oh so you are dstock's other alias. Sorry nwbo is a scam and their phase 3 trial is not approvable in its current format. Rug pull where? I just added. I live Rent free in your lil mind......

Monday morning, 9:10 am EST, Mar 3, 2025: TD Cowen’s 45th Annual Health Care Conference

https://ir.iovance.com/events/event-details/td-cowens-45th-annual-health-care-conference

theorysuit - Man, its tough to be stuck when rug pull is in progress & continues....

As mentioned, this needs DC Vaccine...& without it, its just another technology hype IMO

Reflections.. I see this getting diluted down from 330 Million float to 390 million float by early 2026. They may or may not get profitable in 2 years as burn rate remains high and demand is anemic. Broader market conditions are expected to get worse in 2026. If they miraculously achieve $1B in revenue by 2028, the stock may be valued at $3-4 billion. With 390M float, that would be $10/share. If buyout happens, may get $20-24/share for $10B buyout. Lots of “if’s” here. No point being in love with this stock. Risk is very high and management keeps diluting shamelessly.
For comparison, Acadia. has $1B in revenue, $700 million cash and has market cap $3B today.
Why would IOVA be at $3B market cap any time soon???? Only if lung study is positive and combo study is a big success. Two big ifs.

Yeah you gotta do some reverse engineering based on the 10-ks and info within it. I want to see the updated open short interest at the end of february to confirm. But this walk down with this high volume couple of days provided short cover.

theorysuit - what are you babbling about. You cant force a success here...

This is like a one arm fighter, cant succeed on it on imo...

Needs help from the powerful DC Vaccine Technology.....

Will keep dropping until all gone imo....

Something not discussed often is the amount of trials and patients actively enrolling. It’s a hefty part of cash burn and resources. Once TILVANCE-301 and LUN-202 are finished, it’s going to reduce a lot of that cash burn. END-201 and GM1-201 are small trials. As will be COM-202-3D.

GMH, I won't disagree with that, but I do think a spike in Amtagvi sales is right around the corner where some exponential growth will start to occur, but no reason to guide for that as of yet. Once more ATCs earn their stripes, we'll see that accelerated growth. I think Q1 to Q2 growth will take a lot of investors by surprise based on comps with CAR-T and such (Kymriah, Yescarta for example). I do think Iovance will be able to update and increase guidance after Q1 (don't know if they will).

Back to your main point, timing of cash raises has been terribly timed imo.

That’s an understatement. They should’ve been hammering it like hell throughout approval and for a few months after.

These guys have to be the worst at timing their stock sales.

I think the latter. The average was mid 5s. They’re going to dilute once or twice more before they’re at breakeven which I think is late next year.

ATCs are slow to ramp up and it’s going to take a year before the existing 70 are all at peak operations. Only a few of them currently are. That’s why I think the first half of this year will be rough. They can only be efficient when they’re manufacturing alot of TILs. They can have the capability and the demand but without slots it doesn’t work.

Thankfully all the US + ex-US ATCs will rely on manufacturing at the ICTC and as it scales up the efficiency will scale with it.

And of course by then frontline will be around the corner to secure sufficient demand for profitability for many years.

I’ll wait to talk about it later but I’m quite bullish on LUN-202 data as well.

Thanks - so 22M shares sold since Jan 1, Hope it was early and they sold in the 7+ range before the stock tanked... or maybe cause the stock to tank.

Ah GMH they did use ATM. Share count is 327M and their runway is until end of 2026 now.

What a rough yesterday and the hangover continues today. My broker texted me after the earnings release to say that Iovance had put out a problematic quarter. I responded with "why? they beat revenue, reiterated guidance and cash runway is good for another year."

His response was "they are not meeting their data points, that is all that matters"

what does this mean. INFUSIONS... not enough growth and they are being punished for it until they can prove otherwise.

street was expecting way more than the 95 they reported, i cant remember exactly but they were wanted/expected 107-120?

response below is from stocktwits - 6MILFHUNTER9

Street consensus for Q1, Q2, Q3, Q4 infusion numbers are likely 141, 176, 216, and 247 patients respectively.

What mgmt is guiding from this earnings call is infusion numbers of 107, 142, 184, 227 respectively.

Why didn't they disclose Q1 infusion numbers at this time?

They likely only had around ~71 infusions.

When? Where do you see that? Yes, they have an ATM, but I do not think they hit it. Share count as of 9/30/24 was 304,620,000 and share count as of 12/31/24 was 304,890,000, most likely increase was stock grants. Any raise would have had to occur in Jan/Feb, but I do not see any statement saying that.

They had an open ATM that they hit. same thing as an offerng

GMH, check out page 1 of the 10-K at the bottom. https://ir.iovance.com/financial-information/sec-filings

"The aggregate market value of the registrant’s common stock held by non-affiliates on June 30, 2024, the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $2.1 billion. Shares of common stock held by directors and executive officers and any ten percent or greater stockholders and their respective affiliates have been excluded from this calculation, because such stockholders may be deemed to be "affiliates" of the Registrant. This is not necessarily determinative of affiliate status of other purposes. As of February 21, 2025, there were 327,876,694 shares of the registrant’s common stock outstanding."

Not certain if this answers the question specifically as I haven't dug any further.

I have seen several posts stating that they raised cash thru a dilution, but I cannot find anything to support that. The share count increased modestly (under 1M shares) and I did not see any statement that they raised funds since year-end. Can someone please point me to the source where you are seeing dilution?

Theory, well, most cylinders anyway. There's a few cylinders that could be firing a bit better, but they're definitely working on them. Their new Chief Commercial Officer is already correcting for a few things that were lagging. GL

Largely agree with this. The 2027+ outlook is incredibly bright. To me this is a pseudo clinical commercial stage company with some income from 2L MM but it’s frontline MM, NSCLC, and endometrial that are the future. And most importantly IOV-5001. I have no optimism until lung data but I’m also not remotely worried here. I also didn’t over extend myself and so I don’t ever need the money I put here. And I’ll be slowly adding more as well.

The only way IOVA succeed is to arm it with DC Vaccine combination!!
Otherwise is just a hype IMO....

What changes investor sentiment more than anything? Decline in share price. Got a lot of arm chair QBs trying to justify the decline in price and blaming execution. The last time i checked the company is firing on all cylinders.

You gotta ignore that noise.

FWIW, I did add a few shares today below $4. For everyone that wants to blame the shorts, why do you now blame the company?

This was a very successful short attack, conditions were perfect for such an action. Negative sentiment in the sector, Iovance mostly met their guidance but didn't beat investor's expectations, 2025 guidance wasn't raised (yet), perception/belief that the company is not growing fast enough, money raised through dilution (somewhat expected and predicted, but still not a positive for most investors), but the short attack was happening before the market went into after hours trading and the full report was known.

I'm going to say this was fully preplanned and orchestrated. Not happy, but such is life in the stock market. Shorts may have seen a chance to start covering especially if they've arrived at the belief that Iovance is going to succeed. If that's the case, they needed to act aggressively and in unison to shake loose a lot of shares.

Good luck to the longs. I believe Iovance still has a very bright future, cancer patients will benefit as a result as will we as investors.

Yeah i'm in agreement. They are setting targets and knocking them down. It sucks having connected guy controlling the stock, but it what it is. You see this liquidity yesterday and today.......this is exit liquidity for the large 60M plus short interest. I think the worst is behind us here.

did you not respond to my post???

You are in my head? Don't flatter yourself. I have no room for trash.