Iovance Biotherapeutics Inc (IOVA) 옵션

Had to ignore that obstinate fellow. Looking forward to ASCO, I suspect we’ll get a glimpse at PD-1 knockout IOV-4001 data from GM1-201 and perhaps another data cut from cohorts 1A and 3A from COM-202. The really exciting data (registrational cohorts from LUN-202 and preliminary data from END-201) won’t be until September and November.

https://seekingalpha.com/article/4744274-northwest-biotherapeutics-all-is-not-well-with-this-one
You trust this shitty article written by a fake Ph.D.? I had several rounds of exchange with the author and that's why I called the author a fake Ph.D.

Let's see what will happen to $IOVA and $NWBO this year and I'll leave for other boards.
Good luck to your investment.

dstock, regarding the company you continually reference on Iovance's message board, you said "Its approval could be next month/quarter or even next week." Approval? Explain. I'm likely off base with some of what I'm about to say, but if approval of a new biologic was imminent, wouldn't it be on the FDA calendar? Or certainly the company would want this information public so as to further secure financing since they're virtually broke.

I've got to tell you, there's a lot of questionable information when looking into Northwest Biotherapeutics. I've tried to limit this conversation because it's so far removed from anything to do with Iovance, but at this point you've persisted so allow me this one word - scam. That's just how I see it. I see no reason to consider it as an investment and it has nothing to do with Amtagvi, an approved product for Metastatic Melanoma.

https://pmc.ncbi.nlm.nih.gov/articles/PMC10296384/

On the rare chance that your product receives some approval in the near future, an approval that I can't even verify is in the works, it's still not going to be a competitor for Amtagvi, so why do you continue to post over here when you are so completely off-topic?

Though this article is somewhat limited, it's a relatively well written piece: https://seekingalpha.com/article/4744274-northwest-biotherapeutics-all-is-not-well-with-this-one

And as for public information, here's just a quick summary of what can be expected or should be available:

"While the existence of an IND application itself is generally not publicly disclosed by the FDA unless previously disclosed, the FDA does make certain information related to INDs and clinical trials publicly available through resources like ClinicalTrials.gov and FDA's drug approval reports.

Here's a more detailed explanation:

IND Application Confidentiality: The FDA typically treats the existence of an IND application as confidential commercial information and won't publicly acknowledge it unless it has been previously disclosed or acknowledged by the sponsor.

Public Disclosure of Clinical Trials: The FDA Amendments Act of 2007 requires registration of "applicable clinical trials" (with some exceptions) in ClinicalTrials.gov, ensuring public access to information about certain clinical trials, including access and results.

FDA Drug Approval and IND Activity Reports: The FDA also provides access to reports on new drug and biologic approvals, including IND activity reports, which can offer insights into the drug development process.

Freedom of Information Act (FOIA): Individuals can request information from the FDA through FOIA, including access to IND applications, but the FDA must balance public interest with the need to protect confidential information.

Other Public Information: Information about a drug development program, including the registration of a nonproprietary name, publication of results in academic journals, filing of patents, and reporting development milestones in commercial filings, can also facilitate public disclosure of a drug development program.

Expanded Access Information: Expanded access information is required to be submitted to ClinicalTrials.gov when there is an applicable clinical trial for an investigational drug or biological product and expanded access is available under FDA regulations."



Finally, my point remains: Your continual effort to promote another company's stock and potential product is of no value to this board for all the reasons stated.

I don't know how to be any more clear. You're posting on the wrong board and much of your posting along with a couple others is some personal war that you're all waging with each other and provides no value to those here wanting to discuss Iovance.

IMHO of course.

Would you agree that Wayne Rothbaum joined IOVA because of science?

I suppose he will leave also because of science.

Not even same IND... so no overlap what so ever.

There is no SEC rule that requires the company to PR the BLA submission to FDA.

Pretty pictures, but when is the PDUFA date?

KIPK, that sounds like a problem for those boards and their moderators to deal with and I agree that it's unfortunate. Become a board moderator over there and try to limit some of that noise if it violates iHub's TOS. Moderators only have a little control, so it's not a guarantee that you'll stop the behavior.

Trying to balance healthy discussion while preventing some of the nonsense that you all are engaging in here and on other boards is a challenge to say the least. But by telling me that you're here to cause problems and disruption on this board just because someone is causing problems on another board is absurd, is it not? Maybe even childish?

Just go to the other boards you talking about to find out how many of the so-called Iovance Investors posts degrading stuff against the tickers on those other boards..

How could the discussions be off-topic? DCVax-L also falls in the category of cell therapy, does it not? Its approval could be next month/quarter or even next week. There could be hundreds of mediocre treatments. But in terms of revolution, there is only one and that one is DCVax-L.

The first DC vaccine was developed by the Nobel Prize Winner Dr. Ralph Steinman for his discovery of dendritic cells. His version of vaccine can only present one tumor-specific antigen to immune system. How many tumor antigens can DCVax-L present to immune system? Hundreds!

That's why for the most difficult cancer the cancer cells (blue dots) can be significantly reduced two weeks after the initiation of the vaccination.

Potential competitors? There could be hundreds in time somewhere in the more distant future. But currently approved competitors? Zero.

This is why such discussions are viewed by many on message boards as off-topic. We could spend hours discussing all kinds of cancer treatments throughout all of time and we could also discuss the thousands of trials that are currently occurring around the world. There are plenty of message boards for those types of discussions as well.

Again, this is an Iovance board for discussing specifics of this company. If you have a product that is currently up for FDA approval and you believe it's directly going to compete with Amtagvi, I'm certain we'd all want to hear about it. Is that the current case? No. Point made.

Tell me where we should draw the line?

You know the answer to that question as well as I.

I assume it is always good for Iovance investors to know something about potential competitors.

This is an Iovance board. Please refrain from promoting other companies and tickers on this board. Many recent posts and discussions are off-topic for this board.

iHub has boards dedicated to those other companies and tickers, so that's where those discussions belong. Feel free to invite others to those boards, but refrain from off-topic discussions here.

This board needs more Iovance discussion.

Thank you.

You always do cut-and-paste. You really don't understand what I was talking about. Read the following paper and tell me how immune memory can be triggered.

Dendritic Cell Vaccines for Brain Tumors
https://pmc.ncbi.nlm.nih.gov/articles/PMC2810429/

Amtagvi can only activate mostly CD8 t-cells to eliminate cancer cells and more importantly it cannot trigger sustainable t-cell infiltration into tumor site after the termination of the treatment.

In this paper, researchers at the US NCI (Surgery Branch) looked at which T-cell phenotypes corresponded with response after adoptive cell transfer. They looked (pretty much) at the infusion products given to patients with metastatic melanoma, who either had a complete response (disappearance of all signs of cancer) or disease progression. To cut a long story short, a ''stem-like'' phenotype population (CD8+CD39-CD69-) were significantly higher in responding patient products. [1]

The literature also supports the presence of such a ''stem-like'' phenotype population correlating with responsiveness to ICB [2]

From one IOVA poster: ''Importantly, the novel process led to a pronounced increase in the tumor-homing marker CXCR3 as well as TIL polyfunctionality as evidenced by increased co-expression of IFNy, TNFa, and IL-2 while showing an enrichment in genes associated with stem-like cells and a reduction in exhaustion-associated genes.'' [3]

Refs:
1 https://www.science.org/doi/10.1126/science.abb9847
2 https://www.cell.com/cell/fulltext/S0092-8674(18)31394-1
3 https://ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.2542

Neoadjuvant treatments and the emerging mRNA therapy will cut down the number of patients seeking Amtagvi as 2nd line treatment significantly.

Amtagvi can only activate mostly CD8 t-cells to eliminate cancer cells and more importantly it cannot trigger sustainable t-cell infiltration into tumor site after the termination of the treatment.

Hedge your investment. Did Joseph Edelman sell -4,505,443 shares last quarter?

Average analyst estimates are $83.4M for Q1. If there is no IL-2 stocking, that would require about 140 infusions. I think Q1 will be a big miss on revenue. I am hoping to get about 115 infusions and maybe $2M-$3M in excess IL-2 sales/stocking. I do think we may see the high $2s on Q1 results.

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