badgerkid
3日前
OT, if the goal is to create an atmosphere to drive negotiations, that much has been accomplished regardless the math that got us there. Again and for the record, I try to report what I see, but my plan would likely have looked a lot different (but I'm thinking I may have been hated even more - that's a joke people, I'm very lovable).
Good luck everyone. Tough times for the time being but I do anticipate a positive outcome.
badgerkid
3日前
OT regarding tariffs.
The WSJ today on tariffs and various responses earlier today:
How Countries Are Responding to Trump’s Tariffs
Chelsey Dulaney
Reporter
Global leaders expressed shock at President Trump's tariffs, with some vowing retaliation and others hopeful there is still time to strike a deal with the U.S.
Adding to the confusion, the White House issued two different sets of figures for several countries on which it imposed tariffs, including South Korea.
Here's a rundown of the regional responses to the tariffs:
🇦🇺 Australia (10% tariff): Prime Minister Anthony Albanese said his government would try to negotiate with the U.S. to remove the tariffs, but won't join a "race to the bottom" by retaliating.
🇧🇷 Brazil (10% tariff): Brazil said it was considering its options for a response, including through the World Trade Organization, where countries can lodge disputes. Brazil's Congress passed a bill letting the government respond to foreign tariffs on its goods.
🇨🇦 Canada (no new tariffs; prior tariffs of 10-25% on some exports remain): Prime Minister Mark Carney said Canada would introduce unspecified countermeasures, on top of earlier retaliation.
🇨🇳 China (new additional 34% tariff): Beijing said it would take countermeasures, which it didn't specify. China retaliated against earlier tariffs with relatively modest measures.
🇪🇺 European Union (20% tariff): European Commission President Ursula von der Leyen said the bloc is working on new countermeasures, while finalizing tariffs in response to earlier U.S. metals tariffs. Still, she expressed hope there is still time for negotiation.
🇮🇳 India (27% tariff): New Delhi indicated it had no plans to retaliate, and said it would look for opportunities from U.S. tariffs. Its rate remains lower than others in Southeast Asia.
🇯🇵 Japan (24% tariff): Prime Minister Shigeru Ishiba pledged support for affected domestic businesses and said "we will continue to strongly urge the U.S. to review its measures."
🇲🇾 Malaysia (24%): The government said it wasn’t considering retaliatory tariffs, but would instead try to engage with the U.S.
🇲🇽 Mexico (no new tariffs; prior tariffs on some exports remain): President Claudia Sheinbaum said Mexico will announce on Thursday a comprehensive response to U.S. tariffs, but isn't pursuing "tit-for-tat on tariffs."
🇸🇬 Singapore (10% tariff) Trade minister Gan Kim Yong said the country wouldn’t invoke a dispute-resolution mechanism outlined in its U.S. free-trade agreement, or impose retaliatory tariffs, saying that doing so would add to costs for consumers and businesses.
🇰🇷 South Korea (26% tariff): Acting President and Prime Minister Han Duck-soo said Seoul would provide emergency support for the auto industry and others exposed to tariffs.
🇨🇭 Switzerland (32% tariff): The government said it wouldn’t impose countermeasures at the moment and would begin work on a solution. It also questioned the White House’s methodology, saying in a statement: “the calculations of the U.S. government are not clear to the federal council.”
🇹🇭 Thailand (37% tariff) Bangkok said in a statement that it hoped to negotiate with the U.S., and highlighted how it could be a key part of American “friend-shoring” strategies.
🇬🇧 U.K. (10% tariff): Prime Minister Keir Starmer said his goal is secure a trade deal with the U.S., stressing his government would keep a "cool head." But he said "nothing is off the table."
🇻🇳 Vietnam (46% tariff): Prime Minister Pham Minh Chinh said Vietnam should establish a rapid-response team to formulate a plan.
badgerkid
5日前
Cosa, this one has definitely been a challenge. I expected a little drop after the approval and that big run-up following. I did sell a few shares in that $16-17 range, but I started buying shares back once it dropped back below $14. Then I just kept adding with each additional drop.
I chose to start selling puts as a strategy of picking up a few dollars while risking (willingly) having to buy some more shares at lower prices if they got put to me. I was targeting $8 and $7 strikes on the put side. I fully expected that IOVA wouldn't fall that far given what's ahead for this company thereby expecting I'd simply be keeping that put money that was paid to me. We all can see what the rest of that story turned out to be.
I had quite a few shares put to me with net costs of $5-7 (based on selling $8 and $7 puts with the associated premiums that I got paid). Again, I was not anticipating a further slide below $5-6 when the sector started tanking and yet here we all are.
So, Iovance's future looks very good. We can all complain about how the company poorly executed their cash raises and the timing of those stock sales, but the company is growing, revenues are increasing, they've shored up their staff with a new CCO who seems to have the necessary chops to really move the needle, and a number of positive events are likely over the next 6-9 months. I'm not calling this a bottom, but I can see it from here.
I will likely add a few more shares in the coming months. I'm holding a healthy core position. And when we finally see a reversal in this sector, I will likely trade IOVA along with a few other companies just a bit more as the market and momentum dictate and some positivity returns to the biotech sector.
Good luck. Looks like many of us plan on being here a while longer.
As I like to say, your money, your rules. Do your due diligence and make your own decisions on when to buy, sell, hold, or even avoid.
GL
Badgerkid
badgerkid
7日前
Sunman, that's a silly and inaccurate use of Newton's 3rd law. By you're interpretation, that would also mean that every move down will be followed by a move up. I don't disagree that the dilution has been poorly executed, but I'm not so naïve as to think that this is all collusion with big pharma. To what end?
Everyone has the same opportunity to buy on the cheap right now. Some of us bought early and often at higher prices (I wish I had been more patient), but such is the danger of investing in early commercial stage biotechs. The logistics were far more involved than many of us understood which is, in part, the reason the stock price is currently languishing as the company refines the process. The good news is that many of those early bugs and concerns have been resolved. But the entire biotech sector also took a dump and IOVA got caught up in that negative sentiment. This too will correct in time.
There's over $7 trillion sitting on the sidelines, some of which is waiting for reasons to re-enter the stock market. Lots of good in front of us regardless the current position we find ourselves in.
Good luck to the longs.
badgerkid
2週前
When will the market turn? Here's food for thought:
"As of March 5th, 2025, a record-breaking $7.03 trillion is held in money market funds, representing a significant amount of cash that investors could potentially move into other assets.
Here's a more detailed breakdown:
Record Highs: Assets in money market funds have reached a record high of $7.03 trillion, up from $4.73 trillion last year.
Money Market Funds as a Safe Haven: Investors have flocked to money market funds, seeking the safety and liquidity they offer, especially with the rise in interest rates.
Potential for Movement: This large sum of cash held in money market funds is often referred to as "cash on the sidelines" and is seen as a potential source of capital that could flow into other asset classes, such as stocks, if conditions become favorable."
To bring that money back into other investments like biotechs may depend on a change in interest rate expectations, market sentiment, or overall economic conditions. There's quite a few very good biotech companies selling at very low premiums right now. Iovance will rise as the sector rises again, but it also has many catalysts that likely will help drive share price over the coming months right through the end of this year.
Good luck to the longs.
badgerkid
2週前
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.
jondoeuk
2週前
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
badgerkid
3週前
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
GMH*
3週前
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.
badgerkid
3週前
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.
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