badgerkid
2 일 전
A recent SA article: "Iovance Biotherapeutics: Only For The Brave" Apr. 22, 2025
https://seekingalpha.com/article/4776750-iovance-biotherapeutics-only-for-the-brave
The takeaway:
"Verdict: Despite the company’s aggressive use of its ATM facility, its inability to turn a profit until likely FY27, and a possible (albeit unlikely) return to the capital markets sometime in FY25, the selloff feels somewhat overdone.
For the avoidance of doubt, there are plenty of TIL competitors, but Iovance is the clear leader in the space, certainly flooding the zone with trials to cover all lines in melanoma and NSCLC. Amtagvi is in a solid position to both move into 1L melanoma and expand into NSCLC, providing it an opportunity to be a blockbuster therapy as early as FY27, providing Iovance with multi-bagger potential at current levels.
However, IOVA remains a 'speculative buy' only for aggressive investors, given the negative current investor sentiment around the overall market. Especially around small, unprofitable biotech companies and other 'high beta' parts of the market. That said, I hold a small position in IOVA via covered call positions for the additional downside risk mitigation."
The article is not offering anything specifically new, but I was intrigued by the admission of taking a covered call position - a seemingly lower risk approach to this investment. I've also heard from others that are buying up calls that are 6 months or more out from today, but at the current low share price, I'm a fan of just buying the stock and holding for what is likely to be a 1-2 year big gainer as Iovance moves towards profitability, or doing as this author did and buying shares and selling covered calls to gain a little value during this waiting for the markets to recover period of time.
The article discusses share price history, but that is somewhat lacking in detail as it doesn't discuss the ramifications of dilution while funding ongoing trials nor the company's changing enterprise value. For me, my focus is forward looking from where we are currently with share price, regardless that many of us who invested over the past several years are surprised by how low this share price has gotten along with many other good quality companies in the biotech sector.
Good luck to the longs.
GMH*
5 일 전
They can (and most likely will) file for accelerated approval which would reduce the review time from 10 months to 6 months. The bigger issue would be to make sure enrollment is large enough so they void the MM issue that required the Cohort 4 trial (pushing out approval by 2+ years). Cohort 2 was 66 patients and Cohort 4 was supposed to by 75 (but ended up being 87). Everyone is saying the interim target is 80 but I think they will target the full enrollment of 120 for that specific reason. Only benefit is that Amtagvi/Proleukin is already approved treatment so the toxicity issues already known, so really only a question of efficacy, not safety.
Yes, they could file in other jurisdictions first, but they won't because it is easier (at least historically) for others to follow FDA assessment (and pricing better in US), but almost all countries do their own review process.
badgerkid
2 주 전
FWIW, short interest over 75 million:
03/31/2025 75,186,511
03/14/2025 67,304,707
02/28/2025 59,585,491
02/14/2025 63,597,563
01/31/2025 63,909,963
01/15/2025 61,984,016
I assume there's been some covering over the past week. Trading volume suggests this as well. Trump followed through on his tariff promise and shorts likely increased ahead of the deadline fully expecting it to happen.
IMHO of course.
badgerkid
3 주 전
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 주 전
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
3 주 전
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
3 주 전
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
4 주 전
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
1 월 전
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.
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