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Iovance Biotherapeutics Inc

Iovance Biotherapeutics Inc (IOVA)

11.31
-0.41
(-3.50%)
Closed April 20 4:00PM
11.29
-0.02
(-0.18%)
After Hours: 7:59PM

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IOVA News

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IOVA Discussion

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GMH* GMH* 2 hours ago
On the Corporate Update deck, they said approximately 50 ATCs 90 days after approval so that would be end of May. They are now at 37 as Duke Medical in NC was added late Friday (4/19). I think 50 will not be too difficult, especially if other Cancer Centers are asking to become ATCs.
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GMH* GMH* 2 hours ago
I assume you intended to say Q2 and Q3. There will be minimal revenue in Q1 since TIL revenue is only recognized upon infusion which would occur at around day 34 post surgery which puts the first patient into Q2. There will probably be some revenue as ATCs stock IL-2 in preparation, but think that will be minimal... maybe $4-5M.

Your Q2 numbers are aligned with what I have at about 90-120 patient starts. Your Q3 numbers implies a total billings of 360-480 patients. That does seem high to me but would be 2.4-3.2 patients per ATC per month, so not impossible. IOVA indicated an annual total spend of $320M-$340M (which would include manufacturing costs) or $80M-85M per quarter, your numbers would make IOVA extremely profitable at Q3. I hope your numbers are correct, but just wanted to temper expectations a bit.

As an aside, the 12 analysts tracking IOVA do have them as break-even by 2026, which I think is very conservative. Break-even is the holy grail for any biotech as it means limited dilution risk. Break-even should occur at about 160-170 patients per quarter or a little over 1 patient start per ATC (assuming 50 ATCs) per month.
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badgerkid badgerkid 19 hours ago
Welcome to the board, neptunesashimi.
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badgerkid badgerkid 19 hours ago
Inducement grants awarded. Here's the cool part:

"... today announced that on April 18, 2024 (the โ€œDate of Grantโ€), the Company approved the grant of inducement stock options covering an aggregate of 79,310 shares of Iovanceโ€™s common stock to thirty-seven new, non-executive employees..."

That's 37 new employees. Just saying.

https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-reports-inducement-grants-under-17
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neptunesashimi neptunesashimi 22 hours ago
Firmly believe in IOVA's fundamentals
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neptunesashimi neptunesashimi 22 hours ago
Nice DD, GMH
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neptunesashimi neptunesashimi 22 hours ago
Nice ddm GMH.
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MN Gopher MN Gopher 22 hours ago
GMH, good analysis. To me it should land Q1 between 45 & 60 million.
Q2 between 180 mil & 240 million

Lets see how it plays out in 2024 to have a good idea where 2025 takes us.
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badgerkid badgerkid 1 day ago
GMH, thank you for sharing. I concur.
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GMH* GMH* 1 day ago
I do not think the company will give any guidance until the Corporate Update for 2025 (next Feb). I think they will only report out actual starts (thru end-April for Q1, end-July for Q2, etc) which does give some clarity for next quarters' revenue.

In regards to my estimate, since there is no new data, I have revised my starts to about 115 thru April 30. This is based on the following assumptions:
1) Linear ramp based on starts thru Feb (approximately 1.55 patient starts per ATC per month) for the 30 existing ATCs (assuming no adds from the 6 additional ATCs thru April)
2) Fred's comments upon approval and re-iteration during Cowen fireside that the 20 patients were "a tiny fraction of the bolus".
3) Build of of the iCTC for a capacity of 2,000 (165/month) plus a vendor back up because they did not want to end up in a situation similar to the CAR-T roll out where initial demand outstripped capacity.
4) ATCs investment in time and resources (200 hours for the lead physician + support staff training plus infrastructure) is a big commitment from the Cancer Centers so they would expect some demand before committing to becoming an ATC.

The Q2 analyst revenue projections are 5.2M (low), $28.6M (average) and $60.6M (high). This equates to about 10, 58 and 122 starts thru April. We are already way over the 10 thru Feb and only an additional 38 to get to the average. I am confident that we will blow away those 2 and should be closer to the top-end. I was playing that expected pop using some options, but this continued weakness may not hit those strikes even with a substantial beat.

This weakness continues to surprise me. I will probably add some additional lower strike options right before earnings if this weakness/lower level continues.
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badgerkid badgerkid 1 day ago
Surfkast, we're all down from the high. I wish you good luck and a nice run up soon, but this is still all about earnings going forward and the time it'll take to book those earnings IMO. The entire sector has not been our friend ever since we hit the high as did the sector funds. It's all down.
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badgerkid badgerkid 1 day ago
GMH, have you got any updates on your expectations for guidance regarding Q2, 3 and 4?

I think we're at 36 ATC's currently with the goal of 50 by end of May or June? Somewhere around there.

Thanks in advance.
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surfkast surfkast 1 day ago
Been retired and still up but down from the high big time here.
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GMH* GMH* 1 day ago
Right now I am pretty much all-in on the market (as I was during all of my working career). In retirement, I set up 3 years worth of expenses in a CD ladder (and can extend to 4 if I use my dividends). This will allow me to ride out most of the normal downturns. Political events are always short lived... remember Russia/Ukraine was only a 3 month market downturn and that probably has more ramifications that the Middle East.

Over the long term, a stocks fundamentals will come thru. It is just important to know why you own the stock and when that thesis no longer holds (i.e. price target met or facts change). Stock price at any given time is impacted by a lot of factors but over time, it is the stock fundamentals that matter. Buffet's voting machine vs weighing machine quote.
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badgerkid badgerkid 1 day ago
Surfkast, all markets are affected by uncertainty. People move to safety when things look scary, rational thought is affected by fear. The media will hype even the smallest of negative events, but imagine if the Middle East escalates. Oil goes up, many stock prices come down, fundamentals take a back seat for awhile.

Sunman knows that rebounds for the good companies will happen as certainty returns, but keeping dry powder allows us to pick up a few good companies on the cheap (or cheaper at least) during those times of uncertainty.

If you're of retirement age, there's nothing worse than a negative market sentiment when you want to sell down your positions. If you're younger, these are the times to build portfolios using sound fundamentals.

Good luck. Sunman knows of what he speaks, or so it has always seemed to me.
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surfkast surfkast 1 day ago
I don't see how a cancer cure is affected by something over there.
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Sunman88 Sunman88 2 days ago
A bumpy ride ahead is more likely now for the next several months.
Save dry powder. It will come in very handy.
Sounds cryptic, but tje axis of evil is using the playbook to incite the Middle East and prolong uncertainty and anxiety.
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surfkast surfkast 3 days ago
I held and missed a very nice score. Still up and waiting.
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badgerkid badgerkid 3 days ago
Gopher shared a short article with me and asked that I share it here (some guy named Warren Buffett). I think the message is timely for some of us (definitely me) who get frustrated that the stock price isn't always in line with our fundamental thinking about any particular company that we find ourselves invested in. Thanks Gopher.

https://www.msn.com/en-us/money/savingandinvesting/warren-buffett-criticizes-stock-market-forecasters-make-fortune-tellers-look-good-labels-them-poison-to-be-kept-locked-up/ar-BB1lHZsX?ocid=msedgntp&pc=SMTS&cvid=a5158db669ed48ec80ca132d1902730c&ei=97

It might be a little sales pitchy, but there's some meat in there as well.

Good luck to the longs.
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GMH* GMH* 3 days ago
I would suggest not measuring yourself against perfection (buying at the low and selling at the high). It will drive you crazy. The only points that matter is when you buy and when you sell... ignore the lower lows and higher highs in between. If you made a good return from when you bought to when you sold, it was a good trade/investment.
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surfkast surfkast 3 days ago
need this to move back up. On paper I am down big time since the high.
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retired early retired early 3 days ago
Onward and upward. :)
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surfkast surfkast 4 days ago
We shall see. I am hoping this is turning back up. This is down like 40% from the recent high. Being retired for many years I am having 2nd thoughts about not selling around $15.
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GMH* GMH* 4 days ago
I think those are driven my big "buy/sell at close" orders that come mostly from mutual funds that had big redemption orders coming in that day. They need to raise funds so sell using "at the close" orders. I think these can also come from hedge funds that do day trading and want to close their position overnight.
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badgerkid badgerkid 5 days ago
Surfkast, I don't think it was a "dump". It looks more like an accumulation of smaller purchases that was delivered to a buyer at the end of the day and/or in the after-hours. Might be a fund accumulating again, it might be a short allowing the MM to accumulate during the day without chasing shares and then delivering after hours, it might just be a private customer with the same deal.

It certainly doesn't look like a single position being sold off or I would expect to see the price down even more than what we got today which was in line with the overall sector. Iovance seemed to actually hold up just a bit better than is typical on a down day like today.

The analysts' target prices are for Iovance over the next year, not the next week or even the next month. We've got to see earnings in the Q2, Q3, and maybe even in Q4 before we really see some upside (meaning something over $20) unless the overall sector turns positive again which will float all boats.

Iovance got a nice bump post approval but then got stuck with the overall sector which has been nothing but down since the high back on Feb 28th. Look at the charts and it becomes very obvious what's been happening. No news means no support when the market turns negative, but IOVA is still trading higher relative to the sector post-approval then it was pre-approval.

My explanation is somewhat lacking, but I hope I'm making the point that nothing seems unusual with that large block trading hands today.

The entire block of 1.6 million shares along with another 400K block traded at $11.89 in the after-hours which seems to fit with my explanation.

IMHO
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surfkast surfkast 5 days ago
Looks like someone dumped a big block today. Why if this has so many buy recommendations?
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52172 52172 5 days ago
Whats the 1.6m trade?
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badgerkid badgerkid 5 days ago
Feb 16, 2024 day of FDA approval for Amtagvi, high for IOVA was $10.44. (news came out late on a Friday which dulled the initial price response).

First full trading day post approval IOVA high was $13.41, and XBI high was $93.84.

Feb 28, XBI hit it's one year high at $103.52 the same day that IOVA hit it's high of $18.33.

Today XBI is currently $87.55, down 15.4% from it's recent high and IOVA is currently $12.05, down 34.3% from it's high on the same day that XBI hit it's one year high.

IOVA is trading 2-3x XBI (that's the correlation).

It's been said by many of us who are bullish on Iovance that this is not a short term play. Revenues will drive price, the price will not run-up significantly until such information is verified or additional good news comes in on other items such as foreign market approvals, positive trials and PDUFA dates being established for other TIL therapies for other solid tumor cancers.

Of course, a buyout at any time is possible, but more likely after a few Q's of reported earnings from Amtagvi.

IMHO
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MN Gopher MN Gopher 5 days ago
Thankfully it appears Badger is spot on with the Middle East issues this past weekend.
Luckily not a 9-11 outcome for Israel, a huge shoutout to our friends in the region. What a hot mess this region is day in & day out.
For now, As Badger said its Middle East 101 & we should luckily get past a market meltdown like we had in the 9-11 debacle & such a huge loss of American lives.

Stay Strong Longs, Much Brighter Days Lie Ahead!
#CureCancer
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GMH* GMH* 5 days ago
We are still at 33 approved ATCs. I do think this will be back-loaded because of the time commitment for training that is required to become an approved ATC.
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badgerkid badgerkid 7 days ago
Slow down, MNGopher. These are all measured responses with intent to show force without a likelihood of much damage. It could escalate, but it will more than likely just be business as usual in the Middle East (as sad as that may be). When you announce what you're going to do as Iran did, the intention is more of a warning and retribution as opposed to all out war. It's a dangerous game to play, but it's not that unusual in that part of the world.

Agreed, it does add volatility to the markets, but just how much is hard to say. This is Middle East 101 to give it a college class moniker.

My hope is that our friends and family over there stay safe.

Badgerkid
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MN Gopher MN Gopher 7 days ago
Well everyone, the markets will be in turmoil more then before
Oil prices will spike up quickly & the sell off begins on Monday
In my opinion.
Buy what should be a major meltdown, 10-20% if its like 9-11 was.
We may see 9-10 like I thought IF this happened.
Will present a great โ€œtimelyโ€ buying opportunity before earnings.
Good Luck & Hold Your Shares & Donโ€™t Panic.
#CureCancer
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north40000 north40000 7 days ago
Iranโ€™s drone attack against Israel has begun, per news alert just received.
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GMH* GMH* 1 week ago
For me, nothing has changed since the approval and lifting of the halt on the NSCLC trial, so my intrinsic value price target has not changed. The next catalyst will be patient starts reported at Q1 ER.

In regards to being a good buy here, I generally will not increase my cost basis unless there is new facts that emerge (doing so has cost me dearly in the past). I will add exposure specifically for upcoming catalysts by using the options market. I generally try to use structures that limit premium outlay though.
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surfkast surfkast 1 week ago
Still rated a buy? Good news on Monday to stop this from drifting down any further?
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badgerkid badgerkid 1 week ago
Just a reminder, the reason we want Iovance to succeed is not only because we'll do very well with our investment, but there's the human factor of improved health and lives well lived. Good luck. Check out Toni's story on the website if you need a refresher on Amtagvi and that human component.

https://www.amtagvi.com/

https://vimeo.com/amtagvi (Toni's story)

Good luck to the longs.
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MN Gopher MN Gopher 1 week ago
I wanted to clarify why I thought 9-10 is in play in the next 1-4 weeks before 1st Qtr report.
Geopolitical events coming soon in the Middle East, may set off a downward spiral like 9-11 did.
If Israel & Iran literally go โ€œtoe to toeโ€
Bombing each other n their respective interests, we could see 9-10.
Otherwise, Personally Iโ€™ve stated before the โ€œFloorโ€ to me has been $12.50
Based on Insiders buying at these price points months ago.
Good Luck & hold onto your positions.
Whatever Macro events affect us, its NOT Iovance as a company & Amtagvi as a treatment for Cancer Patients.
#CureCancer
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badgerkid badgerkid 1 week ago
MNGopher, I think you're low guesses exceed what all of the options and insiders are telling us. We're seeing slow acquisition right now regardless the overall market sentiment. The overall market would really have to tank for those levels IMHO. I think today's action is the typical overreaction to news that was already known. Lemmings! Interest rate hikes. Interest rate reductions. Hold those rates. Seems like a shell game at times, doesn't it?

The reasons to own IOVA haven't changed, the share price has. Seemingly painful in the short term, but I suspect we'll all be happy by this time next year (or sooner).

It wasn't that long ago I couldn't wait for us to get up to this current price. After approval, others said that this current price was possible due to the softening demand and the departure of the hot money. Those same people said they'll be adding once again if the stock price came back down to this price point. Looks like they were correct and I suspect they and others will be adding more aggressively now that it has. I may not have enough powder left for a big bang just yet, but I will add a few more shares at these levels.

Let's see what the next few Q's bring.

Good luck to the longs.

IMHO
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MN Gopher MN Gopher 1 week ago
Wednesday Bloodbath in BioTech
LABU & XBI getting slaughtered after hot CPI this morning.
Inflation battle is far from over & The Fed is now losing the battle.
Interest Rates will possibly rise again n again.
Interest Rate cuts Wall Street was expecting this year look like its in 2025, not in 2024.
Buckle Up Longs, We are headed straight down possibly between 9 & 10.
Looks ugly to me on the short term, but good/great news will send us soaring upwards after Q-1 Report n hopefully good Q-2 Forward Guidance.
#CureCancer
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RetiredandHappy RetiredandHappy 2 weeks ago
Don't expect it with share price dropping from $14.82 on March 28th. too $13.15 now, unless the price rises above $14.82 before April 15th.
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badgerkid badgerkid 2 weeks ago
3/28/2024 Short interest report: now 46.38 million shares short, only slightly down from 47.43 million. FWIW

I suspect that number will drop a bit more for the 4/15/24 report.
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GMH* GMH* 2 weeks ago
Allison was one of the investigative physicians while at NY MSK so if anybody would not need additional training, it would be her. I think that they need to provide the training purely for quality control and to make sure everyone knows the approved protocol, which may be a bit different than that used during the trials.
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GMH* GMH* 2 weeks ago
Did not see my previous post so I re-wrote... sorry for the redundancy.
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GMH* GMH* 2 weeks ago
I just re-listened to the Allison Betof-Warner video with AIM. At the 33 minute mark, she discusses payers and how Medicare approved within hours of the submission, but she also notes that other payers (plural) are also covering but may take some assistance from providers and that she had actually just finished one earlier. The video was posted on 3/14 so seems to be more than a handful from Stanford alone. Given that the treating physicians are required to put in 200-300 hours to become an ATC, I would think that treating physicians in other ATCs would be similarly supportive of recommending this treatment.
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badgerkid badgerkid 2 weeks ago
GMH, do we know if those 300 hours of training are independent of other training? If a new Amtagvi ATC has already been approved by other companies as an ATC for administering CAR-T or some similar therapy/treatment, would they not already have a significant amount of the necessary training? I truly don't know the answer to this but having sat with friends and family at various treatment centers, there's a lot of training that is necessary but training that may be redundant for any number of meds, etc thereby not requiring a repeat of training that has already been conducted (a transfer credit so to speak).

Just thinking out loud on this one.
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GMH* GMH* 2 weeks ago
I was just re-listening to the AIM video with Allison Betof-Warner. Interesting to note at the 33 minute mark where she discusses reimbursement and payers. Specifically, the ease at which Medicare approved the treatment (45% of patients) as well as her discussion that "the discussion with each payer is different" implying engagement with multiple commercial insurers. She also said patient advocacy may be needed and she was "working with one insurer on that earlier today."

This video was posted on 3/14 (30 post approval), but it sounds like Stanford had at least a handful of patients in process at that time. I know Allison was an investigator in the trial and has been a big proponent of TIL approval. I just hope we have similar people in the other ATCs. Given that it takes 200-300 hours of training by the physician to become an approved ATC, it is not a small investment so the physicians should be supportive of the treatment. Its not like a phama rep coming in with a brochure trying to get the physician to switch preferred drug percriptions.
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badgerkid badgerkid 2 weeks ago
A few items of note regarding some of the larger positions:

Perceptive Advisors holds 19.2 million shares with an avg cost of 12.94, Blackrock has 19.1 million with an avg cost of 10.07, State Street holds 16.4 million shares with an avg cost 12.50, and Avoro holds 6.7 mil with an avg cost of 16.58.

Additional increases did occur after approval and there doesn't seem to be any rush for the exits.

Good luck to the longs.
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GMH* GMH* 2 weeks ago
Agree with everything you stated. I am reluctant to add more because I generally have not done well when raising my cost basis. I am hoping for break-even earlier than end of 2025 (but I can be overly optimistic at times). I think NSCLC will continue to progress well, especially with the early data on the EGFRwt subgroup. In biotech, everyone wants daily readouts, but it often becomes a long waiting game and people lose interest and move on until the next "surprise" catalyst.
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Sunman88 Sunman88 2 weeks ago
Iโ€™ve been investing in small biotechs for a long time and had predicted we may see $12-13 range before we see $20 plus. I plan to load up at these levels and trust the company leadership will exceed expectations with initial ramp up and point to a revenue trajectory which supports breakeven by end of 2025.
Also, I trust the company to achieve positive results with confirmatory trial for metastatic melanoma. Success with NSCLC study will be icing on the cake. Thanks all for sharing your thoughts and progress updates.
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GMH* GMH* 2 weeks ago
Here is a link with recent (2018-2023) Biotech buyouts and premiums paid. Once you get into the MC size that IOVA is currently, the premium is around 75%-100% of previous close price, so we would be looking at a buyout price of $25-$28. I think that may be a fair price for MM, but the other indications are worth as much, if not more due to TAM. I am willing to wait, at least until mNSCLC data comes out. If we can get approval, even if limited to EGRFwt where we are seeing the greatest efficacy (similar to CAR-T), that could easily generate $2-3B in annual revenue in 3-5 years. I am no spring chicken, but I can wait that out (as long as the data continues to come in favorably of course) and will take a 10x (and go it alone) then vs a 2x now.

https://www.biopharmadive.com/news/biotech-pharma-deals-merger-acquisitions-tracker/604262/
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