Iovance Biotherapeutics Inc (IOVA) News

Apparently the short interest report is filed based on settlement which takes 2-3 days after covering. And there has been a lot of weird heavy after hours activity on many days after that settlement date. I’m curious to see the next report!

Whirlwind, thanks for the update on the short interest. A healthy drop indeed and I take the drop as a good sign. I haven't checked the sector to see if this was across the board or specific to Iovance. I suspect that the drop in SI is bigger still and we'll likely see that in the next report.

I always thought there was a high probability of approval in the EU since EMA often follows the FDA. Bigger issue will be country coverage and reimbursement. I think most countries will cover, but I am sure there will be a couple that push back on the cost/benefit (UK is usually quite difficult so I am rather surprised that they are targeting there early on).

Because there are more MM patients ex-US, I have that number at a little over 2k in my modeling. I think reimbursement will be about 80% of the US rate (similar to CAR-T).

Without question, the data is so compelling and exciting for Lifileucel + pembro for both frontline melanoma and NSCLC!

Next year I’m most excited for continued improvement in ATCs/patients treated/ex-US expansion, as well as the start of the phase 1/2 for IOV-5001 for multiple tumour types. IL-2 treatment will be dramatically reduced and dramatically open up TAM.

I’ll continue to add to my core position. As a postdoc I have a tiny position compared to everyone but I am very excited to see where it ends up several years from now 😄

SB, it's funny how we all key in on different things. I was focused on the fact that Fred said "beginning in 2025." To me, that was a matter of fact statement that they'll be treating patients outside of the U.S. starting next year. That to me speaks of confidence that the approval process is well on its way with no concern about gaining approval. All signs point to the "when not if" was my point.

The numbers are sadly staggering but good news for Iovance as they continue to develop that market for Amtagvi.

GMH has said this before but Fred mentioning 20,000 patients is likely based off melanoma deaths. I think GMH thinks Iovance can likely capture around 1800 American patients for second line melanoma per year and then presumably about another thousand that in ex-US (EU/UK/CA/AU/etc). Even so, at 1800 US patients + 1000 ex-US patients (discounted) that’s a very conservative $1.4 B.

But once they get approval to treat frontline melanoma, they’ll easily be able to treat 5000+ melanoma patients a year and make over $2.5 B from that alone.

I’m more bullish now than I was when I started doing DD here.

Just catching up on recent news from Iovance: https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-announces-promotion-raj-puri-md-phd
"Raj Puri, M.D., Ph.D. has been promoted to the newly created role of Chief Regulatory Officer. Dr. Puri joined Iovance in March 2022 as Executive Vice President, Regulatory Strategy and Translational Medicine."

Certainly deserving and a definite asset to Iovance, but here's the takeaway from the press release: "Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer of Iovance, stated, “Raj was instrumental in our successfully obtaining regulatory approval of Amtagvi™ in the United States, and in advancing regulatory submissions in the European Union, United Kingdom, Canada, Australia, and Switzerland, with the potential to address more than 20,000 patients annually with previously treated advanced melanoma beginning in 2025. Raj has also played a crucial role in advancing our product pipeline, including lifileucel in non-small-cell lung cancer and endometrial cancer and our novel genetically-engineered TIL candidates, with many more regulatory milestones and designations expected in 2025.”

"...the potential to address more than 20,000 patients annually with previously treated advanced melanoma beginning in 2025."

That's right, beginning in 2025. How soon and how much is the current question. It's no longer if, but when.

Good luck to the longs.

Yes - I have my core position as well and plan to hold long term as long as things continue to develop favorably. Really looking at opportunities to add some Puts/Calls if there is another pullback and planning for when/what may be the source. There will always be something that is construed negatively... just trying to anticipate so I don't chase the stock up when those pull backs are almost inevitable.

SB, I believe that the company has already gone over and above what most early stage biotechs are willing to do with future guidance. They're doing very good relative to guidance, but it appears that the market continues to yawn. I believe they may have simply said "No reason to update guidance at this time as it doesn't change the company's trajectory toward success and we're confident in the guidance already given." It's not their job to prop up the share price per se, and they've already demonstrated to all of us as shareholders that they're delivering on their growth projections.

Patience is the challenge for most of us who were hopeful for that quick buyout option. If it's going to take longer to get to those higher share price numbers, so be it. IOVA will still likely prove to be one of my better if not best investments over the coming years. In this I'm very confident.

Good luck.

GMH, agreed. My point, the company seems confident in their guidance and has reiterated that it's conservative. It's also agreed that no matter how good Iovance does, we're not in control of the share price. That said, we seem to be in agreement that the company is growing, has a bright future, and in time will be trading at much higher numbers. In the meantime, we're looking for ways to make a few extra dollars while we wait for the market to catch up to what we already believe will be a very bright future indeed. And in the end, isn't that why we're here - to make a profit on our investments?

Thanks for your continued support on this board.

Thanks for the correction... guess I was thinking of the Q2 ER infusions done into Q3. From 39 to 115 isn't as much of a stretch. Just be careful of the additional ATCs. Anyone coming on after the Q3 ER will not have sufficient time to perform any infusions so that number will have to be hit from the 56 announced ATCs.

Right so I’m also curious about that idea - wouldn’t meeting guidance given for 2025 already be spectacular? Personally I think they’ll handily beat $475M but I wouldn’t expect them to update guidance until Q4 ER or even Q1 ER.

GMH, As of Nov 7th (date of report) 39 patients (or more if the count was taken earlier than the report date) were already infused in Q4 , not 30 as you mentioned: "Amtagvi Infusions: A total of 146 patients have been infused with Amtagvi since the first commercial infusion in April 2024, including 25 patients infused in the second quarter, 82 patients infused in the third quarter, and 39 patients infused since the start of the fourth quarter. " https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-reports-financial-results-and-0

Your points are still valid for consideration, but I don't think the number of patients needed to hit the target guidance is as tall of an order since more ATCs are coming on line. Your points of using these events for trading are certainly worthy of consideration. I still hold a large core position, but I'm also more willing to trade a little around the edges so to speak.

We've seen that regardless the good results from Iovance, the market loves to beat down the winners and run up the losers. Sell the news remains alive and well and computer trading is not our friend. We might as well try to make a few dollars while Iovance continues to prove their worth over the coming months and possible years. I have complete confidence in higher highs over the next 12 months, but I suspect we'll see the occasional beat down now and again, and it may be nothing more sinister than the MMs and hedge funds saw an opportunity for a successful attack based on trading volumes, stop losses sitting open, or other outside fear inducing events that have nothing to do with Iovance specifically.

This company has turned me into a bit more of a trader than I wanted to be.

Good luck to the longs.

The one thing that has bothered me since the Q3 ER is that they did not increase full year guidance. By not doing so, they specifically decreased their original Q4 implicit guidance. For Q2 ER, they said Q3 would be $53M-55M, so take midpoint of $54M. For full year, they said $160M-$165M so taking midpoint would be $162.5. Subtracting off Q1 to Q3 revenue thus gives a Q4 estimate of $76.7M ($162.5M - $0.6M - $31.2M - $54M). When they beat Q3 by $4.6M, they, in essence, decreased the Q4 estimate to $72.1M. I think The Street took this as management does not believe the growth rate will continue, thus the sell-off. I think to overcome this, IOVA needs to not only beat the original guidance of $76.7M, but beat by the $4.6M they beat in Q3. Therefore, The Street will now want to see revenues closer to $81.3M. Is this doable? Assuming another $12M IL2 stocking at the 3rd SD, that would leave $69.3M from treatment revenue. At $0.6M/infusion, that would mean about 115 infusions in Q4. That would be a tall order given only 30 thru Q3 earnings report, especially given the holiday season. I am somewhat expecting a sell-off again after Q4 for these reasons. If so, I will use that opportunity to re-load my long dated (Jan 26) options positions as the growth rate is still phenomenal out of the gate.

nice DROP in Short Interest:

Settlement Date Short Interest Percent Change Average Daily Share Volume Days to Cover
11/15/2024 53,988,814 (9.61)
10/31/2024 59,731,383 (1.01)

Cassava -80%, a reminder of how lucky we are to have invested in a commercial stage company such as iovance. 

The worst is behind us and any smart investor will accept a volatility risk of -30% against an upside of +200% in a company that has not only a game changer product but also a technology platform that could be used in multiple new applications. 

This will develop to become a mini tesla...

Loading back to 120 and hopefully not having to sell the 30 at 12 SP.

 This yo-yo will continue but I hope, and logically speaking, now that we are commercial stage as GMH noted it will be shifting the yo-yo upward from 8 - 12 to 12 - 16 overtime.

Iovance Biotherapeutics Inc. (IOVA): Among the NASDAQ Stocks with Biggest Upside Potential According to Analysts

The path to profitability is well defined at this time. Good luck to the longs.

https://finance.yahoo.com/news/iovance-biotherapeutics-inc-iova-among-124913333.html

Someone on ST mentioned TG Therapeutics so I took a look and think that IOVA share price will likely follow the same pattern. Big pop upon approval (Dec 2022) with a subsequent sell off over the next quarters down to pre-approval levels; run-up to prior highs once they hit break-even (6 quarters post approval). So far, seems to be the pattern we are following.

GMH, good points. The major funds along with WR have mostly added to their positions since approval, so that's an indication to me of what they're seeing. Agreed that some traders have moved on to different pastures, but I won't go as far as to say greener. If it's daily action that they're looking for, IOVA may no longer be that stock for some of them.

We do know there are numerous upcoming events that if timed properly will allow for some trades in IOVA, but we've also recently seen that the share price is still open to the vagaries of a fickle market and the abuses of hedge funds and market makers that can play the stock price as opportunities present themselves. Back to $8 is great if you're still trying to build a position, it's also potentially good if you're swing trading, but it's frustrating if expectations were we'd never see these prices again following a very solid Q3.

Referencing a friend (you know who you are) who's been preaching the need for the market to see 3-4 full Q's of earnings with reasonable revenue growth along with solid 2025 guidance offered with the Q4 results, at that point we should see more stability in the stock price and likely higher highs as well. The good news is that's when many of my shares will be long term capital gains should I decide to sell a few. Personally I expect the much bigger share price numbers to start appearing later in 2025, and by bigger I mean 3-5x or more from where we're at now (the upper range of the analysts' price targets) so why sell too soon?

GMH. keep sharing, it's always appreciated.

Good luck to the longs.

BK

At the beginning of this year, IOVA was considered a clinical biotech start-up. Starting in Q1 2024, IOVA is now considered as a commercial biotech. That shift is similar to the ones you get when a company goes from a high growth company to a value company. As a clinical stage biotech, the valuation is based solely on the pipeline and trial readouts and buyout potential. As a commercial stage biotech, there is going to be a shift for people looking more to the financials. I am wondering if we are not range-bound until the company can show continued top-line growth, margin improvement and road to profitability. I think IOVA is making good progress in that regard, but I suspect you do get a bit of a shift in investor base in moving between those 2 stages. I have found that clinical stage biotechs are always simply trades as you just move from catalyst to capital raise, rinse, repeat with the hopes of a buyout at the end. Commercial stage biotechs have the 3rd option of moving towards a viable stand alone company. This does not mean that a buyout will never happen, but it doesn't need to be the only endpoint.

Share price is being be held tightly in low 8’s. Hope it does not crater to sub-$7 is they miss Q4 patient ramp up and revenue target

FWIW, another day with a large AH's trade - a single block of 5.26 million shares changed hands in today's AH's. Over 42 million shares traded in the last three trading days in addition to the 27 million shares that traded on Nov 8th alone.

Active to be sure and out of the ordinary.

Several job postings of note - Australia: https://iovance.bamboohr.com/careers/1586

And all of the 0042-CELL THERAPY FIELD TEAM postings: https://www.iovance.com/current-opportunities/

Get ready for what's happening - rapid growth as seen in the job listings and current hiring. As stated in today's Stifel Healthcare Conference with Iovance, the company is well on its path to profitability and a multi-billion dollar annual revenue stream.

Good luck to the longs.

BK

$IOVA

Quick messy thoughts from listening to part of the Stifel chat:

1) no slowing of demand, ramp continues for amtagvi
2) ATCs still on track towards 70 but more importantly a lot of them are themselves ramping up! Some of the ones doing 1-2 per month are large and scaling up towards 1-2+ per week within a few months.
3) NSCLC readout next year and there will be a full readout with 2026 with all 120+ patients
4) they have a clear line of sight to profitability without needing a “significant” capital raise

Stifel Healthcare Conference with Iovance just concluded. Certainly worth listening to when time allows. https://ir.iovance.com/events/event-details/stifel-2024-healthcare-conference

What have you verified?

Great post with tons of verifiable information. Not like OTCM scams that put out fake press releases and unaudited financials.
Thanks for your hard work!

Stay up to date with Iovance and IOVA. Here's some source material to get you started:

The Iovance corporate presentation: https://ir.iovance.com/static-files/f81194ff-6f65-4ed4-af92-67362eb17901

Iovance is a fast growing company with a lot of career opportunities: https://www.iovance.com/current-opportunities/

Iovance events and presentations: https://ir.iovance.com/news-events/events-presentations

Who owns Iovance? : https://ir.iovance.com/stock-information/ownership-summary

Here's the approved TIL therapy for Melanoma: https://www.amtagvi.com/

Share the company, share the news, and most definitely share with friends and family that may be dealing with cancer. Numerous other trials for solid tumor cancers are going on at this time: https://www.iovance.com/patients/

Good luck to the longs. Good health for friends and family.

GMH, thanks for that information. When it comes to all the rules for required reporting of stock trades, I'm not well versed in what trades need to be made public and when. I appreciate all that you provide for this board and your efforts to inform.

BK

JDC, you moderate a board for a stock that is trading sub 1 cent and you're here to protect us from posters who may celebrate this investment from time to time. We were all "unsuspecting newbies" at one time, and yet here we are, succeeding (sometimes just surviving) in this shark infested water of investing.

Lesson one, do not rely on any message board for accuracy of info. Lesson two, if someone tells you they're here of their own free will to protect you from some other poster, question their intentions.

Message boards are great places to share ideas and to encourage additional due diligence prior to any investing decision. We've all inadvertently posted incorrect information, even when we had no intention of pumping or lying. Feel free to stay and share, but please don't presume to save us from ourselves. Nearly everyone here has already learned the lesson that they are personally responsible to verify information shared by others.

Personal responsibility - your money, your rules.

JDC, since you're a moderator, maybe revisit what you've agreed to do and to not do when you accepted that role. As for sharing individual trades, lead by example if that's what you believe is of great importance.

Good luck to the IOVA longs.

This board is mostly longs with positions based on the fundamentals and long term projections. Certainly there’s also trading around cores and options but there are no unsuspecting newbies here lol.

Post your trades sir. I highly doubt your self statements. You were pumping this at $11 and now your said you sold? Were you pumping when you were selling? Please post your proof of trades otherwise none us on the board believe you.. 

Are you illiterate? I believe so.

surfkast

Member Level
Re: jdcpa1 post# 1822

Saturday, November 16, 2024 2:19:03 PM

Post#
1833
of 1834
I agree! Glad I sold months ago and bought back in at $7.44. Hope this reverses soon/.
All my posts on the site are to be considered opinions.

Readers determine the veracity of the posts they read and the credibility of other Users

17.44 buy in is crazy.. no wonder why you constantly pump away here.  

I agree! Glad I sold months ago and bought back in at $7.44. Hope this reverses soon/.

I am almost certain these are all Market-On-Close orders. If you invest in mutual funds, you know they require you to submit a buy/sell order usually 30-60 minutes prior to market close. They then aggregate inflows/outflows and put in a MoC order based on the net. This has to be into the exchange 10 minutes prior to close. MM will then adjust pricing to cover all the MoC orders. These also come from day traders wanting to square their position prior to close.

If you go to any chart for the Friday close, you will see the big spike in volume last minute. I checked about 5 including AAPL and all the same. Think you get bigger spikes on market sell offs as people want to exit their mutual funds and move to cash. You can see each individual trades if you go to the exchange website (nasdaq.com for IOVA).

Dark pool trades to not hit the exchanges so these would not show up on the charts which are fed from the exchange data.

Investopedia.com is a great source for anything relating to trading and the markets. Gives insights and stem a lot of the conspiracy theories that get spread around.

Dark Pools: https://www.investopedia.com/articles/markets/050614/introduction-dark-pools.asp

MoC: https://www.investopedia.com/terms/m/marketonclose.asp

Corsair, I don't have a good guess to provide regarding that large block of shares that traded right after regular trading hours. Possibly a dark pool trade? MM getting flat per agreed arrangement at end of day (doubtful)? I'm sure others can address this question far better than I. I don't think we'll know the real answer any time soon.

If anyone has a possible explanation, I'd love to hear it as well regarding the 8+ million share block at the close. It seemed far too big to be tied to options for Nov 15th.

Have a great weekend.

On IBKR, the last downgrade they show is from Piper from back in July. All others showing are maintained or initiated at Buy/Outperform.

Hitcham - you see this in a lot of biotechs. They will run up into a PDUFA or other "known" catalysts and then you get a sell-off. There is always a big FOMO trade in biotechs, but they are always raising cash so they are an easy target for short sellers. That is why I want IOVA to get to break-even cashflow as soon as possible. This takes away the cash raise risk substantially... although it is always there to some extent until they start handing out a dividend.

BK
Sorry to be off topic, read somewhere that 4 of the analysists have lowered their ratings. Have you seen or heard if that's true. I can't find any more details and wondering if it is a short piece. Also any ideas on the end of day trade, shows up here but not on Yahoo.

Syndax dropped by 6% yesterday, announced FDA approval after closing then the SP recovered only 1%!!!

Bulls are in control of the market now and not only iovance and surely all growth stock that are still not profitable. 

I am bracing for a difficult couple of weeks before it gets better and I hope I am wrong...

GMH, that was more of a statement, and yes, fully aware of that. My point was one of implication - meaning since WR has not reported any purchases, he may be locked out due to having MNPI - material non-public information. If he's involved in any on-going discussions with possible suitors for the company, he would not be able to buy or sell. That's all I meant by stating it the way I did. As always, thanks and have a great weekend. BK

Because Quogue is wholly owned by Rothbaum, they would need to disclose any change in ownership as an insider within 3 days of the transaction. Because of that, I do not believe they are required to provide quarterly updates.

Look again at the top 10: https://ir.iovance.com/stock-information/ownership-summary

Everyone added except MHR and Geode reduced a tiny bit (and we don't know what WR/Quogue has done for quite a while). Even they couldn't have predicted all this recent craziness. I would bet they're still adding as we speak.

GMH, if you want to see some unexpected put risk, take a peak at today's SMCI options. There's a lot of new shareholders today that thought they were totally safe when they sold those puts that were way out of the money a while back.

When I sell puts, I like to limit my exposure to shares I'm willing to buy anyway even if my expectations are that I won't ever see those shares. I did sell a handful more today on IOVA for Jan and Mar with a willingness to add those shares if necessary. I do have some puts that I sold a while ago that are currently underwater, but I suspect they won't be at expiration. It's always possible that they could put those shares to me sooner, but not likely as there is still some premium attached to those contracts. Again, I'm okay with that as I'm still accumulating shares, but I certainly didn't expect these levels would be seen once more.

Today was a very healthy pullback across the board and especially in this sector (see XBI) on fear and uncertainty. As for Iovance, all the reasons to be long haven't changed. Whether you bought at $14 or $7 (I've done both), the future of this company will make both of those prices seem like good deals in time.

Have a great weekend. Good luck to the longs.

Timberrrrrr

I am retired and most of my assets are in market index ETFs. If IOVA were to go to $0, it would wipe out about 10% of my value... not concerned about the equity risk but the Put options I kept selling on pullbacks. Biggest risk for me is 7.50P expiring Jan. Couple of days ago, I thought those were 100% safe... now, not so much.

I am in the same boat my friend. 90 k shares so 350 k$ drop over a week.

BUT

I am holding to my shares...

The only change is that I am now adjusting my strategy from 110 +- 20 k into 90 k +- 20 k.

I need to strike the right balance between long term gain and short term blood pressure increase!!

Don't give up all, the fundamentals have not changed.