Iovance Biotherapeutics Inc (IOVA) News

Thanks, GMH, very worthwhile. It was great to hear Dan Kirby's own words. I believe Iovance made a great hiring decision and Mr. Kirby sounds like a man who will enjoy this challenge and bring a wealth of successful experience.

Can we take the NWBO discussion to the NWBO board please.

This was posted on ST and thought I would re-post here. If you were wondering if Dan Kirby was a good hire, give a listen and will answer those questions.

https://www.lifescienceleader.com/doc/commercial-readiness-with-orca-bio-s-dan-kirby-0001

FWIW: Increased institutional IOVA positions.


Swiss National Bank reports 9.28% increase in ownership of IOVA / Iovance Biotherapeutics, Inc.
On February 10, 2025 - Swiss National Bank filed a 13F-HR form disclosing ownership of 417,856 shares of Iovance Biotherapeutics, Inc. (US:IOVA) valued at $3,092,134 USD as of December 31, 2024. The entity filed a previous 13F-HR on November 7, 2024 disclosing 382,356 shares of Iovance Biotherapeutics, Inc.. This represents a change in shares of 9.28% during the quarter. The current value of the position is $2,377,601 USD.



Skandinaviska Enskilda Banken AB (publ) reports 36.62% increase in ownership of IOVA / Iovance Biotherapeutics, Inc.
On February 10, 2025 - Skandinaviska Enskilda Banken AB (publ) filed a 13F-HR form disclosing ownership of 155,684 shares of Iovance Biotherapeutics, Inc. (US:IOVA) valued at $1,152,062 USD as of December 31, 2024. The entity filed a previous 13F-HR on November 7, 2024 disclosing 113,952 shares of Iovance Biotherapeutics, Inc.. This represents a change in shares of 36.62% during the quarter. The current value of the position is $885,842 USD.

Iovance Biotherapeutics Appoints Dan Kirby as Chief Commercial Officer



SAN CARLOS, Calif., February 10, 2025 -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that Dan Kirby will join the Company’s executive leadership team in the newly created role of Chief Commercial Officer, effective today.

LOL - You lie for a buck paid pumpy!!

2025-02-07 13F BlackRock, Inc. 23,476,035 shares.

Looks like an increase of 3.3 million shares.

I'll take this as a positive sign.

Good luck to the longs.

Looking to add huge very very soon to my already large position. Looking for that false breakdown.

Don't worry about their downgrade or any of these analysts. A lot of times they have other interests at heart when they put these out. Don't overthink it. This is purely a move by the those that control this stock. This of this as a buying oppty. Execution in terms of commercial launch (sales, ATCs) are hitting all expections. Ignore the noise.

Crfawling back up?

SG Americas Securities LLC Buys Shares of 69,625 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA)

You forgot to mention that after the publication of the paper on Nature Communications those naysayers from medical field stopped publishing attacking pieces. Do you know why? Let me tell you why. Those people know very well that DCVax-L indeed can trigger intense and sustainable t-cell infiltration into tumor sites which matters the most in immunotherapy. They should be amazed that UCLA team can use GSVA score of a certain gene set after the vaccination to predict OS, which has never been achieved by any one else. See the following figure? The percentage of CD4 t-cells activated by DC vaccine which is essential to trigger immune memory outnumbers that of CD8 t-cells. CD14 monocytes which will differentiate into tumor-associated macrophages once seeping into tumor tissue is also significant, which clearly shows the tumor-associated macrophage immunosuppression that can be dealt with CSF1R inhibitor.

See those targets (highly overexpressed mutated genes) Genentech chose for their precision medicines for different types of cancers. If these targets happen to exist in three types of brain tumors, DCVax-L + Poly-iclc can fix the mutated genes.

This company has the biggest breakthrough in medicine ever. Once investors realize the true value of this company, the management will become one of the richest in the country. They have no interest in the small drop in a bucket. How's your prediciton on NVCR?

https://www.nature.com/articles/s41467-024-48073-y

NWBO's management is both morally and ethically corrupt. After many years of looking at this company, I have concluded the purpose of it is to transfer wealth from the public company into the pockets of private entities. They have been very successful at that!

The DCVax-L trial was negative [1-3] and not a single patient responded to DCVax-Direct [4].

When they went OTC were required to disclose "Third Party Advisors" providing "Promotion of the company" (paid pumpers) [5]. They do have a long history of paying third parties [6].

Refs:
1 https://academic.oup.com/neuro-oncology/article/25/4/631/6958519
2 https://www.sciencedirect.com/science/article/pii/S0035378723009190
3 https://www.practiceupdate.com/content/2022-top-story-in-oncology-dcvax-in-patients-with-newly-diagnosed-and-recurrent-glioblastoma/143631
4 https://aacrjournals.org/clincancerres/article/24/16/3845/277824/Cytokines-Produced-by-Dendritic-Cells-Administered
5 https://www.otcmarkets.com/stock/NWBO/disclosure
6 https://www.nasdaq.com/articles/behind-promotion-northwest-bio-2014-07-07

Thanks for the reply.

Had a longer response but iHub timed out the post. Short version:

1) The finances are critical. NWBO has cash runway of less than 1 quarter.
2) UK approval may provide milestones but this was licensed out so they will only get royalties and only after approval and reimbursement agreement.
3) US trial is P1 so it is years off.
4) Licensing deal pretty much takes any BO off the table.

I have learned that both the science AND the finances are critical in biotech. Many companies "survive" but generally the SP doesn't do well. Just my approach... as Badger says, its your money and your DD. Hope you do well, but not a company I would invest in.

The UK approval is pending. The science is truly amazing. Here is the figure from one patient in the combination of trial with Merck as one of the collaborators and the technology adopted in the trial was licensed from NWBO. The blue dots are cancer cells. Can you see the blue dots were significantly reduced after the second shot of the vaccine? The green dots are tumor-associated macrophages which suppress anti-tumor immune response. Those green dots can be depleted by an inhibitor called CSF1R inhibitor.

BTW, have you seen a company that can survive on OTC for nine years and be able to file for RA approval for the revolutionary technology? I assume you know Provenge developed by the Noble Prize winner Ralph Steinman. Do you know how many antigen his technology can make dendritic cell present to immune system? Only one tumor-specific antigen related to prostate cancer. Guess how many tumor antigens NWBO can make dendritic cells present to immune system. Hundreds of them. That's why for the most difficult cancer--glioblastoma, the trial has amazing data.

It is worth taking a closer look.


https://clinicaltrials.gov/study/NCT04201873

Regarding $NWBO, the finances are not good here and there are no near term catalysts that I can see.

Thanks.

Wow, 140k shares! That's a lot.
Take a look at $NWBO and use the rest capital of 60k to load $NWBO as a way to hedge your current investment.

I have been thinking about the Piper downgrade this weekend, trying to see how much merit there is to the assessment. Most people are dismissing the report, but given that this analyst was the only one who called Q2 correctly, I am wary to do so. The original analysis stated that ramp-up was slow because "The slow uptake is attributed to extended waits for manufacturing slots, which delay infusion times and may restrict patient eligibility." (link: https://www.investing.com/news/company-news/piper-sandler-sees-manufacturing-delays-impacting-iovance-stock-potential-93CH-3540561). This was also confirmed by U of Kansas docs as well as Boston General. The Piper projected 24 infusions which was very close to the 25 actual. However, I think the issues were more than simply slot availability (which I think has been fixed with additional hiring ). I think the issues also included:
1) initial (bolus) patient health with high drop rate early on - note 100+ patients "enrolled" at Q2 ER but only 55 infused at Q3 ER. Now resolved via patient selection
2) Extended initial cycle-time of +/-90 days. to +/-75 days at Q3 and reduced to +/-63 days.
3) At JPM, GS reported Fred saying "management had previously suggested that out-of-spec product was occurring primarily due to poor tumor resection quality, arising in part due to the large number of surgeons resecting samples and where the level of training had been variable. Accordingly, efforts to retrain surgeons on appropriate harvesting techniques focusing on quality and size have been implemented. Management noting that on average, outcomes improve after 2-3 patients but additional efforts are underway, particularly with new ATCs ... to ensure correct tumor resections are occurring with the first patient". (confirmed by U of Kansas docs and also supported by the enrolled to infused number reported in Q2/Q3.

So, the current Piper theory is that, based on the 6 ATCs they surveyed, they have reached a "steady state" of patients. Here is my take on that thesis:
1) I assume that these are the same 6 ATCs that responded to the first survey. As such, they would have been part of the initial 30 ATCs, which are much more likely to be at "steady state" than any subsequently onboarded ATC. Therefore, extrapolation to other ATCs would be inappropriate.
2) IOVA hired most of the regional marketing staff in the last 3 months so community out-reach has really just started.
3) OOS rates should drop (based on above) so even at steady state of patient beds, infusion rates should increase.
4) IOVA has increased staff by 50+ in the 2 months from Nov 7th ER to Jan 13th JPM, so unless these are all marketing/RoW rollout hires, seems like there is still manufacturing growth.
5) Looking at the balance sheet, starting in Q2 2023 (after Proleukin purchase), IOVA started reporting inventory numbers. This was all under WIP and Finished Goods and this was steady at about $10M total until Q1 2024 and has increased $2M/quarter since then. From this, I assume the initial $10M was for planned stocking (very small sales until Q2 2024) and the $2M quarterly increase was being driven by Amtagvi and Proleukin usage. The bigger thing is that raw materials jumped from $0 to $5.6M in Q1 to $13M in Q2 to $23.9M in Q3. This obviously was all driven by Amtagvi manufacturing and the only reason for that build up would be for increased manufacturing.

Bottom line, while Piper got the Q2 call correct, I think they are missing the boat with this call.

They have less than 1 quarter cash runway... always monitor the cash position in biotechs in relationship to any catalyst. Unless there is a clear path to profitability, you will be diluted endlessly... I have learned those companies are trades only.

It seems the sector is crazy lately. Here is another one that is crashing. RNAZ!

https://ih.advfn.com/stock-market/NASDAQ/transcode-therapeutics-RNAZ/stock-news/95244508/transcode-therapeutics-announces-first-patient-dos

Well said Hicham & Badger 🫡 very much agreed

Hicham, you're in good company. I've also increased my position, reduced my average cost, and I'm willing to add more shares in the coming months as my funds become available. I see more reasons now to be long IOVA than I did when the share price was $18. I'm also far more willing to wait for the multitudes of good news expected this year which most certainly should move the share price higher.

The sector has been a bear, but the low multiples that the biotechs are currently trading at should start returning to more realistic levels over the coming months and years. Lots of bargains out there right now including IOVA (or so I believe), but making good choices on what to buy and hold going forward is still the challenge. All of our due diligence on Iovance leading to our share purchases will likely result in very good returns.

Here's a little something I shared on another site: "These guys did okay. Catch Charlie's comment at 1:52:"



Good luck with your investing in 2025.

Painful but nothing new...

I have averaged down my portfolio to 6.6$ down from 9.8 and I have now 140k shares and i am ready to increase it to 200k if the SP continues on  dropping.  By now Iova is my only stock market investment so we can say all In...

I am ready financially to accept a SP drop to 3 because I know sooner or later we will be >20.

Just need to be patient...

As long as the small cohort we saw from LUN-202 scales there’s no issue. And every reason to think things will actually improve because of 2L patient requirement (2L-4L in COM-202) and also increased partial responses over time. I think more like ORR ~30% and mDOR >9 months. We’ll see by September during WCLC 😄

FUD or confusion? I'm seeing some comments being posted about Lung data with the usual what if comments on multiple message boards. Here's my view FWIW (and you're paying nothing for it, so that should establish its value).

TIL therapy works. That much you should know before spending your investment dollars on IOVA. 40 years of research has already proven that case. Where the challenge lies is in the commercialization of TIL therapy and creating a system that can succeed for both the patient and the profitability of the company - Iovance.

I'm investing in the ability of Iovance to succeed with its manufacturing capability and being organized in such a way as to meet the increasing demands of qualified patients while still turning a profit. For my purposes, TIL is already a given and will be approved for multiple cancers.

There were several bumps at the start last February and for several months due to logistics of managing multiple ATCs, docs, hospitals, surgical suites, and so on. Insurance was a minor concern, but that is also now almost fully resolved.

At the start, Amtagvi manufacturing capability at the iCTC wasn't fully ironed out. With lots of new hires, some initial staffing shortages, the usual when starting up what has never been done before, it was logical to assume some glitches. It's easy to criticize the launch, but you don't know what you don't know. Iovance did learn quickly and made all necessary corrections and adjustments.

There are now several reports and comments by the docs themselves that the process to treat patients with Amtagvi has been successfully organized and the operation from beginning to end is much smoother.

Do your due diligence, understand the facts of TIL therapy, the trial process, and what Iovance is doing to become the first and only successful TIL therapy company for years and possibly decades to come.

Iovance may be under a different name (acquired by BP) in the not too distant future, but TIL therapy is here to stay.

Good luck to the longs.

And wishes for good health to all that have to get treatment for cancer.

Iovance Biotherapeutics (IOVA) Forecasts Strong Growth Due to Flagship Treatment
Casey Dylan, CIMA
Jan 28, 2025, 02:24 AM

Tipranks: https://www.tipranks.com/news/iovance-biotherapeutics-iova-forecasts-strong-growth-due-to-flagship-treatment

The two largest failures have been inopportune raises and lack of preparedness for the launch and demand.

Thank you for this. This is something that no matter how much you research a company this will not come up.

I hope this makes you a ton of $$!! I'll cheer with you as a build a position

Iovance is significantly undervalued at this time for any number of reasons that have been discussed to death on this board and on numerous other boards. Do your due diligence. Your multiples are not correct, they should be much higher by simple comparisons to similar companies.

Here's just one of any number of discussions regarding valuations. https://finerva.com/report/biotech-genomics-2024-valuation-multiples/ Here's an excerpt:

"Revenue multiples for BioTech & Genomics companies grew throughout all of 2020, peaking at 17.5x in Q4 2021. After a continued fall throughout all of 2021, revenue multiples stabilised between the 5.5x and 7x mark for the past two years. In Q4 2023 the median EV/Revenue Multiple for BioTech & Genomics companies was 5.7x, after hitting a 5x low in Q3."

The point is that Iovance's TAM is significant, the company continues to build out manufacturing to meet the increasing demand, but Iovance is also notorious for limiting their PRs and updates, which makes it hard for an investor to get a handle on how the company is doing. The next few months should prove very telling with all the expected news that's right in front of us including the Q4 report, annual report, and a 2025 forward guidance update is also expected.

If you dig deep, you'll find plenty to support a much higher share price, but right now biotechs have been beaten down, and some like Iovance have been beaten down even more than the average. When the reversal happens, those are the companies that will likely have the bigger bounce.

Lots of investors want to be spoon fed reasons to buy - Iovance just doesn't do that. That's also why so many investors just follow the crowd and wonder why they never quite get those great returns.

It's your money, it's your rules, do your due diligence, make your choices.

Iovance Biotherapeutics (IOVA) Among Billionaire Joseph Edelman’s Long-Term Stock Picks

https://finance.yahoo.com/news/iovance-biotherapeutics-iova-among-billionaire-201009995.html

I’ll start by telling you I’m heavily long here, this is the vast majority of my portfolio. My outlook is several years from now.

Read the last few ERs and their updated corporate deck for most of the answers to your questions.

Management performance over the last year has been ok. The two largest failures have been inopportune raises and lack of preparedness for the launch and demand.

Fundamentally thankfully nothing has changed. Profitability expected in 2026. Frontline melanoma (combo) and secondline NSCLC (mono) approvals likely in 2027. Phase 1/2 for IOV-5001 starting this year.

Do you think IOVA market cap is too high at the moment?

I have a small position just so it's in my portfolio and I can pay attention to it. I noticed bio's have been trading more towards fair market value of about 2-3x revenue. So if it drops to about $1.2B or below, that would be time to start adding. I haven't started DD. But I want to see their debt, cash on hand, quarterly $ burn rate, and most importantly is their management good.

All of this is tremendously exciting. Strong workforce capable of meeting demand. Strong demand which is growing due to recent updates in the NCCN cutaneous melanoma guidelines. Price increase to IL-2 + TILs. And insurance a non-issue.

This is on track towards profitability.

I’m confident the lung data will be good as well. ORR and mDOR already sufficient based on early data. The inclusion parameters forced 2L and not later line as well so that’s going to dramatically help. This wasn’t the case with the melanoma COM-202 trial. Duration is what’s going to really matter. Don’t need it, even >6 will work, but hoping to see 12 months!

A few bonus links for today:

GU Hospital rolls out TIL: https://thehoya.com/news/gu-hospital-rolls-out-breakthrough-melanoma-treatment/

Chris White: https://www.linkedin.com/posts/yourtilspeaker_atw25-mucosalmelanomasurvivor-yourtilspeaker-activity-7285524574358646784-vpQ6?utm_source=share&utm_medium=member_ios

Game changer: https://stocktwits.com/Bamin/message/600367871

Good news regarding Iovance is nearly a daily occurrence. All you have to do is look. The share price will correct in time, but the company is moving forward to bigger and better.

You seem to know enough. Your approach to trading seems in tune. No secret, I'm a fundamental investor and not overly concerned with daily movements. In the long run, I anticipate my return on IOVA will outstrip most IOVA day traders certainly, and likely even some momentum traders and swing traders. Tough to beat the algos on short term action. Bios have been brutalized. If and when we see a reversal, I assume there'll be a rush to get back in. Just a thought and time will tell.

Good luck to the longs.

Interesting today. It feels as if all the dip buyers are no where to be found as they are wary. It has gone down 9 straight days. I find it very perplexing how an analyst just met with management at conference and reiterated $22 price target. I think that the powers that be have shaken out many of the retail shares. I have started a small position and may add if it finds support. The Biotech world has been upside down for a good while. I remember when a company got FDA approval and the stock moved up. In today’s world FDA approval just means that the short interest will increase and the price will be driven down. It’s a short the launch world. I was happy to see that Hindenburg research closed. I was not of the mindset that they were out to help the world by disclosing fraud. They were in it to open a short position and put out a hit piece in order to capitalize on the fear. Did they expose some wrong doings? Yes. But they also were wrong and exaggerated small findings into big deals in order to drive the fear. I think that they got out because there is going to be more scrutiny on short selling with the change in administration. I could be wrong but that is my guess. I hope that the scrutiny happens as it feels to me that IOVA is a victim of HF manipulation. But what do I know.

Sup guys. Just started looking at this one. Broke some key support areas. 3 month down trend. Looks like revenue projected to start ramping up. OS at 304M. How's their debt?

Lol wow, I knew this was going to get ugly..

Another patent granted to Iovance on 1/14/2025: https://patents.justia.com/assignee/iovance-biotherapeutics-inc

Here's the detail: https://patents.justia.com/patent/12194061

OOPS. Did not hit the sell yesterday! An omen?

Analysts still seem to have a lot of question marks on the guidance. Gross Margins should continue to expand, rapidly at first but decreasing over time. They added 100 employees last quarter, assuming most were for manufacturing, salary of $80k+30% fully loaded costs, and 1 slot / employee / qtr would represent less than 5% of COGS, the rest is a spread of fixed which should diminish quickly with growth. Assumed growth rate for 2025 is 25% QoQ which is really high, but given demand ramp, improving drop rates and 56 to 70 ATC growth, should be an achievable stretch (IMO). That level of growth / margin improvement should get to cash breakeven by Q3/Q4 based on my modeling. Will see, but I view that as the inflection point... and we get 2 data read outs and EMA decision as catalysts on top of quarterly earnings. We will see how the data emerges.

Goldman Sachs reiterates Buy with a $22 price target.

https://www.investing.com/news/analyst-ratings/goldman-sachs-reiterates-buy-on-iovance-stock-following-meeting-with-management-93CH-3811217

Goldman Sachs reiterates Buy on Iovance stock following meeting with management
Investing.com
Editor Rachael Rajan
Analyst Ratings
Published 01/14/2025, 06:11 AM
Goldman Sachs reiterates Buy on Iovance stock following meeting with management

IOVA

On Tuesday, Goldman Sachs reaffirmed their Buy rating on Iovance Biotherapeutics (NASDAQ:IOVA) with a steadfast $22.00 price target. The endorsement follows a recent meeting with Iovance's management at an investor conference. The focal point of the discussion was the 2025 outlook for Amtagvi, as it enters its inaugural full calendar year of sales for melanoma treatment.

Iovance has upheld its revenue guidance for fiscal year 2024, projecting $160-165 million, aligning with Goldman Sachs' estimate of $162 million. This guidance reflects a successful Amtagvi launch, indicated by consistent patient demand, enhanced ATC operations, and improved out-of-spec rates.

Despite this positive outlook, Goldman Sachs anticipates ongoing investor discussions, particularly regarding the breakdown of Amtagvi versus Proleukin revenues leading up to the fourth-quarter earnings report. Investors are keen to dissect the fundamentals of the launch and judge the feasibility of the fiscal year 2025 revenue guidance, which stands at $450-475 million as previously announced.

Additionally, gross margins are under scrutiny as investors seek to understand the long-term profitability of the launch. While Amtagvi remains at the forefront of Iovance's 2025 strategy, Goldman Sachs is also closely watching for pipeline updates that could bolster the credibility of Iovance's TIL platform. Notable developments include expected registrational data from the IOV-LUN-202 study in second-line non-small cell lung cancer (NSCLC) and from the Phase 2 IOV-END-201 study in second-line endometrial cancer, both anticipated in 2025.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

I envy your position here. Certainly excited to be able to invest much more heavily once I get a real job and wrap up this Postdoc haha.

But I too am unfazed 🫡

Well said GMH I had similar takeaways.

I got out today. Something stinks here. Got back in when it hit $7.44 a few months ago and grabbed a few moire but not playing here. Will wit and see if the $3.00 train comes in. So sad.

Holy cow. Something is not right here. Down 25% in 6 trading days.

Here is my take on the Corporate Deck Update:

Negatives:
1) Re-iterating guidance was insufficient for The Street. At Q2, they guided (mid-points) of $54M and $162.5. Given the YTD revenue, the Q4 discrete revenue would be $76.7M, but given that $58.6M was a $4.6M beat, re-iterating guidance means new discrete Q4 is $72.1M which is viewed as a significant deceleration.
2) 70 ATCs "including ATCs in final stages of readiness" is a miss. They should have never guided to the higher number as there was no upside. I am still surprised they got this close given 56 ATCs at Q3 earnings call.

Positives:
1) I think the revenue guide as a simple carry-forward rather than a true update, so I think they meet discrete Q4 revenue and come in somewhere in the $165-170M range (with a relief rally from wherever the SP is).
2) Employee count (going back across various updates);
- 2023 JPM (500+)
- Pre-approval Q4 2023 (500+)
- June 3-Q1 2024 (600+)
- Aug 9-Q2 2024 (700+)
- Nov 7-Q3 2024 (750+)
- Jan 13-JPM Update (800+)
Given Fred's Q3 comments that growth was primarily driven by capacity and capacity is limited by staffing (footnote Corp Deck), the trend seems favorable.
3) GM-201 (PD1 knockout) trial P1 is fully enrolled- reported in Nov but just noticed now. These generally take time as patients are usually done sequentially. P2 should enroll quicker as they can be treated in parallel.

Uncertain:
1) Manufacturing Milestone - Fulfill patient demand for commercial launch and clinical trials. Does this mean demand is slowing or are they are now ahead of the curve on hiring? Thinking the latter, but could be some of the former as well.

These are the facts I gleaned from the update and my take on them. Do with them what you will. I always appreciate people sharing facts and their opinion (bull or bear). I personally try to base my investing thesis on facts rather than opinion and think I can discern between the two so appreciate everyone's input.

Yikes, more liquidations..

Sorry to get you riled up. Long term it should find its ground and move up. Your focus on the long term is appreciated. No need to belabor this. Short term it’s headed lower. We all know the important milestones, potential risks and reward which lie ahead Peace.