IOVA Iovance Biotherapeutics Inc

$IOVA Disclosure: I have been an IOVA investor since 2022 and have a background in medicine and clinical trials. I wanted to share my perspective on the recently released data to help other investors. Despite the potentially transformational results in KRAS/HER2 wild-type NSCLC patients with a smoking history, the market has reacted negatively, seemingly underappreciating their significance. The 59.1% objective response rate (ORR), 9.1% complete response (CR) rate, and encouraging durability in this biomarker-selected subgroup suggest a paradigm-shifting advance over historical second-line therapy (docetaxel) with dismal outcomes (~10–15% ORR, with no CRs). Iovance estimates that approximately 45% of metastatic nonsquamous NSCLC patients qualify for its biomarker-enriched strategy. These remarkable results significantly strengthen Iovance's long-term investment thesis. Precision TIL therapy could transform NSCLC treatment and other solid tumors. A concise review follows.

$IOVA Barclays and GS updated their analyst reports today GS: maintained $15, still lists theoretical M&A value at $29, notes that 1 year mDor contrasts with what’s been seen in melanoma but notes (paraphrase) even if mDor finalizes at 12 months it would still represent a significant improvement over 2L SoC, “highly encouraged” by biomarker pursuit Barclays: pt at $18, views all comers approval as on track, views biomarker pursuit as “under appreciated”, explicitly calls sell off “overdone” Very curious to see what shorts are doing, very curious to hear where our cash is, and whether we will see insider buys via another private sale. This price action has been an axe kick to the cojones but

$IOVA my theory here is this . Goldman Sachs report gave their M&A price forecast of 29 dollars. It is likely WR met with Goldman and BP and agreed , GS would be the middleman of a BO transaction. Firms rarely give their hypotethical "BO price" its been leaked and this whole rushed data and sp dump from scared retsil is for WRs friends to come in before the transaction. The POSITLITY and OPTILUS indications have been added because thats what BP and WR agreed on. BO in 2027 imo

$IOVA Perspective post. If you had a mixed portfolio &it was up by over 200% at this point, you would be dancing in the streets. I know this doesn’t apply to folks who just got in on this latest run but for the rest, like me, who’ve been riding this roller coaster for 2 years or more - this is a great year. We all got caught up in that euphoric run & are pissed off at the mishandling of that call but… -TILs didn’t change. -Pipeline is still intact. -Fundamental story has not changed. -logistics are improving The biggest impact is that trust has been broken - again. What the C-Suite has been signaling w words like “unprecedented” (Gastman) the last 3 months is NOT what was presented in that data. Data that was actually quite good when you dig into it - but they took the most consequential call of the last 3 years & delivered it w all the gravitas of announcing what was for dinner  To me? That trust hurdle is going to be harder to overcome than any clinical data miss.  

$IOVA Just deliver a terrible PR with confusion and misdirection to create a dump. … panic selloff misunderstanding and poor delivery. Drive the price down ….. suitor picks up the shares and a deal is announced. 😳. … 🙏 

$IOVA Let's get our heads out of our A****! Tired of all this negativity. Was the data release messed up? Yes for sure, but the data was very good just wasn't presented like it should have. The company is operating efficiently and has turned the corner. This is a regrettable pull back, believe me, but we have enjoyed a 3 months of euphoria and why was that? All came together after the Q2 ER… the company financial strength is improving moving toward expansion of the TAM, and guess what we still are moving in the right direction. You would think the Lung Data was a bust, well it wasn't, it was impressive, imo. We will be filing a SNDA with priority review soon with the FDA. This too shall pass and I look forward to the Q3 ER in a weeks time! I think management will come out firing on all eight cylinders and is working overtime on getting the correct message out and will provide even stronger financial growth and guidance! BREATH! :)

$IOVA Have a good weekend fellas....this sell off is such BS...these bears and perma bulls(who I think are the worst)posting all this negative BS I want yall to keep this same energy when we crush it.....Headed out to watch my son QB in FNL and daughter Senior Cheerleader night.... Take care fellas/gals

$IOVA back to back days of strong call volume, almost 7x call to put volume today (yest was 5x). No way to bifuricate if the calls were bought or sold but nonetheless, still a positive indication.

$IOVA Remarkable NSCLC Results After Treatment Failure The most extraordinary aspect of Iovance's NSCLC results is lifileucel's efficacy after chemotherapy and immunotherapy failure. To highlight the magnitude of this finding, the results are compared with current frontline therapy. Frontline SOC: Pembrolizumab + chemotherapy (KEYNOTE-189) Previously untreated, more treatment-responsive population: • ORR: 48% • Complete response: ~1% After frontline failure: Prognosis is poor and options are limited. Docetaxel produces only ~10–15% ORR, virtually no complete responses, and short survival. Lifileucel after treatment failure (biomarker-selected, treatment-resistant subgroup): • ORR: 59.1% (13/22) • Complete response: 9.1% (2/22) Remarkably, lifileucel achieved numerically higher ORR and CR rates after treatment failure than standard frontline therapy achieved in previously untreated patients! If confirmed, these findings could transform NSCLC treatment. 1/2

$IOVA From a strategic point of view, it would have been brain-wreating not to have capitalized on the new knowledge! They maximize the value of the various NSCLC indications. Identifying subgroups and taking care of them even better is an enormous gain for the sick! This also means that the bar of $IOVA has increased significantly again for a certain population! That has to be achieved by another company first... Anyway, I'm enjoying the weekend now and thank you to all the friends here who keep their cool heads! copy 🎈

$IOVA Hey team, I've made a new video on X but it's long so it's been trying to upload-failing non-stop and I need to take my dog for a walk. I just wanted to update that I haven't sold. I'm waiting until next week to make a decision. Hoping for the video to upload before end of day explaining why! I hope everyone is well. 🤍

$IOVA It’s as if everyone here has forgotten they’re invested in biotech. Sharp moves around catalysts are expected. Management’s first perceived misstep in over a year and everyone loses their minds. I wouldn’t even call it a fumble, but a necessary strategic pivot. The investment thesis remains intact. Even with a narrower NSCLC label, Iovance can gain a meaningful marketshare, and could offer a meaningful improvement over existing treatments. This also feels like a page out of Wayne Rothbaum’s playbook. Acerta identified a highly responsive subgroup with Calquence, which went on to become a major competitor to Pharmacyclics’ Imbruvica. Sometimes finding the right patients is just as important as finding the right treatment. A narrower label could be the foundation for something much bigger. Calm down. Reassess. Implement. Move on.

$IOVA As Angus Macbeth posted below, it's certainly not easy, but one should add if they can or hold & I have to agree because my wife who was in the Oncology big pharma strategic planning space for over 30 years says their data & numbers are a game changer in the NSCLC space and said to me after listening to the call twice...that going after sub-categories in that space makes much more sense & will make it easier for Oncologists to recommend & insurance companies to approve instead of them going after a broader NSCLC range with lower efficacy. Said she believes they will have no problem getting to the 80 number for the complete study quickly & that FDA approval, depending on the drug labelling...should definitely happen. She said it will take a bit for WS to get it, but they will (hopefully on 11/5 with Gausman & Roche speaking) ...and finally after listening to the call twice & reviewing the decks on their website numerous times...that I should add more shares & just hold the stock

$IOVA IOV-LUN-202 Cohorts 1/2 dataset (24.6% ORR in 69 patients, roughly double typical docetaxel response rates) is intended to support a supplemental BLA for the broader population in 2027. At the same time, the company is launching POSITILITY, a prospective biomarker-enriched cohort focused on KRAS/HER2 wild-type patients (where ORR reached 52–59% retrospectively), with registrational intent. One realistic regulatory scenario is that the FDA could approve the broader indication based on the LUN-202 data (likely under accelerated approval), with POSITILITY serving as the confirmatory trial to verify clinical benefit. This structure is common when a one-time therapy shows clear improvement over current standard of care while further studies refine the optimal population. Full FDA alignment details are expected in 2027 as the process continues. In a setting where docetaxel offers limited durability (5.6 months mDOR), a durable one time cell therapy remains a meaningful advance.

$IOVA Stock went from 1.97 all the way up to 15 bucks. Why anyone is complaining is beyond me. Don't purchase stocks at their height, wait for them to settle, then buy. Nothing goes up forever, just ask my wife 😆

$IOVA the correct PR would have been: our new data confirms what is already known. our therapy is twice as good for response rate than the SOC. full stop. earnings call. then say gee wizz we did some retrospective and found that for a subset of the population the therapy is 6X better than the SoC

$IOVA - I think there must be some friction between management/board, as specifically Wayne Rothbam influecing this, as they released data of 69 now, so they can start the PosiTILity trial sooner (as they are starting the enrollment in Nov) and also announcing frontille Amtagvi + Pembro trial start in 2027. If they wait for full 80 patients data and wait for 2 months for response of last enrolled patients, then it will be late. So, All in All good. but this is why Fred was annoyed and bit aggitated, as I think he may wanted to wait (not use these unconfirmed response and even some response and other patients data is still being read/confirmed by central IRC team), so I think some duration data reported could change as well along with response data. But good that they announed new strategy now, and they will have full data cut in 1st Q and they are going full force preparing for sBLA, (I think in 3rd Q next Year - as they need 8 months from last enrolled patient) Very Very

$IOVA Biotech companies learn and evolve as they move through clinical trials, and I believe we're witnessing a potentially major turning point for Iovance. It looks like IOVA has identified something extremely important: the role of KRAS and HER2 wild-type biomarkers in predicting response to TIL therapy. The difference in response rates is striking, and management now appears to be incorporating these findings into its future clinical development strategy. And this could have implications far beyond 2L NSCLC. Think about the potential applications across frontline NSCLC, frontline melanoma, sarcoma, endometrial, colorectal and breast cancer programs, including IOV-5001. If these biomarkers help identify patients whose tumors are more susceptible to TIL therapy, prospectively selecting those patients could substantially improve response rates across multiple indications. We're potentially talking about ORRs in the 50%+ range in appropriately selected populations.

$IOVA down 35% and nobody’s talking about the real story: AMTAGVI. Institutions pumped the lung narrative, ran it up, then pulled the rug. Updated data (24.6% ORR, 69 pts) was in line with prior — the 59% subgroup was cherry-picked after the fact, FDA won’t accept that without the new POSITILY study (enrolls Nov). Narrower label, 2-3 yrs to revenue from it. Lung’s time will come — that subgroup is unmatched, just not carrying the stock near term. AMTAGVI growth is what nobody’s pricing. That’s the business you’re buying here.

$IOVA Quick update: I’ve seen some posts suggesting that price should soon reverse back to its highs. Can it form a V-bottom? Anything can happen in the market, but it’s a low 15%-20% probability. Price sliced decisively through the 20 EMA & 50 SMA with heavy volume & strong downside momentum. The daily chart remains in a strong downside breakout phase. The 1-hour chart is forming a second leg down. The higher timeframes have not yet transitioned into two-sided trading or shown signs of institutional buying. On the 5-minute chart, short-term traders continue selling rallies at key areas. Before bulls can gain structural control, the market must first transition into two-sided trading. I suggest patience here & holding off on new buys until we see a recognizable base: double bottom, wedge bottom, higher low major trend reversal etc.