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 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 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 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 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 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 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 The FDA’s language for accelerated approval refers to confirmatory “trial or trials,” so running two is allowed and sometimes done. In Iovance’s case Before the biomarker findings, the most likely confirmatory path for a second line NSCLC approval was a frontline randomized trial (adding lifileucel to pembrolizumab ± chemo). Now they also have POSITILITY a prospective, biomarker enriched second line cohort with registrational intent that starts enrolling in November 2026. They are still planning OPTILISM, a frontline trial in the same enriched population, for 2027. It is possible to structure this so that: POSITILITY serves as the primary confirmatory study for a second line accelerated approval based on the broader LUN-202 data, or Both POSITILITY and the frontline OPTILISM contribute confirmatory or supportive evidence, with one designated as the main post marketing requirement. Im shooting from the hip so look out!

$IOVA Two near-term catalysts might shift the direction of share price: 1) Amtagvi revenue exceeding expectations, which could halt the decline and stabilize the price near $10. 2) Positive FDA feedback toward accelerated approval, which might lift the price to $15–$20. Hope the earnings report next week could deliver both or at least one. It seems unusual that Wayne Rothbumn appeared in a company PR given his low profile, implying they might have a strategic plan as a backup to reverse the stock price’s downward trend. This is just my speculations.

$IOVA Well sadly it’s going to be a melanoma story for 2027. 2028-2029 will be the lung story if their retrospective analysis gets validated prospectively. After reading posts/listening to several people smarter than me. I’ve come to accept the following: 1. Company did what they are supposed to, increase the odds of approval for lung cancer even if it’s a narrow label. 2. There is no guarantee that postility will succeed 3. My dream of TIL getting validated as an solid tumor oncology platform got delayed (hopefully) by 1-2 yrs 4. Dreams of a massive valuation for a buyout are gone for now 5. I am afraid the SP will touch $6. Don’t come for me I am not an expert, I just have PTSD 6. Fred should stop adding his own color to the information on calls. Communications team should give him a piece of paper with things to say and most importantly what not to say. I am not selling. I’ll see this through 2028. I am neither bullish nor bearish. I am just confused-ish

$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 They literally cure cancer, they have outstanding results, just amazing what the therapy can do for a lot of really really sick people. But Mr market controls the share price and I think its been a really bad storm the last couple of days, not only with Iovance. I truly believe that the company is on a path to something big. The science is just to good to ignore. This to shall pass.

$IOVA Fred: "You can look at the swimmer's plot, which has a y-axis that goes out to, I think, 54 months. You can see that the responders at the top that are going on for years, and then you can come down around the midpoint and kind of estimate a few more patients coming on to that chart at the end that are responders, where they might land. I think it would be fair to say, yes, we could end up with an mDOR of 18 months or beyond with this data set. I think that would be very reasonable based on what we know about TIL therapy right now in the lung population. Again, we won't know until the data's done." Docetaxel Mdor = 5.6 months Amtagvi Mdor. = 18+ months I'm sure patients and the FDA will want Docetaxel right? Its far superior to Amtagvi right?