Fugitive42

[Fugitive42 @fugitive4242]

$IOVA
Fred hit it out of the park! This company is a juggernaut! We don't have enough shares is the understatement of the year. Load up kids its trading with absolutely nothing priced in.

[Fugitive42 @fugitive4242]

@tg2024org At these levels yes.

[Fugitive42 @fugitive4242]

$IOVA
Nothing currently approved comes close to Amtagvi in the post PD-1 setting.

Ipilimumab plus nivolumab delivers only 9–28% response rates with high toxicity and far less durability, BRAF/MEK inhibitors (when applicable) eventually fail to resistance, and chemotherapy or T-VEC offer minimal benefit.

Amtagvi remains the only one time therapy with real world ORRs of 44% overall and 52%+ in earlier lines, plus multi year durability and treatment free potential that no other option matches.

Delaying with these weaker alternatives only lowers the odds of responding to TIL while the disease progresses and the patient becomes less fit making earlier referral to Amtagvi the higher probability move for durable benefit.

[Fugitive42 @fugitive4242]

Moderna/Merck’s mRNA vaccine is in the adjuvant setting high risk melanoma after complete surgical resection, given with Keytruda to try to prevent recurrence. 12 months from possibly being approved.

Amtagvi is approved for advanced unresectable or metastatic melanoma after PD-1 progression. Different line of therapy, different patient population.
If the vaccine works well in adjuvant it could shrink the pool of patients who eventually progress, which is a longer term market consideration. But it doesn’t replace or compete with TIL therapy once someone is already refractory to PD-1. Those patients still need effective options, and nothing approved currently matches Amtagvi’s response rates and durability in that post PD1 refractory setting.

[Fugitive42 @fugitive4242]

The CEO thinks it will.

In response to an analyst question on durability goals and patient baselines for LUN-202, Vogt said:

“On LUN-202, I just want to, you asked 2 questions there, Etzer, one was, is our internal goal to replicate the durability, is to actually exceed the durability, because when we reported the durability earlier, we had short follow-up and I think what we’re seeing right now, although we’re not going to pre-release the results here obviously right now, we’re seeing very strong durability, I think very similar in overall outcome to what we saw in melanoma. It’s effectively the same type of product, and when we get a response, it’s usually pretty durable.”

[Fugitive42 @fugitive4242]

$IOVA
TIL works. And it works better the earlier you use it.

That’s the quiet truth starting to sink in.

Tumor infiltrating lymphocyte therapy has proven it can attack solid tumors. Real world data shows response rates climb significantly when patients have fewer prior treatments. Frontline is where this modality is likely to perform at its absolute strongest.

Ira Mellman, PhD (a prominent cell biologist and cancer immunologist).
At the Immuno Oncology 360° (IO360) conference, during a keynote plenary, he was asked what he thought was next in “IO 2.0.” His response was “First, TILs” (or “TILs first”), referring to tumor infiltrating lymphocyte therapies as a key next priority in immuno oncology.

Thats a strong endorsement from a highly regarded figure, and it carries meaningful weight in the immuno oncology field.

The science itself isn’t new. Dr. Steven Rosenberg pioneered TIL therapy nearly 50 years ago at the NCI. Iovance licensed the foundational technology, partnered with his lab through a long running CRADA, and successfully scaled a complex, lab intensive process into the first FDA approved TIL therapy for a solid tumor.

Patients with advanced cancer don’t want years of infusions that eventually stop working. They want to be treated once and get on with their lives. A one time cell therapy with curative intent is a fundamentally different value proposition than chronic checkpoint inhibition.

PD-1s were a major step forward. They are also increasingly looking like last generation science. Cell and gene therapy is the next platform, and Iovance is currently the tip of the spear with the only approved TIL product for solid tumors.

This is why the frontline opportunity matters so much. If the strong early data holds, Iovance isn’t just defending a $1B+ second line product it’s building a multi billion dollar melanoma franchise and a platform that extends far beyond it.

The shift from continuous treatment to one and done is the kind of change that rewrites markets. We’ve seen this pattern before. The companies that successfully industrialize the new modality tend to become the powerhouses.

Iovance is still early in that process. But the direction is becoming clearer.

[Fugitive42 @fugitive4242]

$IOVA
Management was clearly upbeat on earnings call for a reason the commercial “gates” are starting to open.

Unaided physician awareness of Amtagvi nearly tripled in the past year, driven by the new marketing campaign launched at ASCO plus better sales force effectiveness.

They’re now treating >50 commercial patients per month.

U.S. 2L+ advanced melanoma pool is 8,000 patients/year (global previously treated >30,000).

Current run.rate of 600+ patients/year is already a solid base. A realistic path to peak looks like 100–150+ patients/month (1,200–1,800+/year), which supports the >$1B U.S. peak assumption in melanoma alone.

A “good” long-term penetration rate here is probably 25–40%+ of the eligible U.S. population achievable given the data and expanding ATC network (already >95 centers, heading to 110+).

The real unlock is earlier treatment. Real world data shows.

44% overall ORR

52%+ ORR in patients with ≤2 prior lines (vs 31% in the more heavily pretreated registrational trial)

Doctors are now seeing these stronger results first hand at their own centers. A one time therapy with durable (and in some cases potentially curative) responses is a completely different value proposition than years of PD-1 infusions that eventually stop working.

Awareness rising plus better real world outcomes + earlier referrals + more centers = the flywheel is starting to turn.

This is why management sounded confident.

[Fugitive42 @fugitive4242]

$IOVA

[Fugitive42 @fugitive4242]

$IOVA

[Fugitive42 @fugitive4242]

@czorbs @A_May_MD NSCLC and Melanoma frontline will be generating revenue within that time frame. For that matter Sarcoma is fast tracked and will be in the mix as well. What's that TAM and revenue projection? 3 billion in revenue with a multiple of 10x = 30B

[Fugitive42 @fugitive4242]

$IOVA @A_May_MD is wrong on multiple levels.

Business & losses: Q2 2026 revenue hit a record $99M (Amtagvi $91M), up 66% YoY and 39% sequentially. Gross margin expanded to 56%. Net loss narrowed sharply to $47M from $112M a year earlier. Cash $304M funds operations into H2 2028. Guidance is under upward review. This is a commercial stage launch still scaling ATCs and manufacturing, not a stalled money pit. Early cell therapy launches burn cash; the trajectory is improving fast.

MRNA/MRK vaccine “killing” IOVA’s market Completely different settings. The Moderna/Merck vaccine is adjuvant therapy for completely resected high risk stage IIB–IV melanoma (disease free patients trying to prevent recurrence). Amtagvi is for unresectable/metastatic disease after PD-1 failure. Even if the vaccine reduces the number who progress, residual metastatic patients still need systemic options. One does not erase the other. Calling this an “undebatable fact” that shrinks IOVA’s addressable patients is a category error.

Toxicity: Lymphodepletion + IL-2 is intense everyone knows it. But Iovance is actively reducing it. In the IOV-LUN-202 NSCLC trial they introduced a reduced non myeloablative lymphodepletion regimen that cut median post-IL-2 hospitalization days by more than half, lowered cytopenia incidence, and shortened recovery times without hurting efficacy. Real-world and high risk melanoma cohorts have also used reduced dose cyclophosphamide successfully. The commercial regimen already uses only a short course of Proleukin (up to 6 doses). Next gen programs aim to reduce or eliminate systemic high dose IL-2 further. Toxicity is real, but it is being mitigated and is accepted when durable complete responses are on the table.

REPL competition: Different modality (intralesional oncolytic virus) aimed more at injectable lesions. Not a systemic replacement for polyclonal TIL. Adcom scrutiny and limited complete responses have been widely discussed. It may serve a niche; it does not “steal” the metastatic TIL opportunity.

Valuation & “cult” label $3.8B market cap prices in commercial melanoma progress plus the NSCLC opportunity (company has called it 7× the melanoma market), sarcoma Fast Track, endometrial work, and frontline melanoma Phase 3 with strong Phase 2 signals (65% ORR / 30% CR).

Calling durable one time therapy data and sequential margin expansion a “cult” is just dismissive rhetoric.
A drug that works and is building commercial traction while expanding into larger indications is not a terrible business proposition. The short thesis relies on freezing the company in its earliest commercial phase and treating adjuvant prevention as if it eliminates metastatic disease. That is not how oncology markets work. 30 Billion Market Cap in 24 months.

[Fugitive42 @fugitive4242]

$IOVA
The Moderna/Merck Phase 3 win with intismeran autogene in adjuvant high risk resected melanoma is a clear signal that big pharma is betting on personalization as a durable direction in cancer treatment. It lends supportive context to companies like Iovance that are already delivering individualized cell therapies.

It validates the core idea of tailoring treatment to each patient’s unique tumor mutations and is the same philosophical foundation behind Iovance’s Amtagvi.

Different technologies. Different patient populations. Same direction of travel.

Tumors are highly individual. Therapies that engage a patient’s own immune system against their specific tumor biology (neoantigen mRNA vaccine vs. expanded autologous TILs) can outperform one size fits all approaches.

Science doesn’t stop. Modalities evolve and improve. One approved therapy and a large, beautiful pipeline of solid tumor indications ready to be bolted on in short order.

Look out cancer we’re coming for you!

[Fugitive42 @fugitive4242]

@kel_nguy @A_May_MD What does that tell anyone with an IQ over room temperature? He's a fraud. He's entitled to his opinion not the facts. The facts dont support his assertions. I've moved on and he is no longer on my feed.

[Fugitive42 @fugitive4242]

$IOVA
You keep calling it a “cult” every time people push back with actual numbers. That’s not a cult that’s people noticing your “mildly bearish” take is stuck in 2023-2024.

Commercial disaster?
Q2 record $99M revenue, Amtagvi $91M (+68% YoY), gross margin 56%, loss cut in half year over year, cash runway into H2 2028, and guidance already under upward review because demand is stronger than expected. That’s the opposite of a stalled launch.

You said the drug works and you’d use it. Cool. So would a growing number of oncologists and patients who are actually getting durable responses (including complete responses) with a one time therapy. Toxicity is being actively reduced with lower lymphodepletion and shorter IL-2 courses data already shown in NSCLC.

Mildly bearish is fine. Repeating the same “commercial disaster + cult” script while the numbers move in the other direction is just refusing to update. Boring.

[Fugitive42 @fugitive4242]

@Speedymm100 @A_May_MD It's all short talk and distorted data. He doesn't understand the science. He is ignored moving forward. Next!

[Fugitive42 @fugitive4242]

@crypto_condom @IovanceBio Well said. I concur!

[Fugitive42 @fugitive4242]

$IOVA
In the Q2 2026 earnings call, CEO Frederick Vogt explicitly framed the frontline melanoma opportunity this way.

“We think lifileucel’s characteristics are perfect for this with the one-time therapy combined with what may end up being fairly limited pembrolizumab dosing and the fact that we can drive a large percentage of patients into what’s effectively a cure.”

He also highlighted the rapid velocity of response and the 1/3 complete response rate as key characteristics they will emphasize at ESMO. This is a clear signal from management that they view the TIL component as the primary driver of the deep, rapid, and durable responses seen in Cohort 1A, with pembrolizumab playing a more supportive or time limited role rather than the continuous long.term dosing typical of Keytruda monotherapy regimens.

That interpretation fits the observed data pattern (high CR rate and fast onset not characteristic of PD-1 alone in this population) and the broader biology discussion around preserving TIL fitness by limiting prolonged prior or concurrent PD-1 exposure. It also aligns with the strategic push into TILVANCE-301 (the Phase 3 frontline trial), which includes an early interim analysis on ORR that could support a potential sBLA for the frontline setting.

The ESMO oral of longer follow up Cohort 1A data plus the explicit “limited pembrolizumab dosing” language from the CEO both reinforce the thesis that the one time TIL is doing the heavy lifting. The field will get a clearer quantitative picture in October when the updated numbers are presented.

[Fugitive42 @fugitive4242]

@RefinedTrader1 @BIOTECHSCANNER It's 5000 patients a year capacity and according to the CEO that number will actually be higher. That was stated at the Jefferies Healthcare Conference.

[Fugitive42 @fugitive4242]

@_donazoff I'll sell when the buyout happens or Wayne Rothbaum starts selling shares.

[Fugitive42 @fugitive4242]

@seedy19tron @Dancingtapas @A_May_MD Good call Vanilla Ice. You obviously have no idea what your talking about. Please short it.