Mountain Ren
198 posts

Mountain Ren
@mountainliren
travel, adventure, van life
Somerville, NJ Katılım Nisan 2022
106 Takip Edilen22 Takipçiler

@Dancingtapas This is very bad if executive branch start such interferences. FDA has been consistent in their review in this case.
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@AscendingBio The initial financial impact will be marginal. The true value of IOVA is its ability to treat a variety of solid tumors. Market really has not realized/price this aspect into the stock prices long term investor will be rewarded.
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$IOVA Australia Approval
There are some logistical challenges of serving Australia with a travel time of about a day to Philadelphia. Yet, they will sort those out.
I am particularly interested in learning the financial details of treating patients under the Australia healthcare system.
I view this as a very encouraging development. Yet, the positive financial impact will likely not occur until 2027. In fact, there will probably be some added expenses in 2026 related to developing this market.
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@TTRAmyloid Did they break down the ORR by US trial and Chinese Trial?
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@Dancingtapas I think market is doing us a favor to allow us buy more shares before IOVA takes off.
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Mountain Ren retweetledi

$IOVA - Amtagvi is approved in Australia. Build it and they will come!
ir.iovance.com/news-releases/…
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@jy201506 I don’t think keep submitting old data without addressing the design flaw will get drug approved unseal FDA is willing to make an example for all future small biotech to keep submitting.
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$REPL submitting RP1+nivo for a 3rd time does not change my core view.
Rejection risk is still very high. The dataset has already been heavily scrutinized, and unless there is truly new evidence that addresses FDA’s prior concerns, this may be more procedural than substantive.
Even in an approval scenario, I don’t see RP1 becoming a major commercial product. Weak/controversial data limit physician enthusiasm, payer confidence, and broad adoption.
The main bullish read-through, in my view, is regulatory flexibility. If FDA becomes more open to single-arm oncology approvals, the bigger beneficiaries may be higher-quality assets elsewhere such as $IOVA, not necessarily $REPL.
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@Dansfera I was not bothered by that at all. More reflecting on how the market reacted to an ER that’s fairly positive in my view.
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@mountainliren UK MAA withdrawal was procedural, not data. They are resubmitting for expedited review. Easy to mistake noise for signal on a day like today.
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@kainvests This is a nice summary and your comment on the use of remarkable is spot on. $IOVA , keep that in mind.
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$IOVA While we have to wait for the ER call in an hour or so to extract additional meaningful information from the Q&A session, let's focus on the key datapoints we have:
The first comment I'd like to make is that words matter and, once more, Iovance management has failed us by utilising the word 'remarkable' absolutely. I swore to myself that I would stay away from manipulative people, and I've decided that, while I will not be decreasing my position, I will no longer be increasing my position at Iovance Biotherapeutics purely out of principle. As much as I (we)'d appreciate better results, I am still bullish when it comes to the clinical value proposition.
Now, margins are low, but this is understandable. As mentioned in my previous posts, this was likely to be a poor quarter due to maintenance, centralisation and lower Prolekuin demand. This is a data point to be reviewed in the next quarter earning report. If in the next two quarters we aren't back to 50% and head toward 60%, then we may have reasons for concern.
On revenue, we had 65M from Amtagvi and 22M from Prolekuin in 25Q4. We expected a decrease in Prolekuin, which has happened, but now we are seeing 60M ONLY from Amtagvi. Where is the remarkable demand led by Amtagvi, Iovance?
On cost management, very positive and extraordinary 12% decrease in R&D expenses, given the best in class, truly extraordinary pipeline we have. Surely a positive!
On expected 26Q2 results, very smart approach from management. This tells us what we are expecting: a poor Q1 but strong Q2.
On the ATCs, more than 90 now. We can expect 110 ATCs active by the end of the year. I'm not sure that's positive enough, but again, what we need to understand is the level of activation of each ATC. How many patients can we expect per ATC?
Let's talk about E2E turnaround time: '32 days or less'. I'd keep my emotional reaction in check. We truly need to bring that number now. Again, they went through a hard and arduous centralisation and maintenance process done in record time. Let's see what the number looks like in two or three quarters.
As for country approvals, rejections or delays. Transparency is much appreciated. While we'd like more approvals, the true catalyst - and need - is business model validation in The US for now.
On the clinicals, wonderful results on the IOV-END-201 end. RECIST again, so not IRCed. The big but? The usual. Population size. An n of 5 patients is an early sign of what we know: TIL therapy works; but that needs to be properly confirmed, indication by indication.
IOV-SAR-201, nice. Early days. I'll deep dive soon enough.
TILVANCE-301, we will celebrate or cry when the time comes.
Now, cash, 'well into 2028'. That could be late 28H1 or 28H2. This takes us closer to profitability and decreases the need for dilution.
Oh, well. I'd say what I always say and I'll say it on X, the most toxic Iovance community filled by permabulls: with Iovance, being conservative works.
It is completely up to us whether we give Iovance some time and grace or we decide to exit. I am staying because I believe in this company and it is clear, since the beginning, that it will take some additional quarters to get there, but that isn't investment advice.
Good luck, team.
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Mountain Ren retweetledi

@BIOTECHSCANNER I share your conviction on IOVA. It’s rare to see a treatment works on both hot and cold solid tumors. The market for Sarcoma may be small but the implication is huge that Amtagvi works.
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$IOVA - Lung cancer, endometrial cancer, head and neck carcinomas. Yes, we don’t have enough shares. To the future 🚀
youtu.be/7S-OaIMK-U4?si…

YouTube
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@arthritisfinger @BIOTECHSCANNER Claude predicted were more likely to be at around 80 - 85 mill due to price increase in February and wholesalers stocked up in q4 25 to avoid it.
I think its a bit pessimistic honestly but dont be too surprised if were around 85-88 milli.
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$IOVA - If earnings are positive (in the $90sM range), good guidance ($375-$400M), good interim data on NSCLC, we won’t see $6 again. $10 by year end if sales continue to rise with additional trial data like IOV-4001, IOV-5001, endometrial cancer, melanoma with brain metastasis. How many precious shares will you have?
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@Henry431171040 @kainvests Agree. Giving it has shown good activities in 4 different solid tumor types, I think the results will be consistent. Actual ORR may vary but should still a meaningful improvement over SOC.
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@mountainliren @kainvests Nsclc full data, im expecting by end of yr..thsts when this will rerate to 8-10sp if good as interim
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$IOVA Position update: I’ve added €6k and are now on my way to 45,000 shares.
While it may have been prudent to wait for Q1’26 earnings next Thursday for more data, I added for a few reasons:
1. We have to maintain a critical mindset when it comes to management and their statements. But this time, both Fred and Corleen have highlighted “remarkable demand”. The last time this was stated was in March,at TD Cowen. By then, they already had 26Q1 datapoints, suggesting the quarter will likely be solid. The key unknown is guidance, which matters more than Q1 itself. After what happened in 25Q1, we expect them to be prudent with guidance.
2. I’m “always” online and can exit quickly if needed. But…
3. NSCLC is the true catalyst with the potential to “destroy” our investment thesis. Since no data was presented at ASCO, the timeline has likely shifted to September/October.
I don’t expect a major downside move until then; should NSCLC data be bad. Of course, I don’t see the future.
Until that, revenue (quarterly performance and guidance) is the main driver.
Feedback so far has been positive, so continued strong quarters could support gradual upside.
We’re currently trading in the $3–4 range, aiming to consolidate in the $4–5 range with a good 26Q1 and guidance.
Volatility should be expected to come back. No short squeeze can be expected.
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