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I think 10b is a *fair* floor for the majestic efficacy we see in the data for such a common and at the same time hard-to-hit target as WT1 in AML. With no side effects and basically zero manufacturing costs. 85+% ORR. Massive off-label potential. Perfect combo with the SLS009 CDK9 inhibitor. Tested against myelodysplastic syndrome, MPM, MM, ovarian cancer... Each of these trials is worth billion on average. For some, this will be the first in class and the best in class at the same time.
In post PD1 setting Pembro+Ipi = 10-13% ORR Amtagvi = 30%+ ORR You do the simple math.
I might be wrong in the sense that results were known before but I believe they presented some additional data from Daiichi Sankyo study on Safu at Jefferies conference last week: https://wsw.com/webcast/jeff332/nuvb/1865089?mobile=True 44% ORR and improved mPFS (i dont remember the exact number). I think that was the main reason for the increase in price. All other things David mentioned at the conference were already known.
I did some digging on this, and while the Woori IO deal structure is real, there are some major red flags you're not mentioning: **First, the float claim is wrong.** You said "very low float (\~2 million shares)" but OSRH has 21.59M shares outstanding according to recent filings. That's not a micro float - it's already pretty diluted for a company with a $12M market cap. **On the deal structure:** Yeah, the $10 conversion clause is interesting, but let's be real about what that means. The stock is at $0.56 right now. For those Woori IO shareholders to convert, OSRH needs to nearly 18x. That's not "aligning incentives" - that's basically a free option for them while OSRH takes on operational risk. If the stock never hits $10, Woori IO stays with the Korean subsidiary and OSRH gets... a company valued at $10.5M that's still in proof-of-concept stage. **The elephant in the room:** OSRH got a Nasdaq delisting warning in September. They need to maintain $1/share by March 2026 or they're gone. The company's down 95% YTD and has been publicly alleging market manipulation and short selling to explain the price action. When management starts blaming shorts for a 95% drop, that's usually not a great sign. **On Vaximm:** The Phase 2a data is decent - 12% ORR and 11.1 month median OS in glioblastoma is encouraging for a small trial. But it's a tiny study (n=25), and glioblastoma trials often show early promise that doesn't pan out. This is years from commercialization even in a best-case scenario. **The math on 10-20X:** * Current price: $0.56 * 10X target: $5.60 * 20X target: $11.20 For context, the stock hit an all-time high of $13.40 in November 2024 (less than a year ago) and has since crashed 96%. What's changed to make you think it's going back up? The Woori IO deal valued at $10.5M? That's less than the current market cap. **Financial reality:** * Revenue (TTM): $761K * Net income: -$11.4M * Burning cash with minimal revenue * Market cap: $12M This is a company that needs to either reverse split to stay listed, raise money (more dilution), or get delisted. None of those scenarios support a 10-20X thesis. **My take:** This feels like you're trying to drum up interest in a heavily diluted penny stock that's on the verge of delisting. The Samsung C-Lab thing is cool, and needleless CGM could be huge *if* the tech actually works at scale, but you're paying $12M market cap for a company that acquired tech valued at $10.5M, has an oncology platform years from commercialization, and is bleeding money. If this does a 10X from here, congrats. But I'd want to see them actually stay listed first before betting on a moonshot. What's your actual cost basis, out of curiosity?
Best Results from CYDY (Leronlimab) Trials – Summary HIV (Combination Therapy & Monotherapy) 1) Achieved primary endpoint in Phase 3 trial for treatment-experienced patients. 2) Some patients on monotherapy maintained viral suppression for years. COVID-19 (Severe/Critical Cases) 1) Phase 3 data showed reduced mortality and faster hospital discharge in critical patients vs. placebo. NASH/MASH (Liver Disease) 1) Phase 2 (open-label): 50% of patients showed ≥80ms reduction in cT1, a key marker of liver disease severity. Preclinical data showed reversal of fibrosis and liver fat reduction. Metastatic Triple-Negative Breast Cancer (mTNBC) 1) In small subgroup, 15/17 patients on ≥525 mg dose showed increased PD-L1 expression (potential synergy with immunotherapy). 2) Some long-term survivors (up to 4 years with no evidence of disease). Metastatic Colorectal Cancer (MSS, CCR5+) 1) FDA cleared Phase 2 trial design combining leronlimab with TAS-102 + bevacizumab. Trial to assess ORR and safety. Promising. Something for the longs to feel hopeful in seeing.
UK and one in Singapore patients completed treated from advanced lung cancer. Just holding and waiting for 25% ORR
Early signals points to 26% ORR in 2L-4L, not 21%… hope they can mantain it
Jumping in here as someone who is also highly interested in the company and with an investment position since June. The beauty of Alpha Tau’s approach to cancer treatment is the fact that it’s a device. Specifically, a small metallic seed containing Radium-224 that’s surgically implanted within a tumor. The half-life is only 3.6 days, and when the isotope decays it sends alpha radiation into the tumor as a means of killing the tissue. Why does that matter? The efficacy is reduced to simple physics. There’s no wondering about ORR or identifying biomarkers that would help indicate a specific sub-population that treatment would work well. You implant the seed (Diffusing Alpha-emitters Radiation Therapy, or Dart) and physics ensures any cells within the “blast radius” die. The blast radius, as I termed it, is known in advance so you implant multiple Darts in larger tumors to eradicate them while positioning them so as not to destroy good cells surrounding the tumor. Pancreatic tumors, brain tumors, lung, breast, skin- the efficacy should be the same because of the lethality of the alpha radiation particles. 100% tumor response rate, as OP mentioned, and I expect to see the same results in larger trials in all cancer types because it’s physics. This is some really exciting stuff that is a blockbuster long term hold.
David today at the Citibiopharma: \- Daichi to realease updated trial evidence on Safusidenib in low grade glioma updating **Progression-Free Survival (PFS)** and (maybe Overall Response Rate (ORR)? --- not sure about that one since the audio was INSANELY BAD---) \- David mentioned being in discussions with the FDA on a pivotal head to head trial against Voarsidenib. \- David confirmed advanced FDA discussions on high grade glioma pivotal study (read phase 3) \- David: “we have more than what we need to get to profitability”. NUVB is coming for a 6B market and I am all here for it. i like this stock
Anytime mate, sorry for the late reply. That’s better, but I’d avoid BTC, I don’t like giving advice on specific stocks but it’s too volatile to be put in such a high percentage alongside ETF’s - the growth from your ETF’s will be absolutely obliterated by the volatility of Crypto. There’s two plays, 50% Global, 15% voo, 10% emerging markets, 10% gold, 10% real state (or something else medium volatility for long term) and then do your 5% BTC so your volatility won’t effect the pie too heavily. ORR. If you’re feeling BTC growth, fuck it, why mess around with ETF’s, go all in on it. I wouldn’t, but I also wouldn’t dare invest 25% of my capital in crypto 🤷♂️
It was the same study 004. Just more patients. The 005 is the P3 Registrational trial yet to start. The data was still very impressive with speed and depth of response. PFS is more important than ORR as the next step.
Not sure where you are looking, but press release says 30% for control arm, 42% on 20mg and 49% on 30mg for Confirmed ORR
104 patient trial and a 19% alleged ORR benefit over control at 49% in CDRF-5 study, which is below expectations given the prior CDRF-4 study of 30 patients achieved 15% higher ORR at 64%, hence why the stock is down after hours.
You’re closer to this than I am for sure, but I found the new efficacy results far more interesting than approval. I do, however, think if they can even sniff the ORR they got for melanoma with NSCLC patients, that this is a very big deal. 61% ORR in 3rd wave or less treatments is pretty solid. Totally agree that the price tag is steep, but it looks like the coverage umbrella is expanding reasonably well, same as ATCs. For this company to really be something special, they will need to see strong results in cancers with bleaker outlooks though, I agree
I worked in oncology for mid-size and big pharma. This data is not as compelling as you think it is. 1. This is Ph1b data with very small sample size. It's not registrational, many things can go wrong before the drug is approved. 2. The outcomes you point out are the weakest surrogate outcomes for oncology (ORR-objective response rate). Company released some data for mPFS and mOS, and they seem okay for a post-PD1/PDL1 setting but again the small sample size makes the data unconvincing. 3. You need to think about the population being treated and thus the potential revenue. The studies are post PD1/PDL1 metastatic melanoma, which cuts down on the eligible patient population. Uveal melanoma is a nothingburger, it's about 5% of metastatic melanoma and maybe 1-2k cases a year are diagnosed in the USA. 4. Melanoma trials are long. It can take years for the Ph3 to read out and be approved. I'm not sure if I saw this company has an accelerated approval strategy. 5. Approval is only the first large barrier, the second is getting utilization and reimbursement from the insurance payers or adoption by the clinical guidelines/pathways that guide access. Without these revenue will falter. As such, there's still a long lead up time to both approval and profitability. A lot can happen (both good and bad) in between then.
Why SLS (Sellas lifesciences) SLS has 2 first in class and best class assets. Most immediately, their phase 3 asset, is GPS. It will mark any WT-1 ( wilms tumor 1) antigen for destruction by the immune system. Training t cells. WT1 is prevalent in many cancers, but cancer trials are expensive. Sellas decided to study AML (leukemia) patients that are not eligible for bone marrow transplant and are CR2–CR stands for Complete Remission. The 2 means for the 2nd time. The CR2 population generally has a mOS (median Overall Survival) of 6-8 months. Many many studies have proven this out, with a slightly higher mOS in some studies. Overall Survival (OS) of 13 months is not common—in the single digits percentage wise. Although the Regal trial—this phase 3 trial is only looking at CR2 AML patients, many think that GPS will be used earlier in the. disease progression as well as many other cancers that exhibit the WT1 mutation. To be clear, GPS will be used as a maintenance phase in remission. Sellas chose this group because there are no other viable answers. Data. This study started with 128 people. People enrolled as they qualified. Beginning enrollment started in 2021 and ended in early 2024. Right now, the last enrollee was admitted is 15 months. From an unrelated study, but with GPS data overlayed, you can see something. Back in Dec 2024, we learned than 60 events (deaths) had occured. Know knowing that KOL(key opinion leaders) have already stated that that 12 months OS is rare, and that 6-8 months is the norm. This is BAT (best available treatment) aka the control. There is nothing to suggest that GPs is not absolutely saving lives. In phase 2, they did not screen for wt1 mutations—and the immune response was only 68 percent. But in phase 3, all where screened and we got 80 percent ORR (overall response rate). In phase 2 the mOS was 21 months. This response rate is referring to the immune response. Definition—mean is half not average. So in phase 2, it took 21 months before half of the people had an event. Many lived longer. Their ORR was only 68 percent bc they didn’t funnel the intake criteria to WT1 positive. Phase 3 did. At IA(interim analysis), the IDMC ( Independent Data Monitoring Committee) said that there is no futility, toxicity or changes to the study necessary. This was announced in jan 2025. The 60th event happened in dec 2024. So it has been several months with bo announcement. The gamble!!! The only gamble is that someone thinks thats these extremely sick patients who have had zero answers, have miraculously recovered! The real answer—i am qualified to answer—is market manipulation, naked short selling and OTC trades with options hedging. That is part of it, the other is warrant conversions. But regardless of what the market makers do to suppress the stock price, none of it will matter when phase 3 data is released. They have a fast track designation for FDA approval and have what is called a rolling BLA —essentially, they have already started the FDA approval process, just waiting on final data. Input all of this into chatgpt or someother AI and see the truth. If you see falsehood!!! Let me know!!!! Anyway, that is the first asset, but not even the best. GPS is amazing, but it is for those in remission. The asset in phase 2 is a debulker. It is for active cancer. A CD kinase! Oncology has been searching for rhis. Other kinases have worked but have been toxic —bc they were not specific enough and stuck around too long. This sls009 is only in phase 2. There are 5 cohorts in this study. The first 3 cohorts top line data has been released and have shown 2-4x mOS increase over standard treatment. Sls009 data due any day now. GPS data due any day now. SLS just got the green light in to the russel 2000 index—forcing more institutional buys. 13gs showing more buys in the last 6 weeks from institutions—recently3 form4s Getting spicy!!! 6-17-2025 Update! And other important points not previously discussed. Today there was the annual meeting for SLS which was virtual. Maybe the recording will be available tomorrow, if so, I will post the link here. Take aways—there are some GPS patients living past 3 years and many living past 2 years. Looks like phase 3 will surpass phase 2 numbers. The trial protocol, which is tightly controlled by the IRB and the FDA, was modified for GPS from the last dose at 13 months to ad infinitum or relapse. Remember rare for control group to get to 12 months, and half expire 6-8 months. The mOS for phase 2 was 21 months. Data readout or topline for phase 2 sls009 was due 1st half of 2025—readout delayed to 2nd half. Why? Patients are living longer than expected. A big deal, about a month ago, a 12 year old was admitted to the phase 2 trial. Hard to imagine that anyone with knowledge would allow a pediatric patient be admitted to a drug trial that had poor outcomes. Other developments—new protocols at the FDA to streamline approvals, especially for indications that have no solid treatments. Possibly opening the door for FDA approval of phase 2 drugs like sls009. Back to the call—the CEO stated that sls009 will become a platform drug. Not just for one indications, but across multiple indications—think keytruda! Other considerations—there is a steep patent cliff and many big pharmaceutical companies are looking for replacements. GPS will probably end up being approved for other indications. This is the pipeline currently. Link didn’t directly post… but this. https://sellaslifesciences.com/pipeline/#indications