u/Emotional-Breath-838

Take a look and see if it's worth an upvote. Thanks!

https://www.reddit.com/r/stocks/comments/1tc00tp/follow_up_alpha_tau_medical_drts_huge_win_vs_rgbm/?utm_source=share&utm_medium=web3x&utm_name=web3xcss&utm_term=1&utm_content=share_button

Original post was here: https://www.reddit.com/r/stocks/comments/1t9ydga/drts_conference_call_today_for_rgbm_biotech/?utm_source=share&utm_medium=web3x&utm_name=web3xcss&utm_term=1&utm_content=share_button

This is a quick follow up since many don't track biotech and many don't subscribe to r/DRTS_Stock

As promised, we had a call with the CEO, CFO, CMO and the Oncologist that performed the three Ohio cases, all against inoperable recurring GBM.

The results were stunning and, quite frankly, better than anyone could have expected.

When analyzing brain cancer trial data, you're looking for results against the RANO 2.0 global standard which categorizes results based on:

Progressive Disease: it got worse

Disease Control: the tumor shrank but less than 50%

Partial Response: the tumor shrank more than 50%

Complete Response: this is the ultimate goal when the MRI shows that there is no trace of the lesion.

Alpha Tau announced that they achieved two (2) Complete Responses. The third was Disease Control with a 30% reduction in the tumor. The side effects were minimal, expected and ended quickly.

Why am I posting this on r/stocks? Several reasons...

1. Everyone knows someone that has lost someone to cancer

2. There is NO standard of care in rGBM. They typically tell you to get your things in order and say goodbye to everyone.

3. The physics based approach that Alpha Tau uses has now been validated by PMDA (Japan's FDA) certification and their 100% DCR against nearly 100 human (not rats) cases of Pancreatic cancer and, as of this conference call, by two CRs against the most horrible rGBM.

4. The stock moved up on the news obviously, but I'm certain it still has room to run and here's why: The market cap has only now crossed the $1B mark. That means that institutional investors can finally dip their massive toes into what was only retail shareholders tiny pond.

5. The same day Alpha Tau announced they were going to share the rGBM results, they also announced that they completed the full testing against skin cancer and are prepared to close the first FDA certification. Given that the remaining rGBM cases (7) in New York City can be completed before year end, a pivotal study could easily be accelerated under the current FDA because there is NO current standard of care for rGBM and Alpha Tau has such limited side effects that it should be fast tracked.

So, you have a company with a unique physics (targeted radiation directly into the worst forms of solid tumors) based platform filling a critical need with certification in Japan, a set of great results from their team up with Keytruda, Merck's $30B baby, and soon to be standard of care all alone for rGBM. Any idea what they can charge for brain cancer?

The "waters" are chummed up for M&A since nearly all of the big pharmas are facing a patent cliff and that means that acquisitions are through the roof. Typical radiology acquisitions go for $4B which would mean that Alpha Tau has roughly a 4X shot of going up on M&A news if they don't stick around and commercialize their 100+ patents themselves.

I am long. I am bullish. I am encouraging you to go to r/DRTS_Stock to gain more insights on how Alpha Tau is handling the radiation and forward logistics and the very powerful team running this for the past ~7 years. Most of all, I'm encouraging you to take a look and see whether you want to front run the institutions and algorithms and etfs and indexes that will almost certainly come once this platform is in place globally.

NFA/DYOR

I have no idea what’s in Ft. Knox and I don’t have a political dog in this race.

We were told a new Ft. Knox assessment of gold holdings would be forthcoming and then it all went quiet.

I am assuming that there is a serious economic impact if they assess too little gold, too much gold, no gold, etc.

What are those economic scenarios and is it possible that we don’t see the gold holdings because of that impact?

https://preview.redd.it/ujcuxkfqwq0h1.png?width=933&format=png&auto=webp&s=baec23b127bb2579ceba25be9dd55c0ff4350bcd

I got DBMF as a hedge for days like these. And it still went down. Credit goes to PIT which stayed up on a very down day. It's performance has been solid for a commodity ETF (a bit better than FMTM, a bit worse than SGRT) but you learn what you have on days like today.

https://preview.redd.it/q32qqq4udj0h1.png?width=2316&format=png&auto=webp&s=ffffe80b5500aa0edef717a464536cd7ff9cb94a

Almost every time over the past year, when I would share due diligence with other subs on Reddit, I would get accused of Pump & Dump.

Why on Earth would anyone sell a stock that is on the verge of FDA approval and becoming the standard of care for rGBM?

Alpha Tau Medical [nasdaq: DRTS] is going to host a conference call Monday AM regarding the preliminary results from their recurrent GBM (inoperable brain cancer) trial.

The shareholders didn't expect this but are taking it as potentially very good news because the remaining cases (they've moved from Ohio to NYC) are still scheduled. The question is, "How good is the news?" We'll have to attend the call to find out so I put together a cheat sheet for those that are wondering what to listen for when considering rGBM progress.

As you're aware, this is not a drug company. This is a medical device company. They use physics (alpha radiation delivered in nanometer level targeting directly into solid tumors) rather than chemistry. If their hyper-local physics don't destroy nearby tissue or the immunity system, then any positive results they get mean that the DaRTs can be used in conjunction with other therapies. That's a very good thing.

More on the rGBM below but for those that haven't heard of Alpha Tau (DRTS), here's a quick primer...

They have already received PMDA (Japan's FDA) certification for Head & Neck cancers, so it's a real platform that provides oncologists with a new tool.

They have been on an insane hot streak since receiving PMDA.

Alpha Tau got approval from the FDA for testing with Keytruda, Merck's $30B baby, and quickly demonstrated a massive (2x, 3x) efficacy increase.

They compiled the results from their Pancreatic Cancer trials which showed an extremely impressive 100% DCR (disease control response.) It is believed they have completed nearly 100 cases of late, late stage PanC and have now been approved for new trials in Japan, France, Italy and Canada.

The FDA has granted five modules for Alpha Tau which includes trials for brain, pancreas, prostate and other solid cancers, either alone or in conjunction with other therapies.

Over the past year, they've run up a gaudy 200%+ and still maintain a market cap of only $750M.

And, because it's rGBM, there is a possibility that the recurring GBM cancer initial trial data changes everything.

THERE ARE NO GOOD TREATMENTS FOR rGBM.

When a neuro-oncologist faces a recurrent GBM case, they are not choosing between good and better options — there is no standard of care, and all available treatments are considered non-curative. They are managing a patient who has already survived longer than most, whose tumor has now outsmarted surgery, radiation, and chemotherapy, and who is almost certainly going to die from this disease. After first-line therapy fails, median progression-free survival is 1.5 to 6 months and median overall survival is 2 to 9 months. The oncologist's toolkit at this point — more chemotherapy, re-irradiation, or bevacizumab — may slow things briefly but changes nothing fundamental. Recurrent GBM is widely considered one of the most disappointing fields in oncology, where decades of research have yielded no meaningful survival benefit. The honest conversation an oncologist has with an rGBM patient is not about getting better. It is about how much time remains, and how to spend it.

Back to Alpha Tau and the hope for hope where none exists...

There have been 3 cases in the 10 person trial so far; all out of Ohio. The remaining 7 will be done in New York City starting this month. We aren't looking for survivability duration. What we're looking for is:

Safety: The procedure (outpatient typically) can be done without causing harm to the brain or immunity system. You'll know it's solid if the patient walks out on their own power within 48 hours of the procedure and follow up testing.

Coverage: How much of the tumor was hit with the targeted radiation? We're looking for 80%+ coverage of the tumor. Hit the tumor hard with high-LET Alpha Radiation.

And we're expecting that the MRI's taken of these initial patients have shown something worth sharing with shareholders but you'll need to understand how to evaluate initial results.

Initial results = RANO

When you're dealing with rGBM, there is a standardized way of understanding trial results called RANO 2.0. RANO is Response Assessment of Neuro-Oncology and it is a standard globally that looks at an MRI taken after treatment to determine whether the tumor has grown, shrunk, how much and whether continued treatment with corticosteroids is needed, etc.

RANO terms to listen for on the conference call:

Stable Disease (SD) No new lesions. No increase in corticosteroid use. Clinical status is seen as stable. If the tumor shrinks but by less than 50%, or stays roughly the same size, you have stable disease. In a cancer as aggressive as rGBM, halting progression is clinically meaningful — but of the four outcomes discussed here, SD is the most modest signal for investors.

Partial Response (PR) The tumor has shrunk by at least 50%. This is incredibly rare and would be considered fantastic news. Even one of the three patients achieving a PR would be a reset for DRTS because it means that there is (FINALLY) a potential way of seriously shrinking the GBM tumor.

Complete Response (CR) A complete obliteration of the tumor. Such a result would be a landmark in rGBM oncology. Nobody should expect this but everyone should understand that this is the dream. The whole world of oncology changes overnight if there is a CR on any one of the three patients.

Abscopal Effect This is a mythological creature. Remember that Alpha Tau's DaRT therapy is a local treatment, meaning that they're inserting the radium-covered darts directly inside a single tumor. There have been, over the past few years, a few odd cases where oncologists noticed the strange reality that distant, untreated tumors responded to the local DaRT treatment. The current thinking is that local tumor destruction releases tumor antigens that prime the immune system to recognize and attack the same cancer elsewhere in the body. Again, nobody expects to see abscopal effects on the first three patients but if you hear it on the call, you know what they're talking about.

So, you have a stock that is up 200% over the past year, it's not a typical biotech stock because it's a device, it has achieved cert in Japan, it has shown phenomenal initial results with Pancreatic cancer and it's on the verge of announcing something positive in recurring GBM. The market cap is $750M and typical M&A in the radiotherapy space goes for $4B.

Hit me up with any questions. Not a medical professional. Not financial advice. And yes, I'm irresponsibly long on this stock because fck cancer.

Alpha Tau Medical [nasdaq: DRTS] is going to host a conference call Monday AM regarding the preliminary results from their recurrent GBM (inoperable brain cancer) trial. If you're interested, the following is what you need to know.

This is not a drug company. This is a medical device company. They use physics (alpha radiation delivered in nanometer level targeting directly into solid tumors) rather than chemistry.

They have already received PMDA (Japan's FDA) certification for Head & Neck cancers, so it's a real platform that provides oncologists with a new tool.

They have been on an insane hot streak since receiving PMDA.

Alpha Tau got approval from the FDA for testing with Keytruda, Merck's $30B baby, and quickly demonstrated a massive (2x, 3x) efficacy increase.

They compiled the results from their Pancreatic Cancer trials which showed an extremely impressive 100% DCR (disease control response.) It is believed they have completed nearly 100 cases of late, late stage PanC and have now been approved for new trials in Japan, France, Italy and Canada.

The FDA has granted five modules for Alpha Tau which includes trials for brain, pancreas, prostate and other solid cancers, either alone or in conjunction with other therapies.

Over the past year, they've run up a gaudy 200%+ and still maintain a market cap of only $750M. There is a possibility that the recurring GBM cancer data changes everything.

THERE ARE NO GOOD TREATMENTS FOR rGBM.

There have been 3 cases in the 10 person trial so far; all out of Ohio. The remaining 7 will be done in New York City starting this month. We aren't looking for survivability duration. What we're looking for is:

Safety: The procedure (outpatient typically) can be done without causing harm to the brain or immunity system. You'll know it's solid if the patient walks out on their own power within 48 hours of the procedure and follow up testing.

Coverage: How much of the tumor was hit with the targeted radiation? We're looking for 80%+ coverage of the tumor. Hit the tumor hard with high-LET Alpha Radiation.

And we're expecting that the MRI's taken of these initial patients have shown something worth sharing with shareholders but you'll need to understand how to evaluate initial results.

Initial results = RANO

When you're dealing with rGBM, there is a standardized way of understanding trial results called RANO 2.0. RANO is Response Assessment of Neuro-Oncology and it is a standard globally that looks at an MRI taken after treatment to determine whether the tumor has grown, shrunk, how much and whether continued treatment with corticosteroids is needed, etc.

RANO terms to listen for on the conference call:

Stable Disease (SD)

No new lesions. No increase in corticoid steroid use. Clinical status is seen as stable. If the tumor shrinks up to 50%, you have a stable disease. This is considered very good news and means that the progression-free survival endpoints may be possible.

Partial Response (PR)

The tumor has shrunk more than 50%. This is incredibly rare and would be considered fantastic news. Even one of the three patients achieving a PR would be a reset for DRTS because it means that there is (FINALLY) a potential way of seriously shrinking the GBM tumor.

Complete Response (CR)

A complete obliteration of the tumor. Such a result would be a landmark in rGBM oncology. Nobody should expect this but everyone should understand that this is the dream. The whole world of oncology changes overnight if there is a CR on any one of the three patients.

Abscopal Effect

This is a mythological creature. Remember that Alpha Tau's DaRTs therapy is a local treatment, meaning that they're inserting the radium covered darts directly inside a single tumor. There have been, over the past few years, a few odd cases where oncologists noticed the strange reality that distant, untreated tumors responded to the local DaRTs. I won't profess to understand how Abscopal works but the way it was dumbed it down for me was to say that the body's immunity system "learns" how to fight tumors once the first tumor is obliterated. Again, nobody expects to see abscopal effects on the first three patients but if you hear it on the call, you know what they're talking about.

So, you have a stock that is up 200% over the past year, it's not a typical biotech stock because it's a device, it has achieved cert in Japan, it has shown phenomenal initial results with Pancreatic cancer and it's on the verge of announcing something positive in recurring GBM. The market cap is $750M and typical M&A in the radiotherapy space goes for $4B.

Hit me up with any questions. Not a medical professional. Not financial advice. And yes, I'm irresponsibly long on this stock because fck cancer.

This subreddit doesn’t want ignorant investors blindly throwing money into an insanely hot opportunity. Get educated!

For today’s rGBM conference call, you need to know RANO.

RANO stands for Response Assessment in Neuro-Oncology (sometimes called the RANO criteria).

In the context of rGBM (recurrent glioblastoma multiforme, or recurrent glioblastoma), it refers to standardized criteria used to evaluate how a brain tumor responds to treatment. These criteria rely primarily on MRI imaging findings (changes in enhancing and non-enhancing tumor components), along with clinical status and steroid use, to categorize response into:

• Complete Response (CR)
• Partial Response (PR)
• Stable Disease (SD)
• Progressive Disease (PD)

RANO was developed by an international working group to improve consistency in clinical trials and patient care for gliomas (including glioblastoma). It addresses limitations of older systems like the Macdonald criteria, such as better handling of pseudoprogression (treatment-related MRI changes that mimic tumor growth) and non-enhancing tumor components.

The original RANO criteria (2010) have evolved. Variants include mRANO (modified, often using post-radiotherapy baseline scans) and iRANO (for immunotherapy).

RANO 2.0 (2023) unifies these into a single updated framework for high- and low-grade gliomas, with refinements for baseline timing, confirmation scans, and IDH mutation status.

Why it matters in rGBM: Recurrent tumors can grow rapidly, and accurate assessment helps determine treatment efficacy, guide decisions on continuing or switching therapies, and standardize reporting across studies.

Now you know!

I got interested in one of the very many new Corgi ETFs. That led me to research on Corgi and I found out they are a VC backed financial shop that figured out how to flood the market with ETFs (30+ in a single week.) I’m not going to advocate for them or say anything bad about anyone who jumps in but I did have questions and a paid LLM account so…

I generated the following AI slop so you could at least get a sense of who Corgi is and what they’ve done. I won’t apologize for the AI slop because I’ve flagged it and I’m telling you up front that I won’t be doing any further DD until they got at least two weeks of a track record.

AI Slop:

Caution on Corgi’s massive ETF launch

Corgi just showed up in the ETF world in a very loud way.

This is not some old-line ETF sponsor with decades of fund-management history. Corgi describes itself as an AI financial infrastructure company building products in insurance and finance. ETF.com called it a Y Combinator-backed insurance startup using a VC-style playbook in ETFs.

In the past few days, Corgi launched roughly three-dozen ETFs, including:

28 actively managed thematic ETFs covering things like AI cybersecurity, crypto infrastructure, quantum computing, drones, space, defense, robotics, genomics, fintech, energy infrastructure, shipping, sports betting, travel, lifestyle brands, NYC-based companies, Bay Area-based companies, and even a “Mag 7” ETF.

It also launched a suite of structured buffer ETFs tied to broad exposures like the S&P 500, Nasdaq-100/growth technology, Russell 2000/small caps, international developed markets, and emerging markets.

Some of this is genuinely interesting. Fees appear low relative to many competing thematic or buffer ETFs. For example, Corgi’s thematic funds are listed with expense ratios generally around 0.20% to 0.35%, and the structured buffer ETFs are advertised with a 0.30% net expense ratio after fee waivers.

But this is exactly where investors should slow down.

A low fee does not automatically make a fund good.

The biggest caution signs:

1. The issuer is new to registered funds.
   Their own disclosure says the adviser is newly registered, has limited experience managing registered funds, and the funds themselves have limited or no operating history.

2. Most of these are narrow thematic ETFs.
   A drone ETF, quantum ETF, AI cybersecurity ETF, shipping ETF, gambling ETF, genomics ETF, or “Bay Area companies” ETF can sound exciting, but narrow themes can get crowded, volatile, and dependent on a small group of stocks.

3. Many themes overlap with existing ETFs.
   Corgi may be cheaper, but investors should still ask: am I getting a better portfolio, or just a new wrapper around stocks I already own through QQQ, SMH, XLF, XLI, ARKK-style funds, or broad-market ETFs?

4. New ETFs often have liquidity issues.
   A fund can be listed and tradable, but still have thin volume, wide bid/ask spreads, small AUM, and poor trading efficiency in the early days.

5. Structured buffer ETFs are not magic protection.
   Buffers usually work only over a defined outcome period and often come with caps on upside. Buying after the outcome period starts can change the risk/reward. “Buffered” does not mean “can’t lose money.”

6. This looks like a spaghetti-cannon strategy.
   ETF.com basically described the launch as throwing a huge number of products at the wall to see what sticks. That may be a good business strategy for a VC-backed issuer. It is not automatically a good investment strategy for retail investors.

My view: Corgi is worth watching, not blindly buying.

Some of these funds may become useful tools. A few may gather assets and become real products. But with a brand-new issuer, dozens of niche themes, little operating history, and likely thin early liquidity, investors should treat these as speculative satellite positions at most — not core holdings.

Before buying one, I’d want to know:

- What are the actual holdings?
- How concentrated is it?
- What is the AUM?
- What is the average trading volume?
- How wide is the bid/ask spread?
- Is this theme already covered in my portfolio?
- Is the ETF solving a real allocation problem, or am I just buying a catchy ticker?

Corgi may be innovative. It may also be a perfect example of why ETF investors need to read past the ticker, the theme, and the fee.

Not financial advice. Just a reminder: new ETF wrappers can make old risks look shiny.

Due diligence here but with a twist. I started to lay out all the various treatments and standard of care and ORR and DCR and then reality hit me…

Recurring GBM doesn’t have anything that works. It is where my father was when he got lyomyosarcoma in the 1980’s and the choice was hospice or be a poison-sack guinea pig and possibly help others. He chose to help others.

Like many of you, I spent a long time learning about PanC and the treatments and why a 100% DCR mattered for the stoppage of internal bleeding, duct blockages, etc.

None of that matters here.

We don’t care about DCR when it comes to rGBM. Controlling the disease isn’t going to tell you anything if it comes back in a month. We are dealing with the biological equivalent of pure evil here.

There are some good and even some great things that could come out of this but remember - this is a safety study first and foremost. Obviously, we hope it works. Desperately. But understand that if all we know at the end of the day Monday is that all three cases are still alive and they achieved 85% or better coverage of the tumor without massive brain damage, we have an important step forward.

With those caveats in mind, let’s go deeper and see what is good news, what is great news, and what is earth shattering news.

Alpha Tau’s Monday GBM Call: A Shareholder’s Guide to “Earth-Shattering” vs. Just “Good” News

TL;DR
Recurrent glioblastoma (rGBM) is oncology’s graveyard. Standard salvage therapies almost always fail within 2–4 months. Alpha Tau’s Monday call (first 3 patients, ~4–5 months follow-up) can’t prove survival yet — but it can deliver the first credible signal that Alpha DaRT actually kills tumor cells in the brain while leaving healthy tissue alone.

Here’s exactly what you need to hear Monday to decide if this is boring, interesting, or earth-shaking.

Why Recurrent GBM Is the Hardest Problem in Oncology

After the Stupp protocol (surgery + radiation + temozolomide), median overall survival is only ~15 months. Once the tumor recurs — which it does in >90% of patients — options collapse:

Re-resection (only if safe and accessible)

Re-irradiation (risk of radiation necrosis and permanent deficits)

Lomustine or temozolomide rechallenge → median PFS ≤2 months, 6-month PFS ~20%

Bevacizumab (Avastin) → often shrinks the enhancing part on MRI (high radiographic ORR ~27%), but this is frequently a pseudoresponse — it just plugs leaky vessels and reduces edema without killing cancer cells. No overall survival benefit. Patients still progress quickly and remain steroid-dependent.

Historical complete response (CR) rate in truly unresectable, post-radiation rGBM? Essentially zero. Partial responses are rare. Most patients decline neurologically, pile on steroids, and die within 6–9 months of recurrence. This is why even modest signals here move the needle dramatically.

What Alpha DaRT Is Trying to Do Differently

Alpha DaRT places tiny radium-224 sources directly into the tumor. Short-lived alpha-emitting daughters travel only a few cell diameters, delivering extremely high-energy, localized cell kill while (theoretically) sparing surrounding brain.

The REGAIN trial’s first three patients are the first humans ever treated with this approach in the brain.

Primary goal right now: safety + feasibility in a 10-patient pilot. Efficacy signals are the bonus that could re-rate the entire platform.

Monday’s Data: The Exact Tiers Shareholders Should Use

Tier 1 – Boring / Baseline “Green Light” (Moves the stock modestly)
3/3 patients alive with 100% local disease control (stable disease or better)

Clean safety: no dose-limiting toxicities, no Grade 3+ treatment-related neurological events, no symptomatic radiation necrosis, no new seizures, no intracranial hemorrhage

Procedure feasible, no surgical complications

What it means: The device works in the brain without destroying the patient. This de-risks the rest of the 10-patient study and keeps the “local therapy” thesis alive. Good, but not transformative. Expect a polite pop and then “show me more durability.”

Tier 2 – Interesting / Very Strong (Commercial de-risking, real momentum)

All 3 patients alive and progression-free at the current follow-up (~4–5 months for the first patient)

At least one (ideally two) partial responses (≥50% shrinkage by RANO criteria)

Steroid weaning or stable/reduced dexamethasone use

Neurologic function stable or improved (KPS bump, motor/cognitive gains)

Tumor shrinkage accompanied by signs of real cell kill (central necrosis, diffusion restriction on MRI, or falling ctDNA) rather than just vascular normalization

Why this matters: Standard salvage therapies almost never keep patients progression-free past 2–4 months.

3/3 progression-free + objective shrinkage at this timepoint would already beat historical benchmarks.

It starts to look like Alpha DaRT is doing something the field has never reliably achieved: potent local tumor destruction without wrecking the brain.

This is the level where serious investors start modeling larger trials and platform potential.

Tier 3 – Earth-Shattering / Paradigm Shift (The one that makes people say “holy shit”)

One or more RANO-confirmed complete responses (ideally with corresponding improvement on T2/FLAIR — proving the non-enhancing infiltrative tumor is also gone, not just the enhancing core)

Two or three objective responses (ORR 67–100%) with clear durability signals

Zero serious brain toxicities + clear clinical benefit (steroid reduction + functional improvement)

Bonus: any hint of abscopal effect (regression at untreated sites) or immune activation

Why this would be historic: In post-radiation unresectable rGBM, a true CR has essentially never been seen outside case reports. A durable CR (or near-CR) with clean safety would validate the core thesis — Alpha DaRT can deliver alpha-particle potency locally while sparing brain tissue.

It would instantly reframe Alpha Tau from “interesting device company” to “potential first real advance in recurrent GBM since temozolomide.”

The stock should rip, and the platform story (other solid tumors, possible systemic immune effects) would explode.

The Magic Phrase to Listen For

Listen for something close to this:
“All three recurrent GBM patients remain alive and progression-free, with 100% local disease control, objective tumor responses in X of 3 patients, no serious treatment-related adverse events, and stable or improved neurologic function and reduced or stable corticosteroid use.”

That single sentence would cover safety + efficacy + clinical benefit. Anything close to it is very strong. Anything short of it (just “stable disease, clean safety”) is the boring tier.

Red Flags & Nuances You Must Understand

Pseudoresponse vs. real response: Bevacizumab can make tumors look smaller on contrast MRI without killing cells. Watch for language about central necrosis, diffusion changes, or FLAIR improvement — those suggest actual tumor destruction.

Short follow-up: Even a dramatic CR on Monday will need a confirmatory scan in 3 months to prove durability. Expect volatility.

N=3 is tiny: One or two great responses are biologically meaningful but not statistically definitive. The market will price in the upside anyway.

Safety is non-negotiable: One serious radiation necrosis or neurological deterioration and the excitement gets capped immediately — this is the first time Alpha DaRT has ever been used in the brain.

Sober Note for Warrant & Stock Holders

Recurrent GBM is the hardest nut to crack for a reason. A “complete response” headline on Monday or an “abscopal effect” will be game changing. The upside we are all positioned for is exactly this: a clean, potent, well-tolerated local therapy that finally moves the needle where everything else has failed.

Bottom line:
Clean safety + stable disease = boring but necessary.

3/3 progression-free + 1–2 PRs + steroid weaning = very interesting, real momentum.

CR (or near-CR) in 1–2 patients + clean safety + clinical improvement = earth-shaking, paradigm shift.

Tune in Monday. This one matters to investors and a lot of people who have no hope at all.

(Positions: long DRTS & warrants. Not financial advice. Do your own due diligence.)

I’m reviewing the skin cancer trial that just closed. Also, I see that the PanC results are in and new cases are showing up across Europe and the GBM results will be announced on Monday which they would NOT do unless there was some positive news, no matter how small.

The PMDA in Japan was the signpost but the FDA allowing whatever trials Alpha Tau suggested made it clear that the only thing left before cert was to conclude the skin cancer trial. Now we have the news that it’s done.

My question is what happens when FDA provides cert?

Both from a partnership and stock perspective.

The obvious is that we start seeing revenue coming in and learn more about the logistics and delivery and there will be more doctors gaining experience and more lives being saved.

The less obvious is the partnerships. PanC and GBM are so huge and so critical that I won’t at all be surprised if they don’t hand skin to a deep pocketed partner.

The ability to deliver intratumoral radiation inside pancreas, brain and prostate were not what many potential investors expected a few short years ago. They saw skin in the US and head & neck in Japan and said “topical cancers.”

They missed that the platform changes the approach to every type of solid tumor, irrespective of where it sits.

So, now, the Israeli skin cancer company with a $225M market cap is soon to be a global $1B+ market cap platform for all solid tumors and that means everything should change very quickly.

It reminds me of what the CFO said a month ago: We will not be the same company this time next year.

Yes, I've made a boatload of money off my insane ETF picks, but I'm in my late 50's and I'm gambling with money that I should be hoarding for retirement.

Allow me to share what I own so you know not to do this if you're my age.

Warning: I have chased performance and I have FOMO. I'll provide you with the pathetic rationalization of each provided you understand the real reason I bought almost everything was because of a quick buck.

FMTM - I went heavy because I was a SPMO guy burned by the last six month period

SGRT - I like the idea that momentum can be done for earnings, and that price will follow

PSI - I saw an ETF in semi's that was outperforming SMH and I sold SMH for it

DRAM - The third Roundhill ETF i've owned that I know I won't own long

AIS - I owned it, sold it, regretted it and bought it back

EWY - I rationalize that it's all for South Korea but it's for the top three holdings really

BWET - I know nothing about supertanker shipping oil but I know BWET goes BRRRRR

PIT - Managed commodities after the silver and gold rush? Yes, please.

DBMF - Maybe the only responsible thing I've bought. It's a hedge when all of this tanks.

WGMI - Bitcoin is back over $80k? Time to load up on the fastest BTC related ETF.

BLOX - Bitcoin is on the rise? Great! Now, maybe I can have some income to pay bills

CHPY - The world's greatest ultra-high yield income ETF. Based on Chips

SOXY - For those that complain I'm leaving money on the table with CHPY

HYDR - Hydrogen? What is this doing here and why is it performing so well?

PTF - Yet another momentum ETF but focused on tech with a solid track record

QQQM - More tech? Really?

SGOV - Whatever. I'm not fooling anyone that I am a responsible investor.

STRC - This is a preferred; not an ETF. It is a ponzi scheme based on BTC. 11% distribs.

I've sold off my URA and my QTUM and my SMH and my GDMN and my LITP and my COPJ and my SILV and my BATT and my BOTT and so many others because I'm chasing hard. If the sun is shining on chips, I want to be there. If it's shining on gold, I'm there. BTC heating up? Hey, here I am.

The sad thing is that it's a lot of work and that, it's working for now but at some point I know performance chasing will fail hard.

I take solace in two things: First, if SCHD starts to outperform QQQ, you know I'll be all over SCHD. And second, I'll be able to help others by serving as a warning not to do what I did.

I get it. I don't like it but I get it...

As a human who has lost people to cancer, I want Alpha Tau to go HULK SMASH on the tumor with full blast coverage of the tumor.

As an investor who is heavily invested in DRTS, I want Alpha Tau to go full blast as well so that we can get not only the 100% DCR but, almost certainly, a higher ORR percentage.

In essence, hit the adenocarcinoma pancreatic tumor with so much radiation that it not only dies but that it shrinks more than 30%. And you do that with a higher coverage than what they used at Hadassah.

But...

That wasn't the point. That wasn't what they were testing at all. They weren't trying to become a "cure for cancer" or demonstrate a 50% ORR or anything of the sort.

They were following the Hippocratic oath: First, do no harm. Test the efficacy of placing the local radiation into the tumors with minimal coverage so that these poor patients who have been through radiation or chemo (more than once, even) don't wind up with horrible side effects from the treatment or worse.

What they were looking for was not what I was looking for: They want to know that the DaRTs could be placed inside one of the nastiest, most common, deadliest forms of solid tumor and have a positive result.

I wanted them to go crazy and destroy the tumor with utter disregard for safety, which is naive, irresponsible, and not at all how you achieve PMDA or FDA certification.

The utter magic of the platform being used effectively in pancreatic cancer when, for so many years, people thought this was just a great treatment for skin cancer, was lost when it should have been celebrated.

The ASCO results may show a bit more that we can celebrate. And, over time, we will learn many more things. How long are people living after DaRTs? How has their cancer stabilized? How much more effective is this when treated in conjunction with a non-physics based approach?

I still want them to go utterly medieval on these tumors. Not because I hate cancer (well, partially) but because I fully believe that they've demonstrated sufficient efficacy and sufficient safety to go barbaric. We don't have the luxury of time. Too many people are getting PanC and we need this weapon in the arsenal years ago.

I just got off a call with someone much more knowledgeable than me and, while he dumbed it down, I understand much better now.

Disclaimer: I'm not a doctor. This is how I understand it and I think it may be helpful.

The latest numbers from DDW give us an early insight into what's possible from Alpha Tau's DaRTs platform but there are key caveats that must be kept in mind:

1. This was adenocarcinoma PanC - the worst and most frequent kind - and I'll have more to say about that below.

2. This was nobody's first rodeo. Sadly, the patients involved in these trials had been through hellish treatments on multiple occasions prior to this - and it turns out that it matters in ways you might not expect.

3. This is all early data and we will know more once we get to ASCO.

TL;DR from what I'll go into below: Coverage is how much radiation was brought to bear against each tumor. Alpha Tau did not "light them up" on this round so you're looking at lighter than what would be expected coverage. ORR is how many of the tumors shrank by greater than 30%. And while Alpha Tau hit a decent 21%+ on tumor shrinkage, you need to understand some things about shrinkage that I'll get into below. DCR is the combination of shrinkage plus "disease control." What this measures is whether the disease is still spreading, causing the hellish ordeal of new tumors appearing, cut off blood supplies, blockages of ducts, internal bleeding, etc. 100% DCR is fantastic because Alpha Tau's targeted radiation is intended to be used in conjunction with broader systemic chemicals (drugs, chemo, immunity boost, etc.) in PanC cases and there are no negative immunity system reactions which would prevent that coordinated course of treatment.

Ok, let's go deeper...

A 100% DCR with only ~21% ORR means Alpha DaRT reliably stops tumors from growing locally, but only a subset shrink significantly. This is, sadly, common is radiation oncology for PanC.

Early patients received deliberately conservative source placement with limited tumor coverage. This suggests that incomplete spatial coverage of the tumor by the alpha-emitting atoms limited the cytoreductive effect in many patients. Meaning: Oncologists will need to use more coverage to gain better reduction results.

The challenge of ORR (tumor reduction) is unique in PanC:

Pancreatic ductal adenocarcinoma (the most frequent and most horrible PanC) has dense stroma, hypoxia and robust DNA repair mechanisms that blunt radiation-induced cell death. While alpha particles (high-LET radiation) are more effective than photons at overcoming some resistance, achieving shrinkage still requires killing enough cells to overcome the tumor's regenerative capacity - a higher bar than simply halting net growth.

The target patients matter. The pooled analysis included patients who had received up to 4 prior chemotherapy lines, with varying performance status and tumor biology. In this scenario, tumors may have evolved mechanisms that factor survival over proliferation which makes stabilization easier to achieve than regression.

(Cancer is a hateful, living, metastasizing, evolving killer and it will try to survive long enough to kill its host.)

Alpha radiation causes dense, localized DNA damage that can trigger immunogenic cell death and tumor remodeling without immediate size reduction. Inflammation or fibrosis post-treatment can also mask shrinking on imaging. Some "stable disease" cases may actually represent biological control not captured because of this.

(That's a mind blower if you think about it. The DaRT destroys the DNA, the tumor can't spread but because of inflammation due to the treatment, it won't be counted in ORR because it didn't "shrink" 30%+.)

What's needed next?

More sources per tumor

Real-time dosimetry to confirm adequate alpha-dose coverage of the entire gross tumor volume

Good news: Earlier interim data already shows that higher Radium-224 activity correlates with stronger responses.

Earlier treatment should improve ORR numbers: Using Alpha DaRT in chemotherapy-naive or first-line locally advanced patients could yield higher ORR because tumors are less adapted and more proliferative which means they are more vulnerable to cytoreduction.

Combine DaRT with systemic therapy

Alpha radiation can induce immunogenic cell death and release tumor antigens. Combining with chemo- or immuno-therapy may create synergistic effects that convert stable disease into shrinkage.

The FDA approved IDE supplement allows testing Alpha DaRT + gemcitabine/nab-paclitaxel which could enhance ORR thorugh complementary mechanisms.

Refine patient selection

Biomarkers predicting radiation sensitivity (e.g. DNA repair status, tumor hypoxia markers) cold identify patients most likely to achieve shrinkage.

Tumors with less desmoplastic stroma or better vascularization may allow more uniform alpha-particle diffusion.

Alpha DaRT is currently delivered as a single implant but it is possible that re-implantation or sequential dosing might deepen responses in tumors with high repopulation rates.

FINE. DOES DCR STILL MATTER?

Absolutely. PanC causes pain, biliary obstruction, gastric outlet obstruction, and bleeding so preventing growth of tumors is very clinically meaningful. A 100% local DCR in heavily pre-treated patients suggests Alpha DaRT can reliably provide this benefit with minimal added toxicity.

Higher ORR would be better, obviously, because tumor shrinkage can enable downstream interventions (e.g. surgery, ablation)

To compare Alpha DaRT to FOLFIRINOX which typically achieves: ORR: ~20-35% and DCR: ~60-80% is to understand that Alpha Tau has, it seems obvious, brought to bear a new weapon in the war against Pancreatic cancer and without side effects or negative impact to immune systems.

The very early 21% ORR in the worst possible cases indicates that Alpha Tau can shrink tumors in some percentage of patients. The 100% DCR indicates that all tumors implanted, despite limited coverage, respond in a meaningful way.

Then it’s over and the good guys won.

The hardest to treat, impossible to do surgery, racked by radiation or poisoned nearly to death by chemo patients were at the very end. And we are hearing strong rumors that Alpha Tau had 100% DCR on these patients with hardly any immunity system left for the fight?!

As an investor, I don’t have to say another word. Owning $DRTS if these numbers are true moves this from a calculated risk to a very simple intelligence test.

As a compassionate person, I get literally misty eyed here. That “shrinkage of the tumor” they’re talking about means that the DaRTs got a tumor up against a blood supply, typically to shrink so that a surgeon could operate without fear of the patient bleeding to death.

This is hope. This is physics. This is a new weapon in a very, very long and miserable battle that is so desperately needed.

100% DCR means the good guys win for a change.