DRTS conference call today for rGBM (Biotech haters, look away!)

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.