Jun. 6 at 8:55 AM
$SLS my response to someone asking me if they should invest in SLS and whether it was a good investment:
I believe it is (at least for myself).
The Regal phase 3 trial for the SLS cancer vaccine GPS stopped enrolling patients in April 2024 (26 months ago) for a cancer (AML leukemia patients in status CR2 (complete remission 2) ineligible for a stem cell transplant) whose life expectancy (median overall survival) is about 8 months (10 if generous) on best available therapy (BAT).
The Regal trial divided 126 patients into 2 groups - the BAT (or control) arm and the treatment arm receiving GPS. It began enrolling patients over six years ago (enrollment began in January 2020) and stopped enrolling them about 27 months ago. The trial ends when 80 of the 126 patients die.
Statistically, substantially ALL (and certainly a lot more than 80 of the 126) of the patients should have died already if GPS were an abject failure. And indeed they designed the study thinking that 80 of the 126 patients would be dead by mid 2025.
Survival times have been so long that they extended the expected life of the study at first from June 2025 to the end of 2025. But the patients kept on living. By the end of 2025, only 72 of the 126 had died. So the study went on. They also ended up reducing the trigger point where the study ends from 105 deaths all the way down to 80 deaths because the patient kept on living.
And now here we are in June 2026, 27 months after the Last of the 126 patients was enrolled and almost 40 percent of the patients are still ALIVE (78 of the 126 are dead).
Moreover, although the study is blind to SLS in terms of who is getting the vaccine, it is not to the doctors giving it, and the doctors are literally asking SLS to continue supplying vaccine to study recipients because the doctors apparently believe the vaccine is keeping the patients alive and in remission. Or more cautiously, REGAL is open-label, so investigators know whether their patients are receiving GPS or BAT. The protocol allows ongoing GPS dosing for patients who remain relapse-free, and SELLAS has also disclosed an expanded access program initiated at investigator request. That suggests continued physician interest in GPS, although it does not prove what investigators believe about the blinded trial outcome.
Bottom line - either there has been a quantum leap in median overall survival time on BAT - something utterly unknown to medicine/oncology OR GPS is a smashing success and dramatically extends survival time for these patients with AML leukemia. I’m going with the later. That is why there is such excitement about SLS.
The primary endpoint for Regal is to achieve a median overall survival mOS hazard ratio for the GPS patients of 0.636 or lower. In layman’s terms, this means that to achieve statistical significance GPS must have reduced the risk of death in the patients taking it during the study period a minimum of approximately 36.4% over those patients in the control group. Stated another way, a hazard ratio of 0.636 corresponds to roughly a 36% reduction in the hazard of death for GPS versus BAT.
In reality, given how long it is taking the patients to die in the Regal clinical trial, many of the people following Regal, including me, believe the actual hazard ratio will be below .4 or even .3 or lower - that is a reduction in the risk of death of at least 60% or 70% or more. Of course, that remains speculative until unblinding at the end of the Regal clinical trial.
Indeed, in the phase 2 clinical trial, the median overall survival time of those patients on GPS was almost 4 times greater than for those on BAT - 21 months vs 5.4 months. The Phase 2 result was highly encouraging, but Phase 2 data are not the same as a blinded, randomized Phase 3 survival result. But to me anyway, given the extreme time of survival in phase 3, my own personal option is that GPS is performing as good or better than it did in phase 2.
When the 80th patient dies, which is expected in the next month or so (78 had died as of 3 weeks ago), SLS will issue a press release of that fact. SLS stock will likely jump upon that news.
Within weeks after that, according to the company, it will release the top line data results from Regal.
If the results are as good as we all believe they will be, SLS stock will jump by a multiple of where it is today. And SLS will almost certainly be bought out by big pharma within six months and the stock will jump even more. A number of key cancer drugs are coming off patent in the next few years and big pharma will be scrambling for replacements.
GPS works by targeting Wilms’ Tumor 1 antigen and spotlights it for the immune system so that the patient’s immune system attacks the cancer cells only because they have the antigen. Or, states more scientifically, GPS is a WT1-targeting peptide immunotherapy designed to stimulate WT1-specific immune responses, including T-cell responses, against WT1-expressing malignant cells.
The really exciting opportunity for potentially large shareholder value is that not only is Wilms’ Tumor 1 antigen expressed in about 97% of AML leukemia cases, but it is also expressed in over 20 different other forms of cancer. SLS’s own SEC filing state that WT1 is present in at least 50% of pathology specimens across about 20 cancers, and is overexpressed in AML, multiple myeloma, CML, mesothelioma, ovarian cancer, small-cell lung cancer, and others.
Accordingly, the big commercial opportunity with GPS is that it will be able to be targeted at many different cancers and become a very broad anti-cancer platform - like Merck’s mega anti-cancer drug Keytruda
Most people holding SLS stock are hoping for a 5 to 10 X return at minimum. Of course there are no guarantees and if the Regal clinical trial is a failure, it will go to about 20% to 30% of where it is now. SLS has one more very significant drug in phase 2 trials.
So a purchase of SLS is essentially a binary bet that the Regal clinical trial will be a success. I personally have 72,300 shares saying it will be but that was my decision after extraordinarily extensive due diligence (probably an investment of over 100 hours of my time reading everything I could and doing my own scientific analysis of AML survival statistics) to come to that conclusion.
Warning - because so much money could potentially be made on this, you should expect tremendous market manipulation and wild swings in the share price the whole way through this. As one example, are still millions of warrants outstanding that need to be exercised, which will lower this share price in the meantime. Last week, the company disclosed that there were still 15 million warrants outstanding of about 30 million originally. That creates downward pressure in the share price. Of course I really don’t care about that as to me these swings in the share price from
$7-
$9 are irrelevant compared to the tremendous gains that will be realized if Regal is a big success. To me anyway, the dips in the share price are opportunities to load up more shares.
Do your own due diligence and this is not investment advice. This is how I came to the conclusions I did with respect to my own investment or my own portfolio.
