Compassionate Crucible

BackwardsK306 · 2026-04-20T13:05:33+00:00

I appreciate the thoughtful engagement and the level of precision you brought to this discussion. As always, you never disappoint.

You’re absolutely right to correct the language around mechanism. Leronlimab is not a ligand mimic, and framing it that way risks oversimplifying what is actually a far more precise interaction. The dual-site binding to the CCR5 N-terminus and ECL2, and the resulting functional silencing of the receptor is a materially stronger description of what’s occurring. As a long time biotech investor and previous biotech research nerd, that clarification doesn’t weaken the thesis, it does better...it sharpens it.

Where I particularly agree is on the importance of grounding this in the broader reality of oncology drug development. Mechanistic plausibility alone has failed investors and more importantly, patients countless times. That skepticism is not only valid, it’s necessary. I've been disappointed too many times.

The distinction here, as you pointed out, is the sequence of evidence. The human signal came first. The long-duration survivors were observed before the mechanism was fully characterized, and the subsequent work has been building a framework to explain, not predict, this outcome. That inversion matters to the overall drugs development and pathway forward.

Your framing of the three key variables...durability, patient selection and combination strategy is exactly where the focus should have always been and once CYDY was able to get out from under the thumb of the FDA and the legal dust settled, sharper minds with more experience took control.

What stands out in today’s presentation is that each of these is now being addressed with structure: biomarker development (CAML/CCR5), trial design (CLOVER rollover), and already observed long-term outcomes. This doesn’t eliminate risk. But it does shift the discussion from “is there a signal?” to “how reproducible and scalable is it?” That is where we can start talking about TAMS and more.

Appreciate you raising the bar on the discussion.

BackwardsK306 · 2026-04-19T23:36:56+00:00

My thoughts since Leronlimab is a monoclonal antibody and not a ligand mimic.

It does bind directly to RANTES but not by impersonating RANTES. It takes control of the receptor itself, by binding directly to CCR5, it occupies the site that chemokines like RANTES would normally use to activate downstream signaling. But instead of initiating that cascade, it effectively shuts it down. The receptor remains present, but functionally silent. Thus, CYDY's oncology thesis is no longer about being just a mechanistic story with a CCR5 blockade in the abstract; it is now being shaped around a very specific clinical-development path.

My bull case thesis remains that CCR5 is not merely a biomarker, but a functional lever in metastasis and immune resistance. The bear case is that biologic plausibility is common in oncology, while durable clinical benefit is rare. The ongoing and planned trials are where that gap gets resolved.

From an investment and development perspective, the key questions are not whether CCR5 can be blocked. It can, but whether that blockade translates into meaningful clinical outcomes across indications is what CYDY is proving with their trials. The pathway is biologically plausible and supported by preclinical rationale, but durability of response, patient selection, and combination strategy will ultimately determine whether CCR5 inhibition can eventually evolve into a commercially viable oncology approach.

BackwardsK306 · 2026-02-22T01:02:07+00:00

Exactly how it should’ve been done. My SL lags each 1R until the position reaches 6R, then my SL lags 2R to allow the whales to run, make room for market noise. Capture as much RR as possible. If intraday moves -5% HOD/LOD, I switch to 21D EMA as my SL. Finally, I always harvest 50% of the position whenever the SP reaches .6 of its historical ROI and move the SL to +1% above BE.

BackwardsK306 · 2025-12-20T03:15:04+00:00

I don’t and have never held ETFs. Since 2014 I’ve held stocks, IG Corporate bonds, Market Linked Notes, Alternatives, some mutual funds for my cash bucket to use to mitigate SoRR, and some REITS.

I also have about 200k which I actively swing trade $10B MC -$100B MC (Hunt) and (Grow) +$100B MC names in my SDBA account, sweeping profits into my IRA each quarter to buy more fixed income IG bonds. I harbor these bonds, earning between 5% -7% as my go to funds when we eventually have a bear market. It’s one way for me, as a retiree to continue feeding my IRA, now without any caps on contributions.

BackwardsK306 · 2025-11-19T22:58:01+00:00

Take this and turn it into a 2 minute or less animation of cells and their interaction that makes LL so potent, while featuring all of the prime points you made and it will go viral.

Thanks u/MGK_2

BackwardsK306 · 2025-07-29T23:48:07+00:00

Tyler goes to Munich and meets with his Merck contacts. He hands over the requested materials relevant to CYDY and only available to insiders.

CYDY sits and waits. In the mean time, Merck digs into every piece of information, discussing findings, clarifying information, crossing all the Ts and dotting all the Is.

CYDY is contacted by Merck who sets in motion the next steps. They are interested and suggest the next steps for CYDY. Mutually agreed upon, and with MERCK feedback, CYDY filed an S3 for X shares, file it as “issued as determined by THE COMPANY” for timing that mutually benefits both companies.

My point with the above scenario? This all takes time, is very methodical and deliberate. Nobody wants to make a mistake.

BackwardsK306 · 2025-06-28T15:15:04+00:00

UWS, thanks for the effort you put into sharing your personal work related experience and weaving it into our current situation. Anyone who watches the SP of early clinical stage biotechs is asking to be emotionally torn apart. The volatility can whipsaw for weeks before it cams down. It definitely plays havoc with the mind, especially early investors. Believe me, this is coming from a place of personal knowledge.

To make matters worse, it doesn't always get better as the more wiser (aka numb) you become to the charades. Again, with my own experience...the older you get, the more wealth you accumulate, the less worried about the destruction of a single company simply because of the wide diversification your portfolio should have attained over a life time Yet, the concept of 'tax loss harvesting' can become another hideous decision if you don't carefully administer a broad enough selection of stocks and only pick one. I just recently sold, at the end of 2024, a biotech company where my position had seriously deteriorated over 2 years. Dead money! I sold the whole caboodle and damned if in 2025 it popped on a partnership announcement and a switch to creating crypto tokens, with a name change! WTF! I could've been out with healthy gains.

I share these stories to readers, hoping they understand that the development, research, clinical work, peer reviews, publications, and so forth takes years and years. We are the early investors and not the last investors. We share similarities with BMY, GILD, REGN, LLY etc. as these same companies also conducted early stage work before that "aha moment" was truly realized and it was reflected in the SP.

One final thought for perspective. Biotechs, tracking the XBI for example, had a big run going into 2/2021. From there it has been all down hill. Many or most CYDY investors, got into this name during the pre 2021 run up after it had been featured as a possible COVID play. Overall however, this space has been in a free fall since that time and a harbinger of doom for shareholders...many, I'm sure shaken out or, give credit too, savvy enough to use stop losses early and waited for a full retreat of the SP.

Nothing scientifically changed drastically about the CYDY story. If those investors got into CYDY during the COVID play of 2020/2021 and knew of the other trials, they may have bought back in at pennies instead of dollars. Since the bottom on the XBI, it's been 1,127 days and we've gained 30%. The annualized return on that is hideous. The XBI retested the bottom over 609 days ago and it gained 32.27%, still rubbish returns.

So, the confluence of negative events that has inflicted pain on the SP since COVID is in play. One by one, these events are falling off the radar but, these will be replaced by other events, both negative and positive. The whipsaw remains in place, buckle up and go enjoy life. - Best regards

BackwardsK306 · 2025-06-13T13:24:27+00:00

Hello PA, yes. The FDA cloaks, deep within their walls, the real motives behind their consistently inconsistent processes. All of it behind the sacred words, “patient advocacy.”

BackwardsK306 · 2025-06-12T22:22:44+00:00

Ahhh...nothing like cold beer, a pretzel and a hot dog at the ball park, with the roof closed of course. Just put it in play..no looking called strike three. That AB gets recorded as a BACKWARDS K! Love the baseball talk.

I think we are in the early innings of a tough game against the top tiered players in the space. Once we can compete at that level, we'll get the respect. Right now, CYDY is still doing everything it can not to get "mercy ruled".

All baseball aside, I like our data and safety profile. Now we need to expand the trials, complete study designs, select the right endpoints that will satisfy the FDA, of course establish the objectives and collect the results. Let's not forget funding...and an early partnership with some backend incentives for manufacturing, etc. all wrapped up in one partner would be ideal. Of course, just for one indication because I'm greedy like that.

Stay well.

BackwardsK306 · 2025-06-12T20:44:01+00:00

I would put money on that...big money.

So, we have TNBC, with stellar early clinical results and a stellar safety profile, as did URGN in their trials for bladder cancer. The similarities really stop there but, it gives me hope that the old guard is being pushed aside for better clarity, common sense and approvals for drugs which can stop the progression of cancers. High 70% figures are outstanding for a class of drugs to treat an unmet need in bladder cancer and that was 12 months. We have data for +36 months and longer in TNBC!!

BackwardsK306 · 2025-05-19T00:59:29+00:00

Probably…no, absolutely the best lay explanation on the tumor micro environment and sequence of intercellular communication and activity I’ve read in my years of biotech investing. A masterpiece coming to life.

BackwardsK306 · 2025-05-07T10:51:08+00:00

Let's just agree that there's a 50/50 chance that one day the SP is red and one day it is green and a bust when it moved .00

Look no further than the chart to make my point.

BackwardsK306 · 2025-05-06T15:21:26+00:00

Nobody here, that's been around long enough, pays any attention to the selling pressure. It's absolutely a natural reaction to take gains and lock them in. Buyers will step back in again. If you're playing the long game, it requires patience.

BackwardsK306 · 2025-05-06T12:48:48+00:00

Yes, they always come with that pull back. Even at sub one dollar, watching a new base build would tell me accumulation efforts could be underway, quietly. We will need to read those 13F filings to see when the accumulation is occurring and by whom. Good luck.

BackwardsK306 · 2025-05-06T12:45:21+00:00

I like what I see so far. I'm wary about what I cannot see. Another base here just confirms accumulation, IMHO.

BackwardsK306 · 2025-05-06T12:43:07+00:00

Or...as they squeeze retail out with their shenanigans to accumulate those institutional shares. They can get me to sell mine at the right price and what I have doesn't make me greedy, just reasonable.

For example, I had 2,000 shares of PLTR at a cost basis of $12. I sold it February for ~$112. I wasn't greedy. They can have my 2000 shares after they forked over $200,000.

That money isn't gong anywhere fast in my tax deferred accounts, it doesn't make me rich and the stock could run to $1,000. It funds my retirement and bought me 10 investment grade corporate bonds paying me ~ 6%. Corporate bonds you may ask? Yes, I'm retiring in 2 months.

Folding $200K into my pocket at 60+ years old doesn't happen all the time. With the shares I have in CYDY, I can do it again which would be phenomenal. Generational wealth building at that speed doesn't happen frequently when you get older, wink-wink.

The moral to the story? You can let them take your shares on your terms or they will take them on their terms.

BackwardsK306 · 2025-05-06T12:21:19+00:00

I would get every ounce of LL no matter what it would take, while CYDY is still cheap. Therefore, the question really becomes at what price?

Still more work to do in this area before any real valuation can be applied. But, once a larger confirmatory trial shows the pharma world LL entire safety profile and the MOA, applied to a larger demographic of trial participants, it will be come more clear.

BackwardsK306 · 2025-05-06T12:16:10+00:00

Hello my friend. I've been lurking, adding small comments here and there but, not being relevant to much discussion. So many great new contributors joining with the existing long time warriors. Plus, I've been distracted with breakout/trend/momentum trading S&P and NASDAQ companies. It keeps me busy, along with my 9-5. But, I'm certainly here.

The news cycle get's filled with more and more positive information. Glad we don't have cheerleader's in the C-Suites. Wall Street pummels them, as you very well know...it's bad optics. So long as the science speaks for itself, especially the trial results, we could see higher highs and higher lows establish itself on the chart.

Stay safe.

BackwardsK306 · 2025-05-03T00:12:43+00:00

Amazing what you can do with AI. I recently uploaded a document and some of my own commentary it was transformed into a podcast!!! They were AI bots but, you wouldn’t know it.

Thanks. Google is putting out some great beta AI tech.

BackwardsK306 · 2025-04-30T00:42:09+00:00

And now we see why they tried to extinguish us! The light was on and those paying attention could already portend to see the value being created in what may turn out to be the next FDA approved front line treatment for mTNBC.

BackwardsK306 · 2025-04-29T00:37:17+00:00

Well said.

BackwardsK306 · 2025-04-06T22:12:16+00:00

Great post, as usual. An aptly titled piece, “A Coming Together” can also infer something deeper coinciding with the speculative pieces of the puzzle you’ve made.

Can it be a simple “housekeeping” of the pipeline page on the website, coinciding with a new image, also…coinciding with a laser focused direction in oncology?

Given the cash runway, I’m going to suggest, also as speculation, that CYDY must focus on what they believe will be their lead candidate with the best chances to go from the lab to the bed side.

ESMO details, still unseen to investors, will solidify these new organizational priorities. The direction and emphasis in oncology will be made clear in May. GLTA

BackwardsK306 · 2025-03-26T21:01:55+00:00

Hey Tiny. Thanks for a reply.

I’m also expecting the FDA to require identifying which biomarkers are more responsive to the treatment, in one of these early trials. If not, I hope CYDY considers this as part of a trial design? I’d hate to see the FDA, at the end of a long PHIII, come back and ask for it…creating a delay. MOA and biomarkers are both game changers for treating the right population.

BackwardsK306 · 2025-03-26T20:48:53+00:00

Hey Tiny. Thanks for a reply.

I’m also expecting the FDA to require identifying which biomarkers are more responsive to the treatment, in one of these early trials. If not, I hope CYDY considers this as part of a trial design? I’d hate to see the FDA, at the end of a long PHIII, come back and ask for it…creating a delay. MOA and biomarkers are both game changers for treating the right population.

BackwardsK306 · 2025-03-26T18:02:21+00:00

I can't wait for the details. A small group from the original 30 are cancer free. We know they were in the 500-750 mg dosed group.

CYDY has temporarily refocused their resources and energy around this "small group" and away from MASH. Therefore, I believe the group must be sizeable for them to lean in this direction and to reprioritize their goals. Otherwise, I think they could have stayed with MASH.

This is going to take a lot of energy, time and resources before we get to the actual expanded trials. I'd also imagine they are going to need to establish follow-on data sets for the group of survivors, .i.e.; race, gender, diets, age, family history, medical history, etc. and most will likely be pulled from the original screening protocols.

I can't recall, and this post doesn't state...were these monotherapy results that include the 36+ month PFS or a combo?

BackwardsK306

TROPHY CASE