Member Info for SNewby

Read about it. People attack Touk, not his arguments.

Signed, wy... I mean Snewby

Haha I thought you were making up a ridiculous claim that I joined on the exact same day as wyn... but I've checked and you are right!

Why am I lumped into being a wyn account? Doesn't that guy literally post thousands of posts per year?

I'm just sharing my take on the PHase I results so far?

Let's start with the uncomfortable number. Only 2 out of 30 patients achieved a partial response. That's 7%.

The standard defence is "but Phase 1 isn't designed for efficacy, these are heavily pretreated patients, you can't judge ORR in this setting." And yeah, there's some truth to that. But let's poke at it a bit.

First, these patients weren't actually that heavily pretreated. The median prior lines of therapy was 1. One. And here's the kicker—7 out of 22 patients in the Phase 1b SGC cohort had zero prior systemic therapy. These were first-line patients. A third of the cohort had never had chemo before.

So when people say "of course ORR is low, these are treatment-resistant patients who've failed everything," that's not quite right. We had a chunk of treatment-naïve patients in there, and the ORR was still 7%.

Second, the "Phase 1 isn't for efficacy" argument cuts both ways. If that's true, why is Avacta trumpeting the 90% DCR and the PFS data? You can't have it both ways—claiming the efficacy signals validate the platform while dismissing the ORR as "not what Phase 1 is for."

The reality is that efficacy signals in Phase 1 matter enormously. Investors obsess over them. Companies highlight any responses they get. Drugs that show zero activity in Phase 1 rarely make it to Phase 2. The industry watches Phase 1 ORR closely because it's predictive of what comes next.

The 90% DCR numbers are real, but the 7% ORR is the number that matters for commercial viability and partnerships. The investment thesis hinges on TNBC showing meaningfully better ORR (>25%) and AVA6103 validating the payload-switch hypothesis. Current

✅ What's validated: The pre|CISION platform works mechanistically—FAP-targeting achieves 100:1 tumor concentration and eliminates cardiac toxicity. This is a genuine technological achievement.

⚠️ What's concerning: Despite pharmacologically active tumor concentrations and 4x higher dosing, only 7% of patients achieved partial responses. Disease control is high but soft. The efficacy gap between "drug reaches tumor" and "tumor shrinks" is unexplained.

❓ What's uncertain: Whether the efficacy limitation is payload-specific (fixable with AVA6103) or platform-inherent (fundamental problem). TNBC data will be critical for answering this.

If ORR is still

If ORR is still

The 90% control rate is a bit deceitful, only 7% of patients had formal partial responses

Is the limited efficacy a PAYLOAD problem or a PLATFORM problem?

If PAYLOAD problem:

AVA6103 with exatecan should show dramatically better ORR

Platform retains full value

Current stock price is opportunity

If PLATFORM problem:

FAP-targeting may achieve drug concentration but not effective cell killing

Bystander effect may be insufficient for heterogeneous tumors

AVA6103 may face same limitations

Current thesis at risk

How to distinguish:

TNBC data (H1 2026): Doxorubicin is more active in TNBC than SGC. If ORR is still

Imo won't close above 60 for a week or two

Absolutely embarrassing board to read. Go to bed all of you

Absolutely not. there is a reason this company went from >£300M to less than 900k. It is an absolute dog of a company. You don't lose >99% and then have a turnaround story. simple as.

@SocialistB,

Fair questions. I've bought a position that I think is a bit too large for my net worth, and am going to scale down. I am long, however!

I agree the signals are encouraging - clean safety through three patients where toxicity kills is meaningful. But I'd push back on "we know it works for months." We know leukemic cells became undetectable in at least one patient, which isn't the same as durable responses that prevent relapse. That's the data we're waiting for.

The bull case isn't just "it kills blasts" - plenty of therapies do that. It's that FLT3 targeting might hit leukemic stem cells and actually cure patients. That's what justifies multiples of current valuation. We have reasons to hope, not proof yet.

On funding - the board has raised before and will again. The concern isn't whether, it's at what price. Every raise below intrinsic value transfers wealth from existing shareholders to new ones.

None of this makes it a bad bet. It makes it a bet. I just don't think there is any sense in valuating this share price. It's literally a lotery ticket.

You're betting that FLT3-targeted CAR-T therapy can cure relapsed/refractory AML by killing leukemic stem cells, not just circulating blasts - and that Hemogenyx can get there before running out of money or hitting a clinical wall.

What We Have

Three patients treated at the lowest dose level. All three passed safety evaluations with no dose-limiting toxicities. In at least one patient, leukemic cells became undetectable. The independent Data Safety Monitoring Board reviewed the data and cleared escalation to the next dose level. They've also received clearance to enrol pediatric patients, suggesting regulators see enough promise to allow expansion into a more vulnerable population.

What We Don't Have

Durability data - we don't know if responses last weeks, months, or years. Higher dose data - efficacy often improves with dose, but so can toxicity. Any evidence yet that this is actually hitting leukemic stem cells rather than just clearing blasts like other therapies. Anything close to statistical significance - three patients tells you almost nothing about true response rates. A funded path to completion - the company has going concern warnings and will need to raise more capital.

That's a nice little narrative you've built up for yourself there

Easiest short in the world. They will try to make a product, try to sell it. this will take ages with most certainly additional funding required, etc

GS wrong about their target or what?

What are you waffling on about?

Currently at a 13% week, 14% month. i'll take that

What 3D Spheroids Are vs. Animal Studies:

The author may have confused the 3D spheroid data with animal studies. Let me clarify:

3D Spheroid Culture (what's in the poster):

Cells grown in dishes to form 3D ball-like structures

More physiologically relevant than flat 2D culture

But still in vitro (in glass/plastic, not in a living organism)

No immune system, no blood vessels, no organ interactions

Not the same as animal studies

I've been working on a investment thesis/breakdown and had it compared against your substack rubbish. This is what Claude has to say:

⚖️ Final Verdict

What's the Truth?

The document is:

❌ Based on unverifiable data (animal study claims)

❌ Uses inappropriate valuation multiples (7-10× NPV for preclinical)

❌ Overstates peak sales potential ($3B without justification)

❌ Misapplies the pathfinder concept (assumes guaranteed success)

❌ Makes impossible comparisons (preclinical AVA6103 vs Phase 1 Enhertu)

✅ Correctly identifies some platform strengths (pathfinder de-risking, FAP validation)

✅ Reasonable on POS adjustment (30-40% is defensible)

Is This Person Credible?

Red Flags:

Claims specific animal data that isn't publicly available

Applies biotech valuation methods incorrectly

Appears to reverse-engineer desired outcome ($13.5-80B) rather than building from first principles

No discussion of comparable failed programs or downside scenarios

Name-drops "Tempus AI" without evidence