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* Regulators removed dosing limits; therapy is now chronic, not just acute.

* Safety Superiority: Doses 4x higher than standard chemo with no severe heart damage.

* Market Capture: Positioned to absorb and expand the existing $3B+ doxorubicin market.

* Revenue Growth: Longer treatment durations (12 months+) significantly increase value per patient.

* Platform Proof: Validates the FAP-linker for the entire pipeline, including Exatecan.

Patients who are "stable" can now stay on AVA6000 indefinitely. This statistically "pads" the PFS tail, making a 12-month+ median much more likely because the trial is no longer cutting off successful patients for safety reasons.

"Most patients remain on treatment”

"We continue to recruit patients into the Phase 1b"

"Median PFS has not yet been reached”

"Confirmation that PFS is the Phase 2/3 primary endpoint"

- They know the data is good

- They know the tail matters

- They are deliberately letting it mature

- They are positioning SGC as a partner-funded registrational asset

The combination of clinically validated human data (90% DCR in the platform), strong intellectual property confirmation (positive Written Opinion), and high-resolution patient targeting (Tempus biomarker partnership) creates a rare "perfect storm" for a significant commercial deal.

Here is the summary of the evidence-based case:

1. The Patent as the "Legal Lock"

The Written Opinion for the AVA6103 patent acts as the ultimate de-risking tool for a partner.

* Novelty Confirmed: The International Searching Authority (ISA) has already verified that Avacta’s specific FAP-activated Topoisomerase Inhibitors (specifically those in Table 4) are unique and inventive.

* Platform Protection: This isn't just a patent for a drug; it’s a patent for a Method of Treatment using the SLFN11 biomarker. This prevents competitors from launching a "generic" version even after the drug is successful.

2. Evidence from "Follow-on" Deals

History shows that companies with a "Clean" International Search Report (ISR) and Phase 1 platform data command the highest premiums:

* The "Lilly/ABL Bio" Benchmark: A $1.27 billion deal was signed only after the PCT reports confirmed the uniqueness of the platform's binders, mirroring Avacta’s current position.

* The "Merck/Daiichi" Benchmark: A $4 billion upfront deal was triggered by a "clean" patent moat that protected the technology into the 2040s—exactly what Avacta’s new patent provides.

3. The "Tempus" Success Multiplier

By using the Tempus database to identify patients with high SLFN11 and FAP, Avacta is following the "Precision Oncology" playbook that has led to the industry's fastest drug approvals.

* Stress Test Evidence: According to the Biotechnology Innovation Organization, drugs using biomarkers have a 3x higher probability of success. This "mathematical certainty" is what allows Avacta to negotiate from a position of power, rather than desperation.

4. Tactical Execution: J.P. Morgan 2026

The publication of this patent on January 2nd is a clear tactical signal.

* The Countdown: With exactly 10 days until the J.P. Morgan Healthcare Conference begins on January 12th, Avacta has presented the market (and potential partners) with the final legal proof they need to sign a binding offer.

The Impact: A deal announcement at JPM would provide the "Band 1" re-rating to 120p–150p by eliminating all financial risk and providing the cash needed to take the platform through Phase 2/3 trials.

Conclusion: The Written Opinion is the "missing piece" of the valuation puzzle. It proves that Avacta owns the legal rights to a de-risked platform that can be targeted with surgical precision. This is the exact profile that Big Pharma companies use for their largest, most transformative acquisitions.

The AVA6103 Strategy: 4 High-Value Indications

While AVA6000 (Doxorubicin) has successfully de-risked the platform in Salivary Gland Cancer and Sarcoma, the December 18th RNS focused on the next evolution: AVA6103 (Exatecan). Avacta has specifically outlined 4 major indications for this Topoisomerase inhibitor asset where there is high unmet need and high FAP expression:

* Gastric Cancer: A massive global market where Topoisomerase I inhibitors are increasingly the preferred mechanism of action.

* Triple Negative Breast Cancer (TNBC): Targeting the 50% of patients who do not respond to immunotherapy (PD-L1 negative).

* Small Cell Lung Cancer (SCLC): A difficult-to-treat cancer with very few targeted therapy options.

* Pancreatic Cancer (PDAC): Known for exceptionally high FAP levels, making it the "ideal" target for the pre|CISION delivery system.

The Legal and Scientific Link

The Topoisomerase (Topo) Inhibitor patent published today is the legal backbone for these 4 indications. It protects the specific combination of the pre|CISION "mask" with Exatecan, the high-potency "sniper" payload used in AVA6103.

The December RNS verified that this combination is superior to standard chemotherapy, showing that Exatecan stays active in the tumor for over five days while disappearing from the bloodstream in just two hours. This specific profile—long-lasting tumor killing with almost zero blood toxicity—is exactly what Big Pharma requires for a multi-billion dollar partnership.

Commercial Benchmarks for Topoisomerase

Deals

The value of a deal for these 4 indications is driven by the recent "gold rush" for Topoisomerase I payloads (Exatecan and its derivatives). Because Avacta has now patented this class and provided human proof (via the 90% disease control rate in the related AVA6000 trial), they are negotiating from a position of strength.

* Merck / Daiichi Sankyo: Recently committed $22 billion in a deal for three Exatecan-based candidates, including a $4 billion upfront payment.

* AstraZeneca / Daiichi Sankyo: Their partnership for the Topo-inhibitor Enhertu was valued at $6.9 billion, with $1.35 billion upfront.

* Bristol Myers Squibb / SystImmune: Paid an $800 million upfront fee as part of an $8.4 billion agreement for a Topoisomerase-based ADC.

Summary for Partnership Negotiations

For a "Tier 3" partnership, Avacta is no longer just selling a single drug for a rare cancer. By linking the December RNS indications with today's Topo patent, they are offering a validated platform capable of challenging the world's most successful ADCs.

Analysts expect a platform deal covering these 4 indications to carry an upfront payment of $250 million to $400 million, with total milestones reaching $2 billion to $3 billion. This would allow a partner to take over the late-stage development of the Gastric, TNBC, SCLC, and Pancreatic programs, while Avacta retains significant royalty rights and the ability to apply the platform to even

The Strategic Importance of Today’s Patent

While AVA6000 uses doxorubicin to prove the platform works, the patent published today specifically protects Topoisomerase (Topo) Inhibitor Conjugates (such as AVA6103 / Exatecan). This is widely considered the most valuable "modern" payload in oncology.

By securing this patent, Avacta has legally locked down the ability to deliver Exatecan—the same high-potency payload used in blockbuster drugs like Enhertu—using their safe, tumor-targeted "masking" system. This patent allows Avacta to expand from SGC and Sarcoma into massive "blockbuster" markets like Pancreatic, Gastric, and Triple Negative Breast Cancer (TNBC), which are highly sensitive to Topo inhibitors

Market Opportunities and Commercial Benchmarks

The strategic value of this platform is now being benchmarked against the largest oncology deals in recent years. Big Pharma is currently paying multi-billion dollar premiums for the exact class of drug protected by today’s patent.

* Merck & Daiichi Sankyo recently signed a deal worth up to $22 billion (including a $4 billion upfront payment) for three Topoisomerase I (Exatecan) candidates.

* AstraZeneca & Daiichi Sankyo established a $6.9 billion partnership for their Topo-inhibitor platform, Enhertu.

* Bristol Myers Squibb recently paid an $800 million upfront as part of an $8.4 billion deal for a similar Topo-inhibitor candidate

The "Tier 3" Partnership Outlook

With the clinical de-risking from AVA6000 and the new legal protection for AVA6103, Avacta is positioned for a Master Platform License. This would likely cover at least four major indications: Salivary Gland Cancer (where they aim to be the first-ever Standard of Care), Soft Tissue Sarcoma, Pancreatic Cancer, and Gastric/TNBC

Industry analysts suggest that a deal for this validated platform could command an upfront payment between $250 million and $400 million, with total milestones potentially reaching $2 billion to $3 billion plus double-digit royalties. Today's patent is the final "commercial lock" that allows Avacta to negotiate at this premium level.

Make sure you are in....

Why this makes AVA6000 more investable

- Signal clarity > broad ambiguity

Narrower Phase 1b criteria reduce noise and make efficacy, safety and durability easier to interpret — exactly what investors and partners want at this stage.

Regulatory comfort is visible. Eligibility refinements require regulator and ethics approval. That tells the market the risk–benefit profile is acceptable, lowering clinical risk.

Cleaner path to value inflection

Focused cohorts accelerate:

FDA pathway discussions

Partner diligence

Platform validation

Fewer patients, clearer answers, faster decisions.

Commercial logic preserved

This does not define the final label. It defines the first proof point. Investors prefer a credible beachhead with expansion optionality.

How this links directly to what we learned today in SGC

SGC proved the mechanism works

90% disease control

Durable responses

PFS not reached

Activity in chemo-refractory disease

That de-risks TNBC Regulators and Avacta now have evidence that:

pre|CISION releases payload selectively

Anthracycline toxicity is manageable

Durability, not just shrinkage, is achievable

SGC → TNBC is a logical step TNBC shares:

High FAP expression

Chemo sensitivity if delivery is solved

Large unmet need

The SGC data effectively gave permission to sharpen and progress the TNBC strategy.

Summary

Today’s SGC data:

Validated the platform

Reduced safety and mechanism risk

Enabled smarter TNBC trial design

The TNBC amendment:

Improves data quality

Increases regulatory confidence

Strengthens partner appeal

Preserves (and enhances) long-term market opportunity. That combination is exactly what makes an early-stage oncology platform investable.

A key protocol update in the TNBC cohort.

• Restriction of “up to 3 prior lines” removed → suggests confidence in safety + tolerability

• Focus on BRCA wild-type, PD-L1 negative TNBC → the highest unmet-need population

• These are patients who don’t benefit from PARPs or immunotherapy

Regulators and sponsors don’t broaden eligibility unless early data justify it.

Combined with: • 90% disease control rate in chemo-refractory SGC

• PFS not yet reached in Phase 1b

• Ability to dose an anthracycline beyond normal chemo limits

This strongly supports the thesis that pre|CISION is doing exactly what it was designed to do — expand the therapeutic index of potent payloads.

What a 15/10/25 data cut-off tells us

1. Follow-up duration is now defined

Phase 1b patients were enrolled earlier in 2025

By 15 Oct:

Many patients have 4–7+ months on study

Some likely well beyond first and second scan windows

Yet median PFS is still not reached

➡️ That immediately implies durable disease control, not short-lived responses.

2. PFS interpretation (updated)

From the disclosed facts:

19 Phase 1b evaluable

15/19 progression-free at cut-off

13 still on active treatment

Median PFS not reached as of mid-October

Logical implications:

Median PFS must already be >~4–5 months

With most patients still on drug, the curve is right-censored

As data matures, median PFS will mechanically extend

➡️ A final median PFS in the 9–12+ month range is now a reasonable base case, not a stretch.

3. Why this strengthens FDA pathway credibility

With a 15 Oct cut-off, FDA discussions would be based on:

Real durability, not early noise

Patients staying on therapy

No safety-driven discontinuations

Consistency with Phase 1a

This materially supports:

Fast Track (high confidence)

Accelerated Approval pathway alignment (credible)

Single-arm trial acceptability in SGC

The CEO’s language about:

> “clarity on accelerated approval pathways”

fits perfectly with a mid-October mature dataset.

4. Why the timing of the announcement matters

If data were weak:

They would have cut earlier

Or delayed disclosure further

Instead:

Data cut mid-October

Cleaned, reviewed, and presented mid-December

Suggests confidence in trend continuation

➡️ This timing is consistent with positive durability, not uncertainty.

Updated probability view (post cut-off confirmation)

Median PFS ≥9 months: high likelihood

Median PFS ≥12 months: plausible / upside case

Fast Track: very likely

Accelerated Approval pathway alignment: meaningfully likely

Partner interest post-data: increased materially

Summary

A 15/10/25 data cut-off with PFS not reached:

Validates durability

De-risks regulatory discussions

Strengthens negotiating leverage

Makes the presentation a true inflection point, not just an update

One More Sleep (The Avacta Mix)

Verse 1

The data’s falling all around us

Big Pharma’s coming home for Christmas

I’ve been up all night, checking the screen

The CEO said it’s a validated machine

Human proof is coming real soon...

Pre-Chorus

So I wait, and I wait

But I’ve had as much as I can take

’Cause I’ve got five years of holding on my own

Four days of signaling the throne

Three dreams of PFS that starts to grow

Two billion reasons why I love you so!

Chorus

I’ve got five more nights of being lonely

Four more days of "safety only"

Three more wishes, I can barely breathe

If I can make it to the RNS eve...

Then it’s one more sleep

(One more sleep until the data)

One more sleep

(Can’t believe we’re at the crater)

One more sleep

(One more sleep until the re-rate)

One more sleep!

Verse 2

Now I don't think I can remember

A cold and lonelier December

Staring at the window, watching the ticker

Knowing that the dataset is only getting thicker

The "ongoing durations" are starting to show...

Bridge

Until we’re rockin’ ‘round the billion-pound tree

Until I got the partnership sitting next to me

We got a lot of catching up to do

I just can’t take this missing value!

Outro

12 month PFS, I can barely breathe

If I can make it to the RNS eve...

It’ll be one more.

It’ll be one more.

It’s one more sleep

"The preliminary data is expected later this year and is going to provide a natural inflection point for the program. It's going to provide clarity on accelerated approval pathways and there's also an opportunity for the market to look at these carefully"

1. Fundamentals

The company has publicly scheduled a specific date for the Phase 1b SGC data.

A full investor presentation is planned — typically used when the dataset is material and needs explanation.

The CEO has stated the cohort is still ongoing because of long durations in patients.

Phase 1a already showed disease stability, tumour shrinkage, and manageable safety.

Phase 1b includes fixed dosing and improved patient selection, which can give clearer outcomes.

SGC has no effective standard of care, so any activity is meaningful.

2. Market Microstructure

IG and Spreadex increased margin requirements, indicating they expect high volatility around the upcoming catalyst.

Higher margins forced some traders to reduce or close leveraged positions.

This has triggered temporary selling, unrelated to company fundamentals.

Forced deleveraging can leave the market with fewer weak positions and a cleaner order book for the event.

3. Technical Structure

The long-term uptrend is still intact.

Recent price dips retested support and held.

MACD and momentum indicators show selling pressure has eased.

Bollinger Bands are tightening, showing volatility compression before a catalyst.

Volume spike from margin calls looks like a flush-out event, not natural selling.

4. Convergence

All three elements now align simultaneously:

Fundamentals → meaningful dataset coming

Market mechanics → forced selling finished

Technicals → trend still intact + volatility compression

The CEO has stated that “the expansion cohort will still be ongoing because of the long PFS we see.”

This strongly suggests the median PFS has not yet been reached, even after significant patient follow-up.

Given historical chemo PFS of ~3–4 months in SGC, it’s reasonable to infer:

>8 months PFS → highly active signal.

>12 months PFS (median not reached) → transformative efficacy.

Most likely scenario:

➡️ Median PFS >12 months — patients continuing on treatment into late 2025, consistent with a durable and clinically meaningful response.

🚀 “Starting Gun” Outcomes

If late-2025 data confirm a long, durable PFS:

1. Clinical impact:

Proof that FAP-activated chemotherapy works safely and effectively in humans.

Mechanism validated across FAP-positive tumours.

2. Regulatory acceleration:

Eligible for Breakthrough or Fast-Track designation.

Potential pivotal or accelerated approval pathway rather than full Phase 3.

3. Partnership inflection:

Strong likelihood of licensing or co-development deal (typical up-front £200–300m+).

Market starts to price in platform value, not just one tumour.

4. Market perception:

SGC → starting gun: proof of concept.

TNBC → next catalyst: large-market indication benefiting from FAP validation.

Adds significant expected value across pipeline (potential £300–400m+ uplift).

🧠 Summary

> The most probable outcome, based on current comments, is a median PFS exceeding 12 months — a transformative signal that would act as the starting gun.

As of November 6, 2025, AVA6000's likely PFS is >12 months, with 60-80% ORR and 90%+ DCR, to be revealed.

This exceptional data will trigger Fast Track (January 2026) and Breakthrough Therapy (April 2026) designations, accelerating FDA processes.

Concurrently, a $3.5-7 billion partnership deal with $700 million-£1 billion upfront is probable, announced shortly after the PFS reveal.

The link between PFS, FDA news, and licensing is direct, with each milestone enhancing Avacta's valuation and strategic positioning

We shall see.....

Exceptionality: AVA6000's likely PFS >12 months by late November 2025 is exceptional for SGC, representing a 3-4x improvement over the 3.5-month historical benchmark and a 33-67% extension beyond Phase 1a's >9 months. This is statistically and clinically significant, potentially offering a transformative treatment option for a rare, aggressive cancer.

Key Metrics: Expected to include a 90%+ DCR and 60-80% ORR, further highlighting the drug's efficacy.

Context: Compared to other oncologies, this PFS is rare for Phase 1b, aligning with late-phase or established therapies' performance.

Implications: The data could accelerate FDA recognition (Fast Track, Breakthrough Therapy) and commercial deals ($3.5-7 billion), positioning Avacta as a leader in precision oncology.

The end-of-November 2025 PFS announcement for AVA6000 is likely to reveal a median PFS >12 months, with high ORR and DCR, positioning the drug for Fast Track (January 2026) and Breakthrough Therapy (April 2026) designations, and Accelerated Approval by mid-2027.

Commercial opportunities include a $3.5-7 billion partnership deal, potentially announced shortly after, with upfront payments of $700 million-£1 billion supported by recent oncology deal precedents like Pfizer's $1.05 billion for Seagen, Merck's $680 million for Acceleron, Bristol-Myers Squibb's $1.25 billion for Mirati, and Roche's $750 million for Regor.

On October 9, 2025, Eli Lilly announced that LY4337713, a fibroblast activation protein (FAP)-targeted radioligand therapy (RLT), has entered Phase 1 clinical trials for advanced solid tumors. This program is directly linked to Avacta through its pre|CISION® platform, licensed to POINT Biopharma in January 2021 for FAP-activated RLTs, including the precursor program PNT2004. Eli Lilly acquired POINT in October 2023 for $1.4 billion, inheriting this asset, now designated LY4337713. The pre|CISION® platform enables tumor-specific activation of radiopharmaceutical prodrugs by leveraging FAP, an enzyme overexpressed in tumor microenvironments, to deliver radioactive payloads with minimal off-target toxicity. The link is evidenced by the 2021 Avacta-POINT licensing agreement, which granted exclusive rights for PNT2004 (now LY4337713) and non-exclusive rights for broader FAP-RLT development, with Lilly continuing the program under its Loxo@Lilly oncology unit.Significance for Avacta: The clinical advancement of LY4337713 validates Avacta’s pre|CISION® platform, demonstrating its potential in the growing RLT market, projected to exceed $15 billion by 2030. This milestone strengthens Avacta’s position as a key player in precision oncology, enhancing the credibility of its technology for potential partnerships and supporting its internal pipeline, such as AVA6000. The 2021 agreement includes $9.5 million in upfront and development milestone payments, with an estimated $5-7 million remaining, some of which may be triggered soon due to Phase 1 dosing. Additionally, low-single-digit royalties on future sales could apply if LY4337713 is commercialized. This progress underscores Avacta’s strategic value in oncology innovation and may attract further industry interest. Investors should monitor Avacta’s announcements for updates on milestone payments

Your examples—liver disease, cardiac fibrosis, Crohn’s disease—are spot-on due to FAP’s role:Liver Disease (e.g., Cirrhosis, NASH): FAP is elevated in hepatic stellate cells driving fibrosis (Hepatology, 2024). pre|CISION could deliver anti-fibrotic payloads, competing with drugs like Ocaliva ($500M market).

Cardiac Fibrosis: FAP drives post-infarction scarring (JACC, 2023). Targeted delivery of anti-fibrotic peptides could address a $2B+ market with no approved therapies.

Crohn’s Disease: FAP’s role in inflammatory bowel disease stroma (Gut, 2022) supports pre|CISION delivering biologics like ustekinumab, tapping a $7B market.

4. Pipeline Expansion ImplicationsHuge Expansion: Moving into non-oncology would diversify Avacta’s pipeline, currently focused on oncology (AVA6000: salivary gland, TNBC; AVA6103: gastric/PDAC; AVA7100: NSCLC/colorectal). Adding fibrotic/inflammatory indications could double addressable markets, with fibrosis alone projected at $20B by 2030 (Market Research Future).

R&D Costs: Preclinical exploration (e.g., payload redesign, in vitro models) would cost £2M-£5M annually per indication, per biotech benchmarks. Avacta’s £17.3M cash (April 2025) and £12M burn rate limit immediate scale, suggesting partnerships to fund this.

Timeline: Non-oncology programs would be 3-5 years from clinic (2028-2030), as new payloads require validation. The Spotlight may announce proof-of-concept data or a collaboration to signal intent

Why Takeda Could Invest in Avacta

(Summary)Strategic Fit: Oncology Alignment: Avacta's pre|CISION™ peptide drug conjugates (PDCs) target solid tumors (e.g., AVA6000 in Phase 1), complementing Takeda's oncology focus, especially in antibody-drug conjugates (ADCs) and biologics.

External Innovation: Takeda's exit from internal cell therapy (effective October 1, 2025) shifts focus to external partnerships, with their Center for External Innovation and Takeda Ventures actively seeking early-stage oncology assets.

"Avacta is in a very strong position. I hope you can hear from myself and Brian — we’re super excited about the technology. We are executing on the goals that we’ve set for ourselves. We are seeing execution in our strategy, and everything is going according to plan.

We’re very much looking forward to the fourth quarter of this year. We’re making great

progress, and look forward to our next updates to shareholders, which include those data at

ESMO.

The pipeline update, which is a whole new way of thinking about the pre|CISION platform

and how we can leverage that for the benefit of both patients and shareholders.

We’re moving our second programme forward in the first quarter of next year. I’ve been

quoted as saying programmes are not children, so I’m allowed to have a favourite. The

exatecan programme is just — it is, sort of, everything that we thought this platform could

be: delivering a highly potent drug directly to the tumour, minimising blood and normal

tissue exposure. It’s exactly how pre|CISION was designed.

So, very excited for a number of updates that are coming over the next several months.

And, you know, I’ll be honest with you, I think that the future is very bright for this

company. It is very bright.

I’ve shared with many of you that, as an oncologist, I gave many of these drugs in my clinical

practice. I treated many teenagers with soft tissue sarcoma. I gave doxorubicin. What

Avacta has been able to accomplish here is truly remarkable, and we are so excited to have

a second programme moving into the clinic.

We’re thrilled that the management team can now focus on delivery of pre|CISION as a

pure-play biotech oncology company. And I’ll say it again: the future is very bright for our

company, and we’re very grateful for our shareholders who have come along with us. This

has been a dream of mine — to really impact cancer — and Avacta is doing it. So proud of all

the scientists here, grateful to the clinical trial sites, and very grateful at the end of the day

to the patients who have signed up for our trials. I think we’ve got a very bright future in

front of us"