Member Info for LiveLongnProsper

Market abuse regulations would preclude the CEO or Chair buying shares if they are in possession of material information not in the public domain. This would include the up-to-date readouts from clinical trials. CC has intimated as such, more data due in Q2.

Happy that CC's options are (from memory, so please check) at 72p, so she will need multiples of that to pay her tax and make some serious money.

GLA

@BV, hope so. The Point (Lilly) CanSEEK™ license is ‘limited and non-exclusive’, so no real constraints on doing business with Novartis (or any other BP – just needs one to declare interest, then this runs).

GLA

@BV, “JPM24: As cancer players jump head-first into ADC field, Novartis CEO explains how he's resisted the temptation”. Interesting isn’t it, so what are they going to be doing ..?

Novartis could really use pre|CISION® - would be like their own version of Lilly / Point Lilly CanSEEK™. Their pipeline is quite ‘heavy’ on radioligand therapy – targeting FAP, PSMA, SSTR, others), particular focus on solid tumours. Specific phase 1 / 2 trial targeting FAP …

https://www.novartis.com/clinicaltrials/study/nct04939610

No ADC’s, no platform. pre|CISION® could be the platform they need to support RLT development - and compete with Lilly, also gets them back to competing with Daiichi/AZN, Merck, et al with a targeted Exatecan (AVA6103) product, plus an early revenue boost with AVA6000. (Surely our CBO must be speaking with Janet?).

GLA

This is a much better watch …

https://www.youtube.com/watch?v=v5kstO1R2vA

Where are we on the Mark McKenna (Prometheus) ‘playbook’..?

We still have a Dx business to sell.

We still need to sort out funding for the next ~18 months or so – though a good deal for the above could resolve that.

Pipeline shaping up nicely. AVA6000 looking great, AVA6103 (“maybe it’s a pre|CISION® thing”, etc.) pre-clinical amazing results, AVA7100 on the horizon.

Data? For Prometheus it was Phase 2, for AVA6000 Phase 1b could well be the key.

Data on track then – ‘pivot the play book’ to operating as an independent company.

No sign of any giveaway licensing deals, and heading for Nasdaq.

Build a team and establish a ‘partnering’ process (Prometheus hired a bank).

Avacta just hired a CSO, then a CFO, now a joint broker (including a ‘top’ healthcare specialist sales guy). And, as we know, the CBO is ‘busy’.

Do ‘all the big funds see the opportunity of a novel breakthrough in a big drug class’?

Poster presentations, Science day, R&D updates, and trials being run at top US hospitals – with Oncology leads on the refreshed SAB. Do these BP folks really not know about Avacta?

Our new comm’s person (Carly Scaduto) seems to be getting the message out to the ‘trade’ press. I wonder if ‘Thrust Strategic Communications’ are doing the same (albeit behind the scenes) with potential investors and BP’s?

Next step - ‘best way to create value for shareholders is to create a competitive process’?

GLA

P1b underway (detail to confirm, RDE, etc.), CFO appointed, AVA6000 (limited) data update, AVA6103 (via R&D spotlight) update, joint broker just appointed. Now we need a ‘commercial’ RNS to move things on – DX, licensing, Nasdaq, II / BP stake, acquisition interest, etc.

Having said that, some good news on the FDA front would also provide a very strong signal. From results published to date, surely we already qualify for some form of FDA support, so what is holding things up?

https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review

‘Breakthrough’ can lead to ‘Fast Track’, which in turn can lead to “Accelerated Approval’ and / or ‘Priority Review’.

“Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).”

“A drug that receives Breakthrough Therapy designation is eligible for the following:

All Fast Track designation features …”.

“Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.”

“A drug that receives Fast Track designation is eligible for some or all of the following: …

Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met”.

“Accelerated Approval … For example, instead of having to wait to learn if a drug actually extends survival for cancer patients, the FDA may approve a drug based on evidence that the drug shrinks tumors, because tumor shrinkage is considered reasonably likely to predict a real clinical benefit.”

“Priority Review … Significant improvement may be demonstrated by the following examples:

evidence of increased effectiveness in treatment, prevention, or diagnosis of condition;

elimination or substantial reduction of a treatment-limiting drug reaction …”.

GLA

What an excellent presentation, thank you CC and Avacta scientists.

08:45 While discussing Exatecan CC quite keen to re-enforce a key point “What’s interesting about this one is, on the left hand side, where we stop treatment, and we still continue with these complete regressions, we’re seeing that in the clinic with AVA6000, and so patients with SGC, who have essentially stopped treatment, due to reaching the max level of cycles, they’re continuing in these responses, maybe it’s a pre|CISION® thing, something we are all going to have to figure out ..”.

Slight digression from today’s presentation - latest corporate deck …

Page 23 – Phase I expansion to phases II/II, SGC (launch 2028/9), TNBC (launch 2031/2) – no other indications mentioned.

Page 14 – Pipeline AVA6000 – SGC, Dedifferentiated Liposarcoma, TNBC – a Sarcoma indication included.

Page 16 – AVA6000 Expansion Cohorts (phase 1B) – TNBC, Hg STS (UPS, DDLPS), SGC – again, a Sarcoma (2) indication included.

Plenty of ‘optionality’ then.

Ending today’s presentation on a remarkably positive note, after discussing the benefits of AI ‘help’ with AVA6103. “It really positions us nicely to have a nice group of 5 or so diseases to take into this phase 1 trial … IND slated for later 2025 …” Included in the ~5, Cervical Cancer, with high unmet need and few treatment options. (Not on page 14 of last corporate deck – updates in real time!).

Come on then, Avacta commercial folks.

GLA

VT, Bella (and https://x.com/Ophidian18), slide 29 shows a quite stunning effect.

Note this slide was marked 'confidential' (along with slide 31 - AVA6103 Project Timelines).

All joking apart, I suspect that the 'deck' is a working document being updated in real-time for on going discussions in the background, we get a 'freeze frame' released from time-to-time.

AVA6000 needs regulatory approval now (fast track, accelerated, whatever) so patients over their (nominal, regulation constrained) lifetime max dose of Dox can continue to be treated with AVA6000.

AVA6103 can potentially take treatment to the next level.

No one else can deliver cancer killing 'warheads' to the TME, avoid release in normal tissue, and extend half-life / control release.

GLA

Some of the pages dated 2024 have clearly been updated since the previous version was released in November 2024, yet we have a bit of a mix of slide dates, and apparently a couple of ‘confidential’ slides have been (err) ‘leaked’.

Pages 2 – 7, 9 – 12, 14 – 17, 19, 21 – 25, 27 – 28, 30, 32 – 33 - “© AVACTA LIFE SCIENCES LIMITED 2024”

Pages 8, 13, 20, 26 – Not dated.

Page 18 - “© AVACTA LIFE SCIENCES LIMITED 2025”

Pages 29, 31 – AVA6103. ‘confidential’? “© AVACTA L IFE SCIENCES LIMITED 2025, (CONFIDENT IAL)”

Looks like this might have been put out in a hurry? (Not that proof reading has ever been Avacta’s forte, spot the AVA600?).

All adds to the intrigue.

GLA

Enough changes to warrant a CC presentation, needs full context.

Would also be a good opportunity to say something of a ‘commercial’ nature.

Page 3 – “and Affimer® technology”. Trojan Horse slide dropped. Page 6 – new.

Page 7 – re-write. Page 9 – new.

Page 10 – added “now completed its Phase 1 and I expansion cohorts”

Page 12 – “AVA8103” in heading,

Old pages 12, 13 dropped. Page 13 – new. Page 14 – updated.

Old page 15 dropped. Page 16, 17 – updated.

Old page 19 dropped, new page 18.

Old page 20 dropped, page 19 updated (vs old 21).

Page 20 – new. Page 21 – updated (vs ol 22), patient pops updated on chart.

Old pages 23, 24 dropped. Page 23 updated (vs old 25).

Page 26 – updated. Old page 29, 31, 32, 34, 35, 36, dropped.

Pages 28, 29, 30, 31, 32, 33 – new. Old page 33 replaced with new 31.

Probably some errors and omissions in my quick comparison, but certainly a significant update.

GLA

Https://avacta.com/wp-content/uploads/2025/01/Avacta-_Corp_Deck_Jan_2025.pd'f

it works’ ™

GLA

Perhaps (?) an example of the ‘the productivity paradox’ - when being ‘busy’ does not equate to being productive.

Our scientists seem to be remarkably productive. Something our commercial folks might reflect on?

CEO certainly one to ‘accentuate the positive’. Perhaps the time fast approaching to ’eliminate the negative’.

After all, we seem to be heading towards doing things the ‘American way’.

GLA

$500bn investment in AI.

https://x.com/OpenAI/status/1881830103858172059

Apparently, one of the objectives is to ‘cure cancer’. We can help with that.

Come on then Philadelphia office folks, let’s get in there quick for a ‘slice of the action’.

GLA

Apologies if already posted.

https://www.oxinst.com/news/chief-financial-officer-succession/

Paul Fry moving into a full time role as CFO at Oxford Instruments from April.

Announced a few days before Brian Hahn’s appointment.

See if he stays on as a NED?

GLA

Good points @Kong and @54.

https://www.databridgemarketresearch.com/reports/global-salivary-gland-cancer-treatment-market?srsltid=AfmBOooOIC1pSlodDXkNE-geXWuNj5ESZQl_3ogddhFqWGlLrYRdFAWj&utm_source=chatgpt.com

2023 US market size $1.65bn (based on 2000-2500 patients, ~13,000 patients worldwide), and projected $3.04bn by 2031.

Assume worldwide 3000 (advanced / metastatic SGC patients) suitable for AVA6000 @ $100-150k per patient gives annual revenue projection of $300-$450m. (Please make your own ‘assumptions’).

SGC is ~6% of head and neck cancer, STS and TNBC are also difficult to treat cancers and have similar market sizes.

Dox is a long established chemotherapy, limited by life threatening side effects. “pre|CISION® is a proprietary warhead delivery system based on a tumor-specific protease (fibroblast activation protein or FAP) that is designed to concentrate highly potent warheads in the tumor microenvironment while sparing normal tissues”.

AVA6000 is pre|CISION® delivered Dox, no MTD so far. Dox, via AVA6000, can be exploited to much greater effect (for the benefit of patients). Seems to be showing effectiveness in ways only recently being revealed in detail (CAF targeting, bystander effect, etc.).

Remember, AVA6000 is the ‘pathfinder’ for pre|CISION®. Next one, AVA6103 (Exatecan) is now coming through.

My own view, company should be acquired (at a fair price), for the benefit of patients, by a BP that has the resources to accelerate and expand the exploitation of, what looks to be, a revolutionary platform.

GLA

Not JPM, but more press (apologies if already posted), from China …

https://www.163.com/dy/article/JM3DH54R05349C3E.html

Bit of a ‘long shot’, but the ‘word’ is certainly spreading.

WuXi AppTec do – drug discovery, pre-clinical and clinical development and contract manufacturing. Co. revenue ~40bn RMB (~$5.5bn).

While they don’t particularly have their own products, they do have a proprietary drug development platform – TIDES ('Therapeutic Innovative Drugs and Enabling Solutions'), which can be (and is being) used to develop PDC’s.

I suppose that Chinese AI will have considered recent trial results, devoured our published patent material, etc. by now and be wondering what to do next?

GLA

More ‘Big Picture’ stuff?

Daiichi Sankyo, known for Enhertu (Trastuzumab Deruxtecan), are further developing the use of Deruxtecan with Datroway (datopotamab deruxtecan-dlnk).

Courtesy Marty McFlt https://x.com/Blueberrymgmnt https://x.com/search?q=%23avct&src=typed_query&f=live

PFS - progression-free survival, OS - overall survival, ORR - objective response rate.

Median PFS was 6.9 months (95% CI: 5.7, 7.4) in the datopotamab deruxtecan-dlnk arm and 4.9 months (95% CI: 4.2, 5.5) in the chemotherapy arm …

Median OS was 18.6 months (95% CI: 17.3, 20.1) in the datopotamab deruxtecan-dlnk arm and 18.3 months (95% CI: 17.3, 20.5) in the chemotherapy arm …

Confirmed ORR was 36% (95% CI: 31, 42) and 23% (95% CI: 19, 28) and median DOR was 6.7 months (95% CI: 5.6, 9.8) and 5.7 months (95% CI: 4.9, 6.8) in the datopotamab deruxtecan-dlnk and chemotherapy arms, respectively.

Draw your own conclusions as to whether a massive improvement over conventional chemotherapy, or not.

We understand that Exatecan is more potent than Deruxtecan, we are informed that the therapeutic index of AVA6103 (pre|CISION® delivered Exatecan) is 75x higher than conventional Exatecan.

I suppose Daiichi Sankyo know where we live (err… Philadelphia?).

GLA

Worth checking RECIST criteria.

Just to qualify a 45% PR means a 45% decrease in the sum of diameters of target lesions. Assume the tumour is roughly spherical, then this translates to a >80% reduction in volume. That is why it is significant.

Similarly, minor responses of 10%-19.5% would translate to ~27%-46% reductions in volume.

Now even if these tumiours by their nature (?) are more ‘flattened’ the volume shrinkage will still be greater than the reduction in diameter.

All looks very positive, particularly considering pre-treated patients, and no particular standard of care for SGC.

Still no MTD by the way – max lifetime Dox exposure regulations need updating for AVA6000 only. Say that again, ‘only AVA6000 can do this’.

GLA

Good coverage, and Fierce Bio is one of the few specialist publications with JPM Healthcare 2025 access.

Message will be spreading.

GLA

Thanks @Dr_DMS, a little more info …

“SERUM HALF-LIFE EXTENDED PD-L1 BINDING POLYPEPTIDES”.

“Document ID - US 20240409638 A1, Date Published - 2024-12-12”.

“Abstract - The present disclosure provides engineered PD-L1-binding Stefin A polypeptide variants, polynucleotides encoding the engineered PD-L1-binding Stefin A polypeptide variants, cells expressing the polypeptide variants, pharmaceutical preparations of the polypeptide variants, and uses of the polypeptide variants in the treatment of various human conditions, including cancer.”

“Application NO - 18/698634, Date Filed - 2022-10-06”

“DISCLOSURE OF INVENTION - Technical Problem”, short abstract …

“[0004] The HSA-PD-L1 AFFIMER® polypeptides of the present disclosure are useful, for example, for targeting cells that express PD-L1 and extending the serum half-life of such polypeptides.”

GLA

For some ‘big’ news, current assessment of ‘top team’ (FWIW) …

Chairman - ‘D’, more-or-less invisible, wanted to be judged after 6 months (so there you go). No Dx sale, no other commercial deals, appointed a NED (apparently with useful experience) who just went off to be CFO somewhere else, continues to allow shareholder value reduction with nothing to say. (Hope for big upgrade soon).

CEO – ‘A-/B+’, great science, nice re-focus and update of pipeline, loved the posters and R&D spotlight presentations, great refresh of SAB, seems to be ‘getting a grip’ on our IP, real passion and enthusiasm. Should have been straight ‘A’. Here are the ‘buts’ - seems to be reluctant to publish all known trial data without any real explanation, update of NCT04969835 should have warranted an RNS, strategic business direction not clear (though hinted), plus the odd silly tweet.

CBO – ‘D’, apparently ‘quite busy’, but no evidence of having achieved anything (will upgrade if Dx done well)?

CFO – Previous one ‘E’, failed, end of. We have a new one (good news) – to take us to ‘Nasdaq and beyond’. Looking forward to rapid progress.

(Scientists – ‘A’, thankyou all. Please keep up the fantastic work.)

Recent RNS says “LONDON and PHILADELPHIA”, indicates new folks engaged (“THRUST Strategic Communications” and “Carly Scaduto Consulting”) – no formal announcements, why?

While a predominately PI share base, we still require effective company communication and clarity to show that the company is acting in our best interests (remember, we collectively own the company). Beware of (and, NED folks, be aware of any tendency towards) ‘hubris’.

GLA