Member Info for B2HS2L

The company made a big thing of making clear our aim was to become a pure Therapeutic entity.

The sale of Launch was RNS'd, once to announce sale, once to announce sale completion.

CC's Leerink presentation ended with:

"...we did disclose that with our divestment of the diagnostics division that we now have runway into the first quarter of 2026."

So no mention of Coris there.

Coris mentioned in RNS 07.03.2025

"Avacta is also in discussions regarding the sale of its remaining and much smaller Belgian-headquartered diagnostics unit, Coris BioConcept SRL.

So in a nutshell Avacta wanting their cake (we are now pure Tx), and eating it (we still have Coris to sell)

From Launch Diagnostics Acquisition RNS - Tue, 18th Oct 2022

...."M&A strategy for growing shareholder value

The Acquisition provides Avacta with an established route to market in the UK and several European IVD markets for existing and future products that it distributes, develops or acquires. It is the first step in building an integrated IVD business with global reach that has the advantage of Avacta's proprietary Affimer® platform to differentiate its immunodiagnostic products in a competitive market."

So for me this was about finding markets for Affimer technology.

Later Coris was bought to manufacture Lateral Flow tests utilising this tech.

+++

Avacta might proceed as follows, - we'll see:

1 to separate Coris from Avacta via a management buyout or other structure, so Avacta can continue to claim to be Tx only. That might take time if this option has only recently been considered, - possibly because the sale is not going well.

If it's an expensive option for Avacta, then it isn't a starter.

2 The sale of Coris is such that Affimer technology is still available to the purchaser, under t's & c's to be negotiated.

ie the original intent is retained to some extent.

FWIW - Grok query: 'UK govt considers rule change on clinical trials for biotech companies'

As of April 7, 2025, the UK government has indeed been actively considering and implementing rule changes to enhance the regulatory framework for clinical trials, including those conducted by biotechnology companies. While there isn’t a single, specific proposal titled "rule change on clinical trials for biotech companies" currently dominating headlines, recent developments reflect a broader effort to streamline and modernize clinical trial regulations, which directly impacts the biotech sector.

In December 2024, new legislation was laid in Parliament to overhaul the clinical trials framework, building on a 2022 public consultation by the Medicines and Healthcare products Regulatory Agency (MHRA) that received over 2,000 responses. This reform, part of the biggest regulatory shake-up in over 20 years, aims to speed up trial approvals, encourage innovative trial designs, and maintain patient safety. Key changes include reducing approval times (targeting a 60-day turnaround for commercial trials), introducing a notification scheme for low-risk trials, and embedding public involvement and diversity in trial design. These updates are designed to make the UK a more attractive hub for biotech firms by cutting bureaucratic delays and fostering innovation.

The government’s push aligns with its Life Sciences Vision, bolstered by initiatives like the £400 million Voluntary Scheme for Branded Medicine Pricing, Access and Growth (VPAG) Investment Programme announced in August 2024. This public-private collaboration aims to accelerate patient access to cutting-edge treatments and support clinical trial infrastructure, including 20 new research hubs. For biotech companies, this could mean faster pathways to market and enhanced support for trials involving novel therapies.

Historically, the MHRA’s 2023 response to the consultation highlighted intentions to align with international standards (rather than strictly EU rules post-Brexit), modernize terminology, and introduce flexibility based on risk proportionality. This is particularly relevant for biotech firms, which often pioneer low-intervention or complex trials (e.g., gene therapies). The government has also rejected some proposals, like factoring past non-compliance into new trial approvals, to avoid deterring biotech investment.

While no single rule change is exclusively branded for biotech, these reforms collectively signal a pro-innovation stance. Biotech companies can expect a more agile regulatory environment, though specifics—like exact timelines or exemptions—may still evolve as guidance is finalized in 2025-2026. For the latest details, checking the MHRA’s website or the government’s clinical trials policy pages would provide any breaking updates beyond this point.

Sorry last part of this sentence didn't make it to the post.

We would generate a commensurate income from milestone payments and royalties, subject to AVA6K STS Approval.

On the subject of STS licensing:

Consequent payments / royalties.

Source: investor webinar video – Turner Pope – 10.04.2024 Q/A session:

Answer 5 provided by Alastair Smith :

"....Orphan indications shouldn't be dismissed from a commercial perspective, biotechs with orphan indications can be extremely successful.

A good example is the company that Elliot Forster lead, - Immunocore - which now has a single drug approved in a small orphan indication called Uveal Melanoma, and that drug (Kimmtrak - developed by a team led by CC) generates $250 million a year, which is reasonably typical for an orphan indication."

Uveal Melanoma incidence = 1,650 to 2,000 new cases per year in USA - [incidence from an AI source]

IF we were to license STS, AS would have expected a licensee to generate an income of $250 million a year.

A year further on, and any licensee should generate AT LEAST that figure.

We would generate a commensurate income from milestone payments and royalties.

Over to those with more knowledge on this to pontificate numbers.

Wyndrum

4 posts and 7 question marks already this morning.

Haven't you got other boards to infest.

...scuttle off quietly never to appear here again.

err no.

If wyndrum were road kill there would be another resurrection, in case you misunderstood the last sermon.

It could possibly be used as a make-weight in a deal, but that depends how useful it may be / could become to the third party.

Glycomimetics bid price today is 0.19 cents.

The stock price has been below $1 since early May last year.

Egress from NASDAQ a possibility.

Dunno what comes next. - oblivion?

Source: https://avacta.com/about/leadership/

Mark A. Goldberg, MD

Non Executive Director

Mark A. Goldberg, MD, is a medical oncologist and hematologist and a biotechnology executive.

In addition to being a Non-executive Director of Avacta, he currently serves on the boards of directors of Idera Pharmaceuticals, GlycoMimetics, Blueprint Medicines, and Walden Biosciences.

wrt GlycoMimetics, Mark's Linkedin page states he was a member of the board of GlycoMimetics July 2014 until Feb 2025.

So it might be that Brian Hahn was recommended for the Avacta CFO vacancy.

Lets hope Brian is as good for Avacta as Mark's recommendation would appear.

Agreed Timster

Your PoV trashed Thorn.

Talk crap elsewhere and stay off this board - unless you have some research to share.

Please.

Thorn last night - 'I thought Phase 1 was a safety trial'

Why would they say it's safe when phase 1 is not completed successfully.

'I need to catch up with the news flow'. - Trust your instincts there.

Not looking as bad as you make out, with so few side effects.

No.

It's a post showing wrt Primary Outcome Measures, all is well so far.

Thorn, 'that's all the trial is designed to demonstrate'.

This is what the trial is designed to demonstrate:

From NCT04969835 version 8 (latest).

Primary Outcome Measures

1 Dose-limiting toxicities (DLTs)

Incidence and nature of DLTs

[Time Frame: Up to 28 days after the first dose of study therapy]

2 Adverse events (AEs)

Incidence and severity of treatment-emergent (TE) and treatment-related adverse events (TRAEs) and Serious Adverse Events (SAEs).

[Time Frame: From Day 1 until up to 30 days after last dose of study drug.]

3 Laboratory abnormalities

Incidence of clinically significant laboratory abnormalities and changes in laboratory values (haematology, coagulation, serum chemistry and urinalysis).

[Time Frame: From Day 1 until up to 30 days after last dose of study drug.]

4 Vital signs

Clinically significant changes in vital signs, physical examination findings, and ECG findings.

[Time Frame: From Day 1 until up to 30 days after last dose of study drug.]

5 Cardiac safety

Clinically significant reduction in LVEF (fallen by > 10% to below the lower level of institutional normal (as assessed by ECHO).

[Time Frame: From Day 1 until up to 30 days after last dose of study drug.]

Not looking as bad as you make out, with so few side effects.

Yeah, - like, we told each other SB was 'busy'.

A nation that treasures business acumen so highly, has tampon dispensers in a male bathroom?

Perhaps I read that wrong. 😏

For the latter part of the phase 1a trial, read:

RNS - Avacta and Tempus Enter Strategic Collaboration to Advance AI-Driven Drug Development in Oncology

LONDON - Oct. 21, 2024 - Avacta Therapeutics (AIM: AVCT), a life sciences company developing next generation peptide drug conjugates (PDC) targeting powerful anti-tumor payloads directly to the tumor, today announces the initiation of an artificial intelligence (AI)-focused collaboration with Tempus AI, Inc. (Nasdaq: TEM), a technology company leading the adoption of artificial intelligence to advance precision medicine and patient care.

So from or possibly even before October 21 2024.

B2HS2L

Posts: 5,069

Price: 47.50

No Opinion

RE: For the new investor’s on the BB, read below 04.12.24 15:32

"And when we try to debate/refuute points raised on AVCT"

Who's WE wyndrum?

Are we to assume you meant yourself Thorno and Touk.

+++

Earlier in the day you posted, and this was my response, copying verbatim the quote of interest to me.

Your post was deleted in the days following, and I'm sure I know why.

'blame the only people' - plural, - team implied.

Very concerned for the financial wellbeing of 'fools'.

Odd behaviour.

The quote is from the Panmure Liberum Initiation document, page 18.

The next paragraph is relevant to current posts:

For the latter part of the Phase 1a trial, patients were screened to show high

FAP levels, with the focus on patients with tumours which would be expected

to respond to exposure to doxorubicin, primarily those with salivary gland

cancer or sarcoma. This part of the Phase 1a trial has shown encouraging

preliminary clinical signs of anti-tumour activity. A high proportion of patients

with relevant cancer types, those that would be expected to respond to

doxorubicin, have shown a reduction in tumour volume or stable disease.

Aldebaran wins todays prize for mentioning Prometheus.

I've been waiting for someone to suggest reviewing the Prometheus way forward, but had to wait 'til 16:26 🙄

'They know exactly what they're sat on.'

The value here is the IP, and particularly the precision platform.

Value for AVA6K increases dramatically after successful end of ph1b.

We won't get the chance to launch ph2 as BP will ensure AVCT changes hands at that point.

One BP will make a play and the bunfight begins, ready or not.