Member Info for B2HS2L

13 March 2025 Source -

Panmure Liberum document - Avacta Group - Initiation - pre|CISION strategy

Page 21

"Avacta is applying for orphan drug designation for the salivary gland cancer indication for FAP-Dox.

Discussions with the FDA are ongoing and a decision in 2025 is likely."

In my notes, I do not have confirmation that Avacta applied for, or received this ODD.

RNS (05 September 2022) confirms ODD for STS only, and Grok confirms.

+++

"Discussions with the FDA are ongoing and a decision in 2025 is likely." - ODD decisions don't usually take 9 months, or any where near 9 months.

With respect to WO2026002995 'Written Opinion'

https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2026002995

Text of 'Written Opinion of the International Searching Authority in XML'

Box Nos iii, iv & vii unticked is good news.

Content of the Supplemental Box

Generally not so good news.

If it's really as important as it looks - your statement - then BP are still required to take action for shareholders to benefit.

The JPM event might catalyse such action.

But BP will act when ready to act, and that doesn't help us a lot.

List so far

* Avacta won’t take 6000 into P2. Probably no one will. They will keep up the pretence until 3Q26 when first 6103 clinical results get published.

* I guess 6104 will deliver doxorubicin.

* TNBC was more or less chosen at random.

* wyndrum - But it has shown me to be in fact honest...

+++

Feel free to update

Quite a lot of name calling at football matches from a team's supporters, baiting the away supporters.

Y'know the ones in the minority at t'other end of the field..

Separated from the home supporters who cheer on the skill and efforts of the home team, and laugh at the away teams performance.

You three forget this is a board for Avacta investors, who cheer Avacta achievements and are naturally disappointed with reverses.

You three are like away supporters in the home end.

Ones that would get physically ejected by stewards, but that's not possible on a BB.

You have an agenda.

One that makes sure that FUD is introduced and promoted as much as possible, to the detriment of Avacta shareholders.

Nobody would do that day in day out for years without having that adverse agenda.

More filtering required chaps, seeing as that is the only tool available, and reporting rarely produces anything concrete.

Don't reply, it makes no sense to do so.

Happy new year everyone.

Except you three, - whom I hope experience the screaming discomfort of terminal piles.

Wikipedia:

"The intent of a challenge study (trial) is to fast-track the timeline for providing evidence of safety and efficacy of a THERAPEUTIC DRUG* or vaccine, especially by compressing (to a few months) the usually lengthy duration of Phase II–III trials (typically, many years).[2][3][13] Following preliminary proof of safety and efficacy of a candidate drug or vaccine in laboratory animals and healthy humans, controlled "challenge" studies may be implemented to bypass typical Phase III research, providing an accelerated path to regulatory approval of the test compound for widespread prevention against an infectious disease, such as COVID-19.[2][9]

The design of a challenge study involves first developing and testing a well-tolerated dose of the infection. A vaccine candidate would be tested for immunogenicity and safety in laboratory animals and healthy adult volunteers (100 or fewer) – which is usually a sequential process using animals first – and second, rapidly advancing its EFFECTIVE DOSE* into a large-scale Phase II–III trial in low-risk, healthy volunteers (such as young adults), who would then be deliberately infected with the disease being tested against for comparison with a placebo control group.[2][3][9] In a challenge study for a vaccine to prevent an infectious disease, participants would be closely monitored for signs of toxicity and adequate immune response, such as by producing substantial levels of antibodies against the virus causing the disease.[2][3][8]

*Capitals are mine .

Yamin 'Mo' Khan is CEO of hVIVO, not Avacta.

However from linkedin 3 months ago - he has this to announce:

I am delighted to share that Shaun Chilton has today joined the Board of hVIVO as Non-Executive Chair.

Shaun brings over three decades of experience in the pharmaceutical and CRO sectors.

His appointment further strengthens the Board as we continue to execute our strategy to drive growth at hVIVO, building on our position as a diversified, full-service CRO and the global leader in human challenge trials.

+++

Human challenge trials - Avacta will be putting first in human AVA6103 into the clinic shortly.

The timing of Shaun's appointment is about right. 🤷🏻

Thanks for the heads-up share-talk. (& alextak).

+++

Wikipedia:

Contract Research Organisation

In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biological assay development, commercialization, clinical development, clinical trials management, pharmacovigilance, outcomes research, and real world evidence.[1]

CROs are designed to reduce costs for companies developing new medicines and drugs in niche markets. They aim to simplify entry into drug markets, and simplify development, as the need for large pharmaceutical companies to do everything ‘in house’ is now redundant. CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMA, etc.).[2]

Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.[3][4] However, the sponsor of the trial retains responsibility for the quality of the CRO's work.[5] CROs range from large, international full-service organizations to small, niche specialty groups. CROs that specialize in clinical-trials services can offer their clients the expertise of moving a new drug or device from its conception to FDA/EMA marketing approval,[6] without the drug sponsor having to maintain a staff for these services.[7]

Agreed.

- I'm going to be re-using the

'View the latest FUD here' thread,

entering titbits, so it's obvious that dreaming up an unrealistic proposition etc,

doesn't mean other posters will automatically contribute, thus protracting the endless Fear - Uncertainty - Doubt.

'I'm sure they are working as closely as they can with the FDA'...

More on what Avacta has been busy preparing for the FDA recently, and thus the possibility of an RNS post application.

This excerpt is from

Peel Hunt ‘Expanding the Pipeline’ Interview with Avacta CEO Christina Coughlin 27.11.2024

https://peelhunthealthcarelifesciences.gallery.video/241127

"Q.

AVA6103 is currently in preclinical IND enabling studies. Could you tell us a little more about the future plans for this asset?

A. CC -

What this stage of development represents is that there are essentially three things that we do in the next stage for AVA6103.

The first is we have to get ready for the clinical trial in terms of manufacturing.

So the way that we make it for the preclinical studies is very different than the way that we have to make it according to good manufacturing practices for the clinic. That can take some time to get it right, and so those studies have just kicked off for AVA6103.

The second is we now move to more intense pharmacology but also to get started on another aspect before the clinical trial which is the toxicology.

And understanding really predicting using different models. What are the doses that we're going to be using in patients.

We have the clinical trials with exatecan to guide us, and so understanding where we are in terms of the toxicity the MTD (the maximum tolerated dose) that is observed across PC’s (pharmacology?) is going to be critically important for us to predict.

What is that dose that we are going to want to use in patients?

The third aspect is that as we get both of those to manufacturing the toxicology and the pharmacology ready.

We are now prepping for our conversations with the health authorities.

A common thought or a common misconception is that we just submit to the agencies.

Not true. We can actually have conversations, the FDA has an entire program called the pre-IND where we can have conversations before.

It allows us to do an early presentation of mechanism of action, the pharmacology, the early days of toxicology and we give them a draft of the trial, and we have a collaborative conversation about this.

All of these aspects, those three that I mentioned, can take over a year before hitting go on manufacturing and really being ready to file that IND. Again we work collaboratively with the health authorities on approving and then opening the trial in the US. "....

FWIW

R&D Spotlight Episode 13: https://avacta.wistia.com/medias/thz9au7cnj - slide 20.

Published December 18th 2025 - still shows an IND event in 2025, ie not 2026.

This suggests we should expect an RNS in the next 3 days.

I would expect them to adjust the time line if news were to have slipped to 2026.

FDA validation would be forthcoming reasonably quickly if / when Avacta applied for accelerated approval.

NFTs If that were announced short term, plenty of punters would miss the bus & have far fewer shares than last week.

Reminder, 3 weeks later - RNS 20 Oct 2025

Equity fund raise of £16 million pounds

Source Ditto.

https://www.investormeetcompany.com/meetings/interim-results-491 Q/A tab

Investormeet:

How much do you expect phase two Faridoxorubicin to cost Avacta? How will you fund this if a partnership doesn't materialize?

CC:

So, we're very confident in the maturing data and the phase 1B of Faridoxorubicin and we think that this will support the long-term value of this asset. Salivary gland cancers, you know, high unmet need and we continue to collect data in the various cohorts.

We have committed that we won't start the further development activities in the absence of a partnership.

However, as I've said, the maturing data set in phase 1B is providing us with ample confidence that precision is working exactly as we designed it to work.

The development in the expansion cohorts is well underway. We believe the preliminary data here will provide that natural inflection point for the program.

It's also going to provide clarity on accelerated approval pathways that we might be able to seek. Also there's really an opportunity for the overall market to digest essentially the commercial potential for the program and the platform.

As I mentioned, we'll have that pipeline update, platform update. And so we're really excited about the fourth quarter for the company.

BH:

Biotech rarely follows a normal path. The only constant is good technology ends up with partnerships or buyouts.

+++

Just a reminder of previous board comments regarding 2025 funding:

Interim Results Presentation TRANSCRIPTION, September 30 2025

Investormeet Q/A session starts:

What are the fundraising priorities for the remainder of 2025 and how do you plan to minimize dilution for existing shareholders whilst ensuring adequate capital for clinical development?

CC:

So as Brian reported, the company currently has a cash runway that extends into the first quarter of 2026. As you know, we are laser focused on strategic partnerships, business development.

We are prioritizing those strategic collaborations that would provide both funding as well as development expertise with potential partners.

Our maturing phase 1A as well as the phase 1B trial data are critical to these discussions. The purpose of those equity raises that we've done a bit earlier in 2025 were exclusively to address the need for the quarterly payments of the convertible bond.

These have been causing negative pressure on the share price. and we're as Brian mentioned as well, we're really happy with the renegotiation of that as we always have been.

We're focused on tight cash control and we carefully allocate our cash very carefully into each of our programs. but in terms of any next steps, we're not giving any timelines.

It would be inappropriate for us to state when and how until any deal is really agreed. Brian, do you have anything to add to that reply?

BH:

Yeah, what I can add here is the board is not worried. You're aware we're working on a number of options to fund our R&D programs.

We have a number of levers including partnerships, JV's, industry investment and or equity funding. The data from precision is only improving.

As Chris mentioned, we are seeing industry interest in our platform increase and our business development activities continue.

CC:

We would just like to add to that we are discussing both indications of Faridoxorubicin - we're now using its new name, - but Faridoxorubicin with a number of potential partners.

There's a lot of interest as well in FAP exatecan, but the company's strategy on that particular molecule remains we want to retain 100% ownership of this one. It's so close to the clinic it's so close and until it enters the clinic and delivers, we want to retain that 100%.

It's been a decision made with the board of directors and that is on track for the first quarter of 2026.

As you all know we're quite energetic in our business development discussions. We have a range of potential partners and it is a key focus of our financial strategy.

Excellent effort everyone, many posters not taking the FUD bait on offer yesterday.

Remember this thread, - FUD list started so we can all update and repost in future, as and when required.

List so far

Avacta won’t take 6000 into P2. Probably no one will. They will keep up the pretence until 3Q26 when first 6103 clinical results get published.

I guess 6104 will deliver doxorubicin.

TNBC was more or less chosen at random.

Https://www.investormeetcompany.com/ai-podcasts

Recommend the AI treatment of the 17.12.25 investormeet presentation.

"And TNBC was more or less chosen at random".

https://fast.wistia.net/embed/iframe/jhkzsr4536?web_component=true&seo=true 10:00

CC answering a question about which three indications still use Doxorubicin.

TNBC not chosen at random.

TNBC (also STS and SGC), not chosen randomly.

Wasn't difficult. - You three plough your fruitless fields on that thread.

1 Avacta won’t take 6000 into P2. Probably no one will. They will keep up the pretence until 3Q26 when first 6103 clinical results get published