Member Info for B2HS2L

You may be right HC, but I feel the exact timing of deals may be more dependent upon:

. FDA AA authorisations acting as a conduit

. Issuing AVA 6000 1b trial data, and the consequent time it takes to bottom out the many interested parties manoeuvrings,

before agreeing a deal (or deals) with successful party (ies).

Recently (16.04.26) posted the following on the subject of Bicycle Thera.

Grok queery: Are Bicycle therapeutics reducing headcount?

Yes, Bicycle Therapeutics (NASDAQ: BCYC) is reducing its headcount by approximately 30%.

The company announced this on March 17, 2026, as part of its Q4 and full-year 2025 financial results and a broader strategic reprioritization.

It plans to cut about 86 positions from its ~288 employees (as of the end of 2025), leaving roughly 200 staff.

This move is intended to halve annual operating expenses and extend its cash runway into 2030.

The reduction follows a prior 25% workforce cut in August 2025, which left around 280 employees at that time.

Why was the Royal Society of Chemistry chosen as the Science Day venue?

I plugged the postcode into Google maps.

Burlington House is directly opposite Fortnum and Masons, Piccadilly.

However, a search reveals 'Sorry, we've found no results for "Philly's baseball giftware"'

There's still no way she'll be extracted before 8pm closing.

https://www.fortnumandmason.com/piccadilly

FWIW

https://www.sciencedirect.com/science/article/pii/S0895435623000495

Journal of Clinical Epidemiology - Volume 157, May 2023

Early phase clinical trial played a critical role in the Food and Drug Administration–approved indications for targeted anticancer drugs: a cross-sectional study from *2012 to 2021*

Key findings

•

One hundred and twelve (59.6%) indications were approved by the FDA on the basis of EPCTs, with a significant increase of 22.2% per year between 2012 and 2021.

•

EPCT mainly included two types of clinical trials: dose-expansion cohort (DEC) and single-arm phase 2 trials (Phase 2 SATs). Out of 112 EPCTs, 32 (28.6%) were DEC trials and 75 (67.0%) were Phase 2 SATs, respectively, with a significant increase of 29.7% and 18.7% per year.

•

Compared with phase 3 RCTs, EPCTs had significantly higher odds in receiving accelerated approval and lower odds in the number of entered patients of pivotal trials.

188 Approved Indications

106 Approved on the basis of Non-Randomized Trials

32 Approved on the basis of Phase 1 Dose Expansion Cohort Trials

Tomorrows instalment -

How to successfully wrestle three sea lions simultaneously - ...Don't

They think its a game, - but you'll end up in the water.

So far today that's 25 posts for one poster to post.

10 for D-Geeman

15 for wyndrum

That poster is not short of practice, and it's all his own piffle.

And my other posts this morning are disruptive, and don't discuss pro's and con's...

You are making yourself a laughing stock.

Assume that's COLDWATER liking your post.

If you attend the May 6th presentation, everyone in the room, as soon as you open your mouth, will know your wyn

or COLDWATER

or D-Geeman.

All those with a LSE logon will be forming a 25 meter exclusion zone around you.

See post - 17 April 2026

New starter skills include

From Grok:

Q What are the latest developments in CAR-T Regulatory (CAR-Treg) Cell Engineering

A CAR-Treg (chimeric antigen receptor regulatory T cell) engineering adapts CAR technology—originally developed for cytotoxic T cells in cancer—to regulatory T cells (Tregs).

These cells naturally suppress excessive immune responses, promoting tolerance rather than killing.

By equipping Tregs with antigen-specific CARs, researchers aim to deliver targeted immunosuppression for applications like organ transplant rejection, autoimmune diseases, graft-versus-host disease (GvHD), and emerging areas such as neurodegenerative conditions and cardiovascular inflammation.

* organ transplant rejection

* autoimmune diseases

* graft-versus-host disease (GvHD)

* emerging areas such as neurodegenerative conditions and cardiovascular inflammation.

All of the above is very unlikely, but a starter for ten.

The teams CC and Yulii is negotiating with might be trying to get her interested in these subjects, - beyond 6207, - and she has a background in CAR-T.

She's not going to start on a subject she does not know a lot about IMO.

Whatever is beyond 6207 she will have discussed in some detail with other directors the ins and outs, and PoS already.

From the RNS: announcing

"The Next Chapter of pre|CISION."

"The Avacta Science Day event for investors will take place in Central London on May 6, 2026 commencing at 10.30 AM."

"Avacta team members will share presentations on the company's scientific achievements *and our aspirations*."

++++

A bit difficult to do this without new info being available.

...heard Tom Winnifrith is attending..

Https://www.bbc.co.uk/news/articles/czxrznlpxzeo

'Similar sightings of a walrus were reported on Tuesday'.

Many more of a Sea Lion today.

RNS 08.04.2026 "Avacta Announces 2026 Science Day Event"

"The Next Chapter of pre|CISION."

"The Avacta Science Day event for investors will take place in Central London on May 6, 2026 commencing at 10.30 AM."

"Avacta team members will share presentations on the company's scientific achievements *and our aspirations*."

"The event will be professionally recorded and the video made available on the Avacta website in due course."

+++++

Apologies if the following has been mentioned before, - to me this is looking like a 06.05.2026 07:00 RNS introducing new information.

One new starter identified recently, - introducing new skills - see post 17 Apr 2026 11:22

+++++

Grok query:

What facilities do Imperial College students enjoy at Scale Space, Imperial College's White City Campus?

A small part of the response is

"Additional Notes for Students

Scale Space emphasizes integration with Imperial, giving businesses (and by extension students) access to talent pipelines, research, and events.

Students may engage through internships, careers fairs, or incubator-related activities.

General campus improvements at White City (e.g., Student Hub nearby) complement Scale Space,

but the site focuses more on innovation/entrepreneurship than traditional study libraries.

For precise access rules (e.g., to teaching rooms or events), check with Imperial's Student Hub, Business School, or the Scale Space reception, as some areas are tenant-focused."

+++++

My personal view is that the new starter has been accessed via Imperial College intermediaries

I'm unaware of other new starters.

Anyone with other views.

(As an aside, CC has been CEO 2 years on 01.05.2026).

Any Charlaton would have been found out after this length of time in charge me thinks.

RNS 21 March 2022

For a fuller understanding of Christina Coughlin's previous experience with T cells and Immunology, and her previous experiences in past companies, read this RNS introducing her as an NED to Avacta.

Many times if I have wasted my time here stupidly trying to justify myself to people.... ❌

Many times I have wasted my time here stupidly trying to justify myself to people.... ✔️

News - you've just increased that waste pile of time by posting.

Correct BV, I am not normaly so bullish on an issue.

She has allowed the question (expected or not) to stay in the video, and her response is commensurate with Avacta having made an application, expecting a response in the short term. No application, no prior discussion has always been the case since CC has been CEO.

She works closely enough with the FDA to know what response to expect.

She mentioned the lifetime limit, and conversations about lifting it, prior to FDA removal. - IVM 17.12.2025 :

Q 11 There's a reference in a broker note to Avacta having conversations around potentially increasing the max cumulative dose equivalent to beyond 550 mg.

Has the uplift from 450 mg to 550 mg seen much impact? And do we want to go higher than 550 mg if we're permitted?

A11

It's a great question. *We are looking to eliminate that lifetime maximum, but it is going to require agreement with the health authorities*.

While I can't comment on ongoing conversations with health authorities, what I can tell you is that the cardiac safety data, especially in patients stopping at the max of 550, these data were very favorable, compared to conventional doxorubicin.

This was something that we presented at ESMO.

I can also commit that once a decision is made we will absolutely communicate this to the investigators, the patients as well as to the shareholders alike. It is an important thing that we are looking at now.

+++

CC could have vetoed that question from IVM, minimising shareholder expectation.

However Business Development would not have had the benefit of including it in discussions with interested parties.

Again, I'm sure B.D. will be actively using expectation of Accelerated Approval in conversations.

One4one - I disagree.

A 60 day period has begun else the question would not have been asked in the video.

IMO it's either Fast Track or Breakthrough Therapy, and the only remaining question is when.

'stay tuned' was maybe inserted into the video contributing to pressure potential partners to progress discussions or change their negotiating position,

as it's now clear that an application to FDA has been made.

CC is going to have some explaining to do it 'stay tuned' turns into > month.

Questioning AI revealed:

Q

FDA Fast track approval process. Once a sponsor has applied for this designation, how long will FDA take to respond.

What other response times for other Accelerated Approval?

A

The FDA Fast Track designation is a program designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. A sponsor (typically the drug developer) can request this designation with an Investigational New Drug (IND) application or at any time thereafter, generally before submitting a marketing application (NDA or BLA). fda.gov

FDA Response Timeline

Once the sponsor submits a request for Fast Track designation, the FDA reviews it and makes a decision within 60 calendar days of receipt. This timeline is required by statute and outlined in official FDA guidance. fda.gov

The FDA will issue either:

A designation letter granting Fast Track status (if the criteria are met), or

A nondesignation letter explaining why it was not granted (e.g., if the request is incomplete or the product does not qualify).

Also

Fast Track and Breakthrough Therapy have explicit 60-day designation response clocks because they are requested early in development. Accelerated Approval does not, as it is more of an approval mechanism tied to the evidence package. Priority Review's 60-day decision applies specifically to the marketing application itself.

+++

CC knows when to expect a response as the question stayed in the video, so yes, this month RATHER THAN next month!

From the recent interview:

"Have you received any of sort of fast track designation?"

CC "I would say stay tuned"

+++

1 Why was the question asked, if CC has power of veto over what the video contains.

2 So the question stayed in and the response is "stay tuned"

A fast track expectation exists within the company, as they work closely with the FDA on many levels.

If Avacta had no expectation, that question would have either been removed or not asked in the first place.

No indication of fast track designation timing, but IMO it's this month or next, else timing for this discussion is poor.

It is another piece of FDA validation, increasing the value of AVA6000 in Business Development discussions.

It should have a further positive effect on the sp 💖🚀

Can't afford to lose another Spitfire, - that tree's coming down tomorrow.

Wait up, - no axe.

He doesn't have an axe to grind, - that's a first. 🪓🪓👀