Member Info for B2HS2L

O Cash runway extended into Q1 2026, supporting ongoing trials. Not the case

Which AI was this please, - worth avoiding.

JY

Avacta has begun the 'FAP-Dox (AVA6000) partnering opportunity' period - which continues to mid 2026 as shown on presentation timelines.

From: https://www.investormeetcompany.com/meetings/interim-results-491

"Interim Results" dated 30.09.2025

"Q11 In the salivary gland cancer data in late 2025 Q1 and 2026 the key inflection point, when will that read out?"

Answer 11

CC: "So, as you have seen, we, can make periodic updates prior to the full salivary gland data set.

We will reveal the entire data set as we have it in late 2025, late this year.

And that data update, this is not the ESMO data. I wanna be 100% transparent here.

The ESMO data is gonna be the dose escalation. That will be an update on the 11 patients that we saw the preliminary data at AACR.

Late 2025, we're gonna be looking at both the expansion cohorts which are ongoing, as well as, the dose escalation.

So, think about, a larger data set, in late 2025.

We commit to hosting an investor meet, regarding these data, we will be hosting an investor meet right along with the ESMO data,

and then later in 2025 with the full data set, as we have it, that will be released in the salivary gland cancer indication."

+++

Can't see a future Avacta presentation scheduled for December 25 or January 26 on the investormeet website.

There is space available presently before Christmas.

1) Late 2025, we're gonna be looking at both the expansion cohorts which are ongoing, as well as, the dose escalation.

2) ...and then later in 2025 with the full data set, as we have it, that will be released in the salivary gland cancer indication.

Personally only expecting SGC phase 1b data to be discussed.

However I could see them making mention of non-specific TNBC activity to assist the Business Development team. 🙂

If you listen very carefully you can hear POTUS's blood simmering..

Implemented in USA, patient health care costs could be reduced / become more affordable.

Is this why the Americans are fed up with the way NHS buys drugs longer term?

From Grok:

Q

The UK NICE facility decides whether a drug is value for money for the NHS. Does NICE factor a yearly increase for the price of drugs or not

A

NICE (the National Institute for Health and Care Excellence) does not automatically apply a fixed yearly percentage increase to drug prices in its cost-effectiveness evaluations. Here’s how NICE actually handles drug prices and potential future changes:

Standard Approach in Most Appraisals

NICE uses the list price (or the confidential commercial price agreed with the NHS via a Commercial Access Agreement) that is expected to apply at the time the drug is launched on the NHS.

In the base-case analysis, NICE assumes that this price remains constant in nominal terms over the entire time horizon of the model (often 10–30 years or lifetime).

→ No routine annual inflation or price increases are added to the drug cost. (EVEN FOR INFLATION - B2)

Exceptions and Sensitivity Analyses

NICE may consider price changes in specific circumstances:

Scenario/sensitivity analyses

If there is evidence or reasonable concern that the price might change (e.g., patent expiry and entry of generics/biosimilars, or a company explicitly stating planned price rises), NICE will test scenarios with different prices over time.

Managed Access Agreements (MAAs)

In some cancer drugs or highly specialised technologies, the agreement may include planned price reductions after a certain period (e.g., after data collection ends). These are explicitly modelled.

Patent expiry and generic/biosimilar entry

NICE routinely models a sharp drop in price when loss of exclusivity occurs (often to 5–20% of the originator price for generics, or 20–40% for biosimilars).

Very rare cases of explicit price escalation

If a company submits evidence that the drug price is contractually due to increase each year (e.g., linked to CPI or a fixed percentage), NICE will usually ask them to justify it and may include it only in sensitivity analysis, not the base case. Such submissions are extremely uncommon and usually not accepted without very strong justification.

Official NICE Position (from the 2022 Methods Guide update)The current NICE methods guide (Process and methods – PMG36, January 2022) states that costs should generally be held constant unless there is robust evidence to do otherwise. It explicitly says:“Costs are generally assumed to remain constant over time unless there is clear evidence that they will change.”

In practice, this means no routine annual price inflation is applied to branded drugs still on patent.

If you listen very carefully you can hear POTAS's blood simmering..

FWIW

Grok: What is annual the value of UK pharmaceutical exports to USA

Response

£6.6 billion

The annual value of UK pharmaceutical exports to the USA in 2024 was £6.6 billion, according to the latest Office for National Statistics data. This category covers medicinal and pharmaceutical products under HS code 30, making up a significant portion of the UK's £10.8 billion total chemical exports to the USA that year. It represented about a fifth of all UK goods exports to the USA by value, though it marked a 22.7% drop from 2023 due to market fluctuations. For context, this positions the UK as the ninth-largest supplier of such products to the USA, behind leaders like Ireland (£65.7 billion) and Switzerland (£19.3 billion), based on US import statistics.

+++

So a fair bit more than £5 bil then.

The round they've just fired into their own foot still resounding....

"Diagnostics

Avacta Group also contains diagnostics company Coris Bioconcept. A process to divest the diagnostics business is currently active, as we move towards delivering a key Board objective of the Company becoming a pure-play biotechnology company."

Relevant past RNS's

a) 24/7/18 Therapeutic Co-Development Partnership

b) TMAC program accelerates

Avacta supplying Affimer tech in a)

We still have Affimer Tech development in AVA7100, but unsure if current development has been curtailed for cost reasons in favour of AVA6000/6103.

+++

26.06.2025 From https://www.trinitydelta.org/wp-content/uploads/2025/06/Avacta-Update-250626.pdf

..."Management also expects to nominate the first product candidate in the FAP-targeted Affimer pre|CISION programme AVA7100 during H225".

Many folks wondering what's round the corner, this is from CC & BH:

Interim Results Transcription of Q/A session 30th Sept '25

https://avacta.com/wp-content/uploads/2025/09/Avacta_Interims_30Sept2025.pdf

Q1 & 2

Q1 CC:

* We are discussing both indications of 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 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.

* 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.

The maturing data really factor into our clinical programs, we are really approaching some key inflection points for the company coming up soon.

Investormeet:

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

CC:

* 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, have a 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.

The maturing data set in phase 1B is providing us with ample confidence that precision is working exactly as we designed it to work.

* We believe the preliminary data here will provide that natural inflection point for the program.

It is also going to provide clarity on accelerated approval pathways that we might be able to seek.

There's an opportunity for the overall market to digest the commercial potential for the program and the platform.

Stated before introducing the AVA6207 double warhead delivery system, and no adverse news subsequently means it's difficult to see how this outlook has changed since 30/9.

Also

BH:

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

In fact, it has a clear strategy which it's executed and we have shown in the clinic that our tech does what we designed it to do, concentrate the drug in the tumor while sparing healthy tissue from toxicity.

CC:

I have to be honest. I don't think that Avacta is given enough credit for the speed with which we have taken AVA6103 through pre-clinical testing and advanced straight to IND enabling studies.

We await RNS'd IND confirmation this month.

Https://www.fiercebiotech.com/biotech/astrazeneca-drops-phase-2-stage-mash-drug-over-disappointing-data

Also

ESMO: AstraZeneca believes latest data 'validate' going it alone on next-gen ADCs

Oct 18, 2025

Europe’s leading cancer conference may be swimming in antibody-drug conjugate data, but AstraZeneca remains convinced that its in-house pipeline sets the pharma apart.

The U.K.-based drugmaker earned its ADC credentials through the blockbuster Enhertu and then sealed the deal with the approval of Datroway at the start of the year. Both of those therapies emerged from a collaboration with Daiichi Sankyo, but AstraZeneca executives told Fierce Biotech earlier this year that the next chapter of the pharma’s ADC story involves “a conscious effort to invest significantly” in its internal pipeline.

Https://www.fda.gov/news-events/press-announcements/fda-awards-second-batch-national-priority-vouchers

+++

FDA Awards Second Batch of National Priority Vouchers

For Immediate Release:

November 06, 2025

The U.S. Food and Drug Administration today announced six additional awardees under the Commissioner’s National Priority Voucher (CNPV) pilot program. This second cohort brings the total number of voucher recipients to 15, underscoring the agency's commitment to accelerating the review of products with the potential to address key national priorities.

***“National priority vouchers are granted to a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We are pioneering new ways of bringing these cures and meaningful treatments to the market faster.”***

Upon submission of a complete application, national priority voucher holders will receive a decision within months, a drastic reduction of the typical review timeline.

The faster timeframe is contingent upon additional requirements from the company, and FDA staff reserve the right to extend the review as needed.

The cornerstone of the accelerated timeline is a one-day “tumor board style” meeting which convenes a multidisciplinary group of physicians and scientists for a team-based review.

Under the Federal Food, Drug, and Cosmetic Act; the 21st Century Cures Act; and the Food and Drug Administration Safety and Innovation Act, the FDA is authorized to test innovative regulatory approaches to accelerate review, foster public health preparedness, and improve access to safe, effective, and affordable therapies.

Thanks Bells.

Grok query -

Has Avacta therapeutics been awarded an FDA CNPV?

No, Avacta Therapeutics has not been awarded a Commissioner's National Priority Voucher (CNPV) by the FDA as of November 27, 2025.

The CNPV pilot program, launched in June 2025, has issued 15 vouchers total: 9 in the first batch on October 16, 2025, and 6 more on November 6, 2025.

These went to products addressing priorities like oncology, obesity, sickle cell disease, and drug-resistant tuberculosis, including zongertinib (Boehringer Ingelheim) for HER2-mutant lung cancer, dostarlimab (GSK) for rectal cancer, casgevy (Vertex) for sickle cell disease, Wegovy (Novo Nordisk) and orforglipron (Eli Lilly) for obesity, and others. No further awards have been announced.

If a private submission occurred, only awardees are publicized.

Rather unfounded predictions than unfounded concerns. 😆🥴

Christmas Shopping ? ✅

Budget debrief ? ✅

Bank account emptied to purchase Avacta shares ✅

..unfounded predictions ❓❓❓..getting busier as I type..

LoL

Spoiler alert:

Chancellor opens her mouth pm.

..effects only short term me thinks.

Post 24 Nov 2025 09:57

Sorry it was long winded, but the point of the post was to show that FDA will await an application before processing a

Priority Review, Fast Track, or Breakthrough Therapy designation.

Grok mentions which trial phase is normally associated with each designation.

'If the Parties, inter alia, fail to remove all relevant articles, agree to not to re publish the articles or allegations and issue an apology within three days, the Company will'....

..engage the services of lawyers currently engaged by POTUS, who will seek damages to the extent of 1 to 5 Billion US Dollars.

That would make a more fitting end to TW's journalistic career.

touk has sold out.

he's guessing how avacta's future is not going to pan out successfully.

he's talked himself into believing all the ****e that was 'brought up' at the weekend.

😂🤣😂