Member Info for Bella6532

Last year the Budiness update was isdued at 07.00 on day of AGM..so prior to AGM.

This year they say a Business Update will be issued following the AGM...???

What's the difference between a Quarterly Update and a Business Update?

B2HS2L..'As things stand, - we have a Quarterly Update, containing a business update due on 30th June, with another on 2nd July.'

I would be very surprisec if we get to updates within a couple of days of each other. I suspect the Qrtly Update which is due, as you said, on 30 June will simply be wrapped into the Business Update issued on the day of the AGM (2 July).

Thanks LDA...and I hope your day is going well too...soon time to break out a cold one or too eh!!!

AimHunter...

1. No...I don't do Social Media.

2. It could come as an RNS, however, whether it's an RNS or in the Business Update, I think it will be after the AGM. Avacta need finance and suddenly we get 2 Non-Execs joining and their backgrounds are

a) Retired Pharma chappie now Head Huntings companies for a US based Financial Investment Fund

b) a chappie known to Avacta through previous investment as a shareholder (or his wife) and we're not quite sure if he/she is still invested plus he heads up Zeus.

On 2 July they will be voted in or out...I think we all know which way the vote will go...

Now doesn't it make sense for the vote to be taken and their places as Non-Execs for Avacta secured for the next year before announcing any possible funding they or their contacts might be bringing to the table.

I really don't think these guys are just using Avacta to make a few bob on the side by attending a couple of Board Meetings each year...Nah! there has to be more to them coming on board and Finance seems to be the BIGGEST common factor.

BUT...as she says covering her but...I could very well be wrong...

LDA...I'm pretty sure you'll be pleasantly surprised on AGM day with the Business Update.

Over the past couple of weeks 300,000 trades seem to be a newidh feature...

20-Jun-25 17:06:24 32.50 15,000 Unknown* 4,875 O

20-Jun-25 16:45:24 33.00 100,000 Unknown* 33.00k O

20-Jun-25 16:45:21 32.50 100,000 Sell* 32.50k O

20-Jun-25 16:45:19 32.00 100,000 Sell* 32.00k O

20-Jun-25 16:35:18 32.50 1,582 Sell* 514.15

Recent events, including the forced departure of a top gene therapy regulator at the FDA and a report highlighting leadership failures in approving a Duchenne Muscular Dystrophy gene therapy despite failed trials, have raised concerns about potential corruption within the agency related to gene therapy oversight. These concerns are further fueled by past incidents of data manipulation in gene therapy trials and the high cost of these therapies.

Specific Issues and Concerns:

Leadership Failures:

A report from Public Citizen's Health Research Group criticized the FDA's approval of a Duchenne Muscular Dystrophy gene therapy, citing leadership decisions that overruled scientific staff recommendations.

Data Manipulation:

The FDA has previously investigated and acknowledged data manipulation in the development of the gene therapy Zolgensma.

Regulatory Actions:

The forced departure of Nicole Verdun, a top FDA official in gene therapy, and her deputy, has created further uncertainty and raised questions about the agency's commitment to rigorous oversight.

High Costs:

The high price tags associated with gene therapies, like Zolgensma, raise concerns about access and affordability, potentially creating incentives for regulatory decisions that favor industry interests.

Conflicts of Interest:

Concerns about potential conflicts of interest within the FDA, particularly in relation to the accelerated approval pathway for gene therapies for rare diseases, have been voiced.

Transparency and Accountability:

The handling of these situations has led to calls for greater transparency and accountability in the FDA's regulatory processes for gene therapies.

In essence, the situation suggests a need for increased scrutiny and reform within the FDA to ensure that the agency's decisions regarding gene therapies are based on sound science and prioritize patient safety and well-being, rather than being influenced by other factors.

I'd love a peak at CC's meetings agenda over the next few days.

'David Bryant is a highly experienced international pharmaceutical executive with over 35 years in the industry. He has a strong track record in commercial leadership roles at GSK and Pfizer and was one of the original management team at Clinigen Group, from its 2012 IPO on AIM to its sale for $1.6bn in 2022. David is currently an Advisor to Healthcare Royalty (HCRx), a US-based healthcare focused private investment business.'

https://www.hcrx.com/contact/

BOSTON….mmm!

'Delighted to be at #BiotechWeekBoston connecting with industry and highlighting the great progress preCISION continues to make in clinic.'

https://x.com/coughlin582/status/1935450591993487719

BioTech Weeks….mmm! Financial Institutions and Govt Agencies!!!!

'The BIO International Convention is the world’s most important event for the biotechnology industry, and it will be held from June 16 to 19, 2025, at the Boston Convention & Exhibition Center. This event brings together hundreds of top companies and institutions, including research centers, universities, hospitals, foundations, patient associations, financial institutions, and government agencies, both from the United States and internationally. The convention is organized by the Biotechnology Innovation Organization (BIO).

The BIO International Convention is the largest and most comprehensive event for biotechnology, representing the full ecosystem of biotech with 20,000 industry leaders from across the globe.'

https://convention.bio.org/bio-2025

'FDA Expedited Programs for Unmet Needs:

Fast Track:

This program aims to expedite the development and review of drugs for serious conditions where there's a potential to address an unmet need. It allows for "rolling submissions," where sponsors can submit portions of the application as they become available, rather than waiting for the entire application to be completed.

Breakthrough Therapy Designation:

This designation is for drugs that treat serious or life-threatening conditions and demonstrate a substantial improvement over existing therapies. It provides intensive guidance from FDA, organizational commitment, and eligibility for rolling review.

Accelerated Approval:

This program allows for earlier approval of drugs based on surrogate endpoints (e.g., blood tests or X-rays that are reasonably likely to predict clinical benefit) rather than waiting for clinical trial results to fully demonstrate the drug's effectiveness. However, post-approval studies are required to confirm the clinical benefit.

Priority Review:

This program focuses on drugs that, if approved, would offer significant improvements in safety or effectiveness in treating a serious condition. It shortens the standard FDA review timeline from ten months to six.

Other Relevant Concepts:

Orphan Drug Designation:

This designation is for drugs that treat rare diseases affecting fewer than 200,000 people in the US. It provides incentives like tax credits and market exclusivity.

Unmet Medical Need:

This refers to a condition for which there are no adequate therapies available or where existing therapies are insufficient.

Surrogate Endpoint:

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit.

In essence, the FDA's expedited programs and other initiatives are designed to accelerate the development and availability of new therapies for serious and life-threatening conditions, ultimately addressing unmet medical needs and providing patients with potentially life-saving or life-improving treatments more quickly. '

Interesting para...not Q4 so could it be sometime July, Aug, Sept...or is she signposting it to actually be part of the AGM business update on 2 July which is in 2nd half of 2025. What other info could the put in the Budiness Update???🤔🤫😉

'The Company plans to publish the final data from the AVA6000 Phase 1a in the second half of 2025. Further, the Company will provide a business update on the date of the Annual General Meeting, on July 2, 2025.'

No problem Timster...

Yes fantastic news and the FUD Brigade should be able to sit back since they were obviously working to get best buy in price for whoever they work for. Too much of a coincidence they appeared enmass, price drop, large trades going through plus trades at mid price...all signs something coming down the tracks.

BTW I've been told officially Funds don't have to report crossing thresholds on AIM.

High five Live....🫸🫷👍

New Response in the FAP-Dox (AVA6000) Phase 1b Trial

LONDON and PHILADELPHIA - June 19, 2025 - Avacta Therapeutics (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs, today announces a new partial response observed in a patient with salivary gland cancer (SGC) in the dose expansion phase of the FAP-Dox (AVA6000) Phase 1b trial.

This further signal of antitumor activity in this disease setting is encouraging as the expansion cohort continues to enroll in the indication of salivary gland cancer. This patient is a 69-year-old male with metastatic salivary gland cancer. His prior therapy includes surgery and radiation with no prior systemic therapy. His combined tumor diameter was reduced at the first scan by almost 50%, qualifying as a partial response.

Recent data presented by the Company at the American Association of Cancer Research (AACR) annual meeting in April 2025 described the Phase 1a cohort of patients with one confirmed partial response and multiple minor responses with a disease control rate of 91%. At the time of the data cutoff, the median progression free survival had not been reached and the data are trending to a doubling of the benchmark PFS in this pretreated setting. Recent benchmark data were published at ESMO in 2024 (Licitra et al. ESMO Annual Congress 2024). The unmet need in this rare tumor type is very high, with metastatic salivary gland cancer having no preferred standard therapy.

The Company plans to publish the final data from the AVA6000 Phase 1a in the second half of 2025. Further, the Company will provide a business update on the date of the Annual General Meeting, on July 2, 2025.

Christina Coughlin, CEO Avacta commented:

"We are thrilled to see the antitumor activity of FAP-Dox (AVA6000) in this disease with no preferred standard therapy. The high unmet need in this indication underscores the potential for FAP-Dox to have a meaningful impact to patients. We are encouraged by this response and remain focused on delivering further updates in this setting later in 2025."

Https://www.londonstockexchange.com/news-article/AVCT/new-response-in-phase-1b-trial/17093512

What news are we due...Coris sale and funding.

Coris sale must be close now and will US holiday mean they might hold off until next week.

Funding. as I said before probably won't be until after AGM when new NED's secure their votes.

Yes I'm expecting news like the rest of you but it's a guessing game as to what and when but sometimes other factors come into play.

Tomorrow is Juneteenth and it's a federal holiday in the United States. It is celebrated annually on June 19 to commemorate the ending of slavery in the United States. Many may also use it to take Ftiday off too for a nice long weekend.

Would Avacta release news on a US holiday?

😉

Lda...I think we're going to have to wait until the AGM is over and the Board is voted in which includes the 2 new NEDs plus they will vote on the Financial perameters. We might be lucky and get a DX fully wound up RNS with final sale but again don't hold your breath...more likely around AGM time.

And this is from Jan 2025...and still they squark...

https://avacta.com/avacta-announces-positive-new-data-from-the-ava6000-phase-1-trial-demonstrating-clinically-meaningful-tumor-shrinkage-in-patients-with-salivary-gland-cancers/

There is no cure for cancer...there is only remission...

Once you understand this you will start to see how effective AVA6000 is and how PreCision will be able to enhance the effectiveness of it's payloads...remission with virtually no side effects...