Member Info for SandyR

Hi Steve,

Thanks for your post regarding questions previously submitted on the old invite link.

I have checked with Investor Meet and questions will have to be resubmitted. Please see their reply to my email:

“Hi Sandy,

Thank you for your email. They will not be carried over to the new meeting, please submit your question by clicking on the ‘Ask a question’ button.”

It made me smile too tbh Wyn.

Panmure Liberum issued a broker note last week titled “Healthcare: A ‘safeish’ haven from tariffs.” The note briefly mentioned AVCT as one of the stocks with zero expected impact from the introduction of tariffs, as it is not yet revenue generating. Their target SP remains at 62p.

Sorry I can’t provide a link - the PDF won’t work as an attachment unfortunately.

Sorry about the weird paragraph spacing - LSE has a mind of its own sometimes.

I will try it again, it’s page 18 of the PL report.

Following the completion of the first seven cohorts (44 patients) where patients

were dosed at a three-weekly interval, a fortnightly dosing safety study was

initiated. This was prompted by the strong safety data seen in the three-weekly

dosing, which suggested that more frequent administration would be tolerated.

Dosing every two weeks would enable FAP-Dox dosing to align with other

chemotherapy treatment schedules. For example, cyclophosphamide and

epirubicin are both given fortnightly and are commonly administered in

combination with doxorubicin.

Completion of the two-weekly dose phase of the trial demonstrated no

difference in outcome or safety profile between the two-weekly and three-

weekly dosing schedules. However, this single-agent data is important in

partnering discussions as it is likely to increase interest from partners who may

be interested in FAP-Dox as a combination treatment with an existing

chemotherapy that has a two-weekly schedule.

Morning Ben,

It is my guess too that the two-weekly arm is so that it can fit in with other chemo regimes. There were a couple of paragraphs in the PL report that made reference to the two-weekly dosing schedule aligning with potential combination treatments:

“Following the completion of the first seven cohorts (44 patients) where patients

were dosed at a three-weekly interval, a fortnightly dosing safety study was

initiated. This was prompted by the strong safety data seen in the three-weekly

dosing, which suggested that more frequent administration would be tolerated.

Dosing every two weeks would enable FAP-Dox dosing to align with other

chemotherapy treatment schedules. For example, cyclophosphamide and

epirubicin are both given fortnightly and are commonly administered in

combination with doxorubicin.

Completion of the two-weekly dose phase of the trial demonstrated no

difference in outcome or safety profile between the two-weekly and three-

weekly dosing schedules. However, this single-agent data is important in

partnering discussions as it is likely to increase interest from partners who may

be interested in FAP-Dox as a combination treatment with an existing

chemotherapy that has a two-weekly schedule”.

Hi Ben & Aldebaran,

CC stated in the recent Leerink presentation that the SGC PFS data would be presented in Q2. Although she didn’t specify which conference, I agree that ASCO sounds a likely option.

"So we will be going to a major medical conference in the second quarter of this year. We have disclosed that, not exactly which one, but there will be an update on the salivary gland data, and especially as we move towards that durability and understanding in the phase 1 what our PFS looked like. It's also going to take into account some of the data that we've seen on how the platform works in the clinic".

Morning Liam, just a quick correction to your presentation start time -I think it kicks off at 6.10pm UK time.

https://goto.webcasts.com/starthere.jsp?ei=1696664&tp_key=a17d7ff4c2&sti=tw

Hi Sam, yes lunchtime time in the US, BUT 6:10pm in the UK for anyone wanting to listen to the presentation.

Hi Wyn,

Apologies, I’m not trying to be difficult, but I don’t quite understand the point of your post. I also don’t agree with your interpretation of CC’s answer. I took it to mean exactly what she said: “We’re looking for a shorter, more effective trial for AVA6000 with evidence of superiority.”

As for safety and tolerance - the data has been excellent.

And yes, of course, they are carefully selecting patients for this part of the trial. It would be illogical not to. They are targeting cancer indications that are sensitive to doxorubicin, and in the case of SGC, where there is a high unmet need.

Hi Icecool,

You might find this reply from CC in last September’s interim presentation interesting. (For reference, it’s Q3 under the Q&A section.)

Question

Based on the safety data so far, even if Phase 2, for some reason, shows that AVA6000 is no more effective than conventional doxorubicin, can it still be assumed that AVA6000 will replace doxorubicin in chosen indications? And therefore already classed as successful?

 

Answer

Always a good debate. There are multiple pathways by which a drug can be approved. This question is referring to one that is called, essentially non-inferiority, meaning that the efficacy is the same, but the safety is better. In order to get a drug approved, though, using this path, it is a much larger trial. The statistics to prove that non-inferiority are essentially looking at a much larger trial, a longer route to approval, as well as a much more expensive trial. But the more favorable scenario for a drug like AVA6000 is to show superior efficacy, and this is one of the reasons that we're spending this bit of time and resource on a very careful selection of what the phase two indication. We're looking for a shorter, more effective trial for AVA6000 with evidence of superiority.

https://www.investormeetcompany.com/meetings/investor-presentation-722

Hi DG, yes if you read the clinical trial detail, I think patients with Adenoid Cystic Carcinoma would be eligible for AVA6000 (capped at a total of 15 patients).

This is from the AVA6000 clinical trial web page -

“SGC: Locally advanced or metastatic salivary gland confirmed by histopathology that cannot be completely resected by surgery who have received 0 or 1 prior lines of therapy in the locally advanced or metastatic setting. In addition, patients with adenoid cystic carcinoma subtypes must not have received prior cytotoxic therapy for locally advanced or metastatic disease. Adenoid cystic carcinoma subtype to be capped at 15 patients (assuming cohort of approximately 30 patients)”

https://clinicaltrials.gov/study/NCT04969835?term=Ava6000&rank=1

Hi Harrogate4. I have just logged in okay (at 17:00) to my II account.

But there was a message on the website: “Access to your Documents may be intermittently unavailable this weekend, due to planned maintenance work. We are sorry for any inconvenience”.

Sorry, the link didn’t work either. Flipping LSE.

https://www.***************************/tissue-regenix-profitable-growth-and-strategic-expansion/4121171528

hope this link works.

(it was a very good interim results presentation on the 10th september

https://www.investormeetcompany.com/meetings/interim-results-for-the-six-months-ended-30-june).

The link GMCC posted, to an Affyxell presentation in April, was interesting. It’s in Korean, but it’s worth scrolling through to the last two slides and google translating. So as CC commented - IND 2025 for AFX-001. Looking at the timeline on the slide, the forecast for phase 1 is 2025-2027.

IPO commencement scheduled for 2026.

https://youtu.be/hP0FBp1rESY?si=JCiu8xTbH1KcU0Vc

Thanks Alex & GMCC.

There was a question asked regarding Affyxell & LG at the AGM.

The below is a transcript:

Question

Just very briefly, we don't really get a regular update of the JVs with the Korean companies. Can you give us a brief update firstly? And secondly we talked about therapeutics and diagnostics. What's the strategy around those JVs with LG & Daewoong for example?

Christina Coughlin

So there's essentially two of them. One is still deeply in research, and working through that is LG. So I really, I can't give you much of an update there.

We did just meet with Affyxell, so I can give you an update there. They are approximately, and I hate doing someone else's timelines, but they are approximately a year from their IND. If I put my cell therapy hat on, it may be longer than that. As many of you know, I've worked on three different cells, T cells, red cells and NK cells. So they are about a year from that. They are right now raising money. And you know, a few of you have seen some of their updates. But yes, those meetings happen a bit more frequently now I would say.

Question

So are you guys just letting them run independently?

Christina Coughlin 1:26:25

So, I can't disclose everything. What I can say is that, having met with them, you know, I've done cell therapy for, well, you know, if you count Carl a long time and so, yes, we are chatting with them a bit more now. Yeah, so I can help them with it. I've done a number of cell therapy IND, but great question.

CC was very clear at the ‘live’ AGM why a phase 1b/three expansion cohorts ARE required. So, I would be surprised if the company have a rethink.

“So this is the pathway that we will follow. At each of those instances that I talked about, the data will de-risk the next step, and will de-risk the cash that needs to be spent to move to that next step. So we wouldn't embark right now, I've been asked multiple times, why not go right now to a phase two trial? We don't know what the optimal indication is. We don't know what the optimal end point is, and we don't have the data to de-risk essentially moving there. So that's why the expansion cohorts. We're going to take three shots, of those three shots we'll pick one, move to Phase Two.” (CC AGM June 2024)

TG2D, the phrase “living on borrowed time” is scaremongering. I don’t know if the company will hit their full revenue target for this year, but the overall revenue trajectory is strong and increasing. The steep SP decline that accompanied the January 2023 Business Update was due to a combination of factors, including the major decision to ditch their own Hycead Ziplex platform and the gloomy economic outlook for small pharma customers.

The outlook is considerably more positive now. The change in focus to large pharma is sensible and they have succeeded in signing up a genuinely huge global pharma company in AstraZeneca. With the “halo” effect this brings and the potential for further more lucrative clinical trials. Then there is the collaboration with Illumina, which could prove transformational. An update in September should be very interesting. The fact that AGL shared time with Illumina at the recent EACR is indicative of the progress being made with the dual CTC/ctDNA analysis. (See the Illumina promotional material, under the Booth Open Hours with experts, title “Liquid biopsy solutions for analysis of ctDNA and circulating tumor cells” Illumina/Angle)

The distributor sales reps are well incentivised. Again the outlook statement in the forthcoming September results should be interesting. (The September interim results date is an assumption on my part based on previous years, and I believe some form of update was also referenced at the AGM).

Two major stakeholders have increased their shareholding.

I don’t always necessarily agree with Bones & Adw, but I respect their opinions. You, in contrast just like to have a good stir.

[Thanks BBN for some excellent posts.]

https://emea.illumina.com/content/dam/illumina-marketing/emea/PDF_Files/Illumina%20EACR%2010-13%20June%202024%20Activity%20Promotion%20A4.pdf

Ps BV,

Can I please now be downgraded from an idiot who engages. I think I prefer a misguided but genuine LTH. Hope you are enjoying the footie.

Part of the reason BV, for my reply to Thorn, was that it was a good opportunity to post a really interesting reply from CC. So hopefully there is some merit in my post. But I agree with your sentiment about engaging with trolls.

I really enjoyed the AGM, CC is an excellent communicator.