Member Info for D-Geeman

I keep a very un-focused eye on Autolus after learning a dad at school has some involvement, and they are a UK company that moved to the Nasdaq (presumably for similar reasons AVCT claim they should move). The dad was saying how brilliant they are (this was 18 months ago).

Anyway, just now clearing out my watchlist I see they are down 50% on when I bookmarked them and mentioned them here. When you read their January news it's perhaps not surprising. Chalk and cheese against AVCT:

'Potential Positives

Autolus Therapeutics received acceptance for an oral presentation and three poster presentations at the prestigious 2025 Tandem Meetings, highlighting their commitment to disseminating research findings in the field of T cell therapies.

The company presented an updated health economic cost model showing that AUCATZYL® has a lower incidence of adverse events compared to other CAR-T therapies, indicating potential cost savings in healthcare expenditures.

AUCATZYL® demonstrated superior efficacy and safety outcomes in comparison to non-CAR-T standard therapies, reinforcing the product’s strong benefit-risk profile for patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Research findings reveal that deep molecular remissions achieved with AUCATZYL® correlate with better clinical outcomes, which can positively influence treatment adoption and patient outcomes.

Potential Negatives

High incidence of severe side effects: AUCATZYL treatment has reported severe adverse events including Cytokine Release Syndrome (CRS) in 75% and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) in 64% of patients, which raises concerns about patient safety.

Warnings of serious complications: The drug carries serious warnings, including potential for secondary malignancies and life-threatening infections, which could impact the company's reputation and patient willingness to use the therapy.

Dependency on clinical trial outcomes: The effectiveness and safety of AUCATZYL heavily relies on data from ongoing trials, which come with inherent uncertainties and risks that could affect its market viability.

https://www.nasdaq.com/articles/autolus-therapeutics-present-data-2025-tandem-meetings-aucatzylr-and-its-economic-impact

I'm not sure I'll sign (haven't signed general 'ban short selling' petitions but this one only relates to companies such as Avct so maybe I will..

https://petition.parliament.uk/petitions/705751

Prohibit short-selling on companies developing life-saving treatment

We the undersigned, call on Parliament to ban the practice of short-selling publicly traded British companies actively engaged in the research and development of treatments for cancer and other life-threatening disorders.

More details

The British biotech sector plays a critical role in advancing healthcare, with companies often investing significant time, capital and intellectual resources into developing novel and transformative treatments for conditions like acute myeloid/lymphoblastic leukaemias and other cancers that have been historically hard to treat. We believe that short-selling damages their ability to complete vital research in the area.

(Link copied from the HEMO BB)

You might like to take a look over RUA which has cash and also supposedly to be profitable before long. One of my more heavily backed shares (market capitalisation: £7.91 million).

Cheers Nonny

ILIKA PLC (IKA) + 3.54%)

XEROS – 8.39%)

Makes me feel a bit better for the moment. Honestly the time and emotion that goes into share buying, makes me wonder if I do actually have a problem. I suppose it's only a problem when you lose. If you make money it's no problem.

I might have a bit of time to get back into Xeros after all. Next week it will have to be, looking at bank balance and weekend payment.. I know you guys want it to go up but forgive me if I wish for a couple of down days first.

I've been reading Seeing Machine RNSs.

' four day week '??

THREE day week I think you'll find.

Playing draughts, doing H/W by candle light. Those were the days...

Https://beertoday.co.uk/2024/10/28/double-diamond-1024/

I sold out again, another small profit. SP was going down this morning and having been caught out here many times transferred money to another share I've been really lucky with, in contrast.

But now I have FOMO with Xeros of course and will be back in the next day or two. Will have to break my own rule of 'no new money' as I don't want to sell anything else.

The share I've been lucky with is Ilika. I think it will do well going forward, if anyone has any spare cash, take a look. It went up a bit after I bought today.

I looked at Seeing Machines a couple of days ago after a poster (watching2 of all people..) mentioned it. Interesting it's been mentioned twice now.

‘Those buses can be very drafty so wrap up warm.’ I’d usually be riding my bike BV! Buses are warm in comparison :)

Didn’t want to start the car to take daughter to dentist esp when collecting from the swimming pool lesson.

Hi BV,

I’m on a bus so a little hard to check all but from memory the FDA were supposed to respond (not pass or fail but respond) within 90 days of this, which I think they did but shareholders didn’t hear till much later, and TLSA still haven’t received fast track designation but it could literally drop any day.

(Good point that TG would not have been a great fit in the US)

‘ Sciences Fast Track Designation Submission for Treatment of Multiple Sclerosis

11th June 2024

NEW YORK, June 11, 2024 – Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment’

'A U.S. listing or..... could trigger a massive rerating overnight' which is what TILS said and I'm afraid the result was actually very different. As ever, things COULD be different for AVCT (& I have a lot – for me – riding on AVCT's success) but in fact I think the market they are on isn't the problem, if there is a problem.

TILS (now TLSA) bombed on moving to the Nasdaq. That was after an initial boost.

They also have an application to the FDA and were supposed to hear back within 90 days. Many months after the deadline passed TLSA slipped in a line about 'being in discussion' with the FDA. That was months ago.

Different companies of course but delays seem common. I just would say that being on the Nasdaq is not the panacea for all problems.

Reading about other cases I guess the FDA haven't failed AVA6K either so whilst there may be a discussion there's still every chance of a pass. That discussion could fit in with the 'data was too good' narrative. We just don't know.

2024 FDA approvals

The FDA approved 50 new therapeutics in 2024, with green lights for a novel schizophrenia drug, a first NASH medicine and much more.

By Asher Mullard

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The FDA’s Center for Drug Evaluation and Research (CDER) approved 50 new small molecules, biologics and oligonucleotide therapeutics last year. The class of 2024 was a little smaller than that of 2023, which had 55 approvals and was the second largest in the past 30 years. The ten-year rolling average now stands at 46.5 novel approvals per year, a new high-water mark (Fig. 1; Table 1).

https://www.nature.com/articles/d41573-025-00001-5

This is interesting too

https://medcitynews.com/2025/01/fda-wraps-up-2024-handing-out-several-notable-regulatory-decisions/#:~:text=First%20the%20FDA%20rejected%20the,sent%20Applied%20a%20warning%20letter.

Sorry, a year out of date..

How busy is the FDA? 2024 was busy it seems:

https://www.biopharmadive.com/news/fda-rejection-amgen-lumakras-zealand-insulin-2023/703402/

Yes wyn, the big farmers seem a lot less gung-ho than us Pi's, probably explains why they are worth billions and we are sitting on losses (most of us..). But Ice does look to be correct that the FDA will clear AVA6k. It would be shocking if they didn't.

'30 years since the initial clinical approval.. PLD is a complex product and we are still in a learning curve' so that's quite a wait for full results :-/

Https://bmjoncology.bmj.com/content/4/1/e000573

'Abstract

In 2025, it will be 30 years since the initial clinical approval of pegylated liposomal doxorubicin (PLD) by the Food and Drug Administration. PLD predated the field of nanomedicine and became a model nanomedicine setting key pharmacological principles (prolonged circulation, slow drug release and the enhanced permeability and retention (EPR) effect) for clinical application of other nano-drugs in cancer therapy. The impressive reduction of cardiotoxicity conferred by PLD is the most valuable clinical asset. While PLD has gained a strong foothold in relapsed ovarian cancer and metastatic breast cancer, it has not been extensively tested in primary (neoadjuvant) and adjuvant therapy and has not fulfilled the expectations from the results in animal models efficacy-wise. This discrepancy may be due to the large dose gap between mice and humans and the apparent variability of the EPR effect in human cancer. PLD is a complex product and we are still in a learning curve regarding a number of factors such as its interaction with the complement system and its immune modulatory properties, as well as its integration in multimodality therapy that may potentiate its value and role in cancer therapy.'

That link is easier, thank you ICE. I had been on the London Stock Exchange site (LSE) and there are 100s, maybe 1000s. But many are from after 7am. Just AIM shares would indeed simplify things a lot.

I'm shan't be paying V O X whatever happens.

Hi ICE,

I just looked and found that way of doing things. Thanks. I hadn't been aware before.

But there are 100's.. I wouldn't have time at 7am, too getting porridge cooked for me and a porridge-loving daughter, and the weetabix for the others.

I can see scrolling through all RNS would highlight other opportunities.

The LSE emails will have to suffice till I have more time, and more money for the 'other opportunities'. I guess phone alerts are a thing of the past for me.

I appreciated your work on the valuation (really hope it comes to pass...).