Maxcyte Share Discussion Threads

[davep4] 01/11/2023 19:51

74tom

I watched some of

I draw attention to OPH 1# through to OPH 13#

It occurs to me that may influence a positive outcome.

[74tom] 01/11/2023 09:20

Some interesting comments on this old seeking alpha article;



"Another important point on the competitive position is the potential long-term customer lock-in that MXCT can achieve, on top of the long-term partnership agreements. If a therapy gets FDA approval using MXCT's tech, that would be considered a critical supplier, I expect it will be very difficult to switch after approval (long and uncertain validation process to prove bio-equivalence, etc).
However, you don't mention anything on MXCT's IP. Is their technology well protected and what's the remaining life of their patents?"

"I agree that there is no sense in switching to another service provider once a therapy is FDA approved using MaxCyte's technology. In terms of IP there is quite a lot of information in the Prospectus. I will just copy an extract here: "As of May 4, 2021, we have 50 granted U.S. and foreign patents, including in foreign 109 jurisdictions such as Australia, Canada, Japan, China, South Korea and certain countries in Europe, as well as 76 pending patent applications worldwide. The main focus of our patent coverage protects our Flow Electroporation, processing chambers/disposables, control and process elements, and methods of using our non-viral delivery platform. Our patent portfolio provides protection over our instruments and related methods through at least 2028 and over our electroporation applications and methods through 2034. We are also working to secure design protection of the ExPERT system, which has the potential to provide protection through at least 2036."

That's very impressive on the patent front...

[74tom] 01/11/2023 09:17

I didn't bother with the pre meeting materials, listening to the expert discussion was far more useful as they distilled the technical info into something more understandable. Numerous commentators on twitter deemed the panel discussion to be extremely positive for approval, not long until we find out. 17% of Crispr is held short so it could get quite explosive!

[adamb1978] 01/11/2023 08:55

Hi Tom

I flicked through the materials though unless oyu review these FDA decisions frequently, its difficult to know whether the other studies was a typical caveat to a decision. I assume that given this is an advisory body, they're typically quite cautious and will always spot additional things which could be done...but difficult to know that definitively without the context of other reviews.

Positive market action already anyway.

Adam

[adamb1978] 01/11/2023 08:53

Over 100% of MXCT average daily volume traded, and its not 9am yet

[74tom] 01/11/2023 08:52

There was no vote;



"The meeting of the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee was unusual in that it didn't actually ask members to vote on whether the therapy's benefits outweigh the risks. Instead, they were asked to discuss if enough research had been done to see exa-cel could be impacted by off-target editing -- essentially editing errors causing unintended genomic changes and, therefore, potential side effects. FDA reviewers flagged the editing and potential side effects in briefing documents."

If you listen to the link I posted you'll see that their opinions of the drug are very favourable, the main uncertainty is what should be done in terms of longer term studies.

Crispr is up 19% in pre market trading.

[adamb1978] 01/11/2023 08:31

I had a flick through of the materials for the meeting yesterday, but went way over my head.

Looking back at previous ones, I couldn't see any announcements of decisions. Does anyone know where they would appear?

[74tom] 01/11/2023 08:21

Fantastic FDA adcomm yesterday, well worth listening to the full 7 hours when time permits;



The final hour was especially positive, approval looks highly likely based on the panel discussion & the fact that there seemed to be unanimous agreement that the significant patient benefits of exa-cel comprehensively outweigh the risks of off target edits.

The whole sector received a boost yesterday, enhanced by Eli Lilly entering the gene editing space via purchasing a Verve Therapeutics license from Beam for $250m.

I strongly suspect the bottom is in & MXCT could see a rapid recovery over the next few of months as both CRISPR indications receive approval.

[adamb1978] 31/10/2023 10:52

You're right Sebass:

[adamb1978] 31/10/2023 08:05

Thanks Sebass. That's very helpful - thank you. Is that vote typically made public?

Hopefully MXCT would RNS it if positive

[sebass] 30/10/2023 17:25

Adam tomorrow is advisory committee for exa-cel. Adcom has a vcote at the end of the meeting which might give guidance on fda decision on 8th December. FDA follows adcom decision 80 percent of the time

[adamb1978] 30/10/2023 15:28

Can anyone remember what the date was at the end of this month when there was going to be some regulatory progress on exa-cel?

The FDA decision is at the end of November I believe as it was meant to be 8 months post the submission, but I thought there was another meeting/milestone too
Thanks

[volsung] 08/10/2023 09:45

Moderna lists its covid substance as a’gene therapy’ in its SFA filing.

[74tom] 05/10/2023 09:55

That has to be one of the stupidest comments I've ever seen on ADVFN

[davemac3] 05/10/2023 09:51

Where was gene therapy used for Covid?

[volsung] 05/10/2023 09:03

The covid scam has killed the gene therapy business.
No-one is going to take the stuff

[74tom] 05/10/2023 08:35

Yes I'm looking at after hours trading, it closed regular trading at $3.27 / £2.70, the warning then dropped it to a low of $2.55 / £2.10 on moderate volume before a close at $2.68. Let's see where it opens this afternoon!

[adamb1978] 05/10/2023 08:25

But the profits warning came after market close Tom....unless you're looking at some after hours trading, the Nasdaq price doesnt reflect the information

[74tom] 05/10/2023 08:24

@AdamB, it makes no sense for the market makers to open it 20% below the NASDAQ close - I think someone must have been margin called on a spread bet and liquidated at open, the stock available at £1.75-1.80 wouldn't have been available otherwise...

[wjccghcc] 05/10/2023 08:19

Yup. Bought back a bunch at 180p.

[adamb1978] 05/10/2023 08:19

I think its possibly just investor apathy 74tom. Not a problem for long-term holders at all though

[74tom] 05/10/2023 08:12

What a crazy reaction - cash at year end forecast to be $200m / £164m, at the current mid price of £1.72 the business is being valued at £15m?!

The last trade on NASDAQ was at $2.68 / £2.21, so I'm very surprised that the LSE market makers have opened it this low. Unless you believe the entire cell / gene therapy space is going to go disappear then it's surely a buy at these levels.

[epicwarlock] 05/10/2023 08:07

Put another 5k in here yesterday just before close ....he'll, what timing!!!!