Member Info for B2HS2L

From - Notification of 2019 final results RNS - 29.04.2020.
Graham Mullis's comment:
"I am proud that innovation remains at the heart of the business and the forthcoming launch of our Exsig™ Free extraction kit will address a significant market need to increase testing availability and throughput".

"...forthcoming launch of our Exsig™ Free extraction kit":

It does't sound to me like the company are planning to get fresh approvals from authorities once direct-to-PCR is sorted.
I assume they are testing traditional qPCR with scarce reagents back to back with "direct-to-PCR" extraction method (Exsig™) on the same swab samples.

"Development is progressing well and Novacyt is on track to launch this new extraction technology in May 2020."

- It doesn't leave much time to apply for and receive new approvals does it.

RorkesDrift - From 11.05 RNS:

"The Affimer reagents have also now been studied further by Avacta and, importantly, this has shown that there are Affimer reagents that can work in pairs, both binding to the spike protein at the same time. This allows tests to be developed that detect both the intact virus particle and the detached spike proteins which become separated from the virus particle during the development of the COVID-19 disease, which may also be important in monitoring disease progression."

CEO, Dr Alastair Smith said in Mondays RNS:

“It is a major accomplishment to have generated Affimer reagents that can work in pairs as well as singly, as this opens up the potential for detecting the detached spike proteins as well as the intact virus particles, which means that we should have the best possible COVID-19 antigen test."

+++++

I believe when the virus particles invade the body, there are no detached spike proteins (see next sentence).
Only a while after infection, can the detached spike proteins be detected, because "detached spike proteins become separated from the virus particle during the development of the COVID-19 disease."

For those tests where just the virus particle is detected, the diagnosis is 'The virus is present and the person has contracted it recently'.
For those tests where the virus particle AND the 'detached spike proteins' are present, the diagnosis is 'The virus is present and the person has been infected a while'.

This to me is the specific benefits we have today that we didn't know we had on Friday.

Quite happy to be proven wrong, but not seen an explanation laid out like the above.

Reading the RNS is like going to the Tower of London to view the Crown Jewels.
If they were all jumbled up in a treasure chest, it would not be possible to see Crowns Gold and Diamonds clearly.

The RNS lays out the prospects and opportunities the company has created as clear and as bright as crown jewels laid out and displayed in full sunlight.

I am as sure as I can be that the use of Affimers on a latteral flow test strip will come good in a timely fashion, and showcase the technology on a global scale.

Myles McNulty quote:

"ANY drug, vaccine, or other therapeutic that uses antibodies could be remade (with superior efficacy, cheaper manufacturing costs, and higher consistency) using Affimers - and no patent is infringed upon. Hundreds of $ billions worth of sales per annum are targetable"

RNS states
"Based on these indications, the directors believe that it remains appropriate to prepare the financial statements on a going concern basis."

Not 'arf Pop Pickers!

Yorkshireboy, Your research was similar to mine, in that these links are familiar to me,
but you have to pay or sign up to a trial for document access. This is why I did not use the links.

I did find that the last link you provided gave a case termination date of 19.06.2018, a year before publication
date of the Annual Report for year ending 2018, (RNS - 04.06.2019), in which the litigation and damages
were notified to share holders.

I was fairly sure the subject had not been discussed on the BB, and as the company paid damages,
I thought others would have an interest in who was paid damages for what.
Gareth likes to report on the length of the cash runway, and I thought others might like to know
why this runway is not £423,000 longer.

It is not clear when the (https://insight.rpxcorp.com/litigation_documents/12513675) link was created,
and the lawsuit made public on the internet.
It is possible though that this page has been available since the Civil Action was filed on 29.06.2017,
and the TRX board might have considered the matter in the public domain on that date.

Management may not have wanted to adversely affect the sp whilst litigation was in progress,
but I consider shareholders should have been advised by RNS after the case was lost (by 19.06.2018)
and damages payable were calculated, - no point in adversely affecting the sp until then.
IMO at this point 'AIM Rules for Companies' rule 11 became applicable, because damages were payable.

Yb, - hoping you are suitably less discombobulated.
"it [the litigation] is historic and therefore shouldn’t influence future progress". - It is the reason however why the cash runway is not longer.

Thanks for your reply Walkingbear.

Rather than your "Such exceptional items are commonplace in business and would not warrant separate disclosure (rns) unless of a very material size or likely to recur in one way or another" interpretation, I'll remain with "would be likely to lead to a significant movement in the price of its AIM securities" found in 'aim rules for companies, rule 11'.

Walkingbear
This is the type of disclosure I was expecting.

https://www.londonstockexchange.com/companies-and-advisors/aim/advisers/rules/aim-rules-for-companies-updated-july2019.pdf

Go to page 6 of the above link, (AIM Rules for Companies March 2018):

General disclosure of price sensitive information
11. An AIM company must issue notification without delay of any new developments which
are not public knowledge which, if made public, would be likely to lead to a significant
movement in the price of its AIM securities.
By way of example, this may include matters
concerning a change in:

— its financial condition; *
— its sphere of activity;
— the performance of its business; or
— its expectation of its performance.*

*So before the publication of the 2018 Annual Report, TRX new the damages they would have to pay (£423,000),
but did not inform shareholders of the litigation, or of the damages.

Thanks for your response Old Bee.

I think I would be putting my point in context if I asked you how you would feel if news of a similar patent infringement were to be published in the same way, inside the 2019 year end report due June 2020.

Most investors would miss the infringement as management intended, - after all they did last time.

If any matter has a material effect on the companies finances, it should be made public as soon as it is known.

The company had lost the case and paid the damages well before the 2018 Annual Report publication as follows:

"Exceptional items: Cost relating to the settlement of a LifeNet litigation case are accounted in the exceptional items, covering a final legal payment and insurance upfront excess."

Transparency is the issue, and shareholders had a right to know about this litigation beforehand.

I hope the next Annual Report has better news for us all, but my most fervent hope is that a deal or a loan is agreed very soon, because the company has been stalemated long enough.

The potential of this stock to multibag is high if the right loan/deal comes along.
Posters on this BB have a lot of faith in Gareth/Jonathan to pull this out of the bag, and I counted myself among them.

I don't feel the posters aspirations are met by the actions of this board past or present.
The news that litigation took place and was buried by previous management within an Annual report,
is not how the issue should have been handled.
The present management are taking far too long to decide to accept a loan or strike a deal with an 'investor',
(to use the wording of recent RNS's).
I would like to know what the monthly lease is on a building we can only dream of putting to good use.

Now that two US govnt loans have turned up, the board intends to spend cash on lengthening the cash runway,
buying themselves more time to ponder the situation.
They will tell us next that a UK Govnt loan is available, extending the cash runway further,
with no further prospect of a decision to break the stalemate.
I hope to be proved wrong, and soon, but this is the present situation.

£423,000 of exceptional item costs would be helpful any time, not least in our present financial situation.

Trek, Unless a patient and his/her doctor can prove they were adversely affected by free Remdesivir.

para 39. Upon information and belief, Defendants are preparing to commercialize a tissue
product under the brand name SurgiPure in the United States in the second half of 2017.

para 40. TRx Group obtained marketing clearance for SurgiPure through FDA’s substantial
equivalence pathway for medical devices, Section 510(k) of the Food, Drug, and Cosmetic Act
(“FDCA”).

para 41. TRx Group represented to the FDA that SurgiPure is substantially equivalent to
LifeCell Corporation’s Strattice™ Reconstructive Tissue Matrix (LTM Surgical Mesh, K070560)
(“Strattice”). In doing so, TRx Group represented that SurgiPure has the same intended uses and
the same or similar indications, technological characteristics, and principles of operation as
Strattice, and that TRx Group has performance data that demonstrates that SurgiPure functions
equivalently to Strattice.

++++

So para 41 shows how TRX and CTS fell foul of a patent holder, when the Surgipure product went through the FDA's substantial
equivalence pathway for medical devices, Section 510(k) of the Food, Drug, and Cosmetic Act (“FDCA”).

I cannot find any details about the judgement, but the 'Exceptional items' entry above shows TRX & CTS paid damages.

++++
From the Annual Report for y.e 31/12/2018:

"SurgiPure XD, a porcine dermis for use in hernia repair was previously granted 510(K) approval for the US and underwent a soft launch at the end of 2018. SurgiPure XD will be manufactured at our facility in Leeds and is the first commercial dCELL product to be manufactured there. We expect to engage multiple relevant distributors for this product during 2019".

From Unaudited Interim Results, 10th Sep 2019 Financial Highlights:

"Commissioned SurgiPure XD post marketing clinical data collection trial
· Continue to exploit global market potential"

AFAIK there are no updates as to who the distributors might be.

In June we can expect the Annual Result for y.e. 31 December 2019.
I thought it would be of interest to long term share holders to review a matter I have not seen discussed here from the 2018 Annual Report:

From RNS 04.06.2019 - Annual Results for the year ended 31 December 2018

"Exceptional items: Cost relating to the settlement of a LifeNet litigation case are accounted in the exceptional items, covering a final legal payment and insurance upfront excess. There are no other costs to be incurred relating to this case."

++++

The Exceptional Item refers to a patent infringement, spelled out in the following link.
Tissue Regenix and COMMUNITY TISSUE SERVICES (the defendants) have been sued by LifeNet, - filed 06/29/2017.

https://insight.rpxcorp.com/litigation_documents/12513675

By its nature, this infringement is notified in a very long winded process, so here is a precis:

para 1. LifeNet is a nonprofit corporation organized under 26 U.S.C. § 501(c)(3),
existing under the laws of the Commonwealth of Virginia and having a principal place of
business in this judicial district at 1864 Concert Drive, Virginia Beach, Virginia 23453.

para 8. The patent asserted by LifeNet in this Complaint, U.S. Patent No. 6,569,200 (“the
’200 Patent”), is a result of LifeNet’s extensive research and development in the field of tissue and
bio-implant technology.

para 24. LifeNet is the assignee of all right, title, and interest in and to the ’200 Patent and
possesses all rights of recovery under the ’200 Patent.

para 25. The ’200 Patent is directed to, inter alia, “plasticized dehydrated or freeze-dried
bone and/or soft tissue product[s] that do[] not require special conditions of storage,” and methods
for producing the same.

para 26 In 2007, LifeNet introduced Preservon® technology, its proprietary bio-implant
tissue-preservation technology based on the ’200 Patent family. It is an ambient temperature
(room temperature) preservation method that simplifies the tissue-preparation and product
distribution processes and storage, saves valuable time in the operating room, and allows allograft
tissue to retain its physical and biomechanical properties.

para 28. In September 2013, LifeNet filed suit in this Court asserting infringement of the
’200 Patent against LifeCell Corporation.

para 29. After a ten-day trial, the jury found that the ’200 Patent was valid and infringed by
LifeCell’s allograft and xenograft tissue products sold under the brand names AlloDerm® RTM
Ready to Use, Strattice™ Reconstructive Tissue Matrix, GraftJacket® Regenerative Tissue Matrix,
and Conexa™ Reconstructive Tissue Matrix.

VanV, - Ramp in constant use great.
but new bike broke?
You'll soon be able to to afford another..

Last month whilst invested in NCYT, when MM's got short of shares they dropped the sp to encourage PI selling, causing large scale oscillations.
This happened a lot because there were so many buyers, not many sellers, and few (68mil) shares in issue.

If you were/are in NCYT, you know what I am referring to.

Although Synergen has 149 mil shares in issue, as soon as sellers are done selling, I predict a similar effect in the coming weeks, for the sp here.

Are we sure Interferon Beta is even available in the quantities we would require?
I have searched for vendors, but they are thin on the ground, and unsure if large amounts are available.

Nah, - Benny sang about a milkman.
I recall Tommy Cooper singing "Don't jump off the roof dad"

Who recalls "Hello my Darlings"?
At least interlude is showing the age group of a lot of posters!

It makes more sense to test international travelers before they get on a plane or a ship.

Otherwise at destination, many are infected.

vrmnd - Thanks, Couldn't ask for a better response.
- No we are not Pioneering.

I have been invested here a while now, and am pleased with the sp progress today... - particularly last thing.

I have assumed up to this point, that this is the first time that anyone has tried to place an Antigene Affimer test onto a lateral flow test strip.

I have always felt this would be the tricky bit and the CEO is super confident about success.

I don't think the Zika virus project got as far as lateral flow test strips though.

Can any one confirm this or has further information on Affimer tests used with lateral flow test strips please?

Are we Pioneering.