Xenetic Bio Share Discussion Threads

[heyho2] 05/8/2013 21:41

Courtesy of gnnmartin over on the GWP thread:

The FT today reports that:
"US biotech stocks ride wave of investor euphoria ...
So far this year, 22 companies have raised $1.7bn from initial public offerings in the US and several more are scheduled to list in the coming months, according to Dealogic.
...
The jump in demand for fledgling drug developers searching for cures to the world?s most serious illnesses is reflected in the Nasdaq Biotechnology index, which has risen 43 per cent this year, outpacing the 18.6 per cent gains on the S&P 500 and all major industry groups on the US benchmark."

[heyho2] 05/8/2013 14:58

I've had Nobrust on filter for a long time now; shame he's turned up here as he's vindictive, foul mouthed and argumentative.Apart from that he's a bl@@dy good chap!

[buywell2] 05/8/2013 14:12

Nimbus is full of hot air

Bit of a blow hard

Thinks that shale gas/oil won't hurt his wind

[corrientes] 05/8/2013 14:09

I think most people know Buywell's 'pedigree' by now, so give it a rest would you.
One would think that you'd lost money by following him. So far on XEN, I'm slightly up, but who knows what'll happen.

[stockmuncherpro] 03/8/2013 15:16

This dog stinks.

[buywell2] 31/7/2013 09:26

Re the RNS today ..... The choice of Australia may have surprised some .... but Xenetic have done their homework



www.australianclinicaltrials.gov.au/industry-and-sponsors/why-conduct-clinical-trial-australia

[buywell2] 31/7/2013 08:01

So with data from Australia coming out in H1 2014 , Xenetic should have several potential partners eager to sign up.

A successful launch in Russia of ErePoxen BEFORE that date would perhaps bring that forwards

More importantly it will start to bring in a REVENUE stream to fund Xenetics other orphan drug development program


M. Scott Maguire, CEO of Xenetic, has commented: "The approval from regulators to commence this trial marks the first trial for a product owned and fully controlled by Xenetic, as well as the first step in moving candidates out of Russia and India into developed-world markets. ErepoXen is designed to reduce the amount of injections for CKD patients relative to the prevailing anemia drug therapies. Once this trial is successfully completed, we expect to move into global Phase III trials including in the US and Europe, leading to product launch in these markets. To be clear, this is the most significant initiative yet announced by the Company in terms of the potential to enhance shareholder value. Our march to become a player in global drug development has now started."

[buywell2] 31/7/2013 07:56

Re the last para above by Scott


He has also stated

"This is a big market drug, very expensive clinical trials, so we are going to be seeking a partner to out-license this as soon as we have data coming out of Australia/New Zealand. He said these locations were chosen because it is cost effective to run big market drug trials there, and the structure of the trials reflects the Food & Drug Administration (FDA) format so it's an easy transition into the US or Europe markets after phase 2 trials.

Importantly, however, in Russia, where the drug is currently in trials, there is a chance to see revenues from ErepoXen sooner. In Russia, Xenetic hopes to see a commercial launch of the drug in the second half of next year and it will be receiving a 10% royalty on its sales in Russia.

[buywell2] 31/7/2013 07:47

The market in this instance has got XEN wrong thus far

Don't happen very often

But when it does the ''correction factor'' will be big and fast







31 July 2013

Xenetic Biosciences plc
('Xenetic' or 'the Company')

Approval to Commence Phase II Clinical Trial for ErepoXen, a novel treatment for anemia

Xenetic Biosciences plc (LSE: XEN), a bio-pharmaceutical company specialising in the development of high-value differentiated biologics, vaccines and novel cancer drugs, announces approval from both the Australian and New Zealand regulatory authorities to commence a Phase II clinical trial of ErepoXen for the treatment of anaemia. Upon successful completion of this trial, Xenetic will seek to conduct Phase III trials in the US and Europe.

The main aim of this phase II, open-label, multi-centre and sequential dose finding trial is to assess the efficacy and safety of multiple doses of polysialylated human erythropoietin (PSA-EPO) in chronic kidney disease ('CKD') subjects who are not receiving dialysis nor receiving erythropoiesis-stimulating agents ('ESA'). The trial is being conducted in compliance with Australian regulations under a clinical protocol that includes eight centres in Australia and two in New Zealand. The trial is expected to be active for up to 14 months with up to 72 adult subjects enrolled. The first report on this trial is expected during H1 2014.

The primary end point of the trial is to demonstrate that multiple doses of this novel drug are efficacious, safe and well tolerated in patients and maintain haemoglobin and other pharmacologic parameter levels. Confidence in the outcome is strengthened by the positive safety results of Phase I and II single dose clinical trials already conducted by Xenetic's partner, the Serum Institute of India.

ErepoXen is a novel therapy for the treatment of anaemia in End Stage Renal Disease patients. Anaemia in subjects with CKD is often accompanied by a decreased quality of life and an increased need for red blood cell transfusions. The dominant treatment for this condition is recombinant human erythropoietin ('rHuEPO') replacement therapy with an ESA, which has been associated with an improved quality of life and fewer Red Blood Cell ('RBC') transfusions. Several ESAs are currently available in the United States and Europe for the correction of anaemia in CKD patients, however ErepoXen is designed to reduce the amount of drug and frequency of injections for these patients.

Xenetic is developing PSA-EPO which is a polysialylated form of human erythropoietin for the treatment of anaemia in CKD patients who may or may not be on dialysis. The product which is covered by several issued patents and pending patent applications in the United States and the rest of the world, contains the identical amino acid sequence of isolated natural human EPO and the polysialic acid used is a natural hydrophilic polymer derived from the cGMP fermentation of E. Coli strain K1. Polysialylation of EPO helps in reducing the required frequency of dosing compared to existing ESAs due to its longer time in circulation.

The treatment has been formulated using the Company's patented PSA-EPO technology. If successful the proprietary PSA-EPO treatment will address a global anemia market currently estimated at US$7.2 billion.

This trial is externally managed and monitored by Novotech (www.novotech-cro.com), the largest Australian based Clinical Research Organisation ('CRO'). Novotech is a highly experienced and internationally recognised CRO, ISO 9001 accredited and working to international Good Clinical Practice standard, to ensure highest quality data and efficient study execution.

M. Scott Maguire, CEO of Xenetic, has commented: "The approval from regulators to commence this trial marks the first trial for a product owned and fully controlled by Xenetic, as well as the first step in moving candidates out of Russia and India into developed-world markets. ErepoXen is designed to reduce the amount of injections for CKD patients relative to the prevailing anemia drug therapies. Once this trial is successfully completed, we expect to move into global Phase III trials including in the US and Europe, leading to product launch in these markets. To be clear, this is the most significant initiative yet announced by the Company in terms of the potential to enhance shareholder value. Our march to become a player in global drug development has now started."

[corrientes] 31/7/2013 07:28

I think they're trying to get the Market to take this company seriously, for so far it hasn't. Either the Market is stupid or we PI's are.

[pilkersa] 31/7/2013 07:21

Very positive rns. Great stuff.

[buywell2] 30/7/2013 18:20

While we wait we can listen, ....... but better with tight underpants on

www.youtube.com/watch?v=nREV8bQJ1MA

[earnestwipplethwaiteiii] 30/7/2013 10:31

Buywell - I think you will find it is just a regulatory requirement under the Takeover Panel rules for XEN's NOMAD, Singer, to report trades that happen under its auspices - i.e. once XEN told the market that they are actively seeking a shell into which to reverse, this requirement became active. I see no sign, either in what XEN has officially reported, or in the (lack of) interest in XEN stock, that there is any substantive move yet.
We wait.

[buywell2] 30/7/2013 07:24

Re the latst RNS .... it looks like a company has made an offer


Xenetic Biosciences shares surge as it seeks US firm to make offer
By Giles Gwinnett

July 16 2013, 5:27pm

As reported previously the company is in the process of moving and expanding its activities to Boston - a centre for orphan drug development

Shares in Xenetic Biosciences (LON:XEN) raced up late on Tuesday as it announced plans to secure an offer from a US company.

The drug developer noted today's share movement and said it was currently seeking a US firm to make an offer for Xenetic.

This, it says, would help it to realise its aim of listing in the US market more easily.

As reported previously the company is in the process of moving and expanding its actvities to Boston - a centre for orphan drug development.

Xenetic highlighted that there was no certainty that any offer would ultimately be made, and as of now, it was not in discussions with any US company.

"The board of Xenetic believes that at the present time smaller quoted bioscience companies, in general, have a higher profile and a better investor following in the US than is found in European markets in general and in the UK market, in particular," it said in a statement.

A listing in the US will allow a number of benefits, it said, including better access to finance and higher levels of share trading liquidity.

Xenetic shares rose 24.44% to 7 pence each.

[stockmuncherpro] 25/7/2013 13:48

How we doing buywell?

LOL LOL LOL

[buywell2] 18/7/2013 08:04

Worth a read

Worth a read again cos I made a couple of mistakes


Xenetic Biosciences expects higher rating from US switch

Xenetic Biosciences (LON:XEN) is finally embarking on the process of "serious value" growth, according to its chief executive.
This week Xenetic announced it is searching for a suitable candidate to reverse into to get a US listing, while the company's own development programmes for potential blockbuster drugs for western markets also starts soon.
Chief executive Scott Maguire recently colourfully compared this process as being like a "battleship leaving the dock".
He's referring to the first western clinical trial of ErepoXen for treating chronic anaemia, which is starting in Australia at the end of this month or next - one of several drugs in the firm's portfolio and a candidate that the firm wholly controls.
Maguire explains that previously Xenetic has been purely research-based, relying on out-licensing partnerships and collaborations with groups in India and Russia.
But, following a fundraising last year, the company has now begun the process of evolving into a drug developer, able to test and commercialise its own products.
Maguire is so excited about this transition because, not only does if offer potentially large rewards for shareholders, but also because the firm's portfolio itself is highly promising.
Xenetic specialises in developing orphan drugs for rare diseases, which have multi-billion dollar potential. Orphan drugs are fast-tracked to the market because they typically address diseases and conditions for which there are few, if any, medications.
Now, following the firm's undeniable progress thus far, what is needed, is delivering on plans and, of course, securing financing, reckons Maguire.
"As I see it, as management, the science is working and it's going to come down to a function of execution and money to deliver on the promise, because it's clear that these products we have in development have blockbuster potential and those are not my words, those are words from the investment and strategic community," he said.
And Maguire highlighted all three of its technological platforms - PolyXen, ImuXen, OncoHist - have products in at least phase 2 clinical trials.
Currently, its main focus is ErepoXen - the firm's most advanced product and likely to be the key share driver. Ironically, perhaps, this drug is one that does not fit into the firm's orphan strategy, in that it is a big, mass-market candidate.
Maguire says the plan is to complete a dose finding study for western markets in December this year before striking a deal.
"The goal of ErepoXen is to out-license as soon as allowable and there is already some interest in this product," he adds.
"This is a big market drug, very expensive clinical trials, so we are going to be seeking a partner to out-license this as soon as we have data coming out of Australia/New Zealand.
He said these locations were chosen because it is cost effective to run big market drug trials there, and the structure of the trials reflects the Food & Drug Administration (FDA) format so it's an easy transition into the US or Europe markets after phase 2 trials.
Importantly, however, in Russia, where the drug is currently in trials, there is a chance to see revenues from ErepoXen sooner.
In Russia, Xenetic hopes to see a commercial launch of the drug in the second half of next year and it will be receiving a 10% royalty on its sales in Russia.
Another candidate the firm is excited about, and which will be added to its portfolio for the western markets, is OncoHist for acute myeloid leukaemia.
Maguire told a conference call last month that he was "particularly" excited about this drug, which he said had "multi-billion dollar" potential.
OnCoHist binds itself to leukaemia cells and leaves healthy cells alone, so there are no serious side effects.
Maguire said a world-leading specialist described it as being the first novel mode of action for the disease he had seen in 20 years.
The firm continues to test the efficacy of this drug and crucial phase 2 data is expected this summer.
Part of the plans to expand into western markets is the move this September of staff to lab and development operations to Boston, USA - the world's leading centre for orphan drug development.
Xenetic has also just announced it will look for a merger with an SEC reporting, unlisted US company, a move that will enable it get a quote on a major US stock market within a reasonable period.
It wants to agree a deal in 2013, a move that will also see it de-list from AIM.
Maguire said the long term benefits of being a US-centric organisation will become apparent as US markets give "significantly" greater value to firms like Xenetic with its broad proprietary drug pipeline.
[...]

buywell2
17 Jul'13 - 19:39 - 675 of 676 0 0 edit

Thank you Earnest

So to explain in more simple terms cos I am a tad thick at times I know and from some of the posts here several are a lot thicker than me. But since I have drawn the short straw in creating the thread I will put my spin on the last post ....

This is MY take .......


1. ErepoXen is due to start Phase 11 human trials in Australia IMMINENTLY even by the end of THIS MONTH ... which should attract a tad of XEN buying I would expect.

2. Interest from potential western partners has been EXPRESSED and they are tracking the data from these trials as they seek to DE-RISK themselves before committing spending a shedload of cash to take ErepoXen to the APPROVAL stage and then commercialize/advertise it's benefits .... serious lolly here ..... so the data has to be good.

3. Meantime our Russian partners have started their OWN DOMESTIC RUSSIAN PHASE 111 trials and have dosed the first patient back in May 2013.

4. This means Xenetic has TWO CHANCES of scoring serious lolly on ErepoXen
a) MEGABUCKS from a Western Capitalista deal after Phase 11 data gets released out of Australia , at which point I see one of the 'interested parties' getting the paper signed before someone else beats them to the punch ..... and

b) Decent revenues to cover other drug developments in the pipeline from the 10% that Xenetic stand to get from ErepoXen sales in Russia when Phase 111 trials end and the state of Russia gives ErepoXen their approval .... which looks in my opinion to be VERY good when one remembers that EPO is not a new drug .... remember EPO has been used before but has gone out of patent. ErepoXen is NOT a step into the unknown for Xenetic.

What Xenetic has done is to reformulate it and apply their own unique IP/ technology so that the drug works MUCH better than it ever did before , and one dose is efficacious for circa 1 MONTH. The data from the new trials SHOULD make ErepoXen the BEST performer on the marketplace V what's out there now.



It is my opinion .... and remember I am a conservative sort of guy .... that the clever new guys recently taken on by Scott are going to use info and any EARLY indications from the trials to MAXIMISE XEN shareholder value when it comes to the reverse takeover/Shell deal in the USA.


It is my considered opinion ..... and if you read my advfn posts ..... I consider much more than most posters ..... that WHOEVER gets to deal with XEN in the USA are going to make a MINT.

[earnestwipplethwaiteiii] 17/7/2013 22:29

Term Report; Buywell Minor

Buywell has worked hard this term and now has a much firmer grasp of the concepts necessary to run a successful thread.

[buywell2] 17/7/2013 19:39

Thank you Earnest

So to explain in more simple terms cos I am a tad thick at times I know and from some of the posts here several are a lot thicker than me. But since I have drawn the short straw in creating the thread I will put my spin on the last post ....

This is MY take .......


1. ErepoXen is due to start Phase 11 human trials in Australia IMMINENTLY even by the end of THIS MONTH ... which should attract a tad of XEN buying I would expect.

2. Interest from potential western partners has been EXPRESSED and they are tracking the data from these trials as they seek to DE-RISK themselves before committing spending a shedload of cash to take ErepoXen to the APPROVAL stage and then commercialize/advertise it's benefits .... serious lolly here ..... so the data has to be good.

3. Meantime our Russian partners have started their OWN DOMESTIC RUSSIAN PHASE 111 trials and have dosed the first patient back in May 2013.

4. This means Xenetic has TWO CHANCES of scoring serious lolly on ErepoXen
a) MEGABUCKS from a Western Capitalista deal after Phase 11 data gets released out of Australia , at which point I see one of the 'interested parties' getting the paper signed before someone else beats them to the punch ..... and

b) Decent revenues to cover other drug developments in the pipeline from the 10% that Xenetic stand to get from ErepoXen sales in Russia when Phase 111 trials end and the state of Russia gives ErepoXen their approval .... which looks in my opinion to be VERY good when one remembers that EPO is not a new drug .... remember EPO has been used before but has gone out of patent. ErepoXen is NOT a step into the unknown for Xenetic.

What Xenetic has done is to reformulate it and apply their own unique IP/ technology so that the drug works MUCH better than it ever did before , and one dose is efficacious for circa 1 MONTH. The data from the new trials SHOULD make ErepoXen the BEST performer on the marketplace V what's out there now.



It is my opinion .... and remember I am a conservative sort of guy .... that the clever new guys recently taken on by Scott are going to use info and any EARLY indications from the trials to MAXIMISE XEN shareholder value when it comes to the reverse takeover/Shell deal in the USA.


It is my considered opinion ..... and if you read my advfn posts ..... I consider much more than most posters ..... that WHOEVER gets to deal with XEN in the USA are going to make a MINT.


I should charge for this




dyor

[earnestwipplethwaiteiii] 17/7/2013 14:51

Xenetic Biosciences expects higher rating from US switch

Xenetic Biosciences (LON:XEN) is finally embarking on the process of "serious value" growth, according to its chief executive.
This week Xenetic announced it is searching for a suitable candidate to reverse into to get a US listing, while the company's own development programmes for potential blockbuster drugs for western markets also starts soon.
Chief executive Scott Maguire recently colourfully compared this process as being like a "battleship leaving the dock".
He's referring to the first western clinical trial of ErepoXen for treating chronic anaemia, which is starting in Australia at the end of this month or next - one of several drugs in the firm's portfolio and a candidate that the firm wholly controls.
Maguire explains that previously Xenetic has been purely research-based, relying on out-licensing partnerships and collaborations with groups in India and Russia.
But, following a fundraising last year, the company has now begun the process of evolving into a drug developer, able to test and commercialise its own products.
Maguire is so excited about this transition because, not only does if offer potentially large rewards for shareholders, but also because the firm's portfolio itself is highly promising.
Xenetic specialises in developing orphan drugs for rare diseases, which have multi-billion dollar potential. Orphan drugs are fast-tracked to the market because they typically address diseases and conditions for which there are few, if any, medications.
Now, following the firm's undeniable progress thus far, what is needed, is delivering on plans and, of course, securing financing, reckons Maguire.
"As I see it, as management, the science is working and it's going to come down to a function of execution and money to deliver on the promise, because it's clear that these products we have in development have blockbuster potential and those are not my words, those are words from the investment and strategic community," he said.
And Maguire highlighted all three of its technological platforms - PolyXen, ImuXen, OncoHist - have products in at least phase 2 clinical trials.
Currently, its main focus is ErepoXen - the firm's most advanced product and likely to be the key share driver. Ironically, perhaps, this drug is one that does not fit into the firm's orphan strategy, in that it is a big, mass-market candidate.
Maguire says the plan is to complete a dose finding study for western markets in December this year before striking a deal.
"The goal of ErepoXen is to out-license as soon as allowable and there is already some interest in this product," he adds.
"This is a big market drug, very expensive clinical trials, so we are going to be seeking a partner to out-license this as soon as we have data coming out of Australia/New Zealand.
He said these locations were chosen because it is cost effective to run big market drug trials there, and the structure of the trials reflects the Food & Drug Administration (FDA) format so it's an easy transition into the US or Europe markets after phase 2 trials.
Importantly, however, in Russia, where the drug is currently in trials, there is a chance to see revenues from ErepoXen sooner.
In Russia, Xenetic hopes to see a commercial launch of the drug in the second half of next year and it will be receiving a 10% royalty on its sales in Russia.
Another candidate the firm is excited about, and which will be added to its portfolio for the western markets, is OncoHist for acute myeloid leukaemia.
Maguire told a conference call last month that he was "particularly" excited about this drug, which he said had "multi-billion dollar" potential.
OnCoHist binds itself to leukaemia cells and leaves healthy cells alone, so there are no serious side effects.
Maguire said a world-leading specialist described it as being the first novel mode of action for the disease he had seen in 20 years.
The firm continues to test the efficacy of this drug and crucial phase 2 data is expected this summer.
Part of the plans to expand into western markets is the move this September of staff to lab and development operations to Boston, USA - the world's leading centre for orphan drug development.
Xenetic has also just announced it will look for a merger with an SEC reporting, unlisted US company, a move that will enable it get a quote on a major US stock market within a reasonable period.
It wants to agree a deal in 2013, a move that will also see it de-list from AIM.
Maguire said the long term benefits of being a US-centric organisation will become apparent as US markets give "significantly" greater value to firms like Xenetic with its broad proprietary drug pipeline.
[...]

[buywell2] 17/7/2013 08:23

I am almost certain it WON'T be another BioTech

They would be far too expensive with too big a Market Cap

BioTechs attract PREMIUMS in the USA not like AIM in the UK hence the rationale to move over

More likely it will turn out to be some boring little company making 'round toits' or some such .... and going nowhere or even defunct ..... a shell .

But with a CEO that sees the potential of XEN and what conversion to the Pharma Biotech sector AT A STROKE by doing a deal with a company that owns unique technology platforms, IP , a pipeline of drugs in late stage human trials plus a FDA approved Orphan 'Fast Track' candidate, close ties with important partners and has Cash.

I have no problem with leaving AIM

Roll on the USA move this looks like a very shrewd idea

[earnestwipplethwaiteiii] 17/7/2013 06:05

jammytass - what's the point? AIM is moribund for junior pharma, all the action is in the US, XEN is moving its "corporate seat" to Boston, hiring over there, firing over here. It costs money to stay on AIM - for what, exactly? How many reasons do you want?

[jammytass] 17/7/2013 05:49

why not a dual listing