Polarean Imaging Share Discussion Threads

[loglorry1] 20/6/2020 18:31

On approval a lot options open up. License the product to a distribution partner. Sell the whole lot to Blue Earth. Debt funding. I'm not expecting more dilution especially if they get approval in under 12 months.

[idiot441] 20/6/2020 17:57

Listening to the interviews I think there are several positives and I am happy with the progress even if we do not appear to have fast track to approval.

1. FDA meeting had no surprises and indeed helped ensure there should be no significant issues during the approval process.
2. POLX are on track to make application in Q3 - considering the FDA meetimg was April I think we may find that is in the first half Q3 and perhaps by end July?
3. Outcome due within 10 months and further 2 months to get exclusivity in usa for 5 years.
4. But even though it's not on a fast track we may find that covid encourages shortened timetable. Personally I think we could see a pleasant surprise with full approval (and exclusivity) confirmed by end May 2021
5. In the meantime POLX will continue to sell units for research... and some clinics may want to make sure they are ready by having it installed in time for approval. Another potential surprise as more firm orders ahead of FDA approval? These will have RNS
6. I am certain POLX will be taking pre-orders that are subject to FDA approval. Perhaps with some cash up front even? Clinics and hospitals etc will know there is going to be a queue once approval granted. Better to sign a pre-order/letter of intent to ensure place in queue. I do not expect the company to release info on those orders until approval - but immediately after FDA approval we may have a pleasant surprise of multiple units on order - perhaps 12 months capacity? More?

Does anyone know what capacity they are gearing up for in 1st and 2nd year after approval?

7. Clearly post approval we can expect a fundraising to increase sales, marketing, manufacturing capacity etc.
With a smooth approval process we might see a fundraise of say up to £10m? But by then price will hopefully be in the 75p to £1 range?

[hedgehog 100] 20/6/2020 17:00

A new POLX video interview was posted on Proactive Investors yesterday:

"Polarean Imaging in commercial launch mode for its lung function scanner
Andrew Scott
07:18 Fri 19 Jun 2020
Polarean Imaging PLC's (LON:POLX) Richard Hullihen caught up with Proactive London's Andrew Scott following a recent pre-NDA meeting with the FDA. He says they're targeting the third quarter of this year to submit an NDA for its drug-device combination which uses hyperpolarised 129-Xenon gas MRI. By inhaling and holding a small amount of the gas for just a few seconds, the patient is able to create a much stronger MRI signal, providing doctors with multiple images of lung structure and function."

Here are a few extracts (not quoted verbatim):

• The pre-NDA meeting went pretty much as POLX expected.
• No delays encountered re. Q3 FDA submission plan.
• POLX's drug-device combination is being managed by the drug side of the FDA.
• POLX are also seeking a FDA regulatory grant of market exclusivity in the US.
• POLX are still selling & installing research equipment - they have an active pipeline - they'll be making a couple of announcements on that in due course.
• POLX have non-research target customers for when FDA approval received.
• POLX are already preparing for non-research commercial launch.
• POLX are excited to be bringing pulmonary medicine in the US into the 21st. century.

[supernumerary] 18/6/2020 10:45

I think they're being very cautious in allowing 12 months for FDA approval - in the current pandemic, when doctors need all the diagnostic help they can get, it should be rushed through.

[buywell3] 18/6/2020 08:42

Chart suggests 20p on no new news

dyor

[lukehold] 18/6/2020 08:38

Added looking for a bounce off 25p

[buywell3] 18/6/2020 08:02

That's a bigger loss this time then

[yasrub] 14/6/2020 14:49

A little bit of buying action late on Friday - hopefully looking forward to an update on progress.

[hedgehog 100] 06/6/2020 16:55

01/06/2020 07:00 UKREG Polarean Imaging PLC Appointment of Non-Executive Director
"Polarean Imaging plc (AIM: POLX), a clinical stage medical imaging technology company developing a proprietary magnetic resonance imaging (MRI) drug-device combination, announces the appointment of Mr. Cyrille Petit to the Company's Board as a Non-Executive Director with immediate effect.
Mr. Petit is Chief Corporate Development Officer and Head of Strategic Initiatives of the Bracco Group, a global leader in diagnostic imaging and medical devices ("Bracco"). Bracco recently acquired a 7.6% interest in the ordinary share capital of Polarean as part of the Company's GBP8.4m fundraise, which was first announced on 13 March 2020. As such, Cyrille Petit is joining the Board of Polarean as a representative of Bracco.
Cyrille Petit began his career at Goldman Sachs and went on to specialise in external growth, mergers and acquisitions, and strategy at General Electric, where he worked for 15 years. In 2012, he joined the executive committee of Smith & Nephew PLC as Chief Corporate Development Officer, and later added the responsibilities of President, Global Business Services. There, he led the group's transformation and helped to accelerate growth through a series of transactions worth in excess of US$3B. ...
Richard Hullihen, Chief Executive Officer o f Polarean, said: "Cyrille's direct experience is well matched to the markets and upcoming evolution of Polarean. He is welcome on the Board, and I am excited that he has agreed to join us in the Non-Executive Director role. On behalf of the Board, I would like to welcome Cyrille to Polarean and we look forward to the skills and advice he will bring to the Company." ..."



As well as having a top role at Bracco, Cyrille Petit is also a director of Blue Earth Diagnostics, which was acquired by Bracco last year for $450M.

I think there's a very good chance that history could repeat itself with POLX.

[yasrub] 01/6/2020 08:10

Richard Hullihen, Chief Executive Officer of Polarean, said: "Cyrille's direct experience is well matched to the markets and upcoming evolution of Polarean."

Not an unexpected appointment I think his career history and current position with Bracco says it all.

The chief executive seems punchy with 'upcoming evolution of Polarean'.

[slicethepie] 01/6/2020 07:21

Interesting to see the Branco appointed Ned already holds 350000 in his own name

[hedgehog 100] 30/5/2020 17:41

America is clearly a huge country: population 329 million, and growing rapidly, and with the world's largest economy.

And America is also a vast and well-funded (multi-trillion dollar) healthcare market, which is at the forefront of applying new technology.

In particular to POLX, America is at the forefront of investing into scanning capacity, especially compared to the UK.
Which, combined with its huge size, shows what an important market it is for POLX.


"Number of magnetic resonance imaging (MRI) units in selected countries as of 2017 (per million population)
United States 37.56
Germany 34.49 …"


"NHS must do more to future-proof its MRI capacity, say imaging experts
Wednesday 10 May 2017
… The UK has 6.1 MRI systems per million people, fewer than countries including Estonia and Slovenia. …"


"Number of computer tomography (CT) scanners in selected countries as of 2017 (per million population) 
Australia 64.35
Iceland 44.33
United States 42.64 ..."


"How does the NHS compare internationally? big election questions
02 June 2017
Authors
Ruth Robertson
... The UK also has fewer CT scanners (8 per million population compared to an EU average of 21.4) and MRI scanners (6.1 per million compared to an EU average of 15.4) than most other European countries. However, this data does not include diagnostic scanners based in non-NHS providers that are used by the NHS. ... "



As an American company, POLX looks particularly well-placed to exploit this huge market opportunity.

And as the majority of POLX's sales are in US Dollars*, their sterling value will increase as sterling weakens against the Dollar, as it has been doing over the last several years.

In addition, as a UK-listed company, a weaker sterling will also make a takeover of POLX cheaper for foreign predators, as they will get more sterling for their own currency.
FDA-approval could potentially be a catalyst for such a takeover.


* 27/06/2019 07:01 UK Regulatory (RNS & others) Polarean Imaging PLC Final Results
"... The Group operates in Canada, Germany, the United Kingdom and the United States of America. Revenue by origin of geographical segment for all entities in the Group is as follows:
Revenue
2018 2017
US$ US$
-------------------------- ---------- ----------
Canada 163,677 340,113
Germany 15,117 24,617
United Kingdom 38,661 111,765
United States of America 2,221,684 760,668
-------------------------- ---------- ----------
Total 2,439,139 1,237,163 ..."



GBPUSD Chart

[hedgehog 100] 27/5/2020 15:41

FDA approval is in effect a licence to sell in the US, which should open the door to a quite enormous market for POLX.

More than thirty million Americans suffer from a chronic lung disease:

29/01/2020 07:00 UK Regulatory (RNS & others) Polarean Imaging PLC Positive pivotal Phase III Clinical Trials results

" ... Richard Hullihen, Chief Executive Officer of Polarean said: "The positive results of these Clinical Trials validate our belief that Polarean's technology allows clinicians to visualise aspects of the lung function, which have never before been visible by MRI, both safely and quantitatively. More than 30 million Americans suffer from a chronic lung disease and the financial burden of lung disease now exceeds US$150 billion annually. Given the limitations of existing methods to diagnose and monitor lung disease, we see a significant unmet need for non-invasive, quantitative and cost-effective image-based diagnosis technology without exposing patients to ionizing radiation. We believe that our technology has the potential to overcome these limitations and we look forward to using data from the Clinical Trials to support our New Drug Application." ... "

[hedgehog 100] 27/5/2020 15:29

Hedgehog 100 16 May '20 - 19:27 - 394 of 398 Edit 0 4 0
" ... In addition, you tend to find that a share price will appreciate a lot during the FDA approval process, in anticipation of the approval. ..."


A good relatively recent example is Shield Therapeutics (STX).

STX rose about six-fold in the first seven months of last year, from about 30p, until just after its FDA approval on 26th. July 2019.

And it more than trebled during this period ahead of the FDA approval, before enjoying a very strong rise at the FDA approval itself.


26/07/2019 07:00 UKREG Shield Therapeutics PLC FDA approves Feraccru® with a broad label

"London, UK, 26 July 2019: Shield Therapeutics plc (LSE: STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency, announces that the U.S. Food and Drug Administration (FDA) has approved its lead product Feraccru(R) / Accrufer(R) for the treatment of iron deficiency in adults.

With this broad label approval Accrufer(R) (as the product will be marketed in the USA) has taken a big step towards exploiting the very large commercial opportunity in the USA, the world's largest and most attractively reimbursed pharmaceutical market. Market research suggests that the prescription market for iron replacement therapy in the USA is worth over $1.0bn annually. There are between 8 million and 9 million patients in the USA who suffer from iron deficiency anaemia and management estimate potentially two to three times this number require treatment for iron deficiency. ..."

[yasrub] 25/5/2020 07:52

Covid-19 the reality seems to be setting in that a vaccine is unlikely for some significant time,if ever.

Always easy to then put forward a company that you are invested in believing their tech will help - charged as guilty!

POLX surely will be in a position ST and LT to be in demand - Based on the history of Jonathan Allis he might know his way around of how to achieve this.

[diversification] 20/5/2020 17:29

Nice post HH, the story here is very compelling and the deeper you research the better the story gets.

[hedgehog 100] 20/5/2020 17:05

Remember that just under a year ago Bracco Imaging acquired a similar company to POLX: Blue Earth Diagnostics ... for $450M.

"Blue Earth Diagnostics sold to Bracco Imaging in $450M deal
by Conor Hale | Jun 27, 2019 11:57am
Molecular PET agent developer Blue Earth Diagnostics has been picked up by the Italian multinational Bracco, which will take in the company as a subsidiary under its medical imaging banner.
Blue Earth’s previous owner, the London-based healthcare group Syncona, traded its outstanding shares in the company to Bracco for $450 million, plus an estimated closing adjustment of $25 million. ..."



Thanks to McFly for these comments about that acquisition:

Mcfly79 5 Jan '20 - 12:04 - 173 of 395
" ... Over $50m has been spent on the development of the product, much by GE before Polarean acquired it.
. To see where the company could go it's worth looking at a company called Blue Earth Diagnostics.
. Very similar business to Polarean. They are a UK imaging device company that developed a novel imaging agent for PET scans to help with prostate cancer imaging (whereas Polarean has developed a novel imaging agent for MR scans for Pulmonary imaging).
. Like Polarean the technology was pulled out of GE.
. From being formed in 2014 the company was sold in June 2019 for $450m to an Italian imaging business. Polarean is valued at $35m.
. As if there weren't enough similarities, the founder and CEO of Blue Earth Diagnostics is Jonathan Allis, who is a non-executive director of Polarean and very active in the business. Jonathan Allis bought 1,540,000 shares in Polarean in October as part of the Amphion buy out.
. It may take a year before we receive FDA approval but I think there is the potential for corporate action in that time, such as a partnership with a very large MR device manufacturer.
. Interestingly the Blue Earth Diagnostics FDA approval only took 6 months under a priority review:
.
... "

[hedgehog 100] 16/5/2020 19:48

Also, there's a lot of potential near-term positive newsflow in the pipeline in addition to the FDA approval process.

Thanks to diversification for this excellent summary:

diversification 28 Apr '20 - 15:39 - 358 of 394 0 3 0
"News pending (IMO)
Today 10:17
- Sale of additional Polarizers (min 3)
- Read out from AstraZeneca Phase 3 study
- Bracco Imaging international expansion/approval
- Big Pharma collab
- Potential scientific user application related to COVID19
- Pre-NDA meeting imminent
- NDA submission
With the share price at 24p we are at a pivotal point. If we breakout today (L2 1v3) with more volume, this tightly held stock could head back towards its ATH with plenty of justification.
Fully funded through to FDA approval their will be plenty of newsflow, some of which I haven’t even mentioned, and with a £40m market cap their isn’t a sector I would rather be in than pulmonary imaging right now!"

[hedgehog 100] 16/5/2020 19:27

RichardJohn1014 May '20 - 18:16 - 390 of 393 0 1 1
"FDA is a year away so why are you investing now? I’m just curious?"


Richard,

In a sector where it can take a decade or more to bring a drug to market, a year will be regarded as pretty close by most investors.

And it could potentially be a lot sooner than a year: say 6 months or so for a priority review ... and even faster than that if it's fast-tracked for the COVID-19 benefit.

In addition, you tend to find that a share price will appreciate a lot during the FDA approval process, in anticipation of the approval.

And remember that with its recent fundraising POLX is fully-funded for the FDA approval process ... and that there's not the same real risk of rejection as with drugs, where there can be unpleasant side effects.


"Priority review
From Wikipedia, the free encyclopedia
Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. ..."


"Fast track (FDA)
From Wikipedia, the free encyclopedia
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days. ..."

[buywell3] 15/5/2020 06:48

Girls

buywell notes your comments

More iron might help

DOW to 15000 next leg down is buywells' call , super might know that

Being an ardent fan

[richardjohn10] 14/5/2020 18:16

FDA is a year away so why are you investing now? I'm just curious?

[diversification] 14/5/2020 17:52

I actually cringed at it, haven’t filtered he/she as it will be hard to rock the boat here and I didn’t have to pay for that laugh.

Earlier today it took 45 minutes to execute my order at 26p, news is imminent imo