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15th Jul 2020 7:00 am RNS Trading Update

"Trading Update

- Strong 2020 performance despite COVID-19 challenge

- Earnings above market expectations

- Net revenue of £78.2million representing 6% annual growth

- Strong cash balance of £37.0 million

- Phase I Peanut program fully funded from existing resources

- Licencing deal signed for new oral treatment, ImmunoBON

- COVID-19 diagnostic facility approved by Spanish authorities

15 July 2020 Allergy Therapeutics plc (AIM: AGY), the fully integrated commercial biotechnology company specialising in allergy vaccines, today provides a trading update for the year ended 30 June 2020 ahead of its Preliminary Results to be announced on 23 September 2020. ...

COVID -19 Diagnostic Facility

In response to the urgent need to increase the global capacity to diagnose infected COVID-19 patients, the Group has invested capital into expanding its microbiological diagnostic facilities in Spain, by incorporating an RT-PCR based SARS-COV-2 diagnostic test into its portfolio. The RT-PCR technique can detect a fragment of RNA (the genetic material) derived from the SARS-COV-2 virus to determine if the patient is currently infected.

The Group's expanded microbiology facilities in Alcalá, named AT Immunolab, have been authorised by Spanish Health Authorities and will provide support in this healthcare crisis helping healthcare providers and patients in this difficult situation. The project has been set up in a significantly accelerated timeframe and received financing from the Centre for the Development of Industrial Technology and the Technology Fund, from the Ministry of Science, Innovation and Universities of Spain. AT Immunolab began SARS-COV-2 testing in the first week of July and, at full capacity, is expected be able to perform 200,000 tests a year. ..."

https://www.lse.co.uk/rns/AGY/trading-update-yf1c3halxv793tq.html

V.lodge,

Applying your philosophy, you could call passing phase I & II trials as negative, because phase III trials success isn't guaranteed.
And if you think that AGY should be conducting trials, then trying to dismiss as negative news that they will be doing so is contradictory.

Regarding any stricter allergy treatment regulation: that would apply equally to all allergy treatment companies. But it's the larger companies like AGY who would be best equipped to deal with it, and to finance the multi-million pound cost of trials.

I sympathise if you've lost money on AGY in the past, but if you bear a grudge against the company and its management this could be blinding you to the opportunity here.

Katoro Gold (KAT): 323,698,310 shares in issue including the new placing shares
x 2.2p current mid price = £7.121M. market cap.

KIBO owns nearly 100M. shares in KAT:

Kibo Energy plc 96,138,738
http://katorogold.com/investors/shareholder-information/

At KAT's current s.p. of 2.2p, KIBO's share is worth £2.115M.

The NPV of KIBO's combined projects is £1.5 billion pounds (at the current sterling-dollar exchange rate of $1.26 per £):

18th Dec 2019 9:00 am RNS Q&A Document

"Are NPVs attached to each project?

Yes, as part of the initial and ongoing economic feasibility assessment and financial modelling of each project, a key element is the assessment of the estimated inherent net present value ("NPV") of a project. In developing and operating large utility-scale power station projects, a 20-30-year view is required and forecasting the attributable cash flows over such a period is more of an art than a science. That said, cash flows can be valued for projects of this nature, utilising discounted cash-flow as a methodology to arrive at an NPV for unlevered free cash flow generated from Kibo's individual and combined power project portfolio. From this, we calculate the value of Kibo's equity share, after debt, the market value of minority interests and Kibo's share of the Developer's Premium is also considered. The most recent example of the foregoing can be seen in the First Equity Research Note as published over a year ago on 28 November 2018 and available on Kibo's website, which estimated the Company's combined projects' NPV at that time at US$1.9bn."

https://www.lse.co.uk/rns/KIBO/q-and-a-document-zbtv81r5kxzudct.html

That highlights the extraordinary undervaluation here at just 0.215p: market cap £2.783M. (1,294,490,188 shares in issue).

"How is this even remotely positive news ..."

It's not rocket science - a ten year old child could see it.

In simple terms:
If something good is invalidated, that's bad news. And vice versa.
So if a successful trial was invalidated, that would be bad news.
And if a failed trial is invalidated, as in this case, that's good news.

It means that AGY has a second chance with this product which could be an enormous money-spinner for the company, as well as helping a huge number of sufferers.

I look forward to some very exciting newsflow on AGY's multiple trials this year, as per yesterday's RNS:
"We look forward to progressing our portfolio of unique allergy vaccines and helping the millions of patients affected by allergy via our phase III studies with Birch MATA MPL as well as Grass MATA MPL and our upcoming first in human peanut trial."

Two hardly constitutes an alarming amount piling up.
One of which was due to negligence from the CRO (contract research organisation), for which AGY has received millions in compensation.
And one which has just been declared invalid.

And on 24th. June this management reported a profit upgrade, at a time when profit downgrades have become the norm, which is hardly a sign of incompetence:
"Reported revenues for the year ended 30 June 2020 are expected to be at least 4% ahead of last year in constant currency terms. A programme of operating cost efficiencies, together with the timing of the planned research and development expenditure over the 3 years to June 2022, are expected to deliver a net profit for the year significantly above market expectations.
The Board looks forward to providing a further update to shareholders for the year to 30 June 2020 in the week commencing 13 July 2020."

A lot of buy have been showing as sells.

And your philosophy is precisely why many investors buy high and sell low, rather than the opposite.

"Technical Analysis for POLX - Polarean Imaging Plc"

"Grade Last Price % Change Price Change
grade A 33.43 21.56% 5.93"

"ADX Long Term Intermediate Term Short Term
Strong Up Up Up"

https://lse.swingtradebot.com/equities/POLX:LSE

"POLX Technical Analysis"

"Summary: STRONG BUY
Moving Averages: BUY Buy (12) Sell (0)
Technical Indicators: STRONG BUY Buy (7) Sell (1)"

https://uk.investing.com/equities/polarean-imaging-plc-technical

A comparison to some other COVID-19 testing plays shows how undervalued IDH is:
RENX 560p, market cap. £333M.
AVCT 131p, market cap. £249M.

IDH at 265p is valued at just £78M.

However, it's still relatively early days, and I'm confident that this disparity will be corrected in due course.

A key should be sales news, and I'm confident that there will be enormous uptake for IDH's offering.

Thanks Mavern.

"Coronavirus: Why surviving the virus may be just the beginning

By Chris Morris
BBC Reality Check

3 July 2020

... Even when that process is a success, it is only the beginning of a long process of physical and psychological recovery. And now the UK has moved past the peak of the virus, attention is turning to the huge challenge - both in the health service and in the community - of rehabilitating Covid-19 survivors. ...

"But because of Covid, and the number of people that it has affected, the need is pressing. It has become a national priority - to support people to get better." ...

Breathlessness

The most common physical challenge for recovering Covid-19 patients is shortness of breath - and that can apply to people who had moderate as well as severe symptoms of the disease.

"For patients that are coming out of hospital," says Sally Singh, "clearly they're breathless because they've had a respiratory disease. Their lungs are temporarily damaged, but they are also deconditioned because they've been lying in a hospital bed for so long that they've become pretty unfit."

It means that simple things like going up and down stairs can become extremely challenging, especially in elderly patients.

But breathlessness is an issue that goes well beyond survivors of intensive care. And a significant minority of people who've been infected with the coronavirus are still struggling to shake it off. ...

Challenges

Previous medical experience with pneumonia suggests it can take months, or in extreme cases years, for patients to get back to where they were before. With Covid-19, we are still early in the cycle of rehabilitation and recovery, and every patient is different.

"The honest answer is we don't yet know how long it will take," says Sally Singh. "People are researching that as we speak - monitoring chest x-rays, symptoms and the wellbeing of patients to help us identify what the best intervention to support these people may be."

The trouble is the provision of rehabilitation services across the country can be patchy, especially for people emerging from critical care. And the NHS is already dealing with a massive backlog of non-Covid cases that have been delayed.

"The huge challenge," says Krystyna Walton, "is going to be the increase in numbers."...

"And my suspicion," Krystyna Walton adds, "is that many patients may have not had their needs assessed properly." ...

It is important to emphasise those rehabilitation needs don't stop after the immediate recovery period. Many patients will suffer from scarring of the lungs - a permanent and often debilitating condition. ...

The NHS and individual hospitals are of course building rehabilitation into their Covid recovery plans, but this is a system that has been overlooked for years. Experts in the field hope, despite all the pressures, that Covid will provide a launch pad for change. ..."

https://www.bbc.co.uk/news/53193835

Here's an additional extract from today's podcast (not quoted verbatim) that I accidentally left out of my 17:33 post - sorry about that:

• Bracco recently acquired a 7% interest in POLX.

It's 6 months or so for a priority review ... but even faster than that if it's fast-tracked for the COVID-19 benefit.

"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. ..."
https://en.wikipedia.org/wiki/Priority_review

"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. ..."
https://en.wikipedia.org/wiki/Fast_track_(FDA)

I441,

POLX's expediated review issue doesn't seem to have been decided yet, and until it is POLX can't change the official timeline its given to the market.
A formal expediation request will probably be made when the FDA application is submitted, and I believe that the FDA will then give an answer on that within 45 days:

"PMA Review Process
... Within 45 days after a PMA is received by FDA, the agency will notify the applicant whether the application has been filed. The letter will include the PMA reference number and the date FDA filed the PMA. Expedited review status, if appropriate, may be communicated at this time. ..."
https://www.fda.gov/medical-devices/premarket-approval-pma/pma-review-process

Interestingly the Blue Earth Diagnostics FDA approval only took 6 months under a priority review, and that was without the increased imperative that COVID-19 has created for POLX's technology.

Thanks I441 for flagging up this new Vox Markets podcast featuring POLX.

"The Vox Markets Podcast with Justin Waite
... The Weekend Podcast
Jul 4, 9:15 AM
On the weekend podcast we talk about super / stupid Saturday, Steve’s last online quarantine disco and mention Gfinity #GFIN Polarean #POLX & Salt Lake Potash #SO4"
https://audioboom.com/posts/7622969-the-weekend-podcast

The podcast talks about three stocks which Justin Waite says he believes will double by the end of the year, and that have ten-bagger stamped all over them.
Apparently these are the only three stocks that he owns.
Justin says that momentum one of the biggest factors in small-cap. stocks.

The section on POLX starts at about 21:30, and lasts for about three and a quarter minutes.

Here are a few extracts (not quoted verbatim):

• POLX passed the phase III clinical trials - that's usually the most risky stage.
• Mr. Petit of the Bracco Group was appointed a POLX non-executive director on 1st. June.
• Bracco Imaging acquired Blue Earth Diagnostics in 2019 $450M.
• Jonathan Allis, the head of Blue Earth, is a non-executive director of POLX, and has invested hundreds of thousands into POLX.
• You can see what's happening here.
• POLX's technology has more potential than Blue Earth's.
• But POLX is valued at £40M. [sic], compared to the $450M. for Blue Earth.
• It's all a formality from here on in.
• POLX's technology is far better than anything else available.
• POLX's FDA application could be fast-tracked because of COVID-19.
• Bracco are probably going to buy POLX out, for multiples of its current level.

Well done and thanks to IDH's management for launching this COVID-19 antibody test bang on schedule, and for keeping the market so well updated.

They look to have played an absolute blinder here in launching this 'platinum standard test' that could be a 'licence to print money'.

And at just 270p IDH still isn't at much of a premium to the 240p+ that it was at for most of the spring, despite this game-changing development from the company.

Though I would expect that to change over time.

30th Jun 2020 7:00 am RNS Launch of assay to detect SARS-CoV-2 antibodies

"Immunodiagnostic Systems Holdings plc (IDS), a specialty solution provider to the clinical laboratory diagnostic market, announces that following the announcement on 12 June, our fully automated SARS-CoV-2 IgG antibody test ("the Test") will be available for sale from today.

The test can now be purchased by customers in the UK, the EU, and a number of other countries which accept the CE mark as the basis of regulatory approval. We have commenced the process of working with various national reference centers and governmental bodies to ensure a roll-out according to national guidelines.

Jaap Stuut, CEO of IDS commented

"We are pleased to announce the release to the market of our automated SARS -CoV-2 antibody test, running on the IDS-iSYS analyser. IDS will now seek to commercialise this test via our direct sales force in Europe, and through our extensive distribution network elsewhere, and we look forward to joining the efforts to minimise the impact of the COVID-19 virus."

About the Test

The Test, which arises from the partnership between IDS and Technogenetics, is designed to run on the installed base of over 600 automated IDS-iSYS analysers. The Test:

· Detects specific IgG antibodies indicating past exposure to the COVID-19 virus and immune response;

· Is a quantitative test which determines antibody concentration (titer);

· Is highly accurate with a sensitivity of 100% and a specificity of 99.4%;

· Provides Test results available within 25 minutes.

Unlike many COVID-19 serology assays currently available, this Test is a quantitative assay, thus it can determine the antibody concentration in patient serum. Although the clinical level of functional immunity conferred by SARS-CoV-2 IgG antibodies has not yet been determined, we believe quantitative tests may ultimately be valuable in determining immunity status based on the levels of antibody in the blood.

All steps of the Test are automated with no manual reagent preparation required, ensuring minimal hands-on time for lab staff and a high daily throughput."

https://www.lse.co.uk/rns/IDH/launch-of-assay-to-detect-sars-cov-2-antibodies-8h15g7t29fy3gkf.html

"A little-known biotech working on a COVID-19 vaccine has surged 304% in 2 days — and it just said it was picked for the US government's Operation Warp Speed program (VXRT)

Matthew Fox
Jun. 26, 2020, 04:06 PM

... Based on Friday-morning trades, Vaxart is set to end the week 328% higher. The firm has seen its market capitalization skyrocket to about $850 million from just under $200 million at the start of the week, according to data from YCharts.com. ..."

https://markets.businessinsider.com/news/stocks/vaxart-stock-price-covid-vaccine-government-warp-speed-program-coronavirus-2020-6-1029346082

The fact that POLX is a spin-out, from GE Healthcare, is another major bull point here.

Because spin-outs on average greatly outperform the market as a whole. -

"3,484 views|Mar 5, 2019,10:38am EST
Spin-Offs Outperforming The Market This Year

Joe Cornell Contributor
Markets

You can beat the Street. At a time when many professional investors lament that the proliferation of ETFs and widespread use of screening techniques have made it harder to find bargains in the stock market, one simple investing approach continues to outperform: spin-offs.

Spin-offs have long been a fruitful investment area; a number of academic studies show that they historically have generated far better returns than the overall stock market. A spin-off occurs when a corporation issues stock in a subsidiary to its shareholders to create a new public company. A related corporate event is an IPO carve-out, through which a company sells the public a stake in a unit, while retaining the rest of the division. (Sometimes, the remainder is later distributed to shareholders).

The Bloomberg U.S. Spin-Off Index, composed of companies spun off from larger companies within the past three years, has outperformed the broader market by nine percentage points since the start of the year through Tuesday (February 26th). The 35 member index contains equities with a value over $1 billion that were spun-off from U.S. companies. ..."

https://www.forbes.com/sites/joecornell/2019/03/05/spin-offs-outperforming-the-market-this-year/#25c2920033bb

A well-known spin-out is Vodafone(VOD), which was spun-out from Racal Electronics, and now has a market capitalisation of over £30 billion.

Stocks being pumped to overvaluations will come down, whereas better value stocks will move up. -

Benjamin Graham:
“In the short run, the market is a voting machine but in the long run, it is a weighing machine.”
HTTP://www.goodreads.com/quotes/831517-in-the-short-run-the-market-is-a-voting-machine

Warren Buffett:
"I would rather be certain of a good result than hopeful of a great one."
HTTP://www.quoteswise.com/warren-buffett-quotes-5.html

At just 240p IDH is looking massively oversold, and nicely poised for a big imminent rebound.

Here are a few more extracts (not quoted verbatim) from the 19.6.20 Vox Markets video featuring a POLX interview:

• The next big milestone will be the FDA application submission.
• POLX also has new orders to announce shortly, as soon as they are papered up.
• Three good reasons to add POLX to a watchlist?
i. POLX's technology is the ideal solution to a huge unmet need in medicine.
ii. POLX's technology is all derisked. About US$60M. has been spent commercialising it.
iii. Great management team and board with specialist expertise in the field.

AGY's next financial year, i.e. July 2020 - June 2021, starts in just a week, and will see several important clinical trials:

04 Mar 2020 Half-year Report
" ... Outlook
This calendar year is key in order to prepare for several important trials for the 2021 financial year. ..."
https://www.allergytherapeutics.com/investors/regulatory-news/

But unlike most biotechs, AGY's strong cash position and trading gives it very solid value underpinning, meaning that the potential huge upside from trials success is 'in for free'.

With a big bonus being potential involvement in COVID-19 vaccines.

And I would expect an RNS on that last point soon.

Indeed I believe that today's trading update 'paves the way' for a COVID-19 RNS.
Similar to ODX in April, where a trading upate was followed a week later by a COVID-19 RNS.
And during April the ODX s.p. multibagged.

02/04/2020 07:00 UK Regulatory (RNS & others) Omega Diagnostics Group PLC Trading Update
09/04/2020 07:00 UK Regulatory (RNS & others) Omega Diagnostics Group PLC COVID-19 Consortium MOU