Member Info for Trader_3

Sham - I think you’ll find Nationwide offers multiple Smart Home options through various companies, including other water leak detection systems, :-

https://www.businesswire.com/news/home/20220315005934/en/Notion-a-Comcast-Company-Continues-to-Grow-Smart-Home-Program-with-Nationwide

https://www.reddit.com/r/homeautomation/comments/y9cegv/notion_smarthome_kit_offered_by_nationwide/

https://getnotion.com/pages/smarthome-partner-programs?_pos=2&_sid=9b9c71617&_ss=r

Frankly, I see this temporary pull back as a positive. It’s good that short term traders are leaving & will only result in strengthening the remaining LTH share base.

Those who have conducted their due diligence and research, understand the as yet unrealised true potential value, in ORPH.

This is a short term dip into a continuing & inevitable SP rising trend. Another great buying opportunity for LTH’s.

IMHO

NB. FYI - I’ll be posting under the moniker of Jigger_1 in the future (I don’t think that the Trader_3 moniker reflects my high conviction buy & hold trading strategy).

‘If the findings on healthy unvaccinated volunteers intentionally exposed to SARS-CoV-2 prove useful, then a challenge component may be incorporated into future clinical trials for COVID vaccines. Said Andrew Catchpole, Chief Scientific Officer at hVIVO, the organization that is signing up potential participants for the Imperial College study (as well as for the second study that Thomas has applied for) “We expect that this study will greatly assist our understanding of this disease and provide insights into its progression, natural immune response, and transmission. We look forward to publishing the study’s results in due course and moving forward with vaccine challenge studies later this year.”

‘The second trial will kick off in May, sponsored by Wellcome Trust and conducted at hospitals affiliated with the University of Oxford. Plans are to enroll up to 64 people aged 18 to 30. Phase 1 will examine lowest-dose-to-reinfect and phase 2 will document immune responses. Findings about the timing of reinfection and the immune response can perhaps then be factored into decisions about re-openings and leaving our COVID pods and bubbles for more normal social behaviour.
People can register their interest in participating in either trial at ukcovidchallenge.com, the website for hVIVO, which has led similar studies for other infectious diseases.’

https://geneticliteracyproject.org/2021/04/20/would-you-agree-to-be-infected-with-covid-for-science-intentional-challenge-studies-underway-as-researchers-explore-new-vaccines-and-treatments/

Further confirmation that hVIVO are collaborating with the second Oxford University reinfection study and are recruiting volunteers for this latest CHIM.

GLA LTH’s

‘The first phase of the trial, led by the University of Oxford, will test the dose of virus required to reinfect through nasal administration. The second phase will record the immune response, including immunity gained through previous infections. Vaccines will not be used at these two stages.

Volunteers will be tracked for one year. Professor Helen said that they will be paid about 5,000 pounds (about 4,5058.5 yuan) during their isolation and tracking. Oxford University’s partners include hVIVO Services, a drug testing company that has experience in challenging trials and also participated in research at Imperial College.’

https://translate.google.com/translate?hl=en&sl=zh-CN&u=https://k.sina.cn/article_7030414608_1a30b9d1002001jkot.html&prev=search&pto=aue

+

Hvivo historical link to Dr Helen Mc Shane, including meeting with: Dr Andrew Catchpole; Adrian Wildfire; Wellcome Trust; Prof Andrew Pollard & Dr Peter Openshaw:-

Third human challenge trial conference, Oxford, United Kingdom, February 6–7, 2020.

https://www.sciencedirect.com/science/article/abs/pii/S1045105620300440?via%3Dihub#!

Based on some detailed research, I’ve discovered something very big that is currently brewing for ORPH, in addition to everything else we know about and anticipate.

I’ve been joining up some dots and found evidence to suggest that a major event may be occurring, in the short term (I think it may be my best find yet!).

This may have contributed to the recent volume & price action performance of ORPH, in addition to the expected news ref the non core asset spin offs, CHIM contracts etc.

Barring any intermediate RNS’s, for those willing to pay close attention (who conduct thorough research and are prepared to be persistent), the signs & rewards are there to be discovered. ;-)

I’ll compile my research over the weekend, with a view to posting it next week (probably on the ORPH Telegram Group).

GLA LTH’s

N.B. Due to this research and for transparency, I have been quietly adding significantly to my ORPH holding in the recent past.

Monoclonal antibody testing is a new area for ORPH and has been mentioned by CF several times:-

1. CF has recently included monoclonal antibody testing, in one of the latest RNS contract wins, stating:

“We have expanded from one clinic to multiple clinics, and it is our stated objective to continue to invest and expand our global capability to ensure our position as the world leader in testing vaccines, antivirals, and monoclonal antibodies through the use of human challenge studies well into the future.”

https://www.londonstockexchange.com/news-article/ORPH/ps7-5m-human-challenge-study-contract/14914677

2. US FDA Fast Track Development of Monoclonal Antibody Products

Development of Monoclonal Antibody Products Targeting SARSCoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency

‘Given the serious concerns raised by the emergence of SARS-CoV-2 variants, FDA intends to leverage its emergency authorities under section 564 of the FD&C Act, when appropriate, to foster the development and availability of therapeutics for use during the current public health emergency. When scientifically supported, FDA will streamline the data necessary to support the development of monoclonal antibody products targeting SARS-CoV-2 and also expedite the review of these data.’

https://www.fda.gov/media/146173/download

Interesting recent FDA report looking to fast track monoclonal antibody products.

3. Cathal emphasised and also stated in a recent presentation, that a new area ORPH were working on are monoclonal antibodies and described them as a ‘really attractive space’.

https://www.proactiveinvestors.co.uk/companies/news/943709/open-orphan-lonorph-presenting-at-the-proactive-one2one-virtual-forum-943709.html

4. Additionally, The Wellcome Trust are heavily encouraging countries to develop monoclonal antibody therapy & vaccines on a global basis, as per below:

https://wellcome.org/sites/default/files/expanding-access-to-monoclonal-antibody-based-products.pdf

Clearly there are a large number monoclonal antibody therapies and vaccines in development (both Covid & Non Covid). The FDA fast track process highlights this industry as another high growth sector.

I can see why Cathal stated that this area is ‘really attractive’, as it could expand ORPH’s services exponentially and generate multiple more lucrative revenue streams, in addition to everything else.

IMHO

hVIVO’s heritage in the development of challenge studies (it has successfully developed eight so far – the largest portfolio in the world), is likely to lead to an adjacent opportunity via its Disease in Motion® digital platform. Using the knowledge of virus progression that the company has built up over the years, this technology aims to provide a data enabled solution for wearable products that can be used to monitor the health of the wearer. This product has already attracted strong interest from large consumer electronics, pharmaceutical and biotech companies, so it may well become part of a comprehensive personal health monitoring solution in the coming years.’

https://sterlingim.co.uk/our-companies/

~ 23min 20 sec

“We’ll do loads of wearable deals, with loads of parties… there will be recurring revenues and license deals……there are great options, we’re going into next year highly profitable, one of the top CRO’s in Europe, a lot of data deals coming, new models, filling out new clinics – we’re able to expand rapidly and then there’s the non core assets.

I’ve never been so exited in my life, I think wow, we’re just in a very very attractive space”

https://www.youtube.com/watch?v=gcvYcAUrqaU&feature=emb_logo&ab_channel=SharesMagazine

Quick list of the ‘known’ imminent RNS share price triggers, we are due very soon:

- 1 or 2 Multi £ Million Non Core Asset Spin Offs (in next 2-3 weeks)

- A ‘few’ Multi £ Million Covid & Non Covid CHIM Contracts

- Positive Financial Results and forward looking statement ‘after Easter’

- Covid CHIM Characterisation Study update

- Possible TR1 confirming Invesco are out

Any one of these RNS’s, have the potential to propel the share price significantly higher.

A combination of one or more of these RNS’s, should provide a long overdue re rate to an undervalued SP (after being disproportionately suppressed by the recent Invesco selling).

Add to this list, anything ‘out of left field’ and the potential rewards increase substantially i.e. China contracts, strategic investor, DIM contracts, takeover discussions etc.

I don’t normally say this but seriously, ‘who would want to be out of this over the weekend’?

With good reason, I believe the next week or two may be very interesting! ;-)

GLA LTH’s

Just a quick update & reminder for any new researchers & investors who may be interested in ORPH:

A few key reasons to invest in ORPH, as follows:

- 1 or 2 imminent RNS’s due this month for multi million £ non core asset spin offs

- A pioneering global leader in testing vaccines via Controlled Human Infection Models (CHIMs) & the first (only) company in the world, able to deliver Covid CHIM studies

- $1 Billion market cap target stated by the CEO (who delivers what he says)

- Ethics & Regulatory approval granted for UK Covid CHIM’s (170221) – subsequently derisking a large pipeline of multi million £ contracts in the short to long term

- International consortium lead to assist Low & Middle Income Countries in implementing CHIM’s via The Wellcome Trust, creating potential additional multiple significant recurring high revenue streams to large population LMIC’s

- New ‘Disease in Motion’ platform with potential current market cap valuation of ~£200 million

- New Whitechapel Quarantine Clinic opened Feb’21 with expanded 19 bed capacity

- Enqs ongoing to locate a 4th clinic with potential 100+ bed capacity

- Potential huge Covid CHIM’s licensing deals or studies with the Chinese State

- Potential expansion of lab facilities with UK Gov, to cope with anticipated on going demand

- Near term large special dividends due from monetisation of Imutex, PrepBiopharm and Influenza Immune Modulator

- Confirmed ~£46 million contract for Covid CHIM’s with UK Government

- Multiple global vaccine co’s queuing up for future Covid CHIM slots ~£10-15 million per contract

- Non Covid CHIM’s fully booked for next 18 months, ~£5 million plus per contract

- Huge & recurring future anticipated revenues from both Covid & Non Covid services

- Excellent CEO Cathal Friel and his team, who deliver on what they say they will do

- CEO with ‘skin in the game’, investing £2.5 million of his own cash (large % holder)

- Low risk ‘picks and shovel’ company, with a ‘large moat’ in a niche & hot sector

- Regular anticipated future annual normal dividends from surplus cash

- Multiple valuable assets i.e. 24 bed London clinic & lab, 8x challenge studies etc

- Cash generating & profitable (~£20 million cash), within a growing global market

- Commitment to no future placings from CEO, who is ‘locked in’ until mid 2022

- Future new CHIMagents challenge studies i.e.malaria, bacterial infections & Pneumococcus

- Future strategic Global Licensing Expansion of a full vaccine & antiviral services company

- Probable future takeover bid from large pharma service’s company

- Low market cap, relative to likely future revenues, assets and high growth prospects

For further research, any new investors may wish to view some video presentations, from our CEO Cathal Friel, as per link below:

https://www.openorphan.com/news-and-media/video-library

GLA LTH’s

‘The Vaccine Task Force (VTF) has created several world class clinical assets which support the development of COVID-19 vaccines but will prove invaluable for future pandemics, namely…..

……the development of the UK’s capacity to run Human Challenge studies for testing vaccines earlier in development and for future vaccines.’

‘The model can be used as a ‘fast to fail’ approach to select the most promising vaccines faster and optimising investment….

…If disease transmission rates are low, the only way that next the wave of vaccines could be ‘immuno-bridged’ to first generation licensed vaccines quickly will be through human challenge studies. The option for large-scale field efficacy studies simply may not exist. Building this world leading, ambitious capability now will enable the UK to optimise and prioritise future pandemic vaccines, generating long term value and pandemic preparedness for the UK for SARS-CoV-2 and beyond - a valuable legacy for the UK.’

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/944308/VTF_Interim_report_-_5th_publication.pdf

Sometimes I think it’s worth taking a step back with ORPH, in order to see where we fit within the UK and Global strategy, in the testing and development of new vaccines.

The UK Gov report above, clearly foresaw the critical role for CHIM’s being utilised on both a National and International level.

This strategy is now being implemented and ORPH is just at the beginning of a new international (UK based) vaccine testing industry, with the relevant UK Gov infrastructure, regulations and approvals process in place.

As Covid transmission levels drop, vaccine development companies, may have no other choice but to utilise Covid CHIM’s, in order to get their product licensed and to market.

It is worth repeating, that this relatively small and significantly undervalued AIM company, is currently the ONLY commercial company in the world, which is able to perform this role.

Taking all this into account (whilst ignoring all the non core asset spin offs etc) and listening to Cathal aiming for a $1 billion market cap, I sometimes wonder why ORPH isn’t valued a lot closer to that right now!

IMHO

Another great presentation from CF last night & some decent price action today.

Now that Invesco are being flushed out, I think it’s just the start of a major re rate for the SP and that’s based just on what has been revealed & in the public domain…so far?

Based on my research, I believe there’s a lot more to come…watch this space! ;-)

GLA LTH’s

Join Cathal Friel graduate of Ulster University and Co-founder & Executive Chairman at Open Orphan plc in a fireside chat with our moderator Sarah Travers as he talks about his latest vaccine venture and the highs and lows of growing companies in unprecedented times.

31 March 2021 12:00PM - 1:00PM

https://www.ulster.ac.uk/alumniandsupporters/events/virtual-events

Following todays Sunday Times article, got me thinking about an Imutex valuation again.

I’m aware of a couple of historical valuations below:

1.'Last year, Seek and Hvivo engaged Goldman Sachs to aid with a possible sale of Imutex.

Documents show that the investment bank was basing its likely fee for its services on two scenarios: Imutex having an enterprise value of up to $1bn (€902m), or more than $1bn.'

hxxps://www.independent.ie/business/irish/open-orphan-in-line-to-take-stake-in-1bn-flu-drug-38808471.html

2. In late July ’20, CF discussed reversing Imutex into a Nasdaq vehicle (now possibly a UK SPAC) with a possible comparative value of 400-500 million euro's,

~20 min 30 secs

https://www.youtube.com/watch?v=hP_dYfoC-Kg&feature=emb_logo&ab_channel=OpenOrphan

Therefore, taking a conservative 450 million Euro valuation @ 49% ownership, equates to ~£190 million pounds or an additional ~28p?

So, a total SP of ~62p (excluding DIM, more CHIM contracts, China deals etc etc)

Any other likely estimates known?

We invest in companies that serve a purpose in society.

Open Orphan Group has become the go to provider of viral challenge studies and laboratory services to global pharma keen to develop vaccines against COVID-19.

‘Open Orphan is a clinical research organisation with two core businesses divisions – hVIVO and Venn Life Sciences. Based in London, hVIVO is a world leader in human challenge study clinical trials that can be used to validate the efficacy of vaccines and other antiviral products. Operating from offices in Paris and the Netherlands, Venn Life Sciences provides drug development consultancy services to large pharmaceutical organisations.

hVIVO’s expertise in challenge studies has come into its own in the face of the COVID-19 pandemic and, in October 2020, it secured a contract with the UK Government for the development of a human challenge study model for COVID-19. The business operates three quarantine clinics that can be used to support these COVID-19 challenge studies and is one of the very few businesses in the world capable of offering such capacity. The output from these studies will play a vital role in the development of effective vaccines against COVID-19.

hVIVO’s heritage in the development of challenge studies (it has successfully developed eight so far – the largest portfolio in the world), is likely to lead to an adjacent opportunity via its Disease in Motion® digital platform. Using the knowledge of virus progression that the company has built up over the years, this technology aims to provide a data enabled solution for wearable products that can be used to monitor the health of the wearer. This product has already attracted strong interest from large consumer electronics, pharmaceutical and biotech companies, so it may well become part of a comprehensive personal health monitoring solution in the coming years.’

https://sterlingim.co.uk/our-companies/

Another great RNS & contract win from ORPH today, but I believe there’s even more to come, in the short term:-

Cathal stated on his recent presentation:-

~9 min 50 sec

“In the very close future we'll be signing quite a few Covid 19 antivirals, quite a few Covid vaccination trials and as soon as they’re signed you’ll see the announcements and most of those trials will be north of £10 million….these are premium products and this is the only place in the world you can get them done.”

https://www.youtube.com/watch?v=qIQpEiS1ZmE&ab_channel=Proactive

So, we’ve had one of the non covid contracts today and a number more to come ‘in the very close future’.

Additionally, Cathal’s RNS comments has given us yet another clue, as to a whole new new work stream for ORPH, in the pipeline:-

“We have expanded from one clinic to multiple clinics, and it is our stated objective to continue to invest and expand our global capability to ensure our position as the world leader in testing vaccines, antivirals, and monoclonal antibodies through the use of human challenge studies well into the future.”

https://www.londonstockexchange.com/news-article/ORPH/ps7-5m-human-challenge-study-contract/14914677

More to follow…? ;-)

When compared to other AIM companies, I believe the current Risk\Reward ratio for ORPH is currently extremely favourable.

The two main risks seem to be either:-

- A Covid CHIM volunteer becoming seriously ill.

This seems a very low risk based on ORPH’s precautionary CHIM volunteer criteria and their past record i.e. Hvivo has ‘safely completed over 50 Human Challenge Studies since we started in 1989. These studies have included more than 3,000 volunteers’.

Or

- Cathal falling under a bus! – very very low risk.

So, how does this compare to the known and very likely rewards, as per below:

- Multiple Covid CHIM contracts pending @ ~£10 million plus each

- Multiple Non Covid CHIM contracts pending @ ~£3-5 million plus each

- Chinese Covid CHIM contracts or Licensing @ ~£15 million plus each?

- Wellcome Trust LMIC licensing & CHIM agent manufacturing @ £x million?

- Influenza Immune Modulator spin off, valued @ £x million?

- PrEPBiopharm spin off, valued @ £x million?

- Imutex spin off, valuation of ~£500 million plus?

- Disease in Motion platform spin off, valued @ ~£1 billion?

All of this on top of: a profitable ‘picks and shovel’ low risk company; with expanding ‘free’ clinical facilities; multiple high value assets and a large global unique ‘moat’ of services.

Additionally, add a revitalised company, driven by an outstanding CEO with ‘skin in the game’ and a commitment to no further placings, in a hot growth ‘in demand’ sector.

Also, throw in a probable future takeover by a large CRO company and an undervalued low market cap.

Taking all this into account, the extremely low risk compared to the potential very high rewards, tends to suggest a very large ‘BUY’.

IMHO

os2 - to quote CF ‘We don’t do anything for free’.

ORPH’s participation in Covid CHIM's is subject to a commercial contract with UK Gov and no one else.

The UK Gov needed ORPH to conduct Covid CHIM’s and paid £46 million for the privilege of their unique services, experience & knowledge.

Everyone else will have to pay the same and probably more.

At best, the campaign may elicit some generic info but no commercially sensitive data would be disclosed.

It does clearly demonstrate alot of interest and demand for Covid CHIM's, which is all good for ORPH.

IMHO

‘The time to act is now. Driven by data and analytics, new technologies and treatments are transforming the way we diagnose, treat and prevent illness. We are determined that the UK is at the forefront of this healthcare revolution and our vision sets out how we will deliver a clinical research ecosystem which capitalises on innovation, delivers for all research sponsors, is resilient in the face of future healthcare crises and offers fresh hope for patients across the UK.

So, as we begin to emerge from the shadow of the pandemic, we must use this as an opportunity to learn lessons and build back better.’What we will achieve

There are 5 key themes underpinning our vision:

3.Streamlined, efficient and innovative research – so the UK is seen as the best place in the world to conduct fast, efficient and cutting-edge clinical research.

4. Research enabled by data and digital tools – to ensure the UK has the most advanced and data-enabled clinical research environment in the world, which capitalises on our unique data assets to improve the health and care of patients across the UK and beyond.

https://www.gov.uk/government/publications/the-future-of-uk-clinical-research-delivery/executive-summary

3 + 4 = ORPH

Our strategy and plans for delivery

We have plans in place to make this vision a reality. We have identified 7 areas for action, to break down traditional barriers and deliver a patient-centred and pro-innovation clinical research environment.

1. Improving the speed and efficiency of study set-up. This includes expediting costing, contracting and approvals, all areas we know can often delay progress. And we’re going further, to actively speed up research approval and delivery. For example, the Health Research Authority (HRA) has launched a rapid ethics review pilot for global clinical and phase I trials, which aims to halve the time to provide a final opinion on research applications.

2. Building upon digital platforms to deliver clinical research. We have seen the power of digital research platforms during COVID-19, with NHS DigiTrials supporting the rapid delivery of vaccine and therapeutic trials. We now need to build on these successes and increase the capacity for digital platforms to improve the delivery of research. This will help address other important population health burdens, such as cancer and cardiovascular disease, reduce the burden on frontline health and care staff and support research delivery for cutting-edge treatments and technologies, including genomic medicines.

3. Increasing the use of innovative research designs. We are seeing study teams across the country adapt research delivery methods to take advantage of virtual processes and technologies in the current environment. We need these new approaches to be adopted across commercial and non-commercial research in future. This will make research easier for people to access and will also release capacity within the NHS. By helping to deliver the best research where it is best suited, we will continue to support innovative studies for cutting-edge treatments and technologies across all phases, for all therapies and for all conditions.

https://www.gov.uk/government/publications/the-future-of-uk-clinical-research-delivery/executive-summary

1 + 2 + 3 = ORPH