Small Company Champion & Lemming Investors Research and Newsletter Updates

Showing posts sorted by relevance for query orph. Sort by date Show all posts
Showing posts sorted by relevance for query orph. Sort by date Show all posts

Sunday, 28 March 2021

Lemming and SCC Updates WE 26 the March 2021

It has been a busy week for both sites, with updates; AVA, DDDD, OPTI SPSY, SBTX and ORPH.


I have incorporated the links for those of you less familiar with the sites. 

Synairgen (SNG) and 4D Pharma (DDDD) are letting us down at the moment. Optibiotix Health  (OPTI), well, it seems normal to be frustrated even in the face of a huge boost in the NAV via SkinBiTherapeutics (SBTX) runaway leading multi-baggers, which is challenging ASX listed AVA for the title.

Those of you who prefer less risk should keep an eye on Spectra Systems (SPSY), Ramsdens (RFX) and Warehouse Reit (WHR), which is also waking up after an acquisition spree to boost growth and take advantage of the growing warehouse and storage needs. 

Remember the search facility on both sites. You can change the date thereafter for new or archives. 

AVA Risk Group is primed to go again. Trust me on this. It is just a matter of time.  The clues are there!

Likewise, ORPH will surprise some of the covid rainbow chasing investors and wonder how this let this gem pass them by.

Finally, it has been pointed out to me I should be wary of suggesting £9 million in sales for SBTX because investors may blame me for misleading them. 

Allow me to be clear; the £9.125m sales figure anyone able to navigate their finger around a calculator accurately and punch in £25,000 per day (psoriasis subscriptions) x 365 = £9.125 million would surely arrive at the same. The subscription figure as is the dose are Stuart Ashman's numbers, and they are not mine. Moreover, I have asked Stuart if he is happy to quote these and the maths; he said I put those figures out there. Another £25 million figure = 10% of the £250m to £300 million is the target for the Croda/Sederma Matrixl market share. 

With respect to the psoriasis probiotic launch, this will be a B2c model, so people thinking this will be a slow process as they have experienced with OptiBiotix's LP-LDL probiotic which via a B2B model. Moreover, as a friend says, people with cardiovascular issues still walk in the McD's and feast on a big mac. Someone suffering from psoriasis is more publicly aware of their image. But let us not forget, the consumer study is no longer about treating the horrible condition: Psoriasis; the company announced on Monday they were expanding the study to enabled the inclusion of an additional cohort of participants with non-psoriatic conditions, e.g. AcneEczema, and RosaceaThere even reports of dandruff clearing up!

I'll say this. Stuart Ashman has discussed talks with several psoriasis associations he is in discussions with. The USA association has more than 8 million registered sufferers. 
My default position is to trust what a CEO tells me unless they give cause not to. 

Monday, 1 February 2021

Open Orphan - Contact Renewal with Carna - Adds Significant Revenues in 2021

 




There is not much to be said about today's announcement from Open Orphan (ORPH) announcement to extend its contracts with Carna Bioscience, Inc., other than to say this was not the announcement I was expecting this morning or anyone else in the investment community and offers assurance post-Brexit normal service has resumed with European partners and indeed the wider business community. I have asked the company's PR for comment, as yet, nothing. Anna is usually quite good or has been in the past, so I have some hope. Even so, I suspect we will learn more during the investor presentations on Wednesday.


I guess we can add the following Tweet to the above Tweet which offers further encouragement as well as raises more questions for Cathal on Wednesday. 

The Tweet appears to be a Flucamp banner on the side of Whitechapel Hotel with 27 bedrooms and immediately opposite the existing 24-bed quarantine facility in East London. Could this be the 3rd facility!? Asks @Eskers1



So, back to the announcement the rapidly growing speciality pharmaceutical services clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces a further contract renewal with Carna Biosciences, Inc. ("Carna"), extending its integrated drug development consultancy services with Venn Life Sciences ("Venn"), part of Open Orphan plc.

Carna Biosciences is a clinical-stage biopharmaceutical company founded in April 2003 in Kobe, Japan to discover and develop innovative therapies to treat serious unmet medical needs, focusing on small molecule drugs, mainly targeting kinases. We also offer a broad range of high-quality products and innovative drug discovery services to scientists worldwide to efficiently identify new kinase inhibitors. Open Orphan and Carna Bio will be focusing on small molecule drugs. The renewal of this contract is expected to deliver significant revenue for Venn over the next twelve months. 

The VENN teams in the Breda office in Holland will provide Chemistry, Manufacturing & Control (CMC), Non-Clinical, Clinical and Regulatory consultancy services to this client for two of the client's leading development programmes. This successful collaboration has been extended until the end of December 2021.

Cathal Friel, Executive Chairman of Open Orphan, said: "The extension of this contract further demonstrates our ability to collaborate successfully with our clients and provide a service that results in repeat business. Venn and Carna have built up a good working relationship over a period of several years where both parties closely collaborated on drug development planning and its execution through consultancy services contracts. We look forward to delivering this contract for Carna in the year ahead."

Masaaki Sawa, Ph.D., Chief Scientific Officer and Head of Research and Development at Carna Biosciences, said: "The partnership with Venn Life Sciences complements our clinical development team and underlines our commitment to become a clinical-stage company. By continuing the collaboration with the Venn team, we will accelerate our drug development."

Saturday, 30 January 2021

Open Orphan - CE-IVD Compliant Antigen Test kits

 


The BTNX SARS Covid-2 Antigen test kits in partnership with Open Orphan (ORPH) are at the top end for their accuracy at 94.55% - 99%, which is higher than most I have seen. What sets these Antigen test kits apart is their CE mark, which means they are UK/EU first CE-IVD compliant even after Brexit. Plus, the test results are ready in 10 minutes, not several hours or overnight P&P like so many are.

The short turnaround for the results makes these test kits ideal for the travel industry, workplaces, care homes, healthcare environments are more who require a faster, more accurate coronavirus test.

Surely, this is a significant partnership yet to be announced by either company, BioNTex or Open Orphan. 

Monday should be exciting. 




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Thursday, 15 April 2021

Open Orphan - Potential demerger of certain non-core assets


 

Shares Open Orphan Plc (AIM: ORPH), took a tumble in early trading (recovering almost all the lost ground at the end of trading) likely due to some confusion over the T&Cs of being handed what is essentially free money. The specialist pharmaceutical services clinical research organisation (CRO) and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces that it is at an advanced stage in planning for a possible spin-out of certain non-core Development IP Assets. However, the use of the word lock-in appears to have spooked some of the lemming natives amongst us. 







Sunday, 11 April 2021

Open Orphan - Launch of Disease in Motion platform Launch

 



 

Open Orphan Plc (ORPH), a rapidly growing speciality pharmaceutical services clinical research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan, has officially launched its Disease in Motion® platform. This unique data-focused platform includes clinical, immunological, virological and digital (wearable) biomarkers. The Disease in Motion platform has multiple infectious disease applications that apply to a wide variety of end-users, including big tech, wearables, pharma and biotech companies.

 



Tuesday, 9 February 2021

Open Orphan - Opportunities Key Events Rocket Boosters

 


The most recent webinar by Open Orphan Plc (ORPH) was again very encouraging on several fronts. It is not unusual for a webinar - Investor presentation not to be optimistic. What is out of the ordinary, from my experience, is the level of opportunities, primers for significant appreciation for even more share price gains; yes, even after the 400% plus increases in 2020, and the bull gains in 2021. Had it not been for Invesco selling down, Open Orphan would likely be north of 40p now.

So what of these opportunities? 

The highlights for me are as follows:

  • The company could be split from its core business resulting in 3 in-species dividends; is 1 for 1 Cathal explained.
  • PrepBiopharm, Influenza Immune Modulator & disease in motion (DIM)
  • He explained the first of these (Imutex) could be as early as 4-6 weeks. He explained Covid-19 had hindered progress but stressed this is very close now.
  • Two further spin-outs, again, one Open Orphan share, one newco share
  • Chinese very keen on challenge studies 
  • Potential huge Covid CHIM licensing deals/studies with the Chinese State
  • Emphasis profitable no more losses 
  • The expectation is to reach a market value of  £1bn as being realistically achievable.
  • FY results after easter - they will not disappoint.
  • Looking for investors stake build 
  • Six challenge models
  • Company is the world leader in testing vaccines via Controlled Human Infection Models (CHIMs)
  • New ''Disease in Motion'' (DIM) platform with potential current market cap valuation of £200m
  • DIM could be spun-out
  • New Whitechapel Quarantine Clinic opened February 2021 with an expanded 19-bed capacity.
On of the question that I could understand (sound issues - mad echo), not, it wasn't a ramping echo chamber. Cathal explained that competitors out there could challenge the company's status as the world leader in disease challenge studies, but expressed scepticism a real challenge would be successful due to the global situation the company has, plus high entry barriers and the time required to gain credibility.

There was a lot of excitement around the DIM - this was pleasing to me because it is exactly the area of the business I emphasised has huge financial implications for the future; its pretty much free cash. On top of the enormous revenues coming in from the vaccine studies, which will be a cash cow for the foreseeable years; it is clear the UK government contract worth £46m for the CHIM's is just the start, not the end, even so, this is a small part of the business. 

Disease In Motion

Intelligent Wearable Technologies and Clinical Applications in Low- and Middle-income Countries (LMIC)

''The webinar will discuss the growing medical applications of wearable technologies for healthcare and potential roles in guiding clinical and public health decision-making. Ongoing work between Imperial College Centre for BioInspired Technology and Oxford University Clinical Research Unit, Vietnam in development and clinical evaluation of these technologies for infectious diseases management will be introduced. This work forms part of a multi-national collaboration funded by the Wellcome Trust Flagships Award.''


Global Smart Devices Market - Huge and Growing Fast

The global wearable medical device market size was valued at USD 13.0bn in 2019 and is expected to witness a CAGR of 27.9% over the forecast period. The growth of industries, such as home healthcare and remote patient monitoring devices, is anticipated to positively influence wearable devices' demand. Besides, increasing consumer focus on fitness and leading a healthy lifestyle positively fuel the product demand.
More from the report here.

The Global Smart Healthcare Market size stood at US$ 141bn in 2019 and is expected to grow at 14.5% through 2030. Smart Healthcare is technology integrated diagnostic tool used for treating patients and improving the quality of life using e-health, m-health and ambient assisted living services. Rising government initiatives for the digitization of healthcare infrastructure are driving the growth of the smart healthcare market.
More from the report here.

The number of connected wearable devices worldwide has more than doubled in the space of three years, increasing from 325m in 2016 to 722min 2019. The number of devices is forecast to reach more than one billion by 2022.

Two important factors to the growth within the wearable devices market are primarily being powered by sales of smartwatches – shipments of smartwatches worldwide are forecast to surpass 100m in 2020. Apple, who unveiled their first smartwatch in 2015, currently dominate the smartwatch market and have held a share of around 45% since 2018. Another reason for the growth of the wearables market is the rise in popularity of wearable devices. Also referred to as earwear or ear-worn devices, this category is expected to soar over the next few years with shipments of devices forecast to increase by 45% to 105m units by 2023.
 
Any search you chose to do for smartwatches, or health monitoring devices will vary from the cheap and nasty, to the premium expensive kind. What is important as far as we are concerned, and Open Orphan, of course, is that the company has a very lucrative database of infectious diseases. Some of the world's largest companies are seeking to supplant in their wearable smart devices. While these devices may have been around for a while, and in some cases become a short-term fad for the post-Christmas fitness bunny, I think, as do Apple and Amazon, probably others, a new more important market has just opened up, one that has the potential to save lives as well as monitor health and wellbeing on an all-new level previously only health care professionals had access too. 

Open Orphan is one of my multi-baggers for 2021

Sunday, 8 November 2020

Open Orphan - Part II

 

Friday, 6 November 2020

Open Orphan - Part II




                                      

                                          





In my original cover piece of Open Orphan (ORPH) on the 30th October 2020, I indicated the company is not a one-trick pony play on covid-19. The company has a portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. East London Queen Mary Bio-Enterprise facility is now close to fully booked until the end of 2021. It is the world leader in testing antivirals and vaccines. What makes the company so attractive to the large pharmaceuticals and government agencies is the fact it has the world's largest database for infectious diseases. However, it must be said the Covid-19 part of the business, namely the world's first company to take part in human for the Covid-19 challenge vaccine trial appears to be an area the retail investors is chasing the money. But wait, there is more to Open Orphans as I will explain a little later in the follow-up.


It is worth noting no more fundraisers' are expected, the last raise was for £12m in May, of which it still had m of this last week, giving at a total of £21.5m plus £10m received on Monday from the UK government, plus £2.5m announced on the 5th November - assuming I have not misheard Cathal's strong Irish accent the company should have somewhere in the region of £34m of cash.

With more £multi million contract wins anticipated it is likely Open Orphan will offer special dividends to shareholders. I don't believe there are any dilutive share options due in the future to the board. I think Cathal referred to these type of options being granted as theft. I'm not sure I agree with this unless the board are amply remunerated. Thus no lifestyle pay packets for the board, Cathal is on £140,000, and he is the highest-paid member of a well-run board.

Due to the company's specialist facilities and database which has positioned the company ahead of any other company in the world, which meaning it has become the goto human vaccine challenge company, thus well-positioned to become rapid cash-cow, with estimates of £4m worth of contracts each month in Q3, with Q4 looking to accelerate the income stream's which could expand at warp speed if the company has as some of us suspect the unnamed US biotechnology company now partnered by their hVIVO arm are involved with Trumps Warp Speed Project.

Operation Warp Speed was introduced in early April 2020, after a round-table meeting with Trump, Pence and industry executives at the White House on March 2. It will promote mass production of multiple vaccines based on preliminary evidence allowing for faster distribution if clinical trials confirm one of the vaccines is safe and effective. As part of the funding the US government has allocated $10 billion for Operation Warp Speed through the Coronavirus Aid, Relief, and Economic Security (CARES) Act, with $6.5 billion designated by Congress for countermeasure development through BARDA, along with $3 billion for NIH research. For the moment we do not know if Open Orphan is part of this project - For now, Cathal Friel is keeping a tight lip. Imagine how exciting, fascinating this project could be for us?

Probable M&A Activity (it is no secrete)

I will focus on Imutex as this has the most potential in terms of value for shareholders, which I believe will be returned in the form of a dividend. Open Orphan has a 49% ownership interest in Imutex - picked up for beans. Earlier this year its hVIVO unit reported successful phase IIb trial of a potential flu vaccine for its FLU-v. This has resulted in a joint-venture peer-reviewed article written in a scientific journal. The data from FLU-v 004 challenge study underlined its ability to reduce mild-to-moderate symptoms of the illness. The publication of the results in the periodical ''npj Vaccines'' follows results from a separate field assessment of the drug, which revealed “cellular and humoral immunogenicity” from a single dose of adjuvanted FLU-v. Meaning the vaccine immediately provoked an immune response.

If as expected Imutex meetings with FDA regulators in the USA ahead of further trials, this should pique interest from M&A suitors.

Open Orphan chief executive Trevor Phillips: “Progression to larger phase III studies with FLU-v can further describe the cellular immune response and evaluate how the vaccine interacts with influenza disease,” Open Orphan chief executive Trevor Phillips.

CEC Cathal Friel: “The need for better, more broadly protective vaccines against influenza is a high priority worldwide, and few new vaccines have demonstrated efficacy in humans as seen in the results of the challenge study for FLU-v 004. “This is the first universal influenza vaccine that has shown this protection from influenza and reduction of symptoms in late-stage studies and together with the highly statistical immune results reported in a peer review article means that the risk of failure in a phase III setting is greatly reduced compared with entering into phase III studies with no efficacy data.”

No doubt revenues are anticipated to grow at pace in the coming months as bed capacity/occupancy increases, if not sooner...probably sooner because of the CEO. Cathal Friel is a man on a mission to gets things done. I am sure we all expect news on this front from Holland and the USA soon. All of this I believe to be just c90 per cent of the business if I understand Cathal Friel.

It is fair to say Open Orphan has struck gold with its acquisition of hVIVO shortly followed by the acquisition of CHIMagent for a nominal fee. Leaving aside the relatively poor performance before Open Orphan opportunistic, or should I say insightful vision. Along with VENN, these little beauties have transformed the company in a matter of a few months, moreover, have not proved to be a cash drain on the company, but have fitted into a brilliant strategy almost seamlessly and the bonus, that they are already producing a lot of cash with much more to come. Which means Q4 group profitability I believe to be at a NET cash level.
 
Smart Us of The World Largest Infection Disease Database
 
I am really excited about the monetisation of the world's largest infectious disease database. The excitement is centered around utilising the data in everyday consumable wearables. Previous management did not seem to understand the value they had until Cathal Friel arrived a shrewder Irishman, and these fellas are not known for missing much when it comes to turning muck into brass. I am not sure I can call infectious diseased much, unpleasant perhaps! No matter, they have considerable value as we are already witnessing, yet Cathal appears to have found another way to unlock more value in a way I find even more exciting. Let's face it, we will need to learn to live with Covid-19 for some time to come, and everyday affordable wearables could help the world live with infectious diseases that make us much more aware of them. 

The talk coming from Open Orphan (not just BB gossip), is Apple and Amazon, plus others, are seeking to use the database for wearable devices, smartwatches, health monitor devices, etc. These are often premium devices, especially if you are Apple or Samsung smartwatches brands. So, what is the market size for smart devices? As investors we shouldn't allow Apple's cash pile reported to be $1900bn to excite us too much - Apple didn't amass that cash pile by giving away money to smaller companies as a charitable donation, these companies a ruthless as I am sure their Chinese workforce would profess to their collective dismay. That said if anyone thinks Cathal, et al. at the company do not realise its worth and do not know how to pitch one corporate off against another are fools. Not many Open Orphan investors strike me as fools. 

Global Smart Devices Market - Huge and Growing Fast

The global wearable medical device market size was valued at USD 13.0bn in 2019 and is expected to witness a CAGR of 27.9% over the forecast period. The growth of industries such as home healthcare and remote patient monitoring devices is anticipated to positively influence the demand for wearable devices. In addition, increasing consumer focus on fitness and efforts toward leading a healthy lifestyle are expected to positively fuel the product demand.
More from the report here.

The Global Smart Healthcare Market size stood at US$ 141bn in 2019 and is expected to grow at 14.5% through 2030. Smart Healthcare is a technology integrated diagnostic tool used for treating patients and improving the quality of life using e-health, m-health and ambient assisted living services. Rising government initiatives for the digitization of healthcare infrastructure are driving the growth of the smart healthcare market.
More from the report here.

The number of connected wearable devices worldwide has more than doubled in the space of three years, increasing from 325m in 2016 to 722m in 2019. The number of devices is forecast to reach more than one billion by 2022.

Two important factors to the growth within the wearable devices market are primarily being powered by sales of smartwatches – shipments of smartwatches worldwide are forecast to surpass 100m in 2020. Apple, who unveiled their first smartwatch in 2015, currently dominate the smartwatch market and have held a share of around 45% since 2018. Another reason for the growth of the wearables market is the rise in popularity of wearable devices. Also referred to as earwear or ear-worn devices, this category is expected to soar over the next few years with shipments of devices forecast to increase by 45% to 105m units by 2023.
 
Any search you chose to do for smartwatches, or health monitoring devices will vary from the cheap and nasty, to the premium expensive kind. What is important as far as we are concerned, and Open Orphan, of course, is the fact the company has a very lucrative database of infectious diseases. Some of the world's largest companies are seeking to supplant in their wearable smart devices. While these devices may have been around for a while, and in some cases become a short-term fad for the post-Christmas fitness bunny, I think, as do Apple and Amazon, probably others, a new more important market has just opened up, one that has the potential to save lives as well as monitor health and wellbeing on an all-new level previously only health care professionals had access too. 

As I understand it. The idea is to license Open Orphan data to smart device manufacturer(s). These devices will have the ability to instantly warn the consumer they have contracted symptoms of an infectious disease, which will have a variety of alert levels related to the disease offering specific advice, like self-isolate, off you pop to hospital, etc. The £multi million questions must be who with? 

One option is to a global leader as a first-mover advantage on an exclusivity period. Naturally, this option would yield significant margins to Open Orphan by the market it would grab ahead of any other adopter because this would, of course, add significant value in today's pandemic environments. 

Then the second highest bidder? Or multiple companies and or government agencies. The moral standpoint I have is one of ethics and morality. (I make no apologies for my Master Mason and Christian beliefs) To my mind I think such ground-breaking technology should be made as widely available as possible because the alert system is lifesaving, track and traceability (IF AN OPTION) could become a problem if governments do not put financial safety nets in place for people contracting Covid -19 or ave some symptoms that require isolation, this being the only real negative I see for such devices as this would reduce its effectiveness. 

The other question is the pricing for such data access and alerts in real-time - will this price the ordinary mid to low salary consumers be priced out of the market, thus reduce the effect if it were not made available more widespread at affordable pricing levels? This must be a factor for opening up the world economy again...yes, it really has the potential to be this important. 

What price could be put on this new ground-breaking market to Open Orphan? Surely global governments have more buying power than any global Apple, Amazon type business. Hellfire, do they deserve this opportunity!


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