Home » Posts tagged 'ORPH'

Tag Archives: ORPH

Open Orphan #ORPH – Result of AGM

open orphan

 

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that  all resolutions put to shareholders at the Company’s Annual General Meeting held earlier today were duly passed.

Open Orphan #ORPH – £7.2m RSV human challenge study contract

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan, has signed a £7.2m contract with an existing top 5 global pharmaceutical company to test its orally administered antiviral product, using hVIVO’s respiratory syncytial virus (“RSV”) Human Challenge Study Model.

The Phase 2a double-blinded placebo-controlled human challenge study will take place at the Company’s specialist quarantine facilities in Whitechapel and will evaluate the safety and efficacy profile of the antiviral against RSV. The study will commence in June 2022, with the revenue being recognised in 2022 and 2023. As part of the study, hVIVO will recruit healthy volunteersvia the Company’s dedicated volunteer recruitment arm, FluCamp.

The client’s antiviral is presently in Phase III clinical trials for another infectious disease indication and the client will use human challenge to assess the efficacy of their antiviral drug candidate against RSV quickly and efficiently, highlighting the value that human challenge studies can bring within the drug development process. The repeat business from this top 5 global pharmaceutical company underlines the Company’s world leading expertise and its ability to attract additional contracts from its existing Big Pharma clients.

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “We’re delighted to be working with this top 5 global pharmaceutical client again to test their antiviral candidate using the hVIVO RSV Human Challenge Study Model. I am especially proud that our world-class offering and customer service has secured repeat business from another Big Pharma client, and that we are seen as the ‘go-to’ partner for an increasing number of global drug developers. The client’s drug has already been shown to be an effective antiviral in certain disease indications, and we’re pleased to now test its efficacy against RSV infection. RSV continues to be a serious global health threat causing an estimated 100,000 annual deaths in children under the age of five.”

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “This contract is a strong example of where human challenge studies can provide significant value. With a drug that has existing safety data and has been approved for one indication, human challenge studies can provide fast, cost-effective efficacy data within a new indication. The data will then indicate whether the candidate is viable for a wider Phase II study, providing substantial time and financial savings compared to traditional field-based studies.”

Interested in becoming a volunteer? 

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com. 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Yamin ‘Mo’ Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen /

Louis Ashe-Jepson

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /
+44 (0) 7747 515393

Notes to Editors 

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models, such as malaria and COVID-19, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.

Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.

About RSV

RSV is the main cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and in adults with chronic medical problems, such as COPD. Globally it affects an estimated 50-million people annually, leading to 4 million hospitalisations and an estimated 100,000 deaths in children under the age of 5 years. There is a lack of understanding and insight into RSV disease, especially in adult groups, despite its considerable impact on society and its high degree of infectivity.

Quoted Micro 13 June 2022

AQUIS STOCK EXCHANGE

Psych Capital (PSY) floated on Aquis so that it can take advantage of the opportunities in the fast-growing psychedelic medicines sector. Management is seeking to invest in early-stage companies, where it can obtain a significant minority stake. Psych Capital raised £810,000 at 5p a share. Pro forma net assets are £2m. Psych Capital has cash of £872,000 following the flotation. There is an investment in Awakn Life Sciences Corp that was valued at £584,563 at the end of June 2021. The share price is declining, and it has reached C$0.96, valuing the stake at around £260,000 at the current exchange rate. The share price fell to 4p on 9 June before recovering to 4.75p (3.5p/6p). There is limited liquidity in the shares with a free float of around 11%. Fellow Aquis company Oscillate (MUSH) holds a 16.15% shareholding in Psych Capital. Chris Akers has increased his stake in Oscillate from 9.02% to 11.4%. He also has a 4.96% stake in Psych Capital.

Capital for Colleagues (CFCP) improved interim revenues from £198,000 to £216,000, while recognised fair value gains declined from £1.04m to £297,000. There were 14 investments at the end of the period and net assets were 68.38p a share at the end of February 2022.

Rural Broadband Solutions (RBBS) had 2,851 monthly fee-paying clients by mid-May. There was net cash of £1.2m at the end of 2021 and infrastructure funding is being negotiated.

Newbury Racecourse (NYR) reopened its hotel in January and more than 105,000 racegoers have visited the racecourse so far this year. There have benefits from the catering deal with Compass and new media rights arrangement start at the beginning of 2024, which will benefit that financial year. More will be spent on prize money. Newbury is debt free, and a special dividend has been paid out of proceeds from the sale of land for housebuilding. Annual dividends may recommence next year.

Quantum technology investment company Quantum Exponential (QBIT) has made three investments at a total cost of £1.16m since it floated. There are discussions with more potential investments. There has been further progress towards setting up a fund. Anthony Lyall has been appointed as investment manager and Anna Spandl as investment analyst.

Altona Rare Earths (ANR) says that it is on track for a maiden JORC resource statement for the Monte Muambe rare earths project in Mozambique. Four new drilling targets have been identified.

Ananda Developments (ANA) had net liabilities of £288,000 at the end of January 2022. There should be further news concerning the purchase of the other 50% of DJT Plants.

Tectonic Gold (TTAU) expects to deploy drill rigs in Queensland in the next few weeks following the rainy season.

RentGuarantor Holdings (RGG) has raised £1m from a 6% unsecured loan note issue, with chief executive Paul Foy subscribing for 50% of the issue. The cash will be spent on hiring staff and marketing.

Wishbone Gold (WSBN) has commenced drilling at the Wishbone II gold copper project in Northern Queensland.

Chapel Down Group (CDGP) non-exec Jamie Brooke has bought 327,000 shares at 30.48p each. Jonathan Neame has sold 2,000 shares in Shepherd Neame (SHEP) at 806p each.

Oberon Investments has increased its stake in TruSpine Technologies (TSP) from 7.93% to 10.9%.

EPE Special Opportunities (ESO) had a NAV of 307.13p a share at the end of May 2022.

Former Aquis-quoted proton beam therapy provider Rutherford Health is being placed in liquidation. There are Rutherford Cancer Centres in Newport, Reading, Liverpool and Northumberland, plus a community diagnostics centre in Somerset. It is unclear whether there will be any buyers interested in these assets. Schroder UK Public Private Trust (SUPP) bought the remaining Woodford stake at the end of 2019. It was valued in the books at £22.8m, which will be written off. That will reduce NAV by 2p a share.

AIM

Like-for-like sales growth at City Pub Group (CPC) was 5% in May and 20% ahead over the Jubilee Bank Holiday. Management took a decision to minimise price rises so that food and drink is still relatively affordable. Two new sites have been opened with two more opening over the next few weeks.

Learning and development products and services provider Mind Gym (MIND) fell into loss in the year to March 2022. Revenues were 24% ahead at £48.7m with US revenues growing even faster. Repeat revenues from customers that have bought products and services in the past three years were 86% of the total. Overheads are higher as management anticipates future growth in demand. There were also £500,000 of non-recuring costs. The investment in digital products and services will pay off in future years when profit is expected to grow sharply.

Greater demand for foreign exchange helped Ramsdens (RFX) to move back into profit in the first half. Jewellery retail and precious metals buying also grew revenues significantly. There was modest growth in pawnbroking revenues although the growth in the loan book means that there will be a higher rate of increase in the second half. Overall revenues were £29.3m, up from £19.3m, and there was a pre-tax profit of £2.2m.

Nexus Infrastructure (NEXS) improved interim revenues from £63.7m to £80.3m and the order book is 7% higher at £306.7m. Civil engineer Tamdown’s revenues were more than one-quarter higher while utilities connections business TriConnect reported a small increase in revenues. The biggest increase came from the eSmart Networks business, but that is still less than 11% of group revenues. Nexus is on course to improve full year pre-tax profit from £2.5m to £5.7m.

Open Orphan (ORPH) has an order book worth £64.25m at the end of May 2022. Open Orphan secured a £14.7m contract for an influenza characterisation study and a follow-on human challenge study. The second half is expected to be stronger than the first and the clinical trials services provider should move into profit this year.

Electrical goods retailer Marks Electrical (MRK) reported its first full year results since flotation last November. In the year to March 2022, revenues increased 44% to £80.5m. Underlying earnings were 5.01p a share and the maiden final dividend is 0.67p a share. The company is gaining market share in the domestic appliance and televisions markets and revenues have grown by one-fifth in the first couple of months of this financial year. Brand recognition is improving, but the overall market is likely to be tough. Expanding the product range is helping growth.

Interims from Hercules Site Services (HERC) reflect a period of consolidation for the staffing business. In the six months to March 2022, revenues improved from £14m to £20m, while pre-tax profit slumped from £954,000 to £31,000. Overheads were £2m higher in anticipation of growth in the coming years. The large staff supply contract for HS2 started later in the reporting period and demand will continue to grow. More suction excavators are being delivered and utilisation rates are high.

Greenland-focused AEX Gold Inc (AEXG) has signed non-binding terms for the creation of a joint venture with ACAM that will hold the group’s strategic mineral assets. ACAM will invest £18m for a 49% stake and AEX Gold will inject the non-gold assets and cover site support, logistics and overhead costs. There is an agreement to inject a further £10m on a pro rata basis as long as certain milestones are achieved. AEX Gold’s core asset is the 100% interest in the Nalunaq project, which includes a former producing gold mine.

Plant-based polymers developer Itaconix (LSE: ITX) had already warned that due to destocking 2021 revenues would fall from $3.29m to $2.6m, which is still double the 2019 figure. Itaconix remains lossmaking, but revenues should be much higher in 2022 due to the increased number of products using its ingredients. Revenues are expected to jump back to $4.7m and the loss could halve to $1m.

Rockwood Strategic (RKW) has acquired a 8.75% stake in window ventilators and parts manufacturer Titon Holdings (TON).

Northbridge Industrial Services (NBI), which is set to change its name to Crestchic, says that trading at the core power reliability business is better than the recently upgraded expectations. Previously full year earnings of 12.1p a share were forecast and this was raised to 13.4p a share.

STM (STM) pre-tax profit halved to £1.2m in 2021 and it is expected to recover to £2.9m this year. This will be helped by the completion of investment in IT that brings the personal pension businesses onto one platform. A flow of new SIPP business is anticipated.

Coral Products (CRU) has announced a final dividend of 0.2p a share, taking the total for the year to 1.1p a share. At 17.5p, the yield is 6.3%.

Eve Sleep (EVE) is outperforming a market that has fallen by 29% in the UK in the first four months of 2022 and by 37% in France. More funding is required even though Eve Sleep and a US-based investor was interested in bidding for the mattress supplier. Talks have ended but management is considering its options.

MAIN MARKET

Citius Resources (CRES) has an initial agreement for the potential acquisition of AUC Mining, which has the Kamalenge gold project in Uganda. The proposed £2m cost would be paid in shares at 4.625p each. More cash would have to be raised at the same time. Trading in the shares was suspended at 3p.

Standard list shell GS Chain (GSC) shares have reached a new high of 6.55p, having risen steadily since flotation on 13 May via an introduction at 1p a share. Net assets were less than 0.18p a share, so the share price is at a substantial premium.

Premium listed Ross Group (RGP) shares jumped from 1.45p to 1.7p following a placing raising £163,000 at 1.79p a share, which is still a premium to the higher market price. The previous placing in October was at 2.8p a share. Ross Group is effectively a shell that has an investment in an aquaculture business and is trying to develop its supply chain management business.

Andrew Hore

Alan Green covers Cobra Resources #COBR & Open Orphan #ORPH on this week’s Stockbox Research Talks

Alan Green covers Cobra Resources #COBR & Open Orphan #ORPH on this week’s Stockbox Research Talks

Open Orphan #ORPH – Final results Reveal Record revenues and EBITDA-profitability accompanied by significant operational progress

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces its audited final results for the 12 months ended 31 December 2021.

Financial highlights

·       Record revenues of £39.0m (2020: £22.2m) achieved representing 76% growth

·       £9m improvement in EBITDA generating £2.9m (2020: £(6.1)m)

·       Cash and cash equivalents as at 31 December 2021 of £15.7m (2020: £19.2m)

·       Significant EPS improvement in 2021 to (0.01)p per share (2020: (1.80)p)

·       Order book growth of 11% to £46m future contracted revenue as at 31 December 2021 (2020: £41.6m)

Operational highlights

·     Delivered a strong and growing pipeline of new challenge study contract wins

Served four of the top 10 global biopharma companies in 2021 among a growing client base of over 60 clients

·     Substantially expanded the Group’s offering into the respiratory market signing an asthma study with a top three global pharma company

·     Completed the world’s first COVID-19 characterisation study which was proven to be safe and well tolerated

·     Contract signed to manufacture a SARS-CoV-2 Delta variant challenge agent with Imperial College London, as part of a Wellcome Trust-funded initiative

·     Opened a new quarantine clinic on a capital efficient basis to facilitate the growing demand for human challenge studies. This new facility, The Whitechapel Clinic, added 19 quarantine bedrooms for future challenge studies 

·     FluCamp screened c. 84,000 volunteers for human challenge studies in 2021 (2020: c.68,000); supported by the cost-efficient expansion of volunteer recruitment centre

New London FluCamp volunteer recruitment centre – converted former coffee shop adjacent to the existing QMB facility

New Manchester FluCamp volunteer recruitment centre

·     Significant CRO experience added to the Board with the appointment of Yamin ‘Mo’ Khan as Non-Executive Director, who was appointed CEO post period end

·     In June 2021, completed a distribution in specie to the Company’s shareholders, through the demerger of certain non-core assets into Poolbeg Pharma

Post-period end highlights

·     Commenced development of a new influenza challenge model for an existing top five global pharmaceutical client and signed a £14.7m contract for the characterisation and challenge trial to follow

·     £7.3m influenza challenge trial and £5m RSV challenge trial contracts signed

·     Launched a new Malaria human challenge model and was awarded by an existing Big Pharma client to act as a vaccination site for a Phase II field study

·     Opened a new primary FluCamp volunteer recruitment facility in Whitechapel, increasing bed capacity by 44% from 43 beds to 62 beds, and opened a new Manchester volunteer recruitment centre at the same cost as the old facility, but with four times the floor space, doubling the Group’s volunteer screening capacity to 1,000 per week

Facilities expansion enables the Group to broaden the scope of the business to offer additional clinical trial services outside of its traditional core challenge study offering

Current trading and outlook

As at 1 June 2022, Open Orphan had an order book of signed contracts worth £64.2m which is expected to be recognised across 2022, 2023 and 2024.

Open Orphan’s pipeline of new opportunities continues to grow with a number of further challenge study opportunities at advanced negotiations across influenza, asthma, RSV, malaria and COVID-19. This growth is driven by the increased success and awareness of human challenge trials, and the development of new challenge models. A significant portion of our pipeline includes returning Big Pharma customers, in addition to a wider group of new clients who have observed the benefits of human challenge trials.

Our Venn Life Sciences subsidiary continues to deliver specialist drug development consultancy services across non-clinical and clinical development, pharmacology, CMC and biometry services, acting as a trusted partner to an extensive range of clients.

These developments reaffirm the Board’s expectations of a profitable growing business with revenues in the region of £50m in 2022.The Group is now well positioned and well capitalised to deliver sustainable long-term profitability.

 

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “2021 was a milestone year for Open Orphan; the Group achieved record revenues, and recorded full year EBITDA-profitability for the first time – a significant turning point for the business. 

“The Group won a record number of human challenge study contracts, serving four of the top 10 global biopharma companies and more than 60 clients in total. We were proud to make a significant contribution to the UK Government’s response to the pandemic by completing the world’s first COVID-19 characterisation study, which furthered our understanding of COVID-19 disease progression. Importantly, the Group accomplished this whilst investing in operational improvements, with volunteer screening and quarantine capacities expanded during the year.

“Post-period end, we have continued our momentum from 2021 into a strong start to trading and significant contract wins. We increased our bed count from 43 to 62, doubled our volunteer screening capacity, and also expanded the scope of our business to offer additional clinical trial services, where we have already signed our first contracts, establishing new revenue streams for the business. We also launched our new Malaria Human Challenge Model, which I believe has further consolidated our position as the leading provider of human challenge trials in infectious and respiratory disease. In my new role as CEO, I look forward to driving further growth across the business this year and converting this substantial progress into value for our shareholders.” 

Interested in becoming a volunteer?

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses. 

1 Source: Citeline Trialtrove, Jan. 2022 and Pharma R&D Annual Review; IQVIA Institute, Global Trends in R&D – Overview Through 2021; Global Data; Evaluate Pharma; Edison Investment Research; Pitchbook

 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Yamin ‘Mo’ Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

 +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

 

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

 

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

 

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen /

Louis Ashe-Jepson

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /

+44 (0)7747 515393

Notes to Editors

Open Orphan plc 

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases, including the recently established COVID-19 model, and is developing a number of new models, such as Malaria, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.

Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.

Link here for full financial statements

Open Orphan #ORPH – Notice of results

 

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials , announces that it will release its full year results for the year ended 31 December 2021 on Tuesday 7 June 2022. 

Investor Presentation 

Yamin ‘Mo’ Khan, Chief Executive Officer, and Leo Toole, Chief Financial Officer, will be hosting a live online presentation relating to the final results via the Investor Meet Company platform at 6pm on Tuesday 7 June 2022. The presentation is open to all existing and potential shareholders.

Investors can sign up to Investor Meet Company for free and register for the presentation here.

Investors who already follow Open Orphan on the Investor Meet Company platform will automatically be invited.

Questions can be submitted pre-event via your IMC dashboard or in real time during the presentation, via the “Ask a Question” function. Whilst the Company may not be in a position to answer every question it receives, it will address the most prominent within the confines of information already disclosed to the market through regulatory notifications. A recording of the presentation and a PDF of the slides used will be available on the Investor Meet Company platform and the Company’s website afterwards.

 

UK Investor Magazine Podcast, we discuss #stagflation, Burberry #BRBY Open Orphan #ORPH & Tertiary Minerals #TYM

investor

 

The UK Investor Magazine is joined by Alan Green for a rundown of key market themes and Uk equities.

We start by looking at Stagflation at the implications for the UK economy and markets. Stagflation is a period of rising inflation, economic contraction, and rising unemployment.

The UK satisfies the first two of these, however, unemployment remains robust. We look at whether rising inflation will soon hit jobs activity and what it could mean for equities.

We also discuss the relationship between the FTSE 100 and US indices and how this may develop if we see recession in the US.

Burberry has posted a respectable set of results and is proving a possible choice for income investors. Margins have improved with sales as the luxury brand jumps back from COVID.

Open Orphan’s valuation is worth attention. One could argue the current market cap doesn’t pay justice to their revenue growth and forecast profitability.

We update on the latest from Tertiary Minerals and their portfolio of assets including a selection in Nevada and Nambia.

Stagflation, Burberry and Open Orphan with Alan Green

Open Orphan #ORPH – £7.3m Influenza human challenge study contract win

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan, has signed a £7.3m influenza human challenge study (“Study”) contract with a leading biotechnology company to test its antiviral product using the hVIVO Influenza Human Challenge Study Model. 

The randomised, double-blinded, placebo-controlled study will test and assess the antiviral prophylactic and post-inoculation treatment activity of the antiviral in healthy adult volunteers enrolled through the Company’s specialist, tech-enabled volunteer recruitment arm,FluCamp. The Study will be conducted by hVIVO’s team of medics at its state-of-the-art quarantine facilities in London and is expected to commence next year. Revenue from the contract is expected to be recognised across FY23 and FY24.

The Company’s specialised virology laboratories, hLAB, will determine the viral load of the influenza challenge agent used to inoculate volunteers, hLAB will also provide serology services and virology services (viral infectivity assay) for the study. 

Influenza is a contagious respiratory illness caused by influenza viruses that affect the nose, throat and the lungs. It can cause mild to severe illness, and occasionally lead to death. According to Financial Times1 analysis of official data in England, since the development of effective vaccines and the emergence of the less severe Omicron variant, influenza is now more lethal than COVID-19. For every 100,000 Omicron infections, 35 will result in death, while the equivalent number of flu infections will lead to around 40 fatalities.

Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to sign a contract with this leading biotechnology company to test its antiviral product using the hVIVO Influenza Human Challenge Study Model. hVIVO has seen a steady increase in flu studies, a reflection of the shift in market sentiment following recent scrutiny of infectious disease data that has outlined the significant threat of flu and the potential of human challenge studies to the advancement of drug development candidates.”

Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “We are excited to test the antiviral prophylactic and post inoculation treatment activity against flu infection using the hVIVO Influenza Human Challenge Study Model. hVIVO has pioneered influenza human challenge studies for decades, with our history dating back to the Salisbury Common Cold Clinic.

“Since the advent of effective vaccines and treatments for COVID-19, there has been renewed focus on influenza and official data shows flu is now a more lethal threat. After completing the study, we hope to provide positive data and early proof of concept for our client’s product, in order to accelerate its development into a Phase II programme.” 

1‘Vaccines and Omicron mean Covid now less deadly than flu in England’, The Financial Times, by Burn-Murdoch, John, and Barnes, Oliver. Link: https://www.ft.com/content/e26c93a0-90e7-4dec-a796-3e25e94bc59b

 

Interested in becoming a volunteer?

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.

Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Yamin Khan, Chief Executive Officer

Liberum Capital (Nominated Adviser and Joint Broker)

  +44 (0) 20 3100 2000

Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King

 

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

 

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

 

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /
+44 (0) 7747 515393  

 

Notes to Editors 

Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models, such as Malaria and COVID-19, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.

Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.

hVIVO has a long history of testing influenza vaccines and treatments, with its history dating back to the Common Cold Unit in Salisbury. The Common Cold Unit was established following the end of the Second World War to investigate the microorganisms which cause typical cold symptoms. It was through this research that the first human coronavirus was discovered in 1960.

Open Orphan #ORPH – Proposal to purchase Poolbeg Pharma shares from distribution in specie shareholders

Open Orphan (ORPH) a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, notes the announcement dated 11 April 2022 from Poolbeg Pharma plc (“Poolbeg”), regarding a number of new investors (“New Investors”) having expressed interest in acquiring up to £1.6m of Poolbeg which are currently locked-up and held in trust by Croft Nominees Limited as a result of the distribution in specie from Open Orphan on 18 June 2021.

As part of these proposals, the New Investors have committed to purchase up to £1.6m of the distribution in specie shares on or around 26 April 2022 at a price of 5.9 pence per share, the closing market price on Friday 8 April 2022. The New Investors have shown great interest in the Poolbeg story, its significant progress since IPO in July 2021, and its capabilities in developing novel products utilising its unique cost-effective model in the fast-growing infectious disease market which is expected to be worth in excess of $250bn by 2025. This is a clear vote of confidence in Poolbeg’s prospects as it enters an extremely exciting phase of its development with its first LPS human challenge clinical trial due to commence in June 2022 with multiple value inflection points expected in 2022 and beyond.

This process will allow the locked-up distribution in specie shareholders in Poolbeg the opportunity to sell part or all of their shareholding, should they wish to do so, prior to receiving the shares once the lock-up period ends on 20 April 2022. The distribution in specie shareholders will receive a letter setting out the New Investors’ proposal and a Form of Election informing them how to participate should they wish to sell some or all of their shares prior to the lock-up ending on 20 April 2022. These proposals are open to all distribution in specie shareholders but participation is at each distribution in specie shareholder’s discretion. For those shareholders who do not participate, the title to their distribution in specie shares will be transferred to them on or around 26 April 2022. If more than £1.6m is offered by way of valid Forms of Election, then the distribution in specie shareholders will be scaled back on a pro-rata basis.

The distribution in specie shares are exempt from income tax for UK resident shareholders due to the advance clearance obtained by the Company from HMRC for a statutory demerger. As such, there should be no UK income tax liabilities for UK resident shareholders on receipt of these shares. The only time that UK resident shareholder will be subject to tax on these shares will be in the event that the shareholder sells them, and in that event there will be a capital gains tax payment due on any chargeable gain. The base cost for capital gains calculation purposes will be 1% of the original cost base of the Open Orphan shares which will be close to nil (0), therefore nearly the full consideration will be subject to capital gains tax. The above comments are intended only as a general guide, shareholders are encouraged and recommended to seek their own financial and tax advice.

Open Orphan plc and Poolbeg Pharma plc ordinary shares are ISA qualifying investments. Open Orphan understands that any distribution in specie shares held in an ISA should be treated in a similar way to any other income generated from ISA qualifying investments.

A copy of the letter to distribution in specie shareholders can be found on Poolbeg’s website here and an FAQ is available here.

Cathal Friel, Executive Chairman of Open Orphan, said: “We were delighted to see that despite the presently turbulent market that Poolbeg has successfully managed to bring in fresh investors to purchase up to £1.6m at 5.9p, the market price on Friday 8 April 2022. The new investors have shown great interest in the Poolbeg story and its significant progress since IPO, its capabilities in developing novel infectious disease products utilising its unique cost-effective model. Poolbeg is well capitalised, with c. £20.9m at year end 2021, so importantly it is not raising any new funds as part of this process and, as such, there will be no dilution of existing shareholders.

“This arrangement has followed significant efforts to help widen the Poolbeg investor base and increase future liquidity, in order to ensure that the dividend in specie remains as beneficial as possible to shareholders of both Open Orphan and Poolbeg in the long-term.

“Due to the nature of the lock-up period, which was designed to allow for an orderly market following Poolbeg’s admission to AIM, prospective investors looking to build more substantial stakes were unable to do so. These proposals ensure that any potential shares sold will be going to quality, long-term holders, whilst giving distribution in specie shareholders the option to sell shares prior to the end of the lock-up period, if they choose to do so. In addition, there will be substantially greater liquidity in our shares once the distribution in specie shares have been distributed after 26 April 2022 and we believe this will certainly help us to attract in even more new shareholders.”

Footnote

The distribution in specie shares were issued to all Open Orphan shareholders on the share register at close of business on 17 June 2021, following this, Poolbeg successfully listed on the London Stock Exchange AIM market on 19 July 2021. While the underlying shareholders retain the beneficial ownership of the shares, the distribution in specie shares are currently held in trust by Croft during a lock-up period of nine calendar months from Poolbeg’s admission to AIM, to contribute to the creation of an orderly market. This lock-up period will end on 20 April 2022 and on or around 26 April 2022, shareholders will be sent a share certificate for the distribution in specie shares. Shareholders will then have the option to dematerialise and hold the shares via CREST. If any Open Orphan shares that gave rise to the entitlement to the distribution in specie shares are held in a nominee account, the share certificate will be sent to the shareholders’ broker. 

The New Investors’ proposals are not open for participation by persons interested in shares who are residents or citizens of or who have an address in, or who otherwise appear to the Company or SLC Registrars to be connected to, the United States (or any of its territories or possessions), Canada, Australia, Japan, Belarus or Russia.

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

Yamin Khan, Chief Executive Officer

Arden Partners plc (Nominated Adviser and Joint Broker)

 +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen / Louis Ashe-Jepson

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

+44 (0)7980 541 893 / +44 (0) 7502 558 258 / +44 (0)

7747 515393  

Notes to Editors

Open Orphan plc

Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases, including the recently established COVID-19 model, and is developing a number of new models, such as Malaria, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.

Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.

Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.

About Poolbeg Pharma

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a capital light clinical model which aims to develop multiple products faster and more cost effectively than the conventional biotech model. The Company, headquartered in London, is led by a team with a track record of creation and delivery of shareholder value and aspires to become a “one-stop shop” for Big Pharma seeking mid-stage products to license or acquire.

The Company is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025.

With its initial assets from  Open Orphan plc , an industry leading infectious disease and human challenge trials business, Poolbeg has access to knowledge, experience, and clinical data from over 20 years of human challenge trials. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. Amongst its portfolio of exciting assets, Poolbeg has a small molecule immunomodulator for severe influenza (POLB 001); a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) drug discovery programmes to accelerate the power of its human challenge model data and biobank. 

For more information, please go to  www.poolbegpharma.com  or follow us @PoolbegPharma

Open Orphan #ORPH – Presentation at World Vaccine Congress

open orphan

Presentation at World Vaccine Congress 

hVIVO presents on the outcomes from the world’s first COVID-19 characterisation study

Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, a subsidiary of Open Orphan plc, will be delivering a presentation at the World Vaccine Congress, Washington D.C., United States, titled ‘Outcome of the world’s first SARS-CoV-2 viral challenge and its utility for vaccine testing’. 

Dr Catchpole will be presenting the results from the world’s first COVID-19 characterisation study, which was a partnership between hVIVO, Imperial College London, the Vaccine Taskforce and Department of Health and Social Care (DHSC), and the Royal Free London NHS Foundation Trust. The landmark study, published in Nature Medicine on 31 March 2022, found that a SARS-CoV-2 human challenge is safe in healthy young adults and provided detailed insights into the course of COVID-19 infection with potential positive public health implications, which will also be outlined in Dr Catchpole’s presentation. 

Full details of the presentation are included below: 

Title

Outcome of the world’s first SARS-CoV-2 viral challenge and its utility for vaccine testing

Date/Time

Wednesday 20 April 2022, 09.40 am (ET)

The World Vaccine Congress will take place at the Marriott Marquis in Washington DC between 18-21 April 2022. hVIVO will be at booth 410 during the congress for potential partnering discussions. 

The World Vaccine Congress is the largest and most established meeting dedicated to vaccines and has run for 21 years. In that period, it has evolved and grown into the leading vaccines congress globally, with hundreds of speakers and thousands of attendees from leading global vaccines developers, academia and policymakers. 

More information about the event, including attendance, can be found here . 

Yamin ‘Mo’ Khan, Chief Executive Officer at Open Orphan, said: “I am delighted that Andrew will be presenting at the largest vaccine event of the year, highlighting the pivotal role hVIVO played in the world’s first COVID-19 characterisation study.”  

Interested in becoming a volunteer?

hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com . By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.   

For further information please contact: 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman
Yamin ‘Mo’ Khan, Chief Executive Officer

Arden Partners plc (Nominated Adviser and Joint Broker)

 +44 (0) 20 7614 5900

John Llewellyn-Lloyd / Louisa Waddell

finnCap plc (Joint Broker)

+44 (0) 20 7220 0500

Geoff Nash / James Thompson / Richard Chambers

Davy (Euronext Growth Adviser and Joint Broker)

+353 (0) 1 679 6363

Anthony Farrell

Walbrook PR (Financial PR & IR)

Paul McManus / Sam Allen /

Louis Ashe-Jepson

+44 (0)20 7933 8780 or openorphan@walbrookpr.com

+44 (0)7980 541 893 / +44 (0) 7502 558 258 /

+44 (0)7747 515 393

I would like to receive Brand Communications updates and news...
Free Stock Updates & News
I agree to have my personal information transfered to MailChimp ( more information )
Join over 3.000 visitors who are receiving our newsletter and learn how to optimize your blog for search engines, find free traffic, and monetize your website.
We hate spam. Your email address will not be sold or shared with anyone else.