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Poolbeg Pharma #POLB – Results of the proposal to purchase shares from Distribution in Specie shareholders

Poolbeg Pharma (AIM: POLB, OTCQB: POLBF, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, announces the results of the proposal from a number of New Investors to purchase shares from distribution in specie shareholders ahead of the end of the lock-up period.

As published via an RNS on 11 April 2022 , the Company sourced a number of New Investors that offered to purchase up to £1.6m distribution in specie shares at a price of 5.9 pence being the closing price on 8 April 2022 (the last trading day prior to that announcement). The Company can now confirm that these proposals have been accepted by distribution in specie shareholders seeking to sell a total of £366k of Poolbeg shares, representing only 3% of the distribution in specie shares.

The vast majority, representing 97% of distribution in specie shareholders, have decided to remain invested in Poolbeg following the end of the lock-up period. Overall, the proposals have demonstrated strong shareholder confidence in the Company as it enters the exciting clinical phase of its development.

The distribution in specie shares were held by Croft Nominees Limited (“Croft”) on behalf of the shareholders who received these shares as a result of the demerger of Poolbeg from Open Orphan plc on 18 June 2021. These shares were locked up for a period of nine months post Poolbeg’s IPO on 19 July 2021, to help create an orderly market in the Poolbeg shares post-IPO.  

This lock-up period ended on 20 April 2022 and the distribution in specie shareholders who decided to remain invested in Poolbeg will be sent a share certificate over the coming days. Shareholders can then dematerialise the share certificate and hold the shares via CREST if they so choose. For any distribution in specie shareholders who originally held their Open Orphan shares on 17 June 2021 in a nominee account or any other type of account, then the new Poolbeg share certificate will be sent to the shareholders’ broker or account manager. Shareholders who accepted the proposal to sell £366k of shares will receive funds to their accounts over the coming days. 

Poolbeg ended 2021 well capitalised with a strong cash balance of £20.9m, so it is important to note that the Company was not raising any new funds as part of this £1.6m proposal from New Investors to purchase distribution in specie shares. As such, there will be no dilution to existing shareholders from the acceptance of the £366k from New Investors to the distribution in specie shareholders. 

An FAQ can be found on the Company’s website   here .

Cathal Friel, Chairman at Poolbeg Pharma said: “We are delighted to see that the vast majority of distribution in specie shareholders have decided to remain invested in Poolbeg. This demonstrates the very strong confidence among these shareholders in the Company, which has made significant progress since its IPO and has multiple value inflection points expected in 2022 and beyond.

“We were pleased to receive interest from the New Investors which ensures that any potential shares sold as part of this initiative would go to committed, long-term investors. This proposal also offered distribution in specie shareholders the option to sell shares prior to the end of the lock-up period, if they chose to do so. Additionally, considering the significant £1.2m unrealised demand by these New Investors, we remain optimistic that some, if not all, of these New Investors may now seek to purchase Poolbeg shares in the open market, given their interest and belief in the Poolbeg story as it enters the exciting clinical phase of its development.

“Going forward, following the end of the lock-up period, we now expect substantially increased liquidity in Poolbeg shares which we believe will help us to attract additional new shareholders, including specialist life science investors, as we continue to deliver on our strategy in order to maximise shareholder value over the long-term.”

The New Investors’ proposals were 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. 

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

– Ends – 

Enquiries

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

+44 (0) 207 183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson
Richard Chambers, Sunila de Silva (ECM)

 

+44 (0) 207 220 0500

Arden Partners PLC (Joint Broker)

John Llewellyn-Lloyd, Louisa Waddell

 

+44 (0) 207 614 5900

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

 

+44 (0) 207 457 2020

poolbeg@instinctif.com

 

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 – 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

Poolbeg Pharma #POLB commences trading on OTCQB Market in the United States

30 March 2022Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’), a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model, announces that trading in the Company’s Ordinary Shares of nominal value of £0.02 each (“Ordinary Shares”) will commence today on the OTCQB Venture Market in the United States. The Company’s OTCQB shares will have the ticker: POLBF.

There is no associated capital raise with this cross trading and Poolbeg’s Ordinary Shares will continue to trade on the Alternative Investments Market (AIM) on the London Stock Exchange under ticker POLB. Cross trading on the OTCQB market allows the Company access to one of the world’s largest investment markets to expand its reach into a broader pool of investors. Poolbeg shares will be available to US investors during US working hours and priced in US dollars and thus has the potential to enable greater liquidity in Poolbeg shares on AIM by easing cross-border trading for potential US investors. Further information about the OTCQB market can be found HERE.

As a Foreign Private Issuer, Poolbeg’s onboarding to the OTC Markets is based on satisfaction of the requirements for OTCQB as applicable to international reporting companies including satisfaction of the criteria for the exemption under the US Exchange Act Rule 12g3-2(b) from SEC reporting.   The Rule 12g3-2(b) exemption includes the disclosure obligation to ensure that certain information made public or distributed under home market regulations is made publicly available on the company’s website or other electronic information delivery system in English. Thus, the Company will have no additional reporting obligations and incur minimal ongoing costs, compared to traditional major exchanges.

As a verified market, the OTCQB offers transparent trading for companies that have met a minimum bid price test, are current in their financial reporting and have undergone an annual verification and management certification process. The cross-trading facility is provided through OTC Markets Group Inc., located in New York. OTC Markets operates the world’s largest electronic interdealer quotation system for US broker dealers and offers multiple media channels to increase the visibility of OTC-listed companies. Online brokers such as Ameritrade, Fidelity Investments, Tradestation, Charles Schwab and E-trade all offer OTCQB trades. US investors can find real-time quotes, market information and access current company news and developments for Poolbeg at www.otcmarkets.com.

Since the Company listed on AIM in July 2021, it has continued to make significant progress on its strategy to develop multiple innovative infectious disease products faster and more cost effectively than the conventional biotech model. Key strategic areas have included:

  • driving the clinical development of its POLB 001 programme for severe influenza which is expected to report initial data from its forthcoming human challenge trial before the end of 2022;
  • delivering on its plans to leverage its proprietary databank of human challenge study derived disease progression data to identify new pharmaceutical assets using artificial intelligence, most recently signing a deal with CytoReason to interrogate its influenza data;
  • obtaining licensed access to use micro- and nanoencapsulation technology to develop oral vaccines for multiple disease indications;
  • adding a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002) to its portfolio; and
  • signing an option to licence a vaccine against the tropical and subtropical disease Melioidosis (POLB 003), while also evaluating a further 5 bacterial vaccine candidates.

Poolbeg engaged Nikolaos Galanopoulos of the corporate securities law firm Galanopoulos & Company as its OTC Markets Sponsor for the OTCQB onboarding.

Cathal Friel, Chairman of Poolbeg Pharma said:

“We believe that having a US cross trading facility is important for the development of Poolbeg. It gives us the opportunity to widen our potential investor base, which we believe may help future liquidity, and capitalises on the interest in European stocks from US investor.  In our view, OTCQB is a good complement to our AIM listing. The OTC markets have expanded in recent years beyond pink sheet listings, and now include a premium market (OTCQX) for companies such as Danone and Roche, and a venture market (OTCQB) for companies of Poolbeg’s size. 

Jeremy Skillington, CEO of Poolbeg Pharma added:

“Importantly, the OTCQB trading facility will provide access to one of the world’s largest investments markets with no additional reporting obligations and minimal ongoing costs, compared to traditional major exchanges. This cross  trading facility  has the potential to enable greater liquidity in Poolbeg shares on AIM by easing cross-border trading for potential US investors.

We believe this listing will enable US institutional and retail investors to share in the growth of Poolbeg as we build the Company into a leading infectious disease pharmaceutical company. This action also fits with our long-term strategy and ambitions to be dual listed on a national securities exchange in the US, such as Nasdaq, subject to meeting their listing requirements; this is a step in the right direction.”

Jonathan Dickson, VP of International Corporate Services at OTC Markets, said:

“We are delighted to welcome Poolbeg Pharma to the OTCQB Venture Market. With its primary listing remaining on London’s AIM, the OTCQB’s cross-trading facility will allow Poolbeg to broaden its horizons and provide investors in the U.S. with the ability to access the Company’s Ordinary Shares in U.S. dollars and during U.S. market hours.

 – Ends –

 

Enquiries

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

+44 207 183 1499
finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson
Richard Chambers, Sunila de Silva (ECM)

 

+44 (0) 20 7220 0500
Arden Partners PLC (Joint Broker)

John Lewellyn-Lloyd, Louisa Waddell

 

+44 (0) 207 614 5900
J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363
Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

+44 (0) 20 7457 2020

poolbeg@instinctif.com

 

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

 

Poolbeg Pharma #POLB – 2021 Annual Report and 2022 AGM Notice

Poolbeg Pharma (AIM: POLB, ‘Poolbeg’ or the ‘Company’) a clinical stage infectious disease pharmaceutical company with a unique capital light clinical model , announces that its Annual Report and Accounts for the period ended 31 December 2021, a notice of the Annual General Meeting (“AGM”) 2022 and voting proxy form have been posted to shareholders.

Persons whose distribution in specie shares are held in trust by Croft Nominees Limited (“Croft”) have also received a Voting Form of Direction and an Accompanying Letter advising them of how to instruct Croft, as the shareholder of record, to enter a vote on their behalf.

In accordance with AIM Rule 26, these documents are also available to view on the Company’s website:

https://www.poolbegpharma.com/documents

The AGM is scheduled to be held at 11.00am on 4 April 2022 at the offices of DAC Beachcroft LLP, at 25 Walbrook, London EC4N 8AF. 

As part of the AGM, there will be nine ordinary resolutions concerning the adoption of the accounts, re-appointment of auditors and fixing of their remuneration, the election/re-election of the Company Directions and general authorisation to issue shares. The special resolutions are in connection with the removal of pre-emption rights on the allotment of new equity shares, cancellation of the share premium account subject to court approval, and permission for and conditions around granting authority for the Company to buy back shares. Full details of all resolutions are available as part of the AGM notice. 

Cathal Friel, Chairman of Poolbeg pharma said: “As outlined in our results announcement, market conditions have been and remain extremely challenging howeverwe are actively working on creating demonstrable value as we drive the business forward. I strongly believe that part of the reason for the recent drop off in our share price has been the false impression that many of the original Open Orphan dividend in specie shareholders may sell their shares after the 19th of April because at that point in time, we will be transferring their shares from Croft Nominees to the shareholders as the 9-month lock in period will have expired. Part of my belief why the shareholders won’t suddenly start to sell these dividend in specie shares is because the distribution is exempt for UK income tax purposes as advance clearance for a statutory demerger was obtained from HMRC. As such, there should be no UK income tax liabilities for UK resident shareholders, the only time that UK resident shareholder will be subject to tax on these dividend in specie shares, will be in the event that they sell them, and in that event there will be a capital gains tax payment due.

As such, I believe we are unlikely to see a sell-off of these shares at the end of the lock in period , however we are remaining very active and are putting in place a series of mitigating actions toprotect and build shareholder value for the long term. As part of this we are seeking approval to potentially use Company funds to buy back share, we are also seeking permission from our shareholders to allow for potential future dividend payments. In addition, we are in the advanced stage of dual-listing on the OTC market in the US to provide additional liquidity in the stock, we expect this to complete in Q2 2022. Finally, it is not in the DNA of the Company to sit back idly and wait for things to happen as the whole premise and business model of Poolbeg is to move fast, create a lot of shareholder value, be very careful with our cash, and ensure that the initial cash raised at IPO lasts us a very long time.”

– Ends –

  Enquiries

 

Poolbeg Pharma Plc

Jeremy Skillington, CEO

Ian O’Connell, CFO

 

+44 (0) 207 183 1499

finnCap Ltd (Nominated Adviser & Joint Broker)

Geoff Nash, James Thompson, Charlie Beeson,

Richard ChambersSunila de Silva (ECM)

 

+44 (0) 207 220 0500

Arden Partners PLC (Joint Broker)

John Lewellyn-Lloyd, Louisa Waddell

 

+44 (0) 207 614 5900

J&E Davy (Joint Broker)

Anthony Farrell, Niall Gilchrist

 

+353 (0) 1 679 6363

Instinctif Partners

Melanie Toyne Sewell, Rozi Morris, Tim Field

+44 (0) 20 7457 2020

poolbeg@instinctif.com

 

About Poolbeg Pharma

Poolbeg Pharma (AIM:POLB) is a clinical stage infectious disease pharmaceutical company with a capital light clinical model which is developing 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 licence or acquire.

The Company is targeting the growing infectious disease market which has become one of the fastest growing pharma markets and is expected to exceed $250bn by 2025.

Poolbeg has access to extensive knowledge, experience, and clinical data from over 20 years of human challenge trials through Open Orphan plc , an industry leading infectious disease and human challenge trials business. The Company is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk.

The Company continues to rapidly expand its portfolio of assets which currently includes POLB 001, a repositioned small molecule immunomodulator for severe influenza. POLB 002, a first-in-class, intranasally administered, RNA-based immunotherapy for respiratory virus infections and POLB 003, an intramuscular Melioidosis vaccine. The Company is also developing an oral vaccine delivery platform and as well as progressing its AI powered drug discovery program to identify pathways and drug candidates using its disease progression data.

Open Orphan #ORPH – Trading Update, Volunteer Recruitment and Laboratory Facilities Expansion

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, provides a trading update for the year ended 31 December 2021. The Company also announces it will be opening a new primary FluCamp volunteer recruitment screening facility in Plumbers Row, London (“Plumbers Row Facility”) and a secondary FluCamp recruitment facility in Manchester.

Trading Update

Subject to completion of the audit, the Company expects both revenues and EBITDA to be in line with the expectation detailed at the time of the interim results.  Accordingly the Company expects 2021 to be EBITDA positive with revenues of approximately £40m. Cash and cash equivalents as of 31 December 2021 was £15.6m (30 June 2021: £14.9m). The Company further expects to be in line with management expectations for year-ending 31 December 2022, targeting revenues in the region of £50m in non-COVID-19 work. COVID-19 revenue for 2022 will be in addition to this and will depend on the eventual timing of these studies.

Facilities Expansion

The new facilities will double the Company’s previous volunteer screening capacity, significantly boosting its ability to identify and enrol study volunteers and patients and further strengthening its world leading human challenge capabilities.

As part of the opening of a new specialised volunteer recruitment facility in London, the Whitechapel quarantine clinic and the Queen Mary’s Bioenterprises Centre (“QMB”) clinic will both be exclusively dedicated to conducting human challenge studies going forward. The space at QMB currently providing volunteer screening will be converted into further quarantine bedrooms. As such, the Company’s QMB facility will expand to 31 beds, adding to the Whitechapel Clinic’s 19 beds and the Plumbers Row Facility’s 12; in total the Company’s bed count will reach 62. These new facilities offer an opportunity to the Company to expand the scope of the business to offer Phase I and Phase II vaccine field trials, PK (pharmacokinetics) studies, bridging studies, and patient trials (as opposed to healthy volunteer human challenge trials) as part of large international multi-centre studies which do not require a quarantine setting.

The increase in volunteer recruitment capacity will enable the Company to recruit larger cohorts more quickly than before and cement Open Orphan’s world leading position and reputation in volunteer recruitment. Particularly in Manchester, the secondary facility extends the Company’s reach for more volunteers and facilitates the increasing demand for human challenge studies. During volunteer screening there are large numbers of volunteers that are ineligible to take part in challenge studies for a variety of reasons, such as previous infection by the virus under investigation. By broadening the business offering to include Phase I and Phase II field trials, a large proportion of the volunteers already in the FluCamp facility could be eligible to take part in these studies.

The Plumbers Row Facility, London, plus the volunteer recruitment facility in Manchester, will have additional laboratory capacity, meaning samples collected during volunteer screening visits can be processed and stabilised on site. As a result, the primary laboratory at QMB has the capacity to expand its virology lab services business and increases its biomarker and molecular testing capabilities.

In addition, the Company’s corporate office will move from Alie Street to an upper floor in Plumbers Row. Both London and Manchester facilities offered attractive terms; the new Plumbers Row space is c. 9,000 sq ft and is a third of the cost of the current space of 4,000 sq ft; the new Manchester facility comes at the same cost as the old facility, but with four times the floor space at c. 2,000 sq ft.

Cathal Friel, Executive Chairman of Open Orphan, said: “Despite difficult market conditions during the year, which have continued into 2022, I am pleased with the performance of the Open Orphan team and during 2021 we signed an impressive number of human challenge study contracts with Big Pharma and biotechnology clients.

“We have continued our strong work at the start of this year, and our new facilities in both London and Manchester will not only enable the Company to screen a greater number of potential volunteers, it will also increase our total bed count to 62. Considering the greater size and functionality of the new facilities, as well as their cost, the Company has executed the expansion in a highly cost-efficient manner.”

Yamin Khan, Chief Executive Officer of Open Orphan, said: “I am delighted to be opening a new primary FluCamp volunteer recruitment and screening facility within walking distance from our other Whitechapel facilities as well as a new, larger Manchester volunteer recruitment facility. These facilities double our volunteer screening capacity and importantly, expand on our already world leading clinical trial and laboratory services offering.

“As a result of the changes, we have the potential to expand the scope of our business as we head into a crucial period of substantial growth across the infectious disease market. I believe we are now very well positioned with an enhanced clinical trial offering and unique volunteer and patient recruitment capacity, which will enable us to serve an increasing pool of Big Pharma and biotechnology clients seeking to test novel therapeutics against different infectious and respiratory diseases.”

Robin Rogiers, Director of Clinical Delivery & Innovation of hVIVO, said: “The opening of the new primary and secondary FluCamp volunteer facilities means we now boast a truly world class clinical trial offering. With quarantine capacity significantly increased and volunteer recruitment capacity doubled, we will be able to expand the scope of our clinical trial business to include vaccine field trials, PK studies, bridging studies and patient trials as part of large international multi-centre studies. The increased scope also includes an enhanced virology lab services offering at QMB, which will now be able to increase its biomarker and molecular testing capabilities.”

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 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 vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been significant growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma, and biotech companies.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing, and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts

Open Orphan #ORPH – Investor presentations to provide introduction to new CEO Yamin ‘Mo’ Khan

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 it will provide two live investor presentations in March 2022. The presentations will provide investors with an introduction to new Chief Executive Officer, Yamin ‘Mo’ Khan, who will make his maiden presentations on Company progress.

London South East

Executive Chairman, Cathal Friel, and Chief Executive Officer, Yamin ‘Mo’ Khan, will give a live investor presentation via London South East alongside other companies as part of an investor webinar on Tuesday 8 March at 7.30 pm (GMT). The presentation is free to attend and requires investors to register via the London South East website. This can be accessed with the following link:

https://us02web.zoom.us/webinar/register/3816460478728/WN_kyeX1ibCT0aXEUdkO9gIOg

Investor Meet Company

Executive Chairman, Cathal Friel, and Chief Executive Officer, Yamin ‘Mo’ Khan, will host a second investor presentation via Investor Meet Company (“IMC”) on Tuesday 15 March at 6.00 pm (GMT). Investors can sign up to Investor Meet Company for free and request to meet Open Orphan plc via the following link:

https://www.investormeetcompany.com/open-orphan-plc/register-investor

Investors who already follow Open Orphan plc 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. 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 regulations and information already disclosed to the market through regulatory notifications. A recording of the presentation will be available on the Investor Meet Company platform afterwards. No new price sensitive information will be disclosed, and a PDF of the presentation will be uploaded to the Company’s website.

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 vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been significant growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma, and biotech companies.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing, and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

Open Orphan #ORPH – FDA Breakthrough Designation for Big Pharma RSV candidate

Vaccine candidate assessed in successful human challenge trial conducted by hVIVO 

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, notes the announcement dated 14 February 2022 from Bavarian Nordic A/S (“Bavarian Nordic”) (OMX: BAVA), reporting that the US Food and Drug Administration (“FDA”) has granted Breakthrough Therapy Designation for Bavarian Nordic’s respiratorysyncytial virus (“RSV”) vaccine candidate, MVA-BN® RSV. hVIVO, a subsidiary of Open Orphan, successfully conducted a Phase 2, double-blinded, placebo controlled human challenge trial to assess MVA-BN® RSV using its RSV Human Challenge Study Model.

A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition. The designation has been granted upon the assessment of preliminary clinical evidence for MVA-BN RSV, indicating that the vaccine candidate may demonstrate substantial improvement over available therapy on a clinically significant endpoint. A significant portion of this preliminary evidence was the successful challenge study conducted by hVIVO. The designation provides an option to work more closely with FDA for the development and review of MVA-BN RSV.

The challenge study conducted by hVIVO to assess MVA-BN® RSV demonstrated a significant reduction in viral load in vaccinated subjects versus placebo, thus meeting the primary endpoint of the study. At the same time, vaccinated subjects showed a significant reduction in clinical symptoms typically associated with RSV infections. The MVA-BN RSV vaccine demonstrated a vaccine efficacy of up to 79% in preventing symptomatic RSV infections. No vaccine-related serious adverse events were observed, and the vaccine was well tolerated, consistent with the safety profile previously reported in Phase 1 and Phase 2 clinical studies.

RSV is a contagious, common respiratory virus that usually causes mild, cold-like symptoms and affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat and is one of the leading causes of hospitalisation to at-risk older adults.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of infectious and respiratory disease areas, including various strains of influenza, RSV, HRV, COVID-19, asthma and malaria, etc.

Cathal Friel, Executive Chairman, said: “We are pleased to see Bavarian Nordic achieve Breakthrough Therapy Designation for its RSV vaccine candidate, MVA-BN® RSV. hVIVO successfully conducted a human challenge trial on behalf of Bavarian Nordic in 2021, where the candidate showed a significant reduction in clinical symptoms associated with RSV.

“The data from this human challenge trial was part of the body of evidence provided by Bavarian Nordic to the FDA in order to secure its Breakthrough Therapy Designation, which could ultimately result in an expedited regulatory review of MVA-BN® RSV. This highlights a major benefit of human challenge trials, in that they enable drug developers to obtain Phase 2/2a efficacy data for their vaccine and antivirals candidates in a fast, cost-effective manner ahead of larger scale studies. This data can then strengthen submissions for important regulatory programmes such as the Breakthrough Therapy Designation.”

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
Cathal Friel, Executive Chairman
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) +44 (0)20 7933 8780 or openorphan@walbrookpr.com
Paul McManus/ Sam Allen / Louis Ashe-Jepson +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 vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been an explosion in the growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

Open Orphan #ORPH – Results from the world’s first COVID-19 Characterisation Study

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 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 results from this landmark study, show that a SARS-CoV-2 human challenge is safe in healthy young adults and provide detailed insights into the course of COVID-19 infection with potential positive public health implications.

As part of the characterisation study, researchers aimed to identify a dose of COVID-19 that caused a safe and reliable infection in unvaccinated volunteers with no prior SARS-CoV-2 infection. The results published today detail the outcome of the 36 healthy male and female volunteers aged 18-29 years which were infected with the original SARS-CoV-2 strain challenge virus. hVIVO clinicians closely monitored volunteers in a controlled quarantined setting and collected disease progression data to provide insights into COVID-19 infection. Volunteers will be followed up for 12 months after discharge from the quarantine facility.

The key clinical insights were as follows:

Viral load (“VL”)

· 18 volunteers (50%) became infected with viral load (VL) rising steeply and peaking at ~five days post-inoculation

· No quantitative correlation was noted between VL and symptoms

Symptoms

·No serious symptoms

·  Mild-to-moderate cold like symptoms were reported by 16 (88%) of 18 infected volunteers including a stuffy or runny nose, sneezing, and a sore throat. Some experienced headaches, muscle/joint aches, tiredness and fever

·   Anosmia (lost or changed sense of smell) occurred in 13 (72% of infected) volunteers

Virus detection

· Average time from first exposure to viral detection and early symptoms (incubation period) was 42 hours

· Virus was detected earliest in the throat but at significantly greater levels in the nose;

Virus detected in the throat on average after 40 hours

Virus detected in the nose on average after 58 hours

· High levels of viable (infectious) virus was seen for approximately nine days post-inoculation, and up to a maximum of 12 days

· Modelling using the study data indicated that regular asymptomatic lateral flow testing (“LFT”) would diagnose infection before 70-80% of infectious virus had been generated, thus if isolation was triggered would decrease community transmission to others

Importantly, no serious adverse events (SAEs) occurred, and the SARS-CoV-2 human challenge study model was shown to be safe and well tolerated in healthy young adults. With the characterisation study disease modelling data completed, and a COVID-19 Human Challenge Model now established, the Company should be able to contract / conduct COVID-19 human challenge studies in 2022, subject to individual ethics and regulatory approvals. The Company is already developing a Delta strain of the COVID-19 virus in partnership with Imperial College London and funded by the Wellcome Trust, which could be used in future trials.

The data published today supports the safety of the infection challenge model which could theoretically provide a ‘plug and play’ platform for testing therapies and vaccines using the original COVID-19 strain as well as variants of the virus.

The characterisation study results and the insights they provide into COVID-19 infection have potential implications for public health. During the study, the average incubation period was 42 hours, which is considerably shorter than existing estimates of five to six days. Results also showed that while virus was detected significantly earlier in the throat, peak levels of virus were far higher in the nose, implying a potentially higher risk of viral shedding from the nose. This underlines the importance of proper facemask use to cover both the mouth and nose. Additionally, insights into the timeline of infection, with viable virus seen after nine days and 12 days for some, support the isolation periods advocated in most guidelines.

Lateral flow tests (LFTs) were also shown to be a good indicator of whether someone was harbouring viable virus. Positive LFTs correlated well with lab-confirmed detection of virus from swabs throughout the course of infection, including in those who were asymptomatic. However, the tests were less effective in picking up lower levels of virus at the very start and end of infection.

The challenge virus used in the study was produced under hVIVO’s supervision by a team at Great Ormond Street Hospital for Children NHS Foundation Trust in London, with support from virologists at Imperial College London. The Human Challenge Programme is funded by the UK Government, who commissioned Imperial College London to act as the clinical study sponsor. The study was conducted by hVIVO at the Royal Free Hospital, under the supervision of the Company’s highly trained scientists and medics.

Cathal Friel, Executive Chairman of Open Orphan, said : “I am delighted that the world’s first COVID-19 characterisation study has completed with no serious adverse events or serious symptoms, demonstrating that a COVID-19 human challenge study is safe in healthy young adults. The results, which have been made public today, have provided invaluable insights into COVID-19 disease progression.

“Crucially, we have now successfully established a COVID-19 Human Challenge Model which could be instrumental in accelerating the development of future COVID-19 therapeutics. New variants, such as Omicron, often mean that vaccines and antivirals have to be quickly re-evaluated to ensure effectiveness. Human challenge studies could prove to be the fastest way to compare old and new vaccines and therapies.”

Dr Andrew Catchpole, Co-investigator on the study and Chief Scientific Officer of hVIVO, said : “The SARS-CoV-2 characterisation study has provided invaluable insights into the progression of COVID-19 infection in healthy young adults. Importantly the study demonstrated that SARS-CoV-2 challenge studies are safe and well tolerated by the volunteers with no serious symptoms and no Serious Adverse Events (SAEs).  The study’s results have provided useful insights which could be used to inform public health decisions on COVID-19 symptoms and virus detection going forward, including isolation periods for infectious individuals, the use of LFTs, and establishing the human challenge platform to investigate further aspects of COVID-19.

“While the characterisation study was focused on the original SARS-CoV-2 strain, and there are differences in transmissibility between it and the other variants, the same factors will be responsible for protection against it, meaning the findings remain valuable for variants such as Delta or Omicron.  These data provide a clear platform to now utilise the human challenge model to expedite product efficacy testing for new vaccines or antivirals

Professor Christopher Chiu, Professor of Infectious Diseases from the Institute of Infection at Imperial College London and Chief Investigator on the trial, said: “First and foremost, we’ve shown that our challenge infection model was safe and well tolerated in healthy young adult participants. People in this age group are believed to be major drivers of the pandemic and these studies, which are representative of mild infection, allow detailed investigation of the factors responsible for infection and pandemic spread.

“Our study reveals some very interesting clinical insights, particularly around the short incubation period of the virus, extremely high viral shedding from the nose, as well as the utility of lateral flow tests, with potential implications for public health.” 

Professor Sir Jonathan Van-Tam, Deputy Chief Medical Officer at Department of Health and Social Care, said: “Human challenge studies have been performed using other pathogens for decades, including flu and Respiratory Syncytial Virus (RSV). They need full independent ethical review and very careful planning – as has been the case this time. Every precaution is taken to minimise risk.

“Scientifically these studies offer real advantage because the timing of exposure to the virus is always known exactly, therefore things like the interval between exposure and the profile of virus shedding can be accurately described.

“This important study has provided further key data on COVID-19 and how it spreads, which is invaluable in learning more about this novel virus, so we can fine-tune our response. Challenge studies could still prove to be important in the future to speed the development of ‘next-generation’ Covid-19 vaccines and antiviral drugs.

“This data underline just how useful a tool lateral flow tests can be to pick up people when infectious and the importance of wearing a face covering in crowded, enclosed spaces.”

Dr Mariya Kalinova, Principal Investigator on the study and Medical Director of hVIVO, said: “Closely observing and examining COVID-19 infection disease progression in volunteers during the SARS-CoV-2 characterisation study has revealed several important insights which will benefit public health going forward. Results uncovered new insights into the average incubation period for COVID-19 infection as well as disparities in viral loads between the nose and mouth, which endorses proper mask wearing guidance. Most importantly, there were no serious or adverse events, which proves a SARS-CoV-2 challenge is safe and well tolerated.”

Dr Sir Michael Jacobs, consultant in infectious diseases at the Royal Free London, said: “We have vast experience of safely managing highly transmissible infections at the Royal Free Hospital and we are really pleased to have been able to play our part in this landmark study.

“The trial has already provided some fascinating new insights into SARS-CoV2 infection, but perhaps its greatest contribution is to open up a new way to study the infection and the immune responses to it in great detail and help test new vaccines and treatments.”

‘Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge’ by Killingley, B. et al. is available on the Research Square pre-print server and has been submitted for peer-review. DOI: 10.21203/rs.3.rs-1121993/v1 https://www.researchsquare.com/article/rs-1121993/v1

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.  

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain. 

For further information please contact:

 

Open Orphan plc

+353 (0) 1 644 0007

Cathal Friel, Executive Chairman

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  

Virus: The challenge virus used was a pre-Alpha strain of SARS-CoV-2, from the B1 lineage, which includes the Alpha, Beta and Delta variants (first detected in England (Kent), South Africa and India, respectively). It contained the D614G mutation in the spike protein, which is believed to have increased transmissibility compared to the originally described strain. The study used virus from very early in the pandemic obtained from a hospitalized patient in the ISARIC4C study.

Viral load: Swabs were taken from participants’ nose and throat twice a day. Viral replication was detected using PCR analysis and lab cultures, enabling analysis of viral load.

Open Orphan plc

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

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models. There has been significant growth of the infectious disease market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma, and biotech companies.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing, and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

Open Orphan #ORPH – £5m Influenza human challenge study contract win

Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in vaccine and antiviral testing using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan plc, has signed a £5m influenza human challenge study contract with a biotech company developing an antiviral drug for protection against respiratory viral infections. 

The study, which is expected to commence in H2 2022, will test and assess the efficacy of a single dosing regimen of the client’s antiviral drug, with healthy adult volunteers, using the hVIVO Influenza human challenge study model.  Conducted at hVIVO’s state-of-the-art facilities in London, Open Orphan expects the majority of revenues to be recognised in 2022.

Respiratory tract infections are infections of parts of the body involved in breathing, such as the sinuses, throat, airways or lungs and are often caused by viruses such as influenza. Seasonal influenza causes significant morbidity and mortality each year and a pandemic influenza continues to pose a worldwide threat. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 – 650,000 deaths per year. Healthy volunteer human challenge studies of wild-type influenza play a major role in the development of vaccines and therapeutics against influenza.

hVIVO has been studying influenza for over 20 years and conducting influenza human challenge studies with its flu disease models for more than 15 years. hVIVO has conducted numerous flu challenge studies for a range of industry, governmental and academic clients, making its models the most well-used commercial flu disease models available on the market. hVIVO also has expertise in safely conducting challenge studies across a range of respiratory viruses, including various strains of Influenza, Respiratory Syncytial Virus (RSV) and human Rhinovirus HRV (common cold virus), malaria, and asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.

Cathal Friel, Executive Chairman of Open Orphan, said: “We are delighted to be working with this biotech client to assess the efficacy of their antiviral product which has the potential to be an important treatment against respiratory viral infections, using the hVIVO Influenza human challenge study model.

“We have now signed contracts for 95% of our 2022 forecasted revenues. This is the fourth Influenza human challenge study that we have signed in 2021 and coupled with the contract wins that we have seen in other disease areas, this further underlines the growing interest in respiratory and infectious diseases within the pharmaceutical and biotechnology industries, which we expect to continue over the coming years.

“Additionally, the continued damaging effects of the COVID-19 pandemic have underlined the need for increased pandemic preparedness in relation to other potential pandemic infectious diseases, such as influenza. Our expertise in testing vaccines and antivirals against our portfolio of infectious disease human challenge models will be important in ensuring we are prepared for the next, potentially more dangerous pandemic disease.”

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

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

Cathal Friel, Executive Chairman

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)

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

Paul McManus/ Sam Allen/ Louis Ashe-Jepson

+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 pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of other models. There has been an explosion in the growth of the infectious disease pharmaceuticals market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

Open Orphan #ORPH – £5.1m RSV Human Challenge Study Contract Win

Open Orphan (AIM: ORPH), a rapidly growing specialist contract 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 signed a £5.1m contract with a biopharmaceutical company to test its Investigational Medicinal Product (IMP) using hVIVO’s respiratory syncytial virus (RSV) Human Challenge Study Model.

The study is due to commence in H2 2022, with the revenue from the contract being recognised across 2021 and 2022. hVIVO will conduct this study on behalf of this biopharmaceutical client to demonstrate the efficacy of its IMP against RSV infection.  

RSV is a contagious virus that affects the respiratory tract of children and at-risk older adults; in severe cases, it can cause pneumonia and other life-threatening breathing difficulties. RSV is a significant public health threat and is one of the leading causes of hospitalisation of young children across the world. It also poses a significant threat to at-risk older adults; in the current climate, RSV may also lower immunity and increase the risk of developing COVID-19, and where these infections occur together, it can worsen the severity of COVID-19 illness.

hVIVO has two decades of experience and expertise in safely conducting challenge studies across a range of respiratory viruses, including RSV, various strains of Influenza, human Rhinovirus HRV (common cold virus), malaria, and asthma. In October 2020, this expanded to include the SARS-CoV-2 virus.

Cathal Friel, Executive Chairman of Open Orphan said: “We are pleased to have signed this contract to test our client’s product using our RSV Human Challenge Study Model. It is testament to our position as the world leading provider of Phase IIa human challenge study clinical trials that innovative biopharmaceutical companies, as well as Big Pharma, are actively and regularly engaging us to test their novel vaccine and antiviral candidates.

“RSV is one of several infectious and respiratory disease areas of unmet need that we are seeing rapidly growing interest in from drug developers. We look forward to working with more companies across the world to test their antivirals and vaccines, as Phase IIa human challenge studies increasingly become part of mainstream clinical trial design.”

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

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

Cathal Friel, Executive Chairman

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)

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

Paul McManus/ Sam Allen/ Louis Ashe-Jepson

+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 pharmaceutical service/contract research company that is a world leader in testing vaccines and antivirals using human challenge clinical trials. The Company provides services to Big Pharma, biotech and government/public health organisations.

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic and its state-of-the-art 24-bedroom QMB clinic with its highly specialised on-site virology and immunology laboratory. Open Orphan has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of other models. There has been an explosion in the growth of the infectious disease pharmaceuticals market, which is estimated to grow to in excess of $250bn by 2025. The Group is focused on refreshing its existing challenge models and develop new models, such as Malaria, to address the dramatic growth potential of the global infectious disease market.

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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies.

Open Orphan’s Paris office has been providing biometry, data management and statistics to its many European pharmaceutical clients for over 20 years. For over 15 years, the Company’s Netherlands office has been providing drug development consultancy and services, including CMC (chemistry, manufacturing and controls), PK and medical writing, to a broad range of European clients. Both offices are now also fully integrated with the London office and working on challenge study contracts as well as supporting third party trial contracts.

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