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Open Orphan #ORPH – First volunteer dosed in intranasal COVID-19 vaccine clinical trial
Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO and a world leader in vaccine and antiviral testing using human challenge clinical trials, announces that the first volunteer has been dosed with the Codagenix Inc. (“Codagenix”) needle free, intranasal COVID-19 vaccine, COVI-VAC. Conducted by hVIVO, part of Open Orphan plc, the Phase I clinical trial of COVI-VAC is being carried out at their facility in the UK. COVI-VAC is a single-dose, intranasal, live attenuated (the entire virus in a weakened form) vaccine against SARS-CoV-2, the virus that causes COVID-19.
Further to the Company’s announcement on 28 July 2020, hVIVO is working in collaboration with US biotech Codagenix to conduct a Phase I study of COVI-VAC. This is a randomised, double-blinded, placebo-controlled dose-escalation study, and will evaluate the safety and tolerability of the single-dose intranasal vaccine candidate in 48 healthy young adult volunteers at hVIVO’s state-of-the-art Quarantine Facility in Whitechapel, London.
The study will also evaluate the vaccine’s ability to provoke an immune response – measuring neutralising antibodies, mucosal immunity in the airway and cellular immunity. COVI-VAC has the potential to address several key logistical challenges to immunisation against SARS-CoV-2 at a global scale. As a single-dose, intranasally-delivered vaccine, COVI-VAC will not require a needle and syringe to be administered, nor ultra-low temperature freezers for storage. COVI-VAC can be manufactured on a large scale and supports ease of administration in a mass vaccination campaign. Codagenix expects to report initial data from the study by mid-2021.
Cathal Friel, Executive Chairman, Open Orphan, commented: “We are delighted to have been chosen by the New York based Codagenix to run this very important COVID-19 vaccine study in our quarantine clinic in London. This vaccine is one of the first of the next generation COVID-19 vaccines, it is a single dose, needle free, intranasal, live attenuated COVID-19 virus vaccine. Thus, in our opinion, because it is a live attenuated virus vaccine, COVI-VAC has the potential to give much longer-lasting cellular immunity against COVID-19 than many of the first-generation vaccines.
“Codagenix sought an inpatient facility for the first in human evaluation of COVI-VAC to allow for thorough evaluation of product safety and real-time volunteer monitoring, and our unique state-of-the-art quarantine facility in East London is one of the few facilities in the world suitable to conduct this trial safely and successfully. hVIVO are providing a full-service trial as part of this contract with Codagenix and the team at FluCamp have been responsible for all aspects of trial recruitment for this study through www.FluCamp.com .
“hVIVO is world-recognised for its expertise in evaluation of live viruses in human volunteers and we look forward to a positive outcome.”
Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said: “Dosing of the first patients in the Phase 1 clinical trial of COVI-VAC, our single-dose, intranasal, live attenuated vaccine against COVID-19, is an important milestone for Codagenix and the hVIVO team. As a live attenuated vaccine, COVI-VAC has the potential to provide a broader immune response in comparison to other COVID-19 vaccines that target only a portion of the virus, which could prove critical as new variants of SARS-CoV-2 have begun to emerge. Additionally, we believe COVI-VAC can address potential gaps in supplying the global immunization effort against COVID-19, especially in developing countries .”
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 . hVIVO welcomes volunteers to take part in our clinical trials under expertly supervised conditions, to further medical research, and help us to take the understanding of respiratory illnesses to a new level. Volunteers are central to the work that we do; our studies focus on testing new treatments on real people, in a safe, controlled, clinical environment.
Further details on all aspects of our volunteer programs including testimonials from previous volunteers can be found at www.flucamp.com .
If you are interested in being contacted and provided with details about future COVID-19 human challenge study research, please leave your contact details at www.UKCovidChallenge.com .
For further information please contact:
Open Orphan plc |
+353 (0) 1 644 0007 |
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Cathal Friel, Executive Chairman |
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Arden Partners plc (Nominated Adviser and Joint Broker) |
+44 (0) 20 7614 5900 |
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John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons |
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finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
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Geoff Nash / James Thompson/ Richard Chambers |
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Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
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Anthony Farrell |
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Walbrook PR (Financial PR & IR) |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com |
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Anna Dunphy / Paul McManus |
+44 (0)7876 741 001 / +44 (0)7980 541 893 |
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About Open Orphan ( www.openorphan.com )
Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com . The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development. Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.
The Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering.
Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO and Venn Life Sciences and is also building out a valuable data platform business. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteers via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc. Venn is an integrated drug development consultancy firm which offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.
BRR Media – Open Orphan #ORPH secure MHRA approval to start Codagenix COVID-19 phase 1 vaccine trial
Open Orphan #ORPH – MHRA approval for nasal COVID-19 vaccine clinical trial
Open Orphan plc (AIM: ORPH), a rapidly growing specialist pharmaceutical services CRO which is the world leader in the testing of vaccines and antivirals using human challenge clinical trials, announces the first in human (Phase I) study of Codagenix intranasal SARS-CoV-2 (COVID-19) vaccine candidate has received approval from the UK’s independent Medicines and Healthcare Products Regulatory Agency (MHRA).
Further to the Company’s announcement on 28 July 2020, hVIVO, part of Open Orphan plc, is working in collaboration with US biotech Codagenix Inc. (“Codagenix”) to conduct this Phase I study of COVI-VAC, Codagenix’s intranasal SARS-CoV-2 (COVID-19) vaccine candidate. The study will evaluate safety and immunogenicity of a single-dose nasal vaccine candidate in 48 healthy young adult volunteers at hVIVO’s state-of-the-art Quarantine Facility in Whitechapel, London.
COVI-VAC is one of the few vaccines that uses the live-attenuated virus (i.e. the entire virus in a weakened form), unlike most other vaccines which only contain the viral spike. This vaccine, therefore, has the potential to induce broad antibody, cellular and mucosal immunity with a single intranasal dose and could be one of the first vaccines to provide long-term immunity from COVID-19.
hVIVO expects the study to commence in January 2021, the initial data expected in early Q2 2020. The Company has already begun enrolling volunteers for this study in its unique East London, 24-bedroom quarantine clinic through hVIVO’s dedicated volunteer recruitment website: www.flucamp.com
Cathal Friel, Executive Chairman of Open Orphan, said:
“We are delighted to have MHRA approval to begin recruiting volunteers for this much needed clinical trial. The volunteers who attend our unique quarantine facility in East London are expertly supervised in a safe, controlled clinical environment and could be contributing to the development of a new breakthrough vaccine candidate that has the potential to confer immunity to individuals over a much longer timescale.
“We hope to demonstrate safety and immunogenicity through this trial, which will then allow us to support Codagenix as they move into a larger Phase II / Phase III programme.”
Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix, said:
“We are very excited to be moving forward with our collaboration with hVIVO for this first-in-human study of COVI-VAC, our live attenuated vaccine against COVID-19. The initial safety and immunogenicity data from healthy adults will position us well to move into larger studies in 2021 with our partners at Serum Institute of India. We believe COVI-VAC, a needle-free, single dose vaccine, is well-suited to address potential gaps in supplying the global community, as there is likely to be significant unmet need even after the initial roll-out of first generation COVID-19 vaccines.”
Dr. Rajeev Dhere, Executive Director, Serum Institute of India, said:
“We at the Serum Institute of India are pleased with the MHRA approval for initiating the first-in-human clinical trial for the novel intranasal product against COVID-19, developed by Codagenix in collaboration with SII. We are happy to have hVIVO conducting the clinical trial of this unique Intranasal vaccine.”
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 / Benjamin Cryer / Dan Gee-Summons | ||
finnCap plc (Joint Broker) | +44 (0) 20 7220 500 | |
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 / Alice Woodings | +44 (0)7980 541 893 / +44 (0)7407 804 654 | |
About Open Orphan (www.openorphan.com)
Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com. The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development. Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.
The Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering.
Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO and Venn Life Sciences and is also building out a valuable data platform business. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc in January 2020. Venn is an integrated drug development consultancy firm which offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.
Most people try to avoid Covid-19. But thousands are signing up to be deliberately exposed – CNN
By Mick Krever, Phil Black and Cristiana Moisescu,
London (CNN) – As most of us obsess with avoiding Covid-19 at all costs, a rapidly growing group of people around the world say they are prepared to deliberately take on the virus.
Tens of thousands of people have signed up to a campaign by a group called 1 Day Sooner to take an experimental vaccine candidate and then face coronavirus in a controlled setting.
Among them is Estefania Hidalgo, 32, a photography student in Bristol, England, who works at a gas station to pay the bills.
“I do night shifts there, and it can be very lonely,” she recalled on a sunny day near her home.
Passing those long lockdown hours with just podcasts to keep her company, she describes discovering the challenge trial movement — and hearing volunteers’ motivations — as a revelatory moment.
“I was shaken,” she said. “No one should be left behind. Old people, poor people, people of color. Everyone just deserves to be healthy.”
“This was a way for me to take back control of the situation, to feel like I was in a less hopeless place, and a less hopeless world, and be like, OK, I can do this. To make it better, I chose not to be in fear.”
So-called human challenge trials, while sometimes controversial, are nothing new. They have been used for cholera, typhoid, malaria, and even the common cold. But unlike for those diseases, we do not yet have a completely effective treatment for Covid-19, should the experimental vaccine fail.
Volunteers in challenge trials are typically compensated for their time and participation, experts say, but organizers must be careful not to pay an amount that could edge on coercive. Critics also say that challenge trials have limited use because the young, healthy people who take part don’t represent the broader population.
Full CNN article here
Open Orphan #ORPH – Interim Results for 6 months ended 30 June, will be operationally profitable in Q4
Open Orphan Plc, a rapidly growing specialist CRO pharmaceutical services company which is the world leader in the testing of vaccines and antivirals using human challenge clinical studies is pleased to announce its interim results for the six months ended 30 June 2020. The interim results include the first six months of hVIVO group (“hVIVO”) following its acquisition by Open Orphan Plc on the 17 January 2020.
Operational Highlights:
· Completed the acquisition of hVIVO plc for an aggregate consideration of approximately GBP£13 million in equity on 17 January 2020
· Implemented a major restructuring and integration of our operations to drive efficiency and competitiveness which is now substantially completed
· Successfully secured a number of RSV human challenge studies in the period including:
– £3.4m contract with a major European biotech company, with anticipated £7m follow-on study
– £3.7m contract with a US biotechnology company
· Driving growth of Dutch early clinical development services while refocussing French operations towards biometry services
· Large contract signed with a global leader in vaccine development
· Launch of COVID-19 Antibody testing partnership with Quotient Ltd
· Appointment of Leo Toole as Group Chief Financial Officer enhancing the executive management team
Financial Highlights:
· Cash and cash equivalents at half year end of GBP £14.7m following two successful placings:
– Executed a fundraise on 31 January 2020 raising GBP £5.3 million at 6.1p per share (before expenses)
– Executed a fundraise on 22 May 2020 raising GBP £12.6 million at 11p per share (before expenses)
· Reported Interim Results
o Revenue of GBP £7.1 m for H1 2020 – continued focus on delivering larger contracts
o EBITDA loss of GBP £4.1m for H1 2020
o Operating Loss of GBP £5.0m for H1 2020
· Pro-forma Interim Results
o Revenue of GBP £7.4m (H1 2019 Revenue of GBP £11.6m)
o EBITDA Loss of GBP £4.7m (H1 2019 EBITDA loss of GBP £4.7m)
o Operating Loss of GBP £5.6m (H1 2019 Operating Loss of GBP £6.3m)
· Post completion of Merger, reduction in overheads on target to deliver annualized cost efficiencies of GBP £10.1m by end of 2020
Post Period End:
· Acquired the CHIMagents team in July, reinforcing hVIVO’s position as the world leading services company in the testing of vaccines and antivirals through human challenge study clinical trials.
· Integrated hVIVO’s unparalleled database of infectious diseases progression data into the Open Orphan data platform – expecting potential commercialisation in Q4, with some of the world’s largest wearable companies for this disease progression data.
· Progressing as planned to monetise two of our non-core assets, the 49% stake in Imutex and the 62.6% stake in PrEP.
· The Company continues to provide testing to large commercial employers in the UK and Ireland as part of a combined COVID-19 antibody and COVID-19 PCR (swab) testing offering.
· Contracts signed post period end include:
– Laboratory services contracts signed with a number of parties – a key strategic growth area for Open Orphan taking advantage of our laboratory expertise.
– Contract signed with Codagenix Inc. for a first-in-human Phase I COVID-19 vaccine study, demonstrating that hVIVO’s quarantine facility is uniquely suited to conducting Phase I studies for infectious disease vaccines such as this.
– Further RSV human challenge study contract for £4m signed with a Top 3 global pharma company with hVIVO acting as sponsor for this study.
– First-in-human clinical pharmacology trial signed with Carna BioSciences.
– Contract signed with a major European pharmaceutical company for data management, statistics and medical writing to support a 750 subject oncology study.
– Contract signed for a further £4.3m human challenge study with a top 10 global vaccine company.
Outlook:
· The Group has a strong pipeline of contracted work and new projects at an advanced stage of negotiation and is targeting growth with strong operating cash flow in the second half of 2020 and is on target to be operationally profitable in Q4.
· As of September 2020, we are close to having the hVIVO quarantine clinic block booked with conventional challenge studies until December 2021. Quarantine clinic block expected to shortly be booked out for the next 18 months to two years with conventional challenge study contracts.
· Further to its announcements of 9 March 2020 and 22 May 2020, the Company is well progressed in developing the world’s first Coronavirus human challenge study model to test a range of COVID-19 vaccines, complementing existing human challenge study models. We are in advanced discussions and negotiations with a range of potential customers, including the UK Government to test COVID-19 vaccines.
Cathal Friel, Executive Chairman of Open Orphan, said:
“Since we acquired hVIVO in January 2020, we have achieved what we set out to do. We have created a leaner more efficient businesses, removed excess costs and we are now a truly unique clinical research organisation (CRO) that is the world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. We have secured larger, more profitable contracts with both large pharma and the leading vaccine developers globally. We have delivered upon our aim of improving revenue streams through the delivery of several new revenue lines including the provision of laboratory services to third parties. We have reinvigorated both the Venn Life Sciences business and the hVIVO business during the first half of 2020 and have created a strong foundation for future growth.
Looking ahead, I am extremely excited by the potential for this business, we have entered a decade of significant spending on vaccines and antivirals by both governments and pharma companies around the world. The Open Orphan Group including hVIVO and Venn Life Sciences is ideally positioned to capitalise on this increase in vaccine development expenditure. Earlier this year we set ourselves the target of being profitable in the second half of 2020 and I am delighted to confirm that, despite profitability taking a few months longer than expected, we are on target to be operationally profitable in Q4 2020.
None of the above would have been possible without the exceptional effort, dedication and professionalism shown by all hVIVO, Venn and Open Orphan team members. They have worked diligently through the past 6 months, despite the added difficulty of the pandemic, to ensure that we have delivered an excellent performance. The teams are really well positioned to thrive as the world leaders in the testing of vaccines and antivirals for the decade ahead.”
Conference call for sell-side analysts and investors
The Company will hold a conference call for sell-side analysts and investors at 10:30 today.
Details for the conference call can be found at: https://www.speakservecloud.com/register-for-call/254ba4b5-e780-48fb-9142-c5762f4ef8ef
A corporate presentation is available to shareholders on the Group’s website at: https://www.openorphan.com/investors/reports-and-presentations/year/2020
Enquiries:
Open Orphan Plc Tel: +353 (0)1 644 0007
Cathal Friel, Executive Chairman
Arden Partners (Nominated Adviser and Joint Broker) Tel: +44 (0)20 7614 5900
John Llewellyn-Lloyd / Benjamin Cryer / Dan Gee-Summons
finnCap plc (Joint Broker) +44 (0) 20 7220 500
Geoff Nash / James Thompson/ Richard Chambers
Davy (Euronext Growth Adviser and Joint Broker) Tel: +353 (0)1 679 6363
Anthony Farrell (Corporate Finance)
Camarco (Financial PR)Tel: +44 (0)20 3757 4980
Tom Huddart / Hugo Liddy
Notes to Editors ‐ Open Orphan:
Open Orphan is a rapidly growing niche CRO pharmaceutical services company which is a world leader in the testing of vaccines and antivirals through the use of human challenge clinical trials. Conducted from Europe’s only 24-bedroom quarantine clinic with onsite virology providing individually isolated rooms and connected to our specialist laboratory facility. hVIVO’s challenge studies require healthy volunteers to take part, volunteers are recruited through FluCamp, learn more at www.FluCamp.com. The hVIVO facility offers highly specialised virology and immunology laboratory services to support pre-clinical and clinical respiratory drug, antiviral, and vaccine discovery and development. Reliable laboratory analysis underpinned by scientific expertise is essential when processing and analysing clinical samples. Robust quality processes support our team of scientists in the delivery of submission ready data.
The Company has a leading portfolio of 8 viral challenge study models which are: 2 FLU, 2 RSV, 1 HRV, 1 Asthma, 1 cough and 1 COPD viral challenge models. As announced in early March, Open Orphan is rapidly advancing a number of Coronavirus challenge study models and expects to be helping many COVID-19 vaccine development companies to test their vaccines. No other company in the world has such a portfolio, with only two competitors globally having 1 challenge study model each. hVIVO also works with companies in the UK and Ireland to provide COVID-19 testing to staff to protect staff and customers from a workplace COVID-19 outbreak through its COVID Clear offering.
Open Orphan comprises of two commercial specialist CRO services businesses, hVIVO and Venn Life Sciences and is also building out a valuable data platform business. hVIVO has built up one of the world’s largest databases of infectious disease progression data and we are populating our Open Orphan Health Data platform with this historical hVIVO data. In our clinical trials going forward, we are also planning to collect data on volunteer’s via wearables during clinical trials. Therefore, Open Orphan’s data, which may yield valuable digital biomarkers, could be one of the more sought-after datasets by many of the large wearables /smart watch wearables providers around the world. In June 2019, Open Orphan acquired AIM-listed Venn Life Sciences Holdings plc in a reverse take-over and in January 2020 it completed the merger with hVIVO plc in January 2020. Venn is an integrated drug development consultancy firm which offers CMC (chemistry, manufacturing and controls), preclinical, Phase I & II clinical trials design and execution. The merger with hVIVO created a European full pharma services company broadening the Company’s customer base and with complementary specialist CRO services, widened the range of the Company’s service offerings.
Executive Chairman’s Statement
Dear Shareholder,
As Executive Chairman, I am very happy to report the first set of combined results since Open Orphan plc’s (formerly Venn Life Sciences Holdings plc) acquisition of hVIVO plc (now hVIVO Limited) in January 2020.
Summary
The 6 months to the end June 2020 have been a period of significant change initially focussed on progressing our strategy to sign contracts for our world leading human challenge studies clinical trials which are used to test vaccines and anti-virals. We are also signing new contracts for biometry services from our Paris office and early clinical development services from our Breda, Netherlands office while at the same time developing further new revenue streams such as laboratory services to complement our existing London business. This has all been done while at the same time we implemented a major restructuring and integration of our operations to drive efficiency and competitiveness which is now substantially completed.
Also, in this period, the Company addressed the rapidly evolving COVID-19 pandemic event by enabling a safe and efficient working environment for our staff at home and in our clinic and laboratory facilities. We have worked proactively with our clients to manage project timetables to minimize the impact of Covid-19 on our revenues streams while continuing to build new relationships to expand our confirmed project pipeline well into 2021 and beyond.
Other highlights include the completion of a placing of £12.6m (before expenses) at 11p per share in May 2020 allowing us to invest to accelerate the development of a world-first coronavirus challenge study model to test COVID-19 vaccines and antivirals. This was all done while also expanding our laboratory service offerings to offer enhanced external laboratory services and to develop testing services to support the nascent testing environment for Covid-19.
Interim Results
Reported results for Open Orphan plc are summarized below and are covered by the schedules and notes from pages 6 to 14 of these Interim Financial Statements (and in particular reflect reverse merger accounting treatment under IFRS 3 and IFRS 10 of the combination of Venn Life Sciences Holdings plc and Open Orphan DAC as of 28 June 2019). We also share for reference the results for hVIVO plc (now hVIVO Limited), Open Orphan plc (formerly Venn Life Sciences Holdings plc) and Open Orphan DAC on a stand-alone basis.
Open Orphan plc(As reported) | hVIVO plc(Proforma results on standalone basis) | Open Orphan plc(formerly Venn Life Sciences Holdings plc -proforma resultson a stand-alone basis) | Open Orphan DAC (proforma resultson a stand-alone basis) | Open Orphan plc(proforma results on a combined basis and including the impact of the 28 June 2019 and 17 January 2020 combinations) | ||||||
Unaudited6 months ended30 June2020£’000 | Unaudited6 months ended30 June2019£’000 | Unaudited6 months ended30 June2020£’000 | Unaudited6 months ended30 June2019£’000 | Unaudited6 months ended30 June2020£’000 | Unaudited6 months ended30 June2019£’000 | Unaudited6 months ended30 June2020£’000 | Unaudited6 months ended30 June2019£’000 | Unaudited6 months ended30 June2020£’000 | Unaudited6 months ended30 June2019£’000 | |
Revenue (incl. Other income) | 7,078 | – | 3,379 | 6,409 | 4,062 | 5,179 | – | – | 7,441 | 11,588 |
Operating (Loss) | (5,005) | (156) | (3,067) | (4,224) | (2,128) | (1,965) | (447) | (159) | (5,642) | (6,348) |
EBITDA before exceptional items | (4,145) | (156) | (2,478) | (3,192) | (1,811) | (1,340) | (445) | (159) | (4,734) | (4,691) |
Loss for the period | (6,490) | (1,070) | (2,934) | (3,833) | (2,408) | (1,809) | (458) | (1,091) | (7,136) | (6,733) |
As at 30 June 2020€’000 | As at 30 June 2019€’000 | |||||||||
Non-current assets | 17,721 | 5,250 | ||||||||
Current assets (excl. cash) | 3,602 | 5,714 | ||||||||
Cash | 14,651 | 4,540 | ||||||||
Total Assets | 35,974 | 15,504 | ||||||||
Equity attributable to owners | 26,994 | 7,576 | ||||||||
Non-current liabilities | 2,271 | 3,304 | ||||||||
Current liabilities | 6,709 | 4,624 | ||||||||
Total equity and liabilities | 35,974 | 15,504 |
Governance
The Board continues to recognise the importance of the high standards of corporate governance and considers that the Group’s success is enhanced by the imposition of a strong corporate governance framework. I am grateful for the contributions of the new Board formed after the acquisition in January 2020 and want to acknowledge the important service of Trevor Philips during his tenure on the Boards of hVIVO plc (now hVIVO Limited) and Open Orphan plc until he stepped down in May 2020.
Outlook
Our business outlook has never been stronger. Demand and interest to complete Challenge studies in our 24-bed quarantine facilities in the UK is translating into a steady flow of signed new contracts and new customer engagement. As a result of the fundraise at the end of May, Open Orphan now has a large, healthy cash balance and, as such, is very well capitalised and we are ideally placed to be providing such services to governments and pharma companies around the world who seek to address the current pandemic and mitigate the risk of future such events. We are progressing a number of encouraging avenues to rapidly develop a human challenge model specific to SARS CoV-2 to fast track the identification of efficacious vaccines and treatments for Covid-19.
Our early clinical development business based out of Breda in the Netherlands is showing strong year on year growth while our biometry services based out of our Paris office, now focussing on data management, biostatistics, medical writing and randomisation, are contributing strongly to generate synergies for our viral challenge studies and expand their pipelines.
Across the second half of 2020, we will see the impact of the major efforts undertaken across the Group to divest from underperforming businesses, reduce overheads, deliver merger integration savings and right-size the management team including combining senior roles in both Venn and hVIVO leading to operational profitability in Q4. Our renewed focus on reducing hierarchy has increased the speed of decision making while empowering our teams to deliver our ambitious goals.
In addition, data is an important upstream area of development for the Group where we believe there will be an important convergence of hVIVO’s global infectious disease progression data with the digitization of other vital signs and biomarkers available through our challenge studies, all with the goal of creating a ground-breaking Open Orphan Health Data platform that can be monetized with major pharma players.
I am very encouraged for the remainder of 2020 and our prospects in 2021. We have a world leading team, focused on ground-breaking work which will create sustainable value for all our stakeholders.
Cathal Friel
Executive Chairman
30 September 2020
Full results announcement with financial statements here
Atlantic View – Keep Buying Kingfisher #KGF, DIY Retailer Flying High Thanks To COVID Lockdown Sales Boom
by John Woolfitt, Atlantic Capital Markets
Fundamentals & Statement Summary
Kingfisher (KGF), the owner of B&Q in the UK and Castorama and Brico-Depot in France, today announced a resilient first-half sales performance after the impact of the COVID lockdown during Q1 was offset by strong sales recovery in Q2. The group said that the crisis had ‘reinforced’ its approach, ‘pushing’ the retailer to be ‘bolder.’ Sales fell 1.3% to £5.9bn, while adjusted pre-tax profit grew by 23.1% to £415m as a huge 164% increase in online sales and a strong recovery in reopened stores offset the temporary closure of all outlets in the UK and France early in the Covid-19 pandemic.
The results comfortably exceeded adjusted profit forecasts of £361m, and as a result Kingfisher said it would repay the £23m it received in furlough payments from the UK government. Free cash flow of £1.04bn, up £838m, reflected higher operating profit, working capital inflow of £656m and lower capex.
Kingfisher said it had benefited from a surge in spending on homes and gardens as people adapted their houses for working from home, using money they would have spent on holidays or entertainment.
Kingfisher CEO Thierry Garnier said the crisis “has prompted more people to rediscover their homes and find pleasure in making them better. It is creating new home improvement needs, as people seek new ways to use space or adjust to working from home. It’s also clear that customers are becoming more comfortable with ordering online. And delivering value to consumers is imperative against a challenging economic backdrop.”
Looking forward, Kingfisher said the momentum had continued into Q3, with UK sales up 18.9%. since the end of July and those in France climbing 16.7%. The group also intends to experiment with new store formats including a pilot with Asda to introduce B&Q mini-stores in supermarkets.
Garnier added that while the near term outlook was uncertain, “the longer term opportunity for Kingfisher is significant. There is a lot more to do, but the new team and new plan is now established in the business and we are committed to returning Kingfisher to growth.”
Chart and Technicals
Source: FactSet and Hargreaves Lansdown
In the run up to the March COVID fall, Kingfisher shares traded steadily, before plunging to a 10 year low of 124p on March 18th. By the end of April however, the shares had not only recovered the 50-day MA, they blew through it, and recovered the benchmark 200-day moving average at 190p less than 1 month later. Since that time KGF has traded above both averages, leading to a bullish golden cross formation on July 10th as the 50-day MA passed through the 200-day MA. The stock drifted back to the 50-day MA in the run up to the results, and having successfully tested that level, opened higher on September 22nd. While above this level, our expectations are that the stock will retest July 2018 highs of 317p by early November 2020.
Summary and Atlantic View
Although the strong trading performance had by and large been flagged up by Kingfisher to the markets, the pace of online growth and resulting profit number caught out even the most bullish pundits. As CEO Thierry Garnier says, people have used the cash they would have spent on holidays and entertainment on home improvements. This factor, also evident in Travis Perkins results earlier this month, led to strong free cashflow and the return of furlough payments to HM Govt. Now, with lockdown and movement restrictions set to return at home and in France, Atlantic Capital Markets believes Kingfisher websites and outlets will be faced with a huge opportunity to cash in on another surge in home improvement spending during the latter part of the year. Backed by this sort of momentum, we expect the shares to push higher and retest the technical target of 317p in the next 4-6 weeks. Keep Buying.
To take advantage of this trading idea, speak to a member of our dealing team on 01872 229000 or visit the Atlantic Capital Markets website here
Atlantic View – Sell Tullow Oil #TLW, group still facing an existential crisis
by John Woolfitt, Atlantic Capital Markets
Fundamentals & Statement Summary
Oil and gas exploration and production company Tullow Oil (TLW.L) has interests in over 70 exploration and production licences across 14 countries. The group today announced half year results for the six months ended 30 June 2020, and reported a working interest production average of 77,700 bopd, in line with expectations, generating revenues of $731m ($872m); gross profit of $164m and a loss after tax of $1.3bn (profit of $103m). A $418m impairment charge on property, plant and equipment and recorded exploration write-off costs of $941m were mainly driven by a write-down of the value of its Ugandan assets.
As of June 30, Tullow reported net debt of $3.0bn; gearing of 3.0x net debt / EBITDAX and liquidity headroom and free cash of $0.5bn.
Production guidance improved to between 73,000 and 77,000 barrels of oil equivalent per day from between 71,000 and 78,000 to reflect recent strong performance in Ghana, although offset to some extent by production curtailments in Gabon.
Group organisational restructuring is well advanced and forecast to deliver cash savings of over $350m over three years, significantly in excess of the previous target of $200m. This will deliver annual sustainable cash savings of over $125m from 2021. Evaluation of various refinancing alternatives with respect to the Group’s capital structure is also ongoing.
Alongside a newly restructured board, including non-Executive Chair Dorothy Thompson and senior oil and gas executive Mitchell Ingram in as a non-executive director, newly appointed CEO Rahul Dhir commented:
“Despite the very tough conditions in the first half of this year, we have successfully delivered reliable production and major, sustainable reductions to our cost base. We are also close to completing the important sale of our interests in Uganda. The quality of Tullow’s assets remains robust.
Since my arrival as CEO, we have been developing new plans for our business, with the support of our Joint Venture Partners and expert advisors. These plans will deliver enhanced value from our assets to benefit all our stakeholders including our host countries and investors. We will host a Capital Markets Day towards the end of 2020 at which we will update the market on these plans to deliver on Tullow’s true potential.”
Chart and Technicals
Source: FactSet and Hargreaves Lansdown
Tullow’s well documented problems are clearly reflected in the charting price action, and while a precipitous pre-COVID fall in Q4 2019 occurred well before the crisis kicked in, an all time low just over 7p serves as a reminder that the oil industry can turn industry bellwethers into penny stocks at the drop of a hat. Since that time, Tullow shares have recovered and from mid April onwards have held or deviated either side of the 50-day MA line, dropping below the MA envelope in late July. If shares can recover the 50-day MA at 24p by mid October, then the falling 200-day MA currently at 39p is a distant prospect, however current divergence indicates a retest of 7p all time lows.
Summary and Atlantic View
The former oil industry bellwether has today put a brave face on what is otherwise an existential crisis. Earlier this year Tullow had highlighted the risk to its own survival, citing a material uncertainty that it would be able to operate as a going concern. The solid production and forward guidance from Ghana are a standout amidst horrendous debt levels, ($3bn) and write-downs from the sale of Ugandan assets. Despite forward guidance on cost savings, there is little sign at present that Tullow can realistically get on top of the debt pile – something the newly appointed management team will need to get to grips with as an absolute priority. Until / when the board can demonstrate clear progress in this regard, Atlantic rates Tullow shares as a sell into any strength, down to the all time lows of 7p. Sell.
To take advantage of this trading idea, speak to a member of our dealing team on 01872 229000 or visit the Atlantic Capital Markets website here
Atlantic View – Robust housing and maintenance market to support Travis Perkins shares
by John Woolfitt, Atlantic Capital Markets
Travis Perkins.
Fundamentals & Statement Summary
UK based building, construction & home improvement supply giant Travis Perkins (TPK.L) today announced half year results for the 6 months to June 30th, stating it had ‘successfully adapted to unprecedented markets.” Revenues for the period fell 19.3% to £2.78bn, leading to a loss per share of (45.7)p (4.2p HY19). Adjusted operating profit of £42m reflected the shortfall from lower volumes, partially offset by actions taken by the group to reduce and control operating costs.
Travis stated that a restructuring programme was underway to reduce overheads in line with the anticipated volume outlook, which will deliver cost savings of £120m on an annualised basis. In line with this, a strong focus on cash and working capital management resulted in a reduction of covenant net debt of £322m from 31 December 2019 to £22m.
The group said that significant improvements in digital platforms across all segments drove customer fulfilment, process simplification and improvements in branch network, underpinning market outperformance and supporting future growth. The demerger of Wickes is now paused until markets become more stable and predictable.
Travis said the long term fundamentals of the Group’s end markets remain robust, with ongoing demand for new housing and underinvestment in the repair, maintenance and improvement of the existing UK housing stock, although significant uncertainty remains in the UK economy in the near term. Technical guidance provided for 2020 included an effective tax rate of 22%, finance charges similar to 2019, capital expenditure in 2020 of around £70m to £80m and property profits of around £10m.
CEO Nick Roberts said Travis had made..“significant strategic and operational progress against the four strategic priorities we outlined at our full year results in March 2020.
“Although considerable uncertainty around the impact of the COVID-19 pandemic remains, the actions we have taken to adapt and innovate in our businesses mean that the Group is well placed to continue to service our customers, support our colleagues, outperform our markets and generate value for our shareholders.”
Chart and Technicals
Source: FactSet and Hargreaves Lansdown
Travis shares have delivered a strong recovery since falling off the ‘COVID cliff’ in early March, dipping briefly to 573p on March 18th before recovering the 50-day MA envelope at the start of May. The stock performed well, trading above the MA envelope through to the end of July, when it briefly dipped below the level. Since that time support has come from the 50-day line, and with the gradual convergence of the 50 day average with the benchmark 200-day average, there is the prospect that the stock could develop a bullish golden cross configuration (the golden cross appears on a chart when a stock’s short-term moving average crosses above its long-term moving average) in the coming weeks. Provided this signal is confirmed, in line with the rising MA envelope and clear forward fundamental guidance provided by the company, our initial target is 1400p, followed by a return to the late February 50-day MA high at 1600p.
Summary and Atlantic View
Travis shares have delivered an impressive and solid recovery since March 18th. Despite the inevitable fall in revenues, delivering an adjusted operating profit during one of the most challenging trading periods faced by any company in history…ever, is a major achievement, and a solid endorsement of management strategy and the prompt response by the board to restructure and cut costs. As the UK starts to return to work, despite the attendant COVID uncertainties, Travis is selling into a robust market, supported by an ever-increasing demand for new homes and burgeoning maintenance market. Supported by a reasonably bullish charting configuration, and clear forward guidance from the company, Atlantic are confident that Travis shares will continue the current recovery and push on to an initial target of 1400p by mid November. Buy.
To take advantage of this trading idea, speak to a member of our dealing team on 01872 229000 or visit the Atlantic Capital Markets website here