Home » Posts tagged 'ORPH'
Tag Archives: ORPH
Open Orphan #ORPH – Change of name to hVIVO plc effective
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, announces that further to its announcement on 8 September 2022, the Company’s change of name to hVIVO plc (AIM: HVO) has now been completed and is expected to take effect on AIM and Euronext Growth from 8.00 am tomorrow.
The Company’s ticker will be HVO and the website address (including the investor relations content and the information required by AIM Rule 26 and Euronext Growth Rule 3.4) will be available at www.hvivo.com.
The Company’s ISIN (GB00B9275X97) and SEDOL (B9275X9) will remain the same.
Shareholders will be unaffected by the change of name and existing share certificates should be retained and will remain valid. Any new share certificates issued after the name change takes effect will bear the name hVIVO plc.
For further information please contact:
|
Open Orphan plc |
+44 (0) 20 7756 1300 |
||
|
Yamin Khan, Chief Executive Officer |
|||
|
Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
||
|
Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
|||
|
finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
||
|
Geoff Nash / James Thompson / Nigel Birks |
|||
|
Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
||
|
Anthony Farrell |
|||
|
Walbrook PR (Financial PR & IR) Stephanie Cuthbert / Phillip Marriage / |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
||
Notes to Editors
hVIVO plc (ticker: HVO) (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials. The Group provides end-to-end early clinical development services to its large, established and growing repeat client base, which includes four of the top 10 largest global biopharma companies.
The Group’s fast-growing services business includes a unique portfolio of 10+ human challenge models to test a broad range of infectious and respiratory disease products, world class challenge agent manufacturing, specialist drug development and clinical consultancy services via its Venn Life Sciences brand, and a lab offering via its hLAB brand, which includes virology, immunology biomarker and molecular testing. The Group offers additional clinical field trial services such as patient recruitment and clinical trial site services.
hVIVO 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 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.
#ORPH Open Orphan Plc – Capital Markets Day
Open Orphan plc (AIM: ORPH), (to be renamed hVIVO plc (AIM: HVO) effective 26 October 2022), 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 be holding a Capital Markets Day for analysts, institutional investors and media on Wednesday 2 November 2022 at 9.30 am – 12.00 pm (GMT).
The event, which will be chaired by CEO Yamin ‘Mo’ Khan, will provide a deeper insight into the Company’s end-to-end early clinical development services business, the human challenge trial market, and the benefits of human challenge to the Company’s clients. There will also be an opportunity for attendees to take part in a Q&A with the Company’s management team including its new CFO, Stephen Pinkerton, and guest speakers which include Peter Openshaw, Professor of Experimental Medicine at Imperial College London.
Analysts, institutional investors and media are welcome to attend the event in the City of London. Due to restrictions on numbers, it will not be possible for all interested parties to attend in-person, however, a live webcast will be available on the Company’s website for retail investors and others to view the presentations here.
To register your interest for the webcast, please contact Walbrook PR on +44 20 7933 8780 or email
openorphan@walbrookpr.com.
A recording of the presentation will be made available on the Company’s website after the event.
For further information please contact:
|
Open Orphan plc |
+44 (0) 20 7756 1300 |
||
|
Yamin ‘Mo’ Khan, Chief Executive Officer |
|||
|
Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
||
|
Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
|||
|
finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
||
|
Geoff Nash / James Thompson / Richard Chambers |
|||
|
Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
||
|
Anthony Farrell |
|||
|
Walbrook PR (Financial PR & IR) Stephanie Cuthbert / Phillip Marriage / |
+44 (0) 20 7933 8780 or openorphan@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
||
Open Orphan #ORPH – CFO appointment & change of Board roles
Open Orphan #ORPH (to be renamed hVIVO plc (Ticker: HVO) effective 26 October 2022), 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 appointment of Stephen Pinkerton as Chief Financial Officer (“CFO”) and as an Executive Director, effective with immediate effect. Stephen will succeed Leo Toole who steps down from the Board and CFO role to pursue other interests. Leo will remain with the Company until 31 December 2022.
Leo was appointed to the Board and as CFO in February 2020 following the acquisition of hVIVO plc. He was a key member of the team that helped to turnaround the Company’s financial position and actively supported the Company in its engagement with the UK Government to complete the world’s first COVID-19 characterisation study in 2021.
Stephen is a chartered accountant with over 25 years of experience in senior financial roles and has served as Commercial Financial Director of hVIVO since July 2017, having previously been a consultant to the Company. Prior to joining hVIVO, Stephen spent 11 years in various senior financial roles at Thomson Reuters. He will be based in the Company’s Plumbers Row headquarters in East London alongside the Company’s CEO Yamin ‘Mo’ Khan.
Stephen has a strong background in financial planning and analysis, commercial finance, financial systems and financial control. As Commercial Financial Director of hVIVO, he has worked to transform the reporting and forecasting of the business, developed pricing models for contracts to help improve average contract value as well as driving margin improvements across the business, and has served as part of the business development team negotiating contract terms. As part of the leadership team, he has worked to help manage costs and restructure the business to improve efficiency, resulting in continued improvements in profitability.
Following the appointment of Yamin ‘Mo’ Khan as CEO on 24 February 2022, Cathal Friel is reverting to Non-Executive Chairman. Cathal remains fully committed to the business and will continue to work closely with Mo and Stephen going forward with particular focus on strategic initiatives for the Company.
Stephen Pinkerton, Chief Financial Officer of Open Orphan plc, said: “Having worked at hVIVO for over six years, both in a permanent role and previously as a consultant, I have built a deep knowledge of the business and forged relationships with many of our longstanding clients as part of the BD team. I am excited to begin this new role as CFO of the wider group as we look to continue the fantastic momentum that we have built in recent years.”
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan plc, said: “I am delighted that Stephen is stepping into the role of Chief Financial Officer. His experience and knowledge of the business mean he is ideally suited to support our growth strategy. I would like to thank Leo for his significant contribution to the Company over the past three years, where he has played a pivotal role in our progress to date.
“I look forward to continuing to work with Cathal as we build on the progress that both the Company and the entire team have made over the last three years.”
Disclosures in accordance with the AIM Rules and Euronext Growth Rules (as relevant)
Stephen Pinkerton, aged 59, holds 67,364 options over ordinary shares in the Company.
|
|
|
|
Current Directorships / Partnerships |
Past Directorships / Partnerships |
|
None |
Westfront Consultancy Limited |
Stephen was a Director at HB: Source Limited from 24 January 2005 to 11 June 2010. Prior to his appointment, HB: Source Limited was pursuing a Company Voluntary Arrangement (“CVA”) and Stephen was appointed to support HB: Source Limited through the CVA. HB: Source Limited was unable to fulfil its obligations under the terms of the CVA and ultimately entered into a creditors voluntary liquidation (“CVL”) on 8 December 2008. The estimated amount that unsecured creditors claimed was £1,380,000.00. The company was dissolved on 11 June 2010.
Save as disclosed above, there are no other disclosures required in relation to paragraph (g) of Schedule 2 of the AIM Rules for Companies.
For further information please contact:
|
Open Orphan plc |
+44 (0) 20 7756 1300 |
||
|
Yamin ‘Mo’ Khan, Chief Executive Officer |
|||
|
Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
||
|
Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
|||
|
finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
||
|
Geoff Nash / James Thompson |
|||
|
Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
||
|
Anthony Farrell |
|||
|
Walbrook PR (Financial PR & IR) Stephanie Cuthbert / Phillip Marriage / |
+44 (0) 20 7933 8780 or openorphan@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
||
Notes to Editors
Open Orphan plc (Ticker: ORPH) is changing its name to hVIVO plc (Ticker: HVO), which is expected to take effect on the AIM market of the London Stock Exchange and the Euronext Growth Exchange market on 26 October 2022.
Open Orphan is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and therapeutics using human challenge clinical trials. The Group provides end-to-end early clinical development services to its large, established and growing repeat client base, which includes four of the top 10 largest global biopharma companies.
The Group’s fast-growing services business includes a unique portfolio of 10+ human challenge models to test a broad range of infectious and respiratory disease products, world class challenge agent manufacturing, specialist drug development and clinical consultancy services via its Venn Life Sciences brand, and a lab offering via its hLAB brand, which includes virology, immunology biomarker and molecular testing. The Group offers additional clinical field trial services such as patient recruitment and clinical trial site services.
hVIVO 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 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.
Open Orphan #ORPH – Upcoming Scientific Presentations
Open Orphan (AIM: ORPH), (to be renamed hVIVO plc (AIM: HVO) effective 26 October 2022), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that three presentations discussing the data and learnings from recent clinical studies and projects will be presented at two upcoming conferences taking place in Belfast, Northern Ireland.
OPTIONS XI for the Control of Influenza is being held 26 – 29 September 2022 and hVIVO will be at booth 6 during the conference for potential partnering discussions. The 12 th International RSV Symposium will take place on 29 September to 2 October 2022 and hVIVO will be at booth 6 during the conference for potential partnering discussions.
Details of the presentations at OPTIONS XI for the Control of Influenza are as follows:
|
Title: |
Immunomodulators and treatment of disease in the influenza human challenge model |
|
Abstract: |
AOXI0665 |
|
Date: |
Wednesday, 28 September 2022 |
|
Location: |
Hall 1, Poster Board Number: P-532 |
|
Title: |
Influenza, COVID-19, RSV and HRV: translating efficacy testing of vaccine and drugs from human challenge models to the field |
|
Abstract: |
AOXI0658 |
|
Date: |
Thursday, 29 September 2022 at 11:12 AM |
|
Session: |
Oral Abstract Session: Translational: Influenza & COVID-19 – Human challenge models |
Details of the presentation at the 12th International RSV Symposium are as follows:
|
Title: |
RSV vaccines/prophylactics: key learnings from the RSV challenge model and Efficacy of Vaccines |
|
Abstract: |
ARNI0259 |
|
Date: |
Friday, September 30, 2022 |
The abstracts and posters will be available on hVIVO’s website from 4 October 2022 here .
For further information please contact:
|
Open Orphan plc |
+44 (0) 20 7756 1300 |
||
|
Yamin Khan, Chief Executive Officer |
|||
|
Walbrook PR (Financial PR & IR) Stephanie Cuthbert / Phillip Marriage / |
+44 (0) 20 7933 8780 or openorphan@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
||
Notes to Editors
Open Orphan plc (London and Euronext: ORPH) is changing its name to hVIVO plc (AIM and Euronext: HVO), which is expected to take effect on the AIM market of the London Stock Exchange and the Euronext Growth Exchange market on 26 October 2022.
hVIVO is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.
The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models, such as malaria and COVID-19, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.
hVIVO 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.
#ORPH Open Orphan PLC – Comment regarding press speculation
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 media report relating to the allegation of an incident of potential insider dealing in the Company’s shares by an unconnected private individual in 2020.
The Company confirms that it was made aware of this allegation by, and at their request, is helping the relevant Irish authorities in respect of this allegation.
The Board of Open Orphan is satisfied that there are no implications for the Company in the resolution of this allegation and confirms that no employee, executive, director or anyone connected with the Company had any involvement whatsoever in this matter nor are they suspected of any wrongdoing.
For further information please contact:
|
Open Orphan plc |
+44 (0) 20 7756 1300 |
||
|
Yamin Khan, Chief Executive Officer |
|||
|
Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
||
|
Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
|||
|
|
|||
|
finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
||
|
Geoff Nash / James Thompson / Richard Chambers |
|||
|
|
|||
|
Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
||
|
Anthony Farrell |
|||
|
|
|||
|
Walbrook PR (Financial PR & IR) Stephanie Cuthbert / Phillip Marriage / |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0) 7796 794 663 / +44 (0) 7867 984 082 / |
||
Open Orphan #ORPH – Name Change – Interim Results & Trading Update
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces its intention to change its name to hVIVO plc, with the change expected to take effect on 26 October 2022.
The Board believes that the name change reflects the Company’s core human challenge and early clinical services business, where the hVIVO name has strong global brand recognition within the biopharma industry and beyond, as well as aligning the Company more closely with its long and established heritage.
The Company’s new ticker will be HVO as of 26 October 2022 and the website address (including the investor relations content and the information required by AIM Rule 26) will be available at www.hvivo.com
The Company’s ISIN (GB00B9275X97) and SEDOL (B9275X9) will remain the same.
Shareholders will be unaffected by the change of name and existing share certificates should be retained and will remain valid. Any new share certificates issued after the name change takes effect will bear the name hVIVO plc.
Financial highlights
· Revenue of £18.9m (H1 2021: £23.2m), with a strong order book for delivery in H2 2022
o Management reiterates full year revenue guidance of c. £50m, underpinned by robust trading in July and August and record contracted order book increased nearly threefold to c. £70m as at 30 June 2022 (H1 2021: £25m)
· EBITDA growth of c.10% to £2.3m (H1 2021: £2.1m) with significantly increased EBITDA margins of 12.1% (H1 2021: 8.9%)
· Cash generative with cash equivalents of £15.9m (H1 2021: £14.9m) as at 30 June 2022
Operational highlights
· Agreement with Vaxart Inc. to develop an Omicron COVID-19 human challenge model with the intent to conduct a subsequent Omicron human challenge study in 2023
· Commenced first full-service influenza challenge model programme for a top five global pharmaceutical client (£14.7m contract)
· Other significant contract wins include £7.3m influenza challenge trial signed with a European biotech, £7.2m respiratory syncytial virus (“RSV”) human challenge study with top five global pharma company and £5m RSV challenge trial signed with a European Biotech
· Modest investment in hVIVO’s facilities enabled the Group to significantly expand screening capacity:
o Doubled volunteer screening capacity to 1,000 per week
o Opened a new primary FluCamp volunteer recruitment facility in Whitechapel, increasing bed capacity by 44% from 43 beds to 62 beds
o Opened a new Manchester volunteer recruitment and screening centre
o hVIVO’s primary lab at QMB expanded and new satellite lab facilities were added in the new screening sites in Whitechapel (East London) and Manchester
· Broadened the scope of the business to offer Phase II / III field based studies
o First contract awarded by existing Big Pharma client to act as a vaccination site for a Phase II field study
· Launched a new Malaria human challenge model to offer anti-parasite challenge models
· Yamin ‘Mo’ Khan appointed Chief Executive Officer in February 2022, strengthening Executive Management Team and bringing significant CRO experience
· Martin Gouldstone appointed Independent Non-Executive Director, adding strong corporate development experience in the CRO, healthcare and pharmaceutical sectors
Post-period end highlights
· £10.4m contract for a new full-service challenge model development programme with an existing top 5 global pharmaceutical client
· £6.2m Influenza human challenge study contract with US biotechnology company Cocrystal Pharma Inc.
· hVIVO’s laboratory received College of American Pathologists (“CAP”) accreditation increasing its marketability to provide third party laboratory services
· Revenue for July and August of c.£9m with cash balance of c. £20m as at 1 September 2022
· As announced this morning, the Group intends to change its name to hVIVO plc, which it expects to take effect on the AIM market of the London Stock Exchange and the Euronext Growth Exchange on 26 October 2022
Current trading and outlook
As at 1 September 2022, Open Orphan’s order book of signed contracts has increased further to c. £80m, which is expected to be recognised across 2022, 2023 and 2024, and remains well capitalised with a cash balance of c.£20m.
Over the period, Open Orphan has further grown its pipeline of new opportunities, with a number of advanced negotiations ongoing with new and existing clients across the Group’s world leading portfolio of human challenge models. This growth is being driven by the Group’s competitive position as market leader coupled with the increasing demand for human challenge services in the rapidly expanding infectious and respiratory disease clinical trials market.
Management is committed to the long-term growth of the Group and is focused on strengthening its position as a partner of choice to the global biopharma industry, to which it counts four of the top 10 global biopharma companies as regular repeat clients. To further drive future growth, the Group has expanded and diversified its offering, and is currently adding new challenge models to its portfolio such as Omicron and a new influenza strain. In addition, hVIVO has expanded its screening facilities, adding new lab and clinical services. Furthermore, Venn has expanded its service offering into new areas including Advanced Therapy Medicinal Products services (ATMP) as it continues to deliver its services to a wider range of clients.
These developments, in addition to an exceptionally strong start to H2 2022, reaffirm the Board’s confidence of meeting current expectations for FY2022. The Group remains well positioned and well capitalised to deliver sustainable long-term profitability targeting double digit EBITDA profit margins of between 13-15%.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “I am pleased to report that the Group has leveraged the strong foundations laid in 2021, continuing its profitable momentum into 2022. Importantly, the Group achieved double digit EBITDA profit margins for the first time, a key goal for the business following the first full year of EBITDA profitability last year. In the second half, we expect revenues to grow considerably and profit margins to increase further as a number of significant contracts signed earlier in the year enter the clinic.
“Going forward, I am highly encouraged by the Group’s market-leading position, expanding addressable markets, and very substantial order book. With an order book of signed contracts worth c. £80m as at 1 September 2022, we have excellent forward visibility into H2 2022 and 2023, which gives us confidence in our ability to sustain our considerable organic growth over the long term. The Board expects to deliver full year revenues in line with guidance, and we look forward to the rest of 2022 and beyond with confidence.”
Investor presentation
Yamin ‘Mo’ Khan, Chief Executive Officer, and Leo Toole, Chief Financial Officer, will provide a live presentation relating to the interim results via the Investor Meet Company platform on 8 September 2022 at 18:00 BST.
The presentation is open to all existing and potential shareholders. Investors can sign up to Investor Meet Company for free and add to meet Open Orphan here.
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.
Poolbeg Pharma #POLB – Interim results for the six months to 30 June 2022
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 its unaudited interim results for the six months to 30 June 2022.
Financial & Operational Highlights
|
• |
Well capitalised with a strong cash balance of £18.9m as at 30 June 2022 |
|
|
• |
Significant progress made on developing POLB 001, a treatment for severe influenza |
|
|
– |
LPS human challenge trial commenced in July 2022 with initial results expected by year end 2022 |
|
|
– |
Supply Agreement signed and GMP manufacturing completed |
|
|
– |
Key US patent granted in May 2022 |
|
|
– |
Continuing to explore further disease indications beyond severe influenza |
|
|
• |
Two AI programmes commenced to analyse Poolbeg’s unique human challenge trial data |
|
|
– |
Agreement signed with OneThree Biotech Inc. in February 2022 to identify new drug targets and treatments for Respiratory Syncytial Virus (RSV). The programme is progressing well with the model build and optimisation completed in June 2022, with results expected by the end of 2022 |
|
|
– |
In March 2022 an agreement was signed with CytoReason Ltd. to identify novel drug targets for influenza. Data analysis is ongoing, and results are expected in Q2 2023 |
|
|
• |
Licensed first-in-class broad spectrum RNA-based immunotherapy (POLB 002) for respiratory virus infections from the University of Warwick in January 2022 |
|
|
– |
Key European and US patents granted in April and May 2022 respectively |
|
|
• |
Diligence completed on POLB 003, an intramuscular vaccine candidate to prevent Melioidosis from University College Dublin. Definitive license agreement being finalised following exclusive option agreement (signed in December 2021) |
|
|
• |
Licensed AnaBio Technologies’ micro- and nanoencapsulation technology to develop oral vaccines in January 2022 |
|
Investor presentation
Jeremy Skillington, PhD, Chief Executive Officer, will provide a live presentation via the Investor Meet Company platform on 6 September 2022 at 6:00pm.
The presentation is open to all existing and potential shareholders. Investors can sign up to Investor Meet Company for free and add to meet Poolbeg Pharma plc here. The presentation and recording will be available on the Company’s website after the event here.
Jeremy Skillington, PhD, CEO of Poolbeg Pharma said: “I am pleased with the progress that the team has made to advance and expand our portfolio of products and platforms, and we intend to build on and accelerate this rate of progress in the remainder of 2022 and beyond.
“Poolbeg is entering a very exciting phase in its development with a number of near-term value inflection points expected before year end. This includes the initial results from our LPS human challenge trial for our severe influenza treatment, POLB 001, after which we will seek to out-licence to pharma and biotech companies, generating revenues from upfront payment and downstream milestones and royalties. In addition, the outputs from our RSV and influenza Artificial Intelligence Programmes are expected by the end of 2022 and in Q2 2023 respectively.
“We have strong financial resources available to progress our products and platforms and also to capitalise on new opportunities as we identify them which, in addition to our upcoming value inflection points, gives me confidence that we can generate strong returns for shareholders.”
– Ends –
Enquiries
|
Poolbeg Pharma Plc Jeremy Skillington, CEO Ian O’Connell, CFO
|
+44 (0) 20 7183 1499 |
|
finnCap Ltd (Nominated Adviser & Joint Broker) Geoff Nash, James Thompson, Charlie Beeson, Richard Chambers, Sunila de Silva (ECM), Nigel Birks
|
+44 (0) 20 7220 0500 |
|
Singer Capital Markets (Joint Broker) Phil Davies, Sam Butcher
|
+44 (0) 20 7496 3000
|
|
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
|
About Poolbeg Pharma
Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a unique 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 pharma and biotech 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) which has commenced its LPS human challenge trial with initial results expected by year end 2022; a first-in-class, intranasally administered RNA-based immunotherapy for respiratory virus infections (POLB 002); and a vaccine candidate for Melioidosis (POLB 003). The Company is also developing an oral vaccine delivery platform and is progressing two artificial intelligence (AI) programmes to accelerate the power of its human challenge model data and biobank, with results from the first programme expected by year end 2022.
For more information, please go to www.poolbegpharma.com or follow us on Twitter and LinkedIn @PoolbegPharma.
Link here to view the full results and financial statements
Open Orphan #ORPH – Result of AGM
Open Orphan plc (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that all resolutions put to shareholders at the Company’s Annual General Meeting held earlier today were duly passed.
Open Orphan #ORPH – £7.2m RSV human challenge study contract
Open Orphan (AIM: ORPH), a rapidly growing specialist contract research organisation (CRO) and world leader in testing infectious and respiratory disease products using human challenge clinical trials, announces that hVIVO, a subsidiary of Open Orphan, has signed a £7.2m contract with an existing top 5 global pharmaceutical company to test its orally administered antiviral product, using hVIVO’s respiratory syncytial virus (“RSV”) Human Challenge Study Model.
The Phase 2a double-blinded placebo-controlled human challenge study will take place at the Company’s specialist quarantine facilities in Whitechapel and will evaluate the safety and efficacy profile of the antiviral against RSV. The study will commence in June 2022, with the revenue being recognised in 2022 and 2023. As part of the study, hVIVO will recruit healthy volunteersvia the Company’s dedicated volunteer recruitment arm, FluCamp.
The client’s antiviral is presently in Phase III clinical trials for another infectious disease indication and the client will use human challenge to assess the efficacy of their antiviral drug candidate against RSV quickly and efficiently, highlighting the value that human challenge studies can bring within the drug development process. The repeat business from this top 5 global pharmaceutical company underlines the Company’s world leading expertise and its ability to attract additional contracts from its existing Big Pharma clients.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan, said: “We’re delighted to be working with this top 5 global pharmaceutical client again to test their antiviral candidate using the hVIVO RSV Human Challenge Study Model. I am especially proud that our world-class offering and customer service has secured repeat business from another Big Pharma client, and that we are seen as the ‘go-to’ partner for an increasing number of global drug developers. The client’s drug has already been shown to be an effective antiviral in certain disease indications, and we’re pleased to now test its efficacy against RSV infection. RSV continues to be a serious global health threat causing an estimated 100,000 annual deaths in children under the age of five.”
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “This contract is a strong example of where human challenge studies can provide significant value. With a drug that has existing safety data and has been approved for one indication, human challenge studies can provide fast, cost-effective efficacy data within a new indication. The data will then indicate whether the candidate is viable for a wider Phase II study, providing substantial time and financial savings compared to traditional field-based studies.”
Interested in becoming a volunteer?
hVIVO recruits many of its volunteers for its challenge study clinical trials through its dedicated volunteer recruitment website, www.flucamp.com. By volunteering to take part in one of our studies in a safe, controlled, clinical environment under expertly supervised conditions you are playing your part to further medical research and help increase the understanding of respiratory illnesses.
Individuals interested in taking part in COVID-19 human challenge study research can learn more at www.UKCovidChallenge.com.
For further information please contact:
|
Open Orphan plc |
+353 (0) 1 644 0007 |
||
|
Yamin ‘Mo’ Khan, Chief Executive Officer |
|||
|
Liberum Capital (Nominated Adviser and Joint Broker) |
+44 (0) 20 3100 2000 |
||
|
Ben Cryer/ Edward Mansfield/ Phil Walker/ Will King |
|||
|
finnCap plc (Joint Broker) |
+44 (0) 20 7220 0500 |
||
|
Geoff Nash / James Thompson / Richard Chambers |
|||
|
Davy (Euronext Growth Adviser and Joint Broker) |
+353 (0) 1 679 6363 |
||
|
Anthony Farrell |
|||
|
Walbrook PR (Financial PR & IR) Paul McManus / Sam Allen / Louis Ashe-Jepson |
+44 (0)20 7933 8780 or openorphan@walbrookpr.com +44 (0)7980 541 893 / +44 (0) 7502 558 258 / |
||
Notes to Editors
Open Orphan plc (London and Euronext: ORPH) is a rapidly growing contract research company that is a world leader in testing infectious and respiratory disease products using human challenge clinical trials. The Company provides services to Big Pharma, biotech, and government/public health organisations.
The Company has a leading portfolio of human challenge study models for infectious and respiratory diseases and is developing a number of new models, such as malaria and COVID-19, to address the dramatic growth of the global infectious disease market. The Paris and Breda offices have over 25 years of experience providing drug development services such as biometry, data management, statistics CMC, PK and medical writing to third party clients as well as supporting the London-based challenge studies.
Open Orphan runs challenge studies in London from its Whitechapel quarantine clinic, its state-of-the-art QMB clinic with its highly specialised on-site virology and immunology laboratory, and its newly opened clinic in Plumbers Row. To recruit volunteers / patients for its studies, the Company leverages its unique clinical trial recruitment capacity via its FluCamp volunteer screening facilities in London and Manchester. The newly opened facilities have expanded the scope of the business to enable the offering of Phase I and Phase II vaccine field trials, PK studies, bridging studies, and patient trials as part of large international multi-centre studies.
Building upon its many years of challenge studies and virology research, the Company is developing an in-depth database of infectious disease progression data. Based on the Company’s Disease in Motion® platform, this unique dataset includes clinical, immunological, virological, and digital (wearable) biomarkers.
About RSV
RSV is the main cause of childhood lower respiratory infections and is responsible for a significant burden of disease in the elderly and in adults with chronic medical problems, such as COPD. Globally it affects an estimated 50-million people annually, leading to 4 million hospitalisations and an estimated 100,000 deaths in children under the age of 5 years. There is a lack of understanding and insight into RSV disease, especially in adult groups, despite its considerable impact on society and its high degree of infectivity.
Quoted Micro 13 June 2022
AQUIS STOCK EXCHANGE
Psych Capital (PSY) floated on Aquis so that it can take advantage of the opportunities in the fast-growing psychedelic medicines sector. Management is seeking to invest in early-stage companies, where it can obtain a significant minority stake. Psych Capital raised £810,000 at 5p a share. Pro forma net assets are £2m. Psych Capital has cash of £872,000 following the flotation. There is an investment in Awakn Life Sciences Corp that was valued at £584,563 at the end of June 2021. The share price is declining, and it has reached C$0.96, valuing the stake at around £260,000 at the current exchange rate. The share price fell to 4p on 9 June before recovering to 4.75p (3.5p/6p). There is limited liquidity in the shares with a free float of around 11%. Fellow Aquis company Oscillate (MUSH) holds a 16.15% shareholding in Psych Capital. Chris Akers has increased his stake in Oscillate from 9.02% to 11.4%. He also has a 4.96% stake in Psych Capital.
Capital for Colleagues (CFCP) improved interim revenues from £198,000 to £216,000, while recognised fair value gains declined from £1.04m to £297,000. There were 14 investments at the end of the period and net assets were 68.38p a share at the end of February 2022.
Rural Broadband Solutions (RBBS) had 2,851 monthly fee-paying clients by mid-May. There was net cash of £1.2m at the end of 2021 and infrastructure funding is being negotiated.
Newbury Racecourse (NYR) reopened its hotel in January and more than 105,000 racegoers have visited the racecourse so far this year. There have benefits from the catering deal with Compass and new media rights arrangement start at the beginning of 2024, which will benefit that financial year. More will be spent on prize money. Newbury is debt free, and a special dividend has been paid out of proceeds from the sale of land for housebuilding. Annual dividends may recommence next year.
Quantum technology investment company Quantum Exponential (QBIT) has made three investments at a total cost of £1.16m since it floated. There are discussions with more potential investments. There has been further progress towards setting up a fund. Anthony Lyall has been appointed as investment manager and Anna Spandl as investment analyst.
Altona Rare Earths (ANR) says that it is on track for a maiden JORC resource statement for the Monte Muambe rare earths project in Mozambique. Four new drilling targets have been identified.
Ananda Developments (ANA) had net liabilities of £288,000 at the end of January 2022. There should be further news concerning the purchase of the other 50% of DJT Plants.
Tectonic Gold (TTAU) expects to deploy drill rigs in Queensland in the next few weeks following the rainy season.
RentGuarantor Holdings (RGG) has raised £1m from a 6% unsecured loan note issue, with chief executive Paul Foy subscribing for 50% of the issue. The cash will be spent on hiring staff and marketing.
Wishbone Gold (WSBN) has commenced drilling at the Wishbone II gold copper project in Northern Queensland.
Chapel Down Group (CDGP) non-exec Jamie Brooke has bought 327,000 shares at 30.48p each. Jonathan Neame has sold 2,000 shares in Shepherd Neame (SHEP) at 806p each.
Oberon Investments has increased its stake in TruSpine Technologies (TSP) from 7.93% to 10.9%.
EPE Special Opportunities (ESO) had a NAV of 307.13p a share at the end of May 2022.
Former Aquis-quoted proton beam therapy provider Rutherford Health is being placed in liquidation. There are Rutherford Cancer Centres in Newport, Reading, Liverpool and Northumberland, plus a community diagnostics centre in Somerset. It is unclear whether there will be any buyers interested in these assets. Schroder UK Public Private Trust (SUPP) bought the remaining Woodford stake at the end of 2019. It was valued in the books at £22.8m, which will be written off. That will reduce NAV by 2p a share.
AIM
Like-for-like sales growth at City Pub Group (CPC) was 5% in May and 20% ahead over the Jubilee Bank Holiday. Management took a decision to minimise price rises so that food and drink is still relatively affordable. Two new sites have been opened with two more opening over the next few weeks.
Learning and development products and services provider Mind Gym (MIND) fell into loss in the year to March 2022. Revenues were 24% ahead at £48.7m with US revenues growing even faster. Repeat revenues from customers that have bought products and services in the past three years were 86% of the total. Overheads are higher as management anticipates future growth in demand. There were also £500,000 of non-recuring costs. The investment in digital products and services will pay off in future years when profit is expected to grow sharply.
Greater demand for foreign exchange helped Ramsdens (RFX) to move back into profit in the first half. Jewellery retail and precious metals buying also grew revenues significantly. There was modest growth in pawnbroking revenues although the growth in the loan book means that there will be a higher rate of increase in the second half. Overall revenues were £29.3m, up from £19.3m, and there was a pre-tax profit of £2.2m.
Nexus Infrastructure (NEXS) improved interim revenues from £63.7m to £80.3m and the order book is 7% higher at £306.7m. Civil engineer Tamdown’s revenues were more than one-quarter higher while utilities connections business TriConnect reported a small increase in revenues. The biggest increase came from the eSmart Networks business, but that is still less than 11% of group revenues. Nexus is on course to improve full year pre-tax profit from £2.5m to £5.7m.
Open Orphan (ORPH) has an order book worth £64.25m at the end of May 2022. Open Orphan secured a £14.7m contract for an influenza characterisation study and a follow-on human challenge study. The second half is expected to be stronger than the first and the clinical trials services provider should move into profit this year.
Electrical goods retailer Marks Electrical (MRK) reported its first full year results since flotation last November. In the year to March 2022, revenues increased 44% to £80.5m. Underlying earnings were 5.01p a share and the maiden final dividend is 0.67p a share. The company is gaining market share in the domestic appliance and televisions markets and revenues have grown by one-fifth in the first couple of months of this financial year. Brand recognition is improving, but the overall market is likely to be tough. Expanding the product range is helping growth.
Interims from Hercules Site Services (HERC) reflect a period of consolidation for the staffing business. In the six months to March 2022, revenues improved from £14m to £20m, while pre-tax profit slumped from £954,000 to £31,000. Overheads were £2m higher in anticipation of growth in the coming years. The large staff supply contract for HS2 started later in the reporting period and demand will continue to grow. More suction excavators are being delivered and utilisation rates are high.
Greenland-focused AEX Gold Inc (AEXG) has signed non-binding terms for the creation of a joint venture with ACAM that will hold the group’s strategic mineral assets. ACAM will invest £18m for a 49% stake and AEX Gold will inject the non-gold assets and cover site support, logistics and overhead costs. There is an agreement to inject a further £10m on a pro rata basis as long as certain milestones are achieved. AEX Gold’s core asset is the 100% interest in the Nalunaq project, which includes a former producing gold mine.
Plant-based polymers developer Itaconix (LSE: ITX) had already warned that due to destocking 2021 revenues would fall from $3.29m to $2.6m, which is still double the 2019 figure. Itaconix remains lossmaking, but revenues should be much higher in 2022 due to the increased number of products using its ingredients. Revenues are expected to jump back to $4.7m and the loss could halve to $1m.
Rockwood Strategic (RKW) has acquired a 8.75% stake in window ventilators and parts manufacturer Titon Holdings (TON).
Northbridge Industrial Services (NBI), which is set to change its name to Crestchic, says that trading at the core power reliability business is better than the recently upgraded expectations. Previously full year earnings of 12.1p a share were forecast and this was raised to 13.4p a share.
STM (STM) pre-tax profit halved to £1.2m in 2021 and it is expected to recover to £2.9m this year. This will be helped by the completion of investment in IT that brings the personal pension businesses onto one platform. A flow of new SIPP business is anticipated.
Coral Products (CRU) has announced a final dividend of 0.2p a share, taking the total for the year to 1.1p a share. At 17.5p, the yield is 6.3%.
Eve Sleep (EVE) is outperforming a market that has fallen by 29% in the UK in the first four months of 2022 and by 37% in France. More funding is required even though Eve Sleep and a US-based investor was interested in bidding for the mattress supplier. Talks have ended but management is considering its options.
MAIN MARKET
Citius Resources (CRES) has an initial agreement for the potential acquisition of AUC Mining, which has the Kamalenge gold project in Uganda. The proposed £2m cost would be paid in shares at 4.625p each. More cash would have to be raised at the same time. Trading in the shares was suspended at 3p.
Standard list shell GS Chain (GSC) shares have reached a new high of 6.55p, having risen steadily since flotation on 13 May via an introduction at 1p a share. Net assets were less than 0.18p a share, so the share price is at a substantial premium.
Premium listed Ross Group (RGP) shares jumped from 1.45p to 1.7p following a placing raising £163,000 at 1.79p a share, which is still a premium to the higher market price. The previous placing in October was at 2.8p a share. Ross Group is effectively a shell that has an investment in an aquaculture business and is trying to develop its supply chain management business.
Andrew Hore
