Home » Open Orphan (ORPH)
Category Archives: Open Orphan (ORPH)
#HVO hVIVO plc – Capital Markets Day
-The event was a success since many attendees went on a facilities tour following the event.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.
#ORPH Open Orphan plc – Positive in vitro results for FLU-v published
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 that positive data from a peer-reviewed study evaluating the in vitro efficacy of FLU-v, Imutex Limited’s (“Imutex”) broad spectrum influenza
vaccine, has been published in the scientific journal Vaccines.1
Previous clinical studies have demonstrated that FLU-v induced increased antibody and cellular responses in vivo. This placebo-controlled study evaluated the ability of FLU-v to induce cellular effector functions and cross-reactivity (both measures of the immune response, with cross-reactivity being particularly important for protection against multiple viral strains) of immune cells extracted from participants, following exposure to five different influenza strains.
The study found that measurements of IFN-γ and granzyme B production in stimulated immune cells from participants that had been previously vaccinated with either FLU-v or placebo, were significantly higher in the FLU-v group both when stimulated with vaccine antigen and also with antigens from a panel of seasonal and pandemic inactivated influenza A and B strains. These results further support the continued development of FLU-v as a broad-spectrum influenza vaccine.
FLU-v is owned by Imutex, a joint venture between hVIVO and PepTcell Limited (the legal name of SEEK Group), to develop vaccines against influenza and mosquito borne diseases such as Zika virus, malaria and other flaviviruses.
Seasonal influenza causes significant morbidity and mortality each year and a pandemic influenza continues to pose a worldwide threat. Influenza is a serious global health threat with an estimated 1 billion cases per year, 3-5 million severe cases and 290,000 – 650,000 deaths per year.
Dr Andrew Catchpole, Chief Scientific Officer of hVIVO, said: “It is encouraging to see further positive data for FLU-v, supporting its continued development as a broad-spectrum influenza vaccine. There is a large unmet need for a broad-spectrum vaccine to help battle emerging seasonal and pandemic influenza A and B viruses. Although FLU-v had already produced successful Phase II clinical data, this in vitro study is particularly important as it showed the ability of the candidate to induce an immune response against a diverse variety of influenza A and B strains.”
1. Oftung, F.; Næss, L.M.; Laake, I.; Stoloff, G.; Pleguezuelos, O. FLU-v, a Broad-Spectrum Influenza Vaccine, Induces Cross-Reactive Cellular Immune Responses in Humans Measured by Dual IFN-γ and Granzyme B ELISpot Assay. Vaccines 2022, 10, 1528. https://doi.org/10.3390/vaccines10091528
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 / |
||
#ORPH Open Orphan PLC – Director dealings
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 that it has received notification that on 29 September 2022, Yamin ‘Mo’ Khan, Chief Executive Officer of the Company, purchased 510,204 ordinary shares of 0.1 pence each in the capital of the Company (“Shares”) at a price of 9.8 pence per Share. Following the purchase of shares Mo holds 510,204 ordinary shares representing approximately 0.08 per cent of the Company’s issued ordinary capital.
Yamin ‘Mo’ Khan, Chief Executive Officer of Open Orphan plc, said: “The purchase of shares in the Company demonstrates both my commitment and my confidence in our long-term growth strategy. Since my appointment as CEO in February 2022, we have made significant progress, delivering continued growth and a record orderbook valued at c.£80m as of 1 September, which provides excellent forward visibility into H2 2022 and 2023.”
The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 (as implemented into English law) (“MAR”). With the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.
For further information please contact:
|
Open Orphan plc |
+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 – 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.
#ORPH Open Orphan PLC – CAP accreditation
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 its clinical laboratories in Queen Mary’s Bioenterprise Centre and Plumbers Row (hLab) have been awarded accreditation by the College of American Pathologists (“CAP”). The Company sought the accreditation as part of its ongoing commitment to maintaining best in class quality systems.
The CAP is the world’s largest organisation of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programmes. The accreditation “supports laboratories performing testing on specimens from human, using methodologies and clinical application within the expertise of the program”. This further expands on the Company’s Good Clinical Practice for Laboratories (GCLP) accreditation from the Medicines and Healthcare products Regulatory Agency (MHRA) and provides additional quality assurances of its laboratory services for its clients, especially within the United States, thus ensuring the accuracy of test results and conforming to the requirements from the US Food and Drug Administration (FDA).
hLab is a highly specialised virology and immunology laboratory, offering a suite of services to support both pre-clinical and clinical respiratory drug and vaccine discovery and development. This includes assay development, transfer and optimisation across immunology, molecular and cell-based assays, including extensive options in sample matrix and stability testing and analysis. hLab is well equipped with Biosafety Level 2 and 3 facilities to provide high quality data outputs to enable clients to achieve early proof of concept, or to make a breakthrough discovery in the pathology and possible treatment of diseases with unmet medical needs. hLAB now provides services beyond supporting the Company’s in-house human challenge trials, offering lab services as a standalone service to s upport vaccine and drug development from pre-clinical studies through Phases I – III clinical trials.
Brandon Londt, Development Operations Director, hLab Development at hVIVO, said : “We are proud to have received the CAP accreditation, which is recognition of the quality of our laboratory and further demonstrates our commitment to maintaining the highest standards of excellence and ensuring that our work practices meet the rigorous CAP assessment standards. This accreditation will provide current and future clients a further degree of confidence in the quality of work performed in our laboratory and assurances of the results we produce.”
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 / |