Open Orphan PLC (ORPH.L) Demerger Update

Further to Open Orphan’s announcement on 14 June 2021 in relation to the distribution in specie, the boards of Open Orphan and Poolbeg Pharma are pleased to announce Poolbeg’s intention to seek admission of its shares to trading on AIM.

A market of the London Stock Exchange (“Admission”). Funds raised as part of Admission will be used primarily to fund the clinical trial costs associated with the development of the Company’s POLB 001 asset as a treatment for severe influenza and to acquire and develop new portfolio assets.

Wide asset portfolio

· Attractive lead asset – POLB 001:

o First-in-class, Phase II ready small molecule immunomodulator for severe influenza.

o Addresses unmet need for effective treatments against severe influenza (c. $800m addressable market)

o Applications beyond influenza are possible with label extensions (and the Company holds worldwide right s for all uses)

· Vaccine D iscovery P latform harnessing data from the human challenge model to potentially discover new vaccines which the Directors believe could generate significant shareholder value

· PredictViral™ Biomarker platform for predicting severe disease – potential to transform the way infectious diseases are treated

· Licensed access to one of the largest infectious disease progression data and bio banks i.e. Open Orphan’s data and biobank, with the potential to interrogate the data with an AI data analysis platform (advanced discussions underway) to accelerate the identification of drug targets / products

· Pipeline of further assets for acquisition post-IPO

Infectious Disease Market

· Market expected to exceed $250bn by 2025

· Cumulative costs of the COVID-19 pandemic in terms of lost output & health reduction is equivalent to 90% of US GDP ($16tn)

· Significant recent M&A and licensing activity in the infectious disease space

Capital light business model

· Enables the Company to develop assets to Phase II quickly with relatively modest investment where they can potentially be monetised / licensed to big pharmaceutical companies

· Platform for growth with a proven, streamlined method of identifying drugs to acquire / license, access to key data to drive that platform and well protected intellectual property

· Faster and more cost-effective development model than traditional biotech’s giving potential for multiple value inflection points as each asset is advanced through the pipeline with a view to ultimate monetisation / licensing to big pharmaceutical companies

· Intend to use c ontingent payments to fund asset acquisitions therefore minimising / eliminating potential equity dilution

Track Record

· Strong heritage – initial assets from Open Orphan, a well-established, revenue generating business with over 20 years’ experience in infectious diseases and human challenge trials

· Track record of delivery and creating value for shareholders – management team has completed three IPOs, built revenue generating businesses and achieved significant exits

Poolbeg IPO

· Signal of quality to prospective partners and customers, raising the profile of the business

· Provides a supportive platform on which to accelerate existing assets through development

· Funds raised will allow the Company to acquire / license additional assets and technologies as appropriate

· A portion of the Placing is expected to qualify for EIS and VCT related tax relief in addition to an expected retail offering via PrimaryBid

· Cathal Friel, Non-Executive Chairman of Poolbeg has committed to participate in the IPO alongside incoming investors on the same terms

Jeremy Skillington, PhD, CEO of Poolbeg Pharma said:

“The COVID-19 pandemic has placed the issue of infectious diseases firmly in the public eye; Governments and international organisations are now investing heavily to ensure they are better prepared.

“Poolbeg Pharma is aiming to carve out a leading position in this rapidly evolving and expanding sector. We have an excellent heritage in infectious diseases and a management team with a track record of delivering value creation.

“Our capital light business model is an important differentiator. Through deep biological analysis of disease progression, we believe that it should enable us to reposition existing drug candidates and develop assets to Phase II stage quickly with relatively modest investment where they can then potentially be acquired / licensed to big pharmaceutical companies. We aim to be customer-led and will use our extensive network to become a ‘one stop shop’ for big pharma, developing the assets that they need.”

Cathal Friel, Executive Chairman of Open Orphan and Non-Executive Chairman of Poolbeg Pharma commented:

“Poolbeg Pharma is a great opportunity to maximise the potential of some of Open Orphan’s pharma assets which are non-core to our successful human challenge clinical trial business in a focused and capital efficient way.

“Poolbeg’s approach to asset development should result in good licensing opportunities and excellent returns in a relatively short period of time with substantially less risk than the traditional biotech model and allow for regular investor newsflow . In addition, in Poolbeg we have assembled a leading management team, generated an exciting pipeline of potential acquisitions and entered advanced discussions with leading AI data analysis platforms to increase the attractiveness of the Company and its offering. Thus, I am confident and excited in the Company’s prospects going forward and will be personally investing alongside incoming investors as part of the potential IPO.

“We are extremely proud that this is now the third life science IPO from the Raglan Capital stable after Amryt Pharma plc and Open Orphan plc, and we are excited to have Jeremy Skillington joining as CEO, bringing his valuable experience and successful track record with Inflazome to the team.”

Notes to Editors

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

Open Orphan runs challenge studies in London from both its 19-bedroom Whitechapel quarantine clinic, opened in February 2021, and its 24-bedroom QMB clinic which also has a highly specialised virology and immunology laboratory on-site. Open Orphan has a leading portfolio of eight human challenge study models for conditions such as RSV, flu, asthma and COPD. In addition, Open Orphan is also developing the world’s first COVID-19 human challenge study model as part of the Human Challenge Programme and has signed a reservation contract with the UK Government for the first three COVID-19 vaccine challenge 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. The Disease in Motion platform has many potential applications across a wide variety of end users including big technology, wearables, pharma and biotech companies. Following COVID-19 there is now a renewed interest and investment in infectious diseases.

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

About Poolbeg Pharma

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a capital light clinical model which the Directors believe enables it to develop multiple products faster and more cost effectively than the traditional biotech model. Poolbeg has aspirations to become the “one-stop shop” for B ig P harma seeking mid-stage products to license or acquire .

Poolbeg is targeting the growing infectious disease market. In the wake of the COVID-19 pandemic, infectious disease has become one of the fastest growing and exciting markets with expected market value of $250bn by 2025. Poolbeg is led by a team who have a track record of creating shareholder value, creating c. $1bn in shareholder value between them.

With its initial assets from Open Orphan plc and headquartered in London, Poolbeg is led by a team with proven capabilities in identifying, acquiring and accelerating assets through development to commercialisation. With access to knowledge, experience and clinical data from over 20 years of Influenza, RSV, HRV and SARS-CoV-2 human challenge trials, Poolbeg is using these insights to acquire new assets as well as reposition clinical stage products, reducing spend and risk. It already has a Phase II ready repositioned small molecule immunomodulator for severe influenza and a portfolio of other exciting assets . The Company plans to broaden th is portfolio further in the next 12 months and is in active discussions with AI data analysis platforms to help accelerate the power of its data and biobank .

Potential risks

Potential risks include execution risk; economic risk; IP risk; regulatory risk; clinical trial risk. Before subscribing for or purchasing any shares in the Company, persons viewing this announcement should ensure that they fully understand and accept all risks which will be set out in the Admission Document if published.

Directors

Cathal Friel, aged 56 – Non-Executive Chairman

Cathal is a successful entrepreneur, starting work at 16 years due to his father’s untimely illness he went on to complete his education at night classes and got an MBA from the University of Ulster in 1990. He spent the following five years lecturing part time in International Marketing and Business Planning at the University of Ulster, while running his own new technology services business. In 2001 he was part of the team who successfully established Merrion Stockbrokers in Dublin and in 2007 he founded Raglan Capital.

Cathal is the Executive Chairman and Co-Founder of Open Orphan which IPO’d on the London and Dublin stock exchanges in June 2019. He also co-founded Amryt Pharma plc in 2015 along with Joe Wiley, which is listed on the London stock exchange since 2016 and which listed on Nasdaq in July 2020.

Prior to Amryt, Cathal founded Fastnet Oil & Gas plc in 2011 which he IPO’d on the London stock exchange. Cathal was a finalist in the International category as part of the EY Entrepreneur of the Year 2020.

Jeremy Skillington, PhD, aged 50 – Chief Executive Officer

Jeremy began his biotechnology career in the Business Development group of Genentech, Inc in California in 2002. At Genentech he was responsible for executing over 40 licensing, investment and collaboration transactions. Returning to Ireland in 2009, he then led Business Development and was a member of the Senior Management team at Opsona Therapeutics Ltd before becoming a founder and CEO of immuno-oncology company TriMod Therapeutics Ltd.

He joined German investment fund HS Lifesciences GmbH in 2014 to provide start-up and business development support to portfolio companies ImmunoQure AG and Ethris GmbH. He joined Inflazome on its founding in 2016 and was instrumental in their acquisition by Roche in September, 2020 for €380M (£325M) upfront and significant downstream milestone payments.

Jeremy studied Biochemistry at the National University of Ireland, Galway where he was awarded his Ph.D. He performed his post-doctoral research at the University of California, San Francisco in the lab of Prof Rik Derynck.

Ian O’Connell, aged 33 – Chief Financial Officer

Ian is an experienced financial professional with a depth of healthcare and public markets experience. He co-founded Open Orphan plc, was made a Board Observer and as VP Corporate Development led the acquisition of hVIVO & the RTO of Venn Life Sciences.

As a member of the core senior management team, he helped drive the company to its position today as a world leader in testing of vaccines and antivirals using human challenge studies. He also worked closely with Cathal Friel and Amryt’s senior management on the establishment of Amryt Pharma plc. Ian has corporate finance experience at both Raglan Capital and Deloitte Corporate Finance.

Ian is a Member of Chartered Accountants Ireland

Patrick Ashe, aged 58 – Independent Non-Executive Director

Patrick Ashe has a career spanning 30 years as a business executive and entrepreneur in the pharmaceutical and biotechnology industry. He spent 16 years with Elan Corporation plc and served as Vice President of Business Development in its US division from 1994 – 2001. He was subsequently a co-founder and led the business and corporate development functions of specialty pharma companies Athpharma (2001-2004) and AGI Therapeutics plc (2004 – 2011), and the orphan disease company Vidara Therapeutics (2011 – 2014). Following the sale of Vidara to Horizon Therapeutics plc in 2014, Patrick became Senior Vice President of Business Development of Horizon, a role he held until his retirement in 2016. Patrick has served as a board director for a number of private and public companies.

Patrick holds a BSc (Hon) in Pharmacology from University College Dublin and an MBA from Dublin City University Business School.

Eddie Gibson, aged 47, Independent Non-Executive Director

Eddie has over 20 years of experience within the pharmaceutical industry working across multiple geographies and senior roles. Eddie is a Managing Director at Wickenstones Ltd, a global pharmaceutical strategy consultancy, focussing on market access and associated technical disciplines. Eddie currently holds Non-Executive Director positions at O-innovations Ltd, supporting the development and commercialisation of its innovative renewable technologies, and Nanovery Ltd, where he supports the development of molecular diagnostics.

Previously, Eddie was a senior director at Aveo Oncology, where he was responsible for new product strategy and European commercialisation. Eddie also spent 9 years at Bristol-Myers Squibb, providing general management and brand leadership through various roles. He is also a Global Pharma Key Opinion Leader at the Korean Health Industry Development Institute. Eddie holds a BSc (Hon) in Chemistry from the University of Bristol and a PhD in Biochemistry from the University of Oxford. He has completed the CEDEP management course and has been a member of the International Society of Pharmacoeconomics and Outcomes Research since 2013.

Prof. Luke O’Neill, aged 57, Independent Non-Executive Director

Luke O’Neill is a world-renowned immunologist and Chair of Biochemistry in the School of Biochemistry and Immunology at Trinity College Dublin. His research focuses on the molecular basis of inflammatory diseases. Luke is also Fellow at the Royal Society & Royal Irish Academy Gold Medal for Life Science.

Luke O’Neill co-founded Inflazome in 2016, a pioneering inflammasome company which developed orally available inhibitors to address clinical unmet needs across a variety of inflammatory diseases. Inflazome was acquired by Roche for €380m in 2020.

Luke was the recipient of the Science Communicator of the Year Award in 2020, and has made contributions regarding Covid-19 to Sky News, The Washington Post, Channel 4, Euronews and the Wall Street Journal.

Scientific Advisory Board

Elaine Sullivan, Scientific Advisor

Elaine Sullivan is CEO of Curadh Pharmaceuticals, a Non-Executive Director at Open Orphan, IP Group plc and Active Biotech AB and is a member of the Supervisory Board at Evotec AG which is listed on the Frankfurt Stock Exchange. She has over 25 years of international experience working in the pharmaceutical and biotech industry. Elaine has worked as part of the most senior management teams in R&D at Eli Lilly and AstraZeneca. She served as Vice President Global External Research and Development at Eli Lilly & Company, Inc., Indianapolis, USA, where she led a global workforce delivering access to business critical external innovation. She was a member of the investment committees of Lilly Ventures and Lilly Asian Ventures and the steering committees of Lilly’s Capital Fund partners.

Prior to joining Eli Lilly, Dr Sullivan held various positions in the area of drug discovery and development at AstraZeneca including Vice President R&D, New Opportunities. In this role, she led AstraZeneca’s virtual therapy disease function which pinpointed new disease areas and created new therapeutic applications for multiple molecular entities and advanced them into the clinic. She also held the role of Vice-President, Science & Technology with the focus on acquiring new technologies which led to decreased attrition of compounds failing for toxicity and efficacy reasons in the clinic. During her career, she gained extensive knowledge of various aspects of drug discovery and development having developed new molecules in virology, cancer and ophthalmology. She co-founded Carrick Therapeutics, a European oncology company which has raised €100 million. She has successfully delivered over 250 collaborations and transactions including spinouts, joint ventures, strategic partnerships and acquisitions.

Dr Sullivan holds a doctorate in Molecular Biology and Virology from the University of Edinburgh, UK, and a bachelor’s degree in Molecular Biology from the University of Glasgow, UK.

Prof. Luke O’Neill, Scientific Advisor

As above.

IMPORTANT NOTICES

THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN, IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR THE REPUBLIC OF SOUTH AFRICA OR ANY JURISDICTION IN WHICH THE SAME WOULD BE UNLAWFUL.

The information contained in this announcement is for background purposes only and does not purport to be full or complete. No reliance may be placed by any person for any purpose on the information contained in this announcement or its accuracy, fairness or completeness.

Any shares referred to herein may not be offered or sold in the United States unless registered under the United States Securities Act of 1933 (“Securities Act”) except pursuant to a transaction exempt from, or not subject to, the registration requirements of the Securities Act. The possible offer and sale of shares referred to herein has not been and will not be registered under the Securities Act or under the applicable securities laws of Australia, Canada, Japan or South Africa. Subject to certain exceptions, the shares referred to herein may not be offered or sold in Australia, Canada, Japan or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or Japan. There will be no public offer of the Shares in Australia, Canada, Japan, the United States or elsewhere.

This announcement may include statements that are, or may be deemed to be, “forward-looking statements”. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “plans”, “projects”, “anticipates”, “expects”, “intends”, “may”, “will” or “should” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These statements reflect beliefs of the Directors (including based on their expectations arising from pursuit of the Company’s strategy) as well as assumptions made by the Directors and information currently available to the Group. Although the Directors consider that these beliefs and assumptions are reasonable, by their nature, forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause the Company’s actual financial condition, results of operations, cash flows, liquidity or prospects to be materially different from any future such metric expressed or implied by such statements. Past performance cannot be relied upon as a guide to future performance and should not be taken as a representation that trends or activities underlying past performance will continue in the future. Forward-looking statements speak only as of the date they are made. No representation is made or will be made that any forward-looking statements will come to pass or prove to be correct.

Any subscription or purchase of shares should be made solely on the basis of information contained in the Admission Document which may be issued by the Company. The information in this announcement is subject to change. Before subscribing for or purchasing any shares, persons viewing this announcement should ensure that they fully understand and accept the risks which will be set out in the Admission Document if published. No reliance may be placed for any purpose on the information contained in this announcement or its accuracy or completeness.

The Company may decide not to go ahead with Admission and there is therefore no guarantee that Admission will occur. You should not base any financial decision on this announcement. Acquiring investments to which this announcement relates may expose an investor to a significant risk of losing all of the amount invested.

Persons considering making investments should consult an authorised person specialising in advising on such investments. The value of shares can decrease as well as increase. Potential investors should consult a professional advisor as to the suitability of any investment for the person concerned. Nothing contained herein constitutes or should be construed as investment, tax, financial, accounting or legal advice or a representation that any investment or strategy is suitable or appropriate to your individual circumstances.

For the avoidance of doubt, the contents of the Company’s website are not incorporated by reference into, and does not form part of, this announcement.

Neither finnCap Limited, Arden Partners Plc or J & E Davy or any of their respective affiliates or any of their or their affiliates’ directors, officers, employees, advisers or agents accepts any responsibility or liability whatsoever for/or makes any representation or warranty, express or implied, as to the truth, accuracy or completeness of the information in this announcement (or whether any information has been omitted from the announcement) or any other information relating to the Company, whether written, oral or in a visual or electronic form, and howsoever transmitted or made available or for any loss howsoever arising from any use of the announcement or its contents or otherwise arising in connection therewith.


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