Shield Therapeutics : Preliminary results for the Year Ended 31 December 2020

Shield Therapeutics plc

("Shield" or the "Company" or the "Group")

Preliminary Results for the Year Ended 31 December 2020

London, UK, 29 April 2021: Shield Therapeutics plc (LSE: STX), a commercial stage pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru®/Accrufer® (ferric maltol), announces its preliminary results for the year ended 31 December 2020.

Operational highlights

• Feraccru® licensed to ASK Pharm in China
• AEGIS-H2Hre-analysis confirms Feraccru®/Accrufer® is a credible alternative to IV therapy for iron deficiency anaemia
• Teva withdraw all oppositions to Shield's European patents
• 2020 sales of Feraccru® packs increase by 70% in Germany and UK compared with 2019
• First stage of paediatric study conducted successfully

Financial highlights

• Revenues of £10.4 million (2019: £0.7 million)
• Loss for the year of £2.6 million (2019: £8.8 million)
• Net cash of £2.9 million (2019: £4.1 million)

Post-period highlights

• £29.2 million gross proceeds raised by means of placing, subscription and open offer
• Decision made for Shield to launch Accrufer® in US

Commenting on the preliminary results, Tim Watts, CEO of Shield Therapeutics plc, said: "The last fifteen months have presented a number of challenges, including the pandemic, and I am very proud of the way in which our employees have worked tirelessly to overcome the challenges and would like to thank them all for their contribution. However I believe Shield this period has been transformational for Shield and the Group is now well placed for substantial future growth. I am excited about the prospects for Accrufer®, which we remain on track to launch in the US by the end of June 2021, and we will update shareholders in mid-Mayas to our progress towards the US launch."

For further information, please contact:
Shield Therapeutics plc	[phone]
Tim Watts (CEO)
Hans-Peter Rudolf (CFO)
Peel Hunt LLP - Nominated Adviser & Joint Broker	[phone]
James Steel / Christopher Golden
finnCap Ltd - Joint Broker	[phone]
Geoff Nash / Alice Lane
Walbrook PR - Financial PR & IR Adviser	[phone]
Paul McManus / Lianne Cawthorne	or [e-mail]

About Shield

Shield is a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with its lead product Feraccru® /Accrufer® (ferric maltol), a novel, stable, non-salt based oral therapy for adults with iron deficiency with or without anaemia.

Shield's lead product, Feraccru®/Accrufer®, has been approved for use in the United States, European Union, UK and Switzerland and has exclusive IP rights until the mid-2030s. The Group plans to launch Accrufer® in the US during 2021 through a highly experienced sales and marketing team. Feraccru® is already being commercialised in the UK and European Union by Norgine B.V., who also have the marketing rights in Australia and New Zealand. Shield also has an exclusive licence agreement with Jiangsu Aosaikang Pharmaceutical Co., Ltd., for the development and commercialisation of Feraccru®/Accrufer® in China, Hong Kong, Macau and Taiwan.

For more information, please visit www.shieldtherapeutics.com. Follow Shield on Twitter @ShieldTx

Forward-Looking Statements

This press release contains forward-looking statements. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. These forward-looking statements are based on management's current expectations and include statements related to the commercial strategy for Feraccru®/ Accrufer® These statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties, many of which are beyond our control, that may cause actual results, performance or achievements to be materially different from management's expectations expressed or implied by the forward- looking statements, including, but not limited to, risks associated with, the Group's business and results of operations, competition and other market factors. The forward-looking statements made in this press release represent management's expectations as of the date of this press release, and except as required by law, the Group disclaims any obligation to update any forward-looking statements contained in this release, even if subsequent events cause our views to change.

Page 2 of 23

Chairman's statement

I was delighted and honoured to be appointed as Chairman of Shield when James Karis stepped down in June 2020 and I believe that 2020 has been a major turning point for the better in the Group's fortunes. I would like to thank James for his contribution to Shield between 2016 and 2020, first as a non-executive director and then Chairman.

2020 was not an easy year for anyone due to the pandemic and I would like to express my gratitude to Shield's employees for their hard work and perseverance during the several lockdowns and for making a success of working from home for most of the last twelve months. Fortunately our team was able to continue to move the business forward and Shield was not severely affected. I would also like to thank the Group's key business partners on which we depend for a wide range of services and support.

In the first half of 2020 we also faced the challenge of the anomalies that surfaced in March 2020 regarding the analysis of the data from the AEGIS-H2H clinical study that had previously been announced in 2019. This study compared Feraccru®/Accrufer®, an oral product, with intravenous iron therapy over a 52 week period and is an important pillar in supporting the rationale for the product. The team responded extremely well by conducting a full re-analysis of the data and I am very pleased that after several months we were able to demonstrate conclusively that Feraccru®/Accrufer® has the ideal attributes of convenience, efficacy and being well tolerated and is therefore a highly credible alternative to intravenous iron.

Probably the most significant activity during 2020, however, was the effort made to find a route to the US market for Accrufer®. Shield's commercialisation strategy since early 2018 has been to out-licence Feraccru®/Accrufer® to regional partners who are well placed to market the product. We have already established major partnerships with Norgine, covering most of Europe, Australia and New Zealand, and ASK Pharm for China, Taiwan, Hong Kong and Macau. In the US, Accrufer® was granted marketing approval for the treatment of iron deficiency in adults by the FDA in July 2019. We spent the rest of 2019 and much of 2020 looking for a US licence partner which would have been able to exploit the full value of Accrufer® across the range of disease areas where iron deficiency is prevalent. Ultimately, although we came close on two occasions to deals with potential partners that we believed would have been successful, we were not able to complete a satisfactory licence transaction. However over that time we came to realise that, provided that we could recruit a high calibre, experienced US commercial team and raise the necessary finance, Shield could launch Accrufer® itself and generate greater value for shareholders than a licence deal. As this was such a significant change in strategy we had multiple discussions with our two largest shareholders, W Health and AOP Orphan International AG ('AOP'), to ensure that we had their full support. I am very grateful to them for backing this change in strategy and for supporting the £29.2 million fundraise, including a significant financial investment by AOP, that completed during March 2021 and which provides the finance required for the Accrufer® launch. I am now looking forward confidently to the launch, expected towards the end of the second quarter of 2021.

As a result of these developments I believe that the prospects for Shield have been transformed. Instead of receiving a royalty stream, perhaps averaging 15%-20%, on a US partner's sales, we will now benefit from a high margin product whose sales could grow to $300 million to $400 million over the next five to six years and which is patent protected until 2035. I am also confident that Norgine and ASK Pharm will have great success with Feraccru®/Accrufer® over the next 15 years and that we will be able to out-licence the product in other parts of the world. All of this has the potential to generate very substantial returns for Shield's shareholders.

Finally, apart from James Karis, there have been two other board changes since the last Annual Report. In June 2020, Christian Schweiger joined the board as a non-executive director. Christian was a co-founder of Shield in 2008, and he brings great enthusiasm for Feraccru®/Accrufer® and medical expertise to the board. Rolf Hoffman, who has been a non-executive director and excellent chair of the Remuneration Committee since 2018, has decided not to seek re-election to the board at the 2021 AGM due to conflicting demands on his time from other appointments. I thank Rolf for his significant contribution to Shield and wish him every success in future.

Hans Peter Hasler, Non-Executive Chairman

Page 3 of 23

Chief Executive Officer's statement and financial review

Life in a small pharmaceutical or biotech company is rarely dull and my first full year as CEO proved to be no exception, but I believe that by the end of the 1st quarter of 2021 the Group is positioned for very substantial growth. There were three major challenges which confronted the business during 2020 and I am immensely proud of the way in which Shield's small team responded to them. The first and all-pervasive challenge has been the coronavirus pandemic which has meant working from home for the entire team for almost all of the last year with the difficulties that has brought, and the inability to travel to meet business partners and potential partners face- to-face. Second was the uncertainty that arose in March 2020 about the quality of the analysis of the AEGIS-H2H(head-to-head) study. The third major challenge was to find a path to commercialising Accrufer® in the US which would give the best outcome to shareholders. I am proud of the manner in which the Shield team rose to these challenges and overcame them, leaving the Group far better placed now than it was at the start of 2020. In addition we mounted a strong and robust defence to the challenges to two of our European patents lodged in 2019 by Teva which ultimately led to them withdrawing the challenges in October 2020, which is a tribute both to the quality of the patents and the work done by the Shield team in preparing our defence.

Commercialisation of Feraccru®/Accrufer®

United States

Shield's commercialisation strategy for Feraccru®/Accrufer® since early 2018 has been to out-licence the product to suitable alliance partners. This has been successfully achieved in Europe and China and, from mid-2019 to late- 2020, was the intention for the US market. Over that time we engaged in a major exercise to find a suitable US commercialisation out-licence partner and came close on two occasions to achieving a licence deal which we believe would have been satisfactory for our shareholders. Frustratingly on both occasions the counter-party pulled out at late stage for reasons unrelated to Accrufer®'s potential. We also had discussions during 2020 with many other companies that were very interested in Accrufer® but which were focused primarily on only one therapy area. However we were unable to identify any other company that we believed would successfully commercialise Accrufer® across the broad range of therapy areas where iron deficiency is prevalent to maximise the potential opportunity or, in cases where they might have been able to do so, that was willing to offer financial terms which would reward Shield's shareholders adequately. In the course of multiple discussions and negotiations we gained extensive insights into how other companies were contemplating the commercialisation of Accrufer® and, over time, this led us to the conclusion that with an experienced US commercial team Shield could realistically contemplate launching Accrufer® itself. An opportunity arose in November 2020 to recruit four US executives, headed by Brian Groch, with extensive experience of launching, selling and marketing pharmaceutical products in the US and who had already spent considerable time assessing Accrufer® while they had been employed by a company which had been contemplating licensing the product from Shield. This enabled us to consider more seriously the option of launching Accrufer® ourselves and consequently we announced in December 2020 that we were exploring this option whilst still reviewing ongoing out-licence possibilities. During December 2020, January and February 2021 we developed plans for a Shield-led launch of Accrufer® and investigated financing options to raise the $30 million to $40 million needed for the launch. The Board reached the conclusion in mid-February that we would be able to raise these funds through an equity placing and made the decision to go ahead with the fundraise and to launch Accrufer® ourselves in 2021.

I am very excited about the potential for Accrufer® in the US. The current market is already large with over 10 million prescriptions of oral iron therapy and around 2.3 million intravenous infusions annually, but there are clear drawbacks with the existing therapies and Accrufer® offers solutions by being convenient to take, effective in restoring and maintaining iron and haemoglobin levels, and well tolerated. We are building an excellent team in the US and are looking forward to the product launch, expected in June 2021.

Europe/Australia

Norgine BV is our licence partner for commercialisation of Feraccru® in most of Europe, Australia and New Zealand.

Page 4 of 23

2020 was clearly a difficult year for selling and marketing pharmaceuticals as the coronavirus pandemic had a severe impact on healthcare providers globally and led to massive re-prioritisation of doctors' areas of focus. Sales and marketing activities have inevitably been impacted but demand for Feraccru® has increased and there are signs that patients and their doctors are becoming more wary of being treated with intravenous iron which requires hospital visits. Despite the pandemic-related constraints, the number of Feraccru® packs sold in Germany and the UK increased by around 70% in 2020 compared with 2019.

Feraccru® was marketed by Norgine in Germany and the UK throughout 2020, and Norgine took over responsibility for marketing in Scandinavia from AOP in the autumn of 2020, and they launched the product in Belgium in January 2021. Norgine are using the updated AEGIS H2H detailed study results to reconfirm pricing and reimbursement strategy for Feraccru® in the major European markets of France, Italy and Spain.

In March 2021, the Australian Therapeutics Goods Administration (the local regulatory authority for medicinal products) registered Feraccru® in the Australian Register of Therapeutic Goods to treat iron deficiency with or without anaemia in adults.

China

We announced in January 2020 that we had entered into an exclusive licence agreement for Feraccru®/Accrufer® with Jiangsu Aosaikang Pharmaceutical Co. Ltd ("ASK Pharm") covering China, Hong Kong, Macau and Taiwan. We received an upfront payment of US$11.4 million when the agreement was signed. Based in Nanjing, Jiangsu Province, ASK Pharm was founded in 2003 and is listed on the Shenzhen stock exchange (XSEC:002755). ASK Pharm is an integrated pharmaceutical business that focuses on the GI and oncology therapeutic areas, being one of China's leading manufacturers of proton pump inhibitor and oncology medications. With a market capitalisation of approximately CNY12 billion (US$1.9 billion), 2019 sales revenues in China were equivalent to more than US$750 million and with over 900 sales representatives, ASK Pharm is well positioned to capitalise on the Feraccru®/Accrufer® opportunity in China, one of the world's largest and fastest growing prescription pharmaceutical markets.

Feraccru® is not yet approved in China but ASK Pharm has submitted an Investigational New Drug (IND) application for Feraccru® to the Chinese regulatory authority (CDE) which has indicated that, for the New Drug Application, it is likely to require only a short-term Phase III study in 120 Inflammatory Bowel Disease (IBD) patients and will not require a Phase III clinical study in Chronic Kidney Disease (CKD) patients. Clinical supplies have been manufactured and released for the study. The study could be completed by the end of 2022 and marketing approval and product launch could follow by late 2023. On approval, Shield is due to receive an $11.4 million milestone payment from ASK Pharm and tiered royalties of 10% or 15% depending on the level of net sales, and up to US$40 million in milestone payments upon the achievement of specified cumulative sales targets. ASK Pharm will be responsible for all clinical and regulatory costs and activities as well as all manufacturing and distribution costs of goods sold in the territory.

We were also pleased to learn during 2020 from the Chinese Patent Office that our composition of matter patent application was allowed providing IP protection until 2035.

Business development

Although the US was our commercialisation priority during 2020 we have continued to have discussions with potential partners in several other countries and are aiming to complete a new licence transaction in 2021.

AEGIS-H2H(Head-to-Head) study

The AEGIS-H2H(head-to-head) study, which was conducted between 2015 and 2019, was a non-inferiority study comparing oral Feraccru®/Accrufer® against intravenous (IV) iron therapy in 250 inflammatory bowel disease (IBD) patients with mild to severe iron deficiency anaemia (IDA) and baseline haemoglobin (Hb) measurements at the start of the study as low as 8.0g/dL. The study was intended and designed to provide data from which health

Page 5 of 23