Hemogenyx Pharmaceuticals PLC Announces Final Results

Final Results for the Year Ended 31 December 2019

LONDON, UK / ACCESSWIRE / April 30, 2020 / Hemogenyx Pharmaceuticals plc (LSE:HEMO) (“Hemogenyx” or the “Company”), the biopharmaceutical group developing new therapies and treatments for deadly blood diseases, announces its results for the year ended 31 December 2019.

Key Highlights

• CDX antibody demonstrated to be effective against Acute Myeloid Leukemia (“AML”) and as a Conditioning Therapeutic in vivo
• CDX antibody effective against Acute Lymphoblastic Leukemia (“ALL”) in vitro
• Development of a new generation of the Company’s humanised mice that is being used as a model for several diseases
• Continued development of CDX with a global pharmaceutical company involving manufacturability assessment and follow-up tests of the antibody

Post-Period End Highlights

• Hemogenyx to use its advanced humanised mice to develop potential treatments for COVID-19 and other emerging pathogens
• New CAR-T product candidate HEMO-CAR-T cells demonstrated to be effective against AML in vivo
• Approval of patents for Hu-PHEC (Human Post-natal Hemogenic Endothelial Cells) in both the US and Europe
• Placing and Subscription in January 2020 raised approximately £650,000

Dr Vladislav Sandler, CEO of Hemogenyx, said:

“2019 was an exceptionally productive year for Hemogenyx, both scientifically and commercially. Not only did we achieve significant progress on our existing product candidates, we were also able to leverage our proprietary technologies and expertise to further broaden and diversify our product pipeline. Our humanised mice have proven to be an immensely useful tool and have allowed the Company to enter new areas of drug development, including for autoimmune diseases and diseases caused by viral infections, in particular COVID-19.”

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this news release contain forward-looking information. These statements address future events and conditions and, as such, involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the statements. Such factors include without limitation the completion of planned expenditures, the ability to complete exploration programs on schedule and the success of exploration programs. Readers are cautioned not to place undue reliance on the forward-looking information, which speak only as of the date of this news release.

Market Abuse Regulation (MAR) Disclosure

Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 until the release of this announcement.

Enquiries:

Hemogenyx Pharmaceuticals plc	https://hemogenyx.com
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder	headquarters@hemogenyx.com
Peter Redmond, Director
SP Angel Corporate Finance LLP	Tel: +44 (0)20 3470 0470
Matthew Johnson, Vadim Alexandre, Soltan Tagiev
Peterhouse Capital Limited	Tel: +44 (0)20 7469 0930
Lucy Williams, Duncan Vasey, Charles Goodfellow
US Media enquiries	Tel: +1 (323) 646-3249
Lowell Goodman	lowell@corbomitecomms.com

About Hemogenyx Pharmaceuticals plc

Hemogenyx Pharmaceuticals plc (“Hemogenyx”) is a publicly traded company (LSE: HEMO) headquartered in London, with its wholly-owned US operating subsidiaries, Hemogenyx LLC and Immugenyx LLC, located at its state-of-the-art research facility in New York City and a wholly-owned Belgian subsidiary, Hemogenyx-Cell SPRL, located in Liège.

Hemogenyx is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx is developing several distinct and complementary product candidates, as well as a platform technology that it uses as an engine for novel product development.

For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. The risks of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is restricted to use only as a last resort. Hemogenyx’s technology has the potential to enable many more patients suffering from devastating blood diseases such as leukemia and lymphoma, as well as severe autoimmune diseases such as multiple sclerosis, aplastic anemia and systemic lupus erythematosus (Lupus), to benefit from bone marrow transplantation.

Chairman’s Statement

I am very pleased to report a highly productive period of scientific and commercial progress in the year ended 31 December 2019. It has been a remarkable year for Hemogenyx in many respects, with strong progress on several fronts.

Our lead product, the CDX bi-specific antibody, was originally designed to provide a safer way to condition patients suffering from blood diseases for bone marrow transplants. As shareholders will be aware, however, the CDX bi-specific antibody has been found to have wider potential applications, including the treatment itself of blood diseases, in particular acute myeloid leukaemia (AML), the most dangerous form of leukaemia. Working with a major global pharmaceutical group, we have made considerable progress in the development of the antibody. We have also developed a new product candidate based on CAR-T, further diversifying and de-risking our product portfolio. This product is designed to be used in the treatment of AML and other blood diseases, as well as in transplant conditioning. Together with these new scientific breakthroughs, we have also been working to take our Hu-PHEC cell therapy product candidate forward.

At the same time, we have made significant advances in the use of our advanced humanised mice. We originally developed these mice as a tool to test our CDX antibodies. As shareholders will know, however, these mice have proved to be of value in their own right. Their exceptional properties are now being used in a number of applications in collaboration with major pharmaceutical companies, such as the continuing work with Johnson & Johnson in relation to Lupus.

As a result of our use of the mice to model Lupus, we made further discoveries about their properties. These findings led us to understand that our mice can be used to model an even wider range of autoimmune diseases, as well as to develop treatments for diseases caused by viral infections. In 2019, we began our efforts to leverage our mouse technology for these purposes, and in view of the recent crisis arising from the COVID-19 pandemic we have now initiated work in a number of areas related to COVID-19, as we recently announced.

Our remarkable progress in all of these areas has been accomplished on budget and with the assistance of our major biopharmaceutical collaborators, our strong and highly qualified advisory board, and not least by our exceptional team of in-house scientists.

I propose to go into more detail about the various components of our product pipeline below.

Background

Hemogenyx is developing two primary sets of products for the multi-billion¹ bone marrow/hematopoietic stem cell transplant market. They are:

• A set of treatments for blood malignancies that includes CDX bi-specific antibody and CAR-T therapy. Both CDX and CAR-T are product candidates that could eliminate relapsed and/or refractory (“R/R”) acute myeloid leukaemia (“AML”), acute lymphoblastic leukaemia (“ALL”), and myelodysplastic syndrome (“MDS”) – forms of blood cancer – as well as certain other blood malignancies, and replace chemotherapy and radiation as a means of pre-transplant conditioning.
• A cell therapy group of products – cell therapies that address the problem of blood stem cell donor availability and issues around relapse or cell rejection after transplantation. These products use Human Postnatal Hemogenic Endothelial Cells (“Hu-PHECs”) as a source of generating cancer-free, patient-matched blood stem cells for transplantation into the patient.

The products address a large and growing need and will be sold into a market that is already substantial. If successfully commercialised, Hemogenyx’s products could enable a much wider range of patients to be treated than is presently the case as the products should be applicable to patients who are unfit for or, through the lack of suitable cell donors, unable to receive blood stem cell transplants at present.

Additionally, the Advanced Hematopoietic Chimera (“AHC”), the Company’s proprietary humanised mouse model originally developed to improve the testing of the Company’s own products in vivo, is generating wide interest across the bio-pharmaceutical industry as a platform for disease modelling and drug discovery, particularly its newly developed form, the Advanced peripheral blood Hematopoietic Chimera (“ApbHC”) which may also have a vital role to play in the rapid development and/or isolation of human antibodies against previously unknown pathogens such as the novel coronavirus, more broadly refred to as bioprotection/biodefence applications.

I would like to take this opportunity to summarise the substantial progress made during 2019. A number of advances have been made in several strategic areas, continuing to strengthen the Company’s intellectual property, portfolio of product candidates and commercial prospects.

CDX Antibodies

The Company made advances in 2019 with research into the use of its CDX antibody as a potential treatment for subsets of AML, ALL and MDS. The antibody was shown to be effective in animal studies against AML-derived cells using the Company’s proprietary humanised mice, following successful test tube studies of the ability of CDX to target and eliminate ALL cells. These potential additional applications of the CDX product candidate could provide life-saving treatments against several forms of blood cancer which remain resistant to current modes of treatment. The use of CDX as a therapy against blood malignancies is beyond the application of CDX purely as a conditioning product for bone marrow transplantation anticipated when the Company listed in 2017.

In July 2019, the Company filed a new patent application for CDX in relation to conditioning patients for bone marrow transplantation and treatments for blood cancers such as AML and ALL. An additional composition of matter patent application is expected to be filed upon the completion of the current development agreement with a global international pharmaceutical company (“GlobalCo”; the identity of GlobalCo must remain confidential at its request). The Company therefore continues to strengthen its intellectual property portfolio and protections.

The work with GlobalCo on the Company’s CDX antibody as a clinical candidate, first announced on 14 May 2018, entered its final phase in 2019. The Company and GlobalCo continue to develop CDX towards clinical readiness. GlobalCo has progressed manufacturability assessment and follow-up tests of the antibody. Hemogenyx and GlobalCo remain optimistic as to the outcome of these tests based on results to date.

The collaboration agreement, originally scheduled to complete in late April 2020, is being extended by a short period due to the impact on GlobalCo’s operations of the novel coronavirus, following which Hemogenyx will either license the antibody to GlobalCo or will in-license GlobalCo’s improvements to it on favourable terms.

In the latter part of 2018 and through 2019, the Company set to work with its monoclonal antibodies to develop a Chimeric Antigen Receptor T-cell (“CAR-T”) product candidate as an alternative potential treatment for blood disorders. The initial laboratory results announced in January and February 2020 are described in the subsequent events section below.

Humanised Mice

Immugenyx, LLC (“Immugenyx”), the Company’s wholly owned subsidiary, developed a further improved version of its humanised mice, termed the Advanced peripheral blood Hematopoietic Chimera (“ApbHC”) that presents several advantages over other mouse models. The ApbHC was initially developed as a research and development tool for the investigation of mature blood cell populations such as human T-cells, B-cells and antibody-producing plasma cells. A major advantage of the ApbHC is the absence of Graft versus Host Disease (“GvHD”), a disease that complicates and often renders impossible the efficient use of peripheral blood mononuclear cells in transplanted mice, shortening their lifespan and suitability for testing.

The ApbHC has a broad range of applications. Hemogenyx has demonstrated that the ApbHC can potentially be used for testing multi-specific antibodies, including its own bi-specific CDX antibody for the elimination of AML and the conditioning of patients for bone marrow transplantation. ApbHC may also be used for the development and testing of new cell therapies involving immune cell reprogramming, such as CAR-T. Immugenyx has further demonstrated that the ApbHC can potentially be used for the modelling of autoimmune diseases, such as Systemic Lupus Erythematosus (aka Lupus), with a goal of developing fundamentally new treatments for those diseases. The Directors also believe that the ApbHC could potentially be used as a tool for the rapid development and/or isolation of human antibodies against previously unknown viruses such as the novel coronavirus or other natural or engineered human-specific pathogens, referred to in biodefence circles as “Disease X”.

As with the original Advanced Hematopoietic Chimera, the Company believes that the ApbHC will be of considerable interest to other drug developers and interest shown to date is promising.

Immugenyx entered into a research agreement with the above-mentioned GlobalCo to develop the ApbHC as a tool for drug development and testing, as announced on 23 October 2019. If the first phase of research produces successful results, Hemogenyx anticipates that further research will be commissioned, as has been the case with other trials using the Company’s humanised mice. According to the agreement, Immugenyx will grant to GlobalCo a worldwide, non-exclusive, royalty-free licence to any know-how and any patent(s) and patent application(s) arising from the agreement to use solely for its own research and product development purposes. Immugenyx will also grant to GlobalCo an option to an exclusive licence of any patents or patent applications arising from the Agreement. The terms of the exclusive licence will be negotiated in good faith and on reasonable commercial terms at the time GlobalCo exercises its option.

Immugenyx has already completed or entered into humanised mouse related projects with a number of other large pharmaceutical companies, including the previously announced agreement with Janssen Research & Development, LLC (“Janssen”), to build a model of human systemic lupus erythematosus (“SLE”, also known as Lupus), an autoimmune disease. The Company is developing independently a cell-based approach to treat Lupus. In parallel, it is engaged in seeking novel druggable targets using its proprietary discovery platform that combines an AHC-based human Lupus model and single cell sequencing.

These agreements confirm the value of the new type of humanised mice within the pharmaceutical community and give the Company an immediate revenue stream which the Company believes can be developed and promoted considerably more widely.

Hu-PHEC Stem Cell Therapy

The Company reviewed and extended its licence agreement with Cornell University, the patent-holder of the Hu-PHEC technology posited and discovered by Hemogenyx’s Co-Founder and CEO Dr Vladislav Sandler while working at Cornell. The restated agreement confirms Hemogenyx’s exclusive, worldwide sub-licensable licence to the patent.

Hemogenyx-Cell SPRL (“Hemogenyx-Cell”) is the Company’s wholly owned subsidiary, established in Belgium in April 2019 to develop Hu-PHEC for the direct treatment of leukaemia and other blood diseases. Hemogenyx-Cell has been considering plans with a number of potential Belgian-based partners, including Orgenesis, Inc. – the provider of funding to Hemogenyx-Cell and also to Immugenyx in a separate agreement through convertible loans – regarding key building blocks for the path through development towards clinical trials of Hu-PHEC, including the establishment of a cell bank.

Discussions continue, both on the Hu-PHEC project and on other initiatives, with the potential partners, who are highly respected names in complementary fields.

Post Period End Updates

Following the end of the period under review, the Company has continued to make progress in a number of areas and can highlight to shareholders the following developments:

A patent application entitled Post-Natal Hemogenic Endothelial Cells and their isolation and use was approved by the United States Patent and Trademark Office and issued on 25 February 2020 as Patent Number 10,570,373. The European Patent Office issued a decision notice in April 2020 that it will grant a patent bearing the same title as Patent Number 3068875. The patent issuance will take effect on the date on which the European Patent Bulletin mentions the grant, scheduled for 13 May 2020. The patent applications were filed in 2014 and are the subject of Hemogenyx’s aforementioned licence first granted in 2015 and restated in 2019.

The Company continued to draw on the cash provided by convertible loan facilities from Orgenesis Inc. for a maximum of US$2,000,000. As at 31 December 2019 a total of US$1,500,000 of the total facilities available had been drawn down, and the remaining $500,000 was drawn down in February 2020.

On 30 January 2020 the Company announced that it had raised £648,200 before expenses through a placing and subscription of 36,011,116 ordinary shares at a price of 1.8p per share. The funds are being used to continue the development and in vivo testing of the Company’s Chimeric Antigen Receptor (CAR) programmed T cells, for the further development and commercialisation of the Company’s ApbHC and models and treatments for diseases, and to provide additional working capital for the Company to progress its core CDX antibody collaboration and to support its various partnerships with other major pharmaceutical companies.

In January and February 2020 the Company announced breakthroughs, first in test tube tests and subsequently in animal studies, in the promising field of CAR-T therapy. Hemogenyx has successfully constructed and tested CAR programmed T cells, termed HEMO-CAR-T, as a potential alternative treatment for AML. HEMO-CAR was constructed using Hemogenyx’s proprietary humanised monoclonal antibody, against a target on the surface of AML cells. The Company has demonstrated that HEMO-CAR was able to programme human T cells (i.e. convert them into HEMO-CAR-T cells) to identify and destroy human AML derived cells.

Following the successful completion of these tests, Hemogenyx is undertaking further engineering of HEMO-CAR to enhance their safety. The Company is introducing and testing a safety switch designed to control the level of activity of HEMO-CAR-T cells, with the aim of creating a “tuneable and controllable drug”. The purpose of these efforts is to dramatically improve the safety and potential versatility of HEMO-CAR-T cells for the treatment of AML and/or conditioning of bone marrow transplants, as well as a number of additional potential indications.

COVID-19

In late April 2020, the Company began applying its groundbreaking research and technologies to develop treatments for COVID-19, the disease caused by the SARS-CoV-2 virus. Hemogenyx is using the exceptional characteristics of its ApbHC mice to discover human neutralising antibodies that could fight the virus. The study aims to demonstrate how Hemogenyx’s technology can be deployed rapidly in emergencies in order to discover human neutralising antibodies against a host of viral pathogens, including what infectious disease experts in the bioprotection and biodefense sectors call “Disease X”, meaning as-yet unknown viruses that may represent a similar or greater threat than the one presented by COVID-19.

Concurrently, Hemogenyx has initiated a pilot study to understand why some individuals who are infected with SARS-CoV-2 are asymptomatic, some exhibit mild symptoms, and some become very sick and even die. Such understanding could prove essential for both the development of new treatments for COVID-19 and managing the current risk of infection. Should the study prove to be successful, Hemogenyx will aim to develop and commercialise a test that would prospectively identify people with potentially high/low risk of severe illness caused by the virus.

Financial Results

During the year the Group made a loss of £1,453,144 (2018: £1,544,324 restated loss).

Scientific Advisory Board & Board Update

I have chaired the Scientific Advisory Board since September 2017 and have worked with the Company to widen its expertise and to bring in advisers that can specifically help given the stage to which the Company’s product development has advanced.

Our Scientific Advisory Board, under my Chairmanship, brings together a number of experienced experts with extensive biotech and large pharma drug development experience and their calibre is a reflection of the potential opportunity that our therapies present.

There were no changes to the composition of the Board during 2019, giving the Company a period of stability in which its talented scientific staff were able to demonstrate their extraordinary capacity to advance the Company’s science and commercial relationships on limited financial resources.

The Board has continued to demonstrate its confidence in the ongoing success of the business throughout the period under review and post-period end. I have elected to receive most of my remuneration in share options and collectively we remain confident that the Company’s shares should deliver significant shareholder return over the long term.

Conclusion

The Company has made progress in further widening its suite of products (e.g. its new ApbHC form of humanised mice and its CAR-T product candidate) and their potential applications (e.g. the use of ApbHC for biodefence purposes and the use of CDX antibodies to treat ALL and MDS) and in cultivating important partnerships and financing.

2019 marked substantial further contributions to the diversification and de-risking of the Company’s prospects and additional steps in opening up yet more disease markets. The period saw increased recognition of the excellence of the Company’s scientific team, and laid further foundations for the realisation of substantial shareholder value as the Company moves ever closer to entering a product candidate to clinical trials.

My fellow Directors and I are greatly encouraged by the Company’s work and on-going conversations with key industry partners on several fronts, and believe that the next 12 months will mark a key inflection point in its growth and maturity.

Prof Sir Marc Feldmann AC, FRS
MB BS, PhD, FRCP, FRCPath, FAA, F Med Sci
Chairman

30 April 2020

Directors’ Report for the year ended 31 December 2019

The Directors present their report with the audited financial statements of the Group for the year ended 31 December 2019.

The Company’s Ordinary Shares were admitted to listing on the London Stock Exchange under the name Silver Falcon plc, on the Official List pursuant to Chapters 14 of the Listing Rules, which sets out the requirements for Standard Listings, on 9 November 2015.

On 4 October 2017 the Company’s shareholders voted in favour of acquiring the biotechnology company Hemogenyx Pharmaceuticals Limited, with shares being readmitted to trading on 5 October 2017 under the name Hemogenyx Pharmaceuticals plc.

Principal Activity

The Group’s principal activity is the discovery, development and commercialisation of novel therapies and treatments for blood diseases such as leukemia and lymphoma. The company’s leading technologies aim to change the way in which bone marrow/hematopoietic stem cell (“BM”/”HSC”) transplants are performed and improve their efficacy. Hemogenyx’s distinct and complementary products include immunotherapy product candidates for the treatment of AML and other blood malignancies and patient conditioning – the CDX bi-specific antibody and CAR-T therapy, and a cell therapy product for BM/HSC transplantation – the Hu-PHEC. Each of these products holds the potential to revolutionise the way BM/HSC transplants are being performed or diseases of the blood are treated, offering solutions that mitigate the dangers and limitations associated with the current standard of care.

The Group has three companies that are located outside of the UK. The principal laboratory of the Group is located in Brooklyn, New York, USA. The Group has also established additional operations in Liège, Belgium.

Results and Dividends

The Consolidated Statement of Comprehensive Loss shows a loss for the year amounting to £1,453,144 (2018: loss of £1,544,324 restated). The Directors do not propose a dividend in respect of the year ended 31 December 2019 (31 December 2018: nil).

Directors and Directors’ Interests

The Directors who held office during the year were as follows:

	Date Appointed	Date Resigned
Professor Sir Marc Feldmann	9 April 2018	–
Dr Vladislav Sandler	4 October 2017	–
Dr Robin Campbell	4 October 2017	5 January 2019
Alexis Sandler	4 October 2017	–
Peter Redmond	29 July 2015	–

The Directors of the Company who held office at 31 December 2019 had the following beneficial interests in the Ordinary shares of the Company at 31 December 2019 according to the register of directors’ interests:

Director	At 31 December 2019	At 31 December 2018
Professor Sir Marc Feldmann	–	–
Peter Redmond*	5,040,714	5,040,714
Dr Vladislav Sandler	41,544,677	40,451,210
Alexis Sandler	75,090,685	75,090,685

* Peter Redmond holds the majority of these shares through Catalyst Corporate Consultants Ltd of which he is the sole shareholder.

At the date of this report, the only change to the Directors’ beneficial interest in the Ordinary shares of the Company as disclosed in the table above is that Peter Redmond’s interest has increased to 5,596,270 shares by virtue of his participation in the Subscription and Placing of January 2020.

According to the Register of Directors’ Interests, no rights to subscribe for shares in or debentures of Group companies were granted to any of the Directors or their immediate families, or exercised by them, during the financial year except as indicated below (see note 20 for detail on option plans):

Options
Date of grant	Number of options at start of year	Options granted or acquired during year	Options lapsed during year	Number of options at end of year
Dr Robin Campbell
4 Oct 2017	3,560,429	–	3,560,429	–
	3,560,429	–	3,560,429	–
Professor Sir Marc Feldmann
9 Apr 2018	18,002,568	–	–	18,002,568
	18,002,568	–	–	18,002,568

Warrants
Date of grant	Number of warrants at start of year	Warrants granted or acquired during year	Warrants lapsed during year	Number of warrants at end of year
Dr Vladislav Sandler
4 October 2017	214,286	–	214,286	–
	214,286	–	214,286	–
Peter Redmond
4 October 2017	1,942,857	–	1,942,857	–
	1,942,857	–	1,942,857	–

Qualifying Third Party Indemnity Provision

At the date of this report, the Company has a third-party indemnity policy in place for all Directors.

Substantial Shareholders

As at 31 December 2019, the total number of issued Ordinary Shares with voting rights in the Company was 361,242,853 (now: 397,253,969). The Company has been notified of the following interests of 3 per cent or more in its issued share capital as at the date of approval of this report.

	Number of Ordinary	% of
Party Name	Shares	Share Capital
Alexis Sandler	75,090,685	18.9
Vladislav Sandler	41,544,677	10.5
Craig Auringer	31,407,913	7.9
HSBC Client Holdings Nominee (UK) Limited	20,125,759	5.1
Samantha Bauer	17,996,487	4.5
Optiva Securities Limited*	18,506,211	4.7
Ron Valk	17,131,193	4.3
Lawshare Nominees Limited	13,397,733	3.4
Mark Hawtin	13,268,570	3.3

* Optiva Securities Limited holds these shares through JIM Nominees Limited.

Relationship Agreement

In accordance with Listing Rule 9.8.4(14)R, the Company has set out below a statement describing the relationship agreement entered into by the Company with its principal shareholder.

On 8 September 2017, the Company entered into a Relationship Agreement with Dr Vladislav Sandler and Alexis Sandler (the “Controlling Parties”), which came into force at the Company’s re-admission. The principal purpose of the Relationship Agreement is to ensure that the Company is capable at all times of carrying on its business independently of the Controlling Parties.

If the Company ceases to be admitted to the Main Market of the London Stock Exchange, or the Controlling Parties (together with their associates) cease to hold 20 per cent or more of the voting rights over the Company’s shares the Relationship Agreement shall terminate save for certain specified provisions.

The Relationship Agreement provides that the Controlling Parties undertake to use all reasonable endeavours to procure that they and their associates shall:

• conduct all transactions with the Company on an arm’s length basis and on a normal commercial basis;
• not take any action that would have the effect of preventing the Company from complying with its obligations under the Listing Rules or the corporate governance principles adopted by the Group;
• not propose or procure the proposal of a shareholder resolution which is intended to, or appears to be intended to, circumvent the proper application of the Listing Rules; and
• not take any actions which is intended to, or appears to be intended to, breach or circumvent the proper application of the Relationship Agreement, the Listing Rules or the corporate governance principles adopted by the Group.

The Directors believe that the terms of the Relationship Agreement enable the Company to carry on its business independently from the Controlling Parties and their affiliates and ensure that all transactions and relationships between the Company and the Controlling Parties are, and will be, at arm’s length and on a normal commercial basis. The Company has and, in so far as it is aware, the Controlling Parties and their associates have, complied with the independence provisions set out in the Relationship Agreement from the date of the agreement, through the relevant period under review. The ordinary shares owned by the Controlling Parties rank pari passu with the other ordinary shares in all respects.

Share Capital

Details of the issued share capital, together with details of the movement in issued share capital during the year, are shown in note 18 to the financial statements.

Financial Instruments

Details of the use of the Company’s financial risk management objectives and policies as well as exposure to financial risk are contained in the Accounting policies and note 25 of the financial statements.

Future Developments and Events Subsequent to the Year End

Further details of the Group’s future developments and events subsequent to the year end are set out in the Chairman’s Statement and Strategic Report.

Corporate Governance

The Corporate Governance report forms part of the Directors’ Report.

Going Concern

The Company’s business activities, together with facts likely to affect its future operations and financial and liquidity positions are set out in the Chairman’s Statement and Directors’ Strategic Report. In addition, note 25 to the financial statements discloses the Company’s capital risk management policy and note 2 details further considerations made by the Directors in respect of going concern, including an assessment of the possible impact on the Company arising from COVID-19.

The Directors, having made due and careful enquiry, are of the opinion that the Company has or will have access to sufficient funding in order to execute its operations over the next 12 months. The Directors therefore have made an informed judgment, at the time of approving the financial statements, that there is a reasonable expectation that the Company has adequate resources to continue in operational existence for the foreseeable future. As a result, the Directors have adopted the going concern basis of accounting in the preparation of the annual financial statements.

Political Donations

The Group made no political donations during the year (2018: £nil).

Charitable Donations

There were no charitable donations made by the Group in the current or prior year.

Auditors

The auditors, PKF Littlejohn LLP, have expressed their willingness to continue in office and a resolution to reappoint them will be proposed at the Annual General Meeting.

Statement of Directors’ Responsibilities

The Directors are responsible for preparing the Annual Report and the financial statements in accordance with applicable law and regulations.

Company law requires the Directors to prepare financial statements for each financial year. Under that law the Directors have elected to prepare the financial statements in accordance with International Financial Reporting Standards (IFRSs) as adopted by the European Union.

Under Company law the Directors must not approve the financial statements unless they are satisfied that they give a true and fair view of the state of affairs of the Company and of the profit or loss of the Company for that year.

In preparing these financial statements, the Directors are required to:

• Select suitable accounting policies and then apply them consistently;
• Make judgments and accounting estimates that are reasonable and prudent;
• State whether applicable IFRSs as adopted by the European Union have been followed, subject to any material departures disclosed and explained in the financial statements; and
• Prepare the financial statements on the going concern basis unless it is inappropriate to presume that the Company will continue in business.

The Directors are responsible for keeping adequate accounting records that are sufficient to show and explain the Group and parent company’s transactions and disclose with reasonable accuracy at any time the financial position of the Group and parent company and enable them to ensure that the financial statements and the Directors’ remuneration report comply with the Companies Act 2006. They are also responsible for safeguarding the assets of the Group and parent company and hence for taking reasonable steps for the prevention and detection of fraud and other irregularities. They are also responsible to make a statement that they consider that the annual report and accounts, taken as a whole, is fair, balanced, and understandable and provides the information necessary for the shareholders to assess the Group and parent company’s position and performance, business model and strategy.

The Directors are responsible for the maintenance and integrity of the corporate and financial information included on the Company’s website. Legislation in the United Kingdom governing the preparation and dissemination of the financial statements may differ from legislation in other jurisdictions.

Directors’ Responsibility Statement Pursuant to Disclosure and Transparency Rules

Each of the Directors confirm that, to the best of their knowledge and belief:

• the financial statements prepared in accordance with IFRS as adopted by the European Union, give a true and fair view of the assets, liabilities, financial position and loss of the Group and parent company; and
• the Annual Report and financial statements, including the Business review, includes a fair review of the development and performance of the business and the position of the Group and parent company, together with a description of the principal risks and uncertainties that they face.

Disclosure of Information to Auditors

So far as the Directors are aware, there is no relevant audit information of which the Company’s auditors are unaware, and each Director has taken all the steps that he ought to have taken as a Director in order to make himself aware of any relevant audit information and to establish that the Company’s auditors are aware of that information.

Approved by the Board on 30 April 2020

Dr Vladislav Sandler
CEO

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1 Milliman Research Report 2014 U.S. organ and tissue transplant cost estimates and discussion

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SOURCE: Hemogenyx Pharmaceuticals plc

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