Hemogenyx Pharmaceuticals Plc Annual Report 2019

Plain-text annual report

H E M O G E N Y X P H A R M A C E U T I C A L S P L C A N N U A L R E P O R T & F I N A N C I A L S TAT E M E N T S F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 2 C O N T E N T S Company Information Chairman’s Statement Board of Directors and Senior Management Strategic Report Directors’ Report Governance Report Directors’ Remuneration Report Independent Auditor’s Report Consolidated Statement of Comprehensive Income Consolidated Statement of Financial Position Company Statement of Financial Position Consolidated Statement of Changes in Equity Company Statement of Changes in Equity Consolidated Statement of Cash Flows Company Statement of Cash Flows Notes to the Financial Statements 3 4 10 13 20 27 34 41 48 49 50 51 52 53 54 55 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 2019 3 C O M P A N Y I N F O R M A T I O N Directors Dr Vladislav Sandler (Chief Executive Officer) Professor Sir Marc Feldmann (Chairman) Alexis Sandler (Non-Executive Director) Peter Redmond (Non-Executive Director) Principal Bankers Metro Bank plc One Southampton Row London WC1B 5HA Registrar Computershare Investor Services plc The Pavilions Bridgewater Road Bristol BS13 8AE Company Secretary Andrew Wright Registered Office 5 Fleet Place London EC4M 7RD Registered Number 08401609 (England and Wales) Broker SP Angel Corporate Finance LLP Prince Frederick House 35-39 Maddox Street London W1S 2PP Independent Auditor PKF Littlejohn LLP Statutory Auditor 15 Westferry Circus Canary Wharf London E14 4HD UK Solicitors Osborne Clarke LLP One London Wall London EC2Y 5EB US Solicitors Rubin & Rudman LLP 50 Rowes Wharf Boston Massachusetts 0211 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 2019 4 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 C H A I R M A N ’ S S T A T E M E N T Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 5 C H A I R M A N ’ S S T A T E M E N T 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-billion 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. 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 6 C H A I R M A N ’ S S T A T E M E N T 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 the antibody. Hemogenyx and GlobalCo remain optimistic as to the outcome of these tests based on results to date. follow-up tests of 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 laboratory results announced disorders. The in January and February 2020 are described in the subsequent events section below. initial further Humanised Mice Immugenyx, LLC ("Immugenyx"), the Company’s wholly owned subsidiary, developed a 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 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 2019Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 7 C H A I R M A N ’ S S T A T E M E N T 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. its Hu-PHEC Stem Cell Therapy The Company reviewed and extended 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. is ("Hemogenyx-Cell") Hemogenyx-Cell SPRL 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: 8 C H A I R M A N ’ S S T A T E M E N T 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. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 2019C H A I R M A N ’ S S T A T E M E N T 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. 9 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. further contributions 2019 marked substantial 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 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201910 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 B O A R D O F D I R E C T O R S A N D S E N I O R M A N A G E M E N T Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 11 B O A R D O F D I R E C T O R S A N D S E N I O R M A N A G E M E N T Professor Sir Marc Feldmann – Non-Executive Director & Chairman – appointed 9 April 2018 Honours, and was honoured in Australia with the knighthood equivalent, the Companion of the Order of Australia. Professor Sir Marc Feldmann is a pre-eminent medically trained immunologist at the University of Oxford where he was Head of the Kennedy Institute of Rheumatology until 2014 and now Emeritus Professor. He trained in medicine at Melbourne University and then earned a Ph.D. in Immunology at the Walter & Eliza Hall Institute with Sir Gus Nossal, before working in London at the Imperial Cancer Research Fund. Sir Marc's main research interests are immunoregulation, understanding mechanisms of autoimmunity and the role of cytokines in disease, and working out how to fill unmet medical needs. for His work in London led to the generation of a new the mechanism of autoimmunity, hypothesis linking upregulated antigen presentation and cytokine expression. Testing this hypothesis led to the discovery, with colleague Sir Ravinder Maini, of the pivotal role of TNFα (Tumour Necrosis Factor alpha) in the pathogenesis of rheumatoid arthritis. This major discovery has revolutionised therapy not only of rheumatoid arthritis but other chronic inflammatory diseases (e.g. inflammatory bowel disease, psoriasis, and ankylosing spondylitis), and helped change the perception of monoclonal antibodies from niche products to mainstream therapeutics. Anti- TNF therapeutics are the current leading drug class with 2016 sales exceeding US$36 billion. This has led to much scientific recognition, for example election to the Royal Society and Academy of Medical Sciences in London, the National Academy of Sciences USA and the Australian Academy of Science, and multiple major International prizes including the Crafoord Prize of the Royal Swedish Academy of Sciences, the Albert Lasker Clinical Research Award (NY), the Ernst Schering Prize, the Paul Janssen Award for Biomedical Research, and the Canada-Gairdner Award. He was also the first recipient in biology or medicine of the EU/European Patent Office Inventor of the Year Award in the Lifetime Achievement category. In addition, Sir Marc has advised more than 20 of the largest pharmaceutical and biotech companies in the world and has mentored some of the most successful scientists, many of whom have become senior figures in the commercial pharmaceutical world. Sir Marc was knighted in the 2010 Queen's Birthday Sir Marc has been at the forefront of promoting effective scientific-medical-pharmaceutical interactions. He has built up a huge network of friends and collaborators who meet regularly in Oxford and who will help Hemogenyx to grow and enter clinical trials. Dr Vladislav Sandler – Chief Executive Officer – appointed 4 October 2017 Dr Vladislav Sandler is the Co-Founder and CEO of Hemogenyx and a research Assistant Professor at the State University of New York (SUNY) Downstate. Dr Sandler is a widely published stem cell scientist with decades of experience in scientific research. In particular, Dr Sandler has extensive experience developing novel methods of direct reprogramming of somatic cells into functional and engraftable hematopoietic stem cells, as well as developing novel sources of pluri- and multi- potent cells. Dr Sandler has conducted his research in Russia, Israel, Canada and the United States, including at the Children's Hospital at Harvard Medical School, the Salk Institute for Biological Sciences, Harvard University and Albert Einstein College of Medicine, among others. He also led a team of scientists at Advanced Cell Technologies, Inc. and was most recently on the faculty of Weill Cornell Medical College. While at Cornell, Dr Sandler made the significant discovery that the cells that give rise to blood stem cells during mammalian development continue to exist after birth, and he developed the method of isolation of these cells from humans. As a result of this important work, Dr Sandler was awarded the inaugural Daedalus Fund Award for Innovation at Cornell. He went on to found Hemogenyx in order to further pursue this significant scientific discovery and his dedication to the translation of science into clinical practice. Dr Sandler has published numerous peer-reviewed papers and has received a number of awards and fellowships for his scientific research. Dr Sandler received his PhD from the University of British Columbia. He is a member of the International Society for Stem Cell Research. 12 B O A R D O F D I R E C T O R S A N D S E N I O R M A N A G E M E N T Alexis Sandler – Non-Executive Director appointed 4 October 2017 Peter Redmond – Non- Executive Director appointed 29 July 2015 Peter Redmond is a corporate financier with some 30 years’ experience in corporate finance and venture capital. He has acted on and assisted a wide range of companies to attain a listing over many years, on the Unlisted Securities Market, the Full List and AIM, whether by IPO or in many cases via reversals, across a wide range of sectors, ranging from technology through financial services to natural resources and, in recent years has done so as a director of the companies concerned. He has been active over many years in corporate rescues and reconstructions on AIM and in reverse transactions into a range of investing companies. He was a founder director of Cleeve Capital plc (now Satellite Solutions plc) and Mithril Capital plc (now BeHeard Group plc), both of which were admitted to the Standard List of the London Stock Exchange, and took a leading role in the reconstruction and refinancing of AIM-quoted Kennedy Investments plc and 3Legs Resources plc (now SalvaRx plc). Peter is Chairman of AIM-quoted Pires Investments plc and URA Holdings plc. Alexis M. Sandler is the co-founder of Hemogenyx, for which she has served as the Chief Operating Officer. Ms Sandler is an attorney specialising in intellectual property, with almost 15 years of experience representing a range companies and institutions. Ms Sandler is especially skilled at handling diverse interests in day-to-day matters of organisations, multi-party agreements and long-term strategic planning. Ms Sandler began her legal practice in Los Angeles at Hogan & Hartson LLP (now Hogan Lovells), where she specialised in entertainment and media law and intellectual property. She then worked for several years at Katten Muchin Rosenman LLP representing studios, production companies, television networks and other major media companies in all aspects of entertainment, media and intellectual property law. For three years, Ms Sandler worked as the Director of Business and Legal Affairs for a division of the Fox Entertainment Group, during which time she was named one of Southern California’s Best Young Lawyers by Los Angeles magazine. While at Fox, Ms Sandler successfully negotiated hundreds of major distribution agreements, in addition to advising the company on important corporate and other legal matters. Ms Sandler went on to become the General Counsel at a Smithsonian affiliate museum in New York City. Ms Sandler is currently the Associate General Counsel for a major New York City cultural institution. She also serves as the Secretary of the Board of Directors for MoMA PS1, the contemporary art space. Ms Sandler received her AB from Harvard University and her JD from the UCLA School of Law and is a member of the State Bar of New York and the State Bar of California. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 2019Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 13 13 D I R E C T O R S ’ S T R A T E G I C R E P O R T F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 14 D I R E C T O R S ’ S T R A T E G I C R E P O R T F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 The Directors present their Strategic Report of Hemogenyx Pharmaceuticals plc for the year ended 31 December 2019. the issue of convertible loans. The Group received other income of £213,126 (2018 - £91,357) from collaborations with partners. Introduction This Strategic Report comprises a number of sections, namely: the Group’s objectives, the Group’s strategy and business model, a review of the Group’s business using key performance indicators, and the principal risks and uncertainties facing the business. Cash flow and cash position Cash used in operations totalled £1,199,873 (31 December 2018: £1,352,727). As at 31 December 2019, the Group had a cash balance of £498,679 (31 December 2018: £1,762,428). Objectives The Group’s objective is to develop breakthrough therapies for the treatment of blood and autoimmune diseases. Strategy and Business Model The Group’s long-term strategy is to create a suite of products to address current problems associated with bone marrow, or hematopoietic stem cell, transplants. The latter represents an important part of the solution to treating blood-related diseases, with the opportunity to improve outcomes through reduced blood stem cell transplant rejection and relapse, and if successful potentially provides long-term cures for these diseases. The Group’s business model aims to advance its therapies through clinical proof-of-concept, taking them towards a final stage of development. A goal is the licensing of one or more of its therapies to partners in return for potential upfront payments, research funding support, success milestone and royalty payments. Operational Review and Outlook The operational review and outlook are set out in the Chairman’s Statement. Key Performance Indicators The Directors have identified the KPIs below that they feel are the most vital measurements for the Group to monitor given its current stage of development. KPIs are monitored on an annual basis to ensure that the remain the most important and relevant measure of performance and progress. Cash management In addition to the revenues from collaborations with partners mentioned above, the Group continued to draw on the cash provided by the 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 (£1,144,167) of the total facilities available had been drawn down, and the remaining US$500,000 was drawn down in February 2020, following the period end. The cash position at 31 December 2019 was £498,679 (31 December 2018: £1,762,428). The Group carefully plans expenditure with rolling cash flow forecasts and tight financial control. The Group takes a collaborative cost sharing approach with business partners and avoids long-term commitments as far as possible. Financial Review The Group incurred a loss for the year to 31 December 2019 of £1,453,144 (31 December 2018 – loss of £1,544,324 restated). In the year to 31 December 2019 the loss mainly arose from operational expenses pursuing the Group’s objectives listed above as well as salaries, consulting and professional fees, and general administration expenses. These expenses have been met from the proceeds of Intellectual property The Group will focus on developing a new conditioning treatment and cell for HSC/BM transplantation. The Group, or its licensors, has applied for patents to protect its proprietary technology and future products, which are in varying stages of development. therapy product The success of the Group will depend largely on the Group’s ability to implement successful drug development programmes, obtain the required regulatory approvals (in Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201915 D I R E C T O R S ’ S T R A T E G I C R E P O R T F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 various territories), protect and exploit its own intellectual property and know-how, and the intellectual property and know-how licensed to it, and to generate a cash flow in accordance with the strategy of the Group. Intellectual property is protected by the Group through taking a pro- active approach to filing patents over its products and technologies, as well as the diligent maintenance and protection of such patents and licenses. The Group patent portfolio currently includes: CDX bi-specific antibodies The patent application relating to CDX bi-specific antibodies was filed by Hemogenyx LLC in the USA on 4 April 2016 ("CDX Patent"). The invention summarised in the patent application is a method of eliminating hematopoietic stem cells/hematopoietic progenitors ("HSC"/"HP") in a patient using bi-specific antibodies specifically binding to a protein predominantly expressed on the surface of HSC/HP and to a protein uniquely expressed on a surface of immune cells. The bound bi-specific antibodies redirect immune cells to eliminate HSC/HP. The invention relates to the required conditioning of a patient prior to a BM/HSC transplant. In this respect, the invention serves two main purposes: • it provides adequate immunosuppression of the patient and clears sufficient niche space in the bone marrow for the transplant of HSC. This allows transplanted cells to engraft in the recipient; and • it could potentially help to eradicate the source of malignancy. The provisional patent application is converted to a PCT application and broadened to cover the composition of matter (in this case, novel sequences of antibodies). On April 4 2017, a PCT (Patent Cooperation Treaty) application was filed by Hemogenyx which includes additional claims that extend the CDX Patent set out in the provisional patent application. These claims protect specific sequences of several high-quality clones discovered and validated by the Group. The claim extension transforms the original "method" provisional patent application into a "composition of matter" PCT application. In July 2019 the Group filed an additional composition of matter patent application in relation to newly-discovered monoclonal antibodies against a target protein expressed on the surface of hematopoietic stem cells/ hematopoietic progenitors and a number of leukaemias, such as AML. It also covers a method of application of the Group’s bi-specific CDX antibodies for conditioning patients for bone marrow transplantation. Hu-PHEC cell therapy The patent relating to Hu-PHEC was filed by Cornell University ("Cornell Patent") in several jurisdictions on 13 November 2014. The patent was approved and issued in the United States of America on 25 February 2020 and will be published by the European Patent Office on 13 May 2020. The invention summarises a method of isolation and identification of post-natal hemogenic endothelial cells, as well as the provision of substantially purified populations of post-natal hemogenic endothelial cells, compositions of post-natal endothelial cells and methods to utilise post-natal hemogenic endothelial cells to regenerate the hematopoietic system in a patient. Advanced Hematopoietic Chimeras The provisional patent application relating to the Group’s proprietary humanised mouse model, the Advanced Hematopoietic Chimera, is an application filed by Dr Sandler and Dr Rita Simone in the USA on 20 February 2018 ("AHC Patent"). The invention summarised in the patent application is mice whose hematopoietic system is at least 40% humanised and methods for preparing the same. The patent was assigned to the Group’s subsidiary Immugenyx LLC on 24 May 2018. In June 2019 the Group announced that Immugenyx LLC has further refined its work to develop the Advanced peripheral blood Hematopoietic Chimera ("ApbHC") as a research and development tool. The major advantage of the ApbHC compared to other humanised mouse models known to the Group is the absence of Graft versus Host Disease, a disease that complicates and often renders impossible the efficient use of peripheral blood mononuclear cells in transplanted mice. The ApbHC can potentially be used for testing multi-specific antibodies, including its own bi- specific CDX antibody, as well as for the development and testing of new cell therapies involving immune cell programming such as CAR-T. ApbHC can also potentially be used for the modeling of autoimmune diseases, such as Systemic Lupus Erythematosus (aka Lupus), with a goal of developing fundamentally new treatments for those diseases. Furthermore, ApbHC could potentially Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201916 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 D I R E C T O R S ’ S T R A T E G I C R E P O R T F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 be used as a tool for the rapid development and/ or isolation of human antibodies against previously unknown human-specific pathogens (bioprotection/ biodefence applications), known in biosecurity circles as "Disease X," such as the novel coronavirus. Organisation as a whole Executive management team Board Men Women 7 2 3 4 - 1 Product development The Group develops therapies to transform bone marrow and blood stem cell transplant procedures. These therapies aim to replace the need for existing methods of preparation of patients for transplantation, such as chemotherapy and radiation treatments, and at the same time address the problem of finding matching stem cell donors whilst reducing the risk of blood stem cell rejection after transplantation. The Group’s two key products, CDX antibodies and in preclinical Hu-PHEC cell therapy, are currently development, along with a CAR-T therapy candidate also based on the Group’s antibodies. In addition, the Group’s AHC product is currently the subject of collaborations with other pharmaceutical companies to evaluate AHCs’ effectiveness as platforms for disease modelling and drug discovery. The Directors monitor product development through results. The CDX product has been pre-clinical successfully evaluated the Group’s proprietary in humanised mouse model, achieving its proof of concept. Furthermore, we have achieved a notable demonstration of CDX’s activity versus AML cells in vitro and in vivo. If successful, the Company may be able to use the CDX product to eliminate R/R AML in patients who qualify for bone marrow transplantation. The Company is also investigating the possibility of using its CDX antibodies in combination with other treatments for AML to increase their effectiveness. Diversity Hemogenyx is committed to workplace diversity which includes but is not limited to gender, age, ethnicity and cultural background. Hemogenyx’s Diversity Policy defines initiatives which assist the Company in maintaining and improving the diversity of its workforce. The table below highlights the proportion of women engaged by the Group: Board of Advisors The Group engages the services of a Board of Advisors who are highly experienced the clinical development of treatments and regulatory processes to commercialisation. in both Dr Alexander Tarakhovsky M.D., Ph.D. SCIENTIFIC ADVISOR • Professor and Head of Laboratories at The Rockefeller University • An expert and recognised thought leader in immunology and epigenetics Dr H. Michael Shepard, Ph.D. SCIENTIFIC ADVISOR • Led the discovery and development of many successful cancer treatments including Herceptin/trastuzumab - annual sales exceed $6.5 billion worldwide • Received Harvard Medical School's prestigious Warren Alpert Prize in recognition of contributions to the field of cancer treatment research • Founded NewBiotics, Inc., acquired by Kiadis Pharma • Founded BioLogix, acquired by Symphogen Dr Koen van Besien M.D. CLINICAL ADVISOR • Professor of Medicine and Director of the Stem Cell Transplant Program at NYP-Weill Cornell College of Medicine • Developed novel methods of transplantation for those patients who lack matching donors • >200 publications in peer reviewed journals • Editor in Chief of the journal Leukemia and Lymphoma Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 17 D I R E C T O R S ’ S T R A T E G I C R E P O R T F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 Corporate Responsibility We have defined the scope of our Group’s responsible business practices as falling within the following key focus areas: • Health and Safety – ensuring the safety and well- being of our staff • Environment – managing our environmental impact areas of waste, energy and water • Employees – supporting our people to develop and flourish within the business • Community – positive interaction with the communities in which we operate • Ethical Standards – operating to the highest ethical standards We remain committed to ensuring these activities become embedded in how we operate and contribute towards the success of our business. This includes not only identifying and managing business risk but exploring opportunities to add value to the business. Greenhouse Gas Emissions Given the nature of its activities, there is limited scope for the Group to have a major impact on environmental matters. Nevertheless, the Directors are mindful of their responsibilities in this regard and strive to seek improvements may be made; opportunities where these are generally concentrated in areas of energy conservation, recycling and waste control. Principal Risks and Uncertainties The Group operates in an uncertain environment and is subject to a number of risk factors. The Directors have carried out a robust assessment of the principal risks facing the Group, including those that threaten its business model, future performance, solvency or liquidity. They consider the following risk factors are of particular relevance to the Group’s activities and to any investment in the Group. It should be noted that the list is not exhaustive and that other risk factors not presently known or currently deemed immaterial may apply. The risk factors are summarised below: Risks relating to the Group’s business strategy The Group’s business is relatively undeveloped The operations of Hemogenyx are at a relatively early stage and, to date, no commercial sales of its products have been made. The ability of the Group to achieve commercialisation is dependent on a number of factors, many of which are outside of the Group’s control. Examples of factors outside of the Group’s control are the impact of Brexit, capital market conditions, FDA approval and competition. Business strategy of the Group The development of clinical products for new medical treatments is inherently uncertain, with high failure rates in clinical studies for both early and late stage development products and such clinical studies can be expensive, time-consuming and complicated and there is no certainty as to the outcome of such studies. Even once clinical studies have been successfully carried out, later phase trials may not successfully replicate or improve on such outcomes. Staffing and key personnel The Group is reliant on a number of the key personnel, in particular Dr Vladislav Sandler who is the founder of Hemogenyx (refer to Corporate Governance Report for further detail). Whilst the Group has endeavoured to ensure that it has contractual arrangements which include non-compete restrictions in place with such persons to lessen the risk of them ceasing to be involved with the Group, in the event that the Group was to lose the services of such individuals, its results could be adversely affected. Costs of commercialisation The ability of the Group to bring its products to first commercial sale will be dependent in part on the overall costs of manufacturing and the costs involved could be significant and there is no guarantee that the sale prices achievable for its products will be viable and sustainable. 18 D I R E C T O R S ’ S T R A T E G I C R E P O R T F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 Clinical studies and timelines risk Hemogenyx is currently progressing its CDX, CAR-T and Hu-PHEC product candidates through preclinical development. Although encouraging results have been achieved so far, there can be no certainty that these results can be reproduced in clinical trials. The monies raised in the Placings and Subscriptions, as well as the Orgenesis convertible loan made to Hemogenyx- Cell SPRL, are intended to support those preclinical development activities. The development of clinical products for new medical treatments is inherently uncertain, with high failure rates in clinical studies for both early- and late-stage development products. Furthermore, such clinical studies (Phase 1, Phase 2a/2b, Phase 3) are typically expensive, complex, can take considerable time to complete and have uncertain outcomes. Furthermore, as a result of adverse, undesirable, unintended or inconclusive results from any testing or clinical trials (which have yet to be designed), the future progress, planning and potential treatment outcome of the products and clinical programmes may be affected and may potentially prevent or limit the commercial use of one, many or all of the Company's products. In addition, later phase clinical trials may fail to show the desired safety and efficacy obtained in earlier studies, and a successful completion of one stage of clinical development of an investigational clinical product does not ensure that subsequent stages of clinical development will be successful. Failure can occur at any stage of clinical development and, as a result, enforced delays to the clinical development plan could delay or prevent commercialisation of the Company's product candidates. Various factors associated with the potential failure or delay in completing a clinical programme include, but are not limited to: • Delays in securing clinical investigators or clinical study sites; • Delays in securing any regulatory authority, hospital ethics committee, or institutional review board approval or approvals necessary to commence a clinical study; • Delays or failure to recruit a sufficient number of clinical study participants in accordance with the clinical study protocol; • Difficulty or inability to monitor subjects adequately during or after treatment; • Inability to replicate in Phase 3 controlled studies any safety and efficacy data obtained from controlled Phase 2a/2b clinical studies; • Difficulty or inability to secure clinical investigator compliance to follow the approved clinical study protocol; and • Unexpected adverse events or any other safety or related issues. Research and development risk The Group operates in the biotechnology and bio- pharmaceutical development sectors and carries out complex scientific research. If the research or preclinical testing or clinical trials of any of Hemogenyx's product candidates fail, meaning that these candidates will not be licensed or marketed, this would result in a complete absence of revenue from these failed candidates. Positive results from preclinical and early clinical studies do not guarantee positive results from clinical trials required to permit application for regulatory approval. Furthermore, the Group may discontinue the development of candidates if results are not positive or unlikely to further its progress towards a meaningful outcome or collaboration. Intellectual property (IP) infringement The Group may be subject to future litigation concerning its own IP and the IP of others. Adverse judgements in relation to its IP would likely have negative outcomes for its results of operations. Intellectual property (IP) control The Group is partially reliant on an exclusive, world-wide licence of a patent from Cornell University for its Hu- PHEC line of business. The exclusivity and exploitable territory for this licence depend on the Group meeting various developmental milestones. Environmental and other regulatory requirements The event of a breach with any environmental or regulatory requirements may give rise to reputational, financial or other sanctions against the Group, and therefore the Board considers these risks seriously and Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 2019Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 1919 to closure, and work continues with prudent hygiene and distancing measures in place including limited work in the laboratory on rota and work from home. The Company is allowing for extended delivery times for some supplies, and for slower progress with collaboration partners. The Board and UK management continue to operate remotely, as usual. At present the Company believes that there should be no significant material disruption to its work, but the Board continues to monitor these risks and the Company’s business continuity plans. Approved by the Board on 29 April 2019 Dr Vladislav Sandler CEO designs, maintains and reviews its policies and processes so as to mitigate or avoid these risks. Whilst the Board has a good record of compliance, there is no assurance that the Group’s activities will always be compliant. Financing The Group’s ability to develop its product through to commercial sale will depend upon the Group’s ability to obtain financing primarily through a further raising of new equity capital. Although the Group has been successful in raising new equity capital, there can be no guarantee that it will be able to do so in the future. The Group may not be successful in procuring the requisite funds on terms which are acceptable to it (or at all) and, if such funding is unavailable, would raise questions over its ability to further develop its products through to commercialisation. Further, Shareholders’ holdings of Ordinary Shares may be materially diluted if debt financing is not available. conditions, Market conditions including general economic Market conditions and their effect on exchange rates, interest rates and inflations rates, may impact the ultimate value of the Group regardless of its operating performance. The Group also faces competition from other organisations, some of which may have greater resources or be more established in a particular territory. The Board considers and reviews all market conditions to try and mitigate any risks that may arise from these. Political and country risk – UK departure from the EU The Company is quoted in the United Kingdom (UK) and operates in the UK and European Union (EU), in addition to other territories. The Company may be subject to the impact of the UK leaving the EU. As a result, given the ongoing uncertainty surrounding the situation, the Company is monitoring matters and seeking advice as to how to mitigate the risks arising. Pandemic and business disruption risk The Company may be affected by disruptions to its operations in one or more locations, particularly for the foreseeable future in light of responses to the novel coronavirus or other potential pandemics. At the time of writing, the Company’s New York operations are classed as an essential business and so are not subject 20 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 D I R E C T O R S ’ R E P O R T F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 21 D I R E C T O R S ’ R E P O R T F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 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 set out on page 44 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: Professor Sir Marc Feldmann Dr Vladislav Sandler Dr Robin Campbell Alexis Sandler Peter Redmond Date Appointed Date Resigned 9 April 2018 4 October 2017 - - 4 October 2017 5 January 2019 4 October 2017 29 July 2015 - - The Directors of the Company who held office at 31 December 2018 had the following beneficial interests in the Ordinary shares of the Company at 31 December 2018 according to the register of directors’ interests: Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201922 D I R E C T O R S ’ R E P O R T F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 Director Professor Sir Marc Feldmann Peter Redmond* Dr Vladislav Sandler Alexis Sandler At 31 December 209 At 31 December 2019 - 5,040,714 41,544,677 - 5,040,714 40,451,210 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 Professor Sir Marc Feldmann 4 Oct 2017 3,560,429 3,560,429 9 Apr 2018 18,002,568 18,002,568 - - - - 3,560,429 3,560,429 - - - - 18,002,568 18,002,568 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201923 D I R E C T O R S ’ R E P O R T F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 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 Peter Redmond 4 Oct 2017 214,286 214,286 4 Oct 2017 1,942,857 1,942,857 - - - - 214,286 214,286 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. Party Name Alexis Sandler Vladislav Sandler Craig Auringer HSBC Client Holdings Nominee (UK) Limited Samantha Bauer Optiva Securities Limited* Ron Valk Lawshare Nominees Limited Mark Hawtin Number of Ordinary Shares % of Share Capital 75,090,685 41,544,677 31,407,913 20,125,759 17,996,487 18,506,211 17,131,193 13,397,733 13,268,570 18.9 10.5 7.9 5.1 4.5 4.7 4.3 3.4 3.3 * Optiva Securities Limited holds these shares through JIM Nominees Limited. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201924 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 D I R E C T O R S ’ R E P O R T F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 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 its Agreement enable the Company to carry on 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 and is disclosed on pages 27-33. 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 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 25 D I R E C T O R S ’ R E P O R T F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 concern basis of accounting in the preparation of the annual financial statements. basis unless it is inappropriate to presume that the Company will continue in business. 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 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, whose names and functions are listed on page 1, 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. 26 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 D I R E C T O R S ’ R E P O R T F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 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 29 April 2019 Dr Vladislav Sandler CEO Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 2727 G O V E R N A N C E R E P O R T 28 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 G O V E R N A N C E R E P O R T Introduction The Company recognises the importance of, and is committed to, high standards of Corporate Governance. The Company has voluntarily applied the main and supporting principles set out in the UK Code of Corporate Governance published by the Financial Reporting Council in 2018 ("the Code"). The Code has been followed to the extent practicable for a company of its size and nature. The Code can be found at frc.org. uk/our-work/publications/Corporate-Governance. The ways in which the Company has applied the Code are explained below: • The Code requires that a smaller company should have at least two Independent Non-Executive Directors. As at 31 December 2019 the Board consisted of an Executive Director and three Non-Executive Directors. The Non-Executive Directors are interested in either ordinary shares in the Company, options over ordinary shares in the Company, or both, and cannot therefore be considered fully independent under the Code. The remuneration of the Non-Executive Directors includes options and this is contrary to best practice, and thus the Company is not in full compliance. However, the Directors consider the present structure and arrangements to be adequate given the size and stage of development of the Company, and all are considered to be independent in character and judgement. • Directors appointed by the Board are subject to election by shareholders at the Annual General Meeting of the Company following their appointment and thereafter are subject to re- election in accordance with the Company’s articles of association. The terms and conditions of appointment of Non-Executive Directors will be made available upon written request. The Board has voluntarily adopted a code for Directors’ dealings based on the Model Code contained in the Listing Rules of the UK Listing Authority that was previously in force. The Board will be responsible for taking all proper and reasonable steps to ensure compliance with the code by the Directors. Compliance with the code is being undertaken on a voluntary basis and the FCA will not have the authority to (and will not) monitor the Company’s voluntary compliance with it, nor to impose sanctions in respect of any failure by the Company to so comply. In addition, the Company will take all proper and reasonable steps to ensure compliance by the Founders with the Code for dealings in the Ordinary Shares. The Company is small with a modest resource base. The Company has a clear mandate to optimise the allocation of limited resources to support its development plans. As such, the Company strives to maintain a balance between conservation of limited resources and maintaining robust corporate governance practices. As the Company evolves, the Board is committed to enhancing the Company’s corporate governance policies and practices deemed appropriate for the size and maturity of the organisation. Set out below are the Company’s corporate governance practices for the year ended 31 December 2019. Committees The Company has established audit, remuneration and nomination committees. Audit Committee The Audit Committee has responsibility for, among other things, the monitoring of the integrity of the financial statements of the Company and its Enlarged Group and the involvement of the Group's auditors in that process. It focuses in particular on compliance with accounting policies and ensuring that an effective system of external audit and financial control is maintained, including considering the scope of the annual audit and the extent of the non-audit work undertaken by external auditors and advising on the appointment of external auditors. The ultimate responsibility for reviewing and approving the annual report and accounts and the half-yearly reports remains with the Board. The Audit Committee will meet at least three times a year at the appropriate times in the financial reporting and audit cycle. The members of the Audit Committee are Peter Redmond, who acts as chairman of the committee, and Professor Sir Marc Feldmann. The Group’s external auditor is PKF Littlejohn LLP who has served as external auditor for five years. The role of external auditor last went to tender in 2015. The Audit Committee closely monitors the level of audit and non- audit services that they provide to the Company and Group. Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 29 G O V E R N A N C E R E P O R T Having assessed the performance, objectivity and independence of the auditors, the Committee will be recommending the reappointment of PKF Littlejohn LLP as auditors to the Company at the 2020 Annual General Meeting. During the year to 31 December 2019 the Audit Committee considered the following key issues in relation to the Financial Statements: Issue Action Accounting policies The Committee reviewed and discussed the significant accounting policies with management and the external auditor and reached the conclusion that each policy was appropriate to the Group. Carrying value of investment in Hemogenyx LLC The Committee reviewed the impairment assessment report prepared by management and agreed that given the reasonable expectation that the Group will achieve its milestone targets over the next 18 months that no impairment to the value of the investment in Hemogenyx LLC was required as at 31 December 2019. Going Concern review The Committee considered the ability of the Group to operate as a Going Concern considering cash flow forecast for the next 12 months and milestone achievements. It was determined by the Committee that it was reasonable to expect that the Group has or will have access to sufficient funding in order to achieve its 12-month milestone targets and that it was appropriate for the Financial Statements to be prepared on a going concern basis. Review of audit and non-audit services and fees The external auditor is not engaged by the Group to carry out any non-audit work in respect of which it might, in the future, be required to express an audit opinion. The Committee reviewed the fees charged for the provision of audit and non-audit services and determined that they were in line with fees charged to companies of similar size and stage of development. The Committee considered and was satisfied the external auditor’s assessment of its own independence. 30 G O V E R N A N C E R E P O R T Remuneration Committee The remuneration committee reviews the performance of the Executive Directors and makes recommendations to the Board on matters relating to their remuneration and terms of employment. The committee also makes recommendations to the Board on proposals for the granting of share awards and other equity incentives pursuant to any share award scheme or equity incentive scheme in operation from time to time. The Remuneration Committee will meet at least twice a year. The members of the Remuneration Committee are Peter Redmond, who acts as chairman of the committee, and Alexis Sandler. Nomination Committee The Nomination Committee is responsible for considering and making recommendations to the Board in respect of appointments to the Board, the Board committees and the chairmanship of the Board committees. It is also responsible for keeping the structure, size and composition of the Board under regular review, and for making recommendations to the Board with regard to any changes necessary, taking into account the skills and expertise that will be needed on the Board in the future. The Nomination Committee meets at least once a year. The members of the Nomination Committee are Peter Redmond, who acts as chairman of the committee, Professor Sir Marc Feldmann, and Alexis Sandler. Leadership The Company is headed by an effective Board which is collectively responsible for the long-term success of the Company. The role of the Board: the Board sets the Company’s strategy, ensuring that the necessary resources are in place to achieve the agreed strategic priorities, and reviews management and financial performance. It is accountable to shareholders for the creation and delivery of strong, sustainable financial performance and long- term shareholder value. To achieve this, the Board directs and monitors the Company’s affairs within a framework of controls which enable risk to be assessed and managed effectively. The Board also has responsibility for setting the Company’s core values and standards of business conduct and for ensuring that these, together with the Company’s obligations to its stakeholders, are widely understood throughout the Company. The Board has a formal schedule of matters reserved which is provided later in this report. Board Meetings: the core activities of the Board are carried out in scheduled meetings of the Board. These meetings are timed to link to key events in the Company’s corporate calendar and regular reviews of the business are conducted. Additional meetings and conference calls are arranged to consider matters which require decisions outside the scheduled meetings. During the year, the Board met on 8 occasions. Outside the scheduled meetings of the Board, the Directors maintain frequent contact with each other to discuss any issues of concern they may have relating to the Company or their areas of responsibility, and to keep them fully briefed on the Company’s operations. Matters reserved specifically for the Board: the Board has a formal schedule of matters reserved that can only be decided by the Board. The key matters reserved are the consideration and approval of: • The Company’s overall strategy; • Financial statements and dividend policy; • Management structure including succession planning, appointments and remuneration; material acquisitions and disposal, material contracts, major capital expenditure projects and budgets; • Capital structure, debt and equity financing and other matters; • Risk management and internal controls; • The Company’s corporate governance and compliance arrangements; and • Corporate policies Summary of the Board’s work in the year: during the year, the Board considered all relevant matters within its remit, but focused in particular on the development and risk diversification of the Company. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201931 G O V E R N A N C E R E P O R T Attendance at meetings Number held and entitled to attend Number attended Dr Vladislav Sandler Professor Sir Marc Feldmann Dr Robin Campbell1 Alexis Sandler Peter Redmond 1 Until resignation on 5 January 2019 The Board is pleased with the high level of attendance and participation of Directors at Board and committee meetings. The Chairman sets the Board Agenda and ensures adequate time for discussion. Non-Executive Directors: the Non-Executive Directors bring a broad range of business and commercial experience to the Company and have a particular to challenge responsibility and constructively the Executive the performance of management (where appointed) and to monitor the performance of the management team in the delivery of the agreed objectives and targets. independently All directors with the exception of the CEO and Professor Sir Marc Feldmann were appointed for an initial term of 12 months. These terms were extended by mutual agreement after satisfactory performance and re- election by shareholders. Other governance matters: all of the Directors are aware that independent professional advice is available to each Director in order to properly discharge their duties as a Director. In addition, each Director and Board committee has access to the advice of the Company Secretary. The Company Secretary: the Company Secretary is Andrew Wright. He is responsible for the Board complying with UK procedures. Effectiveness For the period under review the Board comprised a Chief Executive Officer, a Non-Executive Chairman, and 8 8 - 8 8 8 8 - 8 8 two independent Non-Executive Directors. Biographical details of the Board members are set out on pages 10-12 of this report. The Directors are of the view that the Board and its committees consist of Directors with an appropriate balance of skills, experience, independence and diverse backgrounds to enable them to discharge their duties and responsibilities effectively. Independence: the Non-Executive Directors bring a broad range of business and commercial experience to the Company. The Board considers each of the Non- Executive Directors to be independent in character and judgement. Appointments: the Board is responsible for reviewing and the structure, size and composition of the Board and making recommendations to the board with regards to any required changes. Commitments: all Directors have disclosed any significant commitments to the Board and confirmed that they have sufficient time to discharge their duties. Induction: all new Directors received an induction as soon as practical on joining the Board. Conflict of interest: a Director has a duty to avoid a situation in which he or she has, or can have, a direct or indirect interest that conflicts, or possibly may conflict with the interests of the Company. The Board had satisfied itself that there is no compromise to the independence of those Directors who have appointments on the Boards of, or relationships with, companies outside the Company. The Board requires Directors to declare all appointments and other situations which could result in a possible conflict of interest. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201932 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 G O V E R N A N C E R E P O R T Accountability The Board is committed to providing shareholders with a clear assessment of the Company’s position and prospects. This is achieved through this report and as required other periodic financial and trading statements. a greater understanding of and confidence amongst its shareholders in the medium and longer term strategy of the Group and in the Board’s ability to oversee its implementation. It is the responsibility of the Board as a whole to ensure that a satisfactory dialogue takes place. Going concern: the Company’s business activities, together with factors likely to affect its future operations, financial position, and liquidity position are set out in the Chairman’s Statement and the principle risks and uncertainties sections of the Strategic Report. In addition, the notes to financial statements discloses the Company’s financial risk management practices with respect to its capital structure, liquidity risk, interest rate risk, credit risk, and other related matters. The Directors, having made due and careful enquiry, are of the opinion that the Company has adequate working capital to execute its operations and has the ability to access additional financing over the next 12 months. The Directors, therefore, have made an informed judgement, at the time of approving 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 continued to adopt the going concern basis of accounting in preparing the annual financial statements. Internal controls: the Board of Directors reviews the effectiveness of the Company’s system of internal controls in line with the requirement of the Code. The internal control system is designed to manage the risk of failure to achieve its business objectives. This covers internal financial and operational controls, compliances and risk management. The Company has necessary procedures in place for the year under review and up to the date of approval of the Annual Report and financial statements. The Directors acknowledge their responsibility for the Company’s system of internal controls and for reviewing its effectiveness. The Board confirms the need for an ongoing process for identification, evaluation and management of significant risks faced by the Company. The Directors carry out a risk assessment before signing up to any commitments. Relations with stakeholders The Company is committed to a continuous dialogue with shareholders as it believes that this is essential to ensure Section 172 of the Companies Act 2006 requires Directors to take into consideration the interests of stakeholders in their decision making. The Board is committed to understanding and engaging with all key stakeholder groups of the Company in order to maximise value and promote long-term Company success in line with our strategic objectives. The Board recognises its duties under Section 172 and continuously has regard to how the Company’s activities and decisions will impact employees, those with which it has a business relationship, the community and environment and its reputation for high standards of business conduct. In weighing all of the relevant factors, the Board, acting in good faith and fairly between members, makes decisions and takes actions that it considers will best lead to the long-term success of the Company. During the year, the Board assessed its current activities between the Board and its stakeholders, which demonstrated that the Board actively engages with its stakeholders and takes their various objectives into consideration when making decisions. Specifically, its actions the Board has taken to engage with stakeholders in 2019 include: • Attended the 2019 AGM to answer questions and receive additional feedback from investors; • Arranged meetings with certain stakeholders to provide the Company’s research and development activities and other general corporate updates; them with updates on • Made presentations at conferences and published recordings and slide decks on the Company’s research and development; • Evaluated the relationships with the Company’s various collaborators through management and identified ways to strengthen relationships and arrangements with key collaborations; and • Monitored company culture and engaged with improve to continuously employees on efforts company culture and morale. Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 3333 Viability statement In accordance with the UK Corporate Governance Code published in July 2018, the Directors have assessed the prospects of the Group and concluded that it is appropriate to adopt the going concern basis of accounting. The assessment of going concern is disclosed in note 2. The Board’s assessment of the Group’s current position and principal risks are disclosed in the Directors’ Strategic Report on pages 13-19. Dr Vladislav Sandler CEO The Board believes that appropriate steps and considerations have been taken during the year so that each Director has an understanding of the various key stakeholders of the Company. The Board recognises its responsibility to contemplate all such stakeholder needs and concerns as part of its discussions, decision-making, and in the course of taking actions, and will continue to make stakeholder engagement a top priority in the coming years The Board’s primary shareholder contact is through Peter Redmond, the Non-Executive Director responsible for shareholder relations. The Chairman, the CEO and other Directors, as appropriate, make themselves available for contact with major shareholders and other stakeholders in order to understand their issues and concerns. The Company plans to use the AGM as an opportunity to communicate with its shareholders. Notice of the AGM will be issued shortly and at least 21 days before the date of the meeting. To ensure compliance with the Governance Code, the Board proposes separate resolutions for each issue and proxy forms allow shareholders who are unable to attend the AGM – as may be a particular issue this year in light of travel and meeting restrictions resulting from the COVID-19 pandemic – to vote for or against or to withhold their vote on each resolution. The results of all proxy voting will be published on the Group’s website after the AGM. Shareholders who attend the AGM will have the opportunity to ask questions, and the Company will solicit questions from shareholders who are unable to attend by email in advance of the AGM for consideration. The Group’s web site at https://hemogenyx.com is the primary source of information on the Group. The web site includes an overview of the activities of the Group and all recent Group announcements. 34 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 D I R E C T O R S ’ R E M U N E R A T I O N R E P O R T D I R E C T O R S ’ R E M U N E R A T I O N R E P O R T 35 Company are provided with appropriate incentives to encourage enhanced performance and are, in a fair and responsible manner, rewarded for their individual contributions to the success of the Company; • recommend and monitor the level and structure of remuneration for senior management; • when setting remuneration policy for directors, review and have regard to the remuneration trends across the Company, and review the on-going appropriateness and relevance of the remuneration policy; • obtain reliable, up-to-date information about remuneration in other companies. To help it fulfil its obligations the Committee shall have full authority to appoint remuneration consultants and to commission or purchase any reports, surveys or information which it deems necessary, within any budgetary restraints imposed by the Board; • be exclusively responsible the selection criteria, selecting, appointing and setting the terms of reference for any remuneration consultants who advise the Committee; for establishing • approve the design of, and determine targets for, any performance related pay schemes operated by the Company and approve the total annual payments made under such schemes; • review the design of all share incentive plans for approval by the Board and shareholders. For any such plans, determine each year whether awards will be made, and if so, the overall amount of such awards, the individual awards to executive directors, company secretary and other designated senior executives and the performance targets to be used; • ensure that contractual terms on termination, and any payments made, are fair to the individual, and the Company, that failure is not rewarded and that the duty to mitigate loss is fully recognised; and • oversee any major changes in employee benefits structures throughout the Company. The Company has an established remuneration committee. The Committee reviews the scale and structure of the Directors’ fees, taking into account the interests of shareholders and the performance of the Company and directors. The items included in this report are audited unless otherwise stated. Statement of Hemogenyx Pharmaceutical plc’s Policy on Directors’ Remuneration by the Chairman of the Remuneration Committee As Chairman of the Remuneration Committee I am introduce our Directors’ Remuneration pleased Report. One of the Remuneration Committee’s aims is to provide clear, transparent remuneration reporting for our shareholders which adheres to the best practice corporate governance principles that are required for listed organisations. to The Directors’ Remuneration Policy, which is set out on pages 36 to 40 of this report, will be submitted to shareholders for approval at our Annual General Meeting. A key focus of the Directors’ Remuneration Policy is to align the interests of the Directors to the long-term interests of the shareholders and aims to support a high-performance culture with appropriate reward for superior performance, without creating incentives that will encourage excessive risk taking or unsustainable company performance. This is underpinned through the implementation and operation of incentive plans. Key Activities of the Remuneration Committee • The key activities of the Remuneration Committee are: • to determine and agree with the Board the framework or broad policy for the remuneration of the Company's chairman, chief executive, the executive directors, the company secretary and such other members of the executive management as it is designated to consider; • in determining such policy, take into account all factors which it deems necessary including relevant legal and regulatory requirements, the provisions and recommendations of the UK Corporate Governance Code (the "Code") and associated guidance. The objective of such policy shall be to ensure that members of the executive management of the Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201936 D I R E C T O R S ’ R E M U N E R A T I O N R E P O R T Members The Remuneration Committee comprises the following independent Non-Executive Directors: Name Peter Redmond Alexis Sandler Position Chairman Member Date of appointment 5 October 2017 5 October 2017 Remuneration Components The Company remunerates directors in line with best market practice in the industry in which it operates. The components of Director remuneration that are considered by the Board for the remuneration of directors in future years are likely to consist of: • Base salaries • Pension and other benefits • Annual bonus • Share incentive arrangements The Executive Director has entered into a service agreement with the Company and the Non-Executive Directors have entered into letters of appointment with the Company. All such contracts impose certain restrictions as regards the use of confidential information and intellectual property and the Executive Director’s service contract imposes restrictive covenants which apply following the termination of the agreement. In addition, Dr Vladislav Sandler has a separate contract with Hemogenyx LLC effective 1 September 2017 appointing him as CEO and Chief Scientific Officer of Hemogenyx LLC for a three-year term and setting out his duties in relation to his day-to-day to work in connection with Hemogenyx’s product candidates. Pursuant to this contract, Dr Sandler receives $125,000 per annum and four weeks’ holiday a year. Dr Sandler is also subject to certain non-compete and non-interference covenants in the event of its termination (subject to certain limited exceptions). Dr Sandler also has a separate contract with Immugenyx LLC effective from 1 January 2019 appointing him as CEO and Chief Scientific Officer of Immugenyx LLC for a three-year term and setting out his duties in relation to his day-to-day work in connection with Immugenyx’s development of its AHC. Pursuant to this contract, Dr Sandler receives $60,000 and 10,000 ownership units in Immugenyx LLC per annum. This contract has similar non-compete and non-interference covenants in the event of its termination. Other Matters The Company does not currently have any annual or long-term incentive schemes or any other scheme interests in place for any of the Directors. The Company has established a workplace pension scheme but it does not presently have any employees qualifying under the auto-enrolment pension rules who have not opted out of the scheme. It does not currently pay pension amounts in relation to Directors’ remuneration. The Company has not paid out any excess retirement benefits to any Directors or past Directors. The Company has not paid any compensation to past Directors. Recruitment Policy Base salary levels will take into account market data for the relevant role, internal relativities, their individual experience and their current base salary. Where an individual is recruited at below market norms, they may be re-aligned over time (e.g. two to three years), subject to performance in the role. Benefits will generally be in accordance with the approved policy. For external and internal appointments, the Board may agree that the Company will meet certain relocation and/ or incidental expenses as appropriate. Payment for Loss of Office The Committee will honour Executive Directors’ contractual entitlements. Service contracts do not contain liquidated damages clauses. If a contract is to be Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201937 D I R E C T O R S ’ R E M U N E R A T I O N R E P O R T Service Agreements and Letters of Appointment The Executive Director’s service agreement had an initial term of two years and may subsequently be terminated by the Company or the Executive Director by giving 6 months’ notice. terminated, the Committee will determine such mitigation as it considers fair and reasonable in each case. There is no agreement between the Company and its Executive Directors or employees, providing for compensation for loss of office or employment that occurs because of a takeover bid. The Committee reserves the right to make additional payments where such payments are made in good faith in discharge of an existing legal obligation (or by way of damages for breach of such an obligation); or by way of settlement or compromise of any claim arising in connection with the termination of an Executive Director’s office or employment. Name Date of service agreement Notice period by Company (months) Notice period by Director (months) Dr Vladislav Sandler 4 October 2017 6 6 The Non-Executive Directors of the Company do not have service contracts but are appointed by letters of appointment. Each Non-Executive Director’s term of office runs for an initial period of one year unless terminated earlier upon written notice or upon their resignations. The terms of the Non-Executive Directors’ appointments are subject to their re-election by the Company’s shareholders at any Annual General Meeting at which the Non-Executive Directors stand for re-election. The details of each Non-Executive Director’s current term are set out below: Name Alexis Sandler Peter Redmond Date of service agreement 4 October 2017 4 October 2017 Professor Sir Marc Feldmann 9 April 2018 Current term (years) Notice period by Company (months) Notice period by Director (months) Date of resignation 1 1 3 3 3 3 3 3 3 - - - Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201938 D I R E C T O R S ’ R E M U N E R A T I O N R E P O R T Executive Directors’ Remuneration The table below sets out the remuneration received by each Executive Director for the years ended 31 December 2019 and 2018. Dr Vladislav Sandler was the highest paid Director: Executive Directors Basic salary 2019 £’000 Pension 2019 £’000 Dr Vladislav Sandler Total 145 145 4 4 Executive Directors Basic salary 2018 £’000 Pension 2018 £’000 Dr Vladislav Sandler Lawrence Pemble Total 94 34 138 4 - 4 Share based payments 2019 £’000 32 32 Other* 2019 £’000 - - Share based payments 2018 £’000 Other* 2018 £’000 - 18 18 - - - Total 2019 £’000 177 177 Total 2018 £’000 98 52 150 Non-Executive Directors’ Remuneration The table below sets out the remuneration received by each Non-Executive Director during the years ended 31 December 2019 and 2018: Basic salary 2019 £’000 Share based payments 2019 £’000 Other* 2019 £’000 Dr Robin Campbell Alexis Sandler Peter Redmond Professor Sir Marc Feldmann Total 1 10 36 12 59 - - - - - - - - - - Total 2019 £’000 1 10 36 12 59 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 2019D I R E C T O R S ’ R E M U N E R A T I O N R E P O R T Basic salary 2018 £’000 Share based payments Restated 2018 £’000 Other* 2018 £’000 Dr Robin Campbell Alexis Sandler Peter Redmond Peter Redmond Professor Sir Marc Feldmann Total 45 9 36 3 9 102 19 - - - 90 109 - - - - - - 39 Total 2018 £’000 64 9 36 3 99 211 Relative importance of spend on pay The table below illustrates the year-on-year change in total remuneration compared to distributions to shareholders and loss before tax for the financial years ended 31 December 2019 and 2018: Distributions to shareholders £ Total employee pay £ Operational cash outflow £ Year ended 31 December 2019 Year ended 31 December 2018 Percentage change - - n/a 691,992 813,807 (14.9)% 1,199,873 1,352,727 (11.3)% Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201940 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 D I R E C T O R S ’ R E M U N E R A T I O N R E P O R T Historical share price performance comparison The table below compares the share price performance (based on a notional investment of £100) of Hemogenyx Pharmaceuticals plc against the FTSE SmallCap and FTSE Techmark Mediscience for the period November 2015 to December 2019 calculated on a month end spot basis. The FTSE SmallCap has been chosen to provide a wider market comparator constituting companies of an appropriate size and the FTSE Techmark Mediscience chosen due to sector relevance: Investment Performance Comparison 160.00 140.00 120.00 100.00 80.00 60.00 40.00 20.00 - Nov 15 Apr 16 Sep 16 Feb 17 Jul 17 Dec 17 May 18 Oct 18 Mar 19 Aug 19 HEMO FTSE small cap FTSE Techmark Mediscience Hemogenyx Pharmaceuticals plc was listed in November 2015 (under the name Silver Falcon plc) and therefore no historical share price data exists prior to this period. There was also no data between December 2015 and October 2017 pending completion of a transaction. It is for these reasons that the historical investment performance is not reflective of the current Group. Consideration of shareholder views The Board considers shareholder feedback received and guidance from shareholder bodies. This feedback, plus any additional feedback received from time to time, is considered as part of the Company’s annual policy on remuneration. Approved on behalf of the Board of Directors. Peter Redmond Director & Remuneration Committee Chairman 30 April 2020 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 41 I N D E P E N D E N T A U D I T O R ’ S R E P O R T T O T H E M E M B E R S O F H E M O G E N Y X P H A R M A C E U T I C A L S P L C 42 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 I N D E P E N D E N T A U D I T O R ’ S R E P O R T T O T H E M E M B E R S O F H E M O G E N Y X P H A R M A C E U T I C A L S P L C Opinion We have audited the financial statements of Hemogenyx Pharmaceuticals Plc (the ‘parent company’) and its subsidiaries (the ‘group’) for the year ended 31 December 2019 which comprise the Consolidated Statement of Comprehensive Loss, the Group and Parent Company Statements of Financial Position, the Group and Parent Company Statements of Changes in Equity, the Group and Parent Company Statements of Cash Flows and notes to the financial statements, including a summary of significant accounting policies. The financial reporting framework that has been applied in their preparation is applicable law and International Financial Reporting Standards (IFRSs) as adopted by the European Union and as regards the parent company financial statements, as applied in accordance with the provisions of the Companies Act 2006. • In our opinion: • the financial statements give a true and fair view of the state of the group’s and of the parent company’s affairs as at 31 December 2019 and of the group’s and parent company’s loss for the year then ended; • the group financial statements have been properly prepared in accordance with IFRSs as adopted by the European Union; • the parent company financial statements have been properly prepared in accordance with IFRSs as adopted by the European Union and as applied in accordance with the provisions of the Companies Act 2006; and • the financial statements have been prepared in accordance with the requirements of the Companies Act 2006; and, as regards the group financial statements, Article 4 of the IAS Regulation. Basis for opinion We conducted our audit in accordance with International Standards on Auditing (UK) (ISAs (UK)) and applicable law. Our responsibilities under those standards are further described in the Auditor’s responsibilities for the audit of the financial statements section of our report. We are independent of the group and parent company in accordance with the ethical requirements that are relevant to our audit of the financial statements in the UK, including the FRC’s Ethical Standard as applied to listed public interest entities, and we have fulfilled our other ethical responsibilities in accordance with these requirements. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion. Material uncertainty related to going concern We draw attention to note 2 in the financial statements, which indicates that the Group will need additional equity or non-dilutive funds in the medium term to support its operations. They are in advanced negotiations with several stakeholders and are confident of raising the required funds to ensure they can settle their financial obligations as they fall due. As stated in note 2, these events or conditions, along with the other matters as set forth in note 2, indicate that a material uncertainty exists that may cast significant doubt on the company’s ability to continue as a going concern. Our opinion is not modified in respect of this matter. Our application of materiality For the purposes of determining whether the financial statements are free from material misstatement, we define materiality as the magnitude of misstatement that makes it probable that the economic decisions of a reasonably knowledgeable person, relying on the financial statements, would be changed or influenced. We also determine a level of performance materiality which we use to assess the extent of testing needed to reduce an appropriately low level the probability that the aggregate of uncorrected and undetected misstatements exceeds materiality for the financial statements as a whole. Materiality for the group financial statements was set at £31,000 (2018: £31,000). This was calculated based on 2% of total expenses for the year. Using our professional judgement, we have determined this to be the principal benchmark within the financial statements as it will be most relevant to stakeholders in assessing the financial performance of the group in its early years of development as the Group is not revenue generating. Materiality for the parent company financial statements was set at £25,000. This was calculated based on 2% of total expenses. We have determined this to be the principal benchmark of the parent company as it is not revenue generating. Management target to restrict the 43 I N D E P E N D E N T A U D I T O R ’ S R E P O R T T O T H E M E M B E R S O F H E M O G E N Y X P H A R M A C E U T I C A L S P L C parent company expenditure to a minimum, in order to utilise funds within the growth of the Group. We also determine a level of performance materiality which we use to assess the extent of testing needed to reduce to an appropriately low level the probability that the aggregate of uncorrected and undetected misstatements exceeds materiality for the financial statements as a whole. Performance materiality for the group financial statements was set at £21,700 and the parent company was set at £17,500, being 70% of materiality for the financial statements as a whole respectively. Key audit matters Key audit matters are those matters that, in our professional judgment, were of most significance in our audit of the financial statements of the current period and include the most significant assessed risks of material misstatement (whether or not due to fraud) we identified, including those which had the greatest effect on: the overall audit strategy; the allocation of resources in the audit; and directing the efforts of the engagement team. These matters were addressed in the context of our audit of the financial statements as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters. We agreed to report to those charged with governance all corrected and uncorrected misstatements we identified through our audit with a value in excess of £1,550 and for the parent company a value in excess of £1,250. We also agreed to report any other audit misstatements below that threshold that we believe warranted reporting on qualitative grounds. An overview of the scope of our audit The Group includes the listed parent company and the US based subsidiaries. We tailored the scope of our audit to ensure that we performed enough work to be able to give an opinion on the financial statements as a whole, taking into account the structure of the Group and the Company, the accounting processes and controls, and the industry in which they operate. All entities in the Group were audited by a single engagement team. We did not rely on the work of any component auditors. As part of our planning we assessed the risk of material misstatement including those that required significant auditor consideration at the component and group level. Procedures were then performed to address the risk identified and for the most significant assessed risks of material misstatement, the procedures performed are outlined below in the key audit matters section of this report. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201944 I N D E P E N D E N T A U D I T O R ’ S R E P O R T T O T H E M E M B E R S O F H E M O G E N Y X P H A R M A C E U T I C A L S P L C Key Audit Matter How the scope of our audit responded to the key audit matter Investments in Subsidiary Investment - £8m (note 15) Loan - £1.45m (note 14) The investment in Hemogenyx LLC following the reverse acquisition is the only material asset and represents a significant portion of the Parent Company’s total assets. The Carrying value and recoverability of the investment is ultimately dependent on the value of the underlying assets of the Group. We undertook several audit procedures which included: • Agreeing the accounting entries from supporting documentation and undertaking a review of the acquisition agreement and the admission document issued to investors during the listing. • Reviewing the directors’ assessment of the carrying value and their conclusions thereof. • Our review also included an assessment where we compared the value of the subsidiary’s carrying value plus related party receivables against the market capitalisation of the Group as Hemogenyx Pharmaceuticals plc contains all the Group’s operations. • We also reviewed board minutes for any indications of changes in investments held by the Parent Company and also agreed ownership documents of all the subsidiaries in the Group. We also reviewed the market capitalisation of the Group on the London Stock Exchange at the date of this report as a guide and to provide further assurance of its carrying value subsequent to the year end. Testing in respect of this Key Audit Matter was appropriately covered by the above testing performed. Carrying Value of Intangible Asset (note 13) The carrying value of Intangible Asset recorded in the subsidiary’s books of £273k is the other key risk area as these items will ultimately result in the main source of income for Group. This asset mainly derives from an exclusive licence agreement signed in January 2015, where the Company purchased the patent rights surrounding the two main products it is working on for $347,500. The directors concluded that no impairment was required at this stage and amortisation will commence once the two products are ready for marketing. Our audit procedures included: • Confirmation that the cost of intangibles is correctly recorded by agreeing the price to the supporting documentation. • Review of the directors’ assessment on the intangible assets carrying value and challenging of the underlying assumptions. • Review of the events after the year end for indicators of impairment. During our review of the events after the year end, we also noted that the primary component of its intangible assets received patent confirmation from the US Patent and Trademark Office and the European Patent Office. This further supports the carrying value. Testing in respect of this Key Audit Matter was appropriately covered by the above testing performed. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201945 I N D E P E N D E N T A U D I T O R ’ S R E P O R T T O T H E M E M B E R S O F H E M O G E N Y X P H A R M A C E U T I C A L S P L C Other information The other information comprises the information included in the annual report, other than the financial statements and our auditor’s report thereon. The directors are responsible for the other information. Our opinion on the group and parent company financial statements does not cover the other information and, except to the extent otherwise explicitly stated in our report, we do not express any form of assurance conclusion thereon. In connection with our audit of the financial statements, our responsibility is to read the other information and, in doing so, consider whether the other information is materially inconsistent with the financial statements or our knowledge obtained in the audit or otherwise appears to be materially misstated. If we identify such material inconsistencies or apparent material misstatements, we are required to determine whether there is a material misstatement in the financial statements or a material misstatement of the other information. If, based on the work we have performed, we conclude that there is a material misstatement of this other information, we are required to report that fact. with the UK Corporate Governance Code containing provisions specified for review by the auditor in accordance with Listing Rule 9.8.10R(2) do not properly disclose a departure from a relevant provision of the UK Corporate Governance Code. Opinions on other matters prescribed by the Companies Act 2006 In our opinion the part of the directors’ remuneration report to be audited has been properly prepared in accordance with the Companies Act 2006. In our opinion, based on the work undertaken in the course of the audit: • the information given in the strategic report and the directors’ report for the financial year for which the financial statements are prepared is consistent with the financial statements; and • the strategic report and the directors’ report have been prepared in accordance with applicable legal requirements. We have nothing to report in this regard. Matters on which we are required to report by In this context, we also have nothing to report in regard to our responsibility to specifically address the following items in the other information and to report as uncorrected material misstatements of the other information where we conclude that those items meet the following conditions: • Fair, balanced and understandable set out on page 28 – the statement given by the directors that they consider the annual report and financial statements taken as a whole is fair, balanced and understandable for and provides shareholders to assess the group’s performance, business model and strategy, is materially inconsistent with our knowledge obtained in the audit; or information necessary the • Audit committee reporting set out on page 28 – the section describing the work of the audit committee does not appropriately address matters communicated by us to the audit; or • Directors’ statement of compliance with the UK Corporate Governance Code set out on page 28 – the parts of the directors’ statement required under the Listing Rules relating to the company’s compliance exception In the light of the knowledge and understanding of the group and the parent company and their environment obtained in the course of the audit, we have not identified material misstatements in the strategic report or the directors’ report. We have nothing to report in respect of the following matters in relation to which the Companies Act 2006 requires us to report to you if, in our opinion: • adequate accounting records have not been kept by the parent company, or returns adequate for our audit have not been received from branches not visited by us; or • the parent company financial statements and the part of the directors’ remuneration report to be audited are not in agreement with the accounting records and returns; or • certain disclosures of directors’ specified by law are not made; or remuneration • we have not received all the information and explanations we require for our audit. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201946 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 I N D E P E N D E N T A U D I T O R ’ S R E P O R T T O T H E M E M B E R S O F H E M O G E N Y X P H A R M A C E U T I C A L S P L C Responsibilities of directors As explained more fully in the statement of directors’ responsibilities, which is included in the directors’ report, the directors are responsible for the preparation of the group and parent company financial statements and for being satisfied that they give a true and fair view, and for such internal control as the directors determine is necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error. In preparing the group and parent company financial statements, the directors are responsible for assessing the group’s and the parent company’s ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the directors either intend to liquidate the group or the parent company or to cease operations, or have no realistic alternative but to do so. Auditor’s responsibilities for the audit of the financial statements Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance but is not a guarantee that an audit conducted in accordance with ISAs (UK) will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of these financial statements. A further description of our responsibilities for the audit of the financial statements is located on the Financial Reporting Council’s website at: https://www.frc.org.uk/auditorsresponsibilities. This description forms part of our auditor’s report. Other matters which we are required to address We were appointed by the directors on 2 March 2020 to audit the financial statements for the year ending 31 December 2019. Our total uninterrupted period of engagement is 5 years, covering the periods ending 28 February 2015 to 31 December 2019. The non-audit services prohibited by the FRC’s Ethical Standard were not provided to the group or the parent company and we remain independent of the group and the parent company in conducting our audit. We identified areas of laws and regulations that could reasonably be expected to have a material effect on the financial statements from our sector experience and through discussions with the directors. We considered the extent of compliance with those laws and regulations as part of our procedures on the related financial statement items. We communicated laws and regulations throughout our audit team and remained alert to any indications of non-compliance throughout the audit. identified As with any audit, there remained a higher risk of non- detection irregularities, as these may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal controls. Our audit opinion is consistent with the additional report to the audit committee. Use of our report This report is made solely to the company’s members, as a body, in accordance with Chapter 3 of Part 16 of the Companies Act 2006. Our audit work has been undertaken so that we might state to the company’s members those matters we are required to state to them in an auditor’s report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to anyone, other than the company and the company's members as a body, for our audit work, for this report, or for the opinions we have formed. Zahir Khaki (Senior Statutory Auditor) For and on behalf of PKF Littlejohn LLP Statutory Auditor 15 Westferry Circus Canary Wharf London 30 April 2020 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 47 F I N A N C I A L S T A T E M E N T S F O R T H E Y E A R E N D E D 3 1 D E C E M B E R 2 0 1 9 48 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 C O N S O L I D A T E D S T A T E M E N T O F C O M P R E H E N S I V E I N C O M E Continuing Operations Revenue Administrative Expenses Depreciation Expense Operating Loss Other Income Finance Income Finance Costs Loss before Taxation Income tax Loss for the year Loss attributable to: - Owners of Hemogenyx Pharmaceuticals plc - Non-controlling interests Items that will be reclassified subsequently to profit or loss: Translation of foreign operations Other Comprehensive income for the year Note Year Ended 31 December 2019 £ Year Ended 31 December 2018 Restated £ 6 12 7 10 - - 1,589,407 94,726 1,630,222 51,805 (1,684,133) (1,682,027) 213,126 14,191 (31,328) 91,357 4,374 (1,779) (1,488,144) (1,588,075) 35,000 43,751 (1,453,144) (1,544,324) (1,450,627) (2,517) (1,453,144) (1,544,324) - (1,544,324) 16,176 16,176 51,031 51,031 Total comprehensive income for the year (1,436,968) (1,493,293) Attributable to: Owners of Hemogenyx Pharmaceuticals plc Non-controlling interests Total comprehensive loss for the year Basic and diluted loss per share attributable to the equity owners of the Company 11 (1,434,451) (2,517) (1,436,968) (0.004) (1,493,293) - (1,493,293) (0.004) The notes to the financial statements form an integral part of these financial statements. C O N S O L I D A T E D S T A T E M E N T O F F I N A N C I A L P O S I T I O N Group Note Assets Non-current assets Property, plant and equipment Right of use asset Intangible asset Total non-current assets Current assets Trade and other receivables Cash and cash equivalents Total current assets Total assets Equity and Liabilities Equity attributable to shareholders Paid-in Capital Called up share capital Share premium Other reserves Reverse asset acquisition reserve Foreign currency translation reserve Retained Earnings Equity attributable to owners of the Company Non-controlling interests Total Equity Liabilities Non-current liabilities Lease liabilities Borrowings Total non-current liabilities Current liabilities Trade and other payables Total Liabilities Total Current Liabilities Total Liabilities Total equity and liabilities 12 13 14 17 18 19 20 4 13 23 22 13 49 Year Ended 31 December 2019 £ Year Ended 31 December 2018 Restated £ 123,922 109,442 262,050 495,414 55,804 498,679 554,483 173,943 - 272,753 446,696 90,475 1,762,428 1,852,903 1,049,897 2,299,599 3,612,429 7,699,789 399,229 (6,157,894) 53,223 (5,953,294) (346,518) (2,517) (349,035) 73,192 1,144,167 1,217,359 141,677 39,896 181,573 3,601,762 7,340,267 686,851 (6,157,894) 37,047 (4,548,867) 959,166 - 959,166 - 1,172,826 1,172,826 167,607 - 167,607 1,398,932 1,340,433 1,049,897 2,299,599 The notes to the financial statements form an integral part of these financial statements. This report was approved by the Board and authorised for issue on 30 April 2020 and signed on its behalf by: Dr Vladislav Sandler, CEO Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201950 C O M P A N Y S T A T E M E N T O F F I N A N C I A L P O S I T I O N Company Note Year Ended 31 December 2019 £ Year Ended 31 December 2018 Restated £ Assets Non-current assets Loan to subsidiaries Investment in subsidiary Total non-current assets Current assets Trade and other receivables Cash and cash equivalents Total current assets Total assets Equity and Liabilities Equity attributable to shareholders Paid-in Capital Called up share capital Share premium Other reserves Retained Earnings Total Equity Liabilities Current liabilities Trade and other payables Total Current Liabilities Total Liabilities 15 16 17 18 19 20 22 1,570,839 8,000,000 9,570,839 6,282 14,505 20,787 1,453,736 8,000,000 9,453,736 75,972 461,003 536,975 9,591,626 9,990,711 3,612,429 7,699,789 386,662 (2,205,815) 9,493,065 3,601,762 7,340,267 680,564 (1,765,967) 9,856,626 98,561 98,561 134,085 134,085 98,561 134,085 Total equity and liabilities 9,591,626 9,990,711 Hemogenyx Pharmaceuticals plc has used the exemption granted under s408 of the Companies Act 2006 that allows for the non-disclosure of the Income Statement of the parent company. The after-tax loss attributable to Hemogenyx Pharmaceuticals plc for the year ended 31 December 2019 was £486,048 (2018: £602,874 restated). The notes to the financial statements form an integral part of these financial statements. This report was approved by the Board and authorised for issue on 30 April 2019 and signed on its behalf by Dr Vladislav Sandler, CEO Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201951 C O N S O L I D A T E D S T A T E M E N T O F C H A N G E S I N E Q U I T Y Group Called up Share Capital Share Premium Other reserves Reverse acquisition reserve Foreign currency translation reserve Retained earnings Non- Controlling interests Total Equity £ £ £ £ £ £ £ £ As at 1 January 2018 3,600,514 7,341,056 369,147 (6,157,894) (13,984) (3,006,982) Loss in year Other Comprehensive Income Total comprehensive income for the year Issue of shares – exercise of warrants Embedded derivate on convertible note Issue of options Writeback of options lapsed Write-back of warrants exercised - - - - - - 1,248 3,745 - - - - - - - - - - - 309,322 (2,439) (4,534) 4,534 - - - - 6,287 - - - (1,544,324) 51,031 - 51,031 (1,544,324) - - - - - - - - (2,439) - As at 31 December 2018 3,601,762 7,340,267 686,851 (6,157,894) 37,047 (4,548,867) - - - - - - - - - - 2,131,857 (1,544,324) 51,031 (1,493,293) 4,993 6,287 309,322 - - 2,131,857 Loss in year Other Comprehensive Income Total comprehensive income for the year - - - - - - Issue of shares 10,667 21,333 - - - - Embedded derivate on convertible note Issue of options Writeback of options lapsed Write-back of warrants lapsed - - - - - - - 6,280 90,487 (46,200) 338,189 (338,189) - - - - - - - - - (1,450,627) (2,517) (1,453,144) 16,176 - - 16,176 16,176 (1,450,627) (2,517) (1,436,968) - - - - - - - - 46,200 - - - - - - 32,000 6,280 90,487 - - As at 31 December 2019 3,612,429 7,699,789 399,229 (6,157,894) 53,223 (5,953,294) (2,517) (349,035) The notes to the financial statements form an integral part of these financial statements. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201952 C O M P A N Y S T A T E M E N T O F C H A N G E S I N E Q U I T Y Company Called up Share Capital Share Premium Other reserves Retained earnings/(loss) Total Equity As at 1 January 2018 3,600,514 7,341,056 369,147 (1,165,532) 10,145,185 £ £ £ £ £ As at 31 December 2018 3,601,762 7,340,267 680,564 (1,765,967) 9,856,626 Loss in year Other Comprehensive Income Total comprehensive income for the year Issue of shares – exercise of warrants Issue of options Write-back of options lapsed Write-back of warrants exercised - - - - - - 1,248 3,745 - - - Loss in year Other Comprehensive Income Total comprehensive income for the year - - - - - - Issue of shares 10,667 21,333 - - - - - - - 309,322 (602,874) (602,874) - - (602,874) (602,874) - - 4,993 309,322 (2,439) 2,439 (4,534) 4,534 - - - - - - - 90,487 (486,048) (486,048) - - (486048) (486,048) - - 32,000 90,487 - - Issue of options Write-back of options lapsed Write-back of warrants lapsed - - - (46,200) 46,200 338,189 (338,189) - As at 31 December 2019 3,612,429 7,699,789 386,662 (2,205,815) 9,493,065 The notes to the financial statements form an integral part of these financial statements. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201953 C O N S O L I D A T E D S T A T E M E N T O F C A S H F L O W S Group Note Year Ended 31 December 2019 £ Year Ended 31 December 2018 Restated £ Cash flows generated from operating activities Loss before income tax Depreciation Other Non-cash items interest/professional fees (shares issued) Interest income Interest expense Reverse Acquisition Expense Compensation settled in shares Share based payments Foreign exchange gain (Decrease)/increase in trade and other payables Decrease/(increase) in trade and other receivables 12 4 20 (1,453,144) 94,726 - (14,191) 31,328 - 32,000 90,487 20,745 (17,880) 16,056 (1,544,324) 51,805 - (4,374) 1,779 - - 309,322 (49,000) (98,670) (19,266) Net cash outflow used in operating activities (1,199,873) (1,352,728) Cash flows generated from financing activities Proceeds from issuance of equity securities Proceeds from borrowings Payment of lease liabilities 23 13 - - (39,393) 4,993 1,175,915 - Net cash flow generated from financing activities (39,393) 1,180,908 Cash flows generated from investing activities Interest income Interest paid Purchase of property, plant & equipment Net cash flow generated from investing activities 14,191 - (11,918) 2,273 4,374 (6) (24,589) (20,221) Net (decrease)/increase in cash and cash equivalent (1,236,993) (192,041) Effect of exchange rates on cash (26,756) 77,814 Cash and cash equivalents at the beginning of the period Cash and cash equivalents at the end of the period 1,762,428 498,679 1,876,655 1,762,428 The notes to the financial statements form an integral part of these financial statements. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201954 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 C O M P A N Y S T A T E M E N T O F C A S H F L O W S Company Cash flows generated from operating activities Loss before income tax Other Non-cash items interest/professional fees (shares issued) Foreign exchange (gain) loss Interest income Interest expense Compensation settled in shares Share based payments (Decrease) in trade and other payables Decrease/(increase) in trade and other receivables 20 Note Year Ended 31 December 2019 £ Year Ended 31 December 2018 Restated £ (486,048) (602,874) - 48,621 (76) - 32,000 90,487 (35,524) 69,692 - (105,351) (1,267) 6 - 309,322 (129,514) (9,959) Net cash outflow used in operating activities (280,848) (539,637) Cash flows generated from financing activities Proceeds from issuance of equity securities Net cash flow generated from financing activities Cash flows generated from investing activities Interest income Interest paid Loan to related parties Net cash flow generated from investing activities - - 76 - (151,914) (151,838) 4.993 4.993 1,267 (6) (802,951) (801,690) Net (Decrease)/increase in cash and cash equivalent (432,686) (1,336,334) Effect of exchange rates on cash (13,812) 49,000 Cash and cash equivalents at the beginning of the period Cash and cash equivalents at the end of the period 461,003 14,505 1,748,337 461,003 The notes to the financial statements form an integral part of these financial statements. Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 55 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S 56 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S the discovery, development 1. General information The Group’s business is preclinical-stage biotechnology focused on and innovative treatments relating commercialisation of to bone marrow/hematopoietic (blood-forming) stem cell (BM/HSC) transplants for blood diseases, including leukaemia, lymphoma and bone marrow failure. The products under development are designed to address a range of problems that occur with current standard of care treatments. The Company’s registered office is located at 5 Fleet Place, London EC4M 7RD, and it is listed on the London Stock Exchange. The Company’s registered office is located at 5 Fleet Place, London EC4M 7RD, and it is listed on the London Stock Exchange. 2. Summary of significant accounting policies The principal accounting policies applied the preparation of these financial statements are set out below. These policies have been consistently applied to all the years presented, unless otherwise stated. in Basis of preparation in The financial statements have been prepared accordance with International Financial Reporting Standards (“IFRS”) and IFRS Interpretations Committee (IFRS IC) interpretations as adopted for use by the European Union, and the Companies Act 2006. The financial statements have been prepared under the historical cost convention. Basis of consolidation The consolidated financial statements comprise the financial statements of Hemogenyx Pharmaceuticals plc and its subsidiaries as at 31 December 2019. The financial statements of the subsidiaries are prepared for the same reporting period as the parent company, using consistent accounting policies. intra-group balances, transactions, income and All expenses and profits and losses resulting from intra- group transactions that are recognised in assets, are eliminated in full. Subsidiaries are fully consolidated from the date of acquisition, being the date on which the Group obtains control, and continue to be consolidated until the date that such control ceases. Control is triggered by the acquisition of the majority or all of the share capital of subsidiaries. Please refer to note 4 for information on the consolidation of Hemogenyx LLC. Hemogenyx Pharmaceuticals plc has used the exemption grated under s408 of the Companies Act 2006 that allows for the non-disclosure of the Income Statement of the parent company. The after-tax loss attributable to Hemogenyx Pharmaceuticals plc for the year ended 31 December 2019 was £458,113 (2018: £553,476 restated). Research and development expenditure i. Research and development Expenditure on research activities, undertaken with the prospect of gaining new scientific or technical knowledge and understanding, is expensed in profit or loss as incurred. Development activities involve a plan or design for the production of new or substantially improved products and processes. Development expenditures are capitalised only if development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, and the Company intends to, and has sufficient resources to, complete development and to use or sell the asset. No development costs have been capitalised to date. ii. Clinical trial expenses Clinical trial expenses are a component of the Company's research and development costs. These expenses include fees paid to contract research organisations, clinical sites, and other organisations who conduct development activities on the Company's behalf. The amount of clinical trial expenses recognised in a period related to clinical agreements are based on estimates of the work performed using an accrual basis of accounting. These estimates incorporate factors such as patient enrolment, services provided, contractual terms, and prior experience with similar contracts. iii. Government grants Government grants relate to financial grants from governments, public authorities, and similar local, national or international bodies. These are recognised when there is a reasonable assurance that the Company 57 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S will comply with the conditions attaching to them, and that the grant will be received. Government grants relating to research and development are off-set against the relevant costs. Internally generated IP costs are written off as incurred except where IAS 38 criteria, as described in research and development above, would require such costs to be capitalised. Intangibles Research and development is written off as Research expenditure incurred. Development costs are capitalised only if the expenditure can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, the Group intends to and has sufficient resources to complete development and to use or sell the asset, and it is able to measure reliably the expenditure attributable to the intangible asset during its development. The Group’s view is that capitalised assets have a finite useful life and to that extent they should be amortised over their respective unexpired periods with provision made for impairment when required. Assets capitalised are not amortised until the associated product is available for use or sale. Amortisation is calculated using the straight-line method to allocate the costs of development over the estimated useful economic lives. Estimated useful economic life is assessed by reference to the remaining patent life and may be adjusted after taking into consideration product and market characteristics such as fundamental building blocks and product life cycle specific to the category of expenditure. Intellectual property (IP) IP assets (comprising patents, know-how, copyright and licences) acquired by the Group as a result of a business combination are initially recognised at fair value or as a purchase at cost and are capitalised. The following rates are used: Computer equipment Laboratory equipment The Group’s view is that capitalised IP assets have a finite useful life and to that extent they should be amortised over their respective unexpired periods with provision made for impairment when required. Capitalised IP assets are not amortised until the Group is generating an economic return from the underlying asset and as such no amortisation has been incurred to date as the products to which they relate are not ready to be sold on the open market. When the trials are completed and the products attain the necessary accreditation and clearance from the regulators, the Group will assess the estimated useful economic like and the IP will be amortised using the straight-line method over their estimated useful economic lives. Fixed assets All property, plant and equipment are stated at historical cost less accumulated depreciation or impairment value. Cost includes the original purchase price and expenditure that is directly attributable to the acquisition of the items to bring the asset to its working condition. Depreciation is provided at rates calculated to write off the cost less estimated residual value of each asset over its expected useful economic life. Assets held under finance leases, if any, are depreciated over their expected useful economic life on the same basis as owned assets, or where shorter, the lease term. Assets are reviewed for impairment when events or changes in circumstances indicate that the carrying amount may not be recoverable. 33% 20% - 50% Straight-line Straight-line Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201958 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S Impairment of non-financial assets The Group is required to review, at least annually, whether there are indications (events or changes in circumstances) that non-financial assets have suffered impairment and that the carrying amount may exceed the recoverable amount. If there are indications of impairment then an impairment review is undertaken. An impairment charge is recognised within operating costs for the amount by which the carrying amount exceeds its recoverable amount. The recoverable amount is the higher of the asset’s fair value less costs to sell and the value-in-use. In the event that an intangible asset will no longer be used, for example, when a patent is abandoned, the balance of unamortised expenditure is written off. Impairment reviews require the estimation of the recoverable amount based on value-in-use calculations. Non-financial assets relate typically to investments in related parties and in-process development and patents, and require broader assumptions than for developed technology. Key assumptions taken into consideration relate to technological, market and financial risks and include the chance of product launch taking into account the stage of development of the asset, the scale of milestone and royalty payments, overall market opportunities, market size and competitor activity, revenue projections, estimated useful lives of assets (such as patents), contractual relationships and discount rates to determine present values of cash flows. Investments Equity investments in subsidiaries are held at cost, less any provision for impairment. As there is no quoted price in an active market, fair value cannot be reliably measured. Going concern requires The preparation of financial statements an assessment on the validity of the going concern assumption. The Directors have given particular thought to the impact on the Group that may result from the novel coronavirus and any other potential pandemics that may arise. The Group’s New York operations are classed as an essential business and are not subject to closure, and so work continues with prudent hygiene and distancing measures in place including limited work in the laboratory on rota and work from home. The Group is allowing for extended delivery times for some supplies, and for slower progress with collaboration partners. The Board and UK management continue to operate remotely, as usual. At present the Group believes that there should be no material disruption to its work, but the Board continues to monitor these risks and the Group’s business continuity plans. The Directors have reviewed projections for a period of at least 12 months from the date of approval of the financial statements. The financial statements have been prepared on the going concern basis. The Group’s forecasts and projections, taking account of reasonably possible changes in trading performance, show that the Group will require further funding in the medium term. The Group faces a degree of uncertainty at present as a result of impact from the novel coronavirus, including its ability to access further funding. Any actions relating to fundraising are currently delayed pending the outcome of discussions with collaboration partners and until the financial markets return to more regular patterns of activity. The Directors note that the Group has always been successful with past fundraisings and continue to believe strongly in the Group’s products and the value of its intellectual property. They therefore believe that the Group has or will have access to sufficient funding in order to execute its operations over the next 12 months. Therefore the Directors consider the going concern basis appropriate. Trade and other receivables and payables Trade and other receivables are amounts due from customers for merchandise sold or services performed in the ordinary course of business. If collection is expected in one year or less (or in the normal operating cycle of the business if longer), they are classified as current assets. If not, they are presented as non-current assets. Trade and other receivables are recognised initially at fair value, and subsequently measured at amortised cost using the effective interest method, less provision for impairment. Other liabilities measured at amortised cost are obligations to pay for goods or services that have been acquired in the ordinary course of business from Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201959 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S suppliers. The liabilities are classified as current liabilities if payment is due within one year or less (or in the normal operating cycle of the business if longer. If not, they are presented as non-current liabilities. The liabilities are recognised initially at fair value, and subsequently measured at amortised cost using the effective interest method. Foreign currencies Functional and presentation currency The Company’s presentation currency is the British Pound Sterling (“£”). The functional currency for the Company, being the currency of the primary economic environment in which the Company operates, is the British Pound Sterling. The individual financial statements of each of the Company’s wholly owned subsidiaries are prepared in the currency of the primary economic environment in which it operates (its functional currency). The financial statements of Hemogenyx LLC, Immugenyx LLC and Hemogenyx-Cell SPRL have been translated in to Pound Sterling in accordance with IAS 21 The Effects of Changes in Foreign Exchange Rates. This standard requires that assets and liabilities be translated using the exchange rate at period end, and income, expenses and cash flow items are translated using the rate that approximates the exchange rates at the dates of the transactions (i.e. the average rate for the period). The foreign exchange differences on translation of Hemogenyx LLC, Immugenyx LLC and Hemogenyx-Cell SPRL are recognised in other comprehensive income (loss). Foreign currency transactions Foreign currency transactions are translated into the functional currency using the exchange rates prevailing on the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at period- end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in profit and loss. Share capital Ordinary Shares are classified as equity. Equity instruments issued by the Hemogenyx Group are recorded at the proceeds received, net of direct issue costs. Cash Cash consists of cash bank deposit balances. Share-based payments The Group has applied the requirements of IFRS 2 Share- based Payment for all grants of equity instruments. The Group operates an equity-settled share option plan to certain shareholders. The fair value of the service received in exchange for the grant of options and warrants is recognised as an expense. Equity-settled share based payments are measured at fair value (excluding the effect of non-market based vesting conditions) at the date of grant. The fair value determined at the grant date of equity-settled share-based payment is expensed on a graded vesting basis over the vesting period, based on the Group's estimate of shares that will eventually vest and adjusted for the effect of non-market based vesting conditions. Fair value is measured by use of the Black-Scholes model. The expected life used in the models has been adjusted, based on management's best estimate, for the effects of non-transferability, exercise restrictions, and behavioural considerations. In addition, the Group issues equity-settled share-based payments to the directors and senior management (“Employee Share Options”) and to corporate finance advisers for assistance in raising private equity and to its Scientific Advisory Board members (“Non-employee Share Options”). Equity-settled share-based payments are measured at fair value at the date of grant for Employee Share Options and the date of service for Non-employee Share Options. The fair value determined at the grant date or service date, as applicable, of the equity-settled share-based payments is expensed, with a corresponding credit to equity, on a straight-line basis over the vesting period, based on the Group’s estimate of shares that will eventually vest. At each subsequent reporting date, the Group calculates the estimated Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201960 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S cumulative charge for each award having regard to any change in the number of options that are expected to vest and the expired portion of the vesting period. The change in this cumulative charge since the last reporting date is expensed with a corresponding credit being made to equity. Once an option vests, no further adjustment is made to the aggregate amount expensed. The fair value is calculated using the Black Scholes method for both Employee and Non-employee Share Options as management views the Black Scholes method as providing the most reliable measure of valuation. The expected life used in the model has been adjusted, based on management’s best estimate, for the effects of non-transferability exercise restrictions and behavioural considerations. The market price used in the model is the issue price of Company shares at the last placement of shares immediately preceding the calculation date. The fair values calculated are inherently subjective and uncertain due to the assumptions made and the limitation of the calculations used. Prior year adjustment Due to an oversight the value of options issued in October 2017 and April 2018 was calculated in accordance with the Black Scholes method of options valuation using a 2 year expected life whereas the expected lives of the options should have been 5 years and 3 years respectively. The options have been recalculated using the correct expected lives. As a result the loss for 2018 was understated by £66,792. There was no impact on the cash flow statement and the changes to the Statement of Financial Position were in the Equity section only. Further details are disclosed in note 26. Taxation Current tax The charge for current taxation is based on the results for the year as adjusted for items that are non-assessable or disallowed. It is calculated using rates that have been enacted, or substantially enacted, by the balance sheet date. Current income tax assets and liabilities are measured at the amount expected to be recovered from or paid to the relevant taxation authorities. Deferred tax Deferred income tax is recognised on all temporary differences arising between the tax bases of assets and liabilities and their carrying amounts in the financial statements, with the following exceptions: • where the temporary difference arises from the initial recognition of goodwill or of an asset or liability in a transaction that is not a business combination and, at the time of the transaction, affects neither accounting nor taxable profit or loss; • in respect of taxable temporary differences associated with investment in subsidiaries, associates and joint ventures, where the timing of the reversal of the temporary differences can be controlled and it is probable that the temporary differences will not reverse in the foreseeable future; and • deferred income tax assets are recognised only to the extent that it is probable that taxable profit will be available against which the deductible temporary differences, carried forward tax credits or tax losses can be utilised. Deferred income tax assets and liabilities are measured on an undiscounted basis at the tax rates that are expected to apply when the related asset is realised or liability is settled, based on tax rates and laws enacted or substantively enacted at the statement of financial position date. The carrying amount of deferred income tax assets is reviewed at each statement of financial position date. Deferred income tax assets and liabilities are offset, only if a legally enforcement right exists to set off current tax assets against current tax liabilities, the deferred income taxes related to the same taxation authority and that authority permits the Company to make a single net payment. Income tax is charged or credited directly to equity if it relates to items that are credited or charged to equity. Otherwise income tax is recognised in the statement of comprehensive income. Financial Assets and Liabilities Financial assets and liabilities are recognised in the Company’s statement of financial position when the Company becomes a party to the contractual provisions Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201961 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S of the instrument. The Company currently does not use derivative financial instruments to manage or hedge financial exposures or liabilities. Loans and receivables are non-derivative financial assets with fixed or determinable payments that are not quoted in an active market. They are included in current assets, except for maturities greater than 12 months after the end of the reporting period. These are classified as non- current assets. The Company’s loans and receivables comprise Trade and Other Receivables and Cash and Cash Equivalents in the Statement of Financial Position. Impairment of Financial Assets The Company and Group assesses at each reporting date whether a financial asset is impaired and will recognise the impairment loss immediately through the consolidated statement of comprehensive loss. Interest Bearing Loans and Borrowings Borrowings are initially recognised at the fair value less directly attributable of consideration received transaction costs. After initial recognition, borrowings are subsequently measured at amortised cost using the effective interest rate method. Where borrowings are provided by shareholders at an interest rate discounted to market rates, the difference on initial fair value is taken to equity as a capital contribution. Where the Group has entered into a hybrid instrument whereby there is a debt instrument and an embedded derivative financial liability, the fair value of the debt instrument less the fair value of the derivative financial liability is equal to loan recognised on initial measurement. IFRS 15, Revenue from Contracts with Customers IFRS 15 establishes principles for reporting useful information to users of financial statements about the nature, amount, timing, and uncertainty of revenue and cash flows arising from an entity’s contracts with customers. The standard is effective for annual periods beginning on or after 1 January 2018, and supersedes: IAS 11 Construction Contracts, IAS 18 Revenue, IFRIC 13 Customer Loyalty Programmes, IFRIC 15 Agreements for the Construction of Real Estate, IFRIC 18 Transfers of Assets from Customers, and SIC-31 Revenue—Barter Transactions Involving Advertising Services. The standard establishes a five-step principle-based approach for revenue recognition and is based on the concept of recognising an amount that reflects the consideration for performance obligations only when they are satisfied, and the control of goods or services is transferred. The majority of the Group’s revenue is derived from fees related to collaboration agreements. Management reviewed contracts where the Group received consideration in order to determine whether or not they should be accounted for in accordance with IFRS 15. To date, Hemogenyx has entered into few transactions that meet the scope of IFRS 15. Instead, most income has been generated through collaboration agreements and grants with counterparties that do not meet the definition of a customer, and therefore the contracts fall outside the scope of IFRS 15 and have been accounted for in accordance with IAS 20. Income is recognised at either a point-in-time or over time, depending on the nature of the services and existence of acceptance clauses. Segmental reporting The Group’s operations are located in New York, USA and, in Liège, Belgium with the head office located in the United Kingdom. The main assets of the Group, cash and cash equivalents, are held in the United Kingdom, Belgium and the United States. The Board ensures that adequate amounts are transferred internally to allow all companies to carry out their operational on a timely basis. The Group currently has one reportable segment – a biotechnology company focused on the discovery, development and commercialisation of innovative to bone marrow/hematopoietic treatments relating (blood-forming) stem cell (BM/HSC) transplants for blood disease. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201962 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S New Accounting Standards and Interpretations issued and applied in the Financial Statements IFRS 16, Leases IFRS 16 replaces the current guidance in IAS 17 – ‘Leases’. Under IAS 17, lessees were required to make a distinction between a finance lease (on balance sheet) and an operating lease (off balance sheet). IFRS 16 requires lessees to recognise a lease liability reflecting future lease payments and a ‘right-of-use asset’ for virtually all lease contracts. IFRS 16 includes an optional exemption for certain short- term leases and leases of low-value assets; however, this exemption can only be applied by lessees. For lessors, the accounting remains substantially unchanged. IFRS 16 provides updated guidance on the definition of a lease (as well as the guidance on the combination and separation of contracts); under IFRS 16, a contract is, or contains, a lease if the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. The standard is effective for periods commencing on or after 1 January 2019 and has been endorsed by the EU. Under the provisions of the standard most leases including the majority of those previously classified as operating leases, will be brought onto the statement of financial position, as both a right-of-use asset and a largely offsetting lease liability. The right-of-use asset and lease liability are both based on the present value of lease payments due over the term of the lease, with the asset being depreciated in accordance with IAS 16 'Property, Plant and Equipment' and the liability increased for the accretion of interest and reduced by lease payments. IFRS 16 Leases has been applied for the first time in preparing the annual report and financial statements. Note 13 sets out the key impacts on the Consolidated Statement of Comprehensive Loss and the Consolidated Statement of Financial Position of the adoption of the new standard. New Accounting Standards and Interpretations in issue but not applied in the Financial Statements i. New standards, amendments and Interpretations in issue but not yet effective or not (and in some cases have not yet been adopted by the EU): The standards and interpretations that are issued, but not yet effective, up to the date of issuance of the financial statements are listed below. The Company intend to adopt these standards, if applicable, when they become effective. These are summarised below: Amendments to References to the Conceptual Framework in IFRS Standards: Included are revised definitions of an asset and a liability as well as new guidance on measurement and derecognition, presentation and disclosure. [Issued 29 March 2018, applies to accounting periods beginning on or after 1 January 2020, subject to EU endorsement]. Amendment to IFRS 3: Business Combinations: The amendments clarify that to be considered a business, an acquired set of activities and assets must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create outputs. The definition removes the reference to an ability to reduce costs, and the assessment of whether market participants are capable of replacing any missing inputs or processes and continuing to produce outputs. An optional concentration test that permits a simplified assessment of whether an acquired set of activities and assets is not a business has been included as part of the amendments. [Issued 22 October 2018, applies to accounting periods beginning on or after 1 January 2020, subject to EU endorsement]. Amendments to IAS 1 and IAS 8: Definition of Material: The amendments clarify the definition of material and how it should be applied. The amendments ensure that the definition of material is consistent across all IFRS Standards. [Issued 31 October 2018, applies to accounting periods beginning on or after 1 January 2020, subject to EU endorsement]. The Group has not early adopted any of the above standards and the directors are assessing the impact on future financial statements. There are no other IFRS or IFRIC interpretations that are not yet effective that would be expected to have a material impact on the Group. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 2019 63 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S 3. Significant accounting judgements, estimates and assumptions The preparation of the financial statements in conformity with International Financial Reporting Standards requires the use of certain critical accounting estimates. It also requires management to exercise its judgement in the process of applying the Company’s accounting policies. Estimates and judgements are continually evaluated, and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances. The estimates and assumptions that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed below. The principal areas in which judgement is applied are as follows: Fair value disclosure The embedded derivative elements of the convertible notes are measured using a risk-based pricing model. For more information in relation to the fair value measurement of this derivative please refer to note 23. Valuation of stock options Management uses the Black Scholes model to value the share options. The model requires use of assumptions regarding volatility, risk free interest rate and a calculation of the value of the option at the time of the grant. Please see note 20 for details. is an Intangible assets impairment When there indicator of a significant and permanent reduction in the value of intangible assets, an impairment review is carried out. The impairment analysis is principally based on estimated discounted future cash flows. The determination of the assumptions is subjective and requires the exercise of considerable judgement. Any changes in key assumptions about the outcome of research and development activity, probability of technical and regulatory success, amount and timing of projected future cash flow or changes in market conditions could materially affect whether an impairment exists. 4. Reverse acquisition and LSE listing On 4 October 2017, the Company acquired the entire issued share capital of Hemogenyx LLC, a private company incorporated in the United States, by way of a share for share exchange. Although the transaction resulted in Hemogenyx LLC becoming a wholly owned subsidiary of the Company, the transaction constitutes a reverse acquisition in as much as the shareholders of Hemogenyx LLC own a substantial majority of the outstanding ordinary shares of the Company and 2 out of 4 (5 as of 31 December 2018) members of the Board of Directors of the Company are Hemogenyx LLC shareholders and management. In substance, the shareholders of Hemogenyx LLC acquired a controlling interest in the Company and the transaction has therefore been accounted for as a reverse acquisition. As the Company previously discontinued its investment activities and was engaged in acquiring Hemogenyx LLC and raising equity financing to provide the required funding for the operations of the acquisition and re-listing on the main market of the LSE, it did not meet the definition of a business according to the definition in IFRS 3. Accordingly, this reverse acquisition does not constitute a business combination and was accounted for in accordance with IFRS 2 Share- based payment and IFRIC guidance, with the difference between the equity value given up by the Hemogenyx LLC shareholders and the share of the fair value of net assets gained by the Hemogenyx LLC shareholders charged to the statement of comprehensive income as the cost of acquiring a main market LSE quoted listing. Following the completion of the transaction the Company changed its name to Hemogenyx Pharmaceuticals plc. In accordance with reverse acquisition accounting principles, these consolidated financial statements represent a continuation of the consolidated financial statements of Hemogenyx LLC and include: a. The assets and liabilities of Hemogenyx LLC at their pre-acquisition carrying amounts and the results for both periods; and b. The assets and liabilities of the Company as at 31 December 2017 and its results from 5 October 2017 to 31 December 2017. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201964 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S On 4 October 2017, the Company issued 228,571,428 shares for all 21,923,076 shares of Hemogenyx LLC. The fair value of net assets of Silver Falcon plc was as follows: On 4 October 2017, the quoted share price of Hemogenyx Pharmaceuticals plc was £0.035 and therefore this valued the investment in Hemogenyx LLC at £8,000,000. Because the legal subsidiary, Hemogenyx LLC, was treated as the accounting acquirer and the legal Parent Company, Hemogenyx Pharmaceuticals plc, formerly known as Silver Falcon plc, was treated as the accounting subsidiary, the fair value of the shares deemed to have been issued by Hemogenyx LLC was calculated at £2,341,500 based on an assessment of the purchase in Hemogenyx consideration Pharmaceuticals plc. for a 100% holding Cash and cash equivalents Other assets Liabilities Net assets £ 1,098,640 60,641 (448,800) 710,480 The difference between the deemed cost and the fair value of the net assets acquired of £1,631,020 has been expensed in accordance with IFRS 2, Share based payments, reflecting the economic cost to the Hemogenyx LLC shareholders of acquiring a quoted entity. Year Ended 31 December 2019 Year Ended 31 December 2018 Year Ended 31 December 2017 As at start of year Pre-acquisition losses of Hemogenyx Pharmaceuticals plc1 Hemogenyx LLC issued capital at acquisition2 Investment in Hemogenyx LLC3 Reverse acquisition expense4 £ (6,157,894) £ (6,157,894) - - - - - - - - As at end of year (6,157,894) (6,157,894) £ - (799,763) 1,010,849 (8,000,000) 1,631,020 (6,157,894) The movements on the Reverse acquisition reserve are as follows: 1. These consolidated financial statements present the legal capital structure of the Company. However, under reverse acquisition accounting rules, the Company was not acquired until 4 October 2017 and therefore the entry above is required to eliminate the initial retained losses of the Company. 2. Hemogenyx LLC had issued share capital of equivalent to £1,010,849 as at 4 October 2017. As these financial statements present the capital structure of the parent entity, the issue of equity by Hemogenyx LLC has been recorded in this reserve. 3. The Company issued 228,571,428 shares at £0.35 each, totalling £8,000,000 for the entire issued capital of Hemogenyx LLC. The above entry is required to eliminate the balance sheet impact of this transaction. 4. The reverse acquisition accounting is described in detail in note 4. The entry above represents the difference between the value of the equity issued by the Company, and the deemed consideration given by Hemogenyx LLC to acquire the Company. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201965 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S 5. Segment Information The Group has one reportable segment, the development of breakthrough therapies for the treatment of blood diseases, and administrative functions in the United Kingdom. The following tables present expenditure and certain asset information regarding the Group’s geographical segments for the year ended 31 December 2019: Year Ended 31 December 2019 Year Ended 31 December 2018 Revenue SEGMENT ASSETS United Kingdom • Non-current • Current United States • Non-current • Current Belgium • Non-current • Current Total • Non-current • Current CAPITAL EXPENDITURE United Kingdom United States Belgium £ - 20,787 495,414 513,729 - 19,967 495,414 554,483 - 11,918 - 11,918 £ - 536,976 446,696 1,315,927 - - 446,696 1,852,903 - 24,589 - 24,589 Capital expenditure consists of the purchase of property, plant and equipment. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201966 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S 6. Expenses by nature Group Group Year Ended 31 December 2019 Year Ended 31 December 2018 Restated Laboratory expenses Consumable equipment and supplies Contractors & consultants Travel Staff Costs Insurance Other Operating lease expense Legal and professional fees Foreign exchange loss / (gain) Total Administrative Expenses £ 21,246 400,571 47,666 33,505 691,992 50,499 74,815 - 256,091 13,021 1,589,407 £ 57,653 290,613 40,350 14,632 813,807 50,926 19,804 45,283 291,899 5,255 1,630,222 7. Other income Other income of £213,126 during the year to 31 December 2019 (2018: £91,357) relates to funds received from a third party under a research collaboration programme. 8. Employees Wages and salaries Social security Share based payments Pension contributions Group Group Company Company Year Ended 31 December 2019 Year Ended 31 December 2018 Restated Year Ended 31 December 2019 Year Ended 31 December 2018 Restated £ 547,127 40,667 90,487 13,711 691,992 £ 470,580 23,279 £ 118,251 - £ 145,142 - 309,322 90,487 309,322 10,626 813,807 - - 208,738 454,464 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201967 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S Average number of people (including Executive Directors) employed: Group Group Company Company Year Ended 31 December 2019 Year Ended 31 December 2018 Year Ended 31 December 2018 Year Ended 31 December 2019 5 2 7 5 2 7 - 2 2 - 2 2 Research & development Administration 9. Auditor’s remuneration Fees payable to the Company auditor: Audit of the financial statements of the Group and Company 10. Income tax Current Tax: Corporation tax on loss for the year New York City Biotech tax credit – prior years Deferred Tax Tax on loss on ordinary activities Company Company Year Ended 31 December 2019 Year Ended 31 December 2018 £ £ 45,000 45,000 36,500 36,500 Company Company Year Ended 31 December 2019 Year Ended 31 December 2018 Restated £ - 35,000 - 35,000 £ - 43,751 - 43,751 Loss on ordinary activities before tax (1,453,144) (1,588,075) Analysis of charge in the year: Loss on ordinary activities multiplied by weighted average tax rate for the group of 26.16% (2018: 30.46%) Disallowed items Timing differences Tax losses carried forward Current Tax charge (380,142) 23,137 - (357,005) - (483,727) 99,265 - (384,462) - Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201968 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S Weighted average tax rate is calculated by reference to the tax rates effective in each of the jurisdictions. The tax rates effective at 31 December 2019 are 19%, 27.5% and 29.58% in the UK, the USA and Belgium respectively. The Group has accumulated tax losses arising in the UK of approximately £880,391 (Dec 2018: restated £713,000) that should be available, under current legislation, to be carried forward against future profits. No deferred tax asset has been recognised against these losses. The Group has tax losses carried forward in the US of £1,450,000 available under current rules until 2037. No deferred tax asset has been recognised against these losses. 11. Earnings per share The calculation of the basic and fully diluted earnings per share is calculated by dividing the loss for the year from continuing operations attributable to equity owners of the Group of £(1,450,626) (2018 Restated: £(1,544,324)) by the weighted average number of ordinary shares in issue during the year of 360,719,748 (2018: 360,125,230). Dilutive loss per Ordinary Share equals basic loss per Ordinary Share as, due to the losses incurred in 2019 and 2018, there is no dilutive effect from the subsisting share options. 12. Property, plant and equipment Group Cost 31 December 2017 Additions Foreign exchange movement 31 December 2018 Additions Foreign exchange movement 31 December 2019 Accumulated depreciation and impairment losses 31 December 2017 Depreciation Foreign exchange movement 31 December 2018 Depreciation Foreign exchange movement 31 December 2019 Carrying amounts 31 December 2017 31 December 2018 31 December 2019 Property, plant & equipment Computer equipment £ 235,698 24,589 14,590 274,877 6,355 (11,118) 270,114 44,120 51,805 5,009 100,934 55,464 (6,062) 150,336 191,578 173,943 119,778 £ - - - - 5,563 (184) 5,379 - - - - 1,284 (49) 1,235 - - 4,144 Total £ 235,698 24,589 14,590 274,877 11,918 (11,302) 275,493 44,120 51,805 5,009 100,934 56,748 (6,111) 151,571 191,578 173,943 123,922 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201969 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S 13. Leases The Group has adopted IFRS 16 using the modified retrospective approach with the effect of applying this standard at the date of initial recognition of 1 January 2019. Consequently comparatives have not been restated. As a lessee, the Group has previously classified leases as operating or finance leases based on whether the lease transferred significantly all of the risks and rewards incidental to the ownership of the underlying asset. Under IFRS 16, the Group recognises right-of-use assets and lease liabilities for all leases on its balance sheet. Each of the two US subsidiaries has an agreement for the lease of laboratory facilities to which IFRS 16 has been applied. The key impacts on the Statement of Comprehensive Income and the Statement of Financial Position are as follows: Group & Company Balance on transition Additions Depreciation Interest Lease payments Foreign exchange movements Carrying value at 31 December 2019 Right of use asset Lease liability Income statement £ - 145,923 (37,978) - - 1,497 109,442 £ - (145,923) - (6,830) 39,393 272 £ - - (37,978) (6,830) - - (113,088) (44,808) 14. Intangible assets On 15 January 2015, the Company entered into an Exclusive License Agreement with Cornell University to grant to the Company patent rights to patent PCT/US14/65469 entitled Post-Natal Hematopoietic Endothelial Cells and Their Isolation and Use and rights to any product or method deriving therefrom. The Company paid Cornell University $347,500, consisting of cash payments of $22,500 and a convertible promissory note in the amount of $325,000. Cost 31 December 2017 Exchange movements 31 December 2018 Exchange movements 31 December 2019 Intellectual Property £ 257,525 15,228 272,753 (10,703) 262,050 The carrying value of intangible assets is reviewed for indications of impairment whenever events or changes in circumstances indicate that the carrying value may exceed the recoverable amount. The products to which they relate are not ready to be sold on the open market. When the trials are completed and the products attain the necessary accreditation and clearance from the regulators, the Group will assess the estimated useful economic like and the IP will be amortised using the straight-line method over their estimated useful economic lives. The directors are of the view that no impairment is required as the test results to date have been very positive and these products are now being Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201970 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S moved on the clinical trial phase. Accordingly, the directors continue to believe that the products will eventually attain the necessary accreditation and clearance from the regulators and so no impairment has been considered necessary. Amortisation will be charged to operating costs in the Statement of Comprehensive Income when the Group achieves product sales. 15. Loan to subsidiary Loan to Hemogenyx LLC Company Year Ended 31 December 2019 Company Year Ended 31 December 2018 £ 1,570,839 1,570,839 £ 1,453,736 1,453,736 Hemogenyx Pharmaceuticals plc has made cumulative loans to Hemogenyx LLC of US$2,096,915 (£1,570,839) as at 31 December 2019 (Dec 2018 US$1,896,915; £1,453,736). The loans are interest free and will be repaid when Hemogenyx LLC’s operational cash flow allows. Management has undertaken an impairment assessment of the loan as at 31 December 2019 and has determined that that there was no impairment required. The interest rate and impairment assessment are reviewed on an annual basis. 16. Investment in subsidiary Name Address of the registered office Nature of business Proportion of ordinary shares held directly by parent (%) Proportion of ordinary shares held ultimately by parent (%) Hemogenyx UK Limited 5 Fleet Place, London, UK EC4M 7RD Holding Company 100 - Hemogenyx LLC 9 East Lookerman Street, Suite 3A, Dover, Kent, Delaware, USA, 19901 Immugenyx LLC c/o Corporation Service Company 251 Little Falls Drive, Wilmington, Delaware, USA, 19808 Biomedical sciences - 100 Biomedical sciences - 97.85% Hemogenyx-Cell SPRL Avenue du Parc Industriel 89, 4041 Milmort, Belgique Biomedical sciences - 100 The remaining shares in Immugenyx LLC are held by Dr Vladislav Sandler and by an employee, Carina Sirochinsky, as part of their compensation under their respective roles as CEO and Director of Operations. Hemogenyx LLC owns 500,000 shares in Immugenyx LLC, and Dr Sandler and Ms Sirochinsky receive 10,000 and 1,000 shares respectively for each year of employment from January 2019. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201971 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S 17. Trade and other receivables Group Group Company Company Year Ended 31 December 2019 Year Ended 31 December 2018 Year Ended 31 December 2019 Year Ended 31 December 2018 £ £ £ £ VAT receivable 2,237 64,361 2,237 64,361 Trade & other receivables Prepayments Total trade and other receivables 30,075 23,492 - 26,114 55,804 90,475 - 4,045 6,282 - 11,612 75,973 There are no material differences between the fair value of trade and other receivables and their carrying value at the year end. Number of shares 360,051,358 124,826 360,176,184 1,066,667 361,242,853 No receivables were past due or impaired at the year end. 18. Called up share capital Company As at 31 December 2017 Issue of shares for exercise of warrants 29 May 2018 As at 31 December 2018 Issue of shares 28 June 2019 As at 31 December 2019 19. Share premium Group & Company As at 31 December 2017 Issue of shares for exercise of warrants 29 May 2018 Value of warrants issued in connection with share placements As at 31 December 2018 Issue of shares 28 June 2019 Writeback of value of placement warrants lapsed As at 31 December 2019 £ 3,600,514 1,248 3,601,762 10,667 3,612,429 £ 7,341,056 3,745 (4,534) 7,340,267 21,333 338,189 7,699,789 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201972 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S 20. Other reserves Group As at start of year Charge for the year – employees Fair value of warrants issued in connection with share placement Fair value of warrants lapsed Fair value of options lapsed Convertible Note embedded derivative As at end of year Company As at start of year Charge for the year - employees Fair value of warrants issued in connection with share placement Fair value of warrants lapsed Fair value of options lapsed As at end of year Year Ended 31 December 2019 Year Ended 31 December 2018 Restated £ 686,851 90,487 - (338,189) (46,200) 6,280 399,229 £ 369,147 309,322 4,534 - (2,439) 6,287 686,851 Year Ended 31 December 2019 Year Ended 31 December 2018 Restated £ 680,564 90,487 - (338,189) (46,200) 386,662 £ 369,147 309,322 4,534 - (2,439) 680,564 The expense recognised for employee and non-employee services during the year is shown in the following table: Group and Company Expense arising from equity-settled share-based payment transactions Total expense arising from share-based payment transactions Year Ended 31 December 2019 Year Ended 31 December 2018 Restated £ 90,487 90,487 £ 309,322 309,322 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201973 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S Employee Plan Under the Employee Plan (“EMP”) share options are granted to directors and employees at the complete discretion of the Company. The fair value of the options is determined by the Company at the date of the grant. Options granted vest in tranches on each of the following events/dates: i. Admission to the LSE (“Admission”); ii. On the date falling six (6) months after Admission; iii. On the date falling twelve Admission; and iv. On the date falling twenty-four (24) months after Admission (12) months after On the provision that the option holder remains an employee of the Group. Options granted to all other option holders from 4 January 2018 onwards vest in equal tranches of 12.5% every three months from the date of grant, until fully vested. The fair value of the options is determined using the Black Scholes method as stated in note 2. The contractual life of each option granted is between two and five years. There are no cash settlement alternatives. Options are settled when the Company receives a notice of exercise and cash proceeds from the option holder equal to the aggregate exercise price of the options being exercised. Employees, including directors* Members of the Scientific Advisory Board Total Non-Employee Plan Under the Non-Employee Plan (“NEMP”) share options are granted to non-employees at the complete discretion of the Company. The exercise price of the options is determined by the Company at the date of the grant. The options vest at the date of the grant. The fair value of the options is determined using the Black Scholes method as stated in note 2 and not the value of services provided as this is deemed the most appropriate method of valuation. In all cases non- employee option holders received cash remuneration in consideration for services rendered in accordance with agreed letters of engagement. The contractual life of each option granted ranges from two to five years. There are no cash settlement alternatives. Volatility was determined by calculating the volatility for three similar listed companies and applying the average of the four volatilities calculated. Options are settled when the Company receives a notice of exercise and cash proceeds from the option holder equal to the aggregate exercise price of the options being exercised. A schedule of options granted is below: Number options 21,206,951 11,146,751 32,353,702 * Details of options held by individual directors are disclosed in the Directors’ Report. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201974 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S Group & Company 2019 Number 2019 WAEP2 pence 2017 Number 2017 WAEP3 pence Outstanding at the beginning of the year Granted during the year Lapsed during the year Cancelled during the year 36,071,741 712,085 (6,230,750) - Outstanding at end of year 30,553,076 Exercisable at end of year 22,428,934 3.5 24,566,957 3.5 3.5 - 3.5 3.5 19,426,737 (2,581,310) (5,340,643) 36,071,741 16,339,066 3.5 3.5 3.5 3.5 3.5 3.5 The weighted average remaining contractual life for the share options outstanding as at 31 December 2019 is 2.84 years (2018: 1.25). The weighted average fair value of options granted during the year was 0.007 pence (2018: 0.01). The weighted average fair value of options cancelled or lapsed during the year was 0.018 pence (2018: 0.008). The exercise price for options outstanding at the end of the year was 3.5 pence (2018: 3.5). The following table lists the inputs to the models used for the two plans for the years ended 31 December 2019 and 31 December 2018: Expected volatility % Risk-free interest rate % Expected life of options (years) WAEP - pence Expected dividend yield Model used Jan-2019 (EMP) 52.12 0.956 5 3.5 - Black Scholes Group & Company Nov 2018 (EMP) Apr 2018 (EMP) Jan 2018 (EMP) Oct2017 (EMP) Expected volatility % Risk-free interest rate % Expected life of options (years) WAEP - pence Expected dividend yield 44.06 0.818 5 3.5 - 45.32 0.918 3 3.5 - 46.88 0.577 5 3.5 - 63.82 0.472 5 3.5 - Model used Black Scholes Black Scholes Black Scholes Black Scholes 2/3 Weighted average exercise price Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201975 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S Warrants The share placement that completed on 4 October 2017 with the issue of 57,142,857 shares at £0.035 carried 1 for 2 warrants for qualifying shareholders over 62,021,429 new ordinary shares at £0.04 per share. In order to qualify for these warrants the shareholder must have retained the shares for a period of 60 days after admission. The warrants expired on 4 October 2019. The following table lists the inputs to the models used for the plan for the year ended 31 December 2018: Expected volatility % Risk-free interest rate % Expected life of options (years) WAEP - pence Expected dividend yield Model used (NEMP) 39.56 0.472 2 4.0 - Black Scholes 21. Capital and reserves The nature and purpose of equity and reserves are as follows: Share capital comprises the nominal value of the ordinary issued share capital of the Company. Share premium represents consideration less nominal value of issued shares and costs directly attributable to the issue of new shares. Other reserves represents the value of options in connection with share-based payments, warrants connected with share placements issued by the Company, and the value of the deemed embedded derivative connected with the Convertible Note liability in accordance with IAS39. Reverse asset acquisition reserve is the reserve created in accordance with the acquisition of Hemogenyx LLC on 5 October 2017 in accordance with IFRS 2. Foreign currency translation reserve is used to recognise the exchange differences arising on translation of the assets and liabilities of foreign branches and subsidiaries with functional currencies other than Pounds Sterling, as well as the revaluation of intercompany loans. Retained earnings represent the cumulative retained losses of the Company at the reporting date. Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201976 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S 22. Trade and other payables Group Group Company Company Year Ended 31 December 2019 Year Ended 31 December 2018 Year Ended 31 December 2019 Year Ended 31 December 2018 £ 61,407 80,270 £ £ £ 91,373 34,561 66,727 76,234 64,000 67,358 141,677 167,607 98,561 134,085 141,677 - 167,607 - 98,561 - 134,085 - Trade and other payables Accruals and deferred income Total Current liabilities Non-current liabilities 23. Borrowings The borrowings are comprised of borrowings and convertible notes. As of 1 January 2018 the Group adopted IFRS 9, and as a result, where the instruments contained liability classified embedded derivatives, an election was taken to fair value the entire financial instrument through profit and loss rather than split out the embedded derivative. The notes payable consists of the following: Group & Company Non-current Borrowings Balance at 1 January Drawdowns Interest expense Value of embedded derivative transferred to Other Reserves Foreign exchange movement Balance at 31 December 2019 Convertible Notes Balance at 1 January Drawdowns Interest expense Value of embedded derivative transferred to Other Reserves Foreign exchange movement Balance at 31 December 2019 Total Borrowings at 31 December 2019 Year Ended 31 December 2019 Year Ended 31 December 2018 £ 583,269 - 12,743 (6,280) (18,104) 571,628 589,557 - 11,755 (6,040) (22,733) 572,539 1,144,167 £ - 587,245 882 (6,287) 1,429 583,269 - 588,670 882 - 5 589,557 1,172,826 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201977 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S A summary of the debt facilities is as follows: liabilities and deferred payment. During 2018 Orgenesis entered in to two debt facility agreements with the Group, one each with Hemogenyx LLC and Immugenyx LLC. On 7 November 2018 the Group entered in to a loan agreement with Orgenesis Inc., an organisation with which the Group has an existing collaboration agreement. The loan amount was for not less than US$1,000,000 with the proceeds of the loan to be used solely for the development of the cell therapy technology in accordance with the plan of the collaboration agreement. As at reporting date drawdowns totalling US$750,000 (£587,245) had been made with Hemogenyx LLC receiving the funds. The loan carries an interest rate of 2% and has a term of three years. Orgenesis has the option to convert both principal and accrued interest in to equity in Hemogenyx-Cell at any time prior to maturity. Hemogenyx-Cell SPRL (“Hemo-Cell”) is a wholly owned Belgian entity and was incorporated in April 2019 at which point this loan facility was treated as a borrowing in accordance with the provisions of IAS39. through On 7 November 2018 the Group entered in to a loan its wholly owned subsidiary agreement Immugenyx LLC, with Orgenesis Inc., an organisation with which the Group has an existing collaboration agreement. The loan amount was for not less than US$1,000,000 with the proceeds of the loan to be used solely for the development of the cell therapy technology in accordance with the plan of the collaboration agreement. As at reporting date drawdowns totalling US$750,000 (£588,670) had been made. The loan carries an interest rate of 2% and has a term of three years. Orgenesis has the option to convert both principal and accrued interest in to equity in Immugenyx LLC at any time prior to maturity. 24. Related party disclosures There were no related party disclosures other than Directors’ remuneration as disclosed in the Remuneration Report section of the Directors’ Report. There are no key management personnel other than the Directors and the Company Secretary. 25. Financial instruments The Group’s financial instruments consist of cash, amounts receivable, accounts payable and accrued Fair value of financial assets and liabilities Fair values have been determined for measurement and/or disclosure purposes based on the following methods. When applicable, further information about the assumptions made in determining fair values is disclosed in the notes specific to that asset or liability. The carrying amount for cash, accounts receivable, and accounts payable and accrued liabilities on the statement of financial position approximate their fair value because of the limited term of these instruments. The fair value of deferred payment approximates its fair value. The investment is carried at cost as it is not traded on an active market. Fair value hierarchy Financial instruments that are measured subsequent to initial recognition at fair value are grouped in Levels 1 to 3 based on the degree to which the fair value is observable: • Level 1 fair value measurements are those derived from quoted prices (unadjusted) in active markets for identical assets or liabilities; and • Level 2 fair value measurements are those derived from inputs other than quoted prices included within level 1 that are observable for the asset or liability, either directly (i.e. as prices) or indirectly (i.e. derived from prices); and • Level 3 fair value measurements are those derived from valuation techniques that include inputs for the asset or liability that are not based on observable market data (unobservable inputs). The Group did not have any financial instruments in Level 1, 2 and 3. Financial risk management objectives and policies The Company has exposure to the following risks from its use of financial instruments: • • • Credit risk Liquidity and funding risk Market risk Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201978 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S The following table sets out the categories of financial instruments held by the Company as at the year ended 31 December 2019 and period ended 31 December 2018: Group Group Company Company Year Ended 31 December 2019 Year Ended 31 December 2018 Year Ended 31 December 2019 Year Ended 31 December 2018 £ £ £ £ 32,312 64,361 2,237 64,361 Assets Trade and other receivables, except prepayments Cash and cash equivalents 498,679 1,762,428 14,505 461,003 Right of use assets 109,442 - - - 640,433 1,826,789 16,742 525,364 Liabilities Trade and other payables Lease liabilities Borrowings (61,407) (113,088) (1,144,167) (1,318,662) (167,607) (34,561) (134,085) - (1,172,826) (1,340,433) - - - - (34,561) (134,085) Group 1 January 2019 Cash flows Non-cash changes 31 December 2019 Share repayment Foreign exchange movements Interest charge Long-term borrowings Short-term borrowings 1,172,826 - Total 1,172,826 - - - - - - (53,157) 24,498 1,144,167 - - - (53,157) 24,498 1,144,167 Group 1 January 2018 Cash flows Non-cash changes 31 December 2018 Share repayment Foreign exchange movements Interest charge Long-term borrowings Short-term borrowings Total - - - 1,175,915 - 1,175,915 - - - (4,853) 1,764 1,172,826 - - - (4,853) 1,764 1,172,826 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201979 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S a) Credit risk The Group had receivables of £28,279 owing from customers (31 December 2018: £nil). All bank deposits are held with Financial Institutions with a minimum credit rating of AAA. b) Liquidity and funding risk The Group regularly reviews its major funding positions to ensure that it has adequate financial resources in meeting its financial obligations. The Group takes liquidity risk into consideration when deciding its sources of funds. The principle liquidity risk facing the business is the risk of going concern which has been discussed in note 2. c) Market risk Interest rate risk Interest rate risk is the risk that the value of financial instruments will fluctuate due to changes in market interest rates. The Group's income and operating cash flows are substantially independent of changes in market interest rates as the Group has no significant interest-bearing assets. The borrowings issued at fixed rates expose the Group to fair value interest rate risk. The Company's management monitors the interest rate fluctuations on a continuous basis and acts accordingly. The Company has floating rate financial assets in the form of deposit accounts with major banking institutions; however, it is not currently subjected to any other interest rate risk. Based on cash balances as above as at the statement of financial position date, a rise in interest rates of 1% would not have a material impact on the profit and loss of the Company and such is not disclosed. The interest rates on the Convertible Notes are fixed and hence a rise in interest rates of 1% would not have a material impact on the profit and loss of the Group and such is not disclosed. In relation to sensitivity analysis, there was no material difference to disclosures made on financial assets and liabilities. At the reporting date the interest rate profile of interest- bearing financial instruments was: Group Group Company Company Year Ended 31 December 2019 Year Ended 31 December 2018 Year Ended 31 December 2019 Year Ended 31 December 2018 £ £ £ £ Financial Assets Cash and cash equivalents 498,679 1,762,428 14,505 461,003 Financial Liabilities Borrowings (1,144,167) (1,172,826) - - Foreign currency risk The Group operates internationally and has monetary assets and liabilities in currencies other than the functional currency of the operating company involved. The Group seeks to manage its exposure to this risk by ensuring that where possible, the majority of expenditure and cash of individual subsidiaries within the Group are denominated in the same currency as the functional currency of that subsidiary. The Group has not entered into any derivative instruments to manage foreign exchange fluctuations. The following table shows a currency of net monetary assets and liabilities by functional currency of the underlying companies for the years ended 31 December 2019 and 31 December 2018: Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 2019 80 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S 31 December 2019 Functional Currency Currency of net monetary assets/(liabilities) Pound Sterling £ US Dollars £ - (679,961) - 13,354 1,151 - 14,505 (679,961) Euro £ - (571,628) 19,967 (551,661) Pound Sterling US Dollars US Dollars Total 31 December 2018 Functional Currency Currency of net monetary assets/(liabilities) Pound Sterling £ US Dollars £ Pound Sterling US Dollars US Dollars Total 109,654 351,348 - 461,002 - 26,184 - 26,184 Euro £ - - - - Total £ 13,354 (1,250,438) 19,967 (1,217,117) Total £ 109,654 377,532 - 487,186 Capital risk management The Group defines capital as the total equity of the Company. The Group’s objectives when managing capital are to safeguard the Group’s ability to continue as a going concern in order to provide returns for shareholders and benefits for other stakeholders and to maintain an optimal capital structure to reduce the cost of capital. In order to maintain or adjust the capital structure, the Group may adjust the amount of dividends paid to shareholders, return capital to shareholders, issue new shares or sell assets to reduce debt. Fair value of financial assets and liabilities There are no material differences between the fair value of the Group’s financial assets and liabilities and their carrying values in the financial statements. 26. Prior year restatement Due to an oversight the value of options issued in October 2017 and April 2018 was calculated in accordance with the Black Scholes method of options valuation using a 2 year expected life where the expected lives of the options should have been 5 years and 3 years respectively. The options have been recalculated using the correct expected lives. As a result the loss for 2018 was understated by £66,792. There was no impact on the cash flow statement and the changes to the Statement of Financial Position were in the Equity section only. The effect of this change on the trading result for the year ended 31st December 2018 is shown below. Consolidated Statement of Comprehensive Loss: Administrative expenses increased by £66,792 Loss for the year attributable to equity owners increase by £66,792 Statement of Changes in Equity Group and Company: Total comprehensive loss for the year to 31 December 2018 increased by £66,792 Other reserves increased by £66,792 Retained losses at 31 December increased by £66,792 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201981 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S Statement of Financial Position Consolidated and Company: Other reserves increased by £66,792 Retained losses at 31 December increased by £66,792 A third statement of financial position as at the beginning of the preceding period has not been presented in accordance with IAS paragraph 40(a) as the amount relating to the preceding period is immaterial. 27. Commitments Licence Milestone and royalty payments that may become due under the licence agreement are dependent on, among other factors, clinical trials, regulatory approvals and ultimately the successful development of a new drug, the outcome and timing of which are uncertain. certain development, The Group’s minimum future payments contingent regulatory upon meeting total £780,484 and commercialisation milestones ($1,035,000) plus £377,045 ($500,000) on receipt of marketing approval from each additional market excluding the United States of America and the European Union. Upon commencement of commercial production, the Group will pay a royalty between 2 to 5% on all net sales. In addition, the Group pays an annual licence maintenance fee of up to £56,557 ($75,000) until the commercial sales are achieved. 28. Ultimate controlling party The Directors have determined that there is no controlling party as no individual shareholder holds a controlling interest in the Company. 29. Subsequent events 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 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. 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 Hemogenyx Pharmaceuticals plcAnnual Report & Financial Statements for the Year Ended 31 December 201982 Hemogenyx Pharmaceuticals plc Annual Report & Financial Statements for the Year Ended 31 December 2019 N O T E S T O T H E F I N A N C I A L S T A T E M E N T S 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. 30. Copies of the annual report Copies of the annual report will be available on the Company’s website at https://hemogenyx.com and from the Company’s registered office, 5 Fleet Place London EC4M 7RD. H E M O G E N Y X P H A R M A C E U T I C A L S P L C W W W . H E M O G E N Y X . C O M

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