▸ Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations or prospects.· ● 1 ▸ EU drug marketing and reimbursement regulations may materially affect our ability to market and receive coverage for our products in the EU Member States.· ● 1 ▸ If any collaborator fails to fulfill its responsibilities in a timely manner, or at all, our research, clinical· ● 1 ▸ If the market opportunities for any of our product candidates are smaller than we estimate, even assuming approval of a product candidate, our revenue may be adversely affected, and our business may suffer.· ● 1 ▸ If we are unable to establish sales, marketing and distribution capabilities on our own or through collaborations with partners, we may not be successful in commercializing any approved drugs.· ● 1 ▸ If we or any third-party manufacturers we engage fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs or liabilities that could harm our business.· ● 1 ▸ Obtaining and maintaining marketing approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining marketing approval of our product candidates in other jurisdictions.· ● 1 ▸ Our ability to use net operating losses to offset future income may be subject to certain limitations.· ● 1 ▸ Our business depends on the health of the global economies. If the conditions of the global economies· ● 1 ▸ Our business is subject to risks associated with conducting business internationally.· ● 1 ▸ Our future growth may depend, in part, on our ability to commercialize products in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.· ● 1 ▸ Our intellectual property rights may not adequately protect our technologies and product candidates and may not necessarily address all potential threats to our competitive advantage.· ● 1 ▸ Raising additional capital may cause significant dilution to our shareholders or restrict our operations.· ● 1 ▸ group Risks Related to Commercialization, Marketing and Competition· ● 1 ▸ Risks Related to Discovery, Development and Regulatory Approval of Our Product Candidates· ● 1 ▸ group Risks Related to Our Financial Position and Our Capital Requirements· ● 1 ▸ We rely on third parties to conduct, supervise and monitor our preclinical studies and clinical trials, and if those third parties perform in an unsatisfactory manner it may harm our business.· ● 1 ▸ With respect to certain patents, we enjoy only limited geographical protection, and as a consequence we may not be able to protect our intellectual property rights throughout the world.· ● 1 ▸ As a public company, we incur significant legal, accounting and other expenses, including costs associated with public company reporting requirements. We also incur costs associated with current corporate governance● · 1 ▸ As of March 29, 2024, our directors and executive officers, together with their affiliates and related persons, beneficially own, in the aggregate, approximately 39% of our outstanding ordinary shares. Our Chairman,● · 1 ▸ Changes in patent laws or patent jurisprudence could diminish the value of our patents, thereby impairing our ability to protect our products or product candidates.● · 1 ▸ Chronic dosing of patients with nomacopan could lead to an immune response that causes adverse reactions or impairs the activity of the drug.● · 1 ▸ Environmental, social and corporate governance (“ESG”) issues, including those related to climate change and sustainability, may have an adverse effect on our business, financial condition and results of operations and damage our reputation.● · 1 ▸ Future changes associated with pharmaceutical product or drug reimbursement policies may adversely affect our business.● · 1 ▸ Future sales and issuances of the ADSs or rights to purchase ADSs and any equity financing that we pursue, could result in significant dilution of the percentage ownership of our shareholders and could cause our ADS price to fall.● · 1 ▸ Healthcare reform legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates.● · 1 ▸ If any of our product candidates are approved, but fail to achieve market acceptance or such market is smaller than anticipated, we may not be able to achieve forecasted revenues, if any.● · 1 ▸ If at the time of a takeover offer the Takeover Panel determines that we have our place of central management and control in the United Kingdom, we will be subject to a number of rules and restrictions, including● · 1 ▸ If clinical trials or marketing authorization processes for nomacopan are prolonged, delayed or suspended, we may be unable to commercialize nomacopan on a timely basis.● · 1 ▸ If nomacopan is not convenient for patients to use, then we might be prevented from successful commercialization.● · 1 ▸ If physicians and patients do not adopt our future products or if the market size for indications for which any product candidate is approved is smaller than expected, we may be unable to achieve forecasted revenues, if any.● · 1 ▸ If product liability lawsuits are successfully brought against us or any of our partners, we may incur substantial liabilities and may be required to limit commercialization of any approved products.● · 1 ▸ If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.● · 1 ▸ If we fail to develop and commercialize other product candidates, we may be unable to generate revenues.● · 1 ▸ Long-term animal toxicity and long-term human safety studies of nomacopan could demonstrate that the administration of nomacopan results in serious adverse events.● · 1 ▸ Nomacopan has not yet received marketing authorization for the treatment of any indications, and unexpected problems may arise that could cause us to delay, suspend or terminate our development efforts. To date,● · 1 ▸ Our business could suffer if we are unable to attract and retain key employees.● · 1 ▸ Our employees, principal investigators, consultants, commercial partners or vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards.● · 1 ▸ Our inability to enroll a sufficient number of patients for any of our clinical trials would result in significant delays or may require us to abandon one or more clinical trials.● · 1 ▸ Ownership of our ADSs and/or ordinary shares involves a high degree of risk.● · 1 ▸ Results of earlier preclinical studies or clinical trials may not be predictive of advancement to the next phase of development.● · 1 ▸ Risks Related to the Clinical Development and Marketing Authorization of Our Product Candidates● · 1 ▸ group Risks Related to the Proposed Merger with Peak Bio● · 1 ▸ group Risks Relating to Our Financial Position and Our Business● · 1 ▸ The efficacy of nomacopan may not be known until advanced stages of testing, after we have incurred significant product development costs which may not be recoverable.● · 1 ▸ The receipt of orphan drug designation status does not change the regulatory requirements or process for obtaining marketing approval and orphan drug designation does not mean that marketing approval will be granted.● · 1 ▸ There is no guarantee that the Merger will increase shareholder value or that Peak Bio will be successfully integrated into our operations or achieve its desired benefits.● · 1 ▸ We may be subject to healthcare laws and regulations, and health information privacy and security laws, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.● · 1 ▸ We only have a limited number of employees to manage and operate our business.● · 1 ▸ Any pandemic, epidemic, or outbreak of an infectious disease, may materially and adversely affect our business and our financial results and could cause a disruption to the development of our product candidates.● ● 2 ▸ Holders of ADSs must act through the depositary to exercise their rights as shareholders of our Company.● ● 2 ▸ Holders of our ADSs may be subject to limitations on transfers of ADSs.● ● 2 ▸ If we are deemed or become a passive foreign investment company for U.S. federal income tax purposes in 2024 or in any prior or subsequent years, there may be negative tax consequences for U.S. taxpayers that are holders of our ADSs.● ● 2 rw ▸ If we or our partners market products in a manner that violates fraud and abuse and other healthcare laws, or if we or they violate government price reporting laws, we or our partners may be subject to administrative civil and/or criminal penalties.● ● 2 ▸ Insiders own a significant amount of our outstanding shares which could delay or prevent a change in corporate control or result in the entrenchment of management and/or the board of directors.● ● 2 ▸ Others may claim an ownership interest in our intellectual property, which could expose us to litigation and have a significant adverse effect on our prospects.● ● 2 rw ▸ Our business and operations could suffer in the event of computer system failures or security breaches.● ● 2 ▸ Our business, operating results and growth rates may be adversely affected by current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk.● ● 2 ▸ Our industry is highly competitive, and our product candidates may become obsolete.● ● 2 ▸ Our success depends in part on our ability to protect our intellectual property and proprietary technologies.● ● 2 rw ▸ Provisions in our Articles of Association and under English law could make an acquisition of our Company more difficult and may prevent attempts by our shareholders to replace or remove our organization management.● ● 2 ▸ Provisions in the UK City Code on Takeovers and Mergers may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our shareholders.● ● 2 ▸ group Risks Related to Intellectual Property● ● 2 rw ▸ group Risks Related to Our Reliance on Third Parties● ● 2 ▸ group Risks Related to our Business Operations● ● 2 ▸ group Risks Related to our Ordinary Shares and ADSs● ● 2 ▸ The UK government has confirmed that the EEA is adequate, and so all transfers of personal data from the UK to the EEA will continue to be unrestricted after July 1, 2021.● ● 2 ▸ The market price of our ADSs may be volatile and may fluctuate in a way that is disproportionate to our operating performance.● ● 2 ▸ The rights of holders of our ADSs to participate in any future rights offerings may be limited, which may cause dilution to their holdings, and they may not receive cash dividends if it is impractical to make them available to them.● ● 2 rw ▸ The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation.● ● 2 ▸ The withdrawal of the United Kingdom from the EU (Brexit) could adversely affect our business, financial condition, results of operations and prospects.● ● 2 rw ▸ U.S. investors are urged to consult their own tax advisors regarding the possible application of the PFIC rules.● ● 2 ▸ U.S. investors may not be able to enforce their civil liabilities against our Company or certain of our directors, controlling persons and officers.● ● 2 ▸ Use of third partiesto manufacture our product candidates may increase the risk that we will not have sufficient quantities of our product candidates, products, or necessary quantities at an acceptable cost.● ● 2 ▸ We do not anticipate paying cash dividends, and accordingly, shareholders must rely on appreciation in our ADSs for any return on their investment.● ● 2 ▸ We have a history of operating losses and cannot give assurance of future revenues or operating profits.● ● 2 rw ▸ We incur significant costs and demands upon management as a result of complying with the laws and regulations affecting public companies, which could harm our operating results.● ● 2 ▸ We will require substantial additional capital to fund our operations, and if we are unable to obtain such capital, we will be unable to successfully develop and commercialize any product candidates.● ● 2 rw