Nomacopan

Advancing development of novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads to treat multiple cancer tumors Rounding out executive team with deep oncology experience by appointing new Head of Business Development - Oncology BOSTON and LONDON, May 15, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biotechnology company developing novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads for the treatment of cancer, today reported its financial results for the first quarter ended March 31, 2025 and provided a corporate update. "We remain laser focused on becoming a key player in the ADC space and advancing our novel ADC platform built around immuno-oncology payloads and our lead asset AKTX-101, an ADC targeting Trop2 with our immuno-oncology payload, PH1. We continue to develop and execute a clear path forward for our ADC pipeline and support these efforts with ongoing activities and building the team that we believe positions us for success in the near and long term,” commented Abizer Gaslightwala, President and Chief Executive Officer of Akari. “In particular, we were pleased to recently welcome Mark Kubik, a seasoned leader in the Antibody Drug Conjugate space, as Head of Business Development, Oncology and believe his expertise will be invaluable as we continue to advance our novel ADC platform technology.” Leveraging its innovative payload platform, the Company is advancing a pipeline of potentially first-in-class, best-in-class ADC candidates across a wide range of cancer tumor targets. These initial candidates have shown significant tumor-killing activity in preclinical models with the ability to robustly activate the immune system to drive durable, and sustained outcomes. Upcoming Expected Value-Driving Milestones Novel ADC’s With Immuno-Oncology Payloads Anticipate presenting preclinical data showing that a proof-of-concept ADC with PH1 payload exhibits robust immuno-oncology activity, at a scientific conference in second half of 2025.Complete additional preclinical studies for novel PH1 payload exploring activity in prostate cancer cell lines.Explore preclinical activity for AKTX-101 in different solid tumor indications including lung, as single agent and in combination with other approved agents.Continue to focus on operational excellence and efficient capital allocation to advance novel payload ADC platform.Ongoing efforts to seek strategic partners for research collaborations on PH1 immuno-oncology payload across customized tumor targets. Continued discussions with partners on advancing AKTX-101 ADC (Trop2/PH1 payload) through additional IND-enabling activities. Non-Core Asset Out Licensing Continue efforts to out-license non-core assets across inflammation, ophthalmology, and rare diseases as a source of non-dilutive capital to invest into ADC platform. Summary of Financial Results for First Quarter 2025 The net loss from operations for the three months ended March 31, 2025 was approximately $3.7 million compared to $5.6 million for the same period in 2024. The Company reported research and development expenses of $0.8 million for the three months ended March 31, 2025 compared to approximately $2.3 million for the same period in 2024. The decrease was primarily due to our decision to suspend our HSCT-TMA clinical stage program with nomacopan in May 2024. General and administrative expenses were approximately $2.7 million for the three months ended March 31, 2025 compared to approximately $3.7 million for the same period in 2024. The decrease was primarily due to (i) decreases in legal and professional fees (primarily related to the Merger) and (ii) a decrease in directors’ and officers’ insurance. As of March 31, 2025, the Company had cash of approximately $2.6 million. The net proceeds from the Company’s March 2025 offering, after deducting placement agent fees and other offering expenses, were approximately $6.0 million, of which $4.0 million was received in April 2025. About Akari Therapeutics Akari Therapeutics is an oncology biotechnology company developing novel Antibody Drug Conjugates (ADCs) with immuno-oncology payloads, the first being PH1. Utilizing its innovative ADC discovery platform, the Company has the ability to generate ADC candidates to any cancer tumor target of interest. Akari’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells to deliver its novel PH1 immuno-oncology payload directly into the tumor cells. Unlike current ADCs that use tubulin inhibitors and DNA damaging agents as their payloads, PH1 is a novel payload that is a spliceosome inhibitor designed to disrupt RNA splicing within cancer tumor cells. This splicing inhibition has been shown in preclinical animal models to induce cancer cell death while activating immune cells to drive robust and durable activity. In preclinical studies, AKTX-101 has shown to have significant activity and prolonged survival, relative to ADCs with traditional payloads. Additionally, AKTX-101 has the potential to be synergistic with checkpoint inhibitors and has demonstrated prolonged survival as both a single agent and in combination with checkpoint inhibitors, as compared to appropriate controls. The Company is generating validating data on its immuno-oncology payload PH1 to continue advancing its lead asset, AKTX-101, as well as developing ADCs against other undisclosed targets with its lead immuno-oncology payload, PH1. For more information about the Company, please visit www.akaritx.com and connect on X and LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, about the Company that involve risks and uncertainties relating to future events and the future performance of the Company. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding the ability of the Company to advance its product candidates for the treatment of cancer and any other diseases, and ultimately bring therapies to patients; the Company’s targets, plans, objectives or goals for future operations, including those related to its product candidates. These statements are based on the Company’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the business; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of the Company’s programs or product candidates; risks related to any loss of the Company’s patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for the Company’s product candidates, including as a result of potential tariffs; the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by the Company and/or its collaborators or licensees; the extent to which the results from the research and development programs conducted by the Company, and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of the Company’s product candidates; risks related to competition for the Company’s product candidates; and the Company’s ability to successfully develop or commercialize its product candidates. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. The Company assumes no, and hereby disclaims any, obligation to update the forward-looking statements contained in this press release except as required by law. Investor Relations Contact JTC Team, LLC Jenene Thomas 908-824-0775 AKTX@jtcir.com AKARI THERAPEUTICS, PLCCondensed Consolidated Balance Sheets(Amounts in thousands, except share and per share data)(unaudited) March 31, December 31, 2025 2024 ASSETS Current assets: Cash $2,582 $2,599 Restricted cash 60 60 Prepaid expenses 627 92 Other current assets 80 201 Total current assets 3,349 2,952 Goodwill 8,430 8,430 Other intangible assets 39,180 39,180 Total assets $50,959 $50,562 LIABILITIES AND SHAREHOLDERS’ EQUITY Current liabilities: Accounts payable $13,067 $12,407 Accrued expenses 3,494 3,137 Convertible notes 700 700 Convertible notes, related party 250 250 Notes payable 228 659 Notes payable, related party 668 1,651 Warrant liabilities 1,066 1,012 Liability related to deposits received for share subscriptions 950 — Other current liabilities 484 94 Total current liabilities 20,907 19,910 Other non-current liabilities 266 383 Deferred tax liability 8,040 8,040 Total liabilities 29,213 28,333 Commitments and contingencies (Note 13) Shareholders’ equity: Share capital of $0.0001 par value Authorized: 245,035,791,523 ordinary shares at March 31, 2025 and December 31, 2024, respectively; issued and outstanding: 57,752,981,523 and 53,186,919,523 ordinary shares at March 31, 2025 and December 31, 2024, respectively 5,776 5,319 Additional paid-in capital 215,506 212,706 Capital redemption reserve 52,194 52,194 Accumulated other comprehensive loss (773) (738)Accumulated deficit (250,957) (247,252)Total shareholders’ equity 21,746 22,229 Total liabilities and shareholders' equity $50,959 $50,562 AKARI THERAPEUTICS, PLCCondensed Consolidated Statements of Operations and Comprehensive Loss(amounts in thousands, except share and per share data)(unaudited) Three Months Ended March 31, 2025 2024 Operating expenses: Research and development $813 $2,279 General and administrative 2,712 3,710 Total operating expenses 3,525 5,989 Loss from operations (3,525) (5,989)Other income (expense): Interest income — 2 Interest expense (55) — Gain on debt extinguishment 54 — Change in fair value of warrant liabilities (54) 649 Foreign currency exchange loss, net (125) (226)Other expense, net — (2)Total other (expense) income, net (180) 423 Net loss $(3,705) $(5,566) Net loss per share –– basic and diluted $(0.00) $(0.00)Weighted-average number of ordinary shares used in computing net loss per share –– basic and diluted 54,588,283,841 13,453,147,979 Comprehensive loss: Net loss $(3,705) $(5,566)Other comprehensive (loss) income, net of tax: Foreign currency translation adjustment (35) 279 Total other comprehensive (loss) income, net of tax (35) 279 Total comprehensive loss $(3,740) $(5,287)

Samir R. Patel, M.D., appointed as Chief Executive Officer Abizer Gaslightwala appointed to Board of Directors BOSTON and LONDON, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX) today announced the appointment of Samir R. Patel, M.D., as Chief Executive Officer, effective December 16, 2024. Dr. Patel has served as interim Chief Executive Officer since May 2024. Additionally, the Company announced it has appointed Abizer Gaslightwala to its Board of Directors, effective December 16, 2024. Michael Grissinger, a member of the Board of Directors, provided notice of his resignation on December 16, 2024. “Since beginning my role as interim CEO in May 2024, we have worked diligently to close the merger with Peak Bio, which we accomplished in November, and position Akari for continued growth and value creation. Looking ahead, we are focusing our efforts and resources to streamline operations and execute on our portfolio prioritization – our potentially best-in-class ADC platform. I am pleased to solidify my role with the Akari team and look forward to building momentum and driving shareholder value in the near and long term,” commented Dr. Patel, Chief Executive Officer of Akari. About Samir R. Patel, M.D. Dr. Patel currently serves as founder and principal of PranaBio Investments, LLC, a firm providing consulting, strategic advisory, and investment services for small cap biotechnology companies. He is also a consultant to GE Global Research, GE’s innovation engine that is creating novel products and solutions across several sectors including biomanufacturing and biotechnology. He has more than 20 years of experience in life sciences including founding SPEC Pharma, LLC, a company that develops and manufactures injectables used in human and veterinary applications. Previously, Dr. Patel held multiple roles in Medical Affairs with Centocor, Inc. (now Johnson & Johnson Innovative Medicine, part of Johnson & Johnson). He holds multiple patents, has been an author on several publications and has been an investigator in numerous clinical research studies. He has served on the boards of several public companies, including Rezolute Bio. Dr. Patel received his medical degree from the Medical College of Ohio and completed his internal medicine internship, residency, and rheumatology fellowship at The University of New Mexico School of Medicine Affiliated Hospitals. About Abizer Gaslightwala Mr. Gaslightwala is a well-established biotechnology / pharmaceutical industry leader with a demonstrated track record of success spanning over 25 years in the development and commercialization of novel medicines across a range of companies and therapeutic areas. Mr. Gaslightwala currently serves as the Senior Vice President and Franchise Head for Oncology at Jazz Pharmaceuticals, where he has full responsibility for a portfolio of products spanning both solid and hematological malignancies that have total annual sales of $1B. These brands include ZIIHERA® for HER2+ cancers, ZEPZELCA® for small cell lung cancer, and RYLAZE®, DEFITELIO®, and VYXEOS® for a range of hematological malignancies. “We are pleased to welcome Abizer to our Board of Directors. We believe the depth and breadth of his development and commercialization leadership and expertise amassed over the course of his career will provide valuable insight as we work to propel Akari to its next phase of growth. Additionally, we would like to thank Michael for his years of service on our board. His perspective and guidance have played a key role in getting the Company to where we are today,” added Dr. Patel. Mr. Gaslightwala added, “I'm thrilled to join the Akari board and have been extremely compelled by the Company’s unique ADC platform targeting the spliceosome, that has the potential to set a new standard of care for cancer patients. I look forward to working closely with the management team and other members of the board to advance this platform forward and potentially address areas of significant unmet need for cancer patients.” Prior to his current position at Jazz Pharmaceuticals, Mr. Gaslightwala has led and driven growth in several leadership roles at Amgen, Pfizer, and Johnson & Johnson across multiple brands including Kyprolis®, Vectibix®, Neulasta®, XGEVAf®, Repatha®, and ELIQUIS®. His experience spans business unit leadership, brand marketing, sales leadership, commercial pipeline planning, advanced analytics and insights, and business development. Mr. Gaslightwala also helped lead R&D strategic planning within the autoimmune/inflammation portfolio at Johnson & Johnson, as well as lead commercial planning for Remicade® and several novel pipeline molecules focused on rheumatoid arthritis, inflammatory bowel disease, psoriasis, and atopic dermatitis. Additionally, Mr. Gaslightwala advised several life science companies through his time at the Boston Consulting Group (BCG). Mr. Gaslightwala holds a BS in Chemical Engineering from Cornell University, and an MBA from the Sloan School of Management, and a MS in Chemical Engineering from MIT. About Akari Therapeutics Akari Therapeutics, Plc (Nasdaq: AKTX) is a biotechnology company developing advanced therapies for autoimmune, oncology and inflammatory diseases. Akari has two lead assets, investigational nomacopan and an antibody drug conjugate (ADC) platform. Nomacopan is a bispecific recombinant inhibitor of complement C5 activation and leukotriene B4 (LTB4) activity. The Company’s ADC platform includes novel toxins and linkers coupled with important cancer antibody targets. For more information about Akari, please visit akaritx.com. Cautionary Note Regarding Forward-Looking Statements This press release includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), about the Company that involve risks and uncertainties relating to future events and the future performance of the Company. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding: the business combination and related matters, including, but not limited to, post-closing operations and the outlook for the Company’s business; the Company’s targets, plans, objectives or goals for future operations, including those related to its product candidates; financial projections; future economic performance,; and the assumptions underlying or relating to such statements. These statements are based on the Company’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the risk that Akari and Peak Bio may not realize the anticipated benefits of the Merger in the time frame expected, or at all; the ability to retain and hire key personnel; potential adverse reactions or changes to business relationships resulting from the Merger; the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the combined business; uncertainties as to the long-term value of Akari’s American Depositary Shares (and the ordinary shares represented thereby), including the dilution caused by Akari’s issuance of additional American Depositary Shares (and the ordinary shares represented thereby) in connection with the Merger; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of the Company’s programs or product candidates; risks related to any loss of the Company’s patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for the Company’s product candidates, the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by the Company and/or its collaborators or licensees; the extent to which the results from the research and development programs conducted by the Company, and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of the Company’s product candidates; unexpected breaches or terminations with respect to the Company’s material contracts or arrangements; risks related to competition for the Company’s product candidates; the Company’s ability to successfully develop or commercialize its product candidates; potential exposure to legal proceedings and investigations; risks related to changes in governmental laws and related interpretation thereof, including on reimbursement, intellectual property protection and regulatory controls on testing, approval, manufacturing, development or commercialization of any of the Company’s product candidates; the Company’s ability to maintain listing of its ADSs on the Nasdaq Capital Market. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. The Company assumes no, and hereby disclaims any, obligation to update the forward-looking statements contained in this press release. Investor Contact: JTC Team, LLCJenene Thomas908.824.0775AKTX@jtcir.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/110aebf9-2683-41c9-ba9d-bf06f7e42054