Samir R. Patel, M.D. Appointed Interim CEO; Interim CEO Employment Contract Demonstrates Alignment with Shareholders Plan for Prioritization of Peak Bio’s ADC Cancer Therapeutic Platform Technology and Akari’s PAS-nomacopan for Geographic Atrophy Existing Investors Support the Company with Issuance of $1 Million in Unsecured Convertible Notes Secured $7.6 Million in Upsized Financing Round Receives Positive and Constructive Pre-IND Feedback from US FDA for PAS-nomacopan in Treatment of Geographic Atrophy ...

BOSTON and LONDON, Aug. 19, 2024 (GLOBE NEWSWIRE) -- Akari Therapeutics announced today that the company has received positive and constructive Pre-IND (PIND) feedback from the FDA on July 29, 2024, which provides additional clarity on Akari’s final Investigational New Drug Application (IND)- enabling preclinical plans, drug manufacturing and Phase 1 clinical strategy for long-acting PAS-nomacopan for intravitreal treatment of geographic atrophy (GA). PAS-nomacopan is a long-acting bispecific inhibitor of C ...

Core Viewpoint - Akari Therapeutics Plc has successfully closed an initial private placement financing round, raising approximately $7.6 million from both new and existing investors, reflecting strong investor interest in the company's strategic direction and upcoming merger with Peak Bio [1][2]. Financing Details - The private placement agreement was finalized on May 29, 2024, involving the sale of 4,029,754 unregistered American Depository Shares (ADSs) and Series C Warrants at a unit price of $1.885 [2]. - The warrants have a three-year term and cashless exercise provisions, with an exercise price of $1.76 per ADS for most investors, while Dr. Ray Prudo and Samir R. Patel, M.D., have a slightly higher exercise price of $1.79 per ADS [2]. Proceeds and Issuance - As of the initial closing on May 31, 2024, the company received gross proceeds of approximately $7.2 million, issuing 3,817,553 unregistered ADSs and warrants [3]. - The remaining 212,201 ADSs and warrants are expected to be issued within 90 days of May 31, 2024, pending payment [3]. Company Overview - Akari Therapeutics is focused on developing advanced therapies for autoimmune and inflammatory diseases, with its lead asset being investigational nomacopan, a bispecific recombinant inhibitor targeting complement C5 activation and leukotriene B4 activity [5].

Exhibit 99.1 Entered into a Definitive Merger Agreement with Peak Bio; Expected to Close in the Third Quarter of 2024 Samir R. Patel, M.D. Appointed Interim CEO Plan for Prioritization of Peak Bio's ADC Cancer Therapeutic Platform Technology and Akari's PAS-nomacopan for Geographic Atrophy Implementation of Restructuring Plan to Reduce Operating Costs Existing Investors Support the Company with Issuance of $1 million in Unsecured Convertible Notes BOSTON and LONDON, May 16, 2024 (GLOBE NEWSWIRE) – Akari The ...

Core Viewpoint - Akari Therapeutics has entered into a definitive merger agreement with Peak Bio, expected to close in the third quarter of 2024, with a focus on advancing their respective therapeutic technologies and restructuring to reduce operating costs [1][3][7]. Company Highlights - The merger with Peak Bio will be an all-stock transaction, resulting in a combined entity operating as Akari Therapeutics, Plc, continuing to trade on Nasdaq as AKTX [3][7]. - The leadership has changed with Samir R. Patel, M.D. appointed as interim CEO following the departure of Rachelle Jacques [3]. - A significant reduction in workforce of approximately 67% has been initiated as part of an operational restructuring plan to lower costs [3]. - Existing investors have supported the company with the issuance of $1 million in unsecured convertible notes [1]. Financial Results - As of March 31, 2024, the company reported cash of approximately $1.3 million [4][18]. - Research and development expenses increased to approximately $2.3 million for Q1 2024, compared to $1.7 million in Q1 2023 [4][17]. - General and administrative expenses rose to approximately $3.7 million for Q1 2024, up from $2.9 million in Q1 2023 [4][17]. - The net loss for Q1 2024 was approximately $5.6 million, a significant decline from a net income of approximately $1.0 million in Q1 2023 [5][6][17]. - The weighted-average number of ordinary shares used in computing net loss per share was approximately 13.45 billion for Q1 2024, compared to 7.47 billion for Q1 2023 [17]. Merger Details - The merger agreement stipulates that Peak stockholders will receive Akari shares based on an exchange ratio, leading to an implied equity ownership of approximately 50% for both Akari and Peak stockholders [7]. - The transaction is subject to customary closing conditions, including shareholder approval from both companies [7].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number 001-36288 Akari Therapeutics, Plc (Exact name of Registrant as specified in its Charter) England and Wales ...

BOSTON and LONDON, April 15, 2024 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (NASDAQ:AKTX), a biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the company will present new pre-clinical data on investigational long-acting PAS-nomacopan including drug effect on electroretinography (ERG) testing in a blue light model at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting in Seattle. Akari Chief Scientific Off ...

BOSTON and LONDON, April 15, 2024 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the company will present new pre-clinical data on investigational long-acting PAS-nomacopan including drug effect on electroretinography (ERG) testing in a blue light model at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting in Seattle. Akari Chief Scientific Of ...

[Executive Summary](index=1&type=section&id=Executive%20Summary) Akari Therapeutics reported full-year 2023 financial results and recent highlights, including a definitive merger agreement with Peak Bio Inc - Akari Therapeutics reported full-year 2023 financial results and recent highlights, including a definitive merger agreement with Peak Bio Inc[1](index=1&type=chunk)[2](index=2&type=chunk)[4](index=4&type=chunk) - CEO Rachelle Jacques noted the company advanced Phase 3 and pre-clinical programs and paved the way for a merger to expand the pipeline and create new growth opportunities, despite challenging economic conditions[3](index=3&type=chunk) [Company Highlights & Strategic Developments](index=1&type=section&id=Company%20Highlights) Akari Therapeutics announced a definitive merger with Peak Bio Inc., expanding its pipeline and initiating a strategic assessment [Merger Agreement with Peak Bio](index=1&type=section&id=Merger%20Agreement%20with%20Peak%20Bio) Akari reached a definitive agreement to merge with Peak Bio Inc. in an all-stock transaction, forming a combined entity that will retain the Akari Therapeutics, Plc name and Nasdaq listing - Akari announced a definitive agreement to merge with Peak Bio Inc. in an all-stock transaction, operating as Akari Therapeutics, Plc and continuing to trade on Nasdaq[4](index=4&type=chunk) [Expanded Pipeline Post-Merger](index=1&type=section&id=Expanded%20Pipeline%20Post-Merger) The merger will expand Akari's pipeline to include a robust antibody drug conjugate (ADC) toolkit, a Phase 2-ready neutrophil elastase inhibitor (NEI) program, nomacopan in Phase 3, and long-acting PAS-nomacopan - The combined entity will have an expanded pipeline including: * Robust antibody drug conjugate (ADC) toolkit with novel payload and linker technologies * Phase 2-ready neutrophil elastase inhibitor (NEI) program targeting alpha-1 antitrypsin deficiency (AATD) * Nomacopan (bispecific inhibitor of complement C5 and LTB4) in Phase 3 for pediatric HSCT-TMA * Long-acting PAS-nomacopan for geographic atrophy (GA)[5](index=5&type=chunk) [Strategic Pipeline Assessment](index=1&type=section&id=Strategic%20Pipeline%20Assessment) A strategic assessment is planned to evaluate and prioritize the four programs in the expanded pipeline, aiming to identify updated timelines and near-term value creation opportunities, with completion expected before the merger closes - A strategic assessment of the pipeline is planned to evaluate development, program prioritization, updated timelines, and near-term value creation opportunities[6](index=6&type=chunk)[7](index=7&type=chunk) - The assessment is expected to be complete prior to the closing of the merger[7](index=7&type=chunk) [Clinical Development Programs](index=2&type=section&id=Clinical%20Development%20Programs) Akari is advancing nomacopan in Phase 3 for pediatric HSCT-TMA and PAS-nomacopan in pre-clinical development for geographic atrophy [Nomacopan for Pediatric HSCT-TMA](index=2&type=section&id=Nomacopan%20for%20Pediatric%20HSCT-TMA) The Phase 3 Part A clinical trial for nomacopan in pediatric HSCT-TMA is actively recruiting patients, with 10 treated to date, focusing on PK/PD and dose confirmation. Nomacopan has received multiple regulatory designations, including FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations, making it eligible for a Priority Review Voucher [Phase 3 Clinical Trial Update](index=2&type=section&id=Phase%203%20Clinical%20Trial%20Update) The Phase 3 Part A trial for nomacopan in pediatric HSCT-TMA is actively recruiting, focusing on PK/PD and dose confirmation - The Phase 3 Part A clinical trial for nomacopan in pediatric HSCT-TMA is recruiting patients, with **10 treated to date**, focusing on PK/PD and dose confirmation. Enrollment is guided by new consensus criteria for earlier diagnosis of high-risk patients[8](index=8&type=chunk) - HSCT-TMA is a rare complication with no approved treatments and an **80% mortality rate** in severe patients, positioning nomacopan as a potential first approved treatment[9](index=9&type=chunk) [Regulatory Designations](index=2&type=section&id=Regulatory%20Designations) Nomacopan has received multiple regulatory designations, including FDA Orphan Drug, Fast Track, and Rare Pediatric Disease - Nomacopan received Orphan Drug designation from the European Commission for hematopoietic stem cell transplantation[10](index=10&type=chunk) - FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease designations for nomacopan for pediatric HSCT-TMA, making Akari eligible for a Priority Review Voucher (PRV) upon approval[10](index=10&type=chunk) [PAS-Nomacopan for Geographic Atrophy (GA)](index=2&type=section&id=PAS-Nomacopan%20for%20Geographic%20Atrophy%20%28GA%29) Akari advanced the long-acting PAS-nomacopan into the final stages of pre-clinical development for geographic atrophy, demonstrating positive pre-clinical results and a suitable manufacturing process for intravitreal administration, supporting potential initiation of Phase 1 clinical development. GA affects an estimated 5 million people worldwide - Long-acting PAS-nomacopan advanced into final stages of pre-clinical development as a treatment for geographic atrophy (GA)[11](index=11&type=chunk) - Positive pre-clinical results, including an advanced high-yielding manufacturing process suitable for intravitreal administration, support the potential initiation of Phase 1 clinical development[11](index=11&type=chunk) - PAS-nomacopan is being developed to address significant unmet patient needs, including a longer dose interval and reduction of choroidal neovascularization (CNV) risk associated with approved complement-only inhibitors[11](index=11&type=chunk) - GA is a progressive and sight-threatening condition estimated to affect **5 million people worldwide**, including **1 million patients in the U.S.**[12](index=12&type=chunk) [Full-Year 2023 Financial Results](index=3&type=section&id=Full-Year%202023%20Financial%20Results) Akari Therapeutics reported its full-year 2023 financial results, highlighting reduced operating expenses and a lower net loss [Key Financial Metrics](index=3&type=section&id=Key%20Financial%20Metrics) As of December 31, 2023, Akari had approximately $3.8 million in cash. The company received an additional $2.0 million in gross proceeds from a private placement in March 2024 and plans to secure more capital in Q2 2024 Cash Position | Metric | December 31, 2023 | December 31, 2022 | Change | | :----- | :------------------ | :------------------ | :----- | | Cash | $3.8 million | $13.25 million | ▼ $9.45 million | - In March 2024, the company received approximately **$2.0 million** in gross proceeds from certain existing investors from the sale of ADSs in a private placement and is planning to secure additional capital in the second quarter of 2024[13](index=13&type=chunk) [Operating Expenses](index=3&type=section&id=Operating%20Expenses) Research and development expenses decreased by 43% to $5.5 million in 2023, while general and administrative expenses also saw a 16% reduction to $11.4 million, contributing to a lower loss from operations Operating Expenses Summary | Expense Category | 2023 (in thousands) | 2022 (in thousands) | YoY Change | | :--------------- | :------------------ | :------------------ | :--------- | | R&D | $5,450 | $9,561 | ▼ 43.0% |\ | G&A | $11,356 | $13,527 | ▼ 16.0% |\ | Loss from operations | $(16,806) | $(23,088) | ▼ 27.2% | [Other Income and Net Loss](index=3&type=section&id=Other%20Income%20and%20Net%20Loss) Total other income, net, increased to $6.8 million in 2023, primarily due to non-cash gains from liability-classified warrants. This, combined with reduced operating expenses, led to a significant decrease in net loss to $10.0 million for the year Other Income and Net Loss Summary | Metric | 2023 (in thousands) | 2022 (in thousands) | YoY Change | | :----- | :------------------ | :------------------ | :--------- | | Total other income, net | $6,800 | $5,300 | ▲ 28.3% |\ | Net non-cash gains (warrants) | $6,600 | $5,000 | ▲ 32.0% |\ | Net loss | $(10,008) | $(17,748) | ▼ 43.6% |\ | Net loss (excluding non-cash gains) | $(16,600) | $(22,700) | ▼ 26.9% | [About Akari Therapeutics](index=3&type=section&id=About%20Akari%20Therapeutics) Akari Therapeutics is a biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, with lead asset nomacopan - Akari Therapeutics, plc is a biotechnology company developing advanced therapies for autoimmune and inflammatory diseases[17](index=17&type=chunk) - Akari's lead asset, investigational nomacopan, is a bispecific recombinant inhibitor of complement C5 activation and leukotriene B4 (LTB4) activity, currently in a Phase 3 clinical trial program for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA)[17](index=17&type=chunk)[18](index=18&type=chunk) - Akari's pipeline also includes pre-clinical research of long-acting PAS-nomacopan in geographic atrophy (GA)[19](index=19&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=4&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements) This section outlines the inherent risks and uncertainties associated with forward-looking statements in the press release - This press release contains forward-looking statements subject to known and unknown risks, uncertainties, and other important factors that may cause Akari's actual results, performance, or achievements to be materially different[20](index=20&type=chunk)[22](index=22&type=chunk) - These statements are based largely on current expectations and projections about future events and financial trends and speak only as of the date of the press release[21](index=21&type=chunk) - Readers should not rely on these forward-looking statements as predictions of future events, and Akari does not plan to publicly update or revise them except as required by applicable law[22](index=22&type=chunk) [Contact Information](index=5&type=section&id=For%20more%20information) Provides contact details for investor relations and media inquiries - Investor Contact: Mike Moyer, LifeSci Advisors, (617) 308-4306, mmoyer@lifesciadvisors.com[23](index=23&type=chunk) - Media Contact: Eliza Schleifstein, Schleifstein PR, (917) 763-8106, eliza@schleifsteinpr.com[23](index=23&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) Presents the unaudited condensed consolidated statements of operations and balance sheet data for 2023 and 2022 [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The unaudited condensed consolidated statements of operations show a net loss of $10.0 million for 2023, a significant improvement from $17.7 million in 2022, driven by reduced R&D and G&A expenses and increased other income Statements of Operations and Comprehensive Loss | Metric | Year Ended Dec 31, 2023 (in thousands) | Year Ended Dec 31, 2022 (in thousands) | | :------------------------------------------ | :------------------------------------- | :------------------------------------- | | Research and development | $5,450 | $9,561 |\ | General and administrative | $11,356 | $13,527 |\ | Loss from operations | $(16,806) | $(23,088) |\ | Change in fair value of warrant liability | $6,599 | $6,946 |\ | Other income, net | $199 | $357 |\ | Net loss | $(10,008) | $(17,748) |\ | Net loss per ordinary share — basic and diluted | $(0.00) | $(0.00) |\ | Weighted-average number of ordinary shares | 9,788,980 | 6,243,462 | [Condensed Consolidated Balance Sheet Data](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) The unaudited condensed consolidated balance sheet data shows a decrease in cash from $13.25 million in 2022 to $3.85 million in 2023, and a shift from shareholders' equity of $1.79 million to a deficit of $(0.23) million Balance Sheet Data | Metric | December 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------- | :------------------------------- | :------------------------------- | | Cash | $3,845 | $13,250 |\ | Other assets | $510 | $582 |\ | Total assets | $4,355 | $13,832 |\ | Total liabilities | $4,584 | $12,041 |\ | Total shareholders' (deficit) equity | $(229) | $1,791 |

Financial Performance - For the year ended December 31, 2023, the company reported a loss from operations of $16.8 million, a 27% decrease from a loss of $23.1 million in 2022[368]. - The net loss applicable to common shareholders for 2023 was $10.0 million, compared to $17.7 million in 2022[385]. - The company has not generated any revenue to date and expects to continue incurring substantial operating losses[388]. - The company reported a net decrease in cash of $9.4 million for the year ended December 31, 2023, compared to an increase of $3.9 million in 2022[403]. Research and Development - Total research and development expenses decreased by approximately $4.1 million, or 43%, to $5.45 million in 2023 from $9.56 million in 2022[370]. - The HSCT-TMA clinical development expenses increased by 62% to $1.80 million in 2023, primarily due to the prioritization of the HSCT program[371]. - Research and development expenses are estimated based on discussions with internal personnel and service providers, with adjustments made as necessary to reflect the progress of clinical trials[416]. Cash and Financing - The company had $3.8 million in cash and an accumulated deficit of $227.5 million as of December 31, 2023[387]. - The company expects existing cash, including gross proceeds of approximately $2.0 million from the March 2024 Private Placement, to fund operations through April 2024[397]. - The company raised a total of $7.0 million in net proceeds from various equity offerings in 2023, compared to $25.3 million in 2022[409]. - In December 2023, the company completed a private placement, selling 947,868 ADSs at $2.11 per ADS for gross proceeds of approximately $2.0 million[390]. - In September 2023, the company completed a private placement, selling 551,816 ADSs at $3.30 per ADS, raising approximately $2.0 million in gross proceeds, with net proceeds of about $1.7 million after expenses[391]. - The March 2023 Registered Direct Offering generated approximately $4.0 million in gross proceeds from the sale of 1,333,333 ADSs at $3.00 per ADS, resulting in net proceeds of around $3.5 million[393]. - The company anticipates needing to raise additional capital to continue operations and service obligations in the future, as it currently has no products approved for sale and does not generate revenue[397]. - The company may face significant challenges in obtaining financing, which could adversely affect its ability to continue operations and pursue product development[398]. Expenses - General and administrative expenses decreased by approximately $2.2 million, or 16%, to $11.36 million in 2023 from $13.53 million in 2022[379]. - For the year ended December 31, 2023, the company reported net cash used in operating activities of $16.4 million, a decrease from $21.5 million in 2022, primarily due to a $6.3 million reduction in operating expenses[403]. - As of the filing date, the company has non-cancellable manufacturing-related obligations expected to result in payments of approximately $3.5 million in the third quarter of 2024[406]. Currency and Interest Rate Risks - The company is exposed to currency transactional risk, with operating results translated into U.S. dollars, impacting profitability and asset values due to fluctuations in the British Pound, Euro, and Swiss Franc[419]. - The functional currency is the U.S. dollar, with limited operational exposure to currency fluctuations, and no hedging agreements currently in place[420]. - A hypothetical ten percent adverse movement in interest rates would result in immaterial potential losses in future earnings and cash flows[422]. Valuation and Tax - The estimated fair value of the October 2023 Placement Agent Warrants issued was approximately $0.1 million[392]. - A valuation allowance is recorded to reduce deferred tax assets to realizable amounts, requiring significant judgment based on projected future taxable income and tax planning strategies[417]. - The fair value of the September 2022 Warrants is determined using a Black-Scholes model, with significant fluctuations expected during each remeasurement period due to the subjective nature of the inputs used[414][415].