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Akari Therapeutics(AKTX) - 2023 Q4 - Annual Results
2024-04-01 10:30
[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 |
Akari Therapeutics(AKTX) - 2023 Q4 - Annual Report
2024-03-29 20:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 98-1 ...
Kuehn Law Encourages VIVK, HES, SDPI, and AKTX Investors to Contact Law Firm
Newsfilter· 2024-03-08 21:38
Group 1: Proposed Mergers - Vivakor is set to merge with Empire Diversified Energy, acquiring all outstanding shares for a net consideration of 67,200,000 shares of Vivakor common stock [1] - Hess Corporation will be acquired by Chevron, with Hess shareholders entitled to receive 1.0250 shares of Chevron's common stock per share [1] - Superior Drilling will be acquired by Drilling Tools International for approximately $32.2 million in cash and stock [2] - Akari is combining with Peak Bio, with Akari shareholders expected to own approximately 50% of the combined company [2] Group 2: Shareholder Involvement - Kuehn Law emphasizes the importance of shareholder participation in ensuring the integrity and fairness of financial markets [3] - Shareholders are encouraged to act promptly as legal rights may be time-sensitive [4] - Kuehn Law offers to cover all case costs and does not charge its investor clients [4]
Akari Therapeutics(AKTX) - 2023 Q2 - Quarterly Report
2023-09-28 16:00
Table of Contents Exhibit 99.1 AKARI THERAPEUTICS, PLC For The Six Month Period Ended June 30, 2023 TABLE OF CONTENTS Condensed Consolidated Financial Statements (Unaudited) | Page | | | --- | --- | | Condensed Consolidated Balance Sheets as of June 30, 2023 and December 31, 2022 | 2 | | Condensed Consolidated Statements of Operations and Comprehensive Loss for the Six Months Ended June 30, | | | 2023 and 2022 | 3 | | Condensed Consolidated Statements of Changes in Shareholders' Equity for the Six Months En ...
Akari Therapeutics(AKTX) - 2022 Q4 - Annual Report
2023-04-30 16:00
PART I [Key Information](index=7&type=section&id=Item%203.%20KEY%20INFORMATION) Akari Therapeutics faces significant financial and operational risks, including recurring losses, going concern doubts, and reliance on nomacopan [Risk Factors](index=7&type=section&id=D.%20Risk%20Factors) The company faces substantial financial, operational, and clinical risks, with recurring losses and auditor's doubt about its going concern ability - The company has a history of operating losses, with a net loss of **$17.7 million** in 2022 and an accumulated deficit of **$217.5 million** as of December 31, 2022[53](index=53&type=chunk) - The auditor's report on the 2022 consolidated financial statements includes an explanatory paragraph raising substantial doubt about the company's ability to continue as a going concern due to recurring losses and the need for additional financing[56](index=56&type=chunk) - The company's business is critically dependent on the success of its sole product candidate, nomacopan, which is still in development and faces numerous clinical and regulatory risks[63](index=63&type=chunk) - Akari may be involuntarily delisted from the Nasdaq Capital Market for failing to meet the minimum bid price and shareholders' equity requirements, which could reduce liquidity and hinder capital raising[162](index=162&type=chunk) [Information on the Company](index=42&type=section&id=Item%204.%20INFORMATION%20ON%20THE%20COMPANY) Akari Therapeutics is a clinical-stage biotech company developing nomacopan for autoimmune and inflammatory diseases, relying on third-party manufacturers and holding a patent portfolio [History and Development of the Company](index=42&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) Akari Therapeutics, Plc, established in 2004, shifted focus to rare autoimmune diseases after acquiring Volution Immuno Pharmaceuticals SA in 2015, with ADSs listed on Nasdaq - The company was originally established in 2004 and changed its name to Akari Therapeutics, Plc in 2015 following the acquisition of Volution Immuno Pharmaceuticals SA[195](index=195&type=chunk)[196](index=196&type=chunk) - The acquisition of Volution shifted the company's focus to the development of treatments for rare and orphan autoimmune and inflammatory diseases related to complement C5 dysregulation[196](index=196&type=chunk) - The company's American Depositary Shares (ADSs) are listed on the Nasdaq Capital Market under the symbol "AKTX", with each ADS representing one hundred ordinary shares[197](index=197&type=chunk) [Business Overview](index=43&type=section&id=B.%20Business%20Overview) Akari is a clinical-stage biotech company focused on nomacopan for pediatric HSCT-TMA and preclinical GA, having deprioritized other programs and relying on third-party manufacturing - The lead product candidate, nomacopan, is a second-generation complement inhibitor that acts on complement component-C5 and also inhibits leukotriene B4 (LTB4) activity[202](index=202&type=chunk) - The company's primary clinical target is pediatric HSCT-TMA, with a pivotal Part B Phase 3 trial expected to begin enrollment by the end of 2023[207](index=207&type=chunk)[216](index=216&type=chunk)[217](index=217&type=chunk) - A long-acting version, PAS-nomacopan, is in preclinical development for geographic atrophy (GA), with an IND submission to the FDA planned for the first half of 2024[226](index=226&type=chunk) - In 2022, the company discontinued its clinical program for nomacopan in bullous pemphigoid (BP) to prioritize the HSCT-TMA and GA programs, citing development timelines and costs[228](index=228&type=chunk)[229](index=229&type=chunk) - Nomacopan has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA for various indications, which may provide benefits like market exclusivity and expedited review[204](index=204&type=chunk)[206](index=206&type=chunk) [Organizational Structure](index=74&type=section&id=C.%20Organizational%20Structure) Akari Therapeutics, Plc operates through four wholly-owned subsidiaries, primarily engaged in research and development, with one inactive Corporate Subsidiaries | Name of Subsidiary | Jurisdiction | Activity | Holding | | :--- | :--- | :--- | :--- | | Volution Immuno Pharmaceuticals SA | Switzerland | Research & Development | 100% | | Celsus Therapeutics Inc. | Delaware, USA | Research & Development | 100% | | Morria Biopharma Ltd | Israel | Inactive | 100% | | Akari Malta Limited | Malta | Research & Development | 100% | [Property, Plant and Equipment](index=74&type=section&id=D.%20Property,%20Plant%20and%20Equipment) Akari Therapeutics does not own property, leasing office spaces in New York for approximately $3,000 and London for approximately $12,200 monthly on a short-term basis - Akari Therapeutics does not own any property and leases all its office spaces[372](index=372&type=chunk) Monthly Office Lease Expenses | Location | Monthly Rent (approx.) | | :--- | :--- | | New York, NY | $3,000 | | London, England | $12,200 | [Operating and Financial Review and Prospects](index=74&type=section&id=Item%205.%20OPERATING%20AND%20FINANCIAL%20REVIEW%20AND%20PROSPECTS) Akari Therapeutics reported a **$17.7 million** net loss in 2022, driven by increased operating expenses, with its precarious financial position and auditor's going concern warning [Operating Results](index=74&type=section&id=A.%20Operating%20Results) In 2022, R&D expenses rose **5%** to **$9.6 million**, while G&A expenses surged **67%** to **$13.5 million** due to executive compensation and financing costs, partially offset by a **$5.3 million** non-cash gain from warrant liabilities Comparison of Operating Expenses (2022 vs. 2021) | Expense Category | 2022 (in millions) | 2021 (in millions) | Change (%) | | :--- | :--- | :--- | :--- | | Research & Development | $9.6 | $9.1 | +5% | | General & Administrative | $13.5 | $8.1 | +67% | - The **67%** increase in G&A expenses in 2022 was primarily driven by **$2.4 million** in payroll and stock compensation for new executives and severance, **$1.7 million** in expensed issuance costs from the September 2022 offering, and **$0.7 million** in higher consulting fees[387](index=387&type=chunk) - Other income was approximately **$5.3 million** in 2022, a significant shift from an expense of $210,000 in 2021, primarily due to a **$6.9 million** non-cash gain from the decrease in the fair value of warrant liabilities issued in September 2022[388](index=388&type=chunk) [Liquidity and Capital Resources](index=76&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) As of December 31, 2022, Akari had **$13.2 million** cash and a **$217.5 million** accumulated deficit, with management expecting funds to last only through October 2023, raising substantial doubt about its going concern ability - As of December 31, 2022, the company had **$13.2 million** in cash and an accumulated deficit of **$217.5 million**[390](index=390&type=chunk) - Management expects existing cash, including proceeds from a March 2023 offering, will only be sufficient to fund operations through October 2023, raising substantial doubt about its ability to continue as a going concern[398](index=398&type=chunk)[399](index=399&type=chunk) Cash Flow Summary (2022 vs. 2021) | Cash Flow Activity | 2022 (in millions) | 2021 (in millions) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | $(21.5) | $(18.8) | | Net Cash Provided by Financing Activities | $25.3 | $14.3 | - The company raised gross proceeds of approximately **$12.8 million** in a registered direct offering in September 2022 and an additional **$4.0 million** in March 2023 to fund operations[391](index=391&type=chunk)[392](index=392&type=chunk) [Research and Development, Patents and Licenses](index=79&type=section&id=C.%20Research%20and%20Development,%20Patents%20and%20Licenses) R&D expenses were **$9.6 million** in 2022, primarily for the nomacopan program and clinical trials, involving payments to third-party organizations for manufacturing and research activities Research and Development Expenses (in thousands) | Category | 2022 | 2021 | 2020 | | :--- | :--- | :--- | :--- | | **Direct Expenses:** | | | | | Nomacopan | $3,912 | $3,970 | $4,363 | | Clinical trials | $4,414 | $4,517 | $4,281 | | **Indirect Expenses:** | | | | | Staffing | $2,086 | $2,267 | $2,348 | | Tax credits | $(2,318) | $(3,067) | $(3,372) | | **Total R&D** | **$9,561** | **$9,133** | **$8,820** | [Critical Accounting Estimates](index=80&type=section&id=E.%20Critical%20Accounting%20Estimates) Critical accounting estimates include share-based compensation valued by Black-Scholes and warrants classified as liabilities due to terms preventing equity indexing, requiring fair value remeasurement - Share-based compensation is a critical estimate, with option values determined by the Black-Scholes model using subjective assumptions like expected stock price volatility and option term[415](index=415&type=chunk)[417](index=417&type=chunk) - Warrants issued in September 2022 are classified as liabilities and remeasured to fair value at each reporting date because their terms, specifically volatility inputs, prevent them from being considered indexed to the company's own stock[418](index=418&type=chunk)[419](index=419&type=chunk) - Warrants issued in offerings prior to September 2022 (specifically in March 2022 and December 2021) were classified as equity, as they met the necessary criteria at the time of issuance[421](index=421&type=chunk)[422](index=422&type=chunk) [Directors, Senior Management and Employees](index=83&type=section&id=Item%206.%20DIRECTORS,%20SENIOR%20MANAGEMENT%20AND%20EMPLOYEES) This section details the company's seven-member board, executive compensation, including significant 2022 leadership changes, and its 15 full-time employees [Directors and Senior Management](index=83&type=section&id=A.%20Directors%20and%20Senior%20Management) The company's leadership includes a seven-member board with staggered terms and a senior management team featuring key appointments in 2022, including CEO Rachelle Jacques - Rachelle Jacques was appointed President and Chief Executive Officer in March 2022, bringing experience from Enzyvant Therapeutics and Alexion Pharmaceuticals[436](index=436&type=chunk) - Dr. Ray Prudo, a founder of a predecessor company, transitioned from Executive Chairman to Chairman of the Board effective January 1, 2023[429](index=429&type=chunk)[437](index=437&type=chunk) - The company made several key leadership appointments in 2022, including a new CEO, COO, and CMO, strengthening its executive team[436](index=436&type=chunk)[439](index=439&type=chunk)[441](index=441&type=chunk) [Compensation](index=86&type=section&id=B.%20Compensation) Executive compensation for 2022 included approximately **$3.6 million** for CEO Rachelle Jacques and over **$1 million** for former CEO Clive Richardson, with non-employee directors receiving annual cash retainers and stock options 2022 Executive Compensation Summary | Name and Principal Position | Year | Salary ($) | Bonus ($) | Stock Awards ($) | Option Awards ($) | All Other Comp. ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Ray Prudo, Former Exec. Chairman | 2022 | 412,000 | 206,000 | — | — | — | 618,000 | | Rachelle Jacques, President & CEO | 2022 | 458,333 | 875,000 | 253,410 | 1,965,991 | 49,865 | 3,602,600 | | Clive Richardson, Former CEO & COO | 2022 | 118,195 | 657,764 | — | — | 317,175 | 1,093,134 | | Torsten Hombeck, CFO | 2022 | 300,150 | 72,036 | — | 32,448 | 44,111 | 448,744 | - Non-employee directors received an annual retainer of **$39,338** in 2022, plus additional fees for committee service and an annual stock option grant[472](index=472&type=chunk) [Board Practices](index=94&type=section&id=C.%20Board%20Practices) The board is classified with staggered terms and has independent audit, compensation, and nominating committees, with the company following English corporate law as a foreign private issuer - The board is classified into three groups (Class A, B, C) with staggered terms, ensuring continuity but potentially delaying changes in control[479](index=479&type=chunk) - The Audit, Compensation, and Nominating committees are composed entirely of independent directors[481](index=481&type=chunk)[482](index=482&type=chunk)[483](index=483&type=chunk) - As a foreign private issuer, Akari follows English corporate law for certain governance matters instead of Nasdaq listing requirements[480](index=480&type=chunk) [Employees](index=94&type=section&id=D.%20Employees) As of December 31, 2022, Akari Therapeutics had **15** full-time employees, split between R&D and management, across England and the United States Employee Distribution as of Dec 31, 2022 | Category | Number of Employees | | :--- | :--- | | Total Full-Time | 15 | | Research & Development | 7 | | Management, Admin & Finance | 8 | | **Location** | | | England | 7 | | United States | 8 | [Major Shareholders and Related Party Transactions](index=96&type=section&id=Item%207.%20MAJOR%20SHAREHOLDERS%20AND%20RELATED%20PARTY%20TRANSACTIONS) As of March 31, 2023, directors and executive officers owned **24.7%** of shares, with Chairman Dr. Ray Prudo holding **21.8%**, and related party transactions involving TDL and insider financing participation [Major Shareholders](index=96&type=section&id=A.%20Major%20Shareholders) As of March 31, 2023, directors and executive officers collectively owned **24.7%** of shares, with Chairman Dr. Ray Prudo as the largest insider holder at **21.8%**, and Deutsche Bank holding **99.9%** for ADS holders Beneficial Ownership as of March 31, 2023 | Shareholder | Percentage Owned | | :--- | :--- | | Ray Prudo (Chairman) | 21.8% | | All directors and officers as a group | 24.7% | | RPC Pharma Limited | 8.0% | | PranaBio Investments, LLC | 9.9% | - Deutsche Bank Trust Company Americas, as the depositary for the ADR program, held **99.9%** of the issued share capital on behalf of ADS holders as of March 31, 2023[512](index=512&type=chunk) [Related Party Transactions](index=101&type=section&id=B.%20Related%20Party%20Transactions) The company leases its UK office and procures laboratory services from The Doctors Laboratory (TDL), a related party, and insiders participated in recent financing rounds - The company leases its UK office and procures laboratory testing services from The Doctors Laboratory (TDL), where Director David Byrne is the CEO of TDL, and Chairman Ray Prudo is the Chairman of TDL's board[517](index=517&type=chunk)[518](index=518&type=chunk) Expenses Incurred with TDL (2022) | Service | Expense (approx.) | | :--- | :--- | | Office Lease | $129,000 | | Laboratory Testing | $89,000 | - Chairman Ray Prudo and other insiders participated significantly in the company's financing activities in 2022 and 2023, purchasing shares in the March 2022, September 2022, and March 2023 offerings[522](index=522&type=chunk)[523](index=523&type=chunk) [Financial Information](index=103&type=section&id=Item%208.%20FINANCIAL%20INFORMATION) The full consolidated financial statements, prepared under U.S. GAAP, are in Item 18, with the company having no material legal proceedings and no plans for future cash dividends - The company's full financial statements are prepared in accordance with United States GAAP and are located in Item 18 of the report[525](index=525&type=chunk) - The company does not anticipate declaring or paying any cash dividends in the foreseeable future, retaining earnings for business development and expansion[527](index=527&type=chunk) [Additional Information](index=104&type=section&id=Item%2010.%20ADDITIONAL%20INFORMATION) This section outlines the company's corporate governance under English law, detailing shareholder rights, director duties, and differences from Delaware law, alongside its subjection to the UK City Code on Takeovers and Mergers [Memorandum and Articles of Association](index=104&type=section&id=B.%20Memorandum%20and%20Articles%20of%20Association) The company's governance under English law includes classified board terms, a **75%** special resolution vote, and subjection to the UK City Code on Takeovers and Mergers, with differences from Delaware law - Shareholders are entitled to **one vote per ordinary share**; a special resolution, required for actions like changing the Articles of Association, requires a **75% majority vote**[542](index=542&type=chunk)[566](index=566&type=chunk) - The company's board of directors is classified into three groups with staggered terms, which can delay a change in control[543](index=543&type=chunk)[570](index=570&type=chunk) - The company believes it is subject to the UK City Code on Takeovers and Mergers, which imposes strict rules on potential acquirers, including a mandatory cash offer requirement if an acquirer's stake reaches **30% of voting rights**[571](index=571&type=chunk)[613](index=613&type=chunk) - Under English law, directors can be removed by an ordinary shareholder resolution (simple majority), which differs from the 'for cause' requirement for classified boards under Delaware law[575](index=575&type=chunk) [Taxation](index=122&type=section&id=E.%20Taxation) This section details UK and U.S. tax implications for U.S. ADS holders, noting no UK dividend withholding tax but potential adverse PFIC consequences for 2022 - Under current UK tax law, no tax is withheld at the source from cash dividends paid to U.S. resident holders[627](index=627&type=chunk) - The company may have been a Passive Foreign Investment Company (PFIC) for 2022; if classified as a PFIC, U.S. Holders could face adverse tax consequences, such as gains being taxed as ordinary income and an interest charge on deemed deferred tax[648](index=648&type=chunk)[649](index=649&type=chunk) - Dividends paid to non-corporate U.S. Holders are expected to be treated as "qualified dividends" taxable at a maximum rate of **20%**, provided the company is not a PFIC[641](index=641&type=chunk) [Quantitative and Qualitative Disclosures About Risk](index=129&type=section&id=Item%2011.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20RISK) The company faces foreign currency exchange risk due to international operations but no significant interest rate risk as it has no debt and does not use hedging instruments - The company's operating results are subject to foreign currency exchange risk due to operations in the UK and Europe, with results translated into U.S. dollars for reporting[667](index=667&type=chunk) - The company has no short-term or long-term debt, so it is not currently exposed to significant interest rate risk on liabilities[669](index=669&type=chunk) - Akari has not entered into any hedging instruments to mitigate currency or interest rate risks[668](index=668&type=chunk)[669](index=669&type=chunk) [Controls and Procedures](index=133&type=section&id=Item%2015.%20CONTROLS%20AND%20PROCEDURES) As of December 31, 2022, management concluded that both disclosure controls and internal control over financial reporting were effective, with no material changes identified - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2022[687](index=687&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2022, based on the COSO 2013 framework[689](index=689&type=chunk) - The report does not include an attestation report from the registered public accounting firm on internal controls, as the company is not an accelerated filer[689](index=689&type=chunk) PART III [Financial Statements](index=135&type=section&id=Item%2018.%20FINANCIAL%20STATEMENTS) The consolidated financial statements as of December 31, 2022, show recurring losses, a net capital deficiency, and an auditor's going concern warning, with key figures including **$13.2 million** cash and a **$17.7 million** net loss [Report of Independent Registered Public Accounting Firm](index=142&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The auditor's report confirms fair financial presentation but includes a 'Going Concern Uncertainty' due to recurring losses and a critical audit matter regarding warrant classification - The auditor's report contains a paragraph expressing substantial doubt about the Company's ability to continue as a going concern due to recurring losses from operations and a net capital deficiency[718](index=718&type=chunk) - A critical audit matter was the evaluation of the financial statement classification for warrants issued in December 2021 and September 2022, due to accounting complexities in the warrant agreements[724](index=724&type=chunk) [Consolidated Balance Sheets](index=144&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2022, total assets were **$13.8 million**, liabilities increased to **$12.0 million** due to a **$7.9 million** warrant liability, and shareholders' equity decreased to **$1.8 million** Consolidated Balance Sheet Highlights (as of Dec 31) | Account | 2022 | 2021 | | :--- | :--- | :--- | | Cash | $13,249,945 | $9,361,270 | | Total Assets | $13,831,612 | $11,648,028 | | Warrant liability | $7,852,000 | $0 | | Total Liabilities | $12,040,866 | $6,093,446 | | Total Shareholders' Equity | $1,790,746 | $5,554,582 | [Consolidated Statements of Operations and Comprehensive Loss](index=145&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For 2022, the net loss was **$17.7 million**, driven by increased operating expenses, particularly G&A, partially offset by a non-cash gain on warrant liabilities Statement of Operations Highlights (Year Ended Dec 31) | Account | 2022 | 2021 | | :--- | :--- | :--- | | Research and development expenses | $9,560,897 | $9,133,455 | | General and administrative expenses | $13,527,311 | $8,080,681 | | Loss from operations | $(23,088,208) | $(17,214,136) | | Total other income (expense) | $5,340,146 | $(210,101) | | **Net loss** | **$(17,748,062)** | **$(17,424,237)** | [Consolidated Statements of Cash Flows](index=147&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) In 2022, net cash used in operating activities was **$21.5 million**, offset by **$25.3 million** from financing, resulting in a **$3.9 million** cash increase and a year-end balance of **$13.2 million** Cash Flow Summary (Year Ended Dec 31) | Category | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(21,504,522) | $(18,846,528) | | Net cash provided by financing activities | $25,288,109 | $14,292,753 | | Net increase (decrease) in cash | $3,888,675 | $(4,694,507) | | **Cash, end of period** | **$13,249,945** | **$9,361,270** |
Akari Therapeutics(AKTX) - 2023 Q1 - Quarterly Report
2023-03-30 16:00
[Securities Purchase Agreement](index=1&type=section&id=Securities%20Purchase%20Agreement) [Agreement Parties and Date](index=1&type=section&id=Agreement%20Parties%20and%20Date) This agreement, dated March 30, 2023, outlines the terms for Akari Therapeutics, Plc to issue and sell securities Agreement Details | Item | Detail | | :--- | :--- | | **Agreement Date** | March 30, 2023 | | **Company** | Akari Therapeutics, Plc | | **Parties** | The Company and each purchaser identified on the signature pages | | **Purpose** | To issue and sell securities of the Company to the Purchasers | [ARTICLE I. DEFINITIONS](index=1&type=section&id=ARTICLE%20I.%20DEFINITIONS) [Definitions](index=1&type=section&id=1.1%20Definitions) This section defines key terms like American Depositary Shares, purchase price, and transaction-related terminology - Each American Depositary Share (ADS) represents **100 Ordinary Shares** of the Company[6](index=6&type=chunk)[26](index=26&type=chunk) - The purchase price is defined as **$0.15 per Placed ADS**, subject to adjustments for stock splits and similar transactions[28](index=28&type=chunk) - The securities being sold under this agreement are referred to as "Placed ADSs" and the underlying "Placed Shares"[30](index=30&type=chunk)[33](index=33&type=chunk)[39](index=39&type=chunk) - The transaction is conducted under an effective shelf registration statement on **Form F-3 (Registration No. 333-251673)**[35](index=35&type=chunk) [ARTICLE II. PURCHASE AND SALE](index=5&type=section&id=ARTICLE%20II.%20PURCHASE%20AND%20SALE) [Closing](index=5&type=section&id=2.1%20Closing) The Company agrees to sell up to **$3.5 million** of ADSs to Purchasers via Delivery Versus Payment (DVP) settlement Offering Details | Term | Details | | :--- | :--- | | **Aggregate Offering Size** | Up to $3.5 million | | **Security** | American Depositary Shares (ADSs) | | **Settlement Method** | Delivery Versus Payment (DVP) | [Deliveries](index=5&type=section&id=2.2%20Deliveries) The Company delivers executed agreements and ADSs via DWAC, while Purchasers deliver executed agreements and subscription amounts - The Company is required to deliver executed agreements, legal opinions from both UK and US counsel, and irrevocable instructions to the Depositary to deliver the ADSs via DWAC[46](index=46&type=chunk)[48](index=48&type=chunk) - Each Purchaser is required to deliver the duly executed agreement and their Subscription Amount for DVP settlement[48](index=48&type=chunk) [Closing Conditions](index=6&type=section&id=2.3%20Closing%20Conditions) Closing is contingent on accurate representations, fulfilled obligations, no Material Adverse Effect, and no trading suspension - The Purchasers' obligation to close is conditional upon the absence of any **Material Adverse Effect** on the Company since the agreement date[51](index=51&type=chunk) - Another key condition for the Purchasers is that trading in the ADSs and Ordinary Shares has not been **suspended** by the SEC or the principal Trading Market[51](index=51&type=chunk) [ARTICLE III. REPRESENTATIONS AND WARRANTIES](index=7&type=section&id=ARTICLE%20III.%20REPRESENTATIONS%20AND%20WARRANTIES) [Representations and Warranties of the Company](index=7&type=section&id=3.1%20Representations%20and%20Warranties%20of%20the%20Company) The Company warrants its legal status, valid securities issuance, accurate SEC filings, and compliance with regulations - The Company confirms that the securities, when issued and paid for, will be **duly authorized, validly issued, fully paid, and non-assessable**[60](index=60&type=chunk) - The Company represents that its SEC Reports were filed on time, complied with regulations, and did not contain any **untrue statements of a material fact**[65](index=65&type=chunk) - The Company warrants that since its latest audited financial statements, there has been no event that could reasonably be expected to result in a **Material Adverse Effect**[66](index=66&type=chunk) - The Company confirms it is in compliance with all applicable requirements of the **Sarbanes-Oxley Act of 2002** and maintains sufficient internal accounting controls[79](index=79&type=chunk) - The Company represents that it is not an "investment company" under the **Investment Company Act of 1940**[81](index=81&type=chunk) [Representations and Warranties of the Purchasers](index=21&type=section&id=3.2%20Representations%20and%20Warranties%20of%20the%20Purchasers) Purchasers confirm their authority, accredited investor status, understanding of risks, and intent to acquire for their own account - Each Purchaser confirms they are an "**accredited investor**" as defined in Rule 501(a) of Regulation D or a "**qualified institutional buyer**" under Rule 144A[110](index=110&type=chunk) - Purchasers represent they are acquiring the securities **for their own account** and **not with a view to distribute them** in violation of securities laws[108](index=108&type=chunk) - Each Purchaser confirms they have sufficient knowledge and experience to evaluate the merits and risks of the investment and can bear the economic risk of a **complete loss**[111](index=111&type=chunk) - Purchasers warrant that they have not executed any **Short Sales** of the Company's securities during the **60 days prior** to the execution of the agreement[114](index=114&type=chunk) [ARTICLE IV. OTHER AGREEMENTS OF THE PARTIES](index=24&type=section&id=ARTICLE%20IV.%20OTHER%20AGREEMENTS%20OF%20THE%20PARTIES) [Covenants of the Company and Purchasers](index=24&type=section&id=Covenants%20of%20the%20Company%20and%20Purchasers) The Company covenants timely SEC filings, public disclosure, and proceeds use, while Purchasers agree to confidentiality and no pre-disclosure trading - The Company is required to issue a **press release** and file a Report on **Form 6-K** to disclose the material terms of the transaction by the Disclosure Time[122](index=122&type=chunk) - The Company agrees to use the net proceeds from the sale for **working capital purposes** and is restricted from using them to repay debt (other than trade payables), redeem shares, or settle litigation[126](index=126&type=chunk) - The Company will **indemnify** and hold each Purchaser harmless from losses arising from any breach of its representations, warranties, or covenants in the agreement[127](index=127&type=chunk) - The Company agrees to use commercially reasonable efforts to **maintain the listing** of the ADSs on its current Trading Market[129](index=129&type=chunk) - Each Purchaser covenants **not to execute any purchases or sales** of the Company's securities between the execution of the agreement and the public announcement of the transaction[131](index=131&type=chunk) [ARTICLE V. MISCELLANEOUS](index=27&type=section&id=ARTICLE%20V.%20MISCELLANEOUS) [Miscellaneous Provisions](index=27&type=section&id=Miscellaneous%20Provisions) This article covers termination, fee allocation, New York governing law, several obligations, and jury trial waiver - The agreement may be terminated by any Purchaser if the Closing has not occurred on or before the **fifth Trading Day** following the agreement date[133](index=133&type=chunk) - Each party is responsible for its **own fees and expenses** The Company is responsible for Depositary fees and stamp taxes related to the delivery of ADSs[134](index=134&type=chunk) - The agreement is governed by the internal laws of the **State of New York**, and legal proceedings are to be commenced exclusively in the state and federal courts in New York City[142](index=142&type=chunk) - The obligations of each Purchaser are **several and not joint**, meaning no Purchaser is responsible for the performance of any other Purchaser[152](index=152&type=chunk) - All parties knowingly and irrevocably **waive the right to a trial by jury** in any action, suit, or proceeding related to the agreement[155](index=155&type=chunk) [Signature Pages](index=32&type=section&id=Signature%20Pages) [Execution of Agreement](index=32&type=section&id=Execution%20of%20Agreement) This section contains signature blocks for the Company and Purchasers, including subscription amounts and delivery instructions - Provides the formal signature pages for Akari Therapeutics, Plc and each Purchaser to execute the agreement[156](index=156&type=chunk)[157](index=157&type=chunk) - The Purchaser's signature page requires the specification of the **Subscription Amount** and the **number of ADSs** to be purchased, along with DWAC instructions for delivery[158](index=158&type=chunk)