Akari Therapeutics(AKTX) - 2021 Q2 - Quarterly Report

Condensed Consolidated Financial Statements Condensed Consolidated Balance Sheets As of March 31, 2021, Akari Therapeutics, Plc reported a significant decrease in total assets and cash compared to December 31, 2020, primarily driven by a reduction in cash. Total liabilities also decreased, while shareholders' equity saw a substantial decline Key Balance Sheet Metrics | Metric | March 31, 2021 (Unaudited) ($) | December 31, 2020 ($) | | :---------------------- | :------------------------- | :------------------ | | Cash | $6,668,325 | $14,055,777 | | Total Current Assets | $7,813,285 | $14,577,657 | | Total Assets | $7,839,745 | $14,604,807 | | Total Liabilities | $3,902,938 | $5,220,488 | | Total Shareholders' Equity | $3,936,807 | $9,384,319 | Condensed Consolidated Statements of Comprehensive Loss For the three months ended March 31, 2021, the company experienced an increased net loss and comprehensive loss compared to the same period in 2020, primarily due to higher research and development expenses and foreign currency exchange losses, alongside the absence of a gain from changes in fair value of warrant liabilities seen in the prior year Key Comprehensive Loss Metrics | Metric | Three Months Ended March 31, 2021 ($) | Three Months Ended March 31, 2020 ($) | | :----------------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development expenses | $3,529,384 | $2,732,165 | | General and administrative expenses | $2,019,286 | $2,194,809 | | Total Operating Expenses | $5,548,670 | $4,926,974 | | Net Loss | $(5,838,501) | $(3,745,407) | | Comprehensive Loss | $(5,532,404) | $(3,968,132) | | Loss per ordinary share (basic and diluted) | $(0.00) | $(0.00) | - Foreign currency exchange losses were $(285,854) for the three months ended March 31, 2021, compared to gains of $233,404 in the prior year[9] - There was no gain from changes in fair value of warrant liabilities in Q1 2021, compared to a gain of $949,456 in Q1 2020[9] Condensed Consolidated Statements of Changes in Shareholders' Equity (Deficit) Shareholders' equity decreased significantly from December 31, 2020, to March 31, 2021, primarily due to the comprehensive loss incurred during the period, partially offset by stock-based compensation Shareholders' Equity Changes | Metric | December 31, 2020 ($) | March 31, 2021 ($) | | :----------------------------------- | :---------------- | :------------- | | Total Shareholders' Equity (beginning) | $9,384,319 | $9,384,319 | | Stock-based compensation | - | $84,892 | | Comprehensive income (loss) | - | $(5,532,404) | | Total Shareholders' Equity (ending) | $9,384,319 | $3,936,807 | - For the three months ended March 31, 2020, the company issued share capital related to financing, net of issuance costs, totaling $7,128,619[13] Condensed Consolidated Statements of Cash Flows The company experienced a net decrease in cash for the three months ended March 31, 2021, primarily driven by significant cash used in operating activities, with no cash provided by financing activities in the current period, contrasting with a substantial inflow from financing in the prior year Key Cash Flow Metrics | Metric | Three Months Ended March 31, 2021 ($) | Three Months Ended March 31, 2020 ($) | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | | Net Cash Used in Operating Activities | $(7,418,172) | $(7,739,656) | | Net Cash Provided by Financing Activities | $- | $9,877,988 | | Net (Decrease) Increase in Cash | $(7,387,452) | $2,090,489 | | Cash, beginning of period | $14,055,777 | $5,731,691 | | Cash, end of period | $6,668,325 | $7,822,180 | Notes to Condensed Consolidated Financial Statements – Unaudited NOTE 1 – Nature of Business Akari Therapeutics, Plc is a clinical-stage biopharmaceutical company focused on developing treatments for autoinflammatory diseases. The company faces significant financial challenges, including an accumulated deficit and negative operating cash flows, raising substantial doubt about its ability to continue as a going concern. Operations have also been adversely impacted by the COVID-19 pandemic, causing delays in clinical trials - Akari Therapeutics, Plc is a clinical-stage biopharmaceutical company developing treatments for autoinflammatory diseases involving the complement (C5) and leukotriene (LTB4) pathways[18] Financial Position Highlights | Metric | Amount (as of March 31, 2021) ($) | | :------------------------- | :---------------------------- | | Accumulated Deficit | $188,119,312 | | Cash | $6,668,325 | | Negative Operating Cash Flows | $7,418,172 | - The company has an agreement with Aspire Capital Fund, LLC to purchase up to $30.0 million of ADSs, with $24,000,000 remaining available as of March 31, 2021[19] - Management believes current capital resources are sufficient only into September 2021, and the company plans to raise additional funds through equity, debt, or strategic partnerships[20] - The company's ability to continue as a going concern is in substantial doubt due to expected substantial losses and the need for significant operating and capital expenditures[22] - The COVID-19 pandemic has adversely impacted the company's business, causing disruptions and delays in research and development programs and clinical trials, including the halting of a Phase I/II trial and delay in a Phase III trial[23] NOTE 2 – Summary of Significant Accounting Policies This note details the accounting principles and policies applied in the unaudited condensed consolidated financial statements, including the basis of presentation under U.S. GAAP, principles of consolidation, foreign currency translation, use of estimates, and specific accounting treatments for assets, expenses, and equity instruments. A key change noted is the reclassification of warrants from liabilities to shareholders' equity following a currency redenomination - The financial statements are prepared in accordance with U.S. GAAP for interim financial information and SEC rules, assuming the company will continue as a going concern[24] - The company's functional and reporting currency is U.S. dollars. Foreign currency translation adjustments are recorded as a component of accumulated other comprehensive loss[25][26] - Warrants issued in 2019 and 2020 were initially accounted for as warrant liabilities. On December 8, 2020, due to a change in the nominal currency of ordinary shares from pounds sterling to U.S. dollars, these warrants were reclassified from liabilities to shareholders' equity[28] - Research and development expenses increased to $3,529,384 for the three months ended March 31, 2021, from $2,732,165 in the prior year period[39] - Stock-based compensation expense is recorded using the fair-value based method, with awards settled in ordinary shares classified as equity-classified awards[40] - The company adopted ASU 2019-12, Simplifying the Accounting for Income Taxes, effective January 1, 2021, which did not have a material impact on the consolidated financial statements[49] NOTE 3 – Fair Value Measurements This note explains the company's approach to fair value measurements, particularly for financial instruments like warrants. It details the issuance of warrants in 2019 and 2020 offerings and their subsequent reclassification from Level 3 liabilities to shareholders' equity following a currency redenomination in December 2020 - Fair value is measured using a three-tier hierarchy: Level 1 (quoted prices in active markets), Level 2 (observable inputs other than Level 1), and Level 3 (unobservable inputs)[51] - In 2019, the company issued 1,361,842 unregistered warrants (2019 Warrants) in connection with a registered direct offering, exercisable at $3.00 or $2.85 per ADS[53] - In 2020, the company issued 3,259,759 unregistered warrants (2020 Warrants) in connection with private placements, exercisable at $2.20 or $2.55 per ADS[54][56] - The Warrants were initially classified as Level 3 liabilities due to foreign currency considerations and re-measured at each reporting period. On December 8, 2020, following the redenomination of ordinary shares to U.S. dollars, the Warrants were reclassified to additional paid-in capital within Shareholders' Equity[58][65] Fair Value of Warrants at Reclassification | Warrant Type | Fair Value at December 8, 2020 ($) | | :----------- | :----------------------------- | | 2019 Warrants | $882,237 | | 2020 Warrants | $2,317,316 | | Total | $3,199,553 | Changes in Fair Value of Liabilities Related to Warrants (Level 3) | Event | Fair Value of Liabilities Related to Warrants ($) | | :----------------------------------------------------------------- | :-------------------------------------------- | | Balance at December 31, 2019 | $1,014,868 | | Issuance of 2020 Paulson Warrants | $2,749,369 | | Reclassification of warrant liability to shareholders' equity upon exercise of 12,500 warrant ADSs | $(7,874) | | Change in fair value of liabilities related to warrants | $(556,810) | | Balance at December 8, 2020 | $3,199,553 | | Reclassification to Additional-Paid-In Capital (in) Shareholders' Equity | $(3,199,553) | | Balance at December 31, 2020 | $- | NOTE 4 – Shareholders' Equity This note details the company's equity financing activities, including the 2020 Purchase Agreement with Aspire Capital for up to $30 million in ADS sales, various private placements in 2019 and 2020 that issued ADSs and warrants, and the company's share option plan. It also notes the termination of a prior 2018 Purchase Agreement with Aspire Capital - The 2020 Purchase Agreement with Aspire Capital allows the company to sell up to $30.0 million of its ADSs over a 30-month period. As of March 31, 2021, $24.0 million remains available[66][74] - In consideration for the 2020 Purchase Agreement, the company issued 40,760,900 ordinary shares (2020 Commitment Shares) with a fair value of approximately $900,000, recorded as general and administrative expenses[73] - During the three months ended March 31, 2021, the company did not sell any shares to Aspire Capital under the 2020 Purchase Agreement, compared to $6,000,000 gross proceeds from sales in the twelve months ended December 31, 2020[74] - The 2020 Private Placements resulted in the issuance of 5,620,296 ADSs for approximately $9.5 million and 3,259,759 warrants[75] - The 2019 Registered Direct Offering generated approximately $4.5 million in gross proceeds from the sale of 2,368,392 ADSs and the issuance of 1,361,842 warrants[76][77] Summary of Warrants Outstanding | Description | Exercise Price ($) | Balance March 31, 2021 (Number) | | :---------------------- | :------------- | :--------------------- | | 2019 Investor Warrants | $3.00 | 1,184,213 | | 2019 Placement Warrants | $2.85 | 177,629 | | 2020 Investor Warrants | $2.20 | 2,797,636 | | 2020 Placement Warrants | $2.55 | 449,623 | | Total | | 4,609,101 | - The 2018 Purchase Agreement with Aspire Capital, which allowed for sales of up to $20.0 million of ADSs, was terminated on June 30, 2020[84] - Under the 2014 Equity Incentive Plan, 229,098,427 ordinary shares were available for future issuance as of March 31, 2021[85] Share Option Activity (Employees and Directors) for Three Months Ended March 31, 2021 | Metric | Number of Shares | Weighted Average Exercise Price ($) | | :-------------------------------------- | :--------------- | :------------------------------ | | Options outstanding as of January 1, 2021 | 112,649,035 | $0.09 | | Granted | 3,000,000 | $0.02 | | Options outstanding at March 31, 2021 | 115,649,035 | $0.09 | | Exercisable options at March 31, 2021 | 78,317,785 | $0.12 | - Stock-based compensation expenses for employees and directors were approximately $84,892 for the three months ended March 31, 2021, and $100,504 for the same period in 2020[94] NOTE 5 – Related Party Transactions The company engaged in related party transactions, including office leases and laboratory testing services with The Doctors Laboratory (TDL), where a non-employee director serves as CEO, and consulting services from another non-employee director Related Party Expenses with TDL | Service | Three Months Ended March 31, 2021 ($) | Three Months Ended March 31, 2020 ($) | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Office Lease Expenses | $38,000 | $31,000 | | Laboratory Testing Services | $72,000 | $148,000 | - Outstanding accounts payables with TDL were $132,000 as of March 31, 2021, and $142,000 as of March 31, 2020[95] - Consulting expenses from a non-employee director were approximately $25,000 for both the three months ended March 31, 2021, and 2020[96] NOTE 6 – Commitments and Contingencies The company's primary commitments relate to office leases in London and New York, both operating on a month-to-month basis after their original terms expired - The company leases offices in London and New York on a month-to-month basis, following the expiration of previous lease agreements[96] Rental Expense | Period | Amount ($) | | :-------------------------------- | :---------- | | Three Months Ended March 31, 2021 | $46,000 | | Three Months Ended March 31, 2020 | $41,000 | NOTE 7 – Loss Per Share Due to the company's net loss position, basic and diluted loss per share were identical for the reported periods. Share options and warrants were excluded from the diluted loss per share calculation as their effect would have been anti-dilutive - Basic and diluted net loss per share were the same for the periods presented due to the company's net loss position[97] Anti-Dilutive Share Equivalents | Type | Three Months Ended March 31, 2021 (Number) | Three Months Ended March 31, 2020 (Number) | | :------------ | :-------------------------------- | :-------------------------------- | | Share options | 115,649,035 | 94,349,035 | | Warrants | 460,910,100 | 462,160,100 | | Total | 576,559,135 | 556,509,135 | NOTE 8 – Subsequent Event Subsequent to the reporting period, in May 2021, the company sold additional ADSs to Aspire Capital under the 2020 Purchase Agreement - In May 2021, the company sold 1,176,471 ADSs to Aspire Capital for total gross proceeds of $2,000,001 under the 2020 Purchase Agreement[99]