Full Press Release Details
AKARI THERAPEUTICS, PLC
Quarterly Report For The Period Ended
Condensed Consolidated Financial Statements
| Page | |
| Condensed Consolidated Balance Sheets as of March 31, 2020 (Unaudited) and December 31, 2019 | 2 |
| Condensed Consolidated Statements of Comprehensive Loss for the Three Months Ended March 31, 2020 (Unaudited) and March 31, 2019 (Unaudited) | 3 |
| Condensed Consolidated Statements of Changes in Shareholders' Equity (Deficit) for the Three Months Ended March 31, 2020 (Unaudited) and March 31, 2019 (Unaudited) | 4 |
| Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2020 (Unaudited) and March 31, 2019 (Unaudited) | 5 |
| Notes to Condensed Consolidated Financial Statements - Unaudited | 6-20 |
AKARI THERAPEUTICS, Plc
CONDENSED CONSOLIDATED BALANCE SHEETS
As of March 31, 2020 and December 31, 2019
(in U.S. Dollars, except share data)
| March 31, 2020 | December 31, 2019 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 7,822,180 | $ | 5,731,691 | ||||
| Prepaid expenses and other current assets | 1,828,444 | 712,975 | ||||||
| Deferred financing costs | 288,705 | 321,956 | ||||||
| Total Current Assets | 9,939,329 | 6,766,622 | ||||||
| Property and equipment, net | 2,096 | 5,013 | ||||||
| Patent acquisition costs, net | 27,566 | 30,163 | ||||||
| Total Assets | $ | 9,968,991 | $ | 6,801,798 | ||||
| Liabilities and Shareholders' Equity (Deficit) | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 966,059 | $ | 1,228,772 | ||||
| Accrued expenses | 2,630,857 | 4,228,604 | ||||||
| Liabilities related to options and warrants | 4,556,448 | 3,116,880 | ||||||
| Total Liabilities | 8,153,364 | 8,574,256 | ||||||
| Commitments and Contingencies | ||||||||
| Shareholders' Equity (Deficit): | ||||||||
| Share capital of 0.01 par value | ||||||||
| Authorized: 10,000,000,000 ordinary shares; issued and outstanding: 2,872,895,513 and 2,245,865,913 at March 31, 2020 and December 31, 2019, respectively | 40,085,648 | 31,987,016 | ||||||
| Additional paid-in capital | 109,596,064 | 110,498,824 | ||||||
| Accumulated other comprehensive loss | (571,585 | ) | (348,860 | ) | ||||
| Accumulated deficit | (147,294,500 | ) | (143,909,438 | ) | ||||
| Total Shareholders' Equity (Deficit) | 1,815,627 | (1,772,458 | ) | |||||
| Total Liabilities and Shareholders' Equity (Deficit) | $ | 9,968,991 | $ | 6,801,798 |
See notes to condensed consolidated financial
AKARI THERAPEUTICS, Plc
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
For the Three Months Ended March 31, 2020
| Three Months Ended | ||||||||
| March 31, 2020 | March 31, 2019 | |||||||
| Operating Expenses: | ||||||||
| Research and development expenses (income) | $ | 2,732,165 | $ | (2,318,360 | ) | |||
| General and administrative expenses | 2,194,809 | 2,306,398 | ||||||
| Total Operating Expenses (Income) | 4,926,974 | (11,962 | ) | |||||
| (Loss) Income from Operations | (4,926,974 | ) | 11,962 | |||||
| Other Income (Expenses): | ||||||||
| Interest income | 1,010 | 1,286 | ||||||
| Changes in fair value of option and warrant liabilities - gain/(loss) | 1,309,801 | (2,358,772 | ) | |||||
| Foreign currency exchange gains (losses) | 233,404 | (195,635 | ) | |||||
| Other expenses | (2,303 | ) | (4,124 | ) | ||||
| Total Other Income (Expenses) | 1,541,912 | (2,557,245 | ) | |||||
| Net Loss | (3,385,062 | ) | (2,545,283 | ) | ||||
| Other Comprehensive (Loss) Income: | ||||||||
| Foreign Currency Translation Adjustment | (222,725 | ) | 107,168 | |||||
| Comprehensive Loss | $ | (3,607,787 | ) | $ | (2,438,115 | ) | ||
| Loss per ordinary share (basic and diluted) | $ | (0.00 | ) | $ | (0.00 | ) | ||
| Weighted average ordinary shares outstanding (basic and diluted) | 2,516,280,709 | 1,580,860,080 |
See notes to condensed consolidated financial
AKARI THERAPEUTICS, Plc
CONDENSED CONSOLIDATED STATEMENT OF CHANGES
IN SHAREHOLDERS' EQUITY (DEFICIT) - UNAUDITED
As of and for the Three Months Ended March
| Accumulated | ||||||||||||||||||||||||
| Additional | Other | |||||||||||||||||||||||
| Share Capital | Paid-in | Comprehensive | Accumulated | |||||||||||||||||||||
| Shares | Amount | Capital | Loss | Deficit | Total | |||||||||||||||||||
| Balance, December 31, 2019 | 2,245,865,913 | $ | 31,987,016 | $ | 110,498,824 | $ | (348,860 | ) | $ | (143,909,438 | ) | $ | (1,772,458 | ) | ||||||||||
| Stock-based compensation | - | - | 100,504 | - | - | 100,504 | ||||||||||||||||||
| Issuance of share capital related to financing, net of issuance costs | 627,029,600 | 8,098,632 | (1,003,264 | ) | - | - | 7,095,368 | |||||||||||||||||
| Comprehensive loss | - | - | - | (222,725 | ) | (3,385,062 | ) | (3,607,787 | ) | |||||||||||||||
| Balance, March 31, 2020 | 2,872,895,513 | $ | 40,085,648 | $ | 109,596,064 | $ | (571,585 | ) | $ | (147,294,500 | ) | $ | 1,815,627 |
| Accumulated | ||||||||||||||||||||||||
| Additional | Other | |||||||||||||||||||||||
| Share Capital | Paid-in | Comprehensive | Accumulated | |||||||||||||||||||||
| Shares | Amount | Capital | Income (Loss) | Deficit | Total | |||||||||||||||||||
| Balance, December 31, 2018 | 1,580,693,413 | $ | 23,651,277 | $ | 106,616,083 | $ | (352,426 | ) | $ | (126,803,647 | ) | $ | 3,111,287 | |||||||||||
| Stock-based compensation | - | - | 394,439 | - | - | 394,439 | ||||||||||||||||||
| Issuance of share capital related to financing, net of issuance costs | 5,000,000 | 65,598 | 86,955 | - | - | 152,553 | ||||||||||||||||||
| Comprehensive income (loss) | - | - | - | 107,168 | (2,545,283 | ) | (2,438,115 | ) | ||||||||||||||||
| Balance, March 31, 2019 | 1,585,693,413 | $ | 23,716,875 | $ | 107,097,477 | $ | (245,258 | ) | $ | (129,348,930 | ) | $ | 1,220,164 |
See notes to condensed consolidated financial
AKARI THERAPEUTICS, Plc
CONDENSED CONSOLIDATED STATEMENTS
OF CASH FLOWS - UNAUDITED
For the Three Months Ended March 31, 2020
| Three Months Ended | ||||||||
| March 31, 2020 | March 31, 2019 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (3,385,062 | ) | $ | (2,545,283 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 3,877 | 5,566 | ||||||
| Stock-based compensation | 100,504 | 394,439 | ||||||
| Changes in fair value of option and warrant liabilities - (gain)/loss | (1,309,801 | ) | 2,358,772 | |||||
| Foreign currency exchange (gains) losses | (171,806 | ) | 166,593 | |||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other current assets | (1,115,329 | ) | (464,696 | ) | ||||
| Accounts payable and accrued expenses | (1,862,039 | ) | 313,553 | |||||
| Total adjustments | (4,354,594 | ) | 2,774,227 | |||||
| Net Cash Used in Operating Activities | (7,739,656 | ) | 228,944 | |||||
| Cash Flows from Financing Activities: | ||||||||
| Net proceeds from issuance of shares and warrants | 9,877,988 | 157,743 | ||||||
| Net Cash Provided by Financing Activities | 9,877,988 | 157,743 | ||||||
| Effect of Exchange Rates on Cash | (47,843 | ) | (61,175 | ) | ||||
| Net Increase in Cash | 2,090,489 | 325,512 | ||||||
| Cash, beginning of period | 5,731,691 | 5,967,967 | ||||||
| Cash, end of period | $ | 7,822,180 | $ | 6,293,479 | ||||
| Supplemental Disclosures of Non-Cash Financing Activities: | ||||||||
| Deferred financing costs | $ | 33,251 | $ | 5,190 |
See notes to condensed consolidated financial
AKARI THERAPEUTICS, Plc
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS - UNAUDITED
Akari Therapeutics, Plc, (the "Company"
or "Akari"), is incorporated in the United Kingdom. The Company is a clinical-stage biopharmaceutical company focused
on developing inhibitors of acute and chronic inflammation, specifically the complement system, the eicosanoid or leukotriene system
and the bioamine system for the treatment of rare and orphan diseases. The Company's activities since inception have consisted
of performing research and development activities and raising capital.
As of March 31, 2020, the Company
has an accumulated deficit of $147,294,500 and cash of $7,822,180. On September 26, 2018, the Company entered into a securities
purchase agreement (the "Purchase Agreement") with Aspire Capital Fund, LLC ("Aspire Capital") which provides
that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up
to an aggregate of $20.0 million of the Company's ADSs over the 30-month term of the Purchase Agreement (See Note 4). As
of March 31, 2020, $9,623,525 remains available under the facility.
The Company believes its current
capital resources are sufficient to support its operations through the third quarter of 2020 without giving effect to the sale
of additional shares to Aspire Capital under the Purchase Agreement.
The Company is subject to a number of risks
similar to those of clinical stage companies, including dependence on key individuals, uncertainty of product development and generation
of revenues, dependence on outside sources of capital, risks associated with the outbreak of coronavirus, risks associated with
clinical trials of products, dependence on third-party collaborators for research operations, need for regulatory approval of products,
risks associated with protection of intellectual property, and competition with larger, better-capitalized companies. In addition,
the Company is subject to risks related to an SEC investigation and the coronavirus outbreak.
For the three months ended March
31, 2020, the Company reported a net loss of $3,385,062 and expects to continue to incur substantial losses over the next several
years during its development phase. To fully execute its business plan, the Company will need, among other things, to complete
its research and development efforts and clinical and regulatory activities. These activities may take several years and will require
significant operating and capital expenditures in the foreseeable future. There can be no assurance that these activities will
be successful. If the Company is not successful in these activities or there is not a favorable resolution of the SEC investigation
it could delay, limit, reduce or terminate preclinical studies, clinical trials or other research and development activities. To
fund its capital needs, the Company plans to raise funds through equity or debt financings or other sources, such as strategic
partnerships and alliance and licensing arrangements, and in the long term, from the proceeds from sales of commercial product.
Additional funds may not be available when the Company needs them, on terms that are acceptable to it, or at all. These matters
raise substantial doubt about the Company's ability to continue as a going concern. The financial statements do not include
any adjustments to the carrying amounts and classifications of assets and liabilities that would result if the Company was unable
to continue as a going concern.
In late 2019, a novel strain
of COVID-19, also known as coronavirus, was reported in Wuhan, China. While initially the outbreak was largely concentrated in
China, it has now spread to several other countries, including in the United Kingdom and the United States, and infections have
been reported globally. Public health epidemics or outbreaks such as this can adversely impact the Company's business as
a result of disruptions, such as travel bans, quarantines, and interruptions to access the trial sites and supply chains, which
could result in material delays and complications with respect to our research and development programs and clinical trials. Moreover,
as a result of coronavirus, there is a general unease of conducting unnecessary activities in medical centers. As a consequence,
the Company's ongoing trials have been halted or disrupted. It is too early to assess the full impact of the coronavirus
outbreak on trials for nomacopan, but coronavirus may affect our ability to complete recruitment in the original timeframe. For
example, the Phase I/II clinical trial in patients with AKC study has been halted and the Company anticipates that recruitment
in the Phase III clinical trial in pediatric patients with HSCT-TMA will be delayed. The extent to which the coronavirus impacts
operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the
duration and continued severity of the outbreak, and the actions that may be required to contain the coronavirus or treat its impact.
In particular, the continued spread of the coronavirus globally could adversely impact the Company's operations and workforce,
including research and clinical trials and the ability to raise capital, could affect the operations of key governmental agencies,
such as the FDA, which may delay the development of the Company's product candidates, and could result in the inability of
suppliers to deliver components or raw materials on a timely basis or at all, each of which in turn could have an adverse impact
on the Company's business, financial condition and results of operation.
AKARI THERAPEUTICS, Plc
NOTES TO CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS - UNAUDITED
of Presentation - The accompanying condensed consolidated financial statements have been prepared in accordance
with U.S. GAAP for interim financial information and the rules and regulations of the SEC and assumes that the Company will continue
to operate as a going concern. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP
for complete financial statements. These financial statements have been prepared on the same basis as the Company's annual
financial statements and, in the opinion of management, reflect all adjustments, including normal and recurring adjustments, which
the Company considers necessary for the fair presentation of financial information. The results of operations and comprehensive
loss for the three months ended March 31, 2020 and March 31, 2019, are not necessarily indicative of expected results for the full
fiscal year or any other period. These interim condensed consolidated financial statements should be read in conjunction with the
Company's audited financial statements as of December 31, 2019 and notes thereto included in the 2019 Form 20-F.
of Consolidation - The unaudited Condensed Consolidated Financial Statements include the accounts of the Company
and Volution Immuno Pharmaceuticals SA, a private Swiss company, its wholly-owned subsidiary. All intercompany transactions have
Currency - The functional currency of the Company is U.S. dollars, as that is the primary economic environment
in which the Company operates as well as the currency in which it has been financed.
The reporting currency of the Company is
U.S. Dollars. The Company translated its non-U.S. operations' assets and liabilities denominated in foreign currencies into