Full Press Release Details
Akari Therapeutics Reports Full Year 2021 Financial
Results and Highlights Clinical Progress
NEW YORK and LONDON, May 16, 2022 (GLOBE NEWSWIRE) -- Akari Therapeutics,
Plc (Nasdaq: AKTX), a late-stage biotechnology company focused on advanced therapies for autoimmune and inflammatory diseases, today announced
financial results for the full year ended December 31, 2021, as well as recent pipeline progress.
"During the last twelve months, Akari has advanced nomacopan
pre-clinical and clinical development programs, including three focus areas of autoimmune skin diseases, thrombotic microangiopathies,
and progressive retinal diseases," said Rachelle Jacques, President and CEO of Akari Therapeutics. "Broad and deep research
and development work is producing compelling science in diseases with complex pathologies and is providing the foundation for next steps
in the development of bispecific recombinant nomacopan. Late-stage programs in pediatric HSCT-TMA and BP are active and advancing in Part
A clinical studies, which will inform the pivotal Part B studies that will be the basis for potential regulatory submissions in the U.S.
Full Year 2021 and Recent Clinical Highlights
Late-Stage Program Studying Investigational Nomacopan in Pediatric
Late-Stage Program Studying Investigational Nomacopan in Bullous
Pre-Clinical Program Studying Investigational Long-Acting PAS-Nomacopan
for Geographic Atrophy/Dry Age-Related Macular Degeneration (GA/dAMD)
Studies of Investigational Nomacopan in Inflammation-Implicated
Nomacopan Manufacturing
Full Year 2021 Financial Results
copy of the Company's Annual Report on Form 20-F for the year ended December 31, 2021 will be filed with the Securities and Exchange
Commission and posted on the Company's website at http://investor.akaritx.com/financial-information/sec-filings.
About Akari Therapeutics
Akari Therapeutics, plc (Nasdaq: AKTX) is a biotechnology company focused
on developing advanced therapies for autoimmune and inflammatory diseases. Akari's lead asset, investigational nomacopan, is a bispecific
recombinant inhibitor of C5 complement activation and leukotriene B4 (LTB4) activity. The Akari pipeline includes two late-stage
programs for bullous pemphigoid (BP) and thrombotic microangiopathy (TMA), as well as earlier stage research and development programs
in eye and lung diseases with significant unmet need. For more information about Akari, please visit akaritx.com.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward- looking statements reflect
our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available
to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected
in or suggested by those forward- looking statements are reasonable, we can give no assurance that the plans, intentions, expectations
or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking
statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company
include, but are not limited to: needs for additional capital to fund our operations, our ability to continue as a going concern; uncertainties
of cash flows and inability to meet working capital needs; an inability or delay in obtaining required regulatory approvals for nomacopan
and any other product candidates, which may result in unexpected cost expenditures; our ability to obtain orphan drug designation in additional
indications; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for nomacopan and any
other product candidates and unexpected costs that may result there; difficulties enrolling patients in our clinical trials; failure to
realize any value of nomacopan and any other product candidates developed and being developed in light of inherent risks and difficulties
involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product
candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products
brought to market; risks resulting from unforeseen side effects; risk that the market for nomacopan may not be as large as expected risks
associated with the impact of the COVID-19 pandemic; inability to obtain, maintain and enforce patents and other intellectual property
rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing
arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate
supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; unexpected cost increases
and pricing pressures and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission,
including our most recently filed Annual Report on Form 20-F filed with the SEC. Except as otherwise noted, these forward-looking statements
speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect
events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking
statements contained in this press release.
Consolidated Statements
AKARI THERAPEUTICS, Plc
CONSOLIDATED BALANCE SHEETS
As of December 31, 2021 and 2020
(in U.S. Dollars, except share data)
| December 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 9,361,270 | $ | 14,055,777 | ||||
| Prepaid expenses | 2,173,528 | 292,680 | ||||||
| Other current assets | 90,301 | 229,200 | ||||||
| Total Current Assets | 11,625,099 | 14,577,657 | ||||||
| Patent acquisition costs, net | 22,929 | 27,150 | ||||||
| Total Assets | $ | 11,648,028 | $ | 14,604,807 | ||||
| Liabilities and Shareholders' Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | 1,788,563 | 3,380,782 | ||||||
| Accrued expenses | 3,184,883 | 1,839,706 | ||||||
| Liability related to deposits received for share subscriptions | 1,120,000 | - | ||||||
| Total Liabilities | $ | 6,093,446 | $ | 5,220,488 | ||||
| Commitments and Contingencies | ||||||||
| Shareholders' Equity: | ||||||||
| Share capital of $0.0001 par value | ||||||||
| Authorized: 15,000,000,000 ordinary shares; issued and outstanding: 4,759,731,923 and 3,847,331,923 at December 31, 2021 and December 31, 2020, respectively | 475,973 | 384,733 | ||||||
| Additional paid-in capital | 153,130,813 | 139,734,651 | ||||||
| Capital redemption reserve | 52,193,811 | 52,193,811 | ||||||
| Accumulated other comprehensive loss | (540,967 | ) | (648,065 | ) | ||||
| Accumulated deficit | (199,705,048 | ) | (182,280,811 | ) | ||||
| Total Shareholders' Equity | 5,554,582 | 9,384,319 | ||||||
| Total Liabilities and Shareholders' Equity | $ | 11,648,028 | $ | 14,604,807 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
For the Years Ended December 31, 2021,
(in U.S. Dollars, except share data)
| Years Ended December 31, | ||||||||||||
| 2021 | 2020 | 2019 | ||||||||||
| Operating Expenses: | ||||||||||||
| Research and development expenses | $ | 9,133,455 | $ | 8,820,204 | $ | 8,739,420 | ||||||
| General and administrative expenses | 8,080,681 | 9,160,770 | 8,223,700 | |||||||||
| Total Operating Expenses | 17,214,136 | 17,980,974 | 16,963,120 | |||||||||
| Loss from Operations | (17,214,136 | ) | (17,980,974 | ) | (16,963,120 | ) | ||||||
| Other Income: | ||||||||||||
| Interest income | 10,600 | 13,615 | 5,531 | |||||||||
| Changes in fair value of warrant liabilities - gain | - | 556,810 | 198,948 | |||||||||
| Foreign currency exchange losses | (193,219 | ) | (350,939 | ) | (67,256 | ) | ||||||
| Other expenses | (27,482 | ) | (22,007 | ) | (20,306 | ) | ||||||
| Total Other (Loss) Income | (210,101 | ) | 899,357 | 116,917 | ||||||||
| Net Loss | (17,424,237 | ) | (17,081,617 | ) | (16,846,203 | ) | ||||||
| Other Comprehensive Income: | ||||||||||||
| Foreign Currency Translation Adjustment | 107,098 | (299,205 | ) | 3,566 | ||||||||
| Comprehensive Loss | $ | (17,317,139 | ) | $ | (17,380,822 | ) | $ | (16,842,637 | ) | |||
| Loss per ordinary share (basic and diluted) | $ | (0.00 | ) | $ | (0.01 | ) | $ | (0.01 | ) | |||
| Weighted average ordinary shares (basic and diluted) | 4,292,112,667 | 3,159,037,588 | 1,830,998,609 |
For more information
Sukaina Virji/ Maya Bennison
Consilium Strategic Communications