Full Press Release Details
Akari Therapeutics Reports Full Year 2020 Financial
Results and Highlights Recent Clinical Progress
NEW YORK and LONDON, April 20, 2021 - Akari Therapeutics, Plc (Nasdaq:
AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases
where complement (C5) and/or leukotriene (LTB4) systems are implicated, today announced financial results for the full year ended December
31, 2020, as well as recent clinical progress.
"2020 saw us successfully complete a Phase II study in BP and
align with the FDA and the European Medicines Agency (EMA) on a regulatory pathway to initiate a Phase III pivotal study in BP. In addition,
we have initiated a Phase III study in HSCT-TMA. We have also seen further positive data support development of our back of the eye and
surface of the eye programs," said Clive Richardson, Chief Executive Officer of Akari Therapeutics. "In 2021, we look forward
to progressing our Phase III studies and advancing development of our ophthalmology, lung and trauma programs as we continue to leverage
nomacopan's unique bifunctional action as a dual highly specific inhibitor of LTB4 and complement C5."
Full Year 2020 and Recent Clinical Highlights
Akari's two lead programs - in BP and HSCT-TMA -
are in Phase III development. The Company also has early-stage programs addressing ophthalmology, pulmonary diseases and trauma.
Phase III clinical trial in patients with BP
Phase III clinical trial in pediatric patients with HSCT-TMA
PNH - long term data
EARLY-STAGE PROGRAMS
Ophthalmology program
New histamine inhibition development program
Full Year 2020 Financial Results
A copy of the Company's Annual Report on Form 20-F for the year
ended December 31, 2020 has been filed with the Securities and Exchange Commission and posted on the Company's
About Akari Therapeutics
Akari is a biopharmaceutical company focused on developing inhibitors
of acute and chronic inflammation, specifically for the treatment of rare and orphan diseases, in particular those where the complement
(C5) or leukotriene (LTB4) systems, or both complement and leukotrienes together, play a primary role in disease progression. Akari's
lead drug candidate, Nomacopan (formerly known as Coversin), is a C5 complement inhibitor that also independently and specifically inhibits
leukotriene B4 (LTB4) activity. Nomacopan is currently being clinically evaluated in four indications: bullous pemphigoid (BP), atopic
keratoconjunctivitis (AKC), thrombotic microangiopathy (TMA), and paroxysmal nocturnal hemoglobinuria (PNH). Akari believes that the dual
action of Nomacopan on both C5 and LTB4 may be particularly beneficial in AKC and BP. Akari is also developing other tick derived proteins,
including longer acting versions.
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 therefrom; 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 departure of our former Chief Executive Officers and other executive officers; 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.
AKARI THERAPEUTICS, Plc
CONSOLIDATED BALANCE SHEETS
As of December 31, 2020 and 2019
(in U.S. Dollars, except share data)
| December 31, | December 31, | |||||||
| 2020 | 2019 | |||||||
| As | ||||||||
| Restated | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 14,055,777 | $ | 5,731,691 | ||||
| Prepaid expenses and other current assets | 521,880 | 712,975 | ||||||
| Total Current Assets | 14,577,657 | 6,444,666 | ||||||
| Property and equipment, net | - | 5,013 | ||||||
| Patent acquisition costs, net | 27,150 | 30,163 | ||||||
| Total Assets | $ | 14,604,807 | $ | 6,479,842 | ||||
| Liabilities and Shareholders' Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | 3,380,782 | 1,228,772 | ||||||
| Accrued expenses | 1,839,706 | 4,228,604 | ||||||
| Liability related to warrants | - | 1,014,868 | ||||||
| Total Liabilities | $ | 5,220,488 | $ | 6,472,244 | ||||
| Commitments and Contingencies | ||||||||
| Shareholders' Equity: | ||||||||
| Share capital of $0.0001 par value | ||||||||
| Authorized: 10,000,000,000 ordinary shares; issued and outstanding: 3,847,331,923 and 2,245,865,913 at December 31, 2020 and December 31, 2019, respectively | 384,733 | 31,987,016 | ||||||
| Additional paid-in capital | 139,734,651 | 133,568,636 | ||||||
| Capital redemption reserve | 52,193,811 | - | ||||||
| Accumulated other comprehensive loss | (648,065 | ) | (348,860 | ) | ||||
| Accumulated deficit | (182,280,811 | ) | (165,199,194 | ) | ||||
| Total Shareholders' Equity | 9,384,319 | 7,598 | ||||||
| Total Liabilities and Shareholders' Equity | $ | 14,604,807 | $ | 6,479,842 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
For the Years Ended December 31, 2020, 2019 and
(in U.S. Dollars, except share data)
| Years Ended December 31, | ||||||||||||
| 2020 | 2019 | 2018 | ||||||||||
| As | As | |||||||||||
| Restated | Restated | |||||||||||
| Operating Expenses: | ||||||||||||
| Research and development expenses | $ | 8,820,204 | $ | 8,739,420 | $ | 11,795,376 | ||||||
| General and administrative expenses | 9,160,770 | 8,223,700 | 11,689,926 | |||||||||
| Litigation settlement gain | - | - | (2,700,000 | ) | ||||||||
| Total Operating Expenses | 17,980,974 | 16,963,120 | 20,785,302 | |||||||||
| Loss from Operations | (17,980,974 | ) | (16,963,120 | ) | (20,785,302 | ) | ||||||
| Other Income: | ||||||||||||
| Interest income | 13,615 | 5,531 | 222,256 | |||||||||
| Changes in fair value of warrant liabilities - gain | 556,810 | 198,948 | - | |||||||||
| Foreign currency exchange gains (losses) | 350,939 | (67,256 | ) | 81,501 | ||||||||
| Other expenses | (22,007 | ) | (20,306 | ) | (17,914 | ) | ||||||
| Total Other Income | 899,357 | 116,917 | 285,843 | |||||||||
| Net Loss | (17,081,617 | ) | (16,846,203 | ) | (20,499,459 | ) | ||||||
| Other Comprehensive Income: | ||||||||||||
| Foreign Currency Translation Adjustment | (299,205 | ) | 3,566 | (116,180 | ) | |||||||
| Comprehensive Loss | $ | (17,380,822 | ) | $ | (16,842,637 | ) | $ | (20,615,639 | ) | |||
| Loss per ordinary share (basic and diluted) | $ | (0.01 | ) | $ | (0.01 | ) | $ | (0.01 | ) | |||
| Weighted average ordinary shares (basic and diluted) | 3,159,037,588 | 1,830,998,609 | 1,540,309,840 |
For more information
Sukaina Virji / Nicholas Brown
Consilium Strategic Communications