04/20/2021 | Press release | Distributed by Public on 04/20/2021 16:43
NEW YORK and LONDON, April 20, 2021 (GLOBE NEWSWIRE) -- 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 TRIALS
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
Lung program
Trauma
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 website at http://investor.akaritx.com/financial-information/sec-filings.
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 2018
(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
Investor Contact:
Peter Vozzo
Westwicke/ICR
(443) 213-0505
[email protected]
Media Contact:
Sukaina Virji / Nicholas Brown
Consilium Strategic Communications
+44 (0)20 3709 5700
[email protected]