NEW YORK and LONDON, April 23, 2019 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement and/or leukotriene systems are implicated, today announced its financial results for the fourth quarter and full year ended December 31, 2018.
“The last several months were an important period in which a number of clinical and preclinical study results validated our focus on poorly treated orphan diseases where the combined inhibition of the complement and leukotriene pathways provides a novel treatment option for Nomacopan (Coversin), our dual action C5 and LTB4 inhibitor,” said Clive Richardson, Interim Chief Executive Officer of Akari Therapeutics. “During the last six months, the Company has broadened its clinical targets with two new ongoing orphan disease programs in bullous pemphigoid and atopic keratoconjunctivitis, and a third hematopoietic stem cell transplant-related thrombotic microangiopathy anticipated to open later this year.”
Full Year 2018 and Recent Business Highlights
Nomacopan (Coversin) auto-injector pen
Long-term safety study for Nomacopan (Coversin)
Upcoming Events and Milestones
Fourth Quarter and Full Year 2018 Financial Results
A copy of the Company’s Annual Report on Form 20-F for the year ended December 31, 2018 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. You may request a copy of the Company’s Form 20-F, at no cost to you, by writing to the Chief Financial Officer of the Company at 75/76 Wimpole Street, London W1G 9RT, United Kingdom or by calling the Company at +44 20 8004 0261.
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 (Coversin), is a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity. Nomacopan (Coversin) 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 (Coversin) on both C5 and LTB4 may be 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 (Coversin) 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 (Coversin) 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 (Coversin) 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 (Coversin) may not be as large as expected; risks associated with the departure of our former Chief Executive Officers and other executive officers; risks associated with the SEC investigation; 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 | ||||||||
(in U.S. Dollars, except share data) | ||||||||
December 31, 2018 | December 31, 2017 | |||||||
Assets | ||||||||
Current Assets: | ||||||||
Cash | $ | 5,446,138 | $ | 28,106,671 | ||||
Prepaid expenses and other current assets | 1,423,184 | 706,415 | ||||||
Deferred Financing Costs | 585,000 | - | ||||||
Total Current Assets | 7,454,322 | 28,813,086 | ||||||
Restricted cash | 521,829 | 142,235 | ||||||
Property and equipment, net | 20,425 | 55,898 | ||||||
Patent acquisition costs, net | 32,978 | 39,124 | ||||||
Total Assets | $ | 8,029,554 | $ | 29,050,343 | ||||
Liabilities and Shareholders' Equity | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 1,586,285 | $ | 1,971,161 | ||||
Accrued expenses | 1,489,558 | 4,795,873 | ||||||
Liabilities related to options and warrants | 1,842,424 | 5,081,335 | ||||||
Total Current Liabilities | 4,918,267 | 11,848,369 | ||||||
Other long-term liability | - | 48,003 | ||||||
Total liabilities | 4,918,267 | 11,896,372 | ||||||
Commitments and Contingencies | ||||||||
Shareholders' Equity: | ||||||||
Share capital of £0.01 par value | ||||||||
Authorized: 10,000,000,000 and 5,000,000,000 ordinary shares; issued and outstanding: | ||||||||
1,580,693,413 and 1,525,693,393 at December 31, 2018 and 2017, respectively | 23,651,277 | 22,927,534 | ||||||
Additional paid-in capital | 106,616,083 | 104,799,550 | ||||||
Accumulated other comprehensive loss | (352,426 | ) | (236,246 | ) | ||||
Accumulated deficit | (126,803,647 | ) | (110,336,867 | ) | ||||
Total Shareholders' Equity | 3,111,287 | 17,153,971 | ||||||
Total Liabilities and Shareholders' Equity | $ | 8,029,554 | $ | 29,050,343 | ||||
AKARI THERAPEUTICS, Plc | |||||||||||||||
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | |||||||||||||||
(in U.S. Dollars) | |||||||||||||||
Twelve Months Ended | Three Months Ended | ||||||||||||||
Dec 31, 2018 | Dec 31, 2017 | Dec 31, 2018 | Dec 31, 2017 | ||||||||||||
Operating Expenses: | |||||||||||||||
Research and development costs | $ | 11,795,376 | $ | 23,285,279 | $ | 2,362,358 | $ | 7,117,853 | |||||||
General and administrative expenses | 10,896,158 | 11,798,910 | 2,370,206 | 3,792,813 | |||||||||||
Litigation settlement gain | (2,700,000 | ) | 2,700,000 | - | 2,700,000 | ||||||||||
Total Operating Expenses | 19,991,534 | 37,784,189 | 4,732,564 | 13,610,666 | |||||||||||
Loss from Operations | (19,991,534 | ) | (37,784,189 | ) | (4,732,564 | ) | (13,610,666 | ) | |||||||
Other Income (Expense): | |||||||||||||||
Interest income | 222,256 | 175,393 | 24,110 | 51,036 | |||||||||||
Changes in fair value of option and warrant liabilities - gain | 3,238,911 | 2,581,473 | 1,161,783 | 1,571,468 | |||||||||||
Foreign currency exchange gain (loss) | 81,501 | (358,540 | ) | 39,020 | (127,213 | ) | |||||||||
Other expenses | (17,914 | ) | (13,394 | ) | (5,103 | ) | (2,779 | ) | |||||||
Total Other Income (Expenses) | 3,524,754 | 2,384,932 | 1,219,810 | 1,492,512 | |||||||||||
Net Loss | (16,466,780 | ) | (35,399,257 | ) | (3,512,754 | ) | (12,118,154 | ) | |||||||
Foreign Currency Translation Adjustment | (116,180 | ) | 43,851 | (55,943 | ) | 52,153 | |||||||||
Comprehensive Loss | $ | (16,582,960 | ) | $ | (35,355,406 | ) | $ | (3,568,697 | ) | $ | (12,066,001 | ) | |||
Loss per ordinary share (basic and diluted) | $ | (0.01 | ) | $ | (0.03 | ) | $ | (0.00 | ) | $ | (0.01 | ) | |||
Weighted average ordinary shares (basic and diluted) | 1,540,309,840 | 1,247,293,388 | 1,580,693,413 | 1,453,823,828 | |||||||||||
For more information
Investor Contact:
Peter Vozzo
Westwicke Partners
(443) 213-0505
peter.vozzo@westwicke.com
Media Contact:
Mary-Jane Elliott / Sukaina Virji / Nicholas Brown
Consilium Strategic Communications
+44 (0)20 3709 5700
Akari@consilium-comms.com