NEW YORK and LONDON, May 29, 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 first quarter ended March 31, 2019 and recent clinical progress.
“We have seen positive clinical signals in all three of our new programs in BP, HSCT-TMA and AKC, with rapid improvement in the relevant clinical measures and with no drug-related serious adverse events,” said Clive Richardson, Interim Chief Executive Officer of Akari Therapeutics. “Both AKC and BP have further planned clinical readouts this year, providing a potential opportunity to consider advancing both into pivotal trials in 2020 and further supporting the therapeutic role of combined C5 and LTB4 treatment.”
First Quarter 2019 and Recent Business Highlights
Upcoming Events and Milestones
First Quarter 2019 Financial Results
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, or 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 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 related to material weaknesses in our internal controls over financial reporting and risks relating to the ineffectiveness of our disclosure controls and procedures; 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 | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
As of March 31, 2019 and December 31, 2018 | |||||||
(in U.S. Dollars, except share data) | |||||||
March 31, 2019 | December 31, 2018 | ||||||
Assets | (Unaudited) | ||||||
Current Assets: | |||||||
Cash | $ | 6,145,555 | $ | 5,446,138 | |||
Prepaid expenses and other current assets | 1,887,780 | 1,423,184 | |||||
Deferred financing costs | 579,810 | 585,000 | |||||
Total Current Assets | 8,613,145 | 7,454,322 | |||||
Restricted cash | 147,924 | 521,829 | |||||
Property and equipment, net | 15,834 | 20,425 | |||||
Patent acquisition costs, net | 32,867 | 32,978 | |||||
Total Assets | $ | 8,809,770 | $ | 8,029,554 | |||
Liabilities and Shareholders' Equity | |||||||
Current Liabilities: | |||||||
Accounts payable | $ | 1,763,182 | $ | 1,586,285 | |||
Accrued expenses | 1,625,228 | 1,489,558 | |||||
Liabilities related to options | 4,201,196 | 1,842,424 | |||||
Total Liabilities | 7,589,606 | 4,918,267 | |||||
Commitments and Contingencies | |||||||
Shareholders' Equity: | |||||||
Share capital of £0.01 par value | |||||||
Authorized: 10,000,000,000 ordinary shares; issued and outstanding: 1,585,693,413 | |||||||
and 1,580,693,413 at March 31, 2019 and December 31, 2018, respectively | 23,716,875 | 23,651,277 | |||||
Additional paid-in capital | 107,097,477 | 106,616,083 | |||||
Accumulated other comprehensive loss | (245,258 | ) | (352,426 | ) | |||
Accumulated deficit | (129,348,930 | ) | (126,803,647 | ) | |||
Total Shareholders' Equity | 1,220,164 | 3,111,287 | |||||
Total Liabilities and Shareholders' Equity | $ | 8,809,770 | $ | 8,029,554 | |||
AKARI THERAPEUTICS, Plc | |||||||
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - UNAUDITED | |||||||
For the Three Months Ended March 31, 2019 and 2018 | |||||||
(in U.S. Dollars) | |||||||
Three Months Ended | |||||||
Mar 31, 2019 | Mar 31, 2018 | ||||||
Operating Expenses: | |||||||
Research and development (income) expenses | (2,318,360 | ) | $ | 1,008,388 | |||
General and administrative expenses | 2,306,398 | 3,296,973 | |||||
Total Operating Expenses | (11,962 | ) | 4,305,361 | ||||
Income (Loss) from Operations | 11,962 | (4,305,361 | ) | ||||
Other Income (Expenses): | |||||||
Interest income | 1,286 | 64,638 | |||||
Changes in fair value of option liabilities - (loss)/gains | (2,358,772 | ) | 2,945,531 | ||||
Foreign currency exchange losses | (195,635 | ) | (40,975 | ) | |||
Other expenses | (4,124 | ) | (2,408 | ) | |||
Total Other Income (Expenses) | (2,557,245 | ) | 2,966,786 | ||||
- | |||||||
Net Loss | (2,545,283 | ) | (1,338,575 | ) | |||
Other Comprehensive Income: | |||||||
Foreign Currency Translation Adjustment | 107,168 | 32,799 | |||||
Comprehensive Loss | $ | (2,438,115 | ) | $ | (1,305,776 | ) | |
Loss per ordinary share (basic and diluted) | $ | (0.00 | ) | $ | (0.00 | ) | |
Weighted average ordinary shares (basic and diluted) | 1,580,860,080 | 1,525,693,393 | |||||
For more information
Investor Contact:
Peter Vozzo
Westwicke Partners
(443) 213-0505
peter.vozzo@westwicke.com
Media Contact:
Sukaina Virji / Nicholas Brown / Lizzie Seeley
Consilium Strategic Communications
+44 (0)20 3709 5700
Akari@consilium-comms.com