Full Press Release Details
Revised Press Release
Akari Therapeutics Reports Revised
Third Quarter 2019 Financial Results
And Highlights Recent Clinical Progress
NEW YORK and LONDON, November 27, 2019 - Akari Therapeutics,
Plc (Nasdaq: AKTX), a 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 revised financial results for
the third quarter ended September 30, 2019 and recent clinical progress.
"We are excited about the positive clinical data we are
accumulating in patients treated with nomacopan across our target rare disease indications. The rapid and sustained clinical improvement
combined with the positive long-term safety profile we have observed in patients, helps to offer further validation of nomacopan's
unique method of action as an inhibitor of both the complement and leukotriene pathways," said Clive Richardson, Chief Executive
Officer of Akari Therapeutics. "We look forward to further progress across both our topical and subcutaneous clinical programs
in 2020 as we look to drive nomacopan through the clinic and towards helping patients afflicted by these rare and debilitating
inflammatory conditions. In addition, we seek to partner those programs in which a joint development approach can produce a faster
Third Quarter 2019 and Recent Business Highlights
Akari's strategy is to focus on orphan inflammatory diseases
with significant unmet medical need, where the role of the complement and leukotriene systems are implicated. Akari's lead
programs are in BP, AKC, and HSCT-TMA where clinical data with nomacopan has shown rapid and sustained clinical improvement in
patients. These diseases have no approved treatments.
Further evidence for potential therapeutic benefits of inhibition
of C5 and LTB4 by nomacopan
In the last three months, the Company has announced preclinical
data in both BP and AKC demonstrating the likely combined role of C5 and LTB4 in these two severe inflammatory conditions:
Phase II clinical trial in patients with BP
Phase I/II clinical trial in patients with AKC
Paroxysmal nocturnal hemoglobinuria (PNH) program
Third Quarter 2019 Financial Results
The following selected financial data has been revised to reflect
liability treatment of the warrants issued in connection with the July 3, 2019 registered direct offering, as well as the related
fair market valuation as of September 30, 2019. The warrants were previously reflected using equity treatment in the company's
press release dated November 4, 2019. There is no impact on net cash or operating expenses.
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 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 regarding, among other things, statements
related to the offering, the expected gross proceeds and the expected closing of the offering. 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; our ability to enter into collaborative, licensing, and other commercial relationships
and on terms commercially reasonable to us; 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; 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 September 30, 2019 and December 31,
(in U.S. Dollars, except share data)
| September 30, 2019 | December 31, 2018 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 6,268,667 | $ | 5,446,138 | ||||
| Tax Credit Receivable | 2,902,987 | - | ||||||
| Prepaid expenses and other current assets | 1,058,527 | 1,423,184 | ||||||
| Deferred financing costs | 402,042 | 585,000 | ||||||
| Total Current Assets | 10,632,223 | 7,454,322 | ||||||
| Restricted cash | - | 521,829 | ||||||
| Property and equipment, net | 8,388 | 20,425 | ||||||
| Patent acquisition costs, net | 29,147 | 32,978 | ||||||
| Total Assets | $ | 10,669,758 | $ | 8,029,554 | ||||
| Liabilities and Shareholders' Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 1,315,411 | $ | 1,586,285 | ||||
| Accrued expenses | 3,035,056 | 1,489,558 | ||||||
| Liability related to options and warrants | 3,068,834 | 1,842,424 | ||||||
| Total Liabilities | 7,419,301 | 4,918,267 | ||||||
| Shareholders' Equity: | ||||||||
| Share capital of 0.01 par value | ||||||||
| Authorized: 10,000,000,000 ordinary shares; issued and outstanding: 2,100,865,913 and 1,580,693,413 at September 30, 2019 and December 31, 2018, respectively | 30,123,701 | 23,651,277 | ||||||
| Additional paid-in capital | 109,560,217 | 106,616,083 | ||||||
| Accumulated other comprehensive loss | (402,093 | ) | (352,426 | ) | ||||
| Accumulated deficit | (136,031,368 | ) | (126,803,647 | ) | ||||
| Total Shareholders' Equity | 3,250,457 | 3,111,287 | ||||||
| Total Liabilities and Shareholders' Equity | $ | 10,669,758 | $ | 8,029,554 |
AKARI THERAPEUTICS, Plc
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE
For the Three and Nine Months Ended September
30, 2019 and September 30, 2018
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, 2019 | September 30, 2018 | September 30, 2019 | September 30, 2018 | |||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development expenses | $ | 1,763,057 | $ | 3,303,790 | $ | 3,038,038 | $ | 9,433,018 | ||||||||
| General and administrative expenses | 1,354,263 | 2,382,153 | 6,098,767 | 8,537,191 | ||||||||||||
| Litigation settlement gain | - | (2,700,000 | ) | - | (2,700,000 | ) | ||||||||||
| Total Operating Expenses | 3,117,320 | 2,985,943 | 9,136,805 | 15,270,209 | ||||||||||||
| Loss from Operations | (3,117,320 | ) | (2,985,943 | ) | (9,136,805 | ) | (15,270,209 | ) | ||||||||
| Other Income (Expenses): | ||||||||||||||||
| Interest income | 2,057 | 66,073 | 3,792 | 198,146 | ||||||||||||
| Changes in fair value of option and warrant liabilities - gain/(loss) | 515,489 | (715,846 | ) | (12,594 | ) | 2,077,128 | ||||||||||
| Foreign currency exchange gains (losses) | 37,209 | 36,036 | (71,989 | ) | 42,481 | |||||||||||
| Other expenses | (2,788 | ) | 6,425 | (10,124 | ) | (1,572 | ) | |||||||||
| Total Other Income (Expenses) | 551,967 | (607,312 | ) | (90,915 | ) | 2,316,183 | ||||||||||
| Net Loss | (2,565,353 | ) | (3,593,255 | ) | (9,227,720 | ) | (12,954,026 | ) | ||||||||
| Other Comprehensive (Loss) Income: | ||||||||||||||||
| Foreign Currency Translation Adjustment | 3,281 | (65,848 | ) | (49,667 | ) | (60,237 | ) | |||||||||
| Comprehensive Loss | $ | (2,562,072 | ) | $ | (3,659,103 | ) | $ | (9,277,387 | ) | $ | (13,014,263 | ) | ||||
| Loss per ordinary share (basic and diluted) | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.01 | ) | $ | (0.01 | ) | ||||
| Weighted average ordinary shares outstanding (basic and diluted) | 1,971,025,222 | 1,528,682,540 | 1,721,098,272 | 1,526,700,724 |
For more information
Sukaina Virji / Nicholas Brown / Lizzie Seeley
Consilium Strategic Communications