Full Press Release Details
Akari Therapeutics Announces Fourth Quarter
and Full Year 2017 Financial Results and Highlights Recent Clinical Progress
NEW YORK and LONDON, March 21, 2018 - Akari Therapeutics, Plc
(NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat
orphan autoimmune and inflammatory diseases, today announces its financial results for the fourth quarter and full year ended December
31, 2017 and highlights progress on its clinical development programs.
"We made significant progress in 2017 advancing our lead
product candidate, Coversin , across our clinical pipeline of orphan inflammatory diseases, most importantly in our Phase
II trial for patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) which met its primary endpoint," commented Dr. David
Horn Solomon, Chief Executive Officer of Akari Therapeutics. "With this Phase II trial now completed and the selection of
the dosing regimen which is intended to be used in future clinical trials, we now look forward to the opening of the first clinical
site by the end of March for our first Phase III trial of Coversin in patients with PNH using a convenient patient administered
sub-cutaneous (SC) dosing."
"We believe Akari is well-positioned to move forward with
its priority programs in 2018. In addition to PNH, we are focused on advancing Coversin into Phase II trials in the first half
of 2018 in our other key disease targets involving both the complement and leukotriene pathways, the eye disease atopic keratoconjuntivitis
(AKC) and the skin disorder bullous pemphigoid (BP), both of which are orphan indications with significant unmet need. We are also
continuing our Phase II trial of Coversin in patients with aHUS, which commenced in late 2017. Additionally, we are advancing Coversin
SC in a patient-convenient auto-injector pen device, and are advancing Coversin in topical eye-drops for AKC, and a long-acting
formulation. Having ended 2017 with good momentum, 2018 is set to be an exciting year for the company as we work towards commercializing
treatments for orphan autoimmune and inflammatory diseases."
Clinical Development Programs Highlights
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Atypical Hemolytic Uremic Syndrome (aHUS)
Dual C5 and Leukotriene B4 Program
Atopic Keratoconjunctivitis (AKC) and Bullous Pemphigoid (BP)
Fourth Quarter and Full Year 2017 Financial Results
Based on its current cash position and operating plan, the Company
expects that it has sufficient cash to fund operations into the second quarter of 2019. This estimate assumes no additional funding
from new partnership agreements or debt or equity financing events.
1For the seven patients that completed
the study, LDH as a multiple of ULN (xULN) was 1.4, 2.2, 2.3, 1.4, 1.3, 1.6 and 1.3 at day 28; 1.5, 2.1, 1.8, 1.5, 1.3, 1.4 and
2.2 at day 60; and 1.6, 2.4, 2.0, 1.9, 1.2, 1.5 and 2.5 at day 90.
Management will conduct a conference call at 8:30 a.m. ET today
to review the Company's fourth quarter and full year 2017 financial results. The call can be accessed by dialing (844) 461-9933
or (636) 812-6633 (international), and referencing conference ID 2096211. The conference call will also be webcast live over the
Internet and can be accessed on the "Events & Presentations" page under the "Investors & Media" section
of the Akari Therapeutics website, www.akaritx.com, prior to the event. A replay of the webcast will be available for at least
30 days following the call at www.akaritx.com.
About Akari Therapeutics
Akari is a biopharmaceutical company focused on developing inhibitors
of acute and chronic inflammation, specifically the complement and the eicosanoid system for the treatment of rare and orphan diseases,
in particular those where the complement system or leukotrienes or both complement and leukotrienes together play a primary role
in disease progression. Akari's lead drug candidate Coversin is a C5 complement inhibitor currently being evaluated in paroxysmal
nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). In addition to its C5 inhibitory activity, Coversin
independently and specifically inhibits leukotriene B4 (LTB4) activity. Akari intends to evaluate Coversin in two conditions, the
skin and eye diseases bullous pemphigoid and atopic keratoconjunctivitis, where the dual action of Coversin on both C5 and LTB4
may be beneficial. Akari is also developing other tick derived proteins, including long 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,
an inability or delay in obtaining required regulatory approvals for Coversin and any other product candidates, which may result
in unexpected cost expenditures; risks inherent in drug development in general; uncertainties in obtaining successful clinical
results for Coversin and any other product candidates and unexpected costs that may result therefrom; failure to realize any value
of 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 Coversin may not be as large
as expected; risks associated with the putative shareholder class action and SEC requests for information; 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; our inability to obtain additional capital on acceptable terms, or
at all; unexpected cost increases and pricing pressures; uncertainties of cash flows and inability to meet working capital needs;
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 and in our Report on Form 6-K filed with the SEC on October 17, 2017. 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, 2017 and December 31, 2016
(in U.S. Dollars, except share data)
| December 31, 2017 | December 31, 2016 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 28,106,671 | $ | 34,098,812 | ||||
| Short-term investments | $ | - | 10,021,963 | |||||
| Prepaid expenses and other current assets | $ | 706,415 | 1,513,006 | |||||
| Total Current Assets | $ | 28,813,086 | 45,633,781 | |||||
| Restricted deposit | $ | 142,235 | $ | 142,168 | ||||
| Property and equipment, net | $ | 55,898 | 58,364 | |||||
| Patent acquisition costs, net | $ | 39,124 | 39,365 | |||||
| Total Assets | $ | 29,050,343 | $ | 45,873,678 | ||||
| Liabilities and Shareholders' Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 1,971,161 | 2,214,313 | |||||
| Accrued expenses | $ | 1,970,873 | 1,837,647 | |||||
| Liability related to stock options and warrants | $ | 5,081,335 | 7,662,808 | |||||
| Total Current Liabilities | $ | 9,023,369 | 11,714,768 | |||||
| Other long-term liability | $ | 48,003 | 56,360 | |||||
| Total liabilities | $ | 9,071,372 | 11,771,128 | |||||
| Commitments and Contingencies | ||||||||
| Shareholders' Equity: | ||||||||
| Share capital GBP of .01 par value | ||||||||
| Authorized: 10,000,000,000 and 5,000,000,000 ordinary shares; issued and outstanding: | ||||||||
| 1,525,693,393 and 1,177,693,383 at December 31, 2017 and 2016, respectively | 22,927,534 | 18,340,894 | ||||||
| Additional paid-in capital | 104,799,550 | 90,979,363 | ||||||
| Accumulated other comprehensive loss | (236,246 | ) | (280,097 | ) | ||||
| Accumulated deficit | (107,511,867 | ) | (74,937,610 | ) | ||||
| Total Shareholders' Equity | 19,978,971 | 34,102,550 | ||||||
| Total Liabilities and Shareholders' Equity | 29,050,343 | $ | 45,873,678 |
AKARI THERAPEUTICS, Plc
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
| Twelve Months Ended | Three Months Ended | |||||||||||||||
| Dec 31, 2017 | Dec 31, 2016 | Dec 31, 2017 | Dec 31, 2016 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development costs | $ | 23,285,279 | $ | 17,306,001 | $ | 7,117,853 | $ | 6,569,519 | ||||||||
| General and administrative expenses | 11,673,910 | 9,940,557 | 3,667,813 | 3,283,703 | ||||||||||||
| Excess Consideration | - | - | ||||||||||||||
| Total Operating Expenses | 34,959,189 | 27,246,558 | 10,785,666 | 9,853,222 | ||||||||||||
| Loss from Operations | (34,959,189 | ) | (27,246,558 | ) | (10,785,666 | ) | (9,853,222 | ) | ||||||||
| Other Income (Expense): | ||||||||||||||||
| Interest income | 175,393 | 143,195 | 51,036 | 45,398 | ||||||||||||
| Changes in fair value of option/warrant liabilities-gains | 2,581,473 | 8,733,350 | 1,571,468 | 1,598,578 | ||||||||||||
| Foreign exchange (losses)/gains | (358,540 | ) | 272,985 | (127,214 | ) | (71,392 | ) | |||||||||
| Other expenses | (13,394 | ) | (43,969 | ) | (2,779 | ) | (5,481 | ) | ||||||||
| Total Other Income (Expense) | 2,384,932 | 9,105,561 | 1,492,511 | 1,567,103 | ||||||||||||
| Net Loss | (32,574,257 | ) | (18,140,997 | ) | (9,293,155 | ) | (8,286,119 | ) | ||||||||
| Other Comprehensive Income (Loss): | ||||||||||||||||
| Foreign Currency Translation Adjustment | 43,851 | (436,577 | ) | 52,153 | 61,116 | |||||||||||
| Comprehensive Loss | $ | (32,530,406 | ) | $ | (18,577,574 | ) | $ | (9,241,002 | ) | $ | (8,225,003 | ) | ||||
| Loss per common share (basic and diluted) | $ | (0.03 | ) | $ | (0.02 | ) | $ | (0.01 | ) | $ | (0.01 | ) | ||||
| Weighted average common shares (basic and diluted) | 1,247,293,388 | 1,177,693,383 | 1,453,823,828 | 1,177,693,383 |
For more information
Mary-Jane Elliott / Sukaina Virji / Nicholas Brown
Consilium Strategic Communications