Full Press Release Details
Akari Announces First Quarter 2018 Financial
Results and Update on its
Growing Pipeline of Phase II and Phase III Clinical Trials
NEW YORK and LONDON, August 17, 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 announced its financial results for the first quarter ended March 31, 2018 and
highlights its pipeline of Phase II and Phase III clinical trials.
"We are excited by the range of clinical opportunities
that we are currently exploring. We look forward to providing initial clinical data from these trials starting in the fourth quarter
of 2018," commented Clive Richardson, acting Chief Executive Officer of Akari Therapeutics. "Akari does not intend
to develop all of these programs through to commercialization on its own but rather, intends to partner one or more of its programs.
To that end, a robust business development program has been in progress since early 2018 led by Mike Grissinger, an Akari non-executive
director and pharmaceutical industry veteran who spent 22 years at Johnson & Johnson in business development leadership roles."
Clinical Development Programs Highlights
Akari's clinical program is divided into two separate
workstreams targeting two different sets of clinical conditions. One group of diseases is where the combined inhibition of the
complement and leukotriene pathways provides a potential new treatment solution for a wide range of currently poorly treated orphan
inflammatory conditions. The second group of diseases are those where complement dysregulation is the primary driver.
Dual C5 and Leukotriene B4 Program
The increasing recognition that LTB4 may combine with complement
dysregulation in the etiology of many autoimmune and autoinflammatory conditions has focused Akari's clinical development
on a number of poorly treated conditions where Coversin's dual C5 and LTB4 binding provides a potential novel therapeutic
solution. These programs include bullous pemphigoid (BP), an inflammatory skin disease in which current treatment is limited to
steroids, and immunosuppressants and atopic keratoconjunctivitis (AKC), an eye surface inflammatory disease which can lead to permanent
vision loss and for which there are few effective treatment options. Both are rare conditions for which Akari is seeking orphan
Patient treatment in CAPSTONE, the Phase III trial in na ve
PNH patients, has commenced. We anticipate introducing a new pen injector in 2019 to facilitate patient use which will accommodate
a week's supply of medication. Within the program to treat patients with a polymorphism that makes them resistant to treatment
with Soliris, Akari recently began treating a second PNH patient under an investigational new drug application (IND) in the U.S.
This patient has responded well (LDH <1.5xULN at day 28). In all, three Soliris resistant patients have now been treated with
Coversin; two with PNH and a third with a thrombotic microangiopathy (TMA). All PNH patients remaining on treatment have the option
of entering into the Akari long term safety program. Nine PNH patients have been treated in aggregate for over 11 patient years
with no drug related SAEs to date.
Akari has also opened a clinical program targeting thrombotic
microangiopathies (TMA) including atypical haemolytic syndrome (aHUS). We expect to provide an update on Akari's TMA program
First Quarter 2018 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
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 is currently evaluating 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,
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 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 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 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
associate 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 putative shareholder class action and 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
on July 18, 2018. 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
| AKARI THERAPEUTICS, Plc | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| As of March 31, 2018 and December 31, 2017 | ||||||||
| (in U.S. Dollars, except share data) | ||||||||
| March 31, 2018 | December 31, 2017 | |||||||
| Assets | (Unaudited) | |||||||
| Current Assets: | ||||||||
| Cash | $ | 23,781,441 | $ | 28,106,671 | ||||
| Prepaid expenses and other current assets | $ | 1,484,864 | $ | 706,415 | ||||
| Total Current Assets | $ | 25,266,305 | 28,813,086 | |||||
| Restricted cash | $ | 142,253 | $ | 142,235 | ||||
| Property and equipment, net | $ | 47,345 | $ | 55,898 | ||||
| Patent acquisition costs, net | $ | 39,638 | $ | 39,124 | ||||
| Total Assets | $ | 25,495,541 | $ | 29,050,343 | ||||
| Liabilities and Shareholders' Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 2,384,424 | $ | 1,971,161 | ||||
| Accrued expenses | $ | 4,556,835 | $ | 4,795,873 | ||||
| Liability related to options | $ | 2,135,804 | $ | 5,081,335 | ||||
| Total Current Liabilities | $ | 9,077,063 | 11,848,369 | |||||
| Other long-term liability | $ | 94,325 | $ | 48,003 | ||||
| Total liabilities | $ | 9,171,388 | $ | 11,896,372 | ||||
| Commitments and Contingencies | ||||||||
| Shareholders' Equity: | ||||||||
| Share capital GBP of .01 par value | ||||||||
| Authorized: 10,000,000,000 ordinary shares; issued and outstanding: | ||||||||
| 1,525,693,393 at March 31, 2018 and December 31, 2017, respectively | 22,927,534 | $ | 22,927,534 | |||||
| Additional paid-in capital | 105,275,508 | $ | 104,799,550 | |||||
| Accumulated other comprehensive loss | (203,447 | ) | $ | (236,246 | ) | |||
| Accumulated deficit | (111,675,442 | ) | $ | (110,336,867 | ) | |||
| Total Shareholders' Equity | 16,324,153 | 17,153,971 | ||||||
| Total Liabilities and Shareholders' Equity | 25,495,541 | $ | 29,050,343 |
| AKARI THERAPEUTICS, Plc | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS-UNAUDITED | ||||||||
| For the Three Months Ended March 31, 2018 and 2017 | ||||||||
| (in U.S. Dollars) | ||||||||
| Three Months Ended | ||||||||
| Mar 31, 2018 | Mar 31, 2017 | |||||||
| Operating Expenses: | ||||||||
| Research and development costs | $ | 1,008,388 | $ | 6,002,700 | ||||
| General and administrative expenses | 3,296,973 | $ | 2,280,489 | |||||
| Total Operating Expenses | 4,305,361 | 8,283,189 | ||||||
| Loss from Operations | (4,305,361 | ) | (8,283,189 | ) | ||||
| Other Income (Expense): | ||||||||
| Interest income | 64,638 | $ | 38,888 | |||||
| Changes in fair value of option and warrant liabilities - gain (loss) | 2,945,531 | $ | (4,331,741 | ) | ||||
| Foreign currency exchange loss | (40,975 | ) | $ | (6,759 | ) | |||
| Other expenses | (2,408 | ) | $ | (1,711 | ) | |||
| Total Other Income (Expense) | 2,966,785 | (4,301,323 | ) | |||||
| Net Loss | (1,338,575 | ) | (12,584,512 | ) | ||||
| Other Comprehensive Income (Loss): | ||||||||
| Foreign Currency Translation Adjustment | 32,799 | $ | (45,153 | ) | ||||
| Comprehensive Loss | $ | (1,305,776 | ) | $ | (12,629,665 | ) | ||
| Loss per common share (basic and diluted) | $ | (0.00 | ) | $ | (0.01 | ) | ||
| Weighted average common shares (basic and diluted) | 1,525,693,393 | 1,177,693,383 |
For more information
Mary-Jane Elliott / Sukaina Virji / Nicholas Brown
Consilium Strategic Communications