Full Press Release Details
Akari Therapeutics Reports Fourth Quarter
Financial Results and Business Highlights
Significant Clinical Progress Across Target Indications during
2019 and 2020 Year-to-Date
NEW YORK and LONDON, March 31, 2020 - 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 financial results for the fourth quarter
and full year ended December 31, 2019, as well as recent business highlights.
"2019 was a very important year for the company as we
generated positive clinical data across all four of our programs. For BP, AKC and HSCT-TMA, the rapid patient response we generally
saw in our clinical studies validates these disease targets for nomcaopan where the specific dual action of the drug provides a
potential significant differentiation with its inhibition of both the complement (C5) and leukotriene (LTB4) pathways," said
Clive Richardson, Chief Executive Officer of Akari Therapeutics. "In 2020, we look forward to expanding these programs further
and plan on focusing on preparatory work for potential pivotal studies in anticipation of lessening the impact of the COVID-19
pandemic. At the same time we are working with our employees, partners and patients to help ensure their safety and maintain continuity
Full Year 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.
The Company is working with clinical sites and is following
regulatory and health agency guidance related to the COVID-19 pandemic to help ensure the safety of its employees and patients.
Our BP study has completed recruitment while our AKC study has halted recruitment with around two thirds of patients recruited.
We expect delays in opening sites for our HSCT-TMA program. We expect our long-term safety program will shift to being managed
on a country by country basis and some disruption is expected.
Phase II clinical trial in patients with BP
Phase III clinical trial in pediatric patients with HSCT-TMA
Initiated a pivotal Phase III trial for HSCT-TMA
with nomacopan following the opening of an IND by the FDA. As a result of the COVID-19 pandemic, although we are looking to continue
the process of site openings, we anticipate this will be delayed and hence any enrollment. This two-part Phase III study in pediatric
patients with HSCT-TMA is based on guidance from the Company's end-of-Phase II meeting with the FDA. Part A of the trial
is a dose confirmation study with the dosing agreed with FDA via their Model Informed Drug Development Program (MIDD). Part B of
the trial is a single arm responder-based efficacy study that will follow an interim analysis of Part A and a meeting with the
FDA. This devastating condition has an estimated 80% mortality rate in children, at elevated risk of dying who will be recruited
to the trial and has no approved treatments. Akari has both FDA fast track pediatric patients and orphan drug designation status
Phase I/II clinical trial in patients with AKC
Fourth Quarter and Full Year 2019
A copy of the Company's Annual Report on Form 20-F for
the year ended December 31, 2019 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 Financial Controller of the Company at 75/76 Wimpole Street, London W1G 9RT, United Kingdom or by
calling the Company at +44 20 8004 0261.
Important Message Regarding COVID-19
Public health epidemics or outbreaks could adversely impact
our business. In late 2019, a novel strain of COVID-19, also known as coronavirus, was reported in Wuhan, China. While initially
the outbreak was largely concentrated in China, it has now spread to several other countries, including in the United Kingdom and
the United States, and infections have been reported globally. In particular, our clinical trial sites are based in areas currently
affected by coronavirus. Epidemics such as this can adversely impact our business as a result of disruptions, such as travel bans,
quarantines, and interruptions to access the trial sites and supply chain, which could result in material delays and complications
with respect to our research and development programs and clinical trials. Moreover, as a result of coronavirus, there is a general
unease of conducting unnecessary activities in medical centers. As a consequence, our ongoing trials have been halted or disrupted.
It is too early to assess the full impact of the coronavirus outbreak on trials for nomacopan, but coronavirus is expected to affect
our ability to complete recruitment in our original timeframe. The extent to which the coronavirus impacts our operations will
depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity
of the outbreak, and the actions that may be required to contain the coronavirus or treat its impact. In particular, the continued
spread of the coronavirus globally, could adversely impact our operations and workforce, including our research and clinical trials
and our ability to raise capital, could affect the operations of key governmental agencies, such as the FDA, which may delay the
development of our product candidates and could result in the inability of our suppliers to deliver components or raw materials
on a timely basis or at all, each of which in turn could have an adverse impact on our business, financial condition and 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 (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 impact of the outbreak of coronavirus;; 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
CONSOLIDATED BALANCE SHEETS
(in U.S. Dollars, except share data)
| December 31, 2019 | December 31, 2018 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash | $ | 5,731,691 | $ | 5,446,138 | ||||
| Prepaid expenses and other current assets | 712,975 | 1,423,184 | ||||||
| Deferred Financing Costs | 321,956 | 585,000 | ||||||
| Total Current Assets | 6,766,622 | 7,454,322 | ||||||
| Restricted cash | - | 521,829 | ||||||
| Property and equipment, net | 5,013 | 20,425 | ||||||
| Patent acquisition costs, net | 30,163 | 32,978 | ||||||
| Total Assets | $ | 6,801,798 | $ | 8,029,554 | ||||
| Liabilities and Shareholders' Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 1,228,772 | $ | 1,586,285 | ||||
| Accrued expenses | 4,228,604 | 1,489,558 | ||||||
| Liabilities related to options and warrants | 3,116,880 | 1,842,424 | ||||||
| Total Current Liabilities | 8,574,256 | 4,918,267 | ||||||
| Other long-term liability | - | - | ||||||
| Total liabilities | 8,574,256 | 4,918,267 | ||||||
| Commitments and Contingencies | ||||||||
| Shareholders' (Deficit) Equity: | ||||||||
| Share capital of 0.01 par value | ||||||||
| Authorized: 10,000,000,000 ordinary shares; issued and outstanding: | ||||||||
| 2,245,865,913 and 1,580,693,413 at December 31, 2019 and 2018, respectively | 31,987,016 | 23,651,277 | ||||||
| Additional paid-in capital | 110,498,824 | 106,616,083 | ||||||
| Accumulated other comprehensive loss | (348,860 | ) | (352,426 | ) | ||||
| Accumulated deficit | (143,909,438 | ) | (126,803,647 | ) | ||||
| Total Shareholders' (Deficit) Equity | (1,772,458 | ) | 3,111,287 | |||||
| Total Liabilities and Shareholders' (Deficit) Equity | $ | 6,801,798 | $ | 8,029,554 |