Akari Therapeutics Announces Initiation of Pivotal Phase III Trial of Nomacopan in Pediatric Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy (HSCT-TMA) Following the Opening of its IND NEW YORK and

Akari Therapeutics Announces Initiation of Pivotal Phase

III Trial of Nomacopan in Pediatric Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy (HSCT-TMA) Following

the Opening of its IND

NEW YORK and LONDON, December 23, 2019 - Akari Therapeutics,

Plc (Nasdaq:AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases

where the complement and/or leukotriene systems are implicated, announces that a U.S. Food and Drug Administration (FDA) investigational

new drug application (IND) is open for its multicenter Phase III study for the treatment of pediatric HSCT-TMA with nomacopan,

allowing clinical sites to open in the first quarter of 2020.

"With the pediatric HSCT-TMA IND now open we look forward

to starting the pivotal Phase III study of nomacopan in HSCT-TMA, a potential treatment for a high risk pediatric population that

suffer very high death rates and for which there are currently no approved therapies. If successful, we expect HSCT-TMA to be a

gateway into a range of other poorly treated orphan TMAs," commented Clive Richardson, CEO of Akari Therapeutics. "In

addition, following the recent successful completion of our Phase II bullous pemphigoid study, we expect data from our Phase I/II

atopic keratoconjunctivitis trial in early 2020 and interim data from our Phase III paroxysmal nocturnal hemoglobinuria trial in

the first half of 2020."

HSCT-TMA is an orphan hematological condition that occurs in

up to 30% of patients who have received a hematopoietic stem cell transplant (HSCT). There are no approved treatments for pediatric

HSCT-TMA, and it has an estimated mortality rate of more than 80% in children with the severe form of the disease1.

It is this severe form that is being targeted with nomacopan which is a bifunctional inhibitor of complement C5 and leukotriene

B4 (LTB4). Following the recent end-of-Phase II meeting with the FDA, Akari has now opened an IND to initiate its pivotal pediatric

HSCT-TMA study based on a single arm responder-based design. Recruitment will be focused on specialist pediatric sites in the

U.S. and Europe where treatment tends to be concentrated in specialist centres.

Whilst the role of complement inhibition is understood to play

an important role in pediatric HSCT-TMA, the Company believes LTB4 may also be an important target in reducing epithelial activation

in both TMA and graft versus-host disease2 (GVHD) which often occur simultaneously. The Company believes daily dosing

with nomacopan may also be of particular advantage in facilitating more complete complement suppression, especially in HSCT-TMA

patients with high transfusion requirements.

As previously announced, this two-part pivotal Phase III study

of nomacopan 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. 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. Akari has both FDA fast track and orphan status for this

1 Sonata Jodele, et al. New approaches

in the diagnosis, pathophysiology, and treatment of pediatric hematopoietic stem cell transplantation associated thrombotic microangiopathy.

Transfus Apher Sci . 2016 April; 54(2): 181-190

2 Takatsuka, et al. Predicting the severity

of intestinal graft-versus-host disease from leukotriene B4 levels after bone marrow transplantation. Transplantation 2000, 26:

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). 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.

For more information

Sukaina Virji / Nicholas Brown / Lizzie

Consilium Strategic Communications