Akari Therapeutics Announces New Clinical Data that Show Long-Term Self-Administered Nomacopan is Well-Tolerated and Substantially Reduces Transfusion Dependence in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

Akari Therapeutics Announces New Clinical Data that Show

Long-Term Self-Administered Nomacopan is Well-Tolerated and Substantially Reduces Transfusion Dependence in Patients with Paroxysmal

Nocturnal Hemoglobinuria (PNH)

NEW YORK and LONDON, December 11, 2020 - Akari Therapeutics,

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

diseases where the complement and/or leukotriene systems are implicated, announces new data on the efficacy and safety profile

of long-term self-administration of nomacopan for treatment of patients with PNH.

"The data we have accrued on the use of self-administered

nomacopan in PNH demonstrate that the drug is well tolerated with a positive clinical response, supporting nomacopan's potential

for both short and long-term use across our other clinical programs," said Clive Richardson, Chief Executive Officer of Akari

Therapeutics. "We are now leveraging this positive PNH data to explore regional partnering opportunities."

The data from 19 PNH patients2 treated for a median

of 18.5 months are derived from the Phase II COBALT trial (n=8 patients), the Phase II trial which specifically recruited eculizumab-resistant

patients (n=2 patients), the Phase III CAPSTONE trial (n = 9 patients), and from the long-term safety study CONSERVE (n = 15),

which accepted patients from the Phase II and Phase III studies. Sixteen of the 19 PNH patients were transfusion dependent prior

to treatment with nomacopan, of whom 14 were treated with nomacopan for six months or more.

The data show that long term self-administration of nomacopan

Transfusion independence as used above is defined as a period

of at least six months without transfusion. This duration is considered clinically important as it is the same duration of transfusion

independence as used for the primary endpoint in CAPSTONE and also the pivotal studies of eculizumab and ravulizumab that led to

approval of these drugs for the treatment of PNH.

The 79% transfusion independence reported for the 14 PNH patients

all formerly transfusion dependent who were treated with nomacopan for at least six months, compares favorably to the treatment

of PNH patients on long-term eculizumab therapy where between approximately 50%-60% of transfusion dependent patients become transfusion

independent in a 12-month period (Brodsky et al., 2008, SHEPHERD study on eculizumab, Hillmen et al 2013). Similar data has been

reported in the more recent head to head Phase III comparative study of eculizumab and ravulizumab (Wook Lee et al., 2019) where

transfusion independence in the two arms respectively increased from 21% to 66% of and 23% to74% of patients over the first 6 months

The transfusion data from the CONSERVE long term study is considered

particularly important because it provides "real world" data from a total of 15 patients on nomacopan treatment as

a long-term self-administered therapy. In CONSERVE, clinicians were free to follow their normal transfusion practices and patients

were only scheduled to visit the clinic at three to six monthly intervals, mimicking "real world" clinical practice.

Dr. Austin Kulasekararaj, Lead PNH clinician at King's

College Hospital, London, UK, the principal investigator on the long-term CONSERVE safety and efficacy study of nomacopan in patients

with PNH commented, "The CAPSTONE study was originally designed to achieve approximately 50% transfusion independence in

line with Phase III PNH pivotal trials using eculizumab, so this mature data demonstrate the positive clinical benefits of nomacopan

as a terminal complement inhibitor in PNH. Equally important, self-administered nomacopan appears to be well tolerated with an

excellent safety profile."

The Company's lead programs for nomacopan are focused

on diseases with no approved treatments, including BP and pediatric HSCT-TMA. Data from the Company's PNH programs (CAPSTONE

and CONSERVE), while discontinued, support the Company's main clinical programs, all of which have complement dysregulation

playing an important role.

Full clinical details on all 19 PNH patients treated with nomacopan

will be provided in a manuscript that is currently in preparation.

stem cell transplant-related thrombotic microangiopathy

219 PNH patients: 13 male and 6 female;

median age 39; age range 22 - 69. Three of the 19 patients had a history of thrombosis and 3 other patients a history of

3The number of U PRBC received per month

was simply derived by dividing the total number of U PRBC received by all transfusion dependent patients in the 12 months before

nomacopan treatment (n = 16; total U PRBC = 174; total months 192), and by dividing the total number of U PRBC received by the

same patients while on nomacopan (n = 16; total U PRBC = 65; total months 313). In the Wook Lee et al., 2019 study on eculizumab

and ravulizumab efficacy in PNH patients the authors reported that the mean total number of U PRBC transfused during the first

6-month treatment period was 4.8 (SD + 5.1) on ravulizumab and 5.6 (SD + 5.9) on eculizumab.

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.

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. You should not place undue reliance

upon the Company's forward-looking statements. Except as required by law, the Company

undertakes no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that

may arise after the date of this press release. 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; difficulties enrolling

patients in our clinical trials; our ability to enter into collaborative, licensing, and other commercial relationships and on

terms commercially reasonable to us; 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 COVID-19 pandemic; 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.

Sukaina Virji / Lizzie Seeley

Consilium Strategic Communications