Full Press Release Details
Akari Therapeutics Announces Establishment of
Boston U.S. Headquarters Office to Support Expanding Operations and Start of Registrational Phase 3 Clinical Trials
NEW YORK and LONDON, August 18, 2023 (GLOBE NEWSWIRE) - Akari
Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases
today announced the establishment of a Boston Seaport area office that is the company's U.S. headquarters. The office supports Akari's
current expansion of operations in preparation for the start of enrollment in two registrational nomacopan Phase 3 clinical trials in
pediatric and adult hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) and the start of PAS-nomacopan clinical
trials in geographic atrophy (GA).
"Boston is a vibrant epicenter of biotech innovation in the U.S.
providing Akari access to world-class talent and other resources as we continue to build our U.S. capabilities, advance our pivotal clinical
trials, and work to realize the promise of nomacopan on behalf of patients and our investors," said Rachelle Jacques, Akari President
Enrollment in the Phase 3 clinical trials of nomacopan in pediatric
and adult HSCT-TMA is expected to begin in late 2023 and 2024, respectively. The start of clinical trials of long-acting PAS-nomacopan
as a potential treatment for GA is anticipated in 2024.
About Akari Therapeutics
Akari Therapeutics, plc (Nasdaq: AKTX) is a biotechnology company developing
advanced therapies for autoimmune and inflammatory diseases. Akari's lead asset, investigational nomacopan, is a bispecific recombinant
inhibitor of complement C5 activation and leukotriene B4 (LTB4) activity. Akari's pipeline includes a Phase 3 clinical trial program
investigating nomacopan for severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). Akari has
been granted Orphan Drug, Fast Track and Rare Pediatric Disease designations from the FDA for nomacopan for the treatment of pediatric
HSCT-TMA and orphan drug designation from the European Commission for treatment in hematopoietic stem cell transplantation. Akari's
pipeline also includes a clinical program developing nomacopan for adult HSCT-TMA and pre-clinical research of long-acting PAS-nomacopan
in geographic atrophy (GA). For more information about Akari, please visit akaritx.com.
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 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 there; 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 COVID-19 pandemic; 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.
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