AKTX Akari Therapeutics PLC

  

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 6-K

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

 

For the month of: July 2023

 

Commission file number: 001-36288

 

Akari Therapeutics, Plc

(Translation of registrant’s name into English)

 

75/76 Wimpole Street

London W1G 9RT

United Kingdom

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F  x   Form 40-F ¨

 

 

  

On July 5, 2023, Akari Therapeutics, Plc, a public company with limited liability incorporated under the laws of England and Wales (the “Company”), issued a press release, announcing the appointment of Wa’el Hashad to the Board of Directors (the “Board”) of the Company on June 30, 2023. A copy of such press release is furnished as Exhibit 99.1 to this Report on Form 6-K and incorporated herein by reference.

  

Board Matters

 

Wa’el Hashad has served as Chief Executive Officer of Longeveron Inc. (NASDAQ: LGVN), a U.S. clinical-stage biotechnology company developing regenerative medicines for rare pediatric diseases, aging-related conditions, and unmet medical needs, since February 2023. Prior to that time, Mr. Hashad served as the President and Chief Executive Officer of Avanir Pharmaceuticals from 2017 to 2023. Prior to 2017, he served as the chairman of the strategic advisory board for Morningside Biopharma, a private incubator of several pharmaceutical/bio-tech companies, for three years. In addition, he has held vice president roles at Amgen Inc. (NASDAQ: AMGN), Boehringer Ingelheim, and Eli Lilly and Company (NYSE: LLY). Mr. Hashad earned an executive degree from the Wharton Business School, University of Pennsylvania, an MBA degree from the University of Akron, and a Bachelor of Science degree from the University of Cairo.

 

Additionally, in connection with the departure of three of the Company’s incumbent directors following the Company’s Annual General Meeting of Shareholders held on June 30, 2023, as previously reported by the Company on that certain Report on Form 6-K filed with the Securities and Exchange Commission on June 30, 2023, and the appointment of Mr. Hashad to the Board, the Board made the following appointments to its committees: (i) Mr. Hashad was appointed to serve as a member of the Audit Committee; (ii) Donald Williams was appointed to serve as a member and chairman of the Compensation Committee; and (iii) Mr. Williams, Michael Grissinger and Mr. Hashad were appointed to serve as members of the Nominating and Corporate Governance Committee, whereby Mr. Grissinger will serve as chairman.

 

The information contained in this Report on Form 6-K under the heading “Board Matters” is hereby incorporated by reference into all effective registration statements filed by the Company under the Securities Act of 1933.

   

Exhibit No.
99.1	Press Release issued by Akari Therapeutics, Plc on July 5, 2023

 

  

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

	Akari Therapeutics, Plc
	(Registrant)
	By:	/s/ Rachelle Jacques
	Name:  Title:	Rachelle Jacques President and Chief Executive Officer

 

Date: July 5, 2023

 

 

Exhibit 99.1

 

Akari Therapeutics Appoints Industry Veteran Wa’el Hashad to Board of Directors

 

NEW YORK and LONDON, July 5, 2023 (GLOBE NEWSWIRE) — Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the appointment of industry veteran Wa’el Hashad to the Akari Board of Directors as an independent director. Mr. Hashad, who will serve on both the Audit Committee and Nominating and Governance Committee, brings more than 35 years of biopharmaceutical experience to Akari’s Board of Directors with focus on drug approval and commercialization, mergers and acquisitions, and business development.

 

“I am pleased to welcome Wa’el to our Board of Directors” said Ray Prudo, M.D., Akari Chairman. “His extensive experience in biopharma development will be invaluable as we advance nomacopan into the registrational portion of Phase 3 studies in pediatric and adult HSCT-TMA and toward clinical trials of PAS-nomacopan in geographic atrophy. His appointment strengthens the Board’s biotech and U.S. capabilities.”

 

“This is an exciting time for the company, and I look forward to partnering with Board members and management to advance the company’s lead asset toward a potential regulatory filing,” said Mr. Hashad.

 

Mr. Hashad currently serves as CEO of Longeveron, a U.S. clinical-stage biotechnology company developing regenerative medicines for rare pediatric diseases, aging-related conditions, and unmet medical needs. Previously, he was President and Chief Executive Officer at Avanir Pharmaceuticals. Avanir was acquired by Otsuka Pharmaceutical, and Mr. Hashad led the company’s full integration into Otsuka’s United States operations. Prior to Avanir, Mr. Hashad was Executive Vice President and Chief Commercial Officer at Seres Therapeutics, where he established the company’s launch and marketing strategy for microbiome-based therapies.

 

Mr. Hashad has held multiple leadership roles at Amgen, executing on cardiovascular, neuroscience, metabolic disorder, and nephrology product launches and was the general manager for Africa, the Middle East, and Asia. He was a Vice President at Boehringer Ingelheim leading the U.S. launch of the company’s cardiovascular and metabolic products. Earlier, Mr. Hashad spent 20 years at Eli Lilly and Company, driving the company’s marketing and commercial strategy across multiple regions and therapeutic areas. He concluded his time at Eli Lilly as the Vice President of the United States Cardiovascular Business Unit.

 

 

Mr. Hashad holds an M.B.A. in Finance and International Business from the University of Akron and a B.Sc. in Pharmacy and Pharmaceutical Sciences from the University of Cairo. He held the position of the Chairman of the Strategic Advisory Board at Morningside Biopharma and is currently a member of the Board of California Life Sciences.

 

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. 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.

 

For more information

 

Investor Contact:
Mike Moyer
LifeSci Advisors
(617) 308-4306
mmoyer@lifesciadvisors.com

 

Media Contact:
Eliza Schleifstein
Schleifstein PR 
(917) 763-8106
eliza@schleifsteinpr.com

 

 

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