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: December 2023

 

Commission file number: 001-36288

 

Akari Therapeutics, Plc

(Translation of registrant’s name into English)

 

22 Boston Wharf Road FL 7

Boston, MA 02210

(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 December 1, 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 Samir Patel to the Board of Directors (the “Board”) of the Company on November 29, 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

 

Dr. Patel has served as founder and principal of PranaBio Investments, LLC, a firm providing consulting, strategic advisory, and investment services for small cap biotechnology companies, since 2017. He has also served as a consultant to GE Global Research, GE’s innovation engine that is creating novel products and solutions across several sectors including biomanufacturing and biotechnology, since 2019. Dr. Patel has more than 20 years of experience in life sciences including co-founding Digital Therapeutics, LLC in 2011, a startup advancing a therapy for scleroderma and other rheumatic diseases, and SPEC Pharma, LLC in 2003, a company that develops and manufactures injectables used in rheumatology applications. Previously, Dr. Patel held multiple roles in Medical Affairs with Centocor, Inc. (now Johnson & Johnson Innovative Medicine, part of Johnson & Johnson (NYSE: JNJ)). He holds multiple patents, has been an author on several publications and has been an investigator in numerous clinical research studies. Dr. Patel received his medical degree from the Medical College of Ohio (University of Toledo) in Toledo, Ohio, and completed his internal medicine internship and residency, as well as a rheumatology fellowship, at University of New Mexico School of Medicine Affiliated Hospitals.

 

There are no arrangements or understandings between Dr. Patel and any other person pursuant to which Dr. Patel was appointed as a director of the Company. The Board has determined that Dr. Patel is independent under the applicable rules of the Nasdaq Stock Market.

 

Dr. Patel, through a wholly owned entity, PranaBio Investments LLC, purchased approximately $300,000 of the Company’s ordinary shares and ordinary share equivalents in the Company’s private placement transaction consummated on October 6, 2023 and purchased approximately $450,000 of the Company’s ordinary shares in the Company’s registered direct offering consummated on March 31, 2023. Other than participation in such financings, the Company has not engaged in any transaction, or any currently proposed transaction, in which Dr. Patel had or will have a direct or indirect material interest that would require disclosure pursuant to Item 404(a) of Regulation S-K.

 

Dr. Patel will participate in the standard non-employee director compensation arrangements described under the heading “Director Compensation” contained in the Company’s Annual Report on Form 20-F filed with Securities and Exchange Commission on May 1, 2023 (the “Annual Report”).

 

The Company also expects to enter into its standard director and officer indemnification agreement with Dr. Patel.

 

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 December 1, 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: December 1, 2023

 

 

 

 

 

Exhibit 99.1

 

Akari Therapeutics Appoints Experienced Life Sciences Entrepreneur Samir R. Patel, M.D. to Board of Directors

 

NEW YORK and BOSTON, December 1, 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 experienced life sciences entrepreneur Samir R. Patel, M.D. to the Akari Board of Directors.

 

“Samir is a long-time investor in Akari and brings to us broad life sciences experience and a track record of multiple successful startup companies. I am pleased to welcome him to our Board of Directors at this important time in our company’s development,” said Ray Prudo, M.D., Akari Chairman.

 

“I am truly honored to have this opportunity to further demonstrate my commitment to advance Akari by partnering with other Board members and management to help realize the promise of the company’s novel lead asset, nomacopan, on behalf of patients and our shareholders,” said Dr. Patel.

 

Dr. Patel currently serves as founder and principal of PranaBio Investments, LLC, a firm providing consulting, strategic advisory, and investment services for small cap biotechnology companies. He is also a consultant to GE Global Research, GE’s innovation engine that is creating novel products and solutions across several sectors including biomanufacturing and biotechnology.

 

He has more than 20 years of experience in life sciences including co-founding Digital Therapeutics, LLC, a startup advancing a therapy for scleroderma and other rheumatic diseases, and SPEC Pharma, LLC, a company that develops and manufactures injectables used in rheumatology applications. Previously, Dr. Patel held multiple roles in Medical Affairs with Centocor, Inc. (now Johnson & Johnson Innovative Medicine, part of Johnson & Johnson). He holds multiple patents, has been an author on several publications and has been an investigator in numerous clinical research studies.

 

Dr. Patel received his medical degree from the Medical College of Ohio (University of Toledo) in Toledo, Ohio, and completed his internal medicine internship and residency, as well as a rheumatology fellowship, at University of New Mexico School of Medicine Affiliated Hospitals.

 

 

 

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.

 

 

 

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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