0001654954-19-002232.txt : 20190304 0001654954-19-002232.hdr.sgml : 20190304 20190304093601 ACCESSION NUMBER: 0001654954-19-002232 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20190227 ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190304 DATE AS OF CHANGE: 20190304 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CorMedix Inc. CENTRAL INDEX KEY: 0001410098 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34673 FILM NUMBER: 19652149 BUSINESS ADDRESS: STREET 1: 400 CONNELL DRIVE STREET 2: SUITE 5000 CITY: BERKELEY HEIGHTS STATE: NJ ZIP: 07922 BUSINESS PHONE: 908-517-9500 MAIL ADDRESS: STREET 1: 400 CONNELL DRIVE STREET 2: SUITE 5000 CITY: BERKELEY HEIGHTS STATE: NJ ZIP: 07922 8-K 1 crmd_8k.htm CURRENT REPORT Blueprint
 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of report (Date of earliest event reported): February 27, 2019
 
CORMEDIX INC.
(Exact Name of Registrant as Specified in Charter)
 
Delaware
 
001-34673
 
20-5894890
(State or Other Jurisdictionof Incorporation)
 
(CommissionFile Number)
 
(IRS EmployerIdentification No.)
 
400 Connell Drive, Suite 5000,
Berkeley Heights, NJ
07922
(Address of Principal Executive Offices)
(Zip Code)
 
Registrant’s Telephone Number, Including Area Code: (908) 517-9500
 
 
(Former Name or Former Address, If Changed Since Last Report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
☐ 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
☐ 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
☐ 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
☐ 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 

 
 
 
Item 5.02.    Departure of Directors or Certain Officers; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
 
On February 27, 2019, our Board of Directors appointed Alan W. Dunton, M.D., as a director, effective March 1, 2019, to serve until the 2019 annual meeting or until his respective successor is duly elected and qualified.
 
In 2006, Dr. Duncan founded Danerius, LLC, a biotechnology and pharmaceutical consulting business. Prior to starting Danerius, he was Chief Executive Officer of Panacos Pharmaceuticals, Inc., as well as Metaphore Pharmaceuticals, Inc., both biotechnology companies. He was also President and Managing Director of the Janssen Research Foundation, the research and development and regulatory arm of the pharmaceuticals division at Johnson and Johnson. Dr. Dunton received his Bachelor of Science degree in biochemistry, magna cum laude, from State University of New York at Buffalo, and received his M.D. from New York University School of Medicine.
 
There are no arrangements or understandings between Dr. Dunton and any other person pursuant to which he was appointed as a director of our Board and there are no related party transactions between Dr. Dunton and our company.
 
Item 8.01. Other Events.
 
On March 4, 2019, we issued a press release to report the appointment of the director identified in Item 5.02. A copy of the release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
 
Item 9.01 Financial Statements and Exhibits.
 
(d) Exhibits.
 
Exhibit No.
 
Description
 
 
 
 
Press release of CorMedix Inc. issued March 4, 2019.
  
 
2
 
 
SIGNATURE
 
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 hereunto duly authorized.
 
 
 
CORMEDIX INC.
 
 
 
 
 
Date: March 4, 2019
By:  
/s/ Robert W. Cook  
 
 
 
Name: Robert W. Cook
 
 
 
Title: Chief Financial Officer
 
 
 
 
 
3
EX-99.1 2 crmd_ex991.htm PRESS RELEASE Blueprint
 
Exhibit 99.1
 
 
CORMEDIX INC. APPOINTS ALAN W. DUNTON, M.D. TO BOARD OF DIRECTORS
 
 
Berkeley Heights, NJ – March 4, 2019 – CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that Alan W. Dunton, M.D. has been appointed unanimously to the Company’s Board of Directors. Dr. Dunton becomes the sixth member of the Company’s Board, filling a vacant seat previously occupied by Gary Gelbfish, M.D., who resigned in January 2019.
 
Khoso Baluch, CorMedix Chief Executive Officer stated, “I am excited to have Alan join the board of CorMedix. His significant experience in senior capacities and more recently as a consultant within the pharmaceutical industry will be important to us as we complete Neutrolin’s development and prepare to file the New Drug Application. He has participated significantly in developing and achieving approval of over 20 prescription and OTC drugs. He has led major pharma R&D and regulatory divisions and has been a director of approximately 20 public and private companies. We are pleased to have the benefit of his advice, experience and counsel.”
 
Dr. Dunton commented, “I am excited to be part of the CorMedix board. I look forward to making contributions to the continued success of the Company. I believe that CorMedix’s lead product Neutrolin, which prevents serious infections in patients with central venous catheters, will have a profound and positive impact on medical practice.”
 
Myron Kaplan, Chairman of the CorMedix Board of Directors added, “CorMedix is focused on attracting to its Board individuals with significant relevant and complementary experience in the pharmaceutical industry to help complete successfully the development of Neutrolin as a lock solution for central venous catheters and to realize the potential of the other taurolidine-based assets in our product pipeline to produce the most value we can for our shareholders. Alan’s insights will be very helpful to us as the work continues towards Neutrolin’s approval, and we welcome his involvement.”
 
Dr. Dunton has devoted his 35-year career to the discovery and development of new drug products. Most recently, he was Senior Vice President of Research and Development at Purdue Pharmaceuticals L.P., based in Stamford, CT. During his career, Dr. Dunton has built a successful consulting company, Danerius LLC. He was also chief executive officer of two biotech companies, and was President and Managing Director of the Janssen Research Foundation, the R&D and regulatory arm of the pharmaceutical division of Johnson & Johnson. His earlier experience includes positions at Roche, Syntex, and Novartis. Dr. Dunton holds an M.D. from New York University School of Medicine, where he completed a residency in internal medicine. He was a Fellow in Clinical Pharmacology at the New York Hospital/Cornell University Medical Center. In 1987, he was awarded The Nellie Westerman Prize from the American Federation for Clinical Research for his work in medical ethics.
 
Dr. Dunton currently serves on the boards of two public companies, Palatin Technologies, Inc. and Oragenics, Inc. He chairs the compensation committee and is a member of the audit committee of each of these companies. He is also a member of the board of Cytogel Pharma LLC, a private bio-pharmaceutical development company focused on developing products for pain.
 
 
 
1
 
 
 About CorMedix
 
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product Neutrolin®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and dangerous bloodstream infections associated with the use of central venous catheters, currently in Phase 3 development for patients undergoing chronic hemodialysis. Such infections have significant treatment costs and lead to increased morbidity and mortality. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provide the potential for priority review of a marketing application by FDA and allow for a total of ten years of market exclusivity in the event of U.S. approval. Neutrolin is already marketed as a CE Marked product in Europe and other territories. In parallel, CorMedix is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with active programs in surgical sutures and meshes, and topical hydrogels.  The company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers.  For more information, visit: www.cormedix.com.
 
Forward-Looking Statements
 
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the results of our discussions with the FDA regarding the Neutrolin development path; the resources needed to complete the information required to submit a new drug application for Neutrolin to the FDA; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
 
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
617-535-7746
 
 
 
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