0001654954-19-000530.txt : 20190116 0001654954-19-000530.hdr.sgml : 20190116 20190116162637 ACCESSION NUMBER: 0001654954-19-000530 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20190114 ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190116 DATE AS OF CHANGE: 20190116 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: 19529301 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): January 14, 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 January 14, 2019, Gary Gelbfish, M.D. resigned as a member of our Board of Directors, effective immediately, due to other commitments and necessities. His resignation was not related to any disagreement with our company on any matter relating to our operations, policies or practices.
 
A copy of the press release, dated January 16, 2019, reporting Dr. Gelbfish’s resignation is attached as Exhibit 99.1 hereto.
 
Item 9.01. Financial Statements and Exhibits.
 
(d) Exhibits
 
Exhibit No.            Description
 
99.1                       
Press release dated January 16, 2019


 
 
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: January 16, 2019
By:  
/s/ Robert W. Cook 
 
 
 
Name: Robert W. Cook
 
 
 
Title: Chief Financial Officer
 
 
 
 
 
EX-99.1 2 crmd_ex991.htm PRESS RELEASE Blueprint
  Exhibit 99.1
CORMEDIX INC. ANNOUNCES RESIGNATION OF MEMBER OF ITS BOARD OF DIRECTORS
 
Berkeley Heights, NJ – January 16, 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 Gary A. Gelbfish, MD FACS has resigned his position as a member of the Board of Directors, effective January 14, 2019. Dr. Gelbfish’s most recent tenure on the board began in August 2017. He previously served on CorMedix’s Board from December 2009 to June 2014, including a term as Board Chairman from 2012 to June 2014.
 
Khoso Baluch, CorMedix Chief Executive Officer and a member of the Board stated, “We thank Gary for his service and guidance during the LOCK-IT-100 study. He provided significant insight that contributed to its successful completion. His expertise as a practicing vascular surgeon has been invaluable as CorMedix focuses its efforts on advancing its lead product Neutrolin® for the prevention of catheter-related bloodstream infections in hemodialysis patients. We respect Gary’s desire to focus now on his other professional duties.”
 
Dr. Gelbfish commented, “I am grateful for the opportunity to have played pivotal roles in CorMedix’s history as a member of the Board and more recently with the data collection and interim analysis efforts. Based on the highly significant results of the interim analysis and the recommendations of the DSMB to terminate the trial early, because efficacy had been demonstrated, I am confident that after completing all of the regulatory requirements, Neutrolin will enter clinical use. Ultimately, it will be of significant public health benefit to greatly decrease rates of catheter infections. As a vascular surgeon who treats many catheter patients, it has been an honor to contribute to the advancement of medicine and to develop new therapeutic and preventative methods.”
 
The Company has identified and is pursuing a number of qualified Board candidates with recognized applicable expertise in drug development and FDA interaction who have indicated they would be disposed to accept an invitation to join the CorMedix Board, with the goal of bringing this process to a successful conclusion in the near future.
 
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 cost the U.S. healthcare system approximately $6 billion annually and contribute significantly to increased morbidity and mortality. Neutrolin has FDA Fast Track status and is designated as a Qualified Infectious Disease Product, which provides the potential for priority review of a marketing application by FDA and allows for 5 additional years of QIDP 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 ability to identify and attract qualified directors; the resources needed to terminate the Phase 3 trial and the costs and time needed to submit a new drug application to the FDA; risks related to obtaining FDA approval of the new drug application for Neutrolin; 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; relying on preclinical results that may not be 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