0001654954-19-000870.txt : 20190130 0001654954-19-000870.hdr.sgml : 20190130 20190130091946 ACCESSION NUMBER: 0001654954-19-000870 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20190130 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190130 DATE AS OF CHANGE: 20190130 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: 19550530 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 30, 2019
 
CORMEDIX INC.
(Exact Name of Registrant as Specified in Charter)
 
 
 
 
Delaware
001-34673
20-5894890
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(IRS Employer Identification 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 8.01. Other Events.
 
On January 30, 2019, we issued a press release announcing the topline analysis of the full data set of the results of the interim analysis of our Phase 3 LOCK-IT 100 clinical trial.
 
A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
 
Item 9.01. Financial Statements and Exhibits.
 
(d) Exhibits
 
Exhibit No.           Description
 
99.1   
Press release dated January 30, 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 30, 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 TOPLINE ANALYSIS OF THE FULL DATA SET OF PHASE 3 LOCK-IT-100 STUDY REINFORCES THE INTERIM RESULTS
 
Berkeley Heights, NJ – January 30, 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 the topline results of the full data set of the Company’s Phase 3 LOCK-IT-100 study for Neutrolin® as a catheter lock solution in hemodialysis patients. The Company recently announced the topline results from the interim analysis of the study, which was terminated in August 2018 following the recommendation of the independent Data Safety Monitoring Board (DSMB), because efficacy had been demonstrated and the pre-specified level of statistical significance had been achieved.
 
Efficacy data were available from 653 subjects at the time of the interim analysis, including the first 28 cases of catheter-related blood stream infection (CRBSI). However, because the study continued enrolling and treating subjects until study termination, the final efficacy analysis was based on a total of 795 subjects.
 
The primary endpoint of the Phase 3 LOCK-IT-100 study was the reduction of the risk of occurrence of CRBSI by Neutrolin relative to the active control of heparin. CRBSI frequently result in hospitalization and admission to the intensive care unit, and may potentially cause death. In the analysis of the full data set, a total of 41 CRBSI events were determined by the Clinical Adjudication Committee (CAC). There was a 71% reduction in the risk of occurrence of CRBSIs compared with the active control of heparin, which is well in excess of the study’s assumed treatment effect size of a 55% reduction. In the Neutrolin arm, the CRBSI event rate was 0.13 per 1000 catheter days, which is significantly lower than the event rate of 0.46 per 1000 catheter days in the control arm. The statistical significance of the primary endpoint in the full data set (p=0.0006) was even more impressive than that of the interim analysis (p=0.0034).
 
There were no statistically significant differences between the results in the Neutrolin arm compared with the control arm in the final analysis for the secondary endpoints. The event rate for one of the secondary endpoints, catheter removal for any reason, was 3.48 per 1,000 catheter-days (236 out of 397 subjects) in the Neutrolin arm and 3.23 per 1,000 catheter-days (224 out of 398 subjects) in the control arm (p=0.39).
 
The loss of catheter patency, which was defined either as catheter removal due to loss of catheter patency or the administration of tissue plasminogen activating factor (tPA), was also a secondary endpoint. The event rate for loss of catheter patency was 1.01 per 1,000 catheter-days (64 out of 397 subjects) in the Neutrolin arm and 0.74 per 1,000 catheter-days (48 out of 398 subjects) in the control arm (p=0.10).
 
In the top-line safety analysis, the observed rate of treatment-emergent adverse events was lower in the Neutrolin arm. The rate of adverse events per patient was 5.1 in the Neutrolin arm and 5.8 in the control arm.
 
“We are extremely pleased that the analysis of the primary endpoint of the full data set of LOCK-IT-100 confirms and reinforces the results of the interim analysis,” said Khoso Baluch, Chief Executive Officer. “These data add to the growing body of evidence supporting our conclusion that Neutrolin prevents CRBSIs from central venous catheters of patients with end stage renal disease undergoing hemodialysis.  We expect to share more information as the analyses of the study data progresses over the coming months.”
 
 
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 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
 
 
2
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