8-K
CorMedix Inc. (CRMD)
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 eventreported): September 15, 2020
CORMEDIX INC.
(Exact name of registrant as specifiedin its charter)
| Delaware | 001-34673 | 20-5894890 |
|---|---|---|
| (State of other jurisdiction of<br><br> <br>incorporation or organization) | (Commission File Number) | (I.R.S. Employer<br><br> <br>Identification No.) |
| 400 Connell Drive, Suite 5000<br><br> <br>Berkeley Heights, NJ | 07922 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number,including area code: (908) 517-9500
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<br>communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br>material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement<br>communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement<br>communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| --- | --- |
Securities registered pursuant to Section 12(b) of the Exchange Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common stock, $0.001 par value | CRMD | NYSE American LLC |
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 orCertain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On September 15, 2020, the Board of Directors (the “Board”) of CorMedix Inc. (the “Company”) appointed Paulo F. Costa as a director, effective immediately, to serve until the Company’s next annual meeting of stockholders or until his respective successor is duly elected and qualified.
Mr. Costa, age 70, served as President and Chief Executive Officer of Novartis U.S. Corporation, from October 2005 to August 2008. Prior to his work at Novartis U.S. Corporation, Mr. Costa was President and Chief Executive Officer of Novartis Pharmaceuticals, U.S. from July 1999 to September 2005. Prior to joining Novartis, Mr. Costa spent 30 years at Johnson & Johnson, including as President of Janssen Pharmaceutica, Inc. From August 2009 to August 2012, Mr. Costa served as Chairman of the Board of Amylin Pharmaceuticals Inc, a commercial stage biopharma company, until its sale to Bristol-Myers Squibb and AstraZeneca in a $7 billion transaction in 2012. Mr. Costa currently serves as Chairman of the Board of MacroGenics, Inc., a public late stage biopharma company focused on oncology, and as a director of two privately held life science companies.
In connection with his services as a director, on September 15, 2020, Mr. Costa received an initial stock option grant to purchase 20,000 shares of the Company’s common stock, subject to one-third vesting on the date of grant and one-third vesting on each of the first and second anniversary dates of the date of grant, and a prorated annual grant of 3,750 options, subject to vesting monthly over a one-year period beginning on October 15, 2020. Both sets of options are exercisable at an exercise price equal to the closing price of the Company’s common stock on the date of grant. Mr. Costa will also receive cash compensation on the same basis as paid to the other non-employee members of the Board, as described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission on March 16, 2020.
There are no arrangements or understandings between Mr. Costa and any other person pursuant to which he was appointed as a director of our Board and there are no related party transactions between Mr. Costa and the Company.
Item 8.01. Other Events.
On September 17, 2020, the Company issued a press release to report the appointment of the director identified in Item 5.02. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements andExhibits.
(d) Exhibits.
| Exhibit No. | Description |
|---|---|
| 99.1 | Press release dated September 17, 2020 |
1
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: September 17, 2020 | By: | /s/ Khoso<br> Baluch |
| Name: | Khoso Baluch | |
| Title: | Chief Executive Officer |
2
Exhibit 99.1
Cormedix Appoints Paulo Costa to itsBoard of Directors
Seasoned industry veteran with decadesof strategic and commercial leadership experience in the pharmaceutical sector
Berkeley Heights, NJ – September 17, 2020 – 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 appointment of Paulo F. Costa to its Board of Directors.
“We are excited to welcome Paulo to the CorMedix Board,” said Khoso Baluch, Chief Executive Officer of Cormedix. “Paulo will be a tremendous asset to our Board given his decades of leadership experience in the pharmaceutical sector and significant strategic experience gained in part during his time spent as Chairman of Amylin Pharmaceuticals through its successful sale to BMS and AstraZeneca. His experience at all levels of the business will prove invaluable as CorMedix progresses to the next stage of its evolution.”
Paulo, an industry veteran with years of senior leadership experience at Johnson & Johnson and Novartis, noted, “After reviewing CorMedix’s business and the commercial prospects for Defencath in the hemodialysis setting, I am pleased to join the company’s Board of Directors. Given the upcoming PDUFA date, I believe that CorMedix will succeed in its goal of bringing Defencath to patients and changing the standard of care in this sizable and growing patient population.”
About Paulo Costa
Paulo currently serves as Chairman of the Board of MacroGenics, a public late stage biopharma company focused on oncology. In addition, he served as Chairman of Amylin Pharmaceuticals, a commercial stage biopharma company, until its sale to Bristol-Myers Squibb and AstraZeneca in a $7 billion transaction in 2012.
Prior to his retirement, Paulo served in senior leadership roles at Novartis, including President and CEO of Novartis US Corporation from 2005 to 2008 and President and CEO of Novartis Pharmaceutica US and Head of Americas from 1999 to 2005. Prior to joining Novartis, Paulo spent 30 years at Johnson & Johnson including as President of Janssen Pharmaceutica, Inc.
During the course of his career, Paulo helped launch and grow a broad range of primary and specialty care products and has built and shaped pharmaceutical sales forces globally.
Paulo received his undergraduate degree from São Paulo School of Business Administration and earned a masters degree in business administration from Harvard Business School.
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 Defencath®, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. Defencath’s NDA has been filed and accepted for priority review with a PDUFA date of February 28, 2021. Defencath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product, which provides an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also intends to develop Defencath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with 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. Neutrolin™ is CE Marked and marketed in Europe and other territories as a medical device. 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 Defencath development path, including whether a second Phase 3 clinical trial will be required for approval of Defencath’s marketing approval; the resources needed to secure approval of the new drug application for Defencath from 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 Defencath/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. At this time, we are unable to assess whether, and to what extent, the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. 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
617-430-7576