Form 8-K
8-K — CorMedix Inc.
Accession: 0001213900-26-066061
Filed: 2026-06-08
Period: 2026-06-08
CIK: 0001410098
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — ea0293895-8k_cormedix.htm (Primary)
EX-99.1 — PRESS RELEASE DATED JUNE 8, 2026 (ea029389501ex99-1.htm)
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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): June 8, 2026
CORMEDIX INC.
(Exact
name of registrant as specified in its charter)
Delaware
001-34673
20-5894890
(State
or other jurisdiction of
incorporation)
(Commission
File Number)
(IRS
Employer
Identification No.)
389 Interpace Parkway, Suite 450
Parsippany, NJ
07054
(Address
of principal executive offices)
(Zip
Code)
Registrant’s
telephone number, including area code: (908) 517-9500
N/A
(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))
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
Common stock, $0.001 par value
CRMD
Nasdaq
Global Market
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
7.01 Regulation FD Disclosure
On
June 8, 2026, CorMedix, Inc. (the “Company”) issued a press release on the decision by the United States Court of Appeals
for the Federal Circuit in Melinta Therapeutics, LLC, et al. v. Nexus Pharmaceuticals, Inc., which affirmed the district court’s
judgment that Nexus Pharmaceuticals Inc.’s generic minocycline product infringed two of the Company’s patents and rejected
Nexus’s invalidity challenge. A copy of the press release is furnished as Exhibit 99.1, attached hereto.
The
information in this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall
it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”),
or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Forward-Looking
Statements
This
Current Report on Form 8-K contains “forward-looking statements” within the meaning of the Private Securities Litigation
Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange Act, that are subject to risks and uncertainties.
Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,”
“can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,”
“plan,” “project,” “seek,” “should,” “target,” “will,” “would,”
and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical
facts, regarding management’s expectations, beliefs, goals, plans or the Company’s prospects should be considered forward-looking
statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important
factors, and readers are directed to the Risk Factors identified in the Company’s filings with the SEC, including its most recent
Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from
the Company. The Company may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking
statements speak only as of the date of this Current Report on Form 8-K. Investors should not place undue reliance on these statements.
The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Item
9.01 Financial Statements and Exhibits
(d)
Exhibits
Exhibit
No.
Description
99.1
Press Release dated June 8, 2026
104
Cover Page Interactive Data File (embedded within the
Inline XBRL document)
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: June 8, 2026
By:
/s/
Joseph Todisco
Name:
Joseph Todisco
Title:
Chief Executive Officer
2
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Exhibit
99.1
U.S.
COURT OF APPEALS FOR THE FEDERAL CIRCUIT AFFIRMS VICTORY FOR CORMEDIX THERAPEUTICS IN MINOCIN® PATENT LITIGATION
Parsippany,
NJ – June 8, 2026 – CorMedix Therapeutics (Nasdaq: CRMD) today announced that
the United States Court of Appeals for the Federal Circuit has affirmed the judgment of the U.S. District Court for the Northern District
of Illinois that the patents covering its product MINOCIN® for Injection are valid and infringed by the product developed by Nexus
Pharmaceuticals, Inc.
Following
a four-day bench trial in 2023, the district court found in favor of CorMedix’s wholly owned subsidiary Melinta Therapeutics on
all patent infringement and validity issues. The Federal Circuit’s decision on Friday upheld the district court’s findings
that Nexus’ proposed generic minocycline product infringes the MINOCIN® patents and rejected Nexus’ invalidity challenge.
The Federal Circuit also affirmed the district court’s permanent injunction barring Nexus from marketing its generic product prior
to patent expiration. The patents-at-issue are FDA Orange Book listed and protect the company’s innovative reformulation of intravenous
minocycline, marketed as MINOCIN® for Injection. MINOCIN® is a tetracycline derived antibiotic used primarily in hospital and
acute care settings for patients with a variety of serious and drug-resistant infections.
“We
are pleased that the Federal Circuit has affirmed the district court’s thorough and well-reasoned decision,” said Joseph
Todisco, CorMedix Chairman and CEO. “This ruling validates the strength of the MINOCIN® intellectual property portfolio and
recognizes the innovative work that led to important improvements in intravenous minocycline therapy for patients. The decision reinforces
the importance of protecting pharmaceutical innovation and the substantial investments required to develop improved therapies. We will
continue to protect and defend CorMedix’s intellectual property.”
About
CorMedix
CorMedix
Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment
of life-threatening conditions and diseases in the United States. CorMedix is focused on selling and marketing products in institutional
settings of care in the US and has field based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers.
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, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended,
as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often
identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,”
“plan,” “project,” “seek,” “should,” “target,” “will,”
“would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other
than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects
should be considered forward-looking statements including, but not limited to statements regarding financial and business guidance;
sales, revenue and operating expense estimates; synergy estimates and timing; accretion estimates and Adjusted EBITDA estimates. Readers are cautioned that actual results may
differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors
identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, 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 such forward-looking statements speak only as of the date of
this press release. In addition, pro forma financial information does not necessarily reflect the actual results that we would have
achieved had the pro forma transaction been consummated as of the date indicated nor does it reflect the potential future results of
the combined company. 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
daniel@lifesciadvisors.com
(617)
430-7576
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