Form 8-K

8-K — CorMedix Inc.

Accession: 0001213900-26-114665

Filed: 2026-11-02

Period: 2026-11-02

CIK: 0001410098

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ea0310445-8k_cormedix.htm (Primary)

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8-K — CURRENT REPORT

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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):

November 2, 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 2.02 Results of Operations and Financial Condition

On November 2, 2026, CorMedix Inc. (the “Company”) issued

a press release announcing its cash position for the quarter ended September 30, 2026. A copy of the press release is furnished as Exhibit

99.1 to this report.

The information in this Item 2.02 (including Exhibit

99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (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, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 7.01 Regulation FD Disclosure

On November 2, 2026, the Company issued a press

release providing a business update and announcing the Company’s cash position for the quarter ended September 30, 2026. 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 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 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 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;

the 2027 post-TDAPA Add-on changes for DefenCath; and CorMedix’s forecasts and projections for the 2027 Add-on trajectory. CorMedix

estimates for the 2027 Add-on are subject to several factors and assumptions, including known historical utilization and pricing data,

DefenCath maintaining fee-for-service utilization in line with current trends, and the method by which CMS will apply certain utilization

data in the Add-on calculations. Changes in customer utilization patterns, including fee-for-service utilization, changes in pricing,

or differences between CMS’s application of its calculation methodology and the Company’s assumptions could cause the actual

CMS-determined quarterly Add-on rates and the resulting full-year average to differ materially from CorMedix’s estimates. Increased

reimbursement to dialysis facilities may not result in corresponding increases in CorMedix's realized pricing, product utilization or

revenue. Additional risks include continued pricing pressures and the impact of actions of governmental and private payers affecting pricing

of, reimbursement for, and patient access to pharmaceuticals and reporting obligations related thereto; and the expiration or loss of

intellectual property protection for certain of the Company's products and competition from generic and biosimilar products. 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

and its subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-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 Current Report on Form 8-K. Investors

should not place undue reliance on these statements. CorMedix does not adopt or endorse, and undertakes no obligation to comment on or

correct, any projections, estimates or statements regarding its business or results of operations that are made by third parties, including

analysts and customers, except as required by law. CorMedix 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 November 2, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: November 2, 2026

By:

/s/ Joseph Todisco

Name:

Joseph Todisco

Title:

Chief Executive Officer

EX-99.1 — PRESS RELEASE DATED NOVEMBER 2, 2026

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Exhibit 99.1

CORMEDIX

THERAPEUTICS PROVIDES BUSINESS UPDATE, REAFFIRMS 2026 TOTAL REVENUE GUIDANCE, AND REPORTS THIRD Quarter

Cash Position

Parsippany,

NJ – November 2, 2026 – CorMedix Therapeutics (Nasdaq: CRMD) today provided a business update in advance of a conference

call expected to be held on November 12, 2026 to discuss the Company’s complete quarterly financial performance.

Business Updates

● CorMedix announces unaudited cash and cash equivalents on hand as

of September 30, 2026 of approximately $355 million.

● CorMedix reaffirms its August 2026 total revenue guidance of between

$325 million and $345 million for the full-year 2026.

● On October 28, 2026, CMS released the 2027 End-Stage Renal Disease

Prospective Payment System (ESRD PPS) final rule, which provided for a post-TDAPA Add-on for DefenCath® (taurolidine and heparin)

of $8.32 per dialysis session, for Q1 of 2027, as well as a new quarterly process for calculating Add-On adjustments. The Q1 2027 Add-on

of $8.32 is within the Company’s previously guided range of 3x-5x higher than the current $2.37 in effect for the third and fourth

quarters of 2026.

● The Company is aware of statements made by a large dialysis organization

(LDO) during its investor call about the quarterly trajectory of the 2027 DefenCath post-TDAPA Add-on payments following CMS’s publication

of the 2027 ESRD PPS Final rule. CorMedix has not provided the LDO or any other party with past or forecasted utilization or pricing data

that would be necessary to estimate future quarterly adjustments to the 2027 Add-on. We believe any third-party projections regarding

future quarterly adjustments are subject to significant uncertainty without visibility into the relevant utilization and pricing data.

Investors should not interpret third-party projections as guidance provided or endorsed by CorMedix.

● Based on CorMedix evaluation of sales data and insights that the Company has in connection with DefenCath

fee-for-service utilization, including terms of its contractual arrangements with customers, the Company anticipates that the DefenCath

Add-on will decline in Q2 of 2027 compared to Q1, but increase in Q3 and/or Q4 of 2027 compared to Q2, subject to how CMS applies certain

utilization data. In addition, CorMedix believes that the Add-on rate for all four quarters in 2027 will exceed the current rate of $2.37

and that the average Add-on rate for all four quarters in 2027 will equate to more than 2x the current rate of $2.37.

● CorMedix expects to hold a conference call on November 12, 2026

to discuss its financial results and additional business updates at that time. The Company will provide more specifics about its third

quarter earnings call approximately one week prior to the scheduled meeting.

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 (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; the 2027 post-TDAPA Add-on changes for DefenCath; and CorMedix’s forecasts and projections for

the 2027 Add-on trajectory. CorMedix estimates for the 2027 Add-on are subject to several factors

and assumptions, including known historical utilization and pricing data, DefenCath maintaining fee-for-service utilization in line with

current trends, and the method by which CMS will apply certain utilization data in the Add-on calculations. Changes in customer

utilization patterns, including fee-for-service utilization, changes in pricing, or differences between CMS’s application of its

calculation methodology and the Company’s assumptions could cause the actual CMS-determined quarterly Add-on rates and the resulting

full-year average to differ materially from CorMedix’s estimates. Increased reimbursement to dialysis facilities may not result

in corresponding increases in CorMedix's realized pricing, product utilization or revenue. Additional risks include continued pricing

pressures and the impact of actions of governmental and private payers affecting pricing of, reimbursement for, and patient access to

pharmaceuticals and reporting obligations related thereto; and the expiration or loss of intellectual property protection for certain

of the Company's products and competition from generic and biosimilar products. 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 and its subsequent Quarterly Reports on Form 10-Q and Current

Reports on Form 8-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. Investors should not place undue reliance on these statements. CorMedix does not adopt

or endorse, and undertakes no obligation to comment on or correct, any projections, estimates or statements regarding its business or

results of operations that are made by third parties, including analysts and customers, except as required by law. 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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