What changed in this filing

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Item 9A. Controls and Procedures

2025-03-25 compared with 2024-03-12 · 1414 added, 1832 removed, 256 unchanged (93% of the section changed)

Controls and Procedures

of the end of the period covered by this Annual Report on Form 10-K, we carried out an evaluation, under the supervision and with the

participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design

and operation of our disclosure controls and procedures (as defined in the Exchange Act Rules 13a-15(e) and 15d-15(e)) (the “Exchange

Based on the foregoing evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure

controls and procedures are effective to ensure that information required to be disclosed by us in the reports we file or submit under

the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC,

and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial

Officer, to allow timely decisions regarding required disclosures.

in Internal Control Over Financial Reporting

were no changes in our internal control over financial reporting during our year ended December 31, 2023, or in other factors that could

significantly affect these controls, that materially affected, or are reasonably likely to materially affect, our internal control over

financial reporting.

Annual Report on Internal Controls Over Financial Reporting

management is responsible for establishing and maintaining adequate internal control over financial reporting and for the assessment

of the effectiveness of internal control over financial reporting.

As defined by the Securities and Exchange Commission, internal control

over financial reporting is a process designed by, or under the supervision of, our principal executive and principal financial officers

and effected by our Board of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of

financial reporting and the preparation of the consolidated financial statements in accordance with U.S.

generally accepted accounting

Our internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records

that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of our assets;

(2) provide reasonable assurance

that transactions are recorded as necessary to permit preparation of the consolidated financial statements in accordance with generally

accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management

and directors;

and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition

of our assets that could have a material effect on the consolidated financial statements.

of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.

Also, projections of

any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions,

or that the degree of compliance with the policies or procedures may deteriorate.

connection with the preparation of our annual consolidated financial statements, management, including, our Principal Executive and Financial

Officer, has undertaken an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2023,

based on the criterial established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations

of the Treadway Commission (“COSO”).

Management’s assessment included an evaluation of the design of our internal control

over financial reporting and testing of the operational effectiveness of those controls.

on this evaluation, management has concluded that our internal control over financial reporting was effective as of December 31,

As of the end of the period

covered by this Annual Report on Form 10-K, we carried out an evaluation, under the supervision and with the participation of our management,

including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of the design and operation of our disclosure

controls and procedures (as defined in the Exchange Act Rules 13a-15(e) and 15d-15(e)) (the “Exchange Act”).

foregoing evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures

are effective to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is recorded,

processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that such information is

accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions

regarding required disclosures.

Changes in Internal Control Over Financial

There were no changes in

our internal control over financial reporting during our year ended December 31, 2024, or in other factors that could significantly affect

these controls, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Management’s Annual Report on Internal Controls Over Financial

Our management is responsible

for establishing and maintaining adequate internal control over financial reporting and for the assessment of the effectiveness of internal

control over financial reporting.

As defined by the Securities and Exchange Commission, internal control over financial reporting is

a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by our Board

of Directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the

preparation of the consolidated financial statements in accordance with U.S.

generally accepted accounting principles.

Our internal control over

financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail,

accurately and fairly reflect our transactions and dispositions of our assets;

(2) provide reasonable assurance that transactions are

recorded as necessary to permit preparation of the consolidated financial statements in accordance with generally accepted accounting

principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors;

and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our

assets that could have a material effect on the consolidated financial statements.

Because of its inherent limitations,

internal control over financial reporting may not prevent or detect misstatements.

Also, projections of any evaluation of effectiveness

to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of

compliance with the policies or procedures may deteriorate.

In connection with the preparation

of our annual consolidated financial statements, management, including, our Principal Executive and Financial Officer, has undertaken

an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2024, based on the criterial

established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway

Commission (“COSO”).

Management’s assessment included an evaluation of the design of our internal control over financial

reporting and testing of the operational effectiveness of those controls.

Based on this evaluation,

management has concluded that our internal control over financial reporting was effective as of December 31, 2024.

Other Information

Rule 10b5-1 Plans

During the three months ended December 31, 2024,

no director or officer of the Company (as defined in Rule 16a-1(f) under the Exchange Act) informed us of the adoption or termination of

a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as those terms are defined in Item

408 of SEC Regulation S-K.

2025 Annual Meeting of Shareholders

We currently plan to hold our 2025 Annual Meeting

of Shareholders (the “2025 Annual Meeting”) on June 24, 2025.

The time and location of the 2025 Annual Meeting, and the matters

to be considered, will be as set forth in our definitive proxy statement for the 2025 Annual Meeting to be filed with the SEC.

Because the scheduled date of

the 2025 Annual Meeting is more than 30 days from the anniversary of the Company’s 2024 Annual Meeting of Stockholders, prior disclosed

deadlines regarding the submission of stockholder proposals pursuant to Rule 14a-8 (“Rule 14a-8”) under the Securities Exchange

Act of 1934, as amended (the “Exchange Act”), for the 2025 Annual Meeting are no longer applicable.

The Company is hereby

providing notice of certain revised deadlines for the submission of stockholder proposals in connection with the 2025 Annual Meeting.

In order for a stockholder proposal, submitted pursuant to Rule 14a-8, to be considered timely for inclusion in the Company’s proxy

statement and form of proxy for the 2025 Annual Meeting, such proposal must be received by the Company by April 8, 2025, which the Company

determined to be a reasonable time before the Company plans to begin printing and mailing its proxy materials.

Therefore, in order for

a stockholder to submit a proposal for inclusion in the Company’s proxy materials for the 2025 Annual Meeting, the stockholder must

comply with the requirements set forth in Rule 14a-8, including with respect to the subject matter of the proposal, and must deliver the

proposal and all required documentation to the Company no later than April 8, 2025.

The public announcement of an adjournment or postponement

of the date of the 2025 Annual Meeting will not commence a new time period (or extend any time period) for submitting a proposal pursuant

to Rule 14a-8.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Not applicable.

Directors, Executive Officers, and Corporate Governance

The information required

by this Item will be included in our Proxy Statement, which will be filed within 120 days after the close of the 2024 fiscal year, or

an amendment to this Annual Report, and is hereby incorporated by reference.

Code of Ethics

have adopted a written Code of Conduct and Ethics that applies to our directors, executive officers and all employees.

4 unchanged sentences

- Corporate Governance” section of our website, www.cormedix.com .

following table sets forth the name, age and position of each of our directors as of February 15, 2024:

Director Since

Position(s) with CorMedix

Joseph Todisco

Director and Chief Executive Officer

Janet Dillione

Gregory Duncan

November 2020

Director and Chairman of the Board

Steven Lefkowitz

Robert Stewart

Joseph Todisco

became a director of CorMedix in March 2022.

He was a senior executive at Amneal Pharmaceuticals for 11 years prior to joining CorMedix.

He held various roles at Amneal Pharmaceuticals, most recently as Executive Vice President, Chief Commercial Officer where he was responsible

for Amneal Specialty, a growing branded products business.

During his tenure at Amneal, Mr.

Todisco held roles overseeing corporate development

and international operations, leading commercial teams in several international markets including the UK, Australia and Germany, as well

as leading Amneal’s merger integration with Impax Laboratories in 2018.

He was previously Co-Founder and managing executive of Gemini

Laboratories, a specialty pharmaceutical company focused on the sales and marketing for niche branded products in the US Market.

Laboratories was established as an affiliate of Amneal Pharmaceuticals and was subsequently acquired by Amneal in 2018.

Prior to joining

Todisco was Vice President, Business Development & Licensing at Ranbaxy, Inc.

where he was responsible for developing

and executing Ranbaxy’s North American commercial business strategy.

Prior to Ranbaxy, he held various roles at Par Pharmaceutical,

and in his earlier career held positions at Oppenheimer & Company and Marsh & McLennan Companies.

Todisco obtained his MBA

in finance from Fordham Graduate School of Business and his BA in Economics from Georgetown University.

Among other qualifications, attributes

and skills, Mr.

Todisco’s business expertise and significant executive management experience in the pharmaceutical industry led

to the conclusion of our Board that he should serve as a director of our Company in light of our business and structure.

Dillione has been a director of CorMedix since August 2015.

Since November 2020, Ms.

Dillione has served as the Chief Executive

Officer of Connect America, a nationally recognized leader in comprehensive telehealth and remote patient monitoring solutions.

to joining Connect America and starting in May 2014, she served as Chief Executive Officer of Bernoulli Enterprise, Inc., a real-time

connected healthcare information technology company.

Previously, she was at Nuance Communications, Inc., a leading provider of voice

and language solutions for businesses and consumers around the world, having joined Nuance in April 2010 as Executive Vice President

and General Manager of the Healthcare Division and serving as an executive officer from March 2010 until May 2014.

From June 2000 to

March 2010, Ms.

Dillione held several senior level management positions at Siemens Medical Solutions, a global leader in medical imaging,

laboratory diagnostics, and healthcare information technology, including President and CEO of the global healthcare IT division.

Dillione currently serves as a director of Vizient, Inc., a private health care performance improvement company.

Dillione received

from Brown University in 1981 and completed the Executive Program at The Wharton School of Business of the University of Pennsylvania

She has over 25 years of experience leading global teams in the development and delivery of healthcare technology and services.

Among other qualifications, attributes and skills, Ms.

Dillione’s financial and IT expertise and significant executive management

experience with medical device and healthcare companies led to the conclusion of our Board that she should serve as a director of our

Company in light of our business and structure.

Duncan has been a director of CorMedix since November 2020.

Duncan currently serves as the Chairman and CEO of Virios Therapeutics,

a clinical-stage biopharmaceutical company developing and commercializing innovative antiviral therapies to treat diseases associated

with a viral triggered abnormal immune response, such as fibromyalgia (FM), and has served since April 2020.

From 2014 and prior to joining

his current company, Mr.

Duncan served as President and CEO of Celtaxsys, a privately held biotechnology company focused on cystic fibrosis

and other rare, inflammatory diseases.

Duncan has spent the majority of his career in senior leadership roles in commercial stage

pharmaceutical companies.

From 2007 to 2013, he served as a senior executive at UCB, including as President of its North America business,

as well as an executive committee member.

Prior to his roles with UCB, Mr.

Duncan spent approximately 17 years at Pfizer where he gained

significant experience across sales and marketing functions including serving as SVP of US Marketing and later as President of Pfizer’s

Latin America business from 2005 to 2007.

Duncan received his undergraduate degree from the State University of New York, Albany,

and earned an MBA degree from Emory University.

Among other experience, qualifications, attributes and skills, Mr.

Duncan’s significant

depth of experience in the pharmaceutical industry led to the conclusion of our Board that he should serve as a director of our Company

in light of our business and structure.

has been a director of CorMedix since March 2019.

He is the founder and principal consultant of Danerius,

LLC, a biotechnology and pharmaceutical consulting business which he started in 2006.

From 1994, he served in senior positions in Research

and Development in the Pharmaceutical Division of Johnson and Johnson including President and Managing Director of the Janssen, the major

research, development and regulatory arm of the pharmaceuticals division at Johnson & Johnson.

From January 2007 through March 2009,

Dunton served as President and Chief Executive Officer of Panacos Pharmaceuticals, Inc.

From November 2015 through March 2018, Dr.

Dunton was the Head/Senior Vice President of Research, Development and Regulatory Affairs of Purdue Pharma L.P., a private pharmaceutical

In addition to CorMedix, Dr.

Dunton currently serves on the boards of three public companies, as a Director at Palatin Technologies,

and Oragenics, Inc.

he chairs the Compensation Committees of both companies.

He also serves as a member of the Audit Committees

of these companies.

Additionally, Dr.

Dunton is a member of the board of Recce Pharma Ltd., an Australian public biotechnology company

focused on developing novel anti-infectives for serious and life-threatening diseases.

Dunton received his Bachelor of Science degree

in biochemistry, magna cum laude, from State University of New York at Buffalo, and received his M.D.

from New York University School

Among other qualifications, Dr.

Dunton’s significant depth of experience in the pharmaceutical industry, including

service as a director of public pharmaceutical companies, led to the conclusion of our Board that he should serve as a director of our

Company in light of our business and structure.

Kaplan became a director of CorMedix in April 2016 and became Chairman of the Board in August 2017.

He is a founding partner

of Kleinberg, Kaplan, Wolff & Cohen, P.C., a New York City general practice law firm, where he has practiced corporate and securities

law for more than fifty years.

Kaplan became a trustee of the Lehman Brothers Plan Holding Trust.

Previously, he served

as a member of the board of directors of SAirGroup Finance (USA) Inc., a subsidiary of SAirGroup that had publicly issued debt securities,

Trans World Airlines, Inc.

and Kitty Hawk, Inc.

Among his business and civic involvements, Mr.

Kaplan currently serves on the boards

of directors of a number of private companies and has been active for many years on the boards of trustees and various board committees

of The Children’s Museum of Manhattan and JBI International (formerly The Jewish Braille Institute of America).

Kaplan graduated

from Columbia College and holds a Juris Doctor from Harvard Law School.

Among other experience, qualifications, attributes and skills,

Kaplan’s experience in a broad range of corporate and securities matters and service as a director of public companies led

to the conclusion of our Board that he should serve as a director of our Company in light of our business and structure.

Lefkowitz was a director of CorMedix from August 2011 to June 2016.

He was reappointed to the Board in June 2017.

He also served

as our acting Chief Financial Officer from August 2013 to July 2014.

Lefkowitz has been the President and Founder of Wade Capital

Corporation, a financial advisory services company since June 1990.

Lefkowitz has been a director of both public and private companies.

Lefkowitz received his A.B.

from Dartmouth College in 1977 and his M.B.A.

from Columbia University in 1985.

Among other experience,

qualifications, attributes and skills, Mr.

Lefkowitz’s education, experience and financial expertise led to the conclusion of our

Board that he should serve as a director of our Company in light of our business and structure.

Stewart became a director of CorMedix in April 2023.

Stewart is the current Chief Executive Officer of Theramex, a global

specialty pharmaceutical company dedicated to women’s health, and has served in this role since March 2020.

Prior to this, Mr.

Stewart served as Chief Executive Officer of Amneal Pharmaceuticals Inc.

from 2018 to 2019, and from 2009 through 2018 Mr.

Stewart served

in senior roles with Allergan, formerly Watson and Actavis, most notably as Chief Operating Officer (2015 – 2018) and President,

Global Operations (2009 – 2015).

Stewart has also previously held management roles with Abbott Laboratories, Knoll Pharmaceutical

Company, and Hoffmann La Roche, Inc.

Stewart currently sits on the Board of Directors of Cipla Ltd and serves on the Board of Trustees

for Fairleigh Dickinson University.

Stewart obtained his bachelor’s degree in Finance & Business Management from Fairleigh

Dickinson University.

Among other qualifications, Mr.

Stewarts significant depth of experience in the pharmaceutical industry, including

service as an executive director of other pharmaceutical companies, led to the conclusion of our Board that he should serve as a director

of our Company in light of our business and structure.

common stock is listed on the Nasdaq Global Market.

Under the rules of Nasdaq, independent directors must comprise a majority of a listed

company’s board of directors.

In addition, the rules of Nasdaq require that, subject to specified exceptions, each member of a

listed company’s audit, compensation and nominating and corporate governance committees be independent.

Under the rules of Nasdaq,

a director will only qualify as an “independent director” if, in the opinion of that company’s board of directors,

that person does not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities

of a director.

Additionally, compensation committee members must not have a relationship with us that is material to the director’s

ability to be independent from management in connection with the duties of a compensation committee member.

committee members must also satisfy the independence criteria set forth in Rule 10A-3 under the Exchange Act.

In order to be considered

independent for purposes of Rule 10A-3, a member of an audit committee of a listed company may not, other than in his or her capacity

as a member of the audit committee, the board of directors or any other board of directors committee:

(i) accept, directly or indirectly,

any consulting, advisory or other compensatory fee from the listed company or any of its subsidiaries;

or (ii) be an affiliated

person of the listed company or any of its subsidiaries.

Board has undertaken a review of the independence of our directors and has determined that (i) all current directors other than Mr.

are independent within the meaning of Section 5605(b) of the Nasdaq Marketplace Rules, (ii) all members of our Audit Committee meet the

additional test for independence for audit committee members imposed by SEC regulation and Section 5605(c) of the Nasdaq Marketplace

Rules, (iii) all of the members of our Compensation Committee are independent within the meaning of Section 5605(d) of the Nasdaq Marketplace

Rules, and (iv) all of the members of our Nominating and Governance Committee are independent within the meaning of Section 5605(e) of

the Nasdaq Marketplace Rules.

Board has established an Audit Committee, a Compensation Committee and a Nominating and Governance Committee.

Our Audit Committee currently

consists of Mr.

Lefkowitz (Chair), Dr.

Dunton and Mr.

Our Compensation Committee currently consists of Ms.

Dillione (Chair),

Dunton and Mr.

Our Nominating and Governance Committee currently consists of Mr.

Kaplan (Chair), Ms.

Dillione, and Mr.

The membership of these committees may be changed after our next annual meeting.

of the above-referenced committees operates pursuant to a formal written charter.

The charters for each committee, which have been adopted

by our Board, contain a detailed description of the respective committee’s duties and responsibilities and are available on our

website at www.cormedix.com under the “Investor Relations—Corporate Governance” tab.

From time to time, the Board

also conducts business through other duly appointed committees, such as the Strategy Committee, that are established on an ad hoc basis.

The Strategy Committee was formed by the Board to evaluate and oversee certain of the Company’s strategic planning activities.

2023, the Strategy Committee acted by unanimous written consent on one occasion and held no committee meetings.

The Strategy Committee

consists of Steve Lefkowitz, Myron Kaplan and Rob Stewart.

Audit Committee assists the Board in its oversight of our corporate financial statements and reporting and our external audits, including,

among other things, our internal controls and audit functions, the results and scope of the annual audit and other services provided

by our independent registered public accounting firm and our compliance with legal matters that have a significant impact on our financial

The Audit Committee also consults with our management and our independent registered public accounting firm prior to the

presentation of financial statements to stockholders and, as appropriate, initiates inquiries into aspects of our financial affairs.

The Audit Committee is responsible for establishing procedures for the receipt, retention and treatment of complaints regarding accounting,

internal accounting controls or auditing matters, and for the confidential, anonymous submission by our employees of concerns regarding

questionable accounting or auditing matters.

In addition, the Audit Committee is directly responsible for the appointment, retention,

compensation and oversight of the work of our independent registered public accounting firm, including approving services and fee arrangements.

All related party transactions will be approved by the Audit Committee before we enter into them.

our independent registered public accounting firm and internal financial personnel regularly meet with, and have unrestricted access

to, the Audit Committee.

Board has determined that each of Mr.

Lefkowitz, Dr.

Dunton and Mr.

Duncan qualifies as an “audit committee financial expert”

as that term is defined in the rules and regulations of the SEC.

The designation of each of Mr.

Lefkowitz, Dr.

Dunton and Mr.

as an “audit committee financial expert” does not impose on them any duties, obligations or liability that are greater than

those that are generally imposed on them as a member of the Audit Committee and the Board, and their designation as an “audit committee

financial expert” pursuant to this SEC requirement does not affect the duties, obligations or liability of any other member of

the Audit Committee or the Board.

Compensation Committee reviews and approves our compensation policies and all forms of compensation to be provided to our executive officers,

including, among other things, annual salaries, bonuses, and other incentive compensation arrangements.

The Compensation Committee also

reviews and makes recommendations to our Board regarding changes in director compensation.

In addition, the Compensation Committee administers

our equity compensation plans, including granting stock options to our executive officers.

The Compensation Committee also reviews and

approves employment agreements with executive officers and other compensation policies and matters.

Pursuant to its charter, the Compensation

Committee has the power to form and delegate authority to subcommittees and to delegate authority to one or more members of the Compensation

2016, the Company and the Compensation Committee have periodically engaged Frederic W.

Cook & Co., an independent compensation consultant,

for input on the compensation of our Named Executive Officers and directors.

The Compensation Committee assessed the independence of

Cook & Co., considering the factors required by the Nasdaq Global Market Listing Rules and concluded that no conflict

of interest exists that would prevent Frederic W.

from independently representing our Company.

In the future, we, or the

Compensation Committee, may engage or seek the advice of Frederic W.

Cook & Co., or another compensation consultant.

member of the Compensation Committee is a non-employee director, as defined pursuant to Rule 16b-3 promulgated under the Exchange Act.

and Governance Committee

Nominating and Governance Committee identifies, evaluates and recommends nominees to the Board and committees of the Board, conducts

searches for appropriate directors and evaluates the performance of the Board and of individual directors.

The Nominating and Governance

Committee also is responsible for reviewing developments in corporate governance practices, evaluating the adequacy of our corporate

governance practices and reporting and making recommendations to the Board concerning corporate governance matters.

following table sets forth the name, age and position of each of our executive officers as of December 31, 2023:

Position(s) with CorMedix

Joseph Todisco

Chief Executive Officer

Matthew David

Executive Vice President and Chief Financial Officer

Beth Zelnick Kaufman

Executive Vice President and Chief Legal Officer and Corporate Secretary

Executive Vice President and Chief Commercial Officer

Elizabeth Hurlburt

Executive Vice President and Head, Clinical and Medical Affairs

Phoebe Mounts

Former Executive Vice President and General Counsel and Head of Regulatory, Compliance and Legal

the biography for Joseph Todisco under “Directors.”

M.D ., became our Executive Vice President and Chief Financial Officer in May 2020.

From October 4, 2021 through

May 10, 2022, Dr.

David also served as our interim Chief Executive Officer in addition to his role as Chief Financial Officer.

Prior to joining us, he most recently served as Head of Strategy at Ovid Therapeutics Inc, a late-stage clinical biopharmaceutical company

focused on developing treatments for rare neurological disorders, where he was responsible for financing strategy and investor relations,

and joined in October 2018.

Prior to Ovid, Dr.

David was a Strategic Advisor to Frequency Therapeutics, advising on financing, investor

relations and strategic initiatives from 2017 to early 2019.

Prior to Frequency, Dr.

David spent the majority of his career as an investment

banker specialized in the life sciences sectors, including at Piper Jaffray, Thomas Weisel Partners, Ferghana Partners and most recently

at Bank of America Merrill Lynch.

As part of his experience as an investment banker, Dr.

David has advised on a broad range of capital

raising and strategic transactions.

Earlier in his career, Dr.

David was part of the equity research team at Lehman Brothers, focusing

on Large Pharma.

David began his career as a surgical resident at Beth Israel Hospital, after receiving an M.D.

from NYU School of

David earned his Bachelor of Arts degree in Chemistry, magna cum laude, from Dartmouth College.

Beth Zelnick Kaufman

became our Executive Vice President and Chief Legal Officer and Corporate Secretary on December 12, 2023.

She has more than two decades

of legal, compliance and operations experience in the life sciences industry.

Prior to joining CorMedix, she most recently served as Chief

Legal and Administrative Officer and Corporate Secretary of Akorn Pharmaceuticals, a specialty and generic pharmaceuticals company.

Zelnick Kaufman also served in several roles at Amneal Pharmaceuticals, a publicly traded global generics, biosimilars and branded pharmaceuticals

company, including roles as Assistant General Counsel, Vice President, Legal Affairs, and Head of Government Affairs.

During her tenure

at these and other pharmaceutical companies, Ms.

Zelnick Kaufman gained deep experience in the pharmaceutical industry across legal, regulatory,

government affairs, and other operational areas.

Earlier in her career, Ms.

Zelnick Kaufman held roles at Actavis, Alpharma and Topcon

America and spent time as an Associate in the law firm Brown, Rudnick.

Mistry became our Senior Vice President of Payer Strategy, Government Affairs and Trade in March 2020.

Her current role is Executive

Vice President and Chief Commercial Officer, effective January 2023.

Prior to joining CorMedix, Erin held roles as VP market access at

Intarcia therapeutics as well as Senior Managing Director of the global Value and Access practice at Syneos Health.

During her career,

Erin has worked with emerging, mid-size, and large biopharma companies with a focus on pricing, access and reimbursement.

She currently

serves on the boards of Incubate Coalition and the AntiMicrobial Working Group, both in Washington, DC.

Erin holds a B.S.

in Industrial

Engineering (healthcare) and an M.S.

in Biomechanical Engineering from North Carolina State University.

Hurlburt became our Executive Vice President and Head of Clinical Operations in March 2018.

Her current role is Executive Vice

President and Head of Clinical and Medical Affairs, effective May 2022.

Prior to her employment, Ms.

Hurlburt had been providing us clinical

operations expertise as a consultant since late November 2017.

Before she began her consulting career, she held several progressive management

roles in clinical operations, most recently at Gemphire Therapeutics, as a Senior Director, Clinical Operations from April 2015 to October

2016, then as Vice President, Clinical Operations from October 2016 to March 2018.

Hurlburt received her B.A.

in Leadership and Organizational

Management from Bay Path College and a M.S.

in Management and Leadership from Western Governors University.

December 31, 2023, Phoebe Mounts, our former Executive Vice President and General Counsel and Head of Regulatory, Compliance and Legal,

voluntarily resigned effective December 31, 2023.

See Item 11, Executive Compensation , for further detail on the terms of Ms.

Mounts’ separation with the Company.

Insider Trading Policy

have adopted insider trading and 10b5-1 trading plan policies and procedures applicable to our directors, officers, employees,

and other covered persons, and have implemented processes for the company, that we believe are reasonably designed to promote compliance

with insider trading laws, rules and regulations, and the Nasdaq Stock Market LLC listing standards.

Our insider trading policy and our

10b5-1 trading plan policy are filed as Exhibit 19.1 to this Annual Report on Form 10-K.

Executive Compensation

Compensation in Fiscal 2023

following table shows the compensation earned by each of our non-employee directors for the year ended December 31, 2023:

Earned or Paid in Cash ($)

Awards (1)(2)

Janet Dillione

Gregory Duncan

Steven Lefkowitz

Robert Stewart

amounts included in this column are the dollar amounts representing the full grant date fair

value of each stock option award calculated in accordance with FASB ASC Topic 718 and do

not represent the actual value that may be recognized by the directors upon option exercise.

For information on the valuation assumptions used in calculating these amounts, see Note

7 to our audited financial statements included in this Annual Report on Form 10-K.

of December 31, 2023, the number of shares underlying options held by each non-employee director

was as follows:

83,750 shares for Mr.

145,000 shares for Ms.

112,500 shares for Dr.

126,000 shares for Mr.

108,000 shares

and 39,200 shares for Mr.

(3) Effective

October 15, 2023, Mr.

Costa ceased as a member of the Company’s board of directors.

Compensation Plan

Board, following the recommendation of the Compensation Committee and, based on advice of Frederic W.

Cook & Co., determined that

no adjustment was needed with regard to Board and committee cash compensation for 2023.

The 2023 compensation program

is set forth below in the table.

Each year we make an annual grant of stock options to each non-employee director with respect to 20,000

shares and we make an initial grant of stock options to new non-employee directors with respect to 25,000 shares, prorated as appropriate.

On March 5, 2024, the Board approved an increase in the annual and initial grant of stock options to non-employee directors, whereby

such directors will receive an annual option grant with respect to 30,000 shares (from 20,000 shares) and new non-employee directors

will receive an initial option grant with respect to 30,000 shares (from 25,000 shares).

All stock options are subject to continued service

on the Board through the vesting date.

The exercise price per share of each stock option granted to our non-employee directors is equal

to the fair market value of our common stock as determined based upon the closing sales price for our stock on the date of grant.

First Election to Board

Annual Grant, Prorated in First Year Following Election to the Board

Additional Annual Fee - Board Chair

Additional Annual Fee - Audit Chair

Additional Annual Fee - Compensation Chair

Additional Annual Fee - Nomination and Governance Chair

Additional Annual Fee - Audit Committee Non-Chair Members

Additional Annual Fee - Compensation Committee Non-Chair Members

Additional Annual Fee - Nomination and Governance Committee Non-Chair Members

Additional Annual Fee - Strategic Committee Members

one third each on the date of grant and the first and second anniversary date of grant.

monthly over one year after the grant date.

maintain a Deferred Compensation Plan for Directors, pursuant to which our non-employee directors may defer all of their cash director

fees and restricted stock units.

Any cash fees due to a participating director will be converted into a number of shares of our common

stock by dividing the dollar amount of fees payable by the closing price of our common stock on the date such fees would be payable,

and the director’s unfunded account is credited with the shares.

The shares that accumulate in a director’s account will

be paid to the director on the tenth business day in January following the year in which the director’s service terminates for

whatever reason, other than death, in which case the account will be paid within 30 days of the date of death to the designated beneficiary,

as applicable.

In the event of a change in control of our Company, the director would receive cash in an amount equal to the number of

shares in the account multiplied by the fair market value of our common stock on the change in control date, and the payment would be

accelerated to five business days after the effective date of the change in control.

Compensation Table

following table sets forth information with respect to compensation earned by our Named Executive Officers in the years ended December

31, 2023 and 2022:

and Principal Position

Incentive Plan Compensation

Other Compensation ($)

Executive Officer

Financial Officer

Vice President and Chief Commercial Officer

Executive Vice President and General Counsel and Head of Regulatory, Compliance and Legal

amounts included in this column are the dollar amounts representing the full grant date fair

value of each award calculated in accordance with FASB ASC Topic 718 and do not represent

the actual value that may be recognized by the Named Executive Officers upon option exercise.

(2) Represents

premiums paid by us for health benefits and 401(k) plan employer match.

Mistry became our Chief Commercial Officer on January 15, 2023.

Mistry was not an executive

officer during 2022.

Mounts’ service as an executive officer ceased on December 12, 2023, but her employment

continued through December 31, 2023.

(5) Represents

premiums paid by us for health benefits, Dr.

Mounts’ 401(k) employer match for 2023,

Mounts’ cash severance and accrued but unpaid paid time off through her termination

Disclosure to Summary Compensation Table

Agreements with Named Executive Officers

March 16, 2022, we entered into an employment agreement with Mr.

Todisco, our Chief Executive Officer.

The term of the employment agreement

will automatically renew for additional successive one-year periods on March 16 th of each calendar year, unless either party

notifies the other in writing at least 90 days before the expiration of the then-current term that the term will not be renewed.

Todisco is entitled to an annual salary of $618,000 (effective January 2023), and his target annual bonus is 65% of his base salary,

with the actual bonus entitlement based on the achievement of specified Company objectives.

On May 11, 2020, we entered into an employment agreement with Dr.

to serve as our Executive Vice President and Chief Financial Officer.

The term will automatically renew for additional successive one-year

periods on May 11 th of each calendar year, unless either party notifies the other in writing at least 90 days before the expiration

of the then-current term that the term will not be renewed.

David is entitled to an annual salary of $390,000 (effective January 2023),

and his target annual bonus is 40% of his base salary, with the actual bonus entitlement based on the achievement of specified Company

January 15, 2023, we entered into an employment agreement with Ms.

Mistry to serve as Executive Vice President and Chief Commercial Officer.

After the initial three-year term of the employment agreement, the term will automatically renew for additional successive one-year periods,

unless either party notifies the other in writing at least 90 days before the expiration of the then-current term that the term will

not be renewed.

Mistry receives an annual salary of $392,000, and her target annual bonus is 40% of her base salary, with the actual

bonus entitlement based on the achievement of specified Company objectives.

December 12, 2023, Dr.

Mounts served as our Executive Vice President and General Counsel and Head of Regulatory, Compliance and Legal

and received an annual salary of $375,000, with a target annual bonus of 30% of her base salary, with the actual bonus entitlement based

on the achievement of specified Company objectives.

connection with her departure, the Company and Dr.

Mounts entered into a separation agreement which provided for severance benefits,

including continued payment of her base salary for nine months, payment of her 2023 target annual bonus, and accelerated vesting of her

time-based stock options that were otherwise scheduled to vest on or before the first anniversary of her termination date.

For additional

information regarding Dr.

Mounts’ separation agreement, please see the section titled “ Potential Payments on a Qualifying

Termination .”

Payments Upon Termination or Change in Control

following provisions of the employment agreements with our Named Executive Officers are identical except where noted.

In the event that a Named

Executive Officer’s employment is terminated during the term of his or her employment agreement by the Company other than for Cause

(other than as a result of death or disability), or by the Named Executive Officer for Good Reason (as defined in the employment agreement),

the Named Executive Officer will, subject to execution of a general release of claims, be entitled to:

(i) a continuation of base salary

for a period of nine months;

except that Mr.

Todisco’s base salary will continue for 12 months (or 18 months if such termination

occurs within 24 months following a corporate transaction (as defined in the employment agreement));

(ii) payment on a prorated basis

for any target bonus for the year of termination based on the actual achievement of the specified bonus objectives (or in the case of

Todisco only, for 18 months, if such termination occurs within 24 months following a corporate transaction);

(iii) subsidized

COBRA premiums for up to nine months (or in the case of Mr.

Todisco only, for 18 months, if such termination occurs within 24 months following

a corporate transaction);

and (iv) one year of additional time vesting of the Named Executive Officer’s then-outstanding equity

awards (and in the case of Mr.

Todisco, accelerated vesting of the restricted stock units granted to him on May 10, 2022), or full

vesting if such termination occurs within 24 months following a corporate transaction.

Mounts’ separation agreement provides for severance benefits consistent with the terms of her employment agreement in connection

with a termination without “cause” prior to a corporate transaction.

Specifically, in exchange for a general release of claims

in favor of the Company and its affiliates, Dr.

Mounts’ cooperation with the transition of her position, and continued compliance

with certain restrictive covenants, the Company agreed to provide Dr.

Mounts with (i) a continuation of base salary ($31,250 per

month) for a period of nine months, (ii) payment of her full 2023 target annual bonus (as reflected in the “ Non-equity

Incentive Plan Compensation ” column of the Summary Compensation Table), and (iii) one year of additional time vesting of her

then-outstanding options.

of our Named Executive Officers is prohibited from engaging in any business involving the development or commercialization of a preventive

anti-infective product that would be a direct competitor of DefenCath/Neutrolin or a product containing taurolidine or any other product

being actively developed or produced by us within the United States and the European Union (or in the case of Dr.

David and Mr.

worldwide) on the date of termination of his or her employment for a period of 12 months following any termination of employment.

Company maintains the CorMedix Inc.

Amended and Restated 2019 Omnibus Stock Incentive Plan pursuant to which it has granted equity awards

to the Named Executive Officers, as well as other employees and service providers.

Equity Awards

Todisco was granted stock options to purchase 400,000 shares of the Company’s Common Stock on January 14, 2023.

The options granted

Todisco are scheduled to vest over a period of three years (with the first 25% vesting on the date of the grant, and the remainder

scheduled to vest in equal annual installments over the next three years thereafter, subject to continued employment).

David was granted stock options to purchase 125,000 shares of the Company’s Common Stock on January 14, 2023.

The options granted

David are scheduled to vest over a period of three years (with the first 25% vesting on the date of the grant, and the remainder

scheduled to vest in equal annual installments over the next three years thereafter, subject to continued employment).

Mistry was granted stock

options to purchase 200,000 shares of the Company’s Common Stock on January 14, 2023.

The options granted to Ms.

Mistry are scheduled

to vest over a period of three years (with the first 25% vesting on the date of the grant, and the remainder scheduled to vest in equal

annual installments over the next three years thereafter, subject to continued employment).

Mounts was granted stock options to purchase 125,000 shares of the Company’s Common Stock on January 14, 2023.

The options granted

Mounts were scheduled to vest over a period of three years (with the first 25% vesting on the date of the grant, and the remainder

scheduled to vest in equal annual installments over the next three years thereafter, subject to continued employment).

Equity Awards at Fiscal Year-End 2023

following table contains certain information concerning unexercised options for the Named Executive Officers as of December 31, 2023.

of Shares Underlying Unexercised Options (#)

of Shares Underlying Unexercised Options (#) Unexercisable (1)

Incentive Plan Awards:

Number of Shares Underlying Unexercised Unearned Options

Exercise Price

Expiration Date

Incentive Plan Awards:

Number of Unearned Shares, Units or Other Rights That Have Not Vested

Incentive Plan Awards:

FMV or Payout Value of Unearned Shares, Units or Other Rights That Have Not Vested

Joseph Todisco

Matthew David

Phoebe Mounts (5)

based on continued employment over four years.

vest based on achievement of specific milestones and continued employment and become exercisable

if and when a milestone is achieved.

market value of the shares that could be acquired based on the closing sale price per share

of our common stock on the Nasdaq Global Market on December 31, 2023, which was $3.76.

restricted stock unit represents the right to receive one share of our common stock.

restricted stock units vest as follows:

50% on the first anniversary of the grant date, 30%

on the second anniversary of the grant date, and the remaining 20% on the third anniversary

of the grant date, subject to continued service through the applicable vesting date.

Mounts ceased serving as our General Counsel and Head of Regulatory, Compliance and Legal

effective December 12, 2023, but her employment continued through December 31, 2023.

Payments on a Qualifying Termination

the severance payments called for in our employment agreements for Mr.

David and Ms.

Mistry had been triggered on December

31, 2023, we would have been obligated to make the following payments as described in more detail under the “ Potential Payments

Upon Termination or Change in Control ” summary above:

Equity Vesting

Todisco (no Corporate Transaction)

Todisco (within 24 months following a Corporate Transaction)

David (no Corporate Transaction)

David (within 24 months following a Corporate Transaction)

Mistry (no Corporate Transaction)

Mistry (within 24 months following a Corporate Transaction)

respect to outstanding stock options, represents the difference between the fair market value

of the shares that could be acquired based on the closing sale price per share of our common

stock on the Nasdaq Global Market on December 31, 2023, which was $3.76, and the exercise

prices of the applicable stock options.

With respect to restricted stock units, represents

the fair market value of the shares that could be acquired based on the closing sale price

per share of our common stock on the Nasdaq Global Market on December 31, 2023, which was

Mounts’ separation agreement, her departure was treated as a termination by the Company without Cause and she will be entitled

to receive the severance benefits and payments described under the “ Potential Payments Upon Termination or Change in Control ”

summary above.

Mounts is subject to a noncompete covenant that runs through September 30, 2024, consistent with the terms described

above under “ Non-Compete Covenants ”.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

following table shows the number of shares of our common stock beneficially owned as of March 7, 2024 by:

person known by us to own beneficially more than 5% of the outstanding shares of our common

of our Named Executive Officers;

of our current directors and executive officers as a group.

table is based upon the information supplied by our Named Executive Officers, directors and principal stockholders and from

Schedules 13D and 13G filed with the SEC.

Except as indicated in footnotes to this table, the persons named in this table have sole

voting and investment power with respect to all shares of common stock shown, and their address is c/o CorMedix Inc., 300 Connell

Drive, Suite 4200, Berkeley Heights, New Jersey 07922.

As March 7, 2024 we had 54,981,102 shares of common stock outstanding.

Beneficial ownership in each case also includes shares issuable upon vesting of restricted stock units within 60 days from March 7,

2024 and exercise of outstanding options that can be exercised within 60 days after March 7, 2024 for purposes of computing the

percentage of common stock owned by the person named.

Options owned by a person are not included for purposes of computing the

percentage owned by any other person.

Beneficially Owned (1)

Address of Beneficial Owner

Greater Stockholders

Global Financial Products, Inc.

Lefkowitz (8)

Executive Officers:

Hurlburt (12)

executive officers and directors as a group (11 persons) (15)

upon 54,981,102 shares of our common stock outstanding on March 7, 2024 and, with respect

to each individual holder, rights to acquire our common stock exercisable within 60 days

of March 7, 2024.

solely on information contained in the Statement on Schedule 13G filed with the SEC

on January 29, 2024 by Blackrock, Inc.

Blackrock, Inc.

reported has sole voting power with

respect to 3,480,288 shares of our common stock, has shared voting power with respect to

0 shares of our common stock, has sole dispositive power with respect to 3,507,695 shares

of our common stock and has shared dispositive power with respect to 0 shares of our common

The business address of Blackrock, Inc.

is 50 Hudson Yards, New York, NY 10001.

solely on information contained in Amendment No.

2 to the Statement on Schedule 13G filed

with the SEC on February 14, 2024 by Nomura Global Financial Products, Inc.

NGFP is a wholly owned subsidiary of Nomura Holdings, Inc., which accordingly may be deemed

to beneficially own the shares beneficially owned by NGFP.

NGFP reported has sole voting

power with respect to 0 shares of our common stock, shared voting power with respect to 2,946,531

shares of our common stock, sole dispositive power with respect to 0 shares of our common

stock and shared dispositive power with respect to 2,946,531 shares of our common stock.

The business address of NGFP is Worldwide Plaza, 309 West 49th Street, New York, NY 10019.

The business address of Nomura Holdings, Inc.

is 13-1, Nihonbashi 1-chome, Chuo-ku, Tokyo

103-8645, Japan.

of (i) 53,473 shares of our common stock, and (ii) 145,000 shares of our common stock issuable

upon exercise of stock options.

Dillione also holds 48,909 shares of common stock deferred

under Director’s Compensation Plan, which is excluded for purposes of calculating the

number of shares of our common stock beneficially owned as of February 15, 2024.

of 82,500 shares of our common stock issuable upon exercise of stock options.

of (i) 15,250 shares of our common stock, and (ii) 112,500 shares of our common stock issuable

upon exercise of stock options.

of (i) 151,034 shares of our common stock held directly, (ii) 30,000 shares of our common

stock held by Mr.

Kaplan’s wife, 20,000 of which are held by her individually and 10,000

of which are held as a custodian for two of Mr.

Kaplan’s grandchildren, and (iii) 126,000

shares of our common stock issuable upon exercise of stock options.

of (i) 75,498 shares of our common stock held directly, (ii) 2,000 shares of our common stock

Lefkowitz’s wife, (iii) 30,152 shares of our common stock held by Wade

Capital Corporation Money Purchase Plan, an entity for which Mr.

Lefkowitz has voting and

investment control, and (iv) 108,000 shares of our common stock issuable upon exercise of

stock options.

of (i) 11,000 shares of our common stock, and (ii) 30,866 shares of our common stock issuable

upon exercise of stock options.

(10) Consists

of (i) 135,543 shares of our common stock, and (ii) 391,667 shares of our common stock issuable

upon exercise of stock options.

(11) Consists

of (i) 10,434 shares of our common stock, (ii) 500,084 shares of our common stock issuable

upon exercise of stock options.

(12) Consists

of (i) 7,897 shares of our common stock, and (ii) 407,144 shares of our common stock issuable

upon exercise of stock options.

(13) Consists

of (i) 13,011 shares of our common stock, and (ii) 290,750 shares of our common stock issuable

upon exercise of stock options.

(14) Consists

(i) 7,200 shares of our common stock, and (ii) 507,264 shares of our common stock issuable

upon exercise of stock options.

(15) Consists of the following held by our directors and executive officers

(i) 535,292 shares of our common stock, and (ii) 2,151,177 shares of our common stock issuable upon exercise of stock options.

Compensation Plan Information

following table provides information as of December 31, 2023 about our common stock that may be issued upon the exercise of options,

warrants and rights under all of our existing equity compensation plans (including individual arrangements):

of securities to be issued upon exercise of outstanding options, warrants and rights

Weighted-average

exercise price of outstanding options, warrants and rights

securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column

Equity compensation plans approved

by security holders (1)

6,365,243 (2)

2013 Stock Incentive Plan was approved by our stockholders on July 30, 2013.

Our 2019 Omnibus

Stock Incentive Plan was approved by our stockholders on November 26, 2019.

Our Amended and

Restated 2019 Omnibus Stock Incentive Plan was approved by our stockholders on October 13,

of 6,211,508 underlying stock options and 153,735 underlying restricted stock units.

(3) Applicable

to shares underlying outstanding stock options only.

Certain Relationships and Related Transactions and Director Independence

Party Transactions

related party transactions occurred during the fiscal year ended December 31, 2023.

for Review and Approval of Transactions with Related Persons

to the Audit Committee Charter, the Audit Committee is responsible for reviewing and approving all related party transactions as defined

under Item 404 of Regulation S-K, after reviewing each such transaction for potential conflicts of interests and other improprieties.

Our policies and procedures for review and approval of transactions with related persons are in writing in our Code of Conduct and Ethics

available on our website at www.cormedix.com under the “Investor Relations—Corporate Governance” tab.

information on Board independence is found in Item 10 of this Report under the heading “Board Independence.”

Principal Accounting Fees and Services

Paid to the Independent Registered Public Accounting Firm

The following table sets forth

fees billed to us by Friedman LLP and Marcum LLP, our independent registered public accounting firms for the years ended December 31,

2023 and 2022, for services relating to:

auditing our annual financial statements;

reviewing our financial statements included in our

quarterly reports on Form 10-Q;

reviewing registration statements during 2023 and 2022;

and financing activities in 2023 and 2022.

Audit Fees (Friedman LLP)

Audit Fees (Marcum LLP)

Audit Related Fees

All Other Fees

Committee Pre-Approval Policies and Procedures

to its charter, the Audit Committee is responsible for reviewing and approving in advance any audit and any permissible non-audit engagement

or relationship between us and our independent registered public accounting firm.

The Audit Committee may delegate to one or more designated

members of the Audit Committee the authority to grant pre-approvals, provided such approvals are presented to the Audit Committee at

a subsequent meeting.

If the Audit Committee elects to establish pre-approval policies and procedures regarding non-audit services, the

Audit Committee must be informed of each non-audit service provided by our independent registered public accounting firm.

Audit Committee

pre-approval of audit and non-audit services will not be required if the engagement for the services is entered into pursuant to pre-approval

policies and procedures, provided the policies and procedures are detailed as to the particular service, the Audit Committee is informed

of each service provided and such policies and procedures do not include delegation of the Audit Committee’s responsibilities under

the Exchange Act to our management.

Audit Committee pre-approval of non-audit services (other than review and attestation services) also

will not be required if such services fall within available exceptions established by the SEC.

All services performed by our independent

registered public accounting firm during 2023 were pre-approved by the Audit Committee.

The information required

by this Item will be included in our Proxy Statement, which will be filed within 120 days after the close of the 2024 fiscal year, or

an amendment to this Annual Report, and is hereby incorporated by reference.

Security Ownership of Certain Beneficial Owners and Management

and Related Stockholders Matters

The information required

by this Item will be included in our Proxy Statement, which will be filed within 120 days after the close of the 2024 fiscal year, or

an amendment to this Annual Report, and is hereby incorporated by reference.

Certain Relationships and Related Transactions and Director

The information required

by this Item will be included in our Proxy Statement, which will be filed within 120 days after the close of the 2024 fiscal year, or

an amendment to this Annual Report, and is hereby incorporated by reference.

Principal Accountant Fees and Services

The information required

by this Item will be included in our Proxy Statement, which will be filed within 120 days after the close of the 2024 fiscal year, or

an amendment to this Annual Report, and is hereby incorporated by reference.

Exhibits, Financial Statement Schedules

Financial Statements .

The following consolidated financial statements of CorMedix Inc.

are filed as part of this Annual Report

on Form 10-K:

of Independent Registered Public Accounting Firm (PCAOB ID # 688)

The following

consolidated financial statements of CorMedix Inc.

are filed as part of this Annual Report on Form 10-K:

Report of Independent Registered Public Accounting Firm (PCAOB ID # 688)

Consolidated Balance Sheets as of December 31, 2024 and 2023

4 unchanged sentences

Financial Statement Schedules.

The Financial Statement Schedules have been omitted because of the absence of conditions under which they

are required or because the required information, where material, is shown in the financial statements or notes thereto.

The Financial

Statement Schedules have been omitted because of the absence of conditions under which they are required or because the required information,

where material, is shown in the financial statements or notes thereto.

Exhibit Index .

The following is a list of exhibits filed as part of this Annual Report on Form 10-K:

At-the-Market

Issuance Sales Agreement, dated August 12, 2021, by and among CorMedix Inc., Truist Securities, Inc.

The following is a list of exhibits filed

as part of this Annual Report on Form 10-K:

Exhibit Number

Description of Document

Registrant’s Form

Exhibit Number

Filed or Furnished Herewith

At-the-Market Issuance Sales Agreement, dated August 12, 2021, by and among CorMedix Inc., Truist Securities, Inc.

and JMP Securities LLC

Agreement, dated June 28, 2023, by and among CorMedix Inc., BC Capital Markets, LLC and Truist Securities, Inc.

of Amended and Restated Certificate of Incorporation

of Amendment to Amended and Restated Certificate of Incorporation, dated February 24, 2010

Amended and Restated Bylaws as amended October 8, 2020

of Amendment to Amended and Restated Certificate of Incorporation, dated December 3, 2012

of Amendment to Amended and Restated Certificate of Incorporation, dated August 9, 2017

of Amendment to Amended and Restated Certificate of Incorporation, dated March 25, 2019

and Restated Certificate of Designation of Series C-3 Non-Voting Convertible Preferred Stock of CorMedix Inc., filed with the Delaware

Secretary of State on September 15, 2014

Amended and Restated Certificate of Designation of Series E Convertible Preferred Stock of CorMedix Inc., filed with the Delaware

Secretary of State on September 5, 2019

of Designation of Series G Convertible Preferred Stock of CorMedix Inc., filed with the Delaware Secretary of State on September

of Common Stock Certificate

of Warrant issued on January 8, 2014.

of Series B Warrant to Purchase Common Stock of CorMedix Inc.

Form of Amended and Restated Certificate of Incorporation

Certificate of Amendment to Amended and Restated Certificate of Incorporation, dated February 24, 2010

Second Amended and Restated Bylaws as amended October 8, 2020

Certificate of Amendment to Amended and Restated Certificate of Incorporation, dated December 3, 2012

Certificate of Amendment to Amended and Restated Certificate of Incorporation, dated August 9, 2017

Certificate of Amendment to Amended and Restated Certificate of Incorporation, dated March 25, 2019

Amended and Restated Certificate of Designation of Series C-3 Non-Voting Convertible Preferred Stock of CorMedix Inc., filed with the Delaware Secretary of State on September 15, 2014

Description of Document

Second Amended and Restated Certificate of Designation of Series E Convertible Preferred Stock of CorMedix Inc., filed with the Delaware Secretary of State on September 5, 2019

Certificate of Designation of Series G Convertible Preferred Stock of CorMedix Inc., filed with the Delaware Secretary of State on September 5, 2019

Specimen of Common Stock Certificate

Form of Warrant issued on January 8, 2014.

Form of Series B Warrant to Purchase Common Stock of CorMedix Inc.

issued on May 3, 2017

of Underwriter’s Warrant to Purchase Common Stock of CorMedix Inc., issued May 3, 2017

Form of Underwriter’s Warrant to Purchase Common Stock of CorMedix Inc., issued May 3, 2017

Description of Capital Stock of CorMedix Inc.

4 unchanged sentences

and each of its directors and executive officers

Employment Agreement, dated and effective May 11, 2020, between CorMedix Inc.

Executive Employment Agreement, dated and effective May 11, 2020, between CorMedix Inc.

and Matthew David

Agreement, dated and effective October 26, 2021, between CorMedix Inc.

Letter Agreement, dated and effective October 26, 2021, between CorMedix Inc.

and Matthew David, M.D.

of Securities Purchase Agreement, dated November 17, 2017, between CorMedix Inc.

Form of Securities Purchase Agreement, dated November 17, 2017, between CorMedix Inc.

and the investors signatory thereto

Agreement, dated November 9, 2017, between CorMedix Inc.

Backstop Agreement, dated November 9, 2017, between CorMedix Inc.

and the investor named therein

of Registration Rights Agreement, dated November 9, 2017, by and between CorMedix Inc.

Form of Registration Rights Agreement, dated November 9, 2017, by and between CorMedix Inc.

and the investor named therein

Amendment No.

1, dated as of December 11, 2017, to Registration Rights Agreement, dated November 9, 2017, by and between CorMedix Inc.

the investor named therein

Employment Agreement, dated and effective March 10, 2021, between CorMedix Inc.

and the investor named therein

Executive Employment Agreement, dated and effective March 10, 2021, between CorMedix Inc.

and Elizabeth Hurlburt

Purchase Agreement, dated December 31, 2018, between CorMedix Inc.

Securities Purchase Agreement, dated December 31, 2018, between CorMedix Inc.

and the investor named therein

Agreement, dated as of March 19, 2019, between CorMedix Inc.

and Phoebe Mounts

Exchange Agreement, dated August 14, 2019, by and among CorMedix Inc.

and the Existing Security holders listed on the Schedule of

Holders thereto

and Restated Registration Rights Agreement, dated as of September 6, 2019, by and among CorMedix Inc.

and Manchester Securities Corp.,

and Elliot International, L.P.

Securities Exchange Agreement, dated August 14, 2019, by and among CorMedix Inc.

and the Existing Security holders listed on the Schedule of Holders thereto

Description of Document

Amended and Restated Registration Rights Agreement, dated as of September 6, 2019, by and among CorMedix Inc.

and Manchester Securities Corp., and Elliot International, L.P.

and Elliot Associates, L.P.

3 unchanged sentences

and Joseph Todisco.

Separation Agreement, effective December 14, 2023, between CorMedix Inc.

and Phoebe Mounts.

of Subsidiaries

Executive Employment Agreement, dated December 12, 2023, between CorMedix Inc.

and Beth Zelnick Kaufman.

Amendment No.

1 to the Amended and Restated CorMedix Inc.

2019 Omnibus Stock Incentive Plan

Insider Trading Policies and Procedures

List of Subsidiaries

Consent of Independent Registered Public Accounting Firm

5 unchanged sentences

Inline XBRL Instance Document

XBRL Taxonomy Extension Schema Document.

Inline XBRL Taxonomy Extension Schema Document.

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

2 unchanged sentences

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

Confidential treatment has been granted

for portions of this document.

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

Confidential treatment

has been granted for portions of this document.

The omitted portions of this document have been filed separately with the SEC.

Portions of the exhibit have been omitted

in reliance on Item 601(b)(10)(iv) of Regulation S-K.

These certifications are furnished.

Indicates management contract or compensation

Portions of the exhibit

have been omitted in reliance on Item 601(b)(10)(iv) of Regulation S-K.

These certifications are

Indicates management contract

or compensation plan.

Form 10-K Summary

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 thereunto duly authorized.

Not applicable.

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 thereunto

duly authorized.

CORMEDIX INC.

6 unchanged sentences

Matthew David

Chief Financial Officer

(Principal Financial and Accounting Officer)

to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the

Registrant and in the capacities and on the dates indicated:

/s/ Joseph Todisco

Chief Executive Officer and Director

Pursuant to the requirements

of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in

the capacities and on the dates indicated:

Chief Executive Officer

March 25, 2025

2 unchanged sentences

Matthew David

Executive Vice President and Chief Financial Officer

March 12, 2024

Vice President and Chief Financial Officer

Matthew David

(Principal Financial and Accounting Officer)

/s/ Myron Kaplan

Director and Chairman of the Board

(Principal Financial and

Accounting Officer)

Director and Chairman of

March 25, 2025

/s/ Janet Dillione

March 25, 2025

Janet Dillione

/s/ Gregory Duncan

March 25, 2025

2 unchanged sentences

March 25, 2025

/s/ Steven Lefkowitz

March 25, 2025

Steven Lefkowitz

Robert Stewart

March 25, 2025

Robert Stewart

CORMEDIX INC.

AND SUBSIDIARIES

Statements Index

FINANCIAL STATEMENTS

Financial Statements Index

Report of Independent Registered Public Accounting Firm (PCAOB ID # 688 ) F-2

1 unchanged sentence

Consolidated Statements of Operations and Comprehensive Income (Loss) Years Ended December 31, 2024 and 2023 F-4

Consolidated Statements of Changes in Stockholders’ Equity Years Ended December 31, 2023 and 2022

Consolidated Statements of Cash Flows Years Ended December 31, 2023 and 2022

Consolidated Statements of Changes in Stockholders’ Equity Years Ended December 31, 2024 and 2023 F-5

Consolidated Statements of Cash Flows Years Ended December 31, 2024 and 2023 F-6

Notes to Consolidated Financial Statements F-7

OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Sh areh olders

and Board of Directors of

on the Financial Statements

We have audited the accompanying

consolidated balance sheets of CorMedix Inc.

and Subsidiaries (the “Company”) as of December 31, 2023 and 2022, and the

related consolidated statements of operations and comprehensive income (loss), changes in stockholders’ equity and cash flows

for each of the two years in the period ended December 31, 2023, and the related notes (collectively referred to as the

“financial statements”).

In our opinion, the financial statements present fairly, in all material respects, the

financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of

the two years in the period ended December 31, 2023, in conformity with accounting principles generally accepted in the United

States of America.

financial statements are the responsibility of the Company’s management.

Our responsibility is to express an opinion on the Company’s

financial statements based on our audits.

We are a public accounting firm registered with the Public Company Accounting Oversight Board

(United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S.

securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB.

Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are

free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged to perform, an

audit of its internal control over financial reporting.

As part of our audits we are required to obtain an understanding of internal control

over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over

financial reporting.

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING

To the Shareholders and Board of Directors of

CorMedix Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated

balance sheets of CorMedix Inc.

(the “Company”) and Subsidiaries as of December 31, 2024 and 2023, the related consolidated

statements of operations and comprehensive income (loss), stockholders’ equity and cash flows for each of the two years in the period

ended December 31, 2024, and the related notes (collectively referred to as the “financial statements”).

In our opinion, based

on our audits, the financial statements present fairly, in all material respects, the financial position of the Company as of December

31, 2024 and 2023, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2024,

in conformity with accounting principles generally accepted in the United States of America.

Basis for Opinion

These financial statements are the responsibility

of the Company’s management.

Our responsibility is to express an opinion on the Company’s financial statements based on our audits.

are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are

required to be independent with respect to the Company in accordance with the U.S.

federal securities laws and the applicable rules and

regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the

standards of the PCAOB.

Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial

statements are free of material misstatement, whether due to error or fraud.

The Company is not required to have, nor were we engaged

to perform, an audit of its internal control over financial reporting.

As part of our audits we are required to obtain an understanding

of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal

control over financial reporting.

Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material

misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.

Such procedures

included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.

Our audits also included

evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation

of the financial statements.

Our audits included performing procedures to assess

the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond

to those risks.

Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.

Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating

the overall presentation of the financial statements.

We believe that our audits provide a reasonable basis for our opinion.

Audit Matters

audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be

communicated to the audit committee and that:

(1) relate to accounts or disclosures that are material to the financial statements and

(2) involved our especially challenging, subjective, or complex judgments.

We determined that there are no critical audit matters.

Critical Audit Matters

The critical audit matter communicated below is

a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the

audit committee and that:

(1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially

challenging, subjective, or complex judgments.

The communication of critical audit matters does not alter in any way our opinion on the

financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion

on the critical audit matter or on the accounts or disclosures to which it relates.

Variable Consideration:

Product Returns

Description of the

As discussed in Note

3 of the consolidated financial statements, the Company includes estimates of variable consideration in its transaction price at the

time control of the product transfers to the customer.

The variable consideration includes an estimate for future product returns.

Company permits returns for product that is within six months prior to or past the labeled expiration date.

The Company’s product

return accrual takes into consideration estimates of product held by its customers, the distribution channel, the shelf life of the product

held by customers, as well as when the product is eligible for return based on the contractual terms.

At December 31, 2024, the

Company had $0.7 million in accrued returns allowance.

Auditing the allowance

for sales returns was complex due to the significant estimation required in determining product held by customers and in the distribution

channel, as well as product that may not be sold to, or consumed by, the end user prior to the dates eligible for return under the contractual

The allowance for sales returns is sensitive to the level of product and turnover at the customer and in the distribution channel,

which could exceed future end user demand and be subject to return.

How We Addressed the

Matter in Our Audit

We obtained an understanding

and evaluated the design of the Company's controls over the estimation for sales returns.

In order to test the estimated sales return

reserve, we performed audit procedures that included, among others, reviewing sell-through information of the Company’s major customers.

We analyzed the estimated remaining inventory with selected customers and their distribution channel as compared to product sold to that

customer and forecasted sales to, or usage by, the end users giving consideration to the remaining shelf life of the product.

for direct sales to outpatient dialysis centers, we reviewed the Company’s sales made to certain customers individual dialysis

center locations by month during both the reporting period and through the financial statement issuance date to evidence follow on orders

and utilization by those individual dialysis centers.

We also performed direct management inquiries with Company sales and supply chain

department personnel, and reviewed key customer contract terms and their alignment with such reserve assumptions.

/s/ Marcum llp

We have served as the Company’s auditor

Morristown, New Jersey

March 25, 2025

And Subsidiaries

BALANCE SHEETS

31, 2023 and 2022

Current assets

and cash equivalents

research and development expenses

prepaid expenses and current assets

CONSOLIDATED BALANCE SHEETS

December 31, 2024 and 2023

Current assets

and equipment, net

cash, long term

lease right-of-use assets

AND STOCKHOLDERS’ EQUITY

lease liabilities, short-term

Cash and cash equivalents

Restricted cash

Short-term investments

Trade receivables, net

Prepaid research and development expenses

Other prepaid expenses and current assets

Total current assets

Property and equipment, net

License intangible asset, net

Restricted cash, long term

Operating lease right-of-use assets

$ 118,845,673

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities

lease liabilities, net of current portion

AND CONTINGENCIES (Note 6)

STOCKHOLDERS’

Accounts payable

Accrued expenses

Operating lease liabilities, short-term

Total current liabilities

Operating lease liabilities, net of current portion

TOTAL LIABILITIES

COMMITMENTS AND CONTINGENCIES (Note 7)

STOCKHOLDERS’ EQUITY

Preferred stock - $ 0.001 par value:

2,000,000 shares authorized;

181,622 shares issued and outstanding at December 31, 2023 and 2022

136,623 and 181,622 shares issued and outstanding at December 31, 2024 and 2023, respectively

Common stock - $ 0.001 par value:

160,000,000 shares authorized at December

31, 2023 and 2022;

160,000,000 shares authorized at December 31, 2024 and 2023;

64,411,295 and 54,938,258 shares issued and outstanding at December 31, 2024 and 2023, respectively

other comprehensive gain

paid-in capital

Accumulated other comprehensive gain

Additional paid-in capital

Accumulated deficit

( 339,630,033 )

( 321,700,013 )

STOCKHOLDERS’ EQUITY

LIABILITIES AND STOCKHOLDERS’ EQUITY

accompanying notes are integral part of these consolidated financial statements.

TOTAL STOCKHOLDERS’ EQUITY

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$ 118,845,673

The accompanying notes are integral part of these

consolidated financial statements.

and Subsidiaries

STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

Ended December 31, 2023 and 2022

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE

INCOME (LOSS)

Years Ended December 31, 2024 and 2023

Cost of sales

( 3,190,534 )

Operating Expenses:

2 unchanged sentences

( 13,155,125 )

Selling, general and administrative

Selling and marketing

( 28,736,605 )

( 18,115,313 )

General and administrative

( 29,959,150 )

( 17,687,350 )

Total operating expenses

6 unchanged sentences

Interest income

Foreign exchange transaction (loss) income

Foreign exchange transaction loss

Interest expense

6 unchanged sentences

Other Comprehensive Income (Loss):

Unrealized gain from investments

Foreign currency translation gain (loss)

Unrealized (loss) gain from investments

Foreign currency translation gain

Total other comprehensive gain (loss)

4 unchanged sentences

Weighted Average Common Shares Outstanding – Basic and Diluted

accompanying notes are integral part of these consolidated financial statements.

The accompanying notes are integral part of these

consolidated financial statements.

CORMEDIX INC.

AND SUBSIDIARY

STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIENCY)

Ended December 31, 2023 and 2022

Stock – Series C-3, Series E, Series F and Series G

Other Comprehen-sive

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’

Years Ended December 31, 2024 and 2023

Series F and Series G

Comprehen-sive

Stockholders’

at December 31, 2021

Balance at December 31, 2022

$ 330,294,782

$ ( 275,360,786 )

issued in connection with ATM sale of common stock, net

issued in connection with warrants exercised, cash

comprehensive loss

Stock issued in connection with ATM sale of common stock, net

Stock and pre-funded warrants issued in connection with public offering, net

Stock issued in connection with options exercised

Issuance of vested restricted stock, net of shares withheld for employee withholding taxes

Stock-based compensation

Other comprehensive gain

( 46,339,227 )

at December 31, 2022

Balance at December 31, 2023

$ 391,693,214

$ ( 321,700,013 )

issued in connection with ATM sale of common stock, net

and pre-funded warrants issued in connection with public offering, net

issued in connection with options exercised

of vested restricted stock, net of shares withheld for employee withholding taxes

comprehensive loss

at December 31, 2023

Stock issued in connection with ATM sale of common stock, net

Stock issued in connection with the exercise of pre-funded warrants

Stock issued in connection with options exercised

Conversion of Series G preferred stock to common stock

Issuance of vested restricted stock, net of shares withheld for employee withholding taxes

Cancelation of shares held in escrow

Stock-based compensation

Other comprehensive loss

( 17,930,020 )

accompanying notes are integral part of these consolidated financial statements.

Balance at December 31, 2024

$ 424,131,789

$ ( 339,630,033 )

The accompanying notes are integral part of these

consolidated financial statements.

CORMEDIX INC.

AND SUBSIDIARIES

STATEMENTS OF CASH FLOWS

Ended December 31, 2023 and 2022

FLOWS FROM OPERATING ACTIVITIES:

CONSOLIDATED STATEMENTS OF CASH FLOWS

Years Ended December 31, 2024 and 2023

CASH FLOWS FROM OPERATING ACTIVITIES:

$ ( 17,930,020 )

$ ( 46,339,227 )

to reconcile net loss to net cash used in operating activities:

in right-of-use assets

in operating assets and liabilities:

Adjustments to reconcile net loss to net cash used in operating activities:

Provision for current expected credit losses

Stock-based compensation

Change in right-of-use assets

Amortization of intangible

Changes in operating assets and liabilities:

Increase in trade receivables

Decrease in inventory

( 51,790,583 )

Decrease in prepaid expenses and other current assets

(Decrease) in accounts payable

in accrued expenses

in operating lease liabilities

cash used in operating activities

Increase in inventory

( 5,493,190 )

( 2,106,345 )

FLOWS FROM INVESTING ACTIVITIES:

of short-term investments

Increase in prepaid expenses and other current assets

( 2,399,221 )

(Decrease) Increase in accounts payable

( 2,559,491 )

of short-term investments

cash used in investing activities

Increase in accrued expenses

Decrease in operating lease liabilities

Net cash used in operating activities

( 50,614,653 )

( 38,409,480 )

FLOWS FROM FINANCING ACTIVITIES:

from sale of common stock from at-the-market program, net

from public offering of common stock and pre-funded warrants, net

of employee withholding taxes on vested restricted stock units

Proceeds from exercise

from exercise of stock options

cash provided by financing activities

exchange effects on cash

INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

CASH FLOWS FROM INVESTING ACTIVITIES:

Purchase of short-term investments

( 26,769,749 )

AND CASH EQUIVALENTS AND RESTRICTED CASH – BEGINNING OF YEAR

AND CASH EQUIVALENTS AND RESTRICTED CASH – END OF YEAR

paid for interest

Disclosure of Non-Cash and Investing Activities:

gain (loss) from investments

accompanying notes are integral part of these consolidated financial statements.

1 — Organization, Business and Basis of Presentation:

and Business:

(“CorMedix” or the “Company”) was incorporated in the State of Delaware on July 28, 2006 .

The Company is

a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious

and inflammatory diseases.

Company’s primary focus is on the commercialization of our lead product, DefenCath ® in the United States.

in-licensed the worldwide rights to develop and commercialize DefenCath.

( 77,084,385 )

Maturity of short-term investments

Purchase of equipment

Net cash provided by (used in) investing activities

( 17,061,685 )

CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from sale of common stock from at-the-market program, net

Proceeds from public offering of common stock and pre-funded warrants, net

Payment of employee withholding taxes on vested restricted stock units

Proceeds from exercise of pre-funded warrants

Proceeds from exercise of stock options

Net cash provided by financing activities

Foreign exchange effects on cash

NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS

( 3,067,054 )

CASH AND CASH EQUIVALENTS AND RESTRICTED CASH – BEGINNING OF YEAR

CASH AND CASH EQUIVALENTS AND RESTRICTED CASH – END OF YEAR

Cash paid for interest

Supplemental Disclosure of Non-Cash and Investing Activities:

Liability related to license agreement

Unrealized (loss) gain from investments

The accompanying notes are integral part of these

consolidated financial statements.

CORMEDIX INC.

AND SUBSIDIARIES

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

Note 1 — Organization and Description of Business:

Organization and Business:

CorMedix Inc.

(collectively,

with our wholly owned subsidiaries, referred to herein as “we,” “us,” “our” or the “Company”)

is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions.

Our primary focus is commercializing

our lead product, DefenCath® (taurolidine and heparin), in the U.S.

The name DefenCath is the U.S.

proprietary name approved by

Food and Drug Administration, or FDA.

is an antimicrobial solution (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicated to reduce the incidence

of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through

a central venous catheter (CVC).

It is indicated for use in a limited and specific population of patients.

CRBSI can lead to treatment

delays and increased costs to the healthcare system when they occur due to hospitalizations, need for IV antibiotic treatment, long-term

anticoagulation therapy, removal/replacement of the CVC, related treatment costs, as well as increased mortality.

We believe DefenCath

can address a significant unmet medical need.

On January 30, 2008, we entered

into a License and Assignment Agreement, or the ND License Agreement, with ND Partners LLC, or NDP.

Pursuant to the ND License Agreement,

NDP granted us exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting

infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications

(the “NDP Technology”).

NDP also granted us exclusive licenses, with the right to grant sublicenses, to use and display certain

trademarks in connection with the NDP Technology.

As consideration in part for the rights to the NDP Technology, we paid NDP an initial

licensing fee of $ 325,000 and granted NDP an equity interest in our Company consisting of 73,107 shares of common stock as of December

In addition, we are required to make cash payments to NDP upon the achievement of certain milestones.

The maximum aggregate

amount of cash payments upon achievement of milestones is $ 3,000,000 , with $ 2,000,000 remaining at December 31, 2023.

On November 15, 2023, we announced

that the FDA approved the NDA for DefenCath to reduce the incidence of CRBSI in adult patients with kidney failure receiving chronic hemodialysis

through a CVC.

DefenCath is indicated for use in a limited and specific population of patients.

DefenCath is the first and only FDA-approved

antimicrobial CLS in the U.S.

and was shown to reduce the risk of CRBSI by up to 71 % in a Phase 3 clinical study.

As a result of

the November 2023 FDA approval, we are currently preparing for the commercial launch of DefenCath.

DefenCath is listed in the

Orange Book as having NCE exclusivity (5 years) expiring on November 15, 2028, and the Generating Antibiotic Incentives Now or GAIN exclusivity

extension of the NCE exclusivity (an additional 5 years) expiring on November 15, 2033.

The GAIN exclusivity extension of 5 years is the

result of the January 2015 designation of DefenCath as a Qualified Infectious Disease Product (“QIDP”).

We announced on April 26,

2023 that following the submission of a duplicate New Technology Add-On Payment (“NTAP”) application in the fourth quarter

of 2022 to CMS, CMS has subsequently issued the Inpatient Prospective Payment System (“IPPS”) 2024 proposed rule that includes

a NTAP of up to $ 17,111 per hospital stay for DefenCath.

This NTAP represents reimbursement to inpatient facilities of 75 % of the anticipated

wholesaler acquisition cost price of $ 1,170 per 3 mL vial, and an average utilization of 19.5 vials per hospital stay.

The final IPPS

rule was published in early August 2023 and confirmed this payment amount in that final rule.

This NTAP was conditioned upon the DefenCath

NDA obtaining final FDA approval prior to July 1, 2024.

As the NTAP was calculated by CMS based upon an anticipated WAC price of $ 1,170 ,

and following FDA approval of the DefenCath NDA, an actual WAC of $ 249.99 per 3ml vial was established, we anticipate that CMS will revise

the amount of the NTAP payment to reflect the actual WAC price in the next IPPS rulemaking, effective October 1, 2024.

Upon the listing

in the compendia of the actual WAC price of $ 249.99 per 3ml vial, the Company notified CMS of the new lower WAC pricing and recommended

that CMS make an off-cycle adjustment to the NTAP to reflect the current lower WAC pricing amount.

CMS subsequently communicated to the

Company that they do not intend to update the NTAP reimbursement amount until the next review cycle in October 2024.

On January 25, 2024, CMS determined

that DefenCath should be classified as a renal dialysis service that is subject to the Medicare end-stage renal disease prospective payment

system (“ESRD PPS”).

The ESRD PPS provides bundled payment for renal dialysis services, but also affords a transitional drug

add-on payment adjustment, or TDAPA, which provides temporary, additional payments for certain new drugs and biologicals.

an application for TDAPA on January 26, 2024, and CMS has confirmed receipt.

We also submitted a HCPCS application for a J-code to CMS

on December 8, 2023, for DefenCath, which is relevant to billing and the TDAPA application.

CMS has confirmed the coding application is

under review.

TDAPA reimbursement is calculated based on 100 percent ASP (or 100 percent of wholesale acquisition price or else manufacturers’

list price, respectively, if such data is unavailable).

If CMS grants TDAPA and post-TDAPA add-on payment adjustments for DefenCath, collective

payments would be for five years (with such add-on payments applying to all ESRD PPS payments for years three through five).

CMS confirmed

to the Company that, assuming a favorable review, CMS is working towards a July 1, 2024 implementation date for TDAPA.

We may pursue additional indications

for DefenCath use as a CLS in populations with unmet medical needs that may also represent potentially significant market opportunities.

While we are continuing to assess these areas, potential future indications may include use as a CLS to reduce CRBSIs in total parenteral

nutrition patients using a central venous catheter and in certain oncology patients using a central venous catheter.

In 2024, the company

anticipates discussing with the FDA potential pathways for expanded indications.

We currently have one FDA

approved source for each of our two key APIs for DefenCath, taurolidine and heparin sodium, respectively.

With regards to taurolidine,

we have a DMF filed with the FDA.

There is a master commercial supply agreement between a third-party manufacturer and us in place from

We are currently in the process of identifying and qualifying an alternate third-party manufacturer for taurolidine under

our existing DMF.

With respect to heparin sodium API, we have identified an alternate third party supplier and intend to qualify such

supplier under the DefenCath NDA over the next twelve months.

We received FDA approval of

DefenCath with finished dosage production from our European based CMO Rovi Pharma Industrial Services.

We believe this CMO has adequate

capacity to produce the volumes needed to meet near term projected demand for the commercial launch of DefenCath.

We previously announced commercial

arrangements with additional finished dosage CMOs, Alcami Corporation and Siegfried Hameln, that provide for the manufacture of commercial

sterile parenteral drug products.

The Company anticipates the submission to the FDA of a supplement adding Siegfreid Hameln as an alternate

manufacturing site in the second fiscal quarter of 2024.

The Company will also discontinue its relationship with Alcami as a potential

alternate manufacturing site for DefenCath.

We announced on May 1, 2023

that the USPTO allowed our patent application directed to a locking solution composition for treating and reducing infection and flow

reduction in central venous catheters.

This application was granted on August 29, 2023 as U.S.

Patent reflects the unique and proprietary formulation of our product, DefenCath, for which we received FDA approval on November

This patent supplements the coverage of our existing licensed U.S.

7,696,182, and has the potential to provide an

additional layer of patent protection for DefenCath through 2042.

As part of the DefenCath approval

letter, the FDA communicated the existence of a required pediatric assessment under the Pediatric Research Equity Act, or PREA.

PREA requires

sponsors to conduct pediatric studies for, among other things, NDAs for a new active ingredient, such as taurolidine in DefenCath, unless

a waiver or deferral is obtained from the FDA.

A deferral acknowledges that a pediatric assessment is required but permits the applicant

to submit the pediatric assessment after the submission of an NDA.

FDA deferred submission of the pediatric study for DefenCath because

the product is ready for approval for use in adults and the pediatric study has not been completed.

We are obligated to conduct the study

communicated in the approval letter:

an open-label, two-arm (DefenCath vs.

standard of care) study to assess safety and time to CRBSI

in subjects from birth to less than 18 years of age with kidney failure receiving hemodialysis via a central venous catheter.

this is a required post-marketing study, we must make annual reports to the FDA.

Pediatric studies for an approved product conducted under

PREA may qualify for pediatric exclusivity, which, if granted, provides an additional six months of exclusivity that attaches to the end

of existing marketing exclusivity and patent periods for DefenCath.

Depending on the timing of final report submission, DefenCath could

potentially receive a total marketing exclusivity period of 10.5 years.

However, there are factors that could affect whether this exclusivity

is received or the duration of exclusivity, and DefenCath may or may not ultimately be eligible for the additional 0.5 years of exclusivity

associated with this pediatric study.

Neutrolin was previously sold

in the EU and other territories where we received CE-Mark approval for the commercial distribution of Neutrolin as a CLS.

has elected to discontinue sales of Neutrolin for lack of commercial viability.

The winding down of our operations in the EU is nearly

complete and Neutrolin sales in both the EU and the Middle East have been discontinued since 2022.

addition to DefenCath, we have sponsored a pre-clinical research collaboration for the use of taurolidine as a possible treatment for

rare pediatric tumors.

In February 2018, the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma in

We may seek one or more strategic partners or other sources of capital to help us develop and commercialize taurolidine for

the treatment of neuroblastoma in children.

2 — Liquidity and Uncertainties:

The consolidated financial statements have been

prepared in conformity with generally accepted accounting principles which contemplate continuation of the Company as a going concern.

proprietary name approved by the

Food and Drug Administration (“FDA”).

CorMedix launched the product commercially in April 2024 in the inpatient setting

and July 2024 in the outpatient hemodialysis setting.

DefenCath is an FDA approved

antimicrobial catheter lock solution (“CLS”) (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) indicated

to reduce the incidence of catheter-related bloodstream infections (“CRBSI”) in adult patients with kidney failure receiving

chronic hemodialysis through a central venous catheter (“CVC”).

It is indicated for use in a limited and specific population

CRBSIs can lead to treatment delays and increased costs to the healthcare system when they occur due to hospitalizations,

need for IV antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, related treatment costs, as well

as increased mortality.

We believe DefenCath can address a significant unmet medical need.

On November 15, 2023, we announced that the FDA approved the new drug

application (“NDA”) for DefenCath to reduce the incidence of CRBSI in adult patients with kidney failure receiving chronic

hemodialysis through a CVC.

DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S.

and was shown to reduce the risk

of CRBSI by up to 71 % in a Phase 3 clinical study.

As a result of the November 2023 FDA approval, CorMedix launched the product commercially

in April 2024 in the inpatient setting and July 2024 in the outpatient hemodialysis setting.

Note 2 — Liquidity and Uncertainties:

The consolidated financial

statements have been prepared in conformity with generally accepted accounting principles which contemplate continuation of the Company

as a going concern.

To date, the Company’s commercial operations have not generated sufficient revenues to enable profitability.

As of December 31,

2023, the Company had an accumulated deficit of $ 321.7 million, and incurred net losses of $ 46.3 million and $ 29.7 million for the years

ended December 31, 2023 and 2022, respectively.

Based on the Company’s current development plans for DefenCath and its other operating

requirements, the Company’s existing cash and cash equivalents and short-term investments at December 31, 2023 are expected to fund

its operations for at least twelve months from the issuance of this Annual Report on Form 10-K.

Company may raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships,

potential strategic transactions and/or out-licensing.

Management can provide no assurances that such financing or strategic relationships

will be available on acceptable terms, or at all.

As of December 31, 2023, the Company has $ 104.4 million available under its current

shelf registration for the issuance of equity, debt or equity-linked securities (see Note 7).

Company’s operations are subject to a number of other factors that can affect its operating results and financial condition.

factors include, but are not limited to:

the results of clinical testing and trial activities of the Company’s product candidates;

the ability to market the Company’s products;

The Company’s current commercial and development expenses for DefenCath and its other operating requirements are expected to be

funded for at least twelve months from the issuance of these financial statements by the Company’s existing cash, cash equivalents

and short-term investments at December 31, 2024 as well as the additional expected liquidity from commercial operations.

The Company’s operations are subject to a number of other factors

that can affect its operating results and cash flow projections over the next twelve months from the issuance of these financial statements.

Such factors include, but are not limited to:

the ability to market DefenCath and generate necessary revenue in the time periods required;

ability to manufacture successfully;

competition from products manufactured and sold

or being developed by other companies;

the price of, and demand for, Company products;

the Company’s ability to negotiate favorable

licensing or other manufacturing and marketing agreements for its products;

and the Company’s ability to raise capital to support

its operations.

3 — Summary of Significant Accounting Policies:

The preparation of financial statements in conformity with accounting

principles generally accepted in the United States of America (“GAAP”) requires

management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets

and liabilities at the date of the financial statements and reported amounts of revenue and expenses during the reporting period.

results could differ from those estimates.

of Consolidation

consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries.

All significant intercompany

accounts and transactions have been eliminated in consolidation.

instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and

short-term investments.

competition from products manufactured and sold or being developed by other companies;

of, and demand for, Company products;

and the Company’s ability to negotiate favorable licensing or other manufacturing and marketing

agreements for its products.

As such, the Company may be required to raise additional capital through various potential sources, such

as equity and/or debt financing, strategic relationships, potential strategic transactions and/or out-licensing.

Management can provide

no assurances that such financing or strategic relationships will be available on acceptable terms, or at all.

As of December 31, 2024,

approximately $ 30,216,000 of the Company’s common stock remains available for sale under the 2024 ATM program, with $ 100,000,000

of remaining capacity under the 2024 Shelf Registration Statement for the issuance of Company securities (see Note 8).

Note 3 — Summary of Significant Accounting Policies:

Use of Estimates

The preparation of financial statements in conformity with U.S.

requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes.

The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under

the circumstances.

The amounts of assets and liabilities and disclosure of contingent assets and liabilities in the Company’s consolidated

balance sheets and the reported amounts of revenue and expenses reported for each of the periods presented are affected by estimates and

The more significant areas in which estimates and the exercise of judgment relate include;

variable consideration for product

returns, realization of receivables, valuation of inventory, share-based payment grant date valuation, deferred tax asset valuation changes

and contingent liability recognition and disclosures.

Estimates are based on historical experience and other assumptions that are considered

appropriate in the circumstances.

They are continuously reviewed but may vary from the actual values.

Reclassifications

Certain reclassifications

were made to the prior year’s amounts to conform to the 2024 presentation.

Basis of Consolidation

The consolidated financial

statements include the accounts of the Company and its wholly owned subsidiaries.

All significant intercompany accounts and transactions

have been eliminated in consolidation.

Trade Accounts Receivable and Allowances

The Company recognizes an

allowance that reflects a current estimate of credit losses expected to be incurred over the life of a financial asset, including trade

The allowance for credit losses reflects the best estimate of expected credit losses of the accounts receivable portfolio

determined on the basis of current information, forecasts of future economic conditions, industry knowledge and to some extent our historical

The Company determines its allowance methodology by pooling receivable balances at the customer level.

The Company considers

various factors, including individual credit risk associated with each customer, the current and future condition of the general economy

and industry knowledge.

These credit risk factors are monitored on a quarterly basis and updated as necessary.

To the extent any individual

debtor is identified whose credit quality has deteriorated, the Company establishes allowances based on the individual risk characteristics

of such customer.

The Company makes concerted efforts to collect all outstanding balances due, however account balances are charged off

against the allowance when management believes it is probable the receivable will not be recovered.

The Company does not have any off-balance

sheet credit exposure related to its customers.

Allowances recorded for credit losses as of December 31, 2024 were approximately $ 0.1

million, there were no write-offs or recoveries during the year ended December, 31, 2024.

Concentrations

The major customers of the

Company are defined as those constituting greater than 10% of its total revenue.

For the year ended December 31, 2024, the Company had

sales to one customer that accounted for 86 % of its total revenue of $ 43,472,000 .

For the year ended December 31, 2024, the Company had

two customers that accounted for 87 % and 12 % of the accounts receivable, respectively.

The Company currently has

one FDA approved source for each of our two key active pharmaceutical ingredients (“APIs”) for DefenCath, taurolidine and

heparin sodium, respectively.

With regards to taurolidine, the Company has a drug master file (“DMF”) filed with the FDA.

There is a master commercial supply agreement between a third-party manufacturer which has been in place since August 2018.

the Company is working with its existing manufacture to source sufficient quantities of taurolidine API to cover at least 24 months of

potential future demand.

With respect to heparin sodium API, the Company has identified an alternate third-party supplier and may qualify

such supplier under the DefenCath NDA over the next twelve months.

The Company received FDA

approval of DefenCath with finished dosage production from its European based contract manufacturing organization (“CMO”)

Rovi Pharma Industrial Services.

The Company believes this CMO has adequate capacity to produce the volumes needed to meet near-term

projected demand for the commercial launch of DefenCath.

The Company also qualified Siegfried Hameln as an alternate finished dosage

manufacturing site.

Financial Instruments

Financial instruments that

potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short-term investments

and accounts receivable.

The Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts, the

balances of which, at times, may exceed federally insured limits.

following table is the reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation

and disclosure of financial instruments as shown on the Company’s consolidated statement of cash flows:

balances of which, , may exceed federally insured limits.

The following table is the

reconciliation of the accounting standard that modifies certain aspects of the recognition, measurement, presentation and disclosure

of financial instruments as shown on the Company’s consolidated statement of cash flows:

Cash and cash equivalents

Restricted cash, short-term

and long-term

Total cash, cash equivalents

and restricted cash

appropriate classification of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date.

Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value.

Fair value is determined

using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or

other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Changes in fair value that are considered temporary are reported net of tax in other comprehensive income (loss).

Realized gains and

losses, amortization of premiums and discounts and interest and dividends earned are included in income (expense).

For declines in the

fair value of equity securities that are considered other-than-temporary, impairment losses are charged to other (income) expense, net.

The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to

which fair value is less than cost.

There were no deemed permanent impairments at December 31, 2023 or 2022.

Company’s marketable securities are highly liquid and consist of U.S.

government agency securities, high-grade corporate obligations

and commercial paper with original maturities of more than 90 days.

As of December 31, 2023 and 2022, all of the Company’s investments

had contractual maturities which were less than one year.

The following table summarizes the amortized cost, unrealized gains and losses

and the fair value at December 31, 2023 and 2022 :

Market Funds and Cash Equivalents

Restricted cash, short-term and long-term

Total cash, cash equivalents and restricted cash

The appropriate classification

of marketable securities is determined at the time of purchase and reevaluated as of each balance sheet date.

Investments in marketable

debt, classified as available-for-sale, are reported at fair value.

Fair value is determined using quoted market prices in active markets

for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be

corroborated by observable market data for substantially the full term of the assets or liabilities.

Changes in fair value that are considered

temporary are reported in other comprehensive income.

Realized gains and losses, amortization of premiums and discounts and interest

and dividends earned are included in other income (expense).

The Company considers available evidence in evaluating potential impairments

of its investments, including the duration and extent to which fair value is less than cost.

There were no deemed permanent impairments

at December 31, 2024 or December 31, 2023.

The Company’s marketable

securities are highly liquid and consist of U.S.

government agency securities, high-grade corporate obligations and commercial paper

with original maturities of more than 90 days.

As of December 31, 2024 and 2023, all of the Company’s investments had contractual

maturities which were less than one year.

The following table summarizes the amortized cost, unrealized gains and losses and the fair

value at December 31, 2024 and 2023:

December 31, 2024:

Market Funds and Cash Equivalents

Corporate Securities

Money Market Funds and Cash Equivalents

Government Agency Securities

Total December 31, 2024

December 31, 2023:

Value Measurements

Company’s financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable,

investment securities, accounts payable and accrued expenses.

The carrying value of certain financial instruments, primarily cash

and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon

the short-term nature of their maturity dates.

Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques

used to measure fair value, which is set out below.

The fair value hierarchy gives the highest priority to quoted prices in active markets

for identical assets (Level 1) and the lowest priority to unobservable inputs (Level 3).

If the inputs used to measure fair value fall

within different levels of the hierarchy, the category level is based on the lowest priority level input that is significant to the fair

value measurement of the instrument.

Money Market Funds and Cash Equivalents

Government Agency Securities

Commercial Paper

Total December 31, 2023

Fair Value Measurements

In accordance with Accounting

Standards Codification (“ASC”) 825, Financial Instruments, disclosures of fair value information about financial instruments

is required, whether or not recognized in the consolidated balance sheet, for which it is practicable to estimate that value.

The Company’s

financial instruments recorded in the consolidated balance sheets include cash and cash equivalents, accounts receivable, investment

securities and accounts payable.

The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts

receivable and accounts payable approximate their estimated fair values based upon the short-term nature of their maturity dates.

The Company categorizes its

financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair

The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets (Level 1) and the

lowest priority to unobservable inputs (Level 3).

If the inputs used to measure fair value fall within different levels of the hierarchy,

the category level is based on the lowest priority level input that is significant to the fair value measurement of the instrument.

assets recorded at fair value on the Company’s consolidated balance sheets are categorized as follows:

inputs—Observable

inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active

Significant other observable inputs (e.g., quoted prices for similar items in active markets,

quoted prices for identical or similar items in markets that are not active, inputs other

than quoted prices that are observable such as interest rate and yield curves, and market-corroborated

inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.

inputs— Significant

other observable inputs (e.g., quoted prices for similar items in active markets, quoted prices for identical or similar items in

markets that are not active, inputs other than quoted prices that are observable such as interest rate and yield curves, and market-corroborated

inputs—Unobservable

inputs for the asset or liability, which are supported by little or no market activity and

are valued based on management’s estimates of assumptions that market participants

would use in pricing the asset or liability.

following table provides the carrying value and fair value of the Company’s financial assets measured at fair value as of December

31, 2023 and 2022:

inputs for the asset or liability, which are supported by little or no market activity and are valued based on management’s

estimates of assumptions that market participants would use in pricing the asset or liability.

The following table provides

the carrying value and fair value of the Company’s financial assets measured at fair value as of December 31, 2024 and 2023:

December 31, 2024:

Carrying Value

Funds and Cash Equivalents

Government Agency

Commercial Paper

Money Market Funds and Cash Equivalents

Government Agency Securities

Total December 31, 2024

December 31, 2023:

Money Market Funds and

Cash Equivalents

Government Agency

Corporate Securities

Money Market Funds and Cash Equivalents

Government Agency Securities

Commercial Paper

December 31, 2022

Currency Translation and Transactions

consolidated financial statements are presented in U.S.

Total December 31, 2023

Foreign Currency Translation and Transactions

The consolidated financial

statements are presented in U.S.

Dollars (USD), the reporting currency of the Company.

For the financial statements

of the Company’s foreign subsidiaries, whose functional currency is the EURO, foreign currency asset and liability amounts, if

any, are translated into USD at end-of-period exchange rates.

Foreign currency income and expenses are translated at average exchange

rates in effect during the year.

For the financial statements of the Company’s

foreign subsidiaries, whose functional currency is the EURO, foreign currency asset and liability amounts, if any, are translated into

USD at end-of-period exchange rates.

Foreign currency income and expenses are translated at average exchange rates in effect during the

Translation gains and losses are included in other comprehensive income (loss).

The Company had a foreign

currency translation gain of $ 1,682 and a loss of $ 9,442 for the year ended December 31, 2023 and 2022, respectively.

currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional

currency of the entity recording the transaction.

As of December 31, 2023, and 2022 the Company has restricted cash in

connection with the patent and utility model infringement proceedings against TauroPharm (see Note 6).

The Company had a foreign currency translation

gain of $ 1,368 and $ 1,682 for the years ended December 31, 2024 and 2023, respectively.

Foreign currency exchange

transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than the functional currency of the

entity recording the transaction.

Restricted Cash

The Company was required

3 unchanged sentences

the unfair competition proceedings in Cologne.

During the year ended December 31, 2023, approximately a total of $ 47,000 was released

by the court for the reimbursement of legal fees and other costs which was removed from restricted cash.

As of December 31, 2023, the Company had restricted cash in connection with the patent

and utility model infringement proceedings against TauroPharm in the amount of approximately $ 77,000 , which was refunded to the Company

during the year ended December 31, 2024.

As of December 31, 2024 and

restricted cash in connection with the patent and utility model infringement proceedings were approximately

$ 77,000 and approximately $ 124,000 , respectively.

As of December 31, 2023 and 2022, the Company had $ 103,000 in long-term

restricted cash for a lease security deposit.

Research and Development and Other Prepaid Expenses

expenses consist of payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing,

pre-clinical development and insurance policies.

These advanced payments are amortized to expense either as services are performed or

over the relevant service period using the straight-line method.

The Company engages third parties to manufacture and package inventory

held for sale and warehouse such goods until packaged for final distribution and sale.

Costs related to the manufacturing of the product

incurred prior to FDA approval in order to support the preparation for commercial launch of its product were expensed as R&D as incurred.

Upon FDA approval, costs related to the manufacturing of inventory are stated at the lower of cost or net realizable value with cost determined

on a first-in, first-out basis.

Inventories previously expensed as R&D prior to FDA approval amounted to $ 6,407,266 .

consist of raw materials (including labeling and packaging), work-in-process, and finished goods, if any, for the DefenCath product.

Inventories consist of the following:

2023, the Company had $ 105,000 and $ 103,000 , respectively in long-term restricted cash for a lease security deposit.

Prepaid Research and Development and Other

Prepaid Expenses

Prepaid expenses consist

of payments made in advance to vendors relating to service contracts for clinical trial development, manufacturing, pre-clinical development

and insurance policies.

These advanced payments are amortized to expense either as services are performed or over the relevant service

period using the straight-line method.

The Company engages third

parties to manufacture and package inventory held for sale and warehouse such goods until packaged for final distribution and sale.

related to the manufacturing of DefenCath incurred prior to FDA approval to support the preparation for commercial launch of its product

were expensed as research and development expenses (R&D) as incurred.

Upon FDA approval, costs related to the manufacturing of inventory

are stated at the lower of cost or net realizable value with cost determined on a first-in, first-out basis.

Inventory is valued utilizing

the standard cost method, which approximates costs determined on the first-in first-out basis.

The Company regularly reviews inventory

quantities on hand and writes down to its net realizable value any inventory that it believes to be impaired.

Management considers forecast

demand in relation to the inventory on hand, competitiveness of product offering and sales volume assumptions, market conditions and

product life cycle and expiration dating when determining net realizable value adjustments.

Once inventory is written down and a new

cost basis is established, it is not written back up if demand increases.

The Company has not experienced any write-downs for any items

listed above during 2023 or 2024.

Inventories consist of raw

materials (including labeling and packaging), work-in-process, and finished goods, if any, for the DefenCath product.

Inventories consist

of the following:

Raw materials

Work in progress

and Equipment

and equipment consist primarily of furnishings, fixtures, leasehold improvements, office equipment and computer equipment all of

which are recorded at cost.

Depreciation is provided for by the straight-line method over the estimated useful lives of the related

Leasehold improvements are amortized using the straight-line method over the remaining lease term or the life of

the asset, whichever is shorter.

Property and equipment, as of December 31, 2023 and 2022 were $ 1,866,224 and $ 1,609,679 ,

respectively, net of accumulated depreciation of $ 520,542 and $ 449,787 , respectively.

Depreciation and amortization of property and

equipment is included in selling, general and administrative expenses.

Office equipment and furniture

Leasehold improvements

7 years or remaining

term of the lease

Computer equipment

Computer software

Company determines if an arrangement is a lease at inception.

Operating leases are included in operating lease right-of-use (“ROU”)

assets, current portion of operating lease liabilities (included in accrued expenses), and operating lease liabilities, net of current

portion, on the consolidated balance sheet (see Note 8).

lease ROU assets and operating lease liabilities are recognized based on the present value of the future minimum lease payments over

the lease term at commencement date.

As the Company’s leases do not provide an implicit rate, the Company uses its incremental

borrowing rate based on the information available at commencement date in determining the present value of future payments.

The Company’s

lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option.

Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.

Company has elected, as an accounting policy, not to apply the recognition requirements in ASC 842 to short-term leases.

Short-term leases

are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that the

Company is reasonably certain to exercise.

The Company recognizes the lease payments for short-term leases on a straight-line basis

over the lease term.

Company has also elected, as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components

and, instead, account for them as a single component.

Company uses Accounting Standards Codification (“ASC”) 606, “ Revenue from Contracts with Customers,” issued

by the Financial Accounting Standards Board (“FASB”), that prescribes a five-step model for recognizing revenue which includes

(i) identifying contracts with customers;

(ii) identifying performance obligations;

(iii) determining the transaction price;

(iv) allocating

the transaction price;

and (v) recognizing revenue.

Company recognizes net sales upon shipment of product to the dialysis centers and upon meeting the five-step model prescribed by ASC

606 outlined above.

Per Common Share

loss per common share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding

during the period.

The weighted average number of common shares outstanding during the period included 2,500,625 shares underlying outstanding

pre-funded warrants.

Diluted loss per common share reflects the potential dilution that could occur if securities or other contracts

to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the

earnings of the Company.

Company’s outstanding shares of Series E preferred stock entitle the holders to receive dividends on a basis equivalent to the

dividends paid to holders of common stock.

As a result, the Series E preferred stock meet the definition of participating securities

requiring the application of the two-class method.

Under the two-class method, earnings available to common shareholders, including both

distributed and undistributed earnings, are allocated to each class of common stock and participating securities according to dividends

declared and participating rights in undistributed earnings, which may cause diluted earnings per share to be more dilutive than the

calculation using the treasury stock method.

No loss has been allocated to these participating securities since they do not have contractual

obligations that require participation in the Company’s losses.

the Company has only incurred losses, basic and diluted loss per share are the same as potentially dilutive shares have been excluded

from the calculation of diluted net loss per share as their effect would be anti-dilutive.

The shares outstanding at the end of the respective

periods presented below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect :

Common Stock Issuable At

Finished goods

The pre-commercial inventory previously

expensed as R&D prior to FDA approval, consists of certain raw materials and inventory at various stages of completion with a value

approximating $ 5,318,000 as of December 31, 2024.

Property and Equipment

Property and equipment consist

primarily of furnishings, fixtures, leasehold improvements, office equipment and computer equipment, all of which are recorded at cost.

Depreciation is provided for by the straight-line method over the estimated useful lives of the related assets.

improvements are amortized using the straight-line method over the remaining lease term or the life of the asset, whichever is shorter.

Property and equipment, as of December 31, 2024 and 2023 were approximately $ 1,828,000 and $ 1,866,000 , respectively, net of accumulated

depreciation of approximately $ 674,000 and $ 521,000 , respectively.

Depreciation and amortization of property and equipment is included

in cost of goods sold and general and administrative expenses.

Description Estimated

Useful Life Income

Classification

Office equipment and furniture 5 years G&A

Leasehold improvements 7 years or

remaining term

of the lease G&A

Computer equipment 3 years G&A

Computer software 3 years G&A

Packaging equipment 5 years COGS

The Company determines if

an arrangement is a lease at inception.

Operating leases are included in operating lease right-of-use (“ROU”) assets, current

portion of operating lease liabilities and operating lease liabilities, net of current portion, on the consolidated balance sheet (see

Operating lease ROU assets

and operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at

commencement date.

As the Company’s leases do not provide an implicit rate, the Company uses its incremental borrowing rate based

on the information available at commencement date in determining the present value of future payments.

The Company’s lease terms

may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option.

expense for minimum lease payments is recognized on a straight-line basis over the lease term.

The Company has elected,

as an accounting policy, not to apply the recognition requirements in ASC 842, Accounting for Leases , to short-term leases.

leases are leases that have a term of 12 months or less and do not include an option to purchase the underlying asset that

the Company is reasonably certain to exercise.

The Company recognizes the lease payments for short-term leases on a straight-line

basis over the lease term.

The Company has also elected,

as a practical expedient, by underlying class of asset, not to separate lease components from non-lease components and, instead, account

for them as a single component.

Revenue Recognition

The Company recognizes revenue

from the sale of its product, DefenCath, in accordance with ASC 606, Revenue from Contracts with Customers (“ASC

The provisions of ASC 606 require the following steps to determine revenue recognition:

(1) identify the contract(s) with

(2) identify the performance obligations in the contract;

(3) determine the transaction price;

(4) allocate the transaction

price to the performance obligations in the contract;

and (5) recognize revenue when (or as) the entity satisfies a performance obligation.

The Company recognizes revenue

when it believes that it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services

that will be transferred to the customer.

The Company’s product revenue is recognized at a point in time when the performance obligation

is satisfied by transferring control of the promised goods or services to a customer.

In accordance with the Company’s contracts

with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is received by a customer.

The Company’s customers are located in the United States and consist primarily of outpatient service providers and wholesale distributors.

Variable Consideration

The Company includes an estimate

of variable consideration in its transaction price at the time of sale when control of the product transfers to the customer.

consideration includes:

Distribution service fees;

Prompt pay and other discounts;

Product returns;

Volume incentive rebates;

The Company assesses whether

or not an estimate of variable consideration is constrained based on the probability that a significant reversal in the amount of cumulative

revenue may occur in the future when the uncertainty associated with the variable consideration is subsequently resolved.

Actual amounts

of consideration ultimately received may vary from our estimates.

If actual results in the future vary from estimates, the Company adjusts

these estimates, which would affect product sales and earnings in the period such variances become known.

The specific considerations

that the Company uses in estimating these amounts related to variable considerations are as follows:

Distribution services fees –

The Company pays distribution service fees primarily to its wholesale distributors.

The Company reserves these fees based on actual net

sales and the contractual fee rates negotiated with the customers in the distribution channel.

The Company records these fees as contra

accounts receivable on the balance sheet.

Prompt pay and other discounts

– The Company provides customers with prompt pay discounts.

The specific prompt pay terms vary by customer and are contractually

Prompt pay discounts are expected to be taken by the Company’s customers, so an estimate of the discount is recorded at

the time of sale based on the invoice price.

Prompt pay discount estimates are recorded as contra accounts receivable on the balance

Product returns –

Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration

date by no more than six months.

The Company determines its estimate for product returns based on:

(i) data provided to the Company by

its distributors (including weekly reporting of distributors’ sales and inventory held by distributors that provided the Company

with visibility into the distribution channel in order to determine what quantities were sold to both inpatient and outpatient facilities),

and (ii) the estimated remaining shelf life of DefenCath held by the wholesale distributors and outpatient service providers.

returns primarily consist of expired and short dated products that will not be resold, the Company does not record a return asset for

the right to recover the goods returned by the customer at the time of the initial sale (when recognition of revenue is deferred due

to the anticipated return).

Estimated product returns are recorded as accrued expenses on the balance sheet.

Chargebacks –

Certain covered entities, group purchasing organizations (“GPO”) and government entities will be able to purchase the product

at a price discounted below wholesaler acquisition cost (“WAC”).

The difference between the GPO, government or covered entity

purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company.

The Company estimates the amount

in chargebacks based on the expected number of claims and related cost that is associated with the revenue being recognized for product

that remains in the distribution channel at the end of each reporting period.

Estimated chargebacks are recorded as contra accounts receivable

on the balance sheet.

Rebates – The

Company is or may become subject to negotiated discount obligations to different GPO, direct purchasers, other commercial organizations

or government programs.

The rebate amounts for these programs are determined by statutory requirements or contractual arrangements.

are owed after the product has been dispensed to an end user and the Company has been invoiced.

Rebates are typically invoiced in arrears.

The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid

or for which an invoice has not yet been received, estimates of claims for the current quarter based on expected product utilization,

and estimated future claims that will be made for product that has been recognized as revenue, but remains in the distribution channel

at the end of each reporting period.

Rebate estimates are recorded as accrued expenses on the balance sheet.

Volume Incentive Rebates

– The Company is subject to negotiated volume incentive rebates with certain direct and indirect customers (primarily outpatient

service providers).

Rebates are owed based on predetermined volume levels and payable per the terms in the customer contracts.

estimates and records volume incentive rebates based on anticipated purchase volume with specific customers based on communications with

the customer.

Volume incentive rebates are recorded as accrued expenses on the balance sheet.

Provisions for the revenue

reserves described above totaled $ 24,128,000 for the year ended December 31, 2024.

As of December 31, 2024, total accrued reserves and

allowances to accounts receivable on the balance sheet associated with variable consideration were $ 23,161,000 .

A roll forward of the major categories of variable consideration deductions

for the years ended December 31, 2024 and 2023 is as follows:

Balance at December 31, 2023

Provisions related to sales recorded in the period

Credits/payments issued during the period

Balance at December 31, 2024

License Agreement

The Company’s rights

under the License and Assignment Agreement with ND Partners, LLP are capitalized and stated at cost.

The Company amortizes the intangible

asset utilizing the straight-line method over the estimated economic life of the intangible asset based on the Company’s assessment

of various factors impacting estimated useful lives and cash flows of the acquired rights.

Such factors include the launch date of DefenCath,

the strength of the intellectual property protection of DefenCath and associated technology and various other competitive, developmental

and regulatory considerations, and contractual terms.

See Note 7 – Commitments and Contingencies for further discussion.

Loss Per Common Share

Basic loss per common share

excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period.

Diluted net loss per common share reflects the potential dilution that could occur if securities or other contracts to issue common stock

were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the Company.

The Company’s outstanding

shares of Series E preferred stock entitle the holders to receive dividends on a basis equivalent to the dividends paid to holders of

common stock.

As a result, the Series E preferred stock meet the definition of participating securities requiring the application of

the two-class method.

Under the two-class method, earnings available to common shareholders, including both distributed and undistributed

earnings, are allocated to each class of common stock and participating securities according to dividends declared and participating

rights in undistributed earnings, which may cause diluted earnings per share to be more dilutive than the calculation using the treasury

stock method.

No loss has been allocated to these participating securities since they do not have contractual obligations that require

participation in the Company’s losses.

Since the Company has only

incurred losses, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect

would be anti-dilutive, and therefore basic and diluted loss per share are the same for all periods presented.

The shares outstanding

at the end of the respective periods presented below were excluded from the calculation of diluted net loss per share due to their anti-dilutive

Number of Shares of

Series C non-voting preferred stock

1 unchanged sentence

Series G voting preferred stock

Shares issuable for payment of deferred board

Shares issuable for payment of deferred board compensation

Shares underlying outstanding stock options

Restricted stock units

Total potentially dilutive

compensation cost is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model

for options with service or performance-based conditions.

Stock-based compensation is recognized as expense over the requisite service

period on a straight-line basis or when the achievement of the performance condition is probable.

For options with market-based vesting,

share-based compensation cost is measured at grant date using the Monte Carlo option pricing model and the expense is recognized over

the derived service period.

and Development

and development costs are charged to expense as incurred.

Research and development include fees associated with operational consultants,

contract clinical research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations,

contract central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses.

accrues for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its

external service providers.

Total potentially dilutive shares

Stock-Based Compensation

Stock-based compensation

cost is measured at grant date, based on the estimated fair value of the award using the Black-Scholes option pricing model for options

with service or performance-based conditions.

Stock-based compensation is recognized as expense over the requisite service period on

a straight-line basis or when the achievement of the performance condition is probable.

Research and Development

Research and development

costs are charged to expense as incurred.

Research and development include fees associated with operational consultants, contract clinical

research organizations, contract manufacturing organizations, clinical site fees, contract laboratory research organizations, contract

central testing laboratories, licensing activities, and allocated executive, human resources and facilities expenses.

The Company accrues

for costs incurred as the services are being provided by monitoring the status of the trial and the invoices received from its external

service providers.

As actual costs become known, the Company adjusts its accruals in the period when actual costs become known.

Costs related to the acquisition of technology rights and patents for which development work is still in process are charged to operations

related to the acquisition of technology rights and patents for which development work is still in process are charged to operations

as incurred and considered a component of research and development expense.

tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial

statement carrying amounts of existing assets and liabilities and their respective tax bases.

Deferred tax assets and liabilities are

measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to

be recovered or settled.

The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period

that includes the enactment date.

Valuation allowances are established when it is more likely than not that some or all of the deferred

tax assets will not be realized.

Company records legal costs associated with loss contingencies when they are probable and reasonably estimable.

Authoritative Pronouncements

October 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-06,

“ Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative ,” which modifies

the disclosure or presentation requirements of various FASB topics in the Codification.

The date on which this guidance is effective

for the Company will be the date on which the SEC’s removal of that related disclosure from Regulation S-X or Regulation S-K becomes

effective, with early adoption prohibited.

The Company does not expect the adoption of this guidance to have an impact on its consolidated

financial statements.

Other income relates to a

settlement with a previously utilized vendor, occurring during the year ended December 31, 2024.

Deferred tax assets and liabilities

are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts

of existing assets and liabilities and their respective tax bases.

Deferred tax assets and liabilities are measured using enacted tax

rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled.

The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment

Valuation allowances are established when it is more likely than not that some or all of the deferred tax assets will not be realized.

Recent Authoritative Pronouncements,

not yet adopted

From time to time, new accounting

pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the

Company adopts as of the specified effective date.

Unless otherwise discussed below, the Company does not believe the adoption of recently

issued standards have or may have a material impact on its consolidated financial statements or disclosures.

In December 2023, the FASB

issued Accounting Standards Update (ASU) No.

2023-09, Income Taxes - Improvements to Income Tax Disclosures (Topic 740).

The standard requires disaggregation of the effective rate reconciliation into standard categories, enhances disclosure of income taxes

paid, and modifies other income tax-related disclosures.

The standard will be effective for CorMedix beginning in annual reporting period

ending December 31, 2025, with early adoption permitted.

CorMedix is currently assessing the impact of adopting this guidance on its

consolidated financial statements.

In November 2024, the FASB

issued ASU 2023-07, “ Improvements to Reportable Segment Disclosures ,” which improves reportable segment disclosure

requirements, primarily through enhanced disclosures about significant segment expenses.

The guidance is effective for the Company beginning

in the annual reporting period ending December 31, 2024 and interim periods beginning in fiscal year 2025.

issued ASU 2024-03, ASC 220- Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures , which

requires entities, in the notes to financial statements, with specified information about certain costs and expenses.

The guidance is

effective for CorMedix’s annual reporting period ending December 31, 2027, with interim periods beginning with CorMedix’s

interim period ended March 31, 2027.

Early adoption is permitted.

The Company is assessing the impact of adopting this guidance on its consolidated financial statements.

In December 2023, the FASB issued ASU

2023-09, “ Improvements to Income Tax Disclosures ,” which enhances the transparency and decision usefulness of income

tax disclosures.

The guidance is effective for the Company’s annual reporting period ending December 31, 2025.

Early adoption is

The Company is assessing the impact of adopting this guidance on its consolidated financial statements.

CorMedix is assessing the impact of adopting this guidance on its consolidated

financial statements.

Recently Adopted Authoritative Pronouncements:

In November 2023, the FASB

issued ASU No.

2023-07 Segment Reporting - Improving Reportable Segment Disclosures (Topic 280).

The standard requires disclosures

to include significant segment expenses that are regularly provided to the chief operating decision maker (CODM), a description of other

segment items by reportable segment, and any additional measures of a segment’s profit or loss used by the CODM when deciding how

to allocate resources.

The ASU also requires all annual disclosures currently required by Topic 280 to be included in interim periods.

CorMedix adopted this guidance as of December 31, 2024.

See Note 10 for the disclosure related to the adoption of ASU No.

Note 4 – Other Prepaid Expenses and

Current Assets:

Other Prepaid Expenses and Current Assets

Other prepaid expenses and

current assets consist of the following:

FDA filing fee

Medical affairs

Subscriptions

Note 5 — Accrued Expenses:

Accrued Expenses

expenses consist of the following:

Professional and consulting fees

Accrued expenses consist

of the following:

Accrued gross-to-net-deductions

Accrued payroll and payroll taxes

License agreement payable

Professional and consulting fees

Manufacturing related

Note 5 — Income

Company’s U.S.

and foreign loss before income taxes are set forth below:

Note 6 — Income Taxes:

The Company’s U.S.

and foreign loss before

income taxes are set forth below:

United States

were no current or deferred income tax provision for the years ended December 31, 2023 and 2022 because the Company has incurred operating

losses since inception.

Company’s deferred tax assets consist of the following:

$ ( 19,065,449 )

$ ( 45,946,020 )

$ ( 19,324,790 )

$ ( 46,339,227 )

There were no current or

deferred income tax provision for the years ended December 31, 2024 and 2023 because the Company has incurred operating losses since

The Company’s deferred tax assets consist

of the following:

Net operating loss carryforwards – Federal

6 unchanged sentences

Less valuation allowance

( 69,168,000 )

( 70,777,000 )

Deferred tax assets

valuation allowance is provided when it is more likely than not that some portion or all of the deferred tax assets will not be realized.

The net change in the total valuation allowance for the year ended December 31, 2023 was $ 13,016,000 .

Company had the following potentially utilizable net operating loss tax carryforwards:

A valuation allowance is provided when it is more likely than not that

some portion or all of the deferred tax assets will not be realized.

The net change in the total valuation allowance for the year ended

December 31, 2024 was $ 1,609,000 .

The Company had the following potentially utilizable

net operating loss tax carryforwards:

$ 265,610,000

$ 255,306,000

Approximately $ 113,600,000 of net operating losses generated will expire

in 2026 through 2037 for Federal purposes whereas the operating losses for state purposes will expire between 2039 and 2044.

and Jobs Act of 2017 (the “Act”) limits the net operating loss deduction to 80 % of taxable income for losses arising in tax

years beginning after December 31, 2017.

However, the net operating losses now have an indefinite carryforward as opposed to the

former 20-year carryforward.

The foreign net operating loss tax carryforwards do not expire.

Our federal and state operating loss

carryforwards include windfall tax deductions from stock option exercises.

The Company’s foreign

net operating loss carryforward relates to the Company’s Spanish subsidiary.

During 2021, the Company’s

German subsidiary was audited by the German taxing authorities for the years 2013-2015.

It was determined that the amount of German income

was not sufficient, so the taxing authorities made adjustments accordingly.

Further, amended returns were filed for the subsequent years

to provide the German subsidiary sufficient income.

As a result of these changes, the German subsidiary’s net operating losses were

fully utilized and no longer have a carryforward attribute.

Such adjustments do not have a material effect on the Company’s financial

Approximately $ 113,600,000

of net operating losses generated will expire in 2026 through 2037 for Federal purposes whereas the operating losses for state purposes

will expire between 2043 and 2044.

The Tax Cuts and Jobs Act of 2017 (the “Act”) limits the net operating loss deduction

to 80 % of taxable income for losses arising in tax years beginning after December 31, 2017.

However, the net operating losses now

have an indefinite carryforward as opposed to the former 20-year carryforward.

The foreign net operating loss tax carryforwards do not

Our federal and state operating loss carryforwards include windfall tax deductions from stock option exercises.

The Company’s foreign

earnings are derived from its German and Spanish subsidiaries.

The Company does not expect any foreign earnings to be repatriated in

earnings, if any, are derived from its German and Spanish subsidiaries.

The Company does not expect any foreign earnings to be repatriated

in the near future.

The winding down of its operations in the EU is ongoing and there was no income during the year ended December

Company’s effective tax rate varied from the statutory rate as follows:

The winding down of its operations in the EU is ongoing and there was no income during the year ended

December 31, 2024.

The Company’s effective tax rate varied

from the statutory rate as follows:

Statutory federal tax rate

1 unchanged sentence

Change in foreign NOL

NJ NOL adjustment

Stock compensation prior year true-up

Stock compensation

Sale of NJ NOL

Deferred only adjustment

Other permanent differences

Effect of valuation

assessing the realizability of deferred tax assets, management considers whether it is more-likely-than-not that some portion or all

of the deferred tax assets will not be realized.

The ultimate realization of deferred tax assets is dependent upon the generation of

future taxable income of the appropriate character during the periods in which those temporary differences become deductible and the

loss carryforwards are available to reduce taxable income.

In making its assessment, the Company considered all sources of taxable income

including carryback potential, future reversals of existing deferred tax liabilities, prudent and feasible tax planning strategies, and

lastly, objectively verifiable projections of future taxable income exclusive of reversing temporary differences and carryforwards.

December 31, 2023 and 2022, the Company maintained a full valuation allowance against its net deferred tax assets.

The Company will continue

to assess all available evidence during future periods to evaluate the realization of its deferred tax assets.

following table presents the changes in the deferred tax asset valuation allowance for the periods indicated:

Effect of valuation allowance

Effective tax rate

In assessing the realizability

of deferred tax assets, management considers whether it is more-likely-than-not that some portion or all of the deferred tax assets will

not be realized.

The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income of the appropriate

character during the periods in which those temporary differences become deductible and the loss carryforwards are available to reduce

taxable income.

In making its assessment, the Company considered all sources of taxable income including carryback potential, future

reversals of existing deferred tax liabilities, prudent and feasible tax planning strategies, and lastly, objectively verifiable projections

of future taxable income exclusive of reversing temporary differences and carryforwards.

At December 31, 2024 and 2023, the Company maintained

a full valuation allowance against its net deferred tax assets.

The Company will continue to assess all available evidence during future

periods to evaluate the realization of its deferred tax assets.

The following table presents the changes in the

deferred tax asset valuation allowance for the periods indicated:

(Credited) to

December 31, 2024

$ ( 1,574,000 )

December 31, 2023

for uncertainty in income taxes requires uncertain tax positions to be classified as non-current income tax liabilities unless they are

expected to be paid within one year.

The Company has concluded that there are no uncertain tax positions requiring recognition in its

consolidated financial statements as of December 31, 2023 and 2022.

The Company recognizes interest and penalties related to uncertain

tax positions if any as a component of income tax expense.

Accounting for uncertainty

in income taxes requires uncertain tax positions to be classified as non-current income tax liabilities unless they are expected to be

paid within one year.

The Company has concluded that there are no uncertain tax positions requiring recognition in its consolidated financial

statements as of December 31, 2024 and 2023.

The Company recognizes interest and penalties related to uncertain tax positions if any

as a component of income tax expense.

The Company files U.S.

federal and state returns.

The Company’s

foreign subsidiary also files a local tax return in their local jurisdiction.

federal, state and local perspective the years

that remain open to examination are consistent with each jurisdiction’s statute of limitations.

From a foreign perspective, tax

years 2016 to 2022 remain open to examination.

the year ended December 31, 2023 the Company did not sell any of its unused New Jersey net operating losses (“NOL”) eligible

for sale under the State of New Jersey’s Economic Development Authority’s New Jersey Technology Business Tax Certificate

Transfer program (“NJEDA Program”).

The NJEDA Program allowed the Company to sell $ 626,000 of its total $ 626,000 in available

NOL tax benefits for the state fiscal year 2021, which the Company received net proceeds of approximately $ 586,000 during the year ended

December 31, 2022.

6 — Commitments and Contingencies:

re CorMedix Inc.

and state returns.

The Company’s foreign subsidiary also files a local tax return in their local jurisdiction.

state and local perspective the years that remain open to examination are consistent with each jurisdiction’s statute of limitations.

During the year ended December

31, 2024, the Company received approximately $ 1,395,000 , net of expenses, from the sale of its unused New Jersey net operating losses

(NOL), that was eligible for sale under the State of New Jersey’s Economic Development Authority’s New Jersey Technology

Business Tax Certificate Transfer program (NJEDA Program).

The NJEDA Program allowed the Company to sell its available NOL tax benefits

for the state fiscal year 2023 in the amount of approximately $ 1,500,000 .

During the year ended December 31, 2023 the Company did not

sell any of its unused NOL.

Note 7 — Commitments and Contingencies:

Contingency Matters

In re CorMedix Inc.

Securities Litigation, Case No.

2:21-cv-14020 (D.N.J.)

October 13, 2021, the United States District Court for the District of New Jersey consolidated into In re CorMedix Inc.

Securities Litigation,

2:21-cv 14020-JXN-CLW, two putative class action lawsuits filed on or about July 22, 2021 and September 13, 2021, respectively,

and appointed lead counsel and lead plaintiff, a purported stockholder of the Company.

The lead plaintiff filed a consolidated amended

class action complaint on December 14, 2021, alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934,

as amended, or the Exchange Act, along with Rule 10b-5 promulgated thereunder, and Sections 11 and 15 of the Securities Act of 1933,

as amended, or the Securities Act.

On October 10, 2022, the lead plaintiff filed a second amended consolidated complaint that superseded

the original complaints in In re CorMedix Securities Litigation.

In the second amended complaint, the lead plaintiff seeks to represent

two classes of shareholders:

(i) shareholders who purchased or otherwise acquired CorMedix securities between October 16, 2019 and August

8, 2022, inclusive;

and (ii) shareholders who purchased CorMedix securities pursuant or traceable to the Company’s November 27,

2020 offering pursuant to CorMedix’s Form S-3 Registration Statement, its Prospectus Supplement, dated November 27, 2020, and its

Prospectus Supplement, dated August 12, 2021.

The second amended complaint names as defendants the Company and twelve (12) current and

former directors and officers of CorMedix, namely Khoso Baluch, Robert Cook, Matthew David, Phoebe Mounts, John L.

Armstrong, and Joseph

Todisco (the “Officer Defendants” and collectively with CorMedix, the “CorMedix Defendants”) as well as Janet

Dillione, Myron Kaplan, Alan W.

Dunton, Steven Lefkowitz, Paulo F.

Costa, Greg Duncan (the “Director Defendants”).

amended complaint alleges that the CorMedix Defendants violated Section 10(b) of the Exchange Act (and Rule 10b-5), the Officer Defendants

violated Section 20(a), the Director Defendants, CorMedix, Baluch, and David violated Section 11 of the Securities Act, and that the

Director Defendants, Baluch, and David violated Section 15.

In general, the purported bases for these claims are allegedly false and

misleading statements and omissions related to the NDA submissions to the FDA for DefenCath, subsequent complete response letters, as

well as communications from the FDA related and directed to the Company’s contract manufacturing organization and heparin supplier.

2:21-cv-14020

On October 13, 2021, the

United States District Court for the District of New Jersey consolidated into In re CorMedix Inc.

Securities Litigation, Case No.

14020-JXN-CLW, two putative class action lawsuits filed on or about July 22, 2021 and September 13, 2021, respectively, and appointed

lead counsel and lead plaintiff, a purported stockholder of the Company.

The lead plaintiff filed a consolidated amended class action

complaint on December 14, 2021, alleging violations of Sections 10(b) and 20(a) of the Exchange Act, along with Rule 10b-5 promulgated

thereunder, and Sections 11 and 15 of the Securities Act of 1933.

On October 10, 2022, the lead plaintiff filed a second amended consolidated

complaint that superseded the original complaints in In re CorMedix Securities Litigation.

On March 21, 2024, the court denied Defendant’s

motion to dismiss without prejudice and granted lead plaintiff leave to amend the complaint.

On April 22, 2024, lead plaintiff filed

a third amended consolidated complaint that superseded the second amended consolidated complaint.

In the third amended complaint, the

lead plaintiff seeks to represent a class of shareholders who purchased or otherwise acquired CorMedix securities between October 16,

2019 and August 8, 2022, inclusive.

The third amended complaint names as defendants the Company and six (6) current and former officers

of CorMedix, namely Khoso Baluch, Robert Cook, Matthew David, Phoebe Mounts, John L.

Armstrong, and Joseph Todisco (the “Officer

Defendants” and collectively with CorMedix, the “CorMedix Defendants”).

The third amended complaint alleges that the

CorMedix Defendants violated Section 10(b) of the Exchange Act (and Rule 10b-5) and that the Officer Defendants violated Section 20(a).

In general, the purported bases for these claims are allegedly false and misleading statements and omissions related to the NDA submissions

to the FDA for DefenCath, subsequent complete response letters, as well as communications from the FDA related and directed to the Company’s

contract manufacturing organization and heparin supplier.

The Company intends to vigorously contest such claims.

The Company and the other Defendants filed their motion to dismiss the second

amended complaint on November 23, 2022 and briefing was complete as of February 6, 2023.

The motion to dismiss is currently pending.

CorMedix Inc.

Derivative Litigation, Case No.

The Company filed its

motion to dismiss the third amended complaint on June 6, 2024, and received from Plaintiffs their opposition to the Company’s motion

to dismiss on July 22, 2024.

The Company filed its response on August 21, 2024.

In re CorMedix Inc.

Derivative Litigation,

2:21-cv-18493-JXN-LDW (D.N.J.)

or about October 13, 2021, a purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint

in the United States District Court for the District of New Jersey, in a case entitled Voter v.

On or about October 13, 2021,

a purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States District

Court for the District of New Jersey, in a case entitled Voter v.

Baluch, et al., Case No.

2:21-cv-18493-JXN-LDW

(the “Derivative Litigation”).

2:21-cv-18493-JXN-LDW (the “Derivative

Litigation”).

The complaint names as defendants Khoso Baluch, Janet Dillione, Alan W.

Dunton, Myron Kaplan,

Steven Lefkowitz, Paulo F.

Costa, Greg Duncan, Matthew David, and Phoebe Mounts along with the Company as Nominal Defendant.

The complaint

alleges breaches of fiduciary duties, abuse of control, and waste of corporate assets against the defendants and a claim for contribution

for purported violations of Sections 10(b) and 21D of the Exchange Act against certain defendants.

The individual defendants intend to

vigorously contest such claims.

On January 21, 2022, pursuant to a stipulation between the parties, the Court entered an order staying

the case while the motion to dismiss the class action lawsuit described in the foregoing paragraph is pending.

The stay may be terminated

before the motion to dismiss is resolved according to certain circumstances described in the stipulation available on the Court’s

public docket.

or about January 13, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint

in the United States District Court for the District of New Jersey, in a case entitled DeSalvo v.

Dunton, Myron Kaplan, Steven Lefkowitz, Paulo

Costa, Greg Duncan, Matthew David, Phoebe Mounts and Joseph Todisco along with the Company as Nominal Defendant.

The complaint alleges

breaches of fiduciary duties, abuse of control, and waste of corporate assets against the defendants and a claim for contribution for

purported violations of Sections 10(b) and 21D of the Exchange Act against certain defendants.

The individual defendants intend to vigorously

contest such claims.

On January 21, 2022, pursuant to a stipulation between the parties, the Court entered an order staying the case

while the motion to dismiss the class action lawsuit described in the foregoing paragraph is pending.

The stay may be terminated before

the motion to dismiss is resolved according to certain circumstances described in the stipulation available on the Court’s public

On or about January 13, 2023,

another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States

District Court for the District of New Jersey, in a case entitled DeSalvo v.

Costa, et al.

2:23-cv-00150-JXN-CLW.

Defendants Paulo F.

Costa, Janet D.

Dillione, Greg Duncan, Alan Dunton, Myron Kaplan, Steven Lefkowitz, Joseph Todisco, Khoso Baluch,

Robert Cook, Matthew David, Phoebe Mounts, and John L.

Dillione, Greg Duncan, Alan Dunton, Myron Kaplan, Steven Lefkowitz, Joseph Todisco, Khoso Baluch, Robert Cook,

Matthew David, Phoebe Mounts, and John L.

Armstrong along with the Company as Nominal Defendant.

The complaint alleges breaches

of fiduciary duty and unjust enrichment against the individual defendants.

or about January 25, 2023, another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint

in the United States District Court for the District of New Jersey, in a case entitled Scullion v.

The complaint alleges breaches of fiduciary

duty and unjust enrichment against the individual defendants.

On or about January 25, 2023,

another purported shareholder, derivatively and on behalf of the Company, filed a shareholder derivative complaint in the United States

District Court for the District of New Jersey, in a case entitled Scullion v.

Baluch, et al.

2:23-cv-00406-ES-ESK.

Defendants Khoso Baluch, Janet Dillione, Alan W.

Khoso Baluch, Janet Dillione, Alan W.

Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F.

Costa, Gregory Duncan, Matthew David,

and Phoebe Mounts, along with the Company as Nominal Defendant.

Costa, Gregory Duncan, Matthew David, and Phoebe

Mounts, along with the Company as Nominal Defendant.

The complaint alleges breaches of fiduciary duties.

or about April 18, 2023, the Court entered an order consolidating the above-mentioned shareholder derivative complaints for all purposes,

including pretrial proceedings, trial and appeal.

On or about April 18, 2023,

the Court entered an order consolidating the above-mentioned shareholder derivative complaints for all purposes, including pretrial proceedings,

trial and appeal.

The consolidated derivative action is entitled, In re CorMedix Inc.

Derivative Litigation ,

Derivative Litigation , C.A.

2:21-cv-18493-JXN-LDW.

The provisions of the Order to Stay entered in the Voter Action on January 21, 2022, apply to

the consolidated derivative action.

The consolidated derivative action was then administratively terminated and removed from the Court’s

docket until the motion to dismiss the class action is resolved.

The individual defendants intend to vigorously contest the claims set

forth in the consolidated derivative action when the case moves forward.

or about June 23, 2022, the Company’s Board received a letter demanding it investigate and pursue causes of action, purportedly

on behalf of Company, against certain current and former directors, officers, and/or other employees of the Company (the “Letter”),

which the Board believes are duplicative of the claims already asserted in the Derivative Litigation.

As set forth in the Board’s

response to the Letter, the Board will consider the Letter at an appropriate time, as circumstances warrant, as it continues to monitor

the progress of the Derivative Litigation.

2008, the Company entered into the ND License Agreement with NDP.

Pursuant to the ND License Agreement, NDP granted the Company exclusive,

worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting infections, a biocidal lock

system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and applications(the “NDP

Technology”).

As consideration in part for the rights to the NDP Technology, the Company paid NDP an initial licensing fee of $ 325,000

and granted NDP a 5 % equity interest in the Company, consisting of 7,996 shares of the Company’s common stock.

The Company is required to make cash payments to NDP upon the achievement

of certain milestones.

In 2014, a certain milestone was achieved resulting in the release of 7,277 shares held in escrow.

aggregate amount of cash payments due upon achievement of milestones is $ 3,000,000 , with the balance being $ 2,000,000 as of December 31,

2023 and 2022.

Events that trigger milestone payments include achieving certain worldwide net sales amounts.

There were no milestones

achieved during the years ended December 31, 2023 and 2022.

The ND License Agreement will expire on a country-by-country basis

upon the earlier of (i) the expiration of the last patent claim under the ND License Agreement in a given country, or (ii) the payment

of all milestone payments.

Upon the expiration of the ND License Agreement in each country, we will have an irrevocable, perpetual, fully

paid-up, royalty-free exclusive license to the NDP Technology in such country.

The ND License Agreement also may be terminated by NDP

if we materially breach or default under the ND License Agreement and that breach is not cured within 60 days following the delivery of

written notice to us, or by us on a country-by-country basis upon 60 days prior written notice.

If the ND License Agreement is terminated

by either party, our rights to the NDP Technology will revert back to NDP.

Company entered into a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights,

New Jersey 07922.

The lease agreement, with a monthly average cost of approximately $ 17,000 , commenced on September 16, 2020.

7 — Stockholders’ Equity:

November 2020, the Company filed a shelf registration statement, (the “2020 Shelf Registration”), under which the Company

could issue and sell up to an aggregate of $ 100,000,000 of shares of its common stock, $ 0.001 par value per share.

In November 2020,

the Company allocated to its at-the-market program (“ATM program”), an aggregate of $ 50,000,000 out of the $ 100,000,000 total

under the 2020 Shelf Registration, which has been fully sold.

August 2021, the Company entered into an at-the-market issuance sales agreement with Truist Securities, Inc.

and JMP Securities LLC,

as sales agents, pursuant to which the Company may sell, from time to time, an aggregate of up to $ 50,000,000 , which was the remaining

balance under the 2020 Shelf Registration, of its common stock through the sales agents under its ATM program, subject to limitations

imposed by the Company and subject to the sales agents’ acceptance, such as the number or dollar amount of shares registered under

the 2020 Shelf Registration to which the offering relates.

The sales agents are entitled to a commission of up to 3 % of the gross proceeds

The individual defendants intend to vigorously contest the claims set forth in the consolidated derivative action.

The provisions of

the Order to Stay entered in the Voter Action on January 21, 2022, apply to the consolidated derivative action.

On April 20, 2023,

the consolidated derivative action was administratively terminated and removed from the Court’s docket until the motion to dismiss

the class action is resolved and the Private Securities Litigation Reform Act, or PSLRA, stay is lifted.

On April 22, 2024, the lead

plaintiff in the class action filed a third amended complaint.

The class action remains stayed under the PSLRA.

Demand Letter

On or about June 23, 2022,

the Company’s Board received a letter demanding it investigate and pursue causes of action, purportedly on behalf of the Company,

against certain current and former directors, officers, and/or other employees of the Company (the “Letter”), which the Board

believes are duplicative of the claims already asserted in the Derivative Litigation.

As set forth in the Board’s response to the

Letter, the Board will consider the Letter at an appropriate time, as circumstances warrant, as it continues to monitor the progress

of the Derivative Litigation.

License and Assignment Agreement

In 2008, the Company entered

into a License and Assignment Agreement (the ND License Agreement) with ND Partners, LLP (NDP).

Pursuant to the ND License Agreement,

NDP granted the Company exclusive, worldwide licenses for certain antimicrobial catheter lock solutions, processes for treating and inhibiting

infections, a biocidal lock system and a taurolidine delivery apparatus, and the corresponding United States and foreign patents and

applications (the NDP Technology).

As consideration in part for the rights to the NDP Technology, upon execution of the ND License Agreement,

the Company paid NDP an initial licensing fee of $ 325,000 and granted NDP a 5 % equity interest in the Company, consisting of 7,996 shares

of the Company’s common stock.

Under the ND License Agreement,

the Company is required to make cash and equity payments to NDP upon the achievement of certain milestones.

In 2014, a certain milestone

was achieved resulting in the release of 7,277 shares held in escrow.

As of December 31, 2022, the shares remaining in escrow were cancelled

in accordance with the terms of the escrow agreement.

Under the ND License Agreement, the maximum aggregate amount of cash payments due

upon achievement of applicable milestones was $ 2,500,000 , with the balance being $ 2,000,000 as of December 31, 2024 and 2023.

licensing fee of $ 325,000 , the fair value of the 5 % equity interest ( 7,996 shares of the Company’s common stock) and an additional

$ 500,000 , as a result of the achievement of one milestone, were recognized on the Company’s statement of operations in R&D

in prior periods, as the related milestones were achieved by the Company prior to the FDA approval.

During the year ended December 31,

2024, the Company determined it was probable that the net sales milestones would be achieved in future periods and, as a result, the

Company recorded a license intangible asset of $ 2,000,000 and a license agreement liability of $ 2,000,000 , which is included within accrued

expenses in the Company’s consolidated balance sheet as of December 31, 2024.

These sales milestones were met during the year ended

December 31, 2024.

The Company anticipates payment will be due in accordance with the agreement terms at the end of the twelve month

period post attainment.

Beginning in the second quarter

of 2024, the license intangible asset is amortized as cost of goods sold over its estimated economic life of approximately 10 years.

The amortization start period correlates with the product launch of DefenCath and the first period in which revenue will be recognized.

Amortization expense of approximately $ 156,000 was recorded during the year ended December 31, 2024.

The ND License Agreement

will expire on a country-by-country basis upon the earlier of (i) the expiration of the last patent claim under the ND License Agreement

in a given country, or (ii) the payment of all milestone payments.

Upon the expiration of the ND License Agreement in each country, we

will have an irrevocable, perpetual, fully paid-up, royalty-free exclusive license to the NDP Technology in such country.

The ND License

Agreement also may be terminated by NDP if the Company materially breaches or defaults under the ND License Agreement and that breach

is not cured within 60 days following the delivery of written notice to the Company, or by the Company on a country-by-country basis

upon 60 days prior written notice in the event the Company’s Board determines not to proceed with the development of the NDP Technology.

If the ND License Agreement is terminated by either party, the Company’s rights to the NDP Technology will revert back to NDP.

In December 2024, the Company

entered into a project agreement with Syneos Health Commercial Services, LLC (“Syneos”) where Syneos will provide a field

force of sales representatives to provide certain sales operations services, compliance services and training services with respect to

DefenCath to us in exchange for an up-front implementation fee and a fixed monthly fee.

The term of the agreement is 3 years and is cancelable

provided 60 days written notice, upon the twelve-month anniversary of the deployment date, which has yet to be determined as of the filing

of this Form 10-K.

As of December 31, 2024, the minimum amount committed totals $ 9.6 million.

The Company entered into

a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey 07922.

lease agreement, with a monthly average cost of approximately $ 17,000 , commenced on September 16, 2020.

Note 8 — Stockholders’

Common Stock:

On June 28, 2023, the Company

entered into an underwriting agreement (the “Underwriting Agreement”) with RBC Capital Markets, LLC and Truist Securities,

Inc., as representatives of the several underwriters named therein, relating to the issuance and sale of an aggregate of 7,500,000 shares

of the Company’s common stock, and in lieu of common stock to certain investors, pre-funded warrants to purchase 2,500,625 shares

of common stock to the underwriters.

Pursuant to the Underwriting Agreement, the Company also granted the underwriters a 30-day option

to purchase up to 1,500,093 additional shares of common stock.

The offering pursuant to the 2021 Shelf Registration Statement closed

on July 3, 2023.

Upon closing, the Company issued and sold an aggregate of 7,500,000 shares of its common stock at a public offering

price of $ 4.00 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 2,500,625

shares of its commons stock at a price of $ 3.999 per pre-funded warrants.

The Company realized net proceeds of approximately $ 37,300,000

from the sale of its common stock and the pre-funded warrants.

On July 26, 2023, the underwriters’ representatives fully exercised

the option to purchase additional shares of the Company’s common stock, and on July 28, 2023, the Company issued and sold an aggregate

of 1,500,093 shares of its common stock at the public offering price of $ 4.00 per share, less underwriting discounts and commissions,

and the Company realized net proceeds of approximately $ 5,600,000 .

In October 2024, the pre-funded warrants were exercised resulting

in the issuance of 2,500,625 shares of common stock by the Company.

Due to the pricing of the pre-funded warrants, net proceeds related

to this transaction are de minimis.

On May 9, 2024, the Company

filed a shelf registration statement (the “2024 Shelf Registration Statement”) for the issuance of up to $ 150,000,000 of

Company securities.

Also on May 9, 2024, the Company entered into an At-The-Market Issuance Sales Agreement with Leerink Partners LLC,

as sales agent, pursuant to which the Company may sell, from time to time, an aggregate of up to $ 50,000,000 of its common stock through

the sales agents under the 2024 Shelf Registration Statement, subject to limitations imposed by the Company and subject to the sales

agent’s acceptance (the “2024 ATM program”).

The sales agent is entitled to a commission of up to 3 % of the gross proceeds

from the sale of common stock sold under the 2024 ATM program.

During the year ended December 31, 2023 and 2022, the Company sold 2,977,637

and 4,704,259 shares of its common stock under the ATM program, respectively, and realized net proceeds of $ 12,900,000 and $ 17,800,000 ,

As of December 31, 2024, the Company sold an aggregate of 3,049,878 shares

of its common stock under the 2024 ATM program and realized an aggregate net proceeds of approximately $ 18,900,000 .

Approximately $ 30,216,000

of the Company’s common stock remains available for sale under its 2024 ATM program, with $ 100,000,000 of capacity remaining under

its 2024 Shelf Registration Statement for the issuance of Company securities.

During the year ended December

31, 2023, the Company sold an aggregate 2,977,637 shares of its common stock under the Company’s previous at-the-market program,

realizing net proceeds of approximately $ 12,900,000 .

During the year ended

December 31, 2024 and 2023, the Company issued an aggregate of 1,357,802 and 79,041 shares of its common stock upon exercise of stock

options, resulting in net proceeds to the Company of approximately $ 7,724,000 and $ 288,000 , respectively.

In December 2024, 44,999 shares of Series G preferred stock were converted

to 2,502,005 shares of common stock.

Restricted Stock Units

During the year ended December

31, 2024 and 2023, the Company granted 283,333 and 50,000 restricted stock units (RSUs), respectively, to its executive officers under

its Amended and Restated 2019 Omnibus Stock Incentive Plan with a weighted average grant date fair value of $ 3.47 and $ 3.30 per share,

respectively.

The remaining balance of approximately $ 18,300,000 under the ATM program related to the 2020 Shelf Registration expired

in November 2023.

in August 2021, the Company filed a new shelf registration statement (the “2021 Shelf Registration”) for the issuance of

up to $ 150,000,000 of shares of its common stock of which $ 104,400,000 is currently available for the issuance of equity, debt or equity-linked

June 28, 2023, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with RBC Capital Markets,

LLC and Truist Securities, Inc., as representatives of the several underwriters named therein, relating to the issuance and sale of an

aggregate of 7,500,000 shares of the Company’s common stock, and, in lieu of common stock to certain investors, pre-funded warrants

to purchase 2,500,625 shares of common stock to the underwriters.

Pursuant to the Underwriting Agreement, the Company also granted the

underwriters a 30-day option to purchase up to 1,500,093 additional shares of common stock.

offering, pursuant to the 2021 Shelf Registration, closed on July 3, 2023.

Upon closing, the Company issued and sold an aggregate of

7,500,000 shares of its common stock at a public offering price of $ 4.00 per share and, in lieu of common stock to certain investors,

pre-funded warrants to purchase up to an aggregate of 2,500,625 shares of its commons stock at a price of $ 3.999 per pre-funded warrant

(see Pre-Funded Warrants below).

The Company realized net proceeds of approximately $ 37,300,000 from the sale of its common stock and

the pre-funded warrants.

On July 26, 2023, the underwriters’ representatives fully exercised the option to purchase additional

shares of the Company’s common stock, and on July 28, 2023, the Company issued and sold an aggregate of 1,500,093 shares of its

common stock at the public offering price of $ 4.00 per share, less underwriting discounts and commissions, and the Company realized net

proceeds of approximately $ 5,600,000 .

the year ended December 31, 2023, the Company issued an aggregate of 79,041 shares of its common stock upon exercise of stock options,

resulting in net proceeds to the Company of approximately $ 288,000 .

the year ended December 31, 2022, the Company issued an aggregate of 24,500 shares of its common stock, upon cash exercise of warrants,

resulting in net proceeds to the Company of approximately $ 129,000 .

May 2022, the Company granted 207,469 restricted stock units (“RSUs”) to its Chief Executive Officer under its Amended and

Restated 2019 Omnibus Stock Incentive Plan with a weighted average grant date fair value of $ 3.38 per share.

The fair market value of

the RSUs was estimated to be the closing price of the Company’s common stock on the date of grant.

These RSUs vest as to 50 % on

the first anniversary of the grant date, as to 30 % on the second anniversary of the grant date, and as to 20 % on the third anniversary

of the grant date, subject to continued service as an employee or consultant through the applicable vesting date.

May 2023, 103,734 RSUs vested pursuant to a grant made to its Chief Executive Officer, of which 66,291 shares of common stock were issued

by the Company and 37,443 shares were withheld in lieu of withholding taxes.

In December 2023, the Company granted 50,000 RSUs to its Chief Legal

Officer under its Amended and Restated 2019 Omnibus Stock Incentive Plan with a weighted average grant date fair value of $ 3.30 per share.

The fair market value of the RSUs was estimated to be the closing price of the Company’s common stock on the date of grant.

RSUs vest over four years in four equal installments on the first four anniversaries of the applicable grant date, subject to continued

service as an employee or consultant through the applicable vesting date.

the year ended December 31, 2023 and 2022, compensation expense recorded for the RSUs was $ 262,000 and $ 226,000 , respectively.

compensation expense for these RSUs amounted to $ 378,000 .

The expected weighted average period for the expense to be recognized is 1.6

The fair market value of the RSUs was estimated to be the closing price of the Company’s common stock on the date

The RSUs issued during the year ended December 31, 2024 vest 25 % on the grant date and 25 % each on the first, second and third

anniversaries of the grant date, subject to continued service as an employee or consultant through the applicable vesting date.

the year ended December 31, 2024, the Company issued 42,844 shares upon the vesting of 25 % of these RSUs on the grant date and 27,989

shares were withheld in lieu of withholding taxes.

The RSUs issued during the year ended December 31, 2023 vest over four years in four

equal installments on the first four anniversaries of the applicable grant date, subject to continued service as an employee or consultant

through the applicable vesting date.

In December 2024, 12,500 of these RSUs vested which resulted in the issuance of 6,456 shares of

common stock and 6,044 shares were withheld in lieu of withholding taxes.

During the year ended December

31, 2024 and 2023, 62,241 and 103,734 RSUs vested, respectively, pursuant to a grant made to the Company’s chief executive officer

in May 2022, of which 35,259 and 66,291 shares of common stock were issued by the Company, respectively, and 26,982 and 37,443 shares,

respectively, were withheld in lieu of withholding taxes.

The Company recorded $ 690,000

and $ 262,000 compensation expense for the year ended December 31, 2024 and 2023, respectively.

As of December 31, 2024, unrecognized

compensation expense for RSUs amounted to $ 671,000 and the expected weighted average period for the expense to be recognized is 1.5 years.

As of December 31, 2024, the Company had 291,494 outstanding RSUs.

Company is authorized to issue up to 2,000,000 shares of preferred stock in one or more series without stockholder approval.

The Company’s

board of directors has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend

rights, conversion rights, redemption privileges and liquidation preferences, of each series of preferred stock.

Of the 2,000,000 shares

of preferred stock authorized, the Company’s board of directors has designated (all with par value of $ 0.001 per share) the following:

As of December 31, 2023 and 2022

Outstanding Liquidation

(Per Share) Total

Series C-3 2,000 $ 10.00 $ 20,000

Series E 89,623 $ 49.20 $ 4,409,452

Series G 89,999 $ 187.36 $ 16,862,213

Total 181,622 $ 21,291,665

following rights, privileges, terms and condition apply to the outstanding preferred stock at December 31, 2023:

C-3 Non-Voting Preferred Stock

The Series C-3 non-voting preferred stock will rank senior to our common stock;

senior to any class or series of capital

stock created after the issuance of the Series C-3 non-voting preferred stock;

and junior to the Series E voting convertible preferred

stock in each case, as to dividends or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily or

involuntarily.

Each share of Series C-3 preferred stock is convertible into 2 shares of our common stock (subject to adjustment in the event of

stock dividends and distributions, stock splits, stock combinations, or reclassifications affecting our common stock) at a per share

price of $ 5.00 at any time at the option of the holder, except that a holder will be prohibited from converting shares of Series C-3

preferred stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially

own more than 9.99 % of the total number of shares of our common stock then issued and outstanding.

In the event of our liquidation, dissolution or winding up, holders of Series C-3 preferred stock will receive a payment

equal to $ 10.00 per share of Series C-3 preferred stock before any proceeds are distributed to the holders of our common stock.

the payment of this preferential amount, and subject to the rights of holders of any class or series of our capital stock hereafter created

specifically ranking by its terms senior to the Series C-3 preferred stock and holders of Series C-3 preferred stock will participate

ratably in the distribution of any remaining assets with the common stock and any other class or series of our capital stock hereafter

created that participates with the common stock in such distributions.

Shares of Series C-3 preferred stock will generally have no voting rights, except as required by law and except that the

consent of holders of two thirds of the outstanding Series C-3 preferred Stock will be required to amend the terms of the Series C-3

preferred stock or the certificate of designation for the Series C-3 preferred stock.

Holders of Series C-3 preferred stock are entitled to receive, and we are required to pay, dividends on shares of the Series C-3

preferred stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the

form of common stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of

common stock) are paid on shares of the common stock.

We are not obligated to redeem or repurchase any shares of Series C-3 preferred stock.

Shares of Series C-3 preferred stock are not

otherwise entitled to any redemption rights, or mandatory sinking fund or analogous fund provisions.

There is no established public trading market for the Series C-3 preferred stock, and we do not expect a market to develop.

we do not intend to apply for listing of the Series C-3 preferred stock on any national securities exchange or trading system.

Transactions.

If, at any time that shares of Series C-3 preferred stock are outstanding, we effect a merger or other change of control

transaction, as described in the certificate of designation and referred to as a fundamental transaction, then a holder will have the

right to receive, upon any subsequent conversion of a share of Series C-3 preferred stock (in lieu of conversion shares) for each issuable

conversion share, the same kind and amount of securities, cash or property as such holder would have been entitled to receive upon the

occurrence of such fundamental transaction if such holder had been, immediately prior to such fundamental transaction, the holder of

a share of common stock.

E Voting Convertible Preferred Stock

The Series E voting preferred stock will rank senior to our common stock;

senior to any class or series of capital stock created

after the issuance of the Series E voting convertible preferred stock;

senior to the Series C-3 non-voting convertible preferred stock;

and on parity with the Series G voting convertible preferred stock in each case, as to dividends or distributions of assets upon our

liquidation, dissolution or winding up whether voluntarily or involuntarily.

Each share of Series E preferred stock is convertible into 4.3733 shares of our common stock (subject to adjustment as provided in

the certificates of designation for the Series E preferred stock) at a per share price of $ 3.75 at any time at the option of the holder,

except that a holder will be prohibited from converting shares of Series E preferred stock into shares of common stock if, as a result

of such conversion, such holder, together with its affiliates, would beneficially own more than 4.99 % of the total number of shares of

our common stock then issued and outstanding.

In the event of our liquidation, dissolution or winding up, holders of Series E preferred stock will receive a payment

equal to $ 49.20 per share of Series E preferred stock on parity with the payment of the liquidation preference due the Series G preferred

stock, but before any proceeds are distributed to the holders of common stock, and the Series C-3 non-voting convertible preferred stock.

After the payment of this preferential amount, holders of Series E preferred stock will participate ratably in the distribution of any

remaining assets with the common stock and any other class or series of our capital stock that participates with the common stock in

such distributions.

Shares of Series E preferred stock are entitled to vote on an as-converted basis, based upon an assumed conversion price

Holders of Series E preferred stock are entitled to receive, and we are required to pay, dividends on shares of the Series E preferred

stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common

Preferred Stock

The Company is authorized

to issue up to 2,000,000 shares of preferred stock in one or more series without stockholder approval.

The Company’s board of directors

has the discretion to determine the rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion

rights, redemption privileges and liquidation preferences, of each series of preferred stock.

Of the 2,000,000 shares of preferred stock

authorized, the Company’s board of directors has designated (all with par value of $ 0.001 per share) the following:

As of December 31, 2024

As of December 31, 2023

The following rights, privileges,

terms and conditions apply to the outstanding preferred stock at December 31, 2024:

Series C-3 Non-Voting Preferred Stock

The Series C-3

non-voting preferred stock will rank senior to our common stock;

senior to any class or series of capital stock created after

the issuance of the Series C-3 non-voting preferred stock;

and junior to the Series E voting convertible preferred stock in each case,

as to dividends or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily or involuntarily.

of Series C-3 preferred stock is convertible into 2 shares of our common stock (subject to adjustment in the event of stock dividends

and distributions, stock splits, stock combinations, or reclassifications affecting our common stock) at a per share price of $ 5.00 at

any time at the option of the holder, except that a holder will be prohibited from converting shares of Series C-3 preferred stock into

shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than

9.99 % of the total number of shares of our common stock then issued and outstanding.

Liquidation Preference.

In the event of our liquidation, dissolution or winding up, holders of Series C-3 preferred stock will receive a payment equal to

$ 10.00 per share of Series C-3 preferred stock before any proceeds are distributed to the holders of our common stock.

After the payment

of this preferential amount, and subject to the rights of holders of any class or series of our capital stock hereafter created specifically

ranking by its terms senior to the Series C-3 preferred stock and holders of Series C-3 preferred stock will participate ratably in the

distribution of any remaining assets with the common stock and any other class or series of our capital stock hereafter created that

participates with the common stock in such distributions.

Voting Rights.

of Series C-3 preferred stock will generally have no voting rights, except as required by law and except that the consent of holders

of two thirds of the outstanding Series C-3 preferred Stock will be required to amend the terms of the Series C-3 preferred stock or

the certificate of designation for the Series C-3 preferred stock.

of Series C-3 preferred stock are entitled to receive, and we are required to pay, dividends on shares of the Series C-3 preferred stock

equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common

stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock)

are paid on shares of the common stock.

We are not obligated to redeem or repurchase any shares of Series E preferred stock.

Shares of Series E preferred stock are not otherwise

not obligated to redeem or repurchase any shares of Series C-3 preferred stock.

Shares of Series C-3 preferred stock are not otherwise

entitled to any redemption rights, or mandatory sinking fund or analogous fund provisions.

There is no established public trading market for the Series E preferred stock, and we do not expect a market to develop.

we do not intend to apply for listing of the Series E preferred stock on any national securities exchange or trading system.

Transactions.

If, at any time that shares of Series E preferred stock are outstanding, we effect a merger or other change of control

transaction, as described in the certificate of designation and referred to as a fundamental transaction, then a holder will have the

right to receive, upon any subsequent conversion of a share of Series E preferred stock (in lieu of conversion shares) for each issuable

conversion share, the same kind and amount of securities, cash or property as such holder would have been entitled to receive upon the

occurrence of such fundamental transaction if such holder had been, immediately prior to such fundamental transaction, the holder of

a share of common stock.

As long as any of the Series E preferred stock is outstanding, we cannot create, incur, guarantee, assume or suffer

to exist any indebtedness, other than (i) trade payables incurred in the ordinary course of business consistent with past practice, and

(ii) up to $ 10 million aggregate principal amount of indebtedness with a maturity less than twelve months outstanding at any time, which

amount may include up to $ 5 million of letters of credit outstanding at any time.

In addition to the debt restrictions above, as long as any of the Series E preferred stock is outstanding, we cannot,

among others things:

no established public trading market for the Series C-3 preferred stock, and we do not expect a market to develop.

In addition, we do

not intend to apply for listing of the Series C-3 preferred stock on any national securities exchange or trading system.

Fundamental Transactions.

If, at any time that shares of Series C-3 preferred stock are outstanding, we effect a merger or other change of control transaction,

as described in the certificate of designation and referred to as a fundamental transaction, then a holder will have the right to receive,

upon any subsequent conversion of a share of Series C-3 preferred stock (in lieu of conversion shares) for each issuable conversion share,

the same kind and amount of securities, cash or property as such holder would have been entitled to receive upon the occurrence of such

fundamental transaction if such holder had been, immediately prior to such fundamental transaction, the holder of a share of common stock.

Series E Voting Convertible Preferred Stock

voting preferred stock will rank senior to our common stock;

senior to any class or series of capital stock created after the issuance

of the Series E voting convertible preferred stock;

senior to the Series C-3 non-voting convertible preferred stock;

and on parity with

the Series G voting convertible preferred stock in each case, as to dividends or distributions of assets upon our liquidation, dissolution

or winding up whether voluntarily or involuntarily.

of Series E preferred stock is convertible into 4.3733 shares of our common stock (subject to adjustment as provided in the certificates

of designation for the Series E preferred stock) at a per share price of $ 3.75 at any time at the option of the holder, except that a

holder will be prohibited from converting shares of Series E preferred stock into shares of common stock if, as a result of such conversion,

such holder, together with its affiliates, would beneficially own more than 4.99 % of the total number of shares of our common stock then

issued and outstanding.

Liquidation Preference.

In the event of our liquidation, dissolution or winding up, holders of Series E preferred stock will receive a payment equal to $ 49.20

per share of Series E preferred stock on parity with the payment of the liquidation preference due the Series G preferred stock, but

before any proceeds are distributed to the holders of common stock, and the Series C-3 non-voting convertible preferred stock.

the payment of this preferential amount, holders of Series E preferred stock will participate ratably in the distribution of any remaining

assets with the common stock and any other class or series of our capital stock that participates with the common stock in such distributions.

Voting Rights.

of Series E preferred stock are entitled to vote on an as-converted basis, based upon an assumed conversion price of $ 7.93 .

of Series E preferred stock are entitled to receive, and we are required to pay, dividends on shares of the Series E preferred stock

equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common

stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock)

are paid on shares of the common stock.

not obligated to redeem or repurchase any shares of Series E preferred stock.

Shares of Series E preferred stock are not otherwise entitled

to any redemption rights, or mandatory sinking fund or analogous fund provisions.

no established public trading market for the Series E preferred stock, and we do not expect a market to develop.

In addition, we do not

intend to apply for listing of the Series E preferred stock on any national securities exchange or trading system.

Fundamental Transactions.

If, at any time that shares of Series E preferred stock are outstanding, we effect a merger or other change of control transaction,

as described in the certificate of designation and referred to as a fundamental transaction, then a holder will have the right to receive,

upon any subsequent conversion of a share of Series E preferred stock (in lieu of conversion shares) for each issuable conversion share,

the same kind and amount of securities, cash or property as such holder would have been entitled to receive upon the occurrence of such

fundamental transaction if such holder had been, immediately prior to such fundamental transaction, the holder of a share of common stock.

Debt Restriction.

As long as any of the Series E preferred stock is outstanding, we cannot create, incur, guarantee, assume or suffer to exist any indebtedness,

other than (i) trade payables incurred in the ordinary course of business consistent with past practice, and (ii) up to $ 10 million aggregate

principal amount of indebtedness with a maturity less than twelve months outstanding at any time, which amount may include up to $ 5 million

of letters of credit outstanding at any time.

Other Covenants.

addition to the debt restrictions above, as long as any of the Series E preferred stock is outstanding, we cannot, among others things:

create, incur, assume or suffer to exist any encumbrances on any of our assets or property;

redeem, repurchase or

pay any cash dividend or distribution on any of our capital stock (other than as permitted, which includes the dividends on the Series

E preferred stock and Series G preferred stock);

redeem, repurchase or pay any cash dividend

or distribution on any of our capital stock (other than as permitted, which includes the dividends on the Series E preferred stock and

Series G preferred stock);

redeem, repurchase or prepay any indebtedness (other than as permitted);

any material line of business substantially different from our current lines of business.

In the event we issue any options, convertible securities or rights to purchase stock or other securities pro rata to the

holders of common stock, then a holder of Series E preferred stock will be entitled to acquire, upon the same terms a pro rata amount

of such stock or securities as if the Series E preferred stock had been converted to common stock.

G Voting Convertible Preferred Stock

The Series G voting convertible preferred stock will rank senior to our common stock;

senior to any class or series of capital stock

created after the issuance of the Series G voting convertible preferred stock;

junior to the Series C-3 non-voting convertible preferred

stock, pending the consent of the holders of such series to the subordination thereof;

and on parity with the Series E voting convertible

preferred stock in each case, as to dividends or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily

or involuntarily.

Each share of Series G preferred stock is convertible into approximately 55.5978 shares of our common stock (subject to adjustment as

provided in the certificate of designation for the Series G preferred stock) at a per share price of $ 3.37 at any time at the option

of the holder, except that a holder will be prohibited from converting shares of Series G preferred stock into shares of common stock

if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than 4.99 % of the total number

of shares of our common stock then issued and outstanding.

In the event of our liquidation, dissolution or winding up, holders of Series E preferred stock will receive a payment

equal to $ 187.36452 per share of Series G preferred stock on parity with the payment of the liquidation preference due the Series E preferred

stock, but before any proceeds are distributed to the holders of Series C-3 preferred stock (pending the consent of the holders of such

series to the subordination thereof) and any proceeds are distributed to the holders of common stock.

After the payment of this preferential

amount, holders of Series G preferred stock will participate ratably in the distribution of any remaining assets with the common stock

and any other class or series of our capital stock that participates with the common stock in such distributions.

Shares of Series G preferred stock are entitled to vote on an as-converted basis, based upon an assumed conversion price

Holders of Series G Preferred stock are entitled to receive, and we are required to pay, dividends on shares of the Series G preferred

stock equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common

or engage in any material line of

business substantially different from our current lines of business.

Purchase Rights.

the event we issue any options, convertible securities or rights to purchase stock or other securities pro rata to the holders of common

stock, then a holder of Series E preferred stock will be entitled to acquire, upon the same terms a pro rata amount of such stock or

securities as if the Series E preferred stock had been converted to common stock.

Series G Voting Convertible Preferred Stock

voting convertible preferred stock will rank senior to our common stock;

senior to any class or series of capital stock created after

the issuance of the Series G voting convertible preferred stock;

junior to the Series C-3 non-voting convertible preferred stock, pending

the consent of the holders of such series to the subordination thereof;

and on parity with the Series E voting convertible preferred

stock in each case, as to dividends or distributions of assets upon our liquidation, dissolution or winding up whether voluntarily or

involuntarily.

of Series G preferred stock is convertible into approximately 55.5978 shares of our common stock (subject to adjustment as provided in

the certificate of designation for the Series G preferred stock) at a per share price of $ 3.37 at any time at the option of the holder,

except that a holder will be prohibited from converting shares of Series G preferred stock into shares of common stock if, as a result

of such conversion, such holder, together with its affiliates, would beneficially own more than 4.99 % of the total number of shares of

our common stock then issued and outstanding.

Liquidation Preference .

In the event of our liquidation, dissolution or winding up, holders of Series E preferred stock will receive a payment equal to $187.36452

per share of Series G preferred stock on parity with the payment of the liquidation preference due the Series E preferred stock, but

before any proceeds are distributed to the holders of Series C-3 preferred stock (pending the consent of the holders of such series to

the subordination thereof) and any proceeds are distributed to the holders of common stock.

After the payment of this preferential amount,

holders of Series G preferred stock will participate ratably in the distribution of any remaining assets with the common stock and any

other class or series of our capital stock that participates with the common stock in such distributions.

Voting Rights .

of Series G preferred stock are entitled to vote on an as-converted basis, based upon an assumed conversion price of $ 7.93 .

of Series G Preferred stock are entitled to receive, and we are required to pay, dividends on shares of the Series G preferred stock

equal (on an as-if-converted-to-common-stock basis) to and in the same form as dividends (other than dividends in the form of common

stock) actually paid on shares of the common stock when, as and if such dividends (other than dividends in the form of common stock)

are paid on shares of the common stock.

We are not obligated to redeem or repurchase any shares of Series G preferred stock.

Shares of Series G preferred stock are not otherwise

entitled to any redemption rights, or mandatory sinking fund or analogous fund provisions.

There is no established public trading market for the Series G preferred stock, and we do not expect a market to develop.

we do not intend to apply for listing of the Series G preferred stock on any national securities exchange or trading system.

Transactions .

If, at any time that shares of Series G preferred stock are outstanding, we effect a merger or other change of control

transaction, as described in the certificate of designation and referred to as a fundamental transaction, then a holder will have the

right to receive, upon any subsequent conversion of a share of Series G preferred stock (in lieu of conversion shares) for each issuable

conversion share, the same kind and amount of securities, cash or property as such holder would have been entitled to receive upon the

occurrence of such fundamental transaction if such holder had been, immediately prior to such fundamental transaction, the holder of

a share of common stock.

Restriction .

As long as any of the Series G preferred stock is outstanding, we cannot create, incur, guarantee, assume or suffer

to exist any indebtedness, other than (i) trade payables incurred in the ordinary course of business consistent with past practice, and

(ii) up to $ 10 million aggregate principal amount of indebtedness with a maturity less than twelve months outstanding at any time, which

amount may include up to $ 5 million of letters of credit outstanding at any time.

In addition to the debt restrictions above, as long as any of the Series G preferred stock is outstanding, we cannot,

among others things:

not obligated to redeem or repurchase any shares of Series G preferred stock.

Shares of Series G preferred stock are not otherwise entitled

to any redemption rights, or mandatory sinking fund or analogous fund provisions.

no established public trading market for the Series G preferred stock, and we do not expect a market to develop.

In addition, we do not

intend to apply for listing of the Series G preferred stock on any national securities exchange or trading system.

Fundamental Transactions .

If, at any time that shares of Series G preferred stock are outstanding, we effect a merger or other change of control transaction, as

described in the certificate of designation and referred to as a fundamental transaction, then a holder will have the right to receive,

upon any subsequent conversion of a share of Series G preferred stock (in lieu of conversion shares) for each issuable conversion share,

the same kind and amount of securities, cash or property as such holder would have been entitled to receive upon the occurrence of such

fundamental transaction if such holder had been, immediately prior to such fundamental transaction, the holder of a share of common stock.

Debt Restriction .

As long as any of the Series G preferred stock is outstanding, we cannot create, incur, guarantee, assume or suffer to exist any indebtedness,

other than (i) trade payables incurred in the ordinary course of business consistent with past practice, and (ii) up to $ 10 million aggregate

principal amount of indebtedness with a maturity less than twelve months outstanding at any time, which amount may include up to $ 5 million

of letters of credit outstanding at any time.

Other Covenants .

addition to the debt restrictions above, as long as any of the Series G preferred stock is outstanding, we cannot, among others things:

create, incur, assume or suffer to exist any encumbrances on any of our assets or property;

redeem, repurchase or

pay any cash dividend or distribution on any of our capital stock (other than as permitted, which includes the dividends on the Series

E preferred stock and the Series G preferred stock);

redeem, repurchase or pay any cash dividend

or distribution on any of our capital stock (other than as permitted, which includes the dividends on the Series E preferred stock and

the Series G preferred stock);

redeem, repurchase or prepay any indebtedness (other than as permitted);

in any material line of business substantially different from our current lines of business.

In the event we issue any options, convertible securities or rights to purchase stock or other securities pro rata to the

holders of common stock, then a holder of Series G preferred stock will be entitled to acquire, upon the same terms a pro rata amount

of such stock or securities as if the Series G preferred stock had been converted to common stock.

October 13, 2022, the Company’s shareholders approved the CorMedix Inc.

Amended and Restated 2019 Omnibus Stock Incentive Plan

(the “2022 Plan”), pursuant to which the Company may issue as additional 4,800,000 shares of its common stock, plus any shares

that remain available for grant under its existing plan as of the effective date, as long-term equity incentives to the Company’s

employees, consultants, and directors.

The long-term incentives may be in the form of stock options, stock appreciation rights, restricted

stock, restricted stock units, dividend equivalent rights, or other rights or benefits (collectively, “stock rights”) to

employees, consultants, and directors of the Company or a related entity (collectively, “participants”).

The Company believes

that the effective use of long- term equity incentives is essential to attract, motivate, and retain employees, consultants and directors,

to further align participants’ interests with those of the Company’s stockholders, and to provide participants incentive

compensation opportunities that are competitive with those offered by other companies in the same industry and locations as the Company.

or engage in any material line

of business substantially different from our current lines of business.

Purchase Rights .

the event we issue any options, convertible securities or rights to purchase stock or other securities pro rata to the holders of common

stock, then a holder of Series G preferred stock will be entitled to acquire, upon the same terms a pro rata amount of such stock or

securities as if the Series G preferred stock had been converted to common stock.

Stock Options:

On October 13, 2022, the

Company’s shareholders approved the CorMedix Inc.

Amended and Restated 2019 Omnibus Stock Incentive Plan (the “2022 Plan”),

pursuant to which the Company may issue as additional 4,800,000 shares of its common stock, respectively, plus any shares that remain

available for grant under its existing plan as of the effective date, as long-term equity incentives to the Company’s employees,

consultants, and directors.

On November 21, 2024, the Company’s shareholders approved Amendment No.

1 to the 2022 Plan, which increased

the number of shares authorized for issuance by an additional 3,360,000 shares.

The long-term incentives may be in the form of stock

options, stock appreciation rights, restricted stock, restricted stock units, dividend equivalent rights, or other rights or benefits

(collectively, “stock rights”) to employees, consultants, and directors of the Company or a related entity (collectively,

“participants”).

The Company believes that the effective use of long- term equity incentives is essential to attract, motivate,

and retain employees, consultants and directors, to further align participants’ interests with those of the Company’s stockholders,

and to provide participants incentive compensation opportunities that are competitive with those offered by other companies in the same

industry and locations as the Company.

The 2022 Plan amends and

1 unchanged sentence

The 2013 Stock Incentive Plan and the Amended and Restated 2006 Stock Incentive Plan are referred

to collectively as the “Prior Plans”.

No further awards will be granted under the Prior Plans.

to collectively as the “Prior Plans.” No further awards will be granted under the Prior Plans.

Awards outstanding under the

Prior Plans will remain outstanding in accordance with their terms and the Prior Plans.

the years ended December 31, 2023 and 2022, the Company granted ten-year qualified and non-qualified stock options to its officers, directors,

employees and consultants covering an aggregate of 2,536,200 and 1,627,850 shares of the Company’s common stock under the 2019

Plan, respectively.

The weighted average exercise price of these options is $ 4.18 and $ 3.83 per share, respectively.

the year ended December 31, 2023, the Company issued 79,041 shares of common stock as a result of the exercise of stock options.

Company realized net proceeds of $ 288,000 from the exercise of stock options with a weighted average exercise price of $ 3.64 per share.

During the years ended December 31, 2023 and 2022, total compensation

expense for stock options issued to employees, directors, officers and consultants was $ 5,232,000 and $ 3,843,000 , respectively.

December 31, 2023, there was $ 6,145,000 total unrecognized compensation expense related to unvested stock options granted which expense

is expected to be recognized over an expected remaining weighted average period of 1.6 years.

All share-based awards are recognized on

a straight-line method, assuming all awards granted will vest.

Forfeitures of share-based awards are recognized in the period in which

fair value at grants dates of the grants issued subject to service and performance-based vesting conditions were determined using the

Black-Scholes option pricing model with the following assumptions:

Ended December 31,

interest rate

During the years ended December

31, 2024 and 2023, the Company granted ten-year qualified and non-qualified stock options to its officers, directors, employees and consultants

covering an aggregate of 2,196,167 and 2,536,200 shares of the Company’s common stock under the 2019 Plan, respectively.

average exercise price of these options is $ 3.80 and $ 4.18 per share, respectively.

During the years ended December

31, 2024 and 2023, the Company issued 1,357,802 and 79,041 shares of common stock, respectively, as a result of the exercise of stock

The Company realized net proceeds of $ 7,724,000 and $ 288,000 , respectively, from the exercise of stock options with a weighted

average exercise price of $ 5.69 and $ 3.64 per share, respectively.

During the years ended December

31, 2024 and 2023, total compensation expense for stock options issued to employees, directors, officers and consultants was $ 5,439,000

and $ 5,232,000 , respectively.

As of December 31, 2024, there was $ 6,363,000 total unrecognized compensation expense related to unvested

stock options granted which expense is expected to be recognized over an expected remaining weighted average period of 1.4 years.

share-based awards are recognized on a straight-line method, assuming all awards granted will vest.

Forfeitures of share-based awards

are recognized in the period in which they occur.

The fair value at grants

dates of the grants issued subject to service and performance-based vesting conditions were determined using the Black-Scholes option

pricing model with the following assumptions:

Year Ended December 31,

Risk-free interest rate

3.60 % - 4.65 %

3.45 % - 4.81 %

Expected volatility

93.2 % - 100.5 %

92.2 % - 105.7 %

2.75 – 5 years

dividend yield

Weighted-average

grant date fair value of options granted during the period

Average Expected term (years)

Expected dividend yield

Weighted-average grant date fair value of options granted during the period

The Company estimated the

1 unchanged sentence

The expected term of the stock options granted

to consultants is based upon the full term of the respective option agreements.

The expected stock price volatility for the Company’s

stock options is calculated based on the historical volatility of the Company’s common stock.

The expected dividend yield of 0.0 %

reflects the Company’s current and expected future policy for dividends on the Company’s common stock.

To determine the risk-free

interest rate, the Company utilized the U.S.

Treasury yield curve in effect at the time of grant with a term consistent with the expected

term of the Company’s awards which is 5 years for employees and 10 years for non-employees.

to consultants, if any, is based upon the full term of the respective option agreements.

The expected stock price volatility for the

Company’s stock options is calculated based on the historical volatility of the Company’s common stock.

The expected dividend

yield of 0.0 % reflects the Company’s current and expected future policy for dividends on the Company’s common stock.

the risk-free interest rate, the Company utilized the U.S.

Treasury yield curve in effect at the time of grant with a term consistent

with the expected term of the Company’s awards.

The following table summarizes

the Company’s stock options activity and related information for the year ended December 31, 2024:

Options Weighted-

Price Weighted-

(Years) Aggregate

Outstanding at December 31, 2023 6,211,508 $ 5.44 6.4 $ 700,241

Granted 2,196,167 $ 3.80 -

Exercised ( 1,357,802 ) $ 5.69 -

Expired/Canceled ( 418,932 ) $ 12.27 -

Forfeited ( 348,548 ) $ 3.68 -

Outstanding at December 31, 2024 6,282,393 $ 4.46 7.8 $ 23,567,676

Vested at December 31, 2024 3,377,378 $ 4.91 7.1 $ 11,415,702

Expected to vest in the

aggregate intrinsic value is calculated as the difference between the exercise prices of the underlying options and the quoted closing

price of the common stock of the Company at the end of the reporting period for those options that have an exercise price below the quoted

closing price.

During the year ended December

31, 2022, the Company issued an aggregate of 24,500 shares of its common stock upon cash exercise of warrants, resulting in net proceeds

to the Company of $ 129,000 .

Except for the pre-funded warrants described below, there were no outstanding warrants at December 31, 2023

On July 3, 2023, pursuant to the Underwriting Agreement, the Company’s

issued pre-funded warrants to purchase 2,500,625 shares of its common stock to certain investors.

The pre-funded warrants to purchase

up to an aggregate of 2,500,625 shares of the Company’s commons stock had a price of $ 3.999 per pre-funded warrant, which represents

the per share public offering price for the common stock less the $ 0.001 per share exercise price for each such pre-funded warrant pursuant

to the Underwriting Agreement.

The Company realized net proceeds of approximately $ 9,400,000 from the sale of the pre-funded warrants.

Deferred Compensation Plan for Non-Employee Directors

In 2014, the Company established an unfunded stock-based deferred compensation

plan, providing non-employee directors the opportunity to defer up to one hundred percent of fees and compensation, including restricted

The amount of fees and compensation deferred by a non-employee director is converted into stock units, the number of

which is determined based on the closing price of the Company’s common stock on the date such compensation would have otherwise

been payable.

At all times, the plan participants are one hundred percent vested in their respective deferred compensation accounts.

On the tenth business day of January in the year following a director’s termination of service, the director will receive a number

of common shares equal to the number of stock units accumulated in the director’s deferred compensation account.

accounts for this plan as stock-based compensation under ASC 718.

During the years ended December 31, 2023 and 2022 no compensation

was deferred under this plan.

Company entered into a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights,

New Jersey 07922.

The lease agreement, with a monthly average cost of approximately $ 17,000 commenced on September 16, 2020.

Company entered into an operating lease for office space in Germany that began in July 2017.

The rental agreement has a three-month term

which automatically renews and includes a monthly cost of 400 Euros.

The Company elected to apply the short-term practical expedient

to the office lease.

The Company also has an operating lease for office equipment.

lease expense in the Company’s consolidated statements of operations and comprehensive loss for the year ended December 31, 2023

and 2022 was approximately $ 207,000 and $ 208,000 , respectively, which includes costs associated with leases for which ROU assets have

been recognized as well as short-term leases.

December 31, 2023, the Company has a total operating lease liability of $ 668,000 , of which approximately $ 151 ,000 and $ 517 ,000 were classified

as operating lease liabilities, short-term and operating lease liabilities, net of current portion, respectively, on the consolidated

Expected to vest in the future 2,905,015 $ 3.93 8.6 $ 12,151,975

The aggregate intrinsic value

is calculated as the difference between the exercise prices of the underlying options and the quoted closing price of the common stock

of the Company at the end of the reporting period for those options that have an exercise price below the quoted closing price.

Stock-based Deferred Compensation Plan for Non-Employee Directors

In 2014, the Company established

an unfunded stock-based deferred compensation plan, providing non-employee directors the opportunity to defer up to one hundred percent

of fees and compensation, including restricted stock units.

The amount of fees and compensation deferred by a non-employee director is

converted into stock units, the number of which is determined based on the closing price of the Company’s common stock on the date

such compensation would have otherwise been payable.

At all times, the plan participants are one hundred percent vested in their respective

deferred compensation accounts.

On the tenth business day of January in the year following a director’s termination of service,

the director will receive a number of common shares equal to the number of stock units accumulated in the director’s deferred compensation

The Company accounts for this plan as stock-based compensation under ASC 718.

During the years ended December 31, 2024

and 2023 no compensation was deferred under this plan.

Note 9 — Leases:

The Company entered into

a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey 07922.

lease agreement, with a monthly average cost of approximately $ 17,000 commenced on September 16, 2020.

The Company entered into an operating lease for

office space in Germany that began in July 2017.

The rental agreement has a three-month term which automatically renews and includes

a monthly cost of 400 Euros.

The operating lease was terminated in June 2024.

Operating lease expense in

the Company’s consolidated statements of operations and comprehensive loss for the years ended December 31, 2024 and 2023 was approximately

$ 204,000 and $ 207,000 , respectively, which includes costs associated with leases for which ROU assets have been recognized as well as

short-term leases.

At December 31, 2024, the

Company has a total operating lease liability of $ 517,000 , of which approximately $ 168 ,000 and $ 349 ,000 were classified as operating

lease liabilities, short-term and operating lease liabilities, net of current portion, respectively, on the consolidated balance sheet.

At December 31, 2023, the Company’s total operating lease liability was $ 668 ,000, of which $ 151 ,000 was classified as operating

lease liabilities, short-term and $ 517 ,000 was classified as operating lease liabilities, net of current portion, on the consolidated

balance sheet.

At December 31, 2022, the Company’s total operating lease liability was $ 803,000 , of which $ 135 ,000 was classified

as operating lease liabilities, short-term and $ 668 ,000 was classified as operating lease liabilities, net of current portion, on the

condensed consolidated balance sheet.

Operating ROU assets as of December 31, 2024 and 2023 are $ 493 ,000 and $ 640 ,000, respectively.

the year ended December 31, 2023 and 2022, cash paid for amounts included in the measurement of lease liabilities in operating cash flows

from operating leases was $ 201,000 and $ 199,000 , respectively.

of December 31, 2023 and 2022, the weighted average remaining lease term were 3.8 years and 4.8 years, respectively and the weighted

average discount rate of 9 % and 9 % at December 31, 2023 and 2022, respectively.

of December 31, 2023, maturities of lease liabilities were as follows:

2027 and thereafter

For the years ended December

31, 2024 and 2023, cash paid for amounts included in the measurement of lease liabilities in operating cash flows from operating leases

was $ 205,000 and $ 201,000 , respectively.

As of December 31, 2024 and

2023, the weighted average remaining lease term were 2.8 years and 3.8 years, respectively, and the weighted average discount rate of

9 % at December 31, 2024 and 2023.

As of December 31, 2024, maturities of lease liabilities

were as follows:

Total future minimum lease payments

Less imputed interest

9 — Subsequent Events:

On January 25,

2024 CMS notified the Company that the agency has determined DefenCath will be eligible for reimbursement in accordance with the ESRD

PPS, allowing the Company to submit a TDAPA application, which currently allows for two years of additional payment for certain products

to outpatient renal dialysis providers, and CMS recently adopted a three-year post-TDAPA add-on payment adjustment.

submitted its TDAPA application on January 26, 2024 after receiving the CMS notification.

As a result of CMS’ determination

that DefenCath is within the scope of the ESRD PPS and eligible for TDAPA, the Company established a WAC of $ 249.99 per 3ml vial, to account

for the market dynamics and functionality of the TDAPA framework.

In addition, as discussed above, the Company previously applied for

and received conditional NTAP from CMS for inpatient reimbursement of DefenCath for the FY 2024 IPPS.

As a result of the Company having

established a WAC price for commercialization, the NTAP reimbursement payment to inpatient facilities may also be adjusted.

NTAP was conditioned

upon the DefenCath NDA obtaining final FDA approval prior to July 1, 2024.

The Company intends to work closely with CMS on obtaining TDAPA

and the TDAPA implementation process.

2024, the Company received net proceeds of approximately $ 1,395,000 from the sale of its remaining unused New Jersey state NOL that was

eligible for sale under the NJEDA Program for the state fiscal year 2023.

The NJEDA Program allowed the Company to sell approximately

$ 1,529,000 of its total $ 1,529,000 in available NOL tax benefits for state fiscal year 2023.

Note 10 — Segment Reporting

As noted above, the Company’s primary focus

is the commercialization of our lead product, DefenCath indicated to reduce the incidence of catheter-related bloodstream infections

in adult patients with kidney failure receiving chronic hemodialysis through a CVC.

The Company has determined that it currently operates

in a single segment - Drug Product, located in a single geographic location – the United States.

The accounting policies of the

segment are the same as those described in the summary of significant accounting policies.

Since the Company operates in a single segment,

the measure of segment total assets and loss from operations is the same as that reported on the accompanying balance sheets as total

assets, and the accompanying statement of operations as loss from operations, respectively.

The Company’s Chief Executive Officer is the Chief Operating

Decision Maker (“CODM”).

The CODM manages the Company’s business activities as a single operating and reportable segment.

The CODM uses consolidated profit and loss to evaluate and measure performance against progress in its commercialization efforts and clinical

The following table sets forth significant segment expenses.

Research and development:

Employee expense

Other research and development

Total research and development

Selling and marketing

Employee expense

Other selling and marketing

Total selling and marketing expense

General and administrative

Employee expense

Other general and administrative

Total general and administrative expense

Total operating expenses

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures