# EDGAR Filing Document

**Accession Number:** 0001410098
**File Stem:** 0001213900-23-016996
**Filing Date:** 2023-3
**Character Count:** 15004
**Document Hash:** 1a17b7d26d524377d9734d5859d3ce3e
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-23-016996.hdr.sgml**: 20230303

**ACCESSION NUMBER**: 0001213900-23-016996

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230302

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230303

**DATE AS OF CHANGE**: 20230303

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** CorMedix Inc.
- **CENTRAL INDEX KEY:** 0001410098
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-34673
- **FILM NUMBER:** 23701560

**BUSINESS ADDRESS:**
- **STREET 1:** 300 CONNELL DRIVE
- **STREET 2:** SUITE 4200
- **CITY:** BERKELEY HEIGHTS
- **STATE:** NJ
- **ZIP:** 07922
- **BUSINESS PHONE:** 908-517-9500

**MAIL ADDRESS:**
- **STREET 1:** 300 CONNELL DRIVE
- **STREET 2:** SUITE 4200
- **CITY:** BERKELEY HEIGHTS
- **STATE:** NJ
- **ZIP:** 07922

?xml version="1.0" encoding="utf-8"?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d)**

**of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported): March 2, 2023**

**CORMEDIX INC.**

**(Exact name of registrant as specified in its charter)**

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| | | |
|:---|:---|:---|
| **Delaware** | **001-34673** | **20-5894890** |
| **(State or other jurisdiction of**<br> **incorporation or organization)** | **(Commission File Number)** | **(I.R.S. Employer**<br> **Identification No.)** |

---

---

| | |
|:---|:---|
| **300 Connell Drive, Suite 4200**<br> **Berkeley Heights, NJ**  | **07922** |
| **(Address of principal executive offices)** | **(Zip Code)** |

---

**Registrant's telephone number, including area code: (908) 517-9500**

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (*see* General Instruction A.2, below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Exchange Act:

---

| | | |
|:---|:---|:---|
| **Title of each class** | **Trading Symbol(s)** | **Name of each exchange on which registered** |
| Common stock, $0.001 par value | CRMD | The Nasdaq Stock Market LLC |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**Item 8.01 Other Events**

On March 2, 2023, CorMedix Inc. (the "Company") issued a press release announcing regulatory and manufacturing updates related to U.S. Food and Drug Administration compliance and remediation activities at the Company's contract manufacturing organization and heparin active pharmaceutical ingredient supplier. The Company further outlined manufacturing pathways for resubmission of its New Drug Application, and their respective timelines.

A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

**Item 9.01 Financial Statements and Exhibits** 

(d) Exhibits

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| | |
|:---|:---|
| Exhibit No. | Description |
| 99.1 | [Press Release issued March 2, 2023](ea174602ex99-1_cormedix.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

**SIGNATURE**

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | CORMEDIX INC. | CORMEDIX INC. |
| Date: March 3, 2023 | By: | /s/ Joseph Todisco |
|  | Name: | Joseph Todisco |
|  | Title: | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](image_001.jpg)

**CORMEDIX INC. ANNOUNCES REGULATORY AND MANUFACTURING UPDATES**

**Berkeley Heights, NJ – March 2, 2023** – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced updates related to the FDA compliance remediation activities at its primary contract manufacturing organization ("CMO") and heparin active pharmaceutical ingredient ("API") supplier, as well as updated timelines for potential resubmission of its New Drug Application ("NDA") under various scenarios. More specifically:

&nbsp;&nbsp;&nbsp;&nbsp;· CorMedix has been informed by its primary CMO ("CMO 1") that all corrective actions stemming
from the FDA's June 2022 inspection have been completed and the CMO has provided to FDA documentation showing effectiveness of the
corrective actions. The primary CMO awaits feedback from the Agency with respect to the compliance status of the facility.

&nbsp;&nbsp;&nbsp;&nbsp;· CorMedix has been informed by its existing supplier of heparin API ("API 1") that all corrective
actions related to its June 2022 FDA Warning Letter for a non-heparin API have been completed and implementation is underway, however
it is unclear to the Company based on recent FDA actions if full resolution of the outstanding warning letter would still be required
prior to approving the DefenCath NDA with reference to API 1. The supplier has informed CorMedix that it has made updates to the US Heparin
Drug Master File ("DMF") clarifying which activities take place at the site which is identified in the warning letter (early-stage
processing) and which activities take place at a different FDA registered facility (final processing and release). The supplier has also
informed CorMedix that subsequent to those updates, a supplement to an approved application referring to this DMF was recently approved
by FDA. Based on this recent approval and the update to the DMF, it is possible that full resolution of the outstanding warning letter
is no longer a barrier to FDA approval of the DefenCath NDA. The Company intends to seek confirmation from FDA on this issue as set out
below.

Previously, the Company outlined three manufacturing pathways for resubmission and the targeted timelines for each. Based on today's updates, the Company is communicating revised timelines below for each pathway.

&nbsp;&nbsp;&nbsp;&nbsp;1. CMO 1 + API 1: This scenario potentially remains the fastest pathway to NDA resubmission and approval,
provided FDA concurs that CMO 1 has remediated its compliance deficiencies and that the DMF for API 1 can be utilized prior to full resolution
of the existing warning letter. CorMedix hopes to obtain guidance from FDA on these two important issues in a Type A meeting. The Company
intends to resubmit the application as soon as possible following FDA's positive guidance on these two issues. Given that no new
data would be contained in this resubmission, provided no additional site inspections are required, the Company believes this may be classified
as a Class 1 submission with a 60-day review.

&nbsp;&nbsp;&nbsp;&nbsp;2. CMO 1 + API 2: The Company manufactured three validation batches in Q4 2022 at CMO 1 utilizing a new source
of heparin API ("API 2"). The batches are still undergoing testing and analysis. Should those batches meet specifications,
data for submission will be available in mid-April. The ability to resubmit utilizing this data requires FDA clearance of CMO 1. Given
that this submission would include new manufacturing data, the Company would expect it to be classified as a Class 2 submission with a
6-month review. CorMedix intends to wait for FDA's guidance from the Type A meeting on pathway #1, prior to pursuing a submission
with pathway #2.

&nbsp;&nbsp;&nbsp;&nbsp;3. CMO 2 + API 2: The Company previously guided to the availability of data for submission from an alternate
CMO in the first half of 2023; however, due to delays in completing validation, these data are expected to be available by the end of
the 3<sup>rd</sup> quarter of 2023. The Company remains focused on pathways #1 and #2 as its primary strategy, and currently intends to
utilize pathway #3 as a back-up manufacturing site. In the event CorMedix elects to resubmit the NDA with pathway #3 as its primary manufacturing
site, the Company would expect it to be classified as a Class 2 submission with a 6-month review.

CorMedix will provide additional clarity on these pathways on its year-end earnings call in March, and subsequent updates following its anticipated Type A meeting with FDA.

Joe Todisco, CorMedix CEO stated "I am encouraged by the solid progress made at both our existing CMO and existing heparin supplier toward resolving outstanding compliance deficiencies at their respective sites, as well as the potential precedent set by FDA in recently approving a supplement to an approved application referencing the heparin DMF. I look forward to obtaining FDAs guidance in a Type A meeting. CorMedix's goal is to obtain FDA approval of the DefenCath NDA as quickly as possible, and to do so we have created and strengthened multiple pathways to NDA resubmission. I am hopeful to have additional updates on our year-end earnings call or shortly thereafter."

**About CorMedix**

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on developing its lead product DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. The Company received a Complete Response Letter (CRL) from FDA stating that the original NDA could not be approved until deficiencies at the contract manufacturing organization (CMO) were satisfactorily resolved. FDA notified the Company in a second CRL that the refiled NDA could not be approved until satisfactory resolution of facility deficiencies identified during a pre-approval inspection at and conveyed to the CMO and during an inspection for an unrelated active pharmaceutical ingredient at and conveyed to the manufacturing facility for the heparin supplier for DefenCath. While the CMO and heparin supplier work to resolve outstanding deficiencies, CorMedix is simultaneously working to transfer the technology to an additional CMO and qualify an additional supplier of heparin. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. For more information visit: www.cormedix.com.

**Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or CorMedix's prospects, CorMedix's plans to submit a resubmission of its NDA application for DefenCath and the timing of such submission; CorMedix's future financial position, financing plans, future revenues, projected costs and the sufficiency of our cash and short-term investments to fund our operations should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the ability of the CMO to address the deficiencies identified by the FDA; the ability of the Company's heparin supplier to address the manufacturing deficiencies identified in the warning letter for non-heparin API; the resources needed to secure approval of the NDA for DefenCath from the FDA; the risks and uncertainties of the relationships with the additional CMO and supplier of heparin; the ability to submit a supplement to CorMedix's NDA; the ability to secure final FDA approval prior to July 1, 2023 or obtain CMS approval of a resubmitted NTAP application; the risks and uncertainties associated with CorMedix's ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of DefenCath and research for additional uses for taurolidine; obtaining additional financing to support CorMedix's research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. We continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. These and other risks are described in greater detail in CorMedix's filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.

**Investor Contact:**<br> Dan Ferry<br> Managing Director<br> LifeSci Advisors<br> (617) 430-7576