UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2022

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ________ to ________

Commission file number 001-34673

CORMEDIX INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware		20-5894890
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)

300 Connell Drive, Suite 4200, Berkeley Heights, NJ		07922
(Address of Principal Executive Offices)		(Zip Code)

(908) 517-9500

(Registrant’s Telephone Number, Including Area Code)

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

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common stock, $0.001 par value		CRMD		Nasdaq Global Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The number of shares outstanding of the issuer’s common stock, as of August 8, 2022 was 41,111,277.

CORMEDIX INC. AND SUBSIDIARIES

INDEX

PART I FINANCIAL INFORMATION		1

Item 1.	Unaudited Condensed Consolidated Financial Statements	1

	Condensed Consolidated Balance Sheets as of June 30, 2022 and December 31, 2021	1

	Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2022 and 2021	2

	Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three and Six Months Ended June 30, 2022 and 2021	3

	Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2022 and 2021	5

	Notes to Unaudited Condensed Consolidated Financial Statements	6

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	23

Item 3.	Quantitative and Qualitative Disclosure About Market Risk	34

Item 4.	Controls and Procedures	35

PART II OTHER INFORMATION		36

Item 1.	Legal Proceedings	36

Item 1A.	Risk Factors	38

Item 5.	Other Information	38

Item 6.	Exhibits	39

SIGNATURES		40

PART I
FINANCIAL INFORMATION

Item 1. Unaudited Condensed Consolidated Financial Statements.

CorMedix Inc. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

	June 30, 2022			December 31, 2021
ASSETS
Current assets
Cash and cash equivalents	$	48,929,895		$	53,317,405
Restricted cash		121,214			131,567
Short-term investments		15,692,548			12,149,003
Trade receivables		-			45,368
Inventories		1,720			3,008
Prepaid research and development expenses		28,451			51,993
Other prepaid expenses and current assets		585,141			770,485
Total current assets		65,358,969			66,468,829
Property and equipment, net		1,448,305			1,474,937
Restricted cash, long-term		102,308			102,305
Operating lease right-of-use assets		838,121			899,505
TOTAL ASSETS	$	67,747,703		$	68,945,576

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable	$	2,496,074		$	2,209,552
Accrued expenses		2,648,626			3,014,156
Current portion of operating lease liabilities		127,408			121,368
Total current liabilities		5,272,108			5,345,076
Operating lease liabilities, net of current portion		736,855			802,433
TOTAL LIABILITIES		6,008,963			6,147,509

COMMITMENTS AND CONTINGENCIES (Note 4)

STOCKHOLDERS’ EQUITY
Preferred stock - $0.001 par value: 2,000,000 shares authorized; 181,622 shares issued and outstanding at June 30, 2022 and December 31, 2021		182			182
Common stock - $0.001 par value: 160,000,000 shares authorized; 41,106,777 and 38,086,437 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively		41,107			38,086
Accumulated other comprehensive gain		39,519			87,130
Additional paid-in capital		321,956,046			308,331,750
Accumulated deficit		(260,298,114	)		(245,659,081	)
TOTAL STOCKHOLDERS’ EQUITY		61,738,740			62,798,067
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$	67,747,703		$	68,945,576

See Accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

CORMEDIX INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

AND COMPREHENSIVE LOSS
(Unaudited)

	For the Three Months Ended June 30,						For the Six Months Ended June 30,
	2022			2021			2022			2021
Revenue:
Net sales	$	21,253		$	8,191		$	28,889		$	96,451
Cost of sales		(332	)		(14,426	)		(1,859	)		(75,765	)
Gross profit (loss)		20,921			(6,235	)		27,030			20,686
Operating Expenses:
Research and development		(3,209,471	)		(2,520,203	)		(5,497,058	)		(5,156,535	)
Selling, general and administrative		(5,051,895	)		(3,355,790	)		(9,802,778	)		(7,956,896	)
Total Operating Expenses		(8,261,366	)		(5,875,993	)		(15,299,836	)		(13,113,431	)
Loss From Operations		(8,240,445	)		(5,882,228	)		(15,272,806	)		(13,092,745	)
Other Income (Expense):
Interest income		35,342			3,340			49,094			7,014
Foreign exchange transaction gain (loss)		18,232			(4,233	)		8,026			(9,144	)
Interest expense, including amortization of debt discount		(3,585	)		-			(8,964	)		(5,184	)
Total Other Income (Expense)		49,989			(893	)		48,156			(7,314	)
Loss before income taxes		(8,190,456	)		(5,883,121	)		(15,224,650	)		(13,100,059	)
Tax benefit		585,617			1,250,186			585,617			1,250,186
Net Loss		(7,604,839	)		(4,632,935	)		(14,639,033	)		(11,849,873	)
Other Comprehensive Income (Loss):
Unrealized loss from investments		(1,316	)		(662	)		(35,488	)		(315	)
Foreign currency translation gain (loss)		(9,086	)		1,017			(12,123	)		(2,510	)
Total Other Comprehensive Income (Loss)		(10,402	)		355			(47,611	)		(2,825	)
Comprehensive Loss	$	(7,615,241	)	$	(4,632,580	)	$	(14,686,644	)	$	(11,852,698	)
Net Loss Per Common Share – Basic and Diluted	$	(0.19	)	$	(0.12	)	$	(0.38	)	$	(0.32	)
Weighted Average Common Shares Outstanding – Basic and Diluted		39,761,754			38,083,842			39,008,590			37,211,233

See Accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

CORMEDIX INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY

(Unaudited)

For the three months ended June 30, 2022

	Common Stock				Preferred Stock – Series C-3, Series E and Series G				Accumulated Other Comprehensive Income			Additional Paid-in		Accumulated			Total Stockholders’
	Shares		Amount		Shares		Amount		(Loss)			Capital		Deficit			Equity
Balance at March 31, 2022		38,727,979	$	38,728		181,622	$	182	$	49,921		$	312,473,623	$	(252,693,275	)	$	59,869,179

Stock issued in connection with ATM sale of common stock, net		2,378,798		2,379		-		-		-			8,408,777		-			8,411,156
Stock-based compensation		-		-		-		-		-			1,073,646		-			1,073,646
Other comprehensive loss		-		-		-		-		(10,402	)		-		-			(10,402	)
Net loss		-		-		-		-		-			-		(7,604,839	)		(7,604,839	)
Balance at June 30, 2022		41,106,777	$	41,107		181,622	$	182	$	39,519		$	321,956,046	$	(260,298,114	)	$	61,738,740

For the six months ended June 30, 2022

	Common Stock				Preferred Stock – Series C-3, Series E and Series G				Accumulated Other Comprehensive Income			Additional Paid-in		Accumulated			Total Stockholders’
	Shares		Amount		Shares		Amount		(Loss)			Capital		Deficit			Equity
Balance at December 31, 2021		38,086,437	$	38,086		181,622	$	182	$	87,130		$	308,331,750	$	(245,659,081	)	$	62,798,067

Stock issued in connection with ATM sale of common stock, net		3,020,340		3,021		-		-		-			11,412,351		-			11,415,372
Stock-based compensation		-		-		-		-		-			2,211,945		-			2,211,945
Other comprehensive loss		-		-		-		-		(47,611	)		-		-			(47,611	)
Net loss		-		-		-		-		-			-		(14,639,033	)		(14,639,033	)
Balance at June 30, 2022		41,106,777	$	41,107		181,622	$	182	$	39,519		$	321,956,046	$	(260,298,114	)	$	61,738,740

See Accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

CORMEDIX INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY

(Unaudited)

For the three months ended June 30, 2021

	Common Stock				Preferred Stock – Series C-3, Series E and Series G				Accumulated Other Comprehensive Income		Additional Paid-in		Accumulated			Total Stockholders’
	Shares		Amount		Shares		Amount		(Loss)		Capital		Deficit			Equity
Balance at March 31, 2021		38,046,092	$	38,046		181,622	$	182	$	98,826	$	304,843,806	$	(224,665,793	)	$	80,315,067

Stock issued in connection with warrants exercised, cash		7,611		7		-		-		-		39,950		-			39,957
Stock issued in connection with options exercised		32,734		33		-		-		-		137,002		-			137,035
Stock-based compensation		-		-		-		-		-		1,010,066		-			1,010,066
Other comprehensive income		-		-		-		-		355		-		-			355
Net loss		-		-		-		-		-		-		(4,632,935	)		(4,632,935	)
Balance at June 30, 2021		38,086,437	$	38,086		181,622	$	182	$	99,181	$	306,030,824	$	(229,298,728	)	$	76,869,545

For the six months ended June 30, 2021

	Common Stock				Preferred Stock – Series C-3, Series E and Series G						Accumulated Other Comprehensive Income			Additional Paid-in			Accumulated			Total Stockholders’
	Shares		Amount		Shares			Amount			(Loss)			Capital			Deficit			Equity
Balance at December 31, 2020		33,558,096	$	33,558		241,623		$	242		$	102,006		$	261,536,061		$	(217,448,855	)	$	44,223,012

Stock issued in connection with ATM sale of common stock, net		3,737,862		3,738		-			-			-			41,451,892			-			41,455,630
Stock issued in connection with warrants exercised, cash		31,407		31		-			-			-			164,855			-			164,886
Stock issued in connection with warrants exercised, cashless		70,269		70		-			-			-			(70	)		-			-
Stock issued in connection with options exercised		32,734		33		-			-			-			137,002			-			137,035
Conversion of Series G preferred shares to common stock		556,069		556		(10,001	)		(10	)		-			(546	)		-			-
Conversion of Series C-3 preferred shares to common stock		100,000		100		(50,000	)		(50	)		-			(50	)		-			-
Stock-based compensation		-		-		-			-			-			2,741,680			-			2,741,680
Other comprehensive loss		-		-		-			-			(2,825	)		-			-			(2,825	)
Net loss		-		-		-			-			-			-			(11,849,873	)		(11,849,873	)
Balance at June 30, 2021		38,086,437	$	38,086		181,622		$	182		$	99,181		$	306,030,824		$	(229,298,728	)	$	76,869,545

See Accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

CORMEDIX INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

	For the Six Months Ended June 30,
	2022			2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(14,639,033	)	$	(11,849,873	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		2,211,945			2,741,680
Change in right-of-use assets		61,383			56,350
Depreciation		40,819			24,277
Changes in operating assets and liabilities:
Decrease in trade receivables		43,738			72
Decrease in inventory		1,288			75,737
Decrease in prepaid expenses and other current assets		208,535			265,019
Increase (Decrease) in accounts payable		287,011			(184,681	)
Decrease in accrued expenses		(362,604	)		(857,924	)
Decrease in operating lease liabilities		(59,539	)		(52,983	)
Net cash used in operating activities		(12,206,457	)		(9,782,326	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of short-term investments		(14,279,033	)		(7,595,280	)
Maturity of short-term investments		10,700,000			6,879,685
Purchase of equipment		(14,187	)		(18,698	)
Net cash used in investing activities		(3,593,220	)		(734,293	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from sale of common stock from at-the-market program, net		11,415,372			41,455,630
Proceeds from exercise of warrants		-			164,886
Proceeds from exercise of stock options		-			137,035
Net cash provided by financing activities		11,415,372			41,757,551
Foreign exchange effect on cash		(13,555	)		(4,500	)
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS		(4,397,860	)		31,236,432
CASH, CASH EQUIVALENTS AND RESTRICTED CASH – BEGINNING OF PERIOD		53,551,277			42,096,783
CASH, CASH EQUIVALENTS AND RESTRICTED CASH – END OF PERIOD	$	49,153,417		$	73,333,215
Cash paid for interest	$	8,964		$	5,184
Supplemental Disclosure of Non-Cash Financing Activities:
Conversion of Series G preferred stock to common stock	$	-		$	10
Conversion of Series C-3 preferred stock to common stock	$	-		$	50
Unrealized loss from investments	$	(35,488	)	$	(315	)

See Accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

Note 1 — Organization, Business and Basis of Presentation:

Organization and Business

CorMedix Inc. (“CorMedix” or the “Company”) is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company was incorporated in the State of Delaware on July 28, 2006 and its principal executive office is located in Berkeley Heights, New Jersey. In 2013, the Company formed a wholly-owned subsidiary, CorMedix Europe GmbH and in May 2020, the Company formed a wholly-owned Spanish subsidiary, CorMedix Spain, S.L.U.

The Company’s primary focus is to develop its lead product candidate, DefenCath™, for potential commercialization in the United States, or U.S., and other key markets. The Company has in-licensed the worldwide rights to develop and commercialize DefenCath/Neutrolin®, which is a novel anti-infective solution (a formulation of taurolidine 13.5 mg/mL, and heparin 1000 USP Units/mL) intended for the reduction and prevention of catheter-related infections and thrombosis in patients requiring central venous catheters, or CVCs, in clinical settings such as hemodialysis, total parenteral nutrition, and oncology. Infection and thrombosis represent key complications among hemodialysis, total parenteral nutrition and cancer patients with CVCs. These complications can lead to treatment delays and increased costs to the healthcare system when they occur due to hospitalizations, need for intravenous, or IV, antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the CVC, related treatment costs and increased mortality. The name DefenCath is the U.S. proprietary name conditionally approved by the U.S. Food and Drug Administration, or FDA, while the name Neutrolin is currently used in the European Union, or EU, and other territories where the Company has received CE-Mark approval for the commercial distribution of Neutrolin as a catheter lock solution, or CLS, regulated as a medical device.

In January 2015, the FDA designated DefenCath as a Qualified Infectious Disease Product, or QIDP, for prevention of catheter-related blood stream infections, or CRBSIs, in patients with end stage renal disease receiving hemodialysis through a CVC. CRBSIs and clotting can be life-threatening. The QIDP designation provides five years of market exclusivity in addition to the five years granted for a New Chemical Entity, or NCE, upon approval of a New Drug Application, or NDA. In addition, in January 2015, the FDA granted Fast Track designation to DefenCath Catheter Lock Solution, a designation intended to facilitate development and expedite review of drugs that treat serious and life-threatening conditions so that the approved drug can reach the market expeditiously. The Fast Track designation of DefenCath provides the Company with the opportunity to meet with the FDA on a more frequent basis during the development process, and also ensures eligibility to request priority review of the marketing application.

In December 2015, the Company launched its Phase 3 Prospective, Multicenter, Double-blind, Randomized, Active Control Study to Demonstrate Safety & Effectiveness of DefenCath/Neutrolin in Preventing Catheter-related Bloodstream Infection in Subjects on Hemodialysis for End Stage Renal Disease, or LOCK-IT-100, in patients with hemodialysis catheters in the U.S. The clinical trial was designed to demonstrate the safety and effectiveness of DefenCath compared to the standard of care CLS, Heparin, in preventing CRBSIs. The primary endpoint for the trial assessed the incidence of CRBSI and time to CRBSI for each study subject. Secondary endpoints were catheter patency, which was defined as required use of tissue plasminogen activating factor, or tPA, or removal of catheter due to dysfunction, and removal of catheter for any reason.

As previously agreed with the FDA, an interim efficacy analysis was performed when the first 28 potential CRBSI cases were identified in our LOCK-IT-100 study that occurred through early December 2017. Based on these first 28 cases, there was a highly statistically significant 72% reduction in CRBSI by DefenCath relative to the active control of heparin (p=0.0034). Because the pre-specified level of statistical significance was reached for the primary endpoint and efficacy had been demonstrated with no safety concerns, the LOCK-IT-100 study was terminated early. The study continued enrolling and treating subjects until study termination, and the final analysis was based on a total of 795 subjects. In a total of 41 cases, there was a 71% reduction in CRBSI by DefenCath relative to heparin, which was highly statistically significant (p=0.0006), with a good safety profile.

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

The FDA granted the Company’s request for a rolling submission and review of the NDA which is designed to expedite the approval process for products being developed to address an unmet medical need. Although the FDA usually requires two pivotal clinical trials to provide substantial evidence of safety and effectiveness for approval of an NDA, the FDA will in some cases accept one adequate and well-controlled trial, where it is a large multicenter trial with a broad range of subjects and investigation sites with procedures to ensure trial quality that has demonstrated a clinically meaningful and statistically very persuasive effect on prevention of a disease with potentially serious outcome.

In March 2020, the Company began the modular submission process for the NDA for DefenCath for the prevention of CRBSI in hemodialysis patients, and in August 2020, the FDA accepted for filing the DefenCath NDA. The FDA also granted the Company’s request for priority review, which provides for a six-month review period instead of the standard ten-month review period. As announced in March 2021, the FDA informed in its Complete Response Letter, or CRL, to the Company that it could not approve the NDA for DefenCath in its present form. The FDA noted concerns at the third-party manufacturing facility after a review of records requested by the FDA and provided by the contract manufacturing organization, or CMO. Additionally, the FDA required a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.

In April 2021, the Company and the CMO met with the FDA to discuss proposed resolutions for the deficiencies identified in the CRL to the Company and the Post-Application Action Letter, or PAAL, received by the CMO from the FDA for the NDA for DefenCath. There was an agreed upon protocol for the manual extraction study identified in the CRL, which has been successfully completed. Addressing the FDA’s concerns regarding the qualification of the filling operation necessitated adjustments in the process and generation of additional data on operating parameters for manufacture of DefenCath. The Company and the CMO determined that additional process qualification was needed with subsequent validation to address these issues. The FDA did not request additional clinical data and did not identify any deficiencies related to the data submitted on the efficacy or safety of DefenCath from LOCK-IT-100. In draft labeling discussed with the FDA, the FDA added that the initial approval will be for the limited population of patients with kidney failure receiving chronic hemodialysis through a central venous catheter. This is consistent with the Company’s request for approval pursuant to the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD. LPAD, passed as part of the 21st Century Cures Act, is a new program intended to expedite the development and approval of certain antibacterial and antifungal drugs to treat serious or life-threatening infections in limited populations of patients with unmet needs. LPAD provides for a streamlined clinical development program involving smaller, shorter, or fewer clinical trials and is intended to encourage the development of safe and effective products that address unmet medical needs of patients with serious bacterial and fungal infections. The Company believes that LPAD will provide additional flexibility for the FDA to approve DefenCath to reduce CRBSIs in the limited population of patients with kidney failure receiving hemodialysis through a CVC.

On February 28, 2022, the Company resubmitted the NDA for DefenCath to address the CRL issued by the FDA. In parallel, the Company’s third-party manufacturer submitted responses to the deficiencies identified at the manufacturing facility in the PAAL issued by the FDA concurrently with the CRL. The FDA had stated that it expected all corrections to facility deficiencies to be complete at the time of resubmission so that all corrective actions may be verified during an onsite evaluation of the manufacturing facility in the next review cycle. On March 28, 2022, the Company announced that the resubmission of the NDA for DefenCath has been accepted for filing by the FDA. The FDA considers the resubmission as a complete, Class 2 response with a six-month review cycle. The CMO has notified the Company that an onsite inspection by the FDA was conducted that resulted in FORM FDA 483 observations that are being addressed. The CMO submitted responses to the inspectional observations along with a corrective action plan and requested a meeting with the FDA to discuss. The Company also has been notified by its supplier of heparin, an active pharmaceutical ingredient, or API, for DefenCath, that an inspection by the FDA for an unrelated API, has resulted in a Warning Letter due to deviations from good manufacturing practices for the unrelated API.

On August 8, 2022, the Company announced receipt of a second CRL from the FDA regarding its DefenCath NDA. The FDA stated that the DefenCath NDA cannot be approved until deficiencies conveyed to the CMO and the heparin API supplier are resolved to the satisfaction of the FDA. There were no other requirements identified by the FDA for the Company prior to resubmission of the NDA. As part of the NDA review process, the FDA has also notified the Company that although the tradename DefenCath was conditionally approved, the FDA now has identified potential confusion with another pending product name that is also under review. The ultimate acceptability of the Company’s proposed tradename is dependent upon which application is approved first. As a precaution, the Company has already submitted an alternative proprietary name to the FDA which will undergo review.

The Company also announced that it has finalized an agreement with Alcami Corporation, or Alcami, a U.S. based contract manufacturer with proven capabilities for manufacturing commercial sterile parenteral drug products. Alcami will function as a manufacturing site for DefenCath for the U.S. market, and the Company expects to be able to submit a supplement to its NDA application around the end of the first quarter of 2023 to request approval from FDA for DefenCath manufacturing. As part of the technology transfer and validation of the manufacturing process at Alcami, the Company also expects to qualify an alternate source of heparin API sourced from a major U.S. supplier.

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

The Company intends to pursue additional indications for DefenCath use as a CLS in populations with an unmet medical need that also represent potentially significant market opportunities. While the Company is 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 oncology patients using a central venous catheter.

In addition to DefenCath, the Company has sponsored a pre-clinical research collaboration for the use of taurolidine as a possible treatment for rare orphan pediatric tumors. In February 2018, the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma in children. The Company intends to seek one or more strategic partners or other sources of capital to help develop and commercialize taurolidine for the treatment of neuroblastoma in children. The Company is also evaluating opportunities for the possible expansion of taurolidine as a platform compound for use in certain medical devices. Patent applications have been filed in several indications, including wound closure, surgical meshes, and wound management. The Company will seek to establish development/commercial partnerships as these programs advance.

The Company was granted a deferral by the FDA under the Pediatric Research Equity Act, or PREA, that requires sponsors to conduct pediatric studies for 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. The Company has made a commitment to conduct the pediatric study after approval of the NDA for use in adult hemodialysis patients. Pediatric studies for an approved product conducted under PREA may qualify for pediatric exclusivity, which if granted would provide an additional six months of marketing exclusivity. DefenCath would then have the potential to receive a total marketing exclusivity period of 10.5 years, including exclusivity pursuant to NCE and QIDP.

The FDA regards taurolidine as a new chemical entity and therefore, it is currently an unapproved new drug. In the future, the Company may pursue product candidates that would involve devices impregnated with taurolidine, and the Company believes that at the current time such products would be combination products subject to device premarket submission requirements (while subject also, under review by the FDA, to the standards for drug approvability). Consequently, given that there is no appropriate predicate medical device currently marketed in the U.S. on which a 510(k) approval process could be based and that taurolidine is not yet approved in any application, the Company anticipates that it would be required to submit a premarket approval application (“PMA”) for marketing authorization for any medical device indications that we may pursue for devices containing taurolidine. In the event that an NDA for DefenCath is approved by the FDA, the regulatory pathway for these medical device product candidates may be revisited with the FDA. Although there may be no appropriate predicate, de novo Class II designation can be proposed, based on a risk assessment and a reasonable assurance of safety and effectiveness.

In the EU, Neutrolin is regulated as a Class 3 medical device. In July 2013, the Company received CE Mark approval for Neutrolin and commercially launched Neutrolin in Germany for the prevention of CRBSI, and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access in December 2013. To date, Neutrolin is registered and may be sold in certain European Union countries for such treatment.

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

In September 2014, the TUV-SUD and The Medicines Evaluation Board of the Netherlands, or MEB, granted a label expansion for Neutrolin to include use in oncology patients receiving chemotherapy, IV hydration and IV medications via CVC for the EU. In December 2014, the Company received approval from the Hessian District President in Germany to expand the label for these same expanded indications. The expansion also adds patients receiving medication and IV fluids via CVC in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). An indication for use in total parenteral nutrition was also approved.

In September 2019, the Company’s registration with the Saudi Arabia Food and Drug Administration, or the SFDA, expired. As a result, the Company cannot sell Neutrolin in Saudi Arabia and does not intend to pursue renewal of the Company’s registration with the SFDA.

As announced in May 2022, the Company has begun the process of winding down its operations in the EU and expects to discontinue Neutrolin sales in both the EU and the Middle East.

Note 2 — Summary of Significant Accounting Policies:

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, for interim financial information and with the instructions for Form 10-Q and Article 8 of Regulation S-X. Accordingly, the unaudited condensed consolidated financial statements do not include all information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary to fairly state the interim results. Interim operating results are not necessarily indicative of results that may be expected for the full year ending December 31, 2022 or for any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto of the Company which are included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 29, 2022. The accompanying consolidated balance sheet as of December 31, 2021 has been derived from the audited financial statements included in such Form 10-K.

Liquidity and Uncertainties

The condensed consolidated financial statements have been prepared in conformity with GAAP 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 June 30, 2022, the Company had an accumulated deficit of $260.3 million, and incurred net losses of $7.6 million and $4.6 million for the three months ended June 30, 2022 and 2021, respectively, and $14.6 million and $11.8 million for the six months ended June 30, 2022 and 2021, respectively. Based on the Company’s current development plans for DefenCath/Neutrolin in both the U.S. and foreign markets and its other operating requirements, the Company’s existing cash and cash equivalents and short-term investments at June 30, 2022 are expected to fund its operations at least through the third quarter of 2023.

The Company’s continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships, potential strategic transactions or out-licensing of its products in order to commercially launch DefenCath upon NDA approval and until profitability is achieved, if ever. Management can provide no assurances that such financing or strategic relationships will be available on acceptable terms, or at all. As of June 30, 2022, the Company has $38.2 million available under its At-the-Market Issuance Sales Agreement (the “ATM program”) and has $150.0 million available under its current shelf registration for the issuance of equity, debt or equity-linked securities (see Note 3).

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

The Company’s operations are subject to a number of other factors that can affect its operating results and financial condition. Such factors include, but are not limited to: the results of clinical testing and trial activities of the Company’s product candidates; the ability to obtain regulatory approval to market the Company’s products; 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.

The COVID-19 pandemic and government measures taken in response to the pandemic have had a significant impact, both direct and indirect, on businesses and commerce. In response to the COVID-19 pandemic, “shelter in place” orders and other public health guidance measures were implemented across much of the United States, Europe and Asia, including in the locations of the Company’s offices, clinical trial sites, key vendors and partners. A resurgence of the COVID-19 pandemic may impact the Company’s program timelines which could materially and adversely affect its business, financial conditions and results of operations.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with 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. Actual results could differ from those estimates.

Reclassifications

Certain reclassifications were made to the prior year’s amounts to conform to the 2022 presentation. Non-cash lease expense, as presented on the Company’s condensed consolidated statement of cash flows for the six months ended June 30, 2021, is now presented as change in right-of-use assets and change in operating lease liabilities.

Basis of Consolidation

The condensed consolidated financial statements include the accounts of the Company, CorMedix Europe GmbH and CorMedix Spain, S.L.U., its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.

Financial Instruments

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents and short-term investments. 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.

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

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 condensed consolidated statement of cash flows:

	June 30, 2022		December 31, 2021
Cash and cash equivalents	$	48,929,895	$	53,317,405
Restricted cash		223,522		233,872
Total cash, cash equivalents and restricted cash	$	49,153,417	$	53,551,277

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 and equity securities 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 the condensed consolidated statement of operations. Realized gains and losses, amortization of premiums and discounts and interest and dividends earned are included in other 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 June 30, 2022 or December 31, 2021.

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 June 30, 2022 and December 31, 2021, all of the Company’s investments had contractual maturities of less than one year. As of June 30, 2022, no allowance for credit loss was recorded. The following table summarizes the amortized cost, unrealized gains and losses and the fair value at June 30, 2022 and December 31, 2021:

	Amortized Cost		Gross Unrealized Losses			Gross Unrealized Gains		Fair Value
June 30, 2022:
Money Market Funds included in Cash Equivalents	$	6,950,998	$	(695	)	$	-	$	6,950,303
U.S. Government Agency Securities		9,122,516		(14,117	)		-		9,108,399
Corporate Securities		4,015,563		(17,398	)		-		3,998,165
Commercial Paper		2,594,919		(8,935	)		-		2,585,984
Subtotal		15,732,998		(40,450	)		-		15,692,548
Total June 30, 2022	$	22,683,996	$	(41,145	)	$	-	$	22,642,851
December 31, 2021:
Money Market Funds included in Cash Equivalents	$	10,462,877	$	(23	)	$	-	$	10,462,854
U.S. Government Agency Securities		2,806,597		(1,261	)		-		2,805,336
Corporate Securities		7,548,493		(4,467	)		1		7,544,027
Commercial Paper		1,799,548		-			92		1,799,640
Subtotal		12,154,638		(5,728	)		93		12,149,003
Total December 31, 2021	$	22,617,515	$	(5,751	)	$	93	$	22,611,857

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

Fair Value Measurements

The Company’s financial instruments recorded in the condensed 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.

The Company categorizes its financial instruments into a three-level fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. 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. Financial assets recorded at fair value on the Company’s condensed consolidated balance sheets are categorized as follows:

●

Level 1 inputs—Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.

●

Level 2 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).

●

Level 3 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.

The following table provides the carrying value and fair value of the Company’s financial assets measured at fair value on a recurring basis as of June 30, 2022 and December 31, 2021:

	Carrying Value		Level 1		Level 2		Level 3
June 30, 2022:
Money Market Funds and Cash Equivalents	$	6,950,303	$	6,950,303	$	-	$	-
U.S. Government Agency Securities		9,108,399		9,108,399		-
Corporate Securities		3,998,165		-		3,998,165		-
Commercial Paper		2,585,984		-		2,585,984		-
Subtotal		15,692,548		9,108,399		6,584,149	$	-
Total June 30, 2022	$	22,642,851	$	16,058,702	$	6,584,149	$	-
December 31, 2021:
Money Market Funds and Cash Equivalents	$	10,462,854	$	10,462,854	$	-	$	-
U.S. Government Agency Securities		2,805,336		2,805,336		-
Corporate Securities		7,544,027		-		7,544,027		-
Commercial Paper		1,799,640		-		1,799,640		-
Subtotal		12,149,003		2,805,336		9,343,667		-
Total December 31, 2021	$	22,611,857	$	13,268,190	$	9,343,667	$	-

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

Foreign Currency Translation and Transactions

The condensed consolidated financial statements are presented in U.S. Dollars, or 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, 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 period in which the income and expenses were recognized. Translation gains and losses are included in other comprehensive income (loss). The Company had a foreign currency translation loss of $9,000 and a gain of $1,000 for the three months ended June 30, 2022 and 2021, respectively.

The Company has intercompany loans between the parent company based in New Jersey and its German subsidiary. The intercompany loans outstanding are not expected to be repaid in the foreseeable future and unrealized foreign exchange movements related to long-term intercompany loans are recognized in other comprehensive income (loss).

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

As of June 30, 2022 and December 31, 2021, the Company has restricted cash in connection with the patent and utility model infringement proceedings against TauroPharm (see Note 4). The Company was required by the District Courts of Mannheim to provide security deposit to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. The Company furthermore had to provide a deposit for the first and second instances, respectively, in connection with the unfair competition proceedings in Cologne. As of June 30, 2022 and December 31, 2021, restricted cash in connection with the patent and utility model infringement proceedings were $121,000 and $132,000, respectively.

As of June 30, 2022, the Company had $102,000 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, preclinical 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.

Inventories

Inventories are valued at the lower of cost or net realizable value on a first in, first out basis. Inventories consist of raw materials (including labeling and packaging), work-in-process, and finished goods, if any, for the DefenCath/Neutrolin product. Inventories consist of the following:

		June 30, 2022				December 31, 2021
Finished goods		$	1,720			$	3,008

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

Leases

The Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right-of-use, or ROU, assets, current portion of operating lease liabilities, and operating lease liabilities, net of current portion, on the condensed consolidated balance sheet.

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. Lease 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 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.

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.

Accrued Expenses

Accrued expenses consist of the following:

	June 30, 2022		December 31, 2021
Professional and consulting fees	$	589,885	$	311,408
Accrued payroll and payroll taxes		1,787,260		2,508,398
Manufacturing development related		186,539		99,614
Other		84,942		94,736
Total	$	2,648,626	$	3,014,156

Revenue Recognition

The Company recognizes revenue in accordance with ASC 606, “Revenue from Contracts with Customers.” ASC 606 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.

The Company recognizes net sales upon shipment of product and upon meeting the five-step model prescribed by ASC 606 outlined above.

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

Loss Per Common Share

Basic loss per common share excludes any potential 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 entity. However, since their effect is anti-dilutive, the Company has excluded potentially dilutive shares. The following potentially dilutive shares have been excluded from the calculation of diluted net loss per share as their effect would be anti-dilutive.

	Six Months Ended June 30,
	2022		2021
	(Number of Shares of Common Stock Issuable)
Series C non-voting preferred stock		4,000		4,000
Series E non-voting preferred stock		391,953		391,953
Series G non-voting preferred stock		5,004,069		5,004,069
Shares issuable for payment of deferred board compensation		48,909		48,909
Shares underlying outstanding warrants		56,455		56,455
Shares underlying outstanding stock options		4,433,285		3,765,746
Restricted stock units		207,469		-
Total potentially dilutive shares		10,146,140		9,271,132

Stock-Based Compensation

Share-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. 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. For each restricted stock units, the fair value was estimated to be the closing price of the Company’s common stock on each date of grant.

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, facilities expenses and costs related to the manufacturing of the product that could potentially be available to support the commercial launch prior to marketing approval. The Company accrues for costs incurred as the services are being provided by monitoring the status of the activities and the invoices received from its external service providers. Costs 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.

Note 3 — Stockholders’ Equity:

Common Stock

In 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 $100.0 million of shares of its common stock. On November 27, 2020, the Company entered into an Amended and Restated At Market Issuance Sales Agreement (“Amended Sales Agreement”) with FBR Securities, Inc. (formerly known as B. Riley FBR Inc.) and Needham & Company, LLC, as sales agents. The Amended Sales Agreement relates to the sale of shares of the Company’s common stock under its at-the-market program (“ATM program”), of which the Company may issue and sell common stock from time to time through the sales agents, 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 from the sale of common stock sold under the ATM program. The Company allocated to its ATM program an aggregate of $50.0 million out of the $100.0 million total under the 2020 Shelf Registration leaving a balance of $50.0 million as of June 30, 2021.

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

On August 12, 2021, the Company entered into an At 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 $50.0 million, 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 agent’s 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 from the sale of common stock sold under the ATM program. Additionally, on August 12, 2021, the Company filed a new shelf registration statement (the “2021 Shelf Registration”) for the issuance of up to $150.0 million of shares of its common stock.

During the six months ended June 30, 2022 and 2021, the Company sold an aggregate of 3,020,340 and 3,737,862 shares of its common stock under the ATM program, respectively, and realized net proceeds of $11,415,000 and $41,456,000, respectively.

As of June 30, 2022, the Company has $38.2 million available under its ATM program with Truist Securities, Inc. and JMP Securities LLC, and it has $150.0 million available under the 2021 Shelf Registration for the issuance of equity, debt or equity-linked securities.

During the six months ended June 30, 2021, the Company issued an aggregate of 656,069 shares of its common stock upon conversion of 50,000 Series C-3 preferred shares by an unrelated party and 10,001 Series G preferred shares by a related party.

During the six months ended June 30, 2021, the Company issued an aggregate of 31,407 shares of its common stock, upon cash exercise of warrants, resulting in net proceeds to the Company of $165,000.

During the six months ended June 30, 2021, the Company issued an aggregate of 70,269 shares of its common stock upon cashless exercise of 95,286 warrants.

During the six months ended June 30, 2021, the Company issued an aggregate of 32,734 shares of its common stock upon exercise of stock options, resulting in net proceeds to the Company of $137,000.

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 (the “Board”) 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 and designated by the Company’s Board, all with par value of $0.001 per share, the following are outstanding:

	As of June 30, 2022						As of December 31, 2021
	Preferred Shares Outstanding		Liquidation Preference (Per Share)		Total Liquidation Preference		Preferred Shares Outstanding		Liquidation Preference (Per Share)		Total Liquidation Preference
Series C-3		2,000	$	10.00	$	20,000		2,000	$	10.00	$	20,000
Series E		89,623	$	49.20	$	4,409,452		89,623	$	49.20	$	4,409,452
Series G		89,999	$	187.36	$	16,862,213		89,999	$	187.36	$	16,862,213
Total		181,622			$	21,291,665		181,622			$	21,291,665

During the six months ended June 30, 2021, 50,000 Series C-3 preferred shares was converted into 100,000 shares of the Company’s common stock by an unrelated party and 10,001 Series G preferred shares was converted into 556,069 shares of the Company’s common stock by a related party.

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

Stock Options

During the six months ended June 30, 2022 and 2021, the Company granted ten-year qualified and non-qualified stock options covering an aggregate of 1,377,850 and 1,389,700 shares of the Company’s common stock under the 2019 Stock Incentive Plan, respectively. The weighted average exercise price of these options is $3.73 and $8.48 per share, respectively.

During the three and six months ended June 30, 2022, total compensation expense for stock options issued to employees, directors, officers and consultants was $1,024,000 and $2,162,000, respectively, and $1,010,000 and $2,742,000 for the three and six months ended June 30, 2021, respectively.

As of June 30, 2022, there was approximately $5,962,000 in total unrecognized compensation expense related to stock options granted, which expense will be recognized over an expected remaining weighted average period of 1.6 years.

The fair value of each stock option award estimated on the grant date is determined using the Black-Scholes option pricing model. The following assumptions were used for the Black-Scholes option pricing model for the stock options granted during the six months ended June 30, 2022:

Expected term	5 years
Volatility weighted average		101.17	%
Dividend yield weighted average		0.0	%
Risk-free interest rate weighted average		2.30	%
Weighted average grant date fair value of options granted during the period	$	2.82

The Company estimated the expected term of the stock options granted based on anticipated exercises in future periods. The expected term of the stock options granted 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. 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.

Restricted Stock Units

On May 10, 2022, the Company granted 207,469 restricted stock units (“RSUs”) to its chief executive officer under its 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.

During the three and six months ended June 30, 2022, compensation expense recorded for the RSUs was $50,000. Unrecognized compensation expense for these RSUs amounted to $651,000. The expected weighted average period for the expense to be recognized is 1.6 years.

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

Warrants

During the six months ended June 30, 2021, the Company issued an aggregate of 31,407 shares of its common stock, upon cash exercise of warrants, resulting in net proceeds to the Company of $165,000. There were no cash exercises of warrants during the six months ended June 30, 2022.

During the six months ended June 30, 2021, the Company issued an aggregate of 70,269 shares of its common stock upon cashless exercise of 95,286 warrants. There were no cashless exercises of warrants during the six months ended June 30, 2022.

As of June 30, 2022, there were 56,455 outstanding warrants with a weighted average exercise price of $5.25 per share and a weighted average remaining contractual life of 0.11 years.

Note 4 — Commitments and Contingencies:

Contingency Matters

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. 2:21-cv014020-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. The complaint names as defendants the Company, Khoso Baluch, Matthew David, Phoebe Mounts, John L. Armstrong, Robert Cook, Janet Dillione, Alan W. Dunton, Myron Kaplan, Steven Lefkowitz, Paulo F. Costa, and Greg Duncan, as well as two underwriters of the Company’s secondary stock offering, B. Riley Securities, Inc. and Needham & Company, LLC. The purported bases for these claims are alleged misstatements and omissions in connection with the NDA submitted to the FDA for DefenCath, and the subsequent notification by the FDA that the NDA could not be approved in its present form. The lead plaintiff purports to assert the Exchange Act claims on behalf of persons that purchased or otherwise acquired shares of the Company’s securities between October 16, 2019, and September 6, 2021, and purports to assert the Securities Act claims on behalf of persons that purchased shares of the Company’s securities pursuant or traceable to a secondary offering of stock that commenced on November 27, 2020. The Company intends to vigorously contest such claims and filed a motion to dismiss the current complaint in full, with prejudice, on February 21, 2022. As of this filing, the parties are adhering to the current schedule set by the Court: the Company and the other defendants refiled their motions to dismiss on March 28, 2022, the lead plaintiff filed an opposition to the Defendants’ motions to dismiss on April 27, 2022 and Defendants filed their reply brief on May 26, 2022.

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”). 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 Company intends 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.

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

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 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. The Board will consider the Letter at an appropriate time, as circumstances warrant, as it continues to monitor the progress of the Derivative Litigation.

On September 9, 2014, the Company filed in the District Court of Mannheim, Germany, a patent infringement action against TauroPharm GmbH and Tauro-Implant GmbH as well as their respective CEOs (the “Defendants”) claiming infringement of the Company’s European Patent EP 1 814 562 B1, which was granted by the European Patent Office (the “EPO”) on January 8, 2014 (the “Prosl European Patent”). The Prosl European Patent covers the formulation of taurolidine and citrate with low dose heparin in a catheter lock solution for maintaining patency and preventing infection in hemodialysis catheters. In this action, the Company claims that the Defendants infringe on the Prosl European Patent by manufacturing and distributing catheter locking solutions to the extent they are covered by the claims of the Prosl European Patent. The Company believes that its patent is sound and is seeking injunctive relief and raising claims for information, rendering of accounts, calling back, destruction and damages. Separately, TauroPharm has filed an opposition with the EPO against the Prosl European Patent alleging that it lacks novelty and inventive step. The Company cannot predict the ultimate outcome of either of these related matters. At present, the EPO has revoked the Prosl European Patent as invalid, and the Company has filed an appeal, which is currently pending.

In the same complaint against the same Defendants, the Company also alleged an infringement (requesting the same remedies) of ND Partners’ utility model DE 20 2005 022 124 U1 (the “Utility Model”), which the Company believes is fundamentally identical to the Prosl European Patent in its main aspects and claims. The Court separated the two proceedings and the Prosl European Patent and the Utility Model claims were tried separately. TauroPharm has filed a cancellation action against the Utility Model before the German Patent and Trademark Office (the “German PTO”) based on the similar arguments as those in the opposition against the Prosl European Patent.

The Court issued its decisions on May 8, 2015, staying both proceedings. In its decisions, the Court found that the commercialization by TauroPharm in Germany of its TauroLock catheter lock solutions Hep100 and Hep500 infringes both the Prosl European Patent and the Utility Model and further that there is no prior use right that would allow TauroPharm to continue to make, use or sell its product in Germany. However, the Court declined to issue an injunction in favor of the Company that would preclude the continued commercialization by TauroPharm based upon its finding that there is a sufficient likelihood that the EPO, in the case of the Prosl European Patent, or the German PTO, in the case of the Utility Model, may find that such patent or utility model is invalid. Specifically, the Court noted the possible publication of certain instructions for product use that may be deemed to constitute prior art. As such, the District Court determined that it will defer any consideration of the request by the Company for injunctive and other relief until such time as the EPO or the German PTO made a final decision on the underlying validity of the Prosl European Patent and the Utility Model.

The opposition proceeding against the Prosl European Patent before the EPO is ongoing. The EPO held a hearing in the opposition proceeding on November 25, 2015. However, the EPO did not issue a decision at the end of the hearing but adjourned the matter due to the fact that the panel was of the view that Claus Herdeis, one of the managing directors of TauroPharm, had to be heard as a witness in a further hearing in order to close some gaps in the documentation presented by TauroPharm as regards the publication of the prior art.

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

The German PTO held a hearing in the validity proceedings relating to the Utility Model on June 29, 2016, at which the panel affirmed its preliminary finding that the Utility Model was invalid based upon prior publication of a reference to the benefits that may be associated with adding heparin to a taurolidine based solution. The Company filed an appeal against the ruling on September 7, 2016. An oral hearing was held on September 17, 2019 in which the German Federal Patent Court affirmed the first instance decision that the Utility Model was invalid. The decision has only a declaratory effect, as the Utility Model had expired in November 2015. On April 28, 2020, the Company filed a withdrawal of the complaint on the German utility model, thereby waiving its claims on these proceedings. The proceedings were closed and during the year ended December 31, 2020, final reimbursement of approximately $30,000 for the costs in connection with the utility model infringement were paid to TauroPharm.

On November 22, 2017, the EPO in Munich, Germany held a further oral hearing in this matter. At the hearing, the panel held that the Prosl European Patent would be invalidated because it did not meet the requirements of novelty based on a technical aspect of the European intellectual property law. The Company disagrees with this decision and has appealed the decision. The Company continues to believe that the Prosl European Patent is indeed novel and that its validity should be maintained. There can be no assurance that the Company will prevail in this matter. A hearing has been scheduled for October 27, 2022 by the EPO Board of Appeals.

On January 16, 2015, the Company filed a complaint against TauroPharm GmbH and its managing directors in the District Court of Cologne, Germany. In the complaint, the Company alleged violation of the German Unfair Competition Act by TauroPharm and that TauroPharm is improperly and unfairly using its proprietary information relating to the composition and manufacture of Neutrolin, in the manufacture and sale of TauroPharm’s products TauroLock^TM, TauroLock-HEP100 and TauroLock-HEP500. The Company sought a cease and desist order against TauroPharm from continuing to manufacture and sell any product containing taurolidine (the active pharmaceutical ingredient (“API”) of Neutrolin) and citric acid in addition to possible other components, damages for any sales in the past and the removal of all such products from the market. Hearings in this matter were held in the District Court of Cologne, Germany on November 19, 2015, on November 15, 2016 and on November 20, 2018. A decision was rendered by the court on December 11, 2018, dismissing the complaint in its entirety. The Company therefore appealed in January 2019. An oral hearing was held on September 6, 2019. In view of new arguments brought forward in this hearing, the Court issued an evidentiary order on September 27, 2019 ordering an expert opinion. The expert opinion was not in the Company’s favor. In a supplementary expert opinion submitted after the Company had brought forward arguments against the first expert opinion, the expert confirmed his view. In an oral hearing held on June 18, 2021, the Court only heard from the expert, and the Court, as well as both parties, asked further questions to the expert around his expert opinion. At the end of the hearing and internal deliberation among the panel of judges, the Court indicated that it would dismiss the complaint of the Company, if the Company did not withdraw the appeal. As there were no advantages to further pursuing the matter in view of the Court’s statements, the Company withdrew the appeal and the proceedings are therefore now closed. TauroPharm requested an increase of the value in dispute determined by the Court in order to receive a higher reimbursement of costs (as this is based on the value in dispute under German law) but the request was rejected in view of arguments brought forward against it by legal counsel of the Company. The Company reimbursed costs in the amount of approximately $41,000 plus interest to TauroPharm.

In connection with the aforementioned patent and utility model infringement and unfair competition proceedings against TauroPharm, the Company was required by the District Courts of Mannheim and Cologne to provide security deposits to cover legal fees in the event TauroPharm is entitled to reimbursement of these costs. As of June 30, 2022, the aggregate deposit was approximately $121,000, which the Company recorded as restricted cash on the condensed consolidated balance sheets.

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

Commitments

In-Licensing

In 2008, the Company entered into a License and Assignment Agreement (the “NDP License Agreement”) with ND Partners, LLP (“NDP”). Pursuant to the NDP 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”). The Company acquired such licenses and patents through its assignment and assumption of NDP’s rights under certain separate license agreements by and between NDP and Dr. Hans-Dietrich Polaschegg, Dr. Klaus Sodemann and Dr. Johannes Reinmueller. 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 payments to NDP upon the achievement of certain regulatory and sales-based milestones. Certain of the milestone payments are to be made in the form of shares of common stock currently held in escrow for NDP, and other milestone payments are to be paid in cash. The maximum aggregate number of shares issuable upon achievement of milestones is 29,109 shares. In 2014, a certain milestone was achieved resulting in the release of 7,277 shares held in escrow. The number of shares held in escrow as of June 30, 2022 is 21,832 shares of common stock. The maximum aggregate amount of cash payments due upon achievement of milestones is $3,000,000 with the balance being $2,500,000 as of June 30, 2022 and 2021. Events that trigger milestone payments include but are not limited to the reaching of various stages of regulatory approval and upon achieving certain worldwide net sales amounts. There were no milestones achieved during the quarters ended June 30, 2022 and 2021.

The NDP License Agreement may be terminated by the Company on a country-by-country basis upon 60 days prior written notice. If the NDP License Agreement is terminated by either party, the Company’s rights to the NDP Technology will revert back to NDP.

Note 5 — 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. The lease agreement, with a monthly average cost of approximately $17,000 commenced in September 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 Company elected to apply the short-term practical expedient to the office lease. The Company also has an operating lease for office equipment.

CORMEDIX INC. AND SUBSIDIARIES

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS, Continued

Operating lease expense in the Company’s condensed consolidated statements of operations and comprehensive loss for the three months and six months ended June 30, 2022 was approximately $52,000 and $104,000, respectively, and $52,000 and $105,000 for the three and six months ended June 30, 2021, respectively, which includes costs associated with leases for which ROU assets have been recognized as well as short-term leases.

At June 30, 2022, the Company has a total operating lease liability of $864,000, of which $127,000 was classified as operating lease liabilities, short-term and $737,000 was classified as operating lease liabilities, net of current portion, on the condensed consolidated balance sheet. At December 31, 2021, the Company’s total operating lease liability was $924,000 of which $122,000 was classified as operating lease liabilities, short-term and $802,000 was classified as operating lease liabilities, net of current portion, on the condensed consolidated balance sheet. Operating ROU assets as of June 30, 2022 and December 31, 2021 are $838,000 and $900,000, respectively.

For the three and six months ended June 30, 2022, cash paid for amounts included in the measurement of lease liabilities in operating cash flows from operating leases was $50,000 and $100,000, respectively, and $45,000 and $97,000 for the three and six months ended June 30, 2021, respectively.

The weighted average remaining lease term as of June 30, 2022 and 2021 were 5.3 and 6.3 years, respectively, and the weighted average discount rate for operating leases was 9% at June 30, 2022 and 2021.

As of June 30, 2022, maturities of lease liabilities were as follows:

2022 (excluding the six months ended June 30, 2022)	$	100,000
2023		202,000
2024		205,000
2025		208,000
2026 and thereafter		380,000
Total future minimum lease payments		1,095,000
Less imputed interest		(231,000	)
Total	$	864,000

Note 6 — Concentrations:

At June 30, 2022, there were no net accounts receivable from a customer that exceeded 10% of the Company’s accounts receivable and at December 31, 2021, one customer had exceeded 10% of the Company’s accounts receivable (100%). During the three months ended June 30, 2022, the Company had revenue from two customers that exceeded 10% of its total sales, 79% and 14%. During the six months ended June 30, 2022, the Company had revenue from two customers that each exceeded 10% of its total sales 66% and 23%. During the three months ended June 30, 2021, the Company had revenue from two customers that exceeded 10% of its total sales, 64% and 32%. During the six months ended June 30, 2021, the Company had revenue from three customers that each exceeded 10% of its total sales 43%, 26% and 13%.

Note 7 — Subsequent Events:

On August 1, 2022, the Center for Medicare & Medicaid Services, or CMS, published in the Federal Register the conditional New Technology Add on Payment, or NTAP, reimbursement for DefenCath of $4,387.50 per average hospital stay, which assumes 3 vials of DefenCath utilized for catheter locks following 3 dialysis sessions. The NTAP is conditioned upon DefenCath obtaining final FDA approval of the NDA prior to July 1, 2023, and would take effect in the first calendar quarter following the FDA approval of the NDA. NTAP reimbursement would be specific to hospital inpatient utilization of DefenCath, and the $1,462.50 per vial reimbursement is derived from an expected wholesale acquisition cost, or WAC, price of $1,950.00 per vial. The WAC price of a pharmaceutical is essentially the gross list price for a drug product, and not necessarily representative of the ultimate net price charged to a hospital, institution or clinic. The Company intends to submit a duplicate NTAP application to CMS this October, in order to preserve its ability to obtain a new NTAP, should final FDA approval not be obtained prior to July 1, 2023.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our 2021 Annual Report on Form 10-K, filed with the Securities and Exchange Commission, or the SEC, on March 29, 2022.

Forward Looking Statements

This Quarterly Report on Form 10-Q contains “forward-looking statements” that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Quarterly Report on Form 10-Q that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, referred to herein as the Exchange Act. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would” and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section titled “Risk Factors” included in our most recent annual report on Form 10-K, as well as any amendments thereto, as filed with the SEC and which are incorporated herein by reference. Furthermore, such forward-looking statements speak only as of the date of this report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. Set forth below is a summary of the principal risks we face:

	●	We have a history of operating losses, expect to incur additional operating losses in the future, and may never be profitable;

	●	Our cost of operations could increase significantly more than what we expect depending on the costs to complete our development program for DefenCath and Neutrolin;

	●	We will need to finance our future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. Any additional funds that we obtain may not be on terms favorable to us or our stockholders and may require us to relinquish valuable rights;

	●	The NDA for DefenCath, our lead product candidate, cannot be resubmitted for FDA approval, until the CMO and our heparin supplier address inspectional observations to the satisfaction of the FDA, which may be delayed and cannot be guaranteed;

●

Our third-party contract manufacturers and suppliers are subject to regulatory inspections and any compliance action taken by the FDA, even if unrelated to our product, could impact the timing of DefenCath approval or ongoing commercial supply and may be unable to address the deficiencies identified by the FDA;

	●	Our only product Neutrolin is only approved in Europe and is still in development in the United States, we do not have, and may never obtain, the regulatory approvals we need to market our product candidates outside of the European Union;

	●	Final approval by regulatory authorities of our product candidates for commercial use may be delayed, limited or prevented, any of which would adversely affect our ability to generate operating revenues;

	●	Successful development and commercialization of our other products is uncertain;

	●	If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business;

	●	The successful commercialization of DefenCath will depend on obtaining coverage and reimbursement for use of DefenCath from third-party payors;

●

Changes in funding for the FDA and other government agencies or future government shutdowns or disruptions could cause delays in the submission and regulatory review of marketing applications, which could negatively impact our business or prospects;

	●	The ongoing COVID-19 pandemic, or other pandemic, epidemic or outbreak of an infectious disease may materially and adversely impact our business, including our preclinical studies and clinical trials;

	●	Clinical trials required for our product candidates may be expensive and time-consuming, and their outcome is uncertain;

	●	Even if approved, our products will be subject to ongoing government regulation and regulatory approvals;

●

SEC Form 10-Q filed by CorMedix Inc.